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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended March 31, 2022
OR
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number 001-38596
REPLIMUNE GROUP, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
82-2082553
(I.R.S. Employer
Identification No.)
500 Unicorn Park Drive
rd
3 Floor
Woburn MA 01801
(Address of principal executive offices)
(Zip Code)
(781) 222-9600
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $0.001 per share
Trading Symbol(s)
REPL
Name of each exchange on which registered
The Nasdaq Stock Market LLC (Nasdaq Global
Select Market)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No x
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See
the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
Emerging growth company
☒
☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No x
The aggregate market value of the Common Stock held by non-affiliates of the registrant was approximately $620.3 million, based on the closing price of the registrant’s Common
Stock on September 30, 2021, the last business day of the registrant’s most recently completed second fiscal quarter.
There were 49,069,995 shares of Common Stock outstanding as of May 16, 2022.
DOCUMENTS INCORPORATED BY REFERENCE
The registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended March 31, 2022. Portions of such definitive
proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K.
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REPLIMUNE GROUP, INC.
ANNUAL REPORT ON FORM 10-K
For the Year Ended March 31, 2022
Table of Contents
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Business
Risk factors
Unresolved staff comments
Properties
Legal proceedings
Mine safety disclosures
Market for registrant’s common equity, related stockholder matters and issuer purchases of equity securities
Reserved
Management’s discussion and analysis of financial condition and results of operations
Item 7A.
Quantitative and qualitative disclosures about market risk
Item 8.
Item 9
Item 9A.
Item 9B
Item 9C
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
SIGNATURES
Financial statements and supplementary data
Changes in and disagreements with accountants on accounting and financial disclosures
Controls and procedures
Other Information
Disclosure regarding foreign jurisdictions that prevent inspections
Directors, executive officers and corporate governance
Executive compensation
Security ownership of certain beneficial owners and management and related stockholder matters
Certain relationships and related transactions, and director independence
Principal accountant fees and services
Exhibits and financial statement schedules
10-K summary
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Special note regarding forward-looking statements
This Annual Report on Form 10-K contains forward-looking statements concerning our business, operations and financial performance and
condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained
herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify these forward-looking
statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,”
“predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking
statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to
differ materially from those indicated in these statements. We believe these factors include, among other things:
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the timing, progress, and results of preclinical studies and clinical trials for our product candidates, including the timing of initiation and
completion of studies or trials and related preparatory work and the period during which the results of the trials will become available;
our ability to obtain additional funding as necessary;
the timing, scope or likelihood of regulatory filings and approvals, including timing of our Biologics License Application, or BLA, and filing
for, and final approval by the U.S. Food and Drug Administration, or the FDA, of, RP1 or any of our other product candidates;
the timing, scope, or likelihood of foreign regulatory filings and approvals;
our ability to develop our product candidates for use in combination with other checkpoint blockade therapies, including anti-PD-1;
our ability to develop and advance any future product candidates into, and successfully complete, clinical trials;
our expectations regarding the size of the patient populations for RP1, RP2 and/or RP3 or any other product candidates from our RPx
platform if approved for commercial use;
our ability to successfully complete transfer of our product manufacturing to our in-house manufacturing facility from our contract
manufacturers including comparability analysis and to qualify, obtain approval for, and maintain successful operation, approval and
qualification of our in-house manufacturing operations;
our ability to obtain and maintain sufficient quantities of raw material supplies or access single or limited sources of goods or services needed
to build or maintain our product candidate supplies or otherwise operate our in-house manufacturing facility;
the costs of operating our in-house manufacturing facility;
our estimates regarding expenses and capital requirements;
the implementation of our business model and our strategic plans for our business, RP1 and our other product candidates;
the rate and degree of market acceptance and clinical utility of RP1 and our other product candidates;
the potential benefits of and our ability to establish or maintain future collaborations or strategic relationships;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights
covering RP1 and our other product candidates, claims others may make regarding rights in our intellectual property, and any potential
infringement, misappropriation or other violation of any third-party intellectual property rights;
our competitive position, and developments and projections relating to our competitors and our industry;
negative developments in the field of immuno-oncology;
the impact of laws and regulations;
the impact of the COVID-19 coronavirus, or COVID-19, as a global pandemic and related public health, travel, and supply chain issues;
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the impact of the Russian - Ukrainian conflict on the global economy and related governmental imposed sanctions;
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of
2012; and
the other risks and uncertainties described under “Risk factors.”
The forward-looking statements made in this Annual Report on Form 10-K relate only to events as of the date on which the statements are made.
These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this Annual
Report on Form 10-K. Moreover, we operate in a competitive and rapidly changing environment. New risks and uncertainties emerge from time to time,
and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Annual
Report on Form 10-K. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information,
future developments or otherwise, except to the extent required by applicable law. You should not rely on forward-looking statements as predictions of
future events. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements.
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Item 1. Business
Overview
PART I
We are a clinical-stage biotechnology company committed to applying our leading expertise in the field of oncolytic immunotherapy to transform the
lives of cancer patients through our novel tumor-directed oncolytic immunotherapies. Our proprietary tumor-directed oncolytic immunotherapy product
candidates are designed and intended to maximally activate the immune system against cancer.
Oncolytic immunotherapy is an emerging drug class, which we intend to establish as the second cornerstone of immune-based cancer treatments,
alongside checkpoint blockade. Oncolytic immunotherapy exploits the ability of certain viruses to selectively replicate in and directly kill tumors, as well
as induce a potent, patient-specific, anti-tumor immune response. Our product candidates incorporate multiple mechanisms of action into a practical “off-
the-shelf” approach that is intended to maximize the immune response against a patient’s cancer and to offer significant advantages over other approaches
to inducing anti-tumor immunity, including personalized vaccine approaches. We believe that the bundling of multiple approaches for the treatment of
cancer into single therapies will increase clinical efficacy and simplify the development path of our product candidates, while also improving patient
outcomes at a lower cost to the healthcare system than the use of multiple different drugs.
Our proprietary RPx platform is based on a proprietary, engineered strain of herpes simplex virus 1, or HSV-1, backbone with payloads added to
maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a unique dual local and systemic
mechanism of action, or MOA, consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor-derived antigens and
altering of the tumor microenvironment, or TME, to ignite a strong and durable systemic response. This MOA is expected to be synergistic with most
established and experimental cancer treatment modalities, and, with an attractive safety profile, the RPx platform is expected to have the versatility to be
developed alone or combined with a variety of other treatment options. We currently have three RPx product candidates in our development pipeline, RP1
(vusolimogene oderparepvec), our lead product candidate, RP2 and RP3. Although our fiscal year runs from April 1st - March 31st, our programs and
program updates are reported on a calendar year basis.
We are conducting a number of clinical trials of RP1, both as a monotherapy and in combination with anti-PD-1 therapy, with a focus on immune-
responsive tumors. We are actively enrolling patients in a randomized, controlled Phase 2 clinical trial of RP1 with cutaneous squamous cell carcinoma, or
CSCC, RP1’s lead indication, which is referred to herein as CERPASS or the CERPASS trial, under an agreement with our partner Regeneron
Pharmaceuticals, Inc., or Regeneron. CERPASS is a registration directed clinical trial evaluating RP1 in combination with cemiplimab, an anti-PD-1
therapy developed by Regeneron, versus cemiplimab alone. CERPASS is enrolling approximately 180 evaluable patients with locally advanced or
metastatic CSCC who are naïve to anti-PD1 therapy. The CERPASS trial will evaluate complete response, or CR rate, and overall response rate, or ORR, as
its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival, or PFS, and overall
survival, or OS, as secondary endpoints. Regeneron has granted to us a non-exclusive royalty-free license to cemiplimab for use in this trial, is funding one-
half of the clinical trial costs, and is supplying cemiplimab at no cost. If the CERPASS trial generates compelling clinical data demonstrating the benefits of
the combined treatment, we believe the data could support a filing with regulatory authorities seeking marketing approval. We expect to complete
enrollment of the CERPASS trial in mid-year 2022 and for the primary data analysis to be triggered six months thereafter with top line data to be released
in early 2023.
We continue our collaboration with Bristol-Myers Squibb Company, or BMS, under which BMS has granted us a non-exclusive, royalty-free license
to, and is supplying at no cost, its anti-PD-1 therapy, nivolumab, for use in combination with RP1 in a multi-cohort Phase 1/2 clinical trial, which is
referred to herein as IGNYTE, or the IGNYTE trial. There are four tumor specific cohorts currently enrolling in the IGNYTE trial including a registration
directed Phase 2 expansion cohort enrolling 125 patients with anti-PD-1 failed cutaneous melanoma who are being treated with RP1 in combination with
nivolumab. The additional three cohorts are in non-melanoma skin cancers, or NMSC, which includes patients with both naïve and anti-PD-1 failed
disease, in anti-PD-1 failed microsatellite instability high, or MSI-H/dMMR tumors (which we recently changed by protocol amendment from anti-PD1
naïve disease), and in anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC.
We initiated the registration directed Phase 2 expansion cohort in the IGNYTE trial enrolling 125 patients with anti-PD-1 failed cutaneous melanoma
after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30
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patients with melanoma, which demonstrated the tolerability and clinical activity of the combination of RP1 and nivolumab in patients with melanoma,
including those who had failed prior anti-PD-1 when given alone or in combination with CTLA-4 blockade. In March 2021, we held a Type B meeting with
the FDA to discuss the design of the 125 patient expansion cohort in the IGNYTE trial. In this meeting, the FDA expressed that while a randomized
controlled clinical trial would always be preferred for registration purpose, that in this patient population with no clear standard of care, if the clinical data
is sufficiently compelling then the data could be considered for submission by the FDA under the accelerated approval pathway. The FDA also indicated
that a randomized confirmatory trial would also be needed as is required under the accelerated approval pathway. The design of the confirmatory trial is
intended to be discussed with the FDA prior to a BLA submission. In March 2022, we released updated data showing that RP1 combined with nivolumab
continues to demonstrate deep and durable responses in patients with melanoma, including a 37.5% overall response rate in anti-PD-1 failed disease. We
expect to release initial directional data from the first 75 patients with six month follow up in late 2022. In order to document sufficient durability of
response, an important secondary endpoint of the study, the primary analysis upon which a filing is intended to be made is expected to be triggered 12
months following the last patient being enrolled.
We continue to enroll patients in our three additional IGNYTE Phase 2 cohorts under our collaboration with BMS in which we are evaluating RP1 in
combination with nivolumab. In NMSC, enrollment in the anti-PD-1 naïve NMSC cohort has completed, included patients with cutaneous squamous cell
carcinoma, or CSCC, basal cell carcinoma, or BCC, merkel cell carcinoma, or MCC, and angiosarcoma. Updated data from the CSCC patients in the anti-
PD-1 naïve NMSC cohort, presented in March 2022, continued to show nearly half of the patients achieving a complete response and nearly 65% achieving
a complete or partial response. We are currently enrolling 30 patients in an extension of the NMSC cohort of RP1 in combination with nivolumab in NMSC
patients who have failed prior treatment with anti-PD(L)-1. In March 2022, we reported initial data from this extension cohort where responses had been
observed in anti-PD(L)-1 failed CSCC, MCC and angiosarcoma tumors. We believe the activity of RP1 combined with nivolumab in this anti-PD(L)-1
failed cohort represents a new potential therapeutic option for these patients and supports the broad potential for RP1 in anti-PD(L)-1 failed disease beyond
melanoma. Enrollment is ongoing in our MSI-H/dMMR and NSCLC cohorts.
We also have open for enrollment a Phase 1b/2 clinical trial of single agent RP1 in solid organ transplant recipients with skin cancers, including CSCC,
which is referred to herein as ARTACUS or the ARTACUS trial, which we believe to be potentially registrational (in its own right or, subject to discussion
with regulatory authorities, following enrollment of additional patients, including as a potential label expansion after an initial approval of RP1 in a
different indication). We are currently enrolling up to 65 patients in the ARTACUS trial to assess the safety and efficacy of RP1 in liver and kidney
transplant recipients with skin cancers. Enrollment in this clinical trial has been impacted by COVID-19, as the patient population is severely immune-
compromised and considered very high risk. However, more recently we have seen an increase in enrollment as the COVID-19 impact continues to evolve.
Even though the patient numbers are currently small, as reported in March 2022, we have observed responses in these patients with RP1as monotherapy
with a similar safety profile to that observed in our other RP1 clinical trials in patients who are not immune suppressed.
We are also developing additional product candidates, RP2 and RP3, that have been further engineered to enhance anti-tumor immune responses and
are intended to address additional tumor types, including traditionally less immune responsive tumor types. In addition to the expression of GALV-GP R(-)
and human GM-CSF as in RP1, RP2 has been engineered to express an antibody-like molecule intended to block the activity of CTLA-4, a protein that
inhibits the full activation of an immune response, including to tumors. RP3 has been engineered with the intent to further stimulate an anti-tumor immune
response through activation of immune co-stimulatory pathways through the additional expression of the ligands for CD40 and 4-1BBL, as well as anti-
CTLA-4 and GALV-GP R(-), but without the expression of GM-CSF.
We initiated a Phase 1 clinical trial of RP2 alone and in combination with nivolumab in the second half of 2019. This clinical trial is also being
conducted as part of our collaboration with BMS, under which BMS has granted us a non-exclusive, royalty-free license to, and will supply at no cost,
nivolumab, for use in combination with RP2. In November 2020, we and BMS agreed to increase the number of patients in the combination part of this
clinical trial from 12 to 30 patients. We have presented data from the single agent RP2 portion of this clinical trial that showed deep and durable responses,
including demonstration of tumor response in uninjected lesions and in patients with difficult to treat advanced cancers. We believe that this data supports
the hypothesis that anti-CTLA-4 delivered intra-tumorally through oncolytic virus replication, with accompanying antigen release and presentation, can
provide potent anti-tumor effects. We have also presented combination data from the clinical trial that showed compelling activity in patients with immune
insensitive tumors and with anti-PD-1 failed disease. In the second half of 2021, we reported full enrollment in the initial 30 patient combination with
nivolumab part of the Phase 1 clinical trial following which a protocol amendment was made to expand this clinical trial to enroll additional patients who
are required to have specific tumor types of interest, including lung cancer, breast cancer, gastro-intestinal cancers, head
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and neck cancer and uveal melanoma, rather than any type of tumor as were eligible for the initial 30 patient group. Initial data from this expanded cohort
of RP2 Phase 1 patients is expected toward the end of 2022.
We have obtained clearance from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to enter clinical development
with RP3 and in December 2020 we initiated dosing in this clinical trial. This Phase 1 clinical trial is designed to evaluate RP3 alone and combined with
anti-PD-1 therapy in advanced solid tumor patients. In March 2022, we reported initial data from the single agent monotherapy cohort of RP3 in superficial
and deep tumors exploring two dose levels of RP3, including injections into deep tumors. The higher dose level has been confirmed as the recommended
Phase 2 dose and no new safety signals have been observed as compared to RP1 or RP2. Enrollment of the combination part of this study has begun,
combining RP3 with nivolumab under a collaboration and supply agreement with BMS. This cohort is focusing on enrolling patients with gastro-intestinal
cancers, breast cancer, lung cancer and head and neck cancer. Initial data from this expanded cohort of RP3 Phase 1 patients is expected toward the end of
2022.
We intend to initiate a Phase 2 development plan for RP2 and RP3 to target a range of tumor types with un-met need, including where liver tumors are
common and in patients with early disease where the objective of treatment would be to increase the proportion of patients achieving cure. This includes
the development of RP2 and/or RP3 in combination with the current standard of care, including immunotherapy, chemotherapy and radiation, and in
settings following the current standard of care. We are planning for initial signal finding single arm Phase 2 clinical trials in the following tumor types:
squamous cell carcinoma of the head and neck, or SCCHN, hepatocellular carcinoma, or HCC, and micro-satellite stable colorectal cancer, or CRC, with
additional signal finding studies intended to follow. We expect to initiate this Phase 2 development work around the end of 2022.
RP1, RP2 and RP3 are administered by direct injection into solid tumors, guided either visually or by ultrasound, computerized tomography, or CT, or
other imaging methods. We believe that direct injection maximizes virus-mediated tumor cell death, provides the most efficient delivery of virus-encoded
immune activating proteins into the tumor with the goal of activating systemic immunity, and limits the systemic toxicities that could be associated with
intravenous administration. Activation of systemic immunity through local administration is intended to lead to the induction of anti-tumor immune
responses leading to clinical response of tumors that have not themselves been injected.
Our approach — Oncolytic immunotherapy
Our product candidates are designed to induce a robust immune response against a patient’s cancer and turn immunologically “cold” tumors “hot.” To
achieve this objective, we use oncolytic immunotherapies that combine multiple mechanisms of action in a single product candidate. We believe our
product candidates will initiate or enhance an immune response in patients with no or minimal pre-existing cancer immunity, including to tumor neo-
antigens, and thereby increase the effectiveness of immune checkpoint blockade therapies.
Our product candidates are intended to act at several key points in the pathways involved in the initiation of an immune response. Following direct
injection into tumors, our viruses replicate in cancer cells and then lyse, or break them open, releasing tumor antigens, including neo-antigens specific to
the patient, which could otherwise be hidden from the immune system. This process of necrotic cell death releases intra-cellular markers of “danger,” the
danger associated molecular patterns, or DAMPs, while the virus produces pathogen associated markers of danger, or PAMPs. These trigger various
pathways of the innate immune system, including the STING pathway and pathways mediated through toll-like receptors, or TLRs, each resulting in the
production of interferon. Innate immune activation would be expected to itself provide anti-tumor effects, as interferon activates natural killer cells which
can destroy tumor cells. Innate immune activation would also be expected to help trigger adaptive anti-cancer immunity, in which antigen presenting cells,
or APCs, are attracted to the injected tumor. APCs internalize cancer antigens, including neo-antigens, and traffic back to the draining lymph nodes where
they present the antigens to T cells. Primed with the antigens, these T cells then proliferate and disperse systemically to seek and destroy cancer cells with
the same antigen profile throughout the body, resulting in the potential destruction of distant tumor deposits.
To further augment these intended effects, our product candidates are genetically encoded with multiple potent, cell-killing and immune-stimulating
proteins — in other words, our product candidates are “armed” with these therapeutic genes.
We believe that our ability to incorporate multiple mechanisms of action into a practical “off-the-shelf” approach to initiating or enhancing an anti-
tumor immune response, including to neo-antigens, will offer significant advantages over the various approaches to immune activation that are currently in
development, including personalized vaccine treatments. Tumor neo-antigens are uniquely present in tumors, rather than normal tissue, because they result
from the genetic changes that occur
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as cancer develops. Unlike the antigens present in normal tissue, the immune system identifies neo-antigens as foreign. As a result, the immune system is
able to mount an immune response to tumor neo-antigens in the same way that it would to the antigens contained in disease-causing micro-organisms,
which the immune system also identifies as foreign. Researchers believe immune responses to tumor neo-antigens are particularly important in the immune
system’s ability to combat cancer, and as a consequence various “personalized vaccine” approaches to generating immune responses to tumor neo-antigens
are in development. These approaches are generally both expensive and time consuming because a vaccine cannot be designed and manufactured until a
tumor biopsy is taken and analyzed in the laboratory to identify the mutated tumor antigens that will be targeted by the treatment. We also believe that our
“off-the-shelf” approach may offer significant advantages over other approaches to anti-cancer immune activation that only target a single pathway of the
immune system, as is the case with most of the other immuno-oncology therapies currently under development. Importantly, our product candidates are
intended to maximally activate an immune response against cancer, which we believe is the missing element needed to allow anti-PD-1 or anti-PD(L)-1
therapy to treat more patients and tumor types, unlike some other therapies that are intended to act by blocking additional defense mechanisms against an
anti-tumor immune response once it has been initiated.
Our Oncolytic Immunotherapy platform and product candidates
Our current product candidate pipeline is summarized in the table below:
The foundation of our oncolytic immunotherapy product candidates consists of a proprietary strain of HSV-1 that we have engineered to replicate
selectively in tumors and to express a fusogenic glycoprotein, a protein that triggers the fusion of the membranes between cells. HSV-1 is both highly cell
lytic and inflammatory, and also has a large carrying capacity, which makes it possible to incorporate multiple genes encoding therapeutic proteins. We
believe our combination of HSV-1 with the expression of the fusogenic glycoprotein increases the natural ability of HSV-1 to kill tumor cells and to induce
an anti-tumor immune response. The fusogenic functionality of our product candidates is intended not only to increase the number of tumor cells that are
killed, but also to cause highly immunogenic death of tumor cells. We believe that these factors will increase the potency of the systemic anti-tumor
immune response that is generated by our product candidates. With the intention of further amplifying the anti-tumor response, we have also engineered
product candidates that express a range of additional potent, immune activating genes encoding therapeutic proteins in tumors.
Our lead product candidate, RP1, serves as the base from which our additional product candidates, RP2 and RP3, are being developed to express
additional therapeutic proteins. We believe that our sequential development approach of further enhancing our product candidates with additional
therapeutic proteins reduces clinical risk, as we are able to study the safety profile of each therapeutic protein prior to moving to the next product candidate
with an additional therapeutic protein that is intended to provide more potent anti-tumor immune effects.
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Lead product candidate: RP1
Our lead product candidate, RP1, is a selectively replicating version of HSV-1 that expresses GALV-GP R(-) and human GM-CSF. RP1 has the
following properties:
• we have deleted the ICP34.5-encoding gene, which enables tumor-selective virus replication;
• we have deleted the ICP47-encoding gene, which is intended to prevent the inhibition of the antigen presentation pathway otherwise caused by
ICP47 binding to the transporter associated with antigen presentation. ICP47 deletion is also intended to result in the increased and earlier
expression of the HSV-1 US11 gene by placing the HSV-1 US11 gene under the control of ICP47 promoter which we believe will increase virus
replication in tumors without reducing tumor-selectivity; and
• we have inserted the sequences for GALV-GP R(-) and human GM-CSF, resulting in the expression of these therapeutic proteins with the intention
of increasing both the direct tumor cell killing and the potency of the anti-tumor immune response that is induced.
We have developed RP1 as a monotherapy and for use in combination with immune checkpoint blockade therapy, particularly therapies targeting PD-1
or PD-(L)-1. We believe that the robust release of tumor antigens and the highly immunogenic tumor cell death intended to be caused by RP1 will further
increase the previously observed synergy between oncolytic viruses and immune checkpoint blockade therapy.
Pipeline product candidates: RP2 and RP3
We have designed our RP2 product candidate to express an anti-CTLA-4 antibody-like protein intended to block the inhibition of the immune response
otherwise caused by CTLA-4. We believe that RP2 may offer advantages compared with current CTLA-4 approaches, including ipilimumab. By expressing
anti-CTLA-4 only locally in the tumor and draining lymph nodes, we believe that activity will be retained, but that toxicity will be reduced. We intend that
our RP2 product candidate will be used in combination with other treatment approaches, including anti-PD-1 therapy, which we believe will result in both
synergy with the oncolytic immunotherapy and the expression of anti-CTLA-4 in the tumor.
We have designed our RP3 product candidate to express further immune-activating proteins that stimulate T cells, in addition to anti-CTLA-4 and
GALV-GP R(-). These immune activating proteins are the ligands for two immune co-stimulatory pathways responsible for T cell proliferation and/or
activation, the CD40L and 4-1BBL pathways.
Intellectual property
We believe our rights under issued patents, if obtained, and patent applications will provide a competitive advantage. Our success depends in part on
our ability to obtain and maintain proprietary protection for our product candidates, technology and know-how, to operate without infringing the proprietary
rights of others and to prevent others from infringing upon our proprietary rights. Our policy is to seek to protect our proprietary position by, among other
methods, filing United States and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the
development of our business. We also rely on trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary
position.
For the core technology in our RPx platform and each of our product candidates, we have filed six patent applications under the Patent Cooperation
Treaty, or PCT. All six of these PCT applications have entered the national phase and are pending in a range of countries. Examination has started in
connection with some of the national phase applications. Four US patents have been granted by the applicable authorities in the US. Three European
patents have been granted by the applicable authorities in the European Union, two patents have been granted by the applicable authorities in Hong Kong
and one patent has been granted by the applicable authorities in each of Japan, Singapore and Israel. Notices of allowance have been issued on two
Japanese patent applications and a notice of allowance has been issued on one Israeli patent application. The granted US patents include US patent numbers
10,570,377; 10,612,005; 10,626,377; and 10,947,513 and include description and claims directed to oncolytic virus compositions of matter, pharmaceutical
compositions encompassing an oncolytic virus and methods of use in treating cancer with oncolytic virus compositions. Two of our European patents have
been opposed and one of our US patents has been petitioned for post-grant review. We continue to vigorously pursue advancement and defense of our
patents and patent applications through the respective patent offices in which they are granted or pending throughout the world.
The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we
file, the patent term is 20 years from the earliest date of filing a non-provisional patent application.
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In the United States, the patent term of a patent that covers an FDA-approved drug may also be eligible for patent term extension, which permits patent
term restoration of a portion of the patent term lost during the U.S. clinical development and FDA regulatory review process. The Hatch-Waxman Act
permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of
time the drug is under clinical development in the United States and the length of time the drug is under regulatory review. Patent term extension cannot
extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to an approved drug may
be extended. Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug. In the
future, if and when our products receive FDA approval, and if and when patents grant, we expect to apply for patent term extensions on patents covering
those products. We plan to seek patent term extensions to any of our issued patents in any jurisdiction where these are available, however there is no
guarantee that the applicable authorities, including the FDA in the United States, will agree with our assessment of whether such extensions should be
granted, and if granted, the length of such extensions.
We may rely, in some circumstances, on trade secrets to protect our technology. We seek to protect our proprietary technology and processes, in part,
by confidentiality agreements with our employees, consultants, scientific advisors and other contractors, as well as physical security of our premises and
our information technology systems.
Competition
The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on
proprietary rights. We compete in the highly competitive markets that address cancer and face significant competition from many sources, including
pharmaceutical, biopharmaceutical and biotechnology companies, as well as universities and private and public research institutions. Many of our
competitors have significantly greater financial, manufacturing, marketing and drug development resources than we do. Large biopharmaceutical
companies in particular have extensive experience in clinical testing and in obtaining regulatory approvals for drugs and biologicals. These companies also
have significantly greater research capabilities than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly
through collaborative arrangements with large and established companies or universities and research institutions.
Our competitors fall primarily into the following groups of treatment:
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traditional cancer therapies, including chemotherapy, surgery, radiation and targeted therapies;
approved immunotherapy antibodies and immunotherapy antibodies in clinical trials;
oncolytic immunotherapies, including T-Vec and other oncolytic immunotherapies in clinical trials;
therapies aimed at activating innate immunity such as those targeting STING and TLRs;
cancer vaccines including personalized vaccines and those targeting tumor neo-antigens; and
cell-based therapies, such as CAR-T, T cell receptor-based, and NK cell therapies.
Our commercial opportunity will be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have
fewer side effects, are easier to administer or are less expensive alone or in combination with other therapies than any products that we may develop alone
or in combination with other therapies, especially if these get to market sooner than our products. These third parties also compete with us in recruiting and
retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring
technologies and technology licenses complementary to our programs or advantageous to our business.
Our oncolytic product candidates, if and when marketed, will compete with a number of drugs that are currently marketed or in development that also
target cancer but that utilize a different mechanism of action. To compete effectively with these agents, our product candidates will need to demonstrate
advantages that lead to improved clinical efficacy and safety compared with these competitors. At the same time, however, we believe that our oncolytic
product candidates, if and when ultimately marketed, would likely be used principally in combination with checkpoint blockade therapies in addition to
existing cancer therapies, including surgery, chemotherapy, radiation therapy and other biological therapies such as antibodies targeting particular surface
receptors. We therefore believe that our product candidates, if and when marketed, would largely complement rather than compete directly with these
existing treatment options.
We do, however, expect to face direct and increasing competition from a number of companies that are also seeking to develop cancer therapies based
on oncolytic viruses and other ways to prime the immune system, including neo-antigen vaccination. We believe that our ability to successfully compete
will depend, among other things, on our ability to:
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expeditiously advance the development of our product candidates;
design, enroll patients in and successfully complete appropriate clinical trials in a timely fashion;
gain regulatory approval for our product candidates in their first indications as well as further indications;
establish collaborations and partnerships for the development and marketing of our product candidates;
commercialize our product candidates successfully, including demonstrating the safety and efficacy of our product candidates over currently
approved therapies to physicians, insurers and third-party payors;
secure sufficient coverage from insurers and other payors;
secure, maintain and protect intellectual property rights based on our innovations; and
• manufacture or otherwise obtain and sell commercial quantities of future products to the market.
Manufacturing and suppliers
We have established an operations leadership team with extensive experience in manufacturing biologics based on viruses, including oncolytic
products and gene therapy products, and in the construction, validation, operation and approval of facilities for the manufacture and filling of complex
biological products. Our team has already developed a robust and reproducible manufacturing process for our product candidates. We are also developing
our product candidates for maximum practicality of use compared with some other oncolytic immunotherapies.
Traditionally, our third-party contract manufacturer in Europe has been responsible for the cGMP manufacture and filling of our product candidates for
use in our clinical trials. We have established our raw material supply chain for our product candidates as part of the process of establishing and qualifying
our own manufacturing facility and intend to enter into commercial supply, collaboration or similar agreements as needed to operate the in-house
manufacturing of our product candidates for our clinical trials and, if approved, build commercial supply of our products.
Our approximately 63,000 square foot manufacturing facility in Framingham, Massachusetts is fully operational. We have completed the process of
transferring the manufacturing of RP1 and RP2 from our third-party contract manufacturer and are nearly complete with the transfer of the manufacturing
of RP3 from our third-party contract manufacturer. We have completed comparability analysis of RP1 produced at our Framingham facility with the
contract manufacturer material used in our clinical studies and a report has been submitted to the FDA. We are currently conducting comparability studies
of RP2 manufactured from our in-house facility to our current clinical trial supply material manufactured from our third-party contract manufacturer. We
plan to operate our in-house manufacturing facility in order to secure our product candidates for our ongoing and planned clinical studies and, if approved,
commercial launch and supply. The facility has been designed to allow us to produce enough material to cover full global commercialization of all our
current product candidates. The facility is intended to give us control over key aspects of the supply chain for our products and product candidates.
By establishing our own manufacturing facility, we aim to minimize or eliminate our reliance on contract manufacturing organizations, which typically
have limited capacity at commercial scale and long-lead time to conduct manufacturing campaigns. We believe that having control over the whole
manufacturing process will allow us to reduce cycle times and cost of goods for commercial production and to shorten overall timelines for new product
candidates in our development pipeline, as well as help us to develop drug formulations or presentations to simplify distribution and/or administration of
future oncolytic immunotherapies. We also believe that having a dedicated manufacturing facility will allow us to optimize commercial-scale processes and
to ensure security of supply to support market launch and commercialization of our product candidates, if approved.
Sales and marketing
None of our product candidates have been approved for sale. If and when our product candidates receive marketing approval, we intend to
commercialize them on our own in the United States and potentially with pharmaceutical or biotechnology partners in other geographies. On April 21,
2021, we announced the strengthening of our executive team with the appointment of Sushil Patel, Ph.D. as our Chief Commercial Officer effective May 3,
2021. Following the appointment of our Chief Commercial Officer, we have further built our in-house sales, marketing or commercialization capabilities
with the addition of sales and marketing expertise. Clinical data, the size of the opportunity for our product candidates, RP1, RP2 and RP3, and the size of
the commercial infrastructure required will influence our commercialization plans and decision making.
Collaborations
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BMS
In February 2018, we entered into a Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb Company, or BMS. Pursuant to the
agreement, BMS is providing to us, at no cost, nivolumab, its anti-PD-1 therapy, for use in combination with RP1 in our ongoing Phase 1/2 clinical trial.
Under the agreement, we will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon protocol. BMS granted us a non-exclusive,
non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use nivolumab in the clinical trial and has agreed to
supply nivolumab, at no cost to us, for use in the clinical trial. Both parties will own the study data produced in the clinical trial, other than study data
related solely to nivolumab, which will belong solely to BMS, or study data related solely to RP1, which will belong solely to us. In January 2020, this
agreement was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.
Unless earlier terminated, the agreement will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data have been
delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the clinical trial protocol or any analysis
otherwise agreed upon by the parties. The agreement may be terminated by either party (x) in the event of an uncured material breach by the other party,
(y) in the event the other party is insolvent or in bankruptcy proceedings or (z) for safety reasons. Upon termination, the licenses granted to us to use
nivolumab in the clinical trial will terminate. The agreement contains representations, warranties, undertakings and indemnities customary for a transaction
of this nature.
In April 2019, we entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to
which BMS will provide, at no cost to us, nivolumab for use in our Phase 1 clinical trial of RP2 in combination with nivolumab.
Regeneron
In May 2018, we entered into a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals, Inc., or Regeneron.
Pursuant to the agreement we agreed to undertake one or more clinical trials with Regeneron for the administration of our product candidates in
combination with cemiplimab, an anti-PD-1 therapy developed by Regeneron, across multiple solid tumor types, the first of which is our ongoing Phase 2
clinical trial testing RP1 in combination with cemiplimab versus cemiplimab alone in patients with CSCC. Each clinical trial will be conducted pursuant to
an agreed study plan which, among other things, will identify the name of the sponsor and which party will manage the particular study, and include the
protocol, the budget and a schedule of clinical obligations. The first study plan related to the Phase 2 clinical trial in CSCC has been agreed.
Pursuant to the terms of the agreement, each party granted the other party a non-exclusive license of their respective intellectual property and agreed to
contribute the necessary resources needed to fulfill their respective obligations, in each case, under the terms of agreed study plans. Development costs of a
particular clinical trial will be split equally. The agreement contains representations, warranties, undertakings and indemnities customary for a transaction
of this nature. The agreement also contains certain time-based covenants that restrict us from entering into a third-party arrangement with respect to the use
of our product candidates in combination with an anti-PD-1 therapy and that restrict Regeneron from entering into a third-party arrangement with respect to
the use of cemiplimab in combination with an HSV-1 virus, in each case, for the treatment of a tumor type that is the subject of a clinical trial to which the
covenants apply. Unless otherwise mutually agreed in a future study plan, these covenants are only applicable to our ongoing Phase 2 clinical trial in
CSCC.
The agreement may be terminated by either party if (i) there is no active study plan for which a final study report has not been completed and the
parties have not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most recent final study report or
(ii) in the event of a material breach.
Regulatory matters
Government authorities in the United States, at the federal, state, and local level, and in other countries, extensively regulate, among other things, the
research, development, testing, approval, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import,
and export of biopharmaceutical products such as those we are developing. In addition, manufacturers of biopharmaceutical products participating in
Medicaid and Medicare are required to comply with mandatory price reporting, discount, and rebate requirements. The processes for obtaining regulatory
approvals in the United States and in foreign countries, along with compliance with applicable statutes and regulations, require the expenditure of
substantial time and financial resources. The FDA and governmental authorities in other countries have issued a growing body of guidance documents on
various regulatory matters, including those specific to cell and gene therapy development. Moreover, in light of the COVID-19 pandemic, the FDA and
governmental authorities in other countries have
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also issued a number of guidance documents to assist companies navigating COVID-19, product development, and manufacturing during the pandemic.
FDA and EU regulation
In the United States, the FDA regulates biologics under the Federal Food, Drug, and Cosmetic Act, or FDCA, the Public Health Services Act, or
PHSA, and their implementing regulations. The process required by the FDA before product candidates may be marketed in the United States generally
involves the following:
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completion of preclinical laboratory tests, animal studies, and formulation studies in compliance with GLP regulations;
submission to the FDA of an IND, which must become effective before human clinical trials may begin at United States clinical trial sites;
approval by an IRB for each clinical site, or centrally, before each trial may be initiated;
adequate and well-controlled human clinical trials to establish the safety, purity, and potency of the proposed product candidate for its intended
use, performed in accordance with GCPs;
development of manufacturing processes to ensure the product candidate’s identity, strength, quality, purity, and potency;
submission to the FDA of a BLA;
satisfactory completion of an FDA advisory committee review, if applicable;
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the products are produced to assess compliance
with current cGMPs, and to assure that the facilities, methods, and controls are adequate to preserve the therapeutics’ identity, strength, quality,
purity, and potency as well as satisfactory completion of an FDA inspection of selected clinical sites and selected clinical investigators to
determine GCP compliance; and
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FDA review and approval of the BLA to permit commercial marketing for particular indications for use.
The process in the European Union and other countries with developed regulatory regimes is broadly comparable.
Preclinical studies and IND submission
The testing and approval process of product candidates requires substantial time, effort, and financial resources. Satisfaction of the FDA’s and other
countries’ regulatory authorities’ pre-market approval requirements typically takes many years and the actual time required may vary substantially based
upon the type, complexity, and novelty of the product or disease. Preclinical studies include laboratory evaluation of chemistry, pharmacology, toxicity, and
product formulation, as well as animal studies to assess potential safety and efficacy. Such studies must generally be conducted in accordance with the
FDA’s GLPs. Prior to commencing the first clinical trial at a United States or other country’s investigational site with a product candidate, an IND sponsor
must submit the results of the preclinical tests and preclinical literature, together with manufacturing information, analytical data, any available clinical data
or literature, and proposed clinical study protocols among other things, to the FDA as part of an IND (or equivalent in other countries).
An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, notifies the applicant of
safety concerns or questions related to one or more proposed clinical trials and places the trial on a clinical hold. In such a case, the IND sponsor and the
FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during
trials due to safety concerns or non-compliance. As a result, submission of an IND may not result in FDA authorization to commence a clinical trial. A
separate submission to an existing IND must also be made for each successive clinical trial conducted during product development.
Clinical trials
Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance
with federal regulations and GCP requirements, which include the requirements that all research subjects provide their informed consent in writing for their
participation in any clinical trial, as well as review and approval of the study by an IRB. Investigators must also provide certain information to the clinical
trial sponsors to allow the sponsors to make certain financial disclosures to the FDA. Clinical trials are conducted under protocols detailing, among other
things, the objectives of the trial, the trial procedures, the parameters to be used in monitoring safety, the effectiveness criteria to be evaluated, and a
statistical analysis plan. A protocol for each clinical trial, and any subsequent protocol amendments, must be submitted to the FDA as part of the IND. In
addition, an IRB at each study site participating in the clinical trial or a central IRB must review and approve the plan for any clinical trial, informed
consent forms, and communications to study subjects before a
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study commences at that site. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are
reasonable in relation to anticipated benefits, and whether the planned human subject protections are adequate. The IRB must continue to oversee the
clinical trial while it is being conducted. Once an IND is in effect, each new clinical protocol and any amendments to the protocol must be added to the
IND for FDA review, and sent to the IRB for approval. If a product candidate is being investigated for multiple intended indications, separate INDs may
also be required. Progress reports detailing the results of the clinical trials must also be submitted at least annually to the FDA and the IRB and more
frequently if serious adverse events or other significant safety information is found.
The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical
trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. An IRB may also
require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements or if the trial poses an
unexpected serious harm to subjects. The FDA or an IRB may also impose conditions on the conduct of a clinical trial. Clinical trial sponsors may also
choose to discontinue clinical trials as a result of risks to subjects, a lack of favorable results, or changing business priorities.
Information about certain clinical trials, including a description of the study and study results, must be submitted within specific timeframes to the
National Institutes of Health, or NIH, for public dissemination on their clinicaltrials.gov website. Manufacturers or distributors of investigational products
for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions must also have a publicly available policy on evaluating and
responding to requests for expanded access requests.
Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor that regularly
reviews accumulated data and advises the study sponsor regarding the continuing safety of the trial. This group may also review interim data to assess the
continuing validity and scientific merit of the clinical trial. This group receives special access to unblinded data during the clinical trial and may advise the
sponsor to halt the clinical trial if it determined there is an unacceptable safety risk for subjects or on other grounds, such as no demonstration of efficacy.
Moreover, certain studies involving recombinant and synthetic nucleic acid molecules are subject to review by Institutional Biosafety Committees, or
IBCs, under the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
The manufacture of investigational biologics for the conduct of human clinical trials is subject to current cGMP requirements. Investigational biologics
and active ingredients imported into the United States are also subject to regulation by the FDA. Further, the export of investigational products outside of
the United States is subject to regulatory requirements of the receiving country as well as United States export requirements under the FDCA.
In general, for purposes of BLA approval, human clinical trials are typically conducted in three sequential phases, which may overlap or be combined.
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Phase 1 — Trials are initially conducted in healthy human volunteers or subjects with the target disease or condition and test the product candidate
for safety, dosage tolerance, structure-activity relationships, mechanism of action, absorption, metabolism, distribution, and excretion. If possible,
Phase 1 trials may also be used to gain an initial indication of the activity of the product candidate.
Phase 2 — Controlled trials are conducted in limited subject populations with a specified disease or condition to evaluate the effectiveness of the
product candidate for a particular indication or indications, identify optimal dosages, dosage tolerance and schedule, possible adverse effects and
safety risks, and expanded evidence of safety.
Phase 3 — These adequate and well controlled clinical trials are undertaken in expanded subject populations, generally at geographically dispersed
clinical trial sites, to generate enough data to provide statistically significant evidence of clinical efficacy and safety of the product for approval, to
establish the overall risk benefit profile of the product, and to provide adequate information for the labeling of the product. Typically, two Phase 3
trials are required by the FDA for product approval. Under some limited circumstances, however, approval may be based upon a single adequate
and well-controlled clinical trial plus confirmatory evidence or a single large multicenter trial without confirmatory evidence.
Additional kinds of data may also help to support a BLA, such as patient experience data and real-world evidence. Real world evidence may also be
used to assist in clinical trial design. For appropriate indications sought through supplemental BLAs, data summaries may provide marketing application
support. For genetically targeted products and variant protein targeted products intended to address an unmet medical need in one or more patient
subgroups with a serious or life threatening rare disease or condition, the FDA may allow a sponsor to rely upon data and information previously developed
by the sponsor or for which the sponsor has a right of reference, that was submitted previously to support an approved application for a product
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that incorporates or utilizes the same or similar genetically targeted technology or a product that is the same or utilizes the same variant protein targeted
drug as the product that is the subject of the application.
Further, under certain circumstances, manufacturers and sponsors of investigational biopharmaceutical product candidates can provide access to the
product candidates to certain qualifying patients outside of clinical trials. For instance, under the FDA’s expanded access program, with FDA approval and
subject to certain requirements, sponsors may provide access to product candidates to patients with serious or immediately life threatening diseases or
conditions for which there is no comparable or satisfactory alternative therapy, provided that the potential patient benefit justifies the risks, the risks are not
unreasonable in the context of the disease or condition to be treated, and the provision of the product candidate for the requested use will not interfere with
clinical investigations. The specific expanded access criteria and requirements depend on the number of expanded access patients. Sponsors and
investigators of expanded access programs must still comply with the FDA’s clinical trial guidelines and are subject to subject protection regulations.
Federal and state laws in the United States, referred to as right to try laws, also establish a separate mechanism through which certain patients with life
threatening diseases or conditions, who have exhausted all approved treatment options and are unable to participate in a clinical trial, may request access to
investigational product candidates that have completed a Phase 1 clinical trial. While certain criteria must be met for a patient to be eligible for access to
product candidates under right to try laws, these laws do not require the FDA to approve the use of the product candidate and do not require compliance
with the majority of the FDA’s clinical trial regulations.
The FDA may also require, or companies may conduct, additional clinical trials for the same indication after a product is approved. These so-called
Phase 4 trials may be made a condition to be satisfied after approval. The results of Phase 4 trials can confirm or refute the effectiveness of a product
candidate and can provide important safety information.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry
and physical characteristics of the product candidate as well as finalize a process for manufacturing the product in commercial quantities in accordance
with current cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and,
among other things, manufacturers must develop methods for testing the identity, strength, quality, potency, and purity of the final product. Additionally,
appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo
unacceptable deterioration over its shelf life.
In relation to the clinical trial in the United Kingdom and in so far as trials will be conducted in other countries with a view to obtaining a marketing
authorization from the European Medicines Agency, there are broadly equivalent GLP, GCP, cGMP and ethical approval requirements. In the European
Union, these rules are memorialized in the form of Regulations, which are directly enforceable in all EU member states or Directives, which may only be
implemented nationally. However, enforcement of such rules is conducted by the regulatory authority in which the trial is carried out, which is the MHRA
in the United Kingdom. With the full departure of the United Kingdom from the European Union in January 2021, the United Kingdom is not covered by
the European Union Clinical Trial Regulation, in force since January 2022, which inter alia introduced a portal to streamline cross-border trial applications,
and is instead subject to rules equivalent to the previous 2001 EU Clinical Trials Regulation.
Combination Products
Biologic products may be regulated as combination products if they are intended for use in conjunction with medical devices, such as a delivery
device. In such cases, the use of the two products together (i.e., the biological product and the device) must be shown to be safe and effective for the
proposed intended use, and, the labeling of the two products must reflect their combined use. In some cases, the device component may require a separate
premarket submission; for example, when the device component is intended for use with multiple therapeutics. Sponsors of clinical studies using
investigational devices are required to comply with FDA’s investigational device exemption regulations. Once approved or cleared, the sponsor of the
device component submission (or the combination product submission, if both components are covered by one premarket submission) would need to
comply with FDA’s post-market device requirements, including establishment registration, device listing, device labeling, unique device identifier, quality
system regulations, medical device reporting, and reporting of corrections and removals. In the European Union there are specific quality requirements for
drug-device combinations.
BLA submission, review by the FDA, and marketing approval
Assuming successful completion of the required clinical and preclinical testing, the results of product development, including chemistry, manufacture,
and controls, non-clinical studies, and clinical trial results, including negative or ambiguous results as well as positive findings, are all submitted to the
FDA, along with the proposed labeling, as part of a BLA requesting approval to market the product for one or more indications. In most cases, the
submission of a BLA is subject to a substantial application user fee. These user fees must be paid at the time of the first submission of the application, even
if the application is
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being submitted on a rolling basis. Fee waivers or reductions are available in certain circumstances. One basis for a waiver of the application user fee is if
the applicant employs fewer than 500 employees, including employees of affiliates, the applicant does not have an approved marketing application for a
product that has been introduced or delivered for introduction into interstate commerce, and the applicant, including its affiliates, is submitting its first
marketing application.
In addition, under the Pediatric Research Equity Act, or PREA, a BLA or supplement to a BLA for a new active ingredient, indication, dosage form,
dosage regimen, or route of administration, must contain data that are adequate to assess the safety and effectiveness of the product for the claimed
indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe
and effective. Also, under the FDA Reauthorization Act of 2017, for applications for product candidates intended for the treatment of adult cancer which
are directed at molecular targets that the FDA determines to be substantially relevant to the growth or progression of pediatric cancer, in place of the PREA
investigations, sponsors must submit, with the application, reports from molecularly targeted pediatric cancer investigations designed to yield clinically
meaningful pediatric study data, using appropriate formulations, to inform potential pediatric labeling. The FDA may, on its own initiative or at the request
of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers
from the pediatric data requirements.
The FDA also may require submission of a REMS to ensure that the benefits of the biologic outweigh the risks. The REMS plan could include
medication guides, physician communication plans, and elements to assure safe use, such as restricted distribution methods, patient registries, or other risk
minimization tools. An assessment of the REMS must also be conducted at set intervals. Following product approval, a REMS may also be required by the
FDA if new safety information is discovered and the FDA determines that a REMS is necessary to ensure that the benefits of the biologic outweigh the
risks.
Once the FDA receives an application, it has 60 days to review the BLA to determine if it is substantially complete to permit a substantive review
before it accepts the application for filing. The FDA may request additional information rather than accept a BLA for filing. In this event, the application
must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the
submission is accepted for filing, the FDA begins an in-depth substantive review.
Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA has set the review goal of
completing its review of 90% of all applications within ten months from the 60-day filing date for its initial review of a BLA. This review goal is referred
to as the PDUFA date. The PDUFA date is only a goal, thus, the FDA does not always meet its PDUFA dates. The review process and the PDUFA date
may also be extended if the FDA requests or the sponsor otherwise provides substantial additional information or clarification regarding the submission.
Additionally, this review period may change as the PDUFA statute must be reauthorized by Congress by September 2022.
The FDA may also refer certain applications to an advisory committee. An advisory committee is typically a panel that includes clinicians and other
experts, which review, evaluate, and make a recommendation as to whether the application should be approved and under what conditions. The FDA is not
bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
The FDA reviews applications to determine, among other things, whether a product is safe, pure and potent and whether the manufacturing methods
and controls are adequate to assure and preserve the product’s identity, strength, quality, potency, and purity. Before approving a BLA, the FDA typically
will inspect the facility or facilities where the product is manufactured, referred to as a Pre-Approval Inspection. The FDA will not approve an application
unless it determines that the manufacturing processes and facilities, including contract manufacturers and subcontractors, are in compliance with current
cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA the
FDA will inspect one or more clinical trial sites to assure compliance with GCPs.
After evaluating the BLA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the
manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a Complete Response Letter, or CRL. A CRL
indicates that the review cycle of the application is complete and the application is not ready for approval, and describes all of the specific deficiencies that
the FDA identified in the BLA. A CRL generally contains a statement of specific conditions that must be met in order to secure final approval of the BLA
and may require additional clinical or preclinical testing in order for the FDA to reconsider the application. The deficiencies identified may be minor, for
example, requiring labeling changes, or major, for example, requiring additional clinical trials. If a CRL is issued, the applicant may either: resubmit the
BLA, addressing all of the deficiencies identified in the letter; withdraw the application; or request an opportunity for a hearing. The FDA has the goal of
reviewing 90% of application resubmissions in either two or six months of the resubmission date, depending on the kind of resubmission. Even with
submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
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If and when those conditions have been met to the FDA’s satisfaction, the FDA may issue an approval letter. An approval letter authorizes commercial
marketing of the product with specific prescribing information for specific indications.
Even if the FDA approves a product, it may limit the approved indications or populations for use of the product, require that contraindications,
warnings, or precautions be included in the product labeling, including a boxed warning, require that post-approval studies, including Phase 4 clinical trials,
be conducted to further assess a product’s safety and efficacy after approval, require testing and surveillance programs to monitor the product after
commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS which can
materially affect the potential market and profitability of the product. The FDA may also not approve label statements that are necessary for successful
commercialization and marketing.
After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling
claims, are subject to further testing requirements and FDA review and approval. The FDA may also withdraw the product approval if compliance with the
pre- and post-marketing regulatory standards are not maintained or if problems occur after the product reaches the marketplace. Further, should new safety
information arise, additional testing, product labeling, or FDA notification may be required.
While there is no direct equivalent to the separate route for biologics, broadly equivalent requirements and controls similarly apply to the submission
of pediatric testing and marketing authorization applications to the European Medicines Agency in the European Union and, post-approval, to the holding
of such marketing authorizations, including conditionality.
Biosimilars and exclusivity
The BPCIA creates an abbreviated approval pathway for biological products shown to be highly similar to or interchangeable with an FDA-licensed
reference biological product. Biosimilarity sufficient to reference a prior FDA-approved product requires a high similarity to the reference product
notwithstanding minor differences in clinically inactive components, and no clinically meaningful differences between the biological product and the
reference product in terms of safety, purity, and potency. Biosimilarity must be shown through analytical studies, animal studies, and at least one clinical
trial, absent a waiver by the FDA. There must be no difference between the reference product and a biosimilar in mechanism of action, conditions of use
(though a biosimilar may be licensed for fewer indications than that of its reference product), route of administration, dosage form, and strength. A
biosimilar product may be deemed interchangeable with a prior approved product if it meets the higher hurdle of demonstrating that it can be expected to
produce the same clinical results as the reference product and, for products administered multiple times, the biosimilar and the reference biologic may be
switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference
biologic. The FDA has issued a number of guidance documents outlining its approach to review and approval of biosimilars, including guidance documents
on the demonstration of interchangeability and the licensure of biosimilar and interchangeable products for fewer than all of the reference product’s
licensed conditions of use.
A reference biologic is granted 12 years of exclusivity from the time of first licensure of the reference product, and no application for a biosimilar can
be submitted for four years from the date of licensure of the reference product and not approved for another 8 years from the date of licensure of the
reference product. However, certain changes and supplements to an approved BLA, and subsequent applications filed by the same sponsor, manufacturer,
licensor, predecessor in interest, or other related entity do not qualify for the twelve-year exclusivity period. The PHSA also includes provisions to protect
reference products that have patent protection. The biosimilar product sponsor and reference product sponsor may exchange certain patent and product
information for the purpose of determining whether there should be a legal patent challenge. Based on the outcome of negotiations surrounding the
exchanged information, the reference product sponsor may bring a patent infringement suit and injunction proceedings against the biosimilar product
sponsor. The biosimilar applicant may also be able to bring an action for declaratory judgment concerning the patent.
The FDA maintains a publicly-available online database of licensed biological products, which is commonly referred to as the “Purple Book”. The
Purple Book lists product names, dates of licensure, and applicable periods of exclusivity. Further, pursuant to a statute to enable biological product patent
transparency, the reference product sponsor must provide patent information and patent expiry dates to the FDA following the exchange of patent
information between biosimilar and reference product sponsors. This information is then published in the Purple Book.
In the European Union there is a period of 10 years (or 11 years for significant new indications) of data exclusivity so that those seeking to market
biosimilars cannot apply on an abridged basis for a marketing authorization for eight years from when the product was first marketed in the European
Union and cannot place it on the market for 10 or 11 years from such first marketing.
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If approved, biologics may also be eligible for periods of United States patent term restoration. If granted, patent term restoration extends the patent
life of a single unexpired patent, that has not previously been extended, for a maximum of five years. The total patent life with the extension also cannot
exceed fourteen years from the product’s approval date. Subject to the prior limitations, the period of the extension is calculated by adding half of the time
from the effective date of an IND to the initial submission of a marketing application, and all of the time between the submission of the marketing
application and its approval. This period may also be reduced by any time that the applicant did not act with due diligence.
In the European Union, a supplementary protection certificate, or SPC, can similarly extend a patent term for a maximum of five years. A further six-
month additional extension is available if the SPC relates to a medicinal product for which data has been submitted according to a Pediatric Investigation
Plan.
In an effort to increase competition in the biologic product marketplace, Congress, the executive branch, and FDA have taken certain legislative and
regulatory steps. By way of example, measures have been proposed and implemented to facilitate product importation. Moreover, the 2020 Further
Consolidated Appropriations Act included provisions requiring that sponsors of approved biologic products, including those subject to REMS, provide
samples of the approved products to persons developing biosimilar products within specified timeframes, in sufficient quantities, and on commercially
reasonable market-based terms. Failure to do so can subject the approved product sponsor to civil actions, penalties, and responsibility for attorney’s fees
and costs of the civil action.
Post-approval requirements
Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among
other things, requirements related to manufacturing, recordkeeping, and reporting, including adverse experience reporting, deviation reporting, shortage
reporting, risk management plans, supply chain security, and periodic reporting, product distribution, advertising, marketing, promotion, certain electronic
records and signatures, and post-approval obligations imposed as a condition of approval, such as Phase 4 clinical trials, REMS, and surveillance to assess
safety and effectiveness after commercialization.
After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA notice or
review and approval. There also are continuing annual program user fee requirements for approved products. In addition, manufacturers and other entities
involved in the manufacture and distribution of approved therapeutics are required to register their establishments with the FDA and certain state agencies,
list their products, and are subject to periodic announced and unannounced inspections by the FDA and these state agencies for compliance with current
cGMP and other requirements, which impose certain procedural and documentation requirements upon sponsors and third-party manufacturers. Recently,
the information that must be submitted to FDA regarding manufactured products was expanded through the Coronavirus Aid, Relief, and Economic
Security, or CARES, Act to include the volume of drugs produced during the prior year. Manufacturers must continue to expend time, money, and effort in
the areas of production and quality-control to maintain compliance with current cGMPs. Regulatory authorities may withdraw product approvals, require
label modifications or request product recalls, among other actions, if a company fails to comply with regulatory standards, if it encounters problems
following initial marketing, or if previously unrecognized problems are subsequently discovered.
Changes to the manufacturing process are strictly regulated and often require prior FDA approval or notification before being implemented. FDA
regulations also require investigation and correction of any deviations from current cGMP and specifications and impose reporting and documentation
requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend
time, money, and effort in the area of production and quality control to maintain current cGMP compliance.
The FDA also strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. A company can make only
those claims relating to safety and efficacy, purity, and potency that are approved by the FDA. Physicians, in their independent professional medical
judgment, may prescribe legally available products for unapproved indications that are not described in the product’s labeling and that differ from those
tested and approved by the FDA. Biopharmaceutical companies, however, are required to promote their products only for the approved indications and in
accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of
off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including, but not limited to,
criminal and civil penalties under the FDCA and False Claims Act, exclusion from participation in federal healthcare programs, mandatory compliance
programs under corporate integrity agreements, suspension and debarment from government contracts, and refusal of orders under existing government
contracts.
Moreover, the Drug Quality and Security Act imposes obligations on manufacturers of biopharmaceutical products related to product tracking and
tracing. Among the requirements of this legislation, manufacturers are required to provide certain information regarding the products to individuals and
entities to which product ownership is transferred, are required to label
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products with a product identifier, and are required to keep certain records regarding the product. The transfer of information to subsequent product owners
by manufacturers is also required to be done electronically. Manufacturers must also verify that purchasers of the manufacturers’ products are appropriately
licensed. Further, under this legislation, manufactures have product investigation, quarantine, disposition, and notification responsibilities related to
counterfeit, diverted, stolen, and intentionally adulterated products that would result in serious adverse health consequences or death to humans, as well as
products that are the subject of fraudulent transactions or which are otherwise unfit for distribution such that they would be reasonably likely to result in
serious health consequences or death. Similar requirements additionally are imposed through this legislation on other companies within the
biopharmaceutical product supply chain, such as distributors and dispensers.
Adverse event reporting and submission of periodic reports, including annual reports and deviation reports, are required following FDA approval of a
BLA. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with
manufacturing processes, or failure to comply with regulatory requirements, may result in significant regulatory actions. Such actions may include refusal
to approve pending applications, license suspension or revocation, imposition of a clinical hold or termination of clinical trials, warning letters, untitled
letters, cyber letters, modification of promotional materials or labeling, provision of corrective information, imposition of post-market requirements
including the need for additional testing, imposition of distribution or other restrictions under a REMS, product recalls, product seizures or detentions,
refusal to allow imports or exports, total or partial suspension of production or distribution, FDA debarment, injunctions, fines, consent decrees, corporate
integrity agreements, suspension and debarment from government contracts, refusal of orders under existing government contracts, exclusion from
participation in federal and state healthcare programs, restitution, disgorgement, or civil or criminal penalties, including fines and imprisonment, and result
in adverse publicity, among other adverse consequences.
The FDA post-approval requirements are continually evolving. For example, in March 2020, the U.S. Congress passed the Coronavirus Aid, Relief,
and Economic Security Act, or CARES Act, which includes various provisions regarding FDA drug shortage and manufacturing volume reporting
requirements, as well as provisions regarding supply chain security, such as risk management plan requirements, and the promotion of supply chain
redundancy and domestic manufacturing. As part of the CARES Act implementation, the FDA issued a guidance on the reporting of the volume of drugs
produced, which reporting will require additional administrative efforts by drug manufacturers.
Broadly equivalent requirements, controls and sanctions similarly apply to supply, QA, manufacture, labelling, advertising, pharmacovigilance and
tracing of medicinal products as imposed by European Union laws and enforced by European Union national regulatory authorities.
Additional controls for biologics
To help reduce the increased risk of the introduction of adventitious agents, the PHSA emphasizes the importance of manufacturing controls for
products whose attributes cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses in situations where
there exists a danger to public health, to prepare or procure products in the event of shortages and critical public health needs, and to authorize the creation
and enforcement of regulations to prevent the introduction or spread of communicable diseases in the United States and between states.
After a BLA is approved, the product may also be subject to official lot release as a condition of approval. As part of the manufacturing process, the
manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release
by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing the results of all of the
manufacturer’s tests performed on the lot. The FDA may also perform certain confirmatory tests on lots of some products before releasing the lots for
distribution by the manufacturer.
In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological
products. There are also a number of additional standards that apply to oncolytic virus products. The FDA has issued various applicable guidance
documents on factors that the agency considers during product development including, but not limited to, preclinical assessments; chemistry manufacturing
and controls; and long-term patient and clinical study subject follow up and regulatory reporting. In the European Union, while there is no direct equivalent
to the separate route for biologics, the EMA issues scientific guidelines on biological medicinal products and the standard Common Technical Document
structure is modified for biologicals and plasma-derived products.
Fraud and abuse, data privacy and security, and transparency laws and regulations
Our business activities, including but not limited to, research, sales, promotion, distribution, medical education, and other activities following product
approval will be subject to regulation by numerous federal and state regulatory and law enforcement authorities in the United States in addition to the FDA,
including potentially the Department of Justice, the
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Department of Health and Human Services and its various divisions, including the CMS and the Health Resources and Services Administration, the
Department of Veterans Affairs, the Department of Defense, and state and local governments. Our business activities must comply with numerous
healthcare laws, including but not limited to, anti-kickback and false claims laws and regulations as well as data privacy and security laws and regulations,
which are described below, as well as state and federal consumer protection and unfair competition laws.
The federal Anti-Kickback Statute, which regulates, among other things, marketing practices, educational programs, pricing policies, and relationships
with healthcare providers or other entities, prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting, or
receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering, or
arranging for or recommending the purchase, lease, or order, or the referral to another for the furnishing or arranging for the furnishing of any item or
service reimbursable under Medicare, Medicaid, or other federal healthcare programs, in whole or in part. The term “remuneration” has been interpreted
broadly to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between biopharmaceutical manufacturers
on one hand and prescribers, purchasers, formulary managers, and beneficiaries on the other, as well as free trial and starter prescriptions provided through
pharmacies. There are certain statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. HHS recently
promulgated a regulation that is effective in two phases. First, the regulation excludes from the definition of “remuneration” limited categories of (a) PBM
rebates or other reductions in price to a plan sponsor under Medicare Part D or a Medicaid Managed Care Organization plan reflected in point-of sale
reductions in price and (b) PBM service fees. Second, effective January 1, 2023, the regulation expressly provides that rebates to plan sponsors under
Medicare Part D either directly to the plan sponsor under Medicare Part D, or indirectly through a pharmacy benefit manager will not be protected under
the anti-kickback discount safe harbor. The exceptions and safe harbors are drawn narrowly, and practices that involve remuneration that may be alleged to
be intended to induce prescribing, purchases, or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure
to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the
Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of the facts
and circumstances. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving
remuneration is to induce referrals of federal healthcare covered business, including purchases of products paid by federal healthcare programs, the statute
has been violated. The ACA modified the intent requirement under the Anti-Kickback Statute to a stricter standard, such that a person or entity no longer
needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the ACA also provided that
a violation of the federal Anti-Kickback Statute is grounds for the government or a whistleblower to assert that a claim for payment of items or services
resulting from such violation constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or
fraudulent claim for payment to, or approval by, the federal government, knowingly making, using, or causing to be made or used a false record or
statement material to a false or fraudulent claim to the federal government, or avoiding, decreasing, or concealing an obligation to pay money to the federal
government. A claim includes “any request or demand” for money or property presented to the U.S. government. The civil False Claims Act has been used
to assert liability on the basis of kickbacks and other improper referrals, improperly reported government pricing metrics such as Best Price or Average
Manufacturer Price, improper use of Medicare provider or supplier numbers when detailing a provider of services, improper promotion of off-label uses not
expressly approved by the FDA in a product’s label, and allegations as to misrepresentations with respect to products, contract requirements and services
rendered. In addition, private payers have filed follow-on lawsuits alleging fraudulent misrepresentation, although establishing liability and damages in
these cases is more difficult than under the civil False Claims Act. Intent to deceive is not required to establish liability under the civil False Claims Act.
Civil False Claims Act actions may be brought by the government or may be brought by private individuals on behalf of the government, called “qui tam”
actions. If the government decides to intervene in a qui tam action and prevails in the lawsuit, the individual will share in the proceeds from any fines or
settlement funds. If the government declines to intervene, the individual may pursue the case alone. The civil False Claims Act provides for treble damages
and a civil penalty for each false claim, such as an invoice or pharmacy claim for reimbursement, which can aggregate into millions of dollars. For these
reasons, since 2004, civil False Claims Act lawsuits against biopharmaceutical companies have increased significantly in volume and breadth, leading to
several substantial civil and criminal settlements, as much as $3.0 billion, regarding certain sales practices and promoting off label uses. Civil False Claims
Act liability may further be imposed for known Medicare or Medicaid overpayments, for example, overpayments caused by understated rebate amounts,
that are not refunded within 60 days of discovering the overpayment, even if the overpayment was not caused by a false or fraudulent act. In addition,
conviction or civil judgment for violating the civil False Claims Act may result in exclusion from federal health care programs, suspension and debarment
from government contracts, and refusal of orders under existing government contracts.
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The government may further prosecute conduct constituting a false claim under the criminal False Claims Act. The criminal False Claims Act prohibits
the making or presenting of a claim to the government knowing such claim to be false, fictitious, or fraudulent and, unlike the civil False Claims Act,
requires proof of intent to submit a false claim.
The civil monetary penalties statute is another potential statute under which biopharmaceutical companies may be subject to enforcement. Among
other things, the civil monetary penalties statute imposes fines against any person who is determined to have knowingly presented, or caused to be
presented, claims to a federal healthcare program that the person knows, or should know, is for an item or service that was not provided as claimed or is
false or fraudulent.
Payment or reimbursement of prescription therapeutics by Medicaid or Medicare requires manufacturers to submit certified pricing information to
CMS. The Medicaid Drug Rebate statute requires manufacturers to calculate and report price points, which are used to determine Medicaid rebate
payments shared between the states and the federal government and Medicaid payment rates for certain therapeutics. The Medicaid Drug Rebate statute
also imposes inflation penalties, and recent legislative proposals have called for removal of caps limiting the magnitude of these penalties and the
implementation of new inflation penalties applicable to the Medicare program. In addition to the Medicaid statutory rebate, states are authorized to
negotiate supplemental rebates on pharmaceuticals included in their formularies. For therapeutics paid under Medicare Part B, manufacturers must also
calculate and report their Average Sales Price, which is used to determine the Medicare Part B payment rate. For products approved under a BLA
(including biosimilars), or an NDA, the Veterans Health Care Act, or VHCA, requires manufacturers to calculate and report to the Department Veterans
Affairs, or VA, a different price called the Non-Federal Average Manufacturer Price, which is used to determine the maximum price that can be charged to
certain federal agencies, referred to as the Federal Ceiling Price, or FCP. Like the Medicaid rebate amount, the FCP includes an inflation penalty. A
Department of Defense regulation requires manufacturers to provide this discount on therapeutics dispensed by retail pharmacies when paid by the
TRICARE Program. All of these price reporting requirements create risk of submitting false information to the government, and potential FCA liability.
The VHCA also requires manufacturers of covered therapeutics participating in the Medicaid program to enter into Federal Supply Schedule contracts
with the VA through which their covered therapeutics must be sold to certain federal agencies at FCP. This necessitates compliance with applicable federal
procurement laws and regulations, including submission of commercial sales and pricing information and certification of compliance with the Trade
Agreements Act, and subjects us to contractual remedies as well as administrative, civil, and criminal sanctions. In addition, the VHCA requires
manufacturers participating in Medicaid to agree to provide different mandatory discounts to certain Public Health Service grantees and other safety net
hospitals and clinics under the 340B program based on the manufacturer’s reported Medicaid pricing information. The 340B program has its own
regulatory authority to impose sanctions for non-compliance and adjudicate overcharge claims against manufacturers by the purchasing entities.
The federal Health Insurance Portability and Accountability Act of 1996, as amended, or HIPAA, also created federal criminal statutes that prohibit,
among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent
pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, a healthcare benefit program, regardless
of whether the payor is public or private, in connection with the delivery or payment for health care benefits, knowingly and willfully embezzling or
stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying,
concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment
for, healthcare benefits, items, or services relating to healthcare matters. Additionally, the ACA amended the intent requirement of certain of these criminal
statutes under HIPAA so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to violate it, to have
committed a violation.
Under the federal Physician Payments Sunshine Act and its implementing regulations, manufacturers of biologics for which payment is available under
Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) must make annual reports to CMS regarding payments and other
transfers of value made to or at the request of covered recipients, such as, but not limited to, physicians, physician assistants, nurse practitioners, clinical
nurse specialists, and certified registered nurse anesthetists and teaching hospitals, as well as ownership and investment interests held by physicians and
their immediate family. Certain payments for clinical trials are included within the ambit of this law. CMS makes the reported information publicly
available.
Further, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.
HIPAA, as amended by the HITECH Act, and its respective implementing regulations imposes requirements on covered entities relating to the privacy,
security, and transmission of certain individually identifiable health information known as protected health information. Among other things, the HITECH
Act, through its implementing regulations, makes HIPAA’s security standards and certain privacy standards directly applicable to business associates,
defined as a person or organization, other than a member of a covered entity’s workforce, that creates, receives, maintains, or transmits
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protected health information on behalf of a covered entity for a function or activity regulated by HIPAA. The HITECH Act also strengthened the civil and
criminal penalties that may be imposed against covered entities, business associates, and individuals, and gave state attorneys general new authority to file
civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing
federal civil actions. In addition, other federal and state laws, such as the California Consumer Privacy Act, may govern the privacy and security of health
and other information in certain circumstances, many of which differ from each other in significant ways and may not be preempted by HIPAA, thus
complicating compliance efforts.
Many states have also adopted laws similar to each of the above federal laws, which may be broader in scope and apply to items or services reimbursed
by any third-party payor, including commercial insurers. Certain state laws also regulate manufacturers’ use of prescriber-identifiable data. Certain states
also require implementation of commercial compliance programs and compliance with the pharmaceutical industry’s voluntary compliance guidelines and
the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments or the provision of other items of value that
may be made to healthcare providers and other potential referral sources; impose restrictions on marketing practices; or require manufacturers to track and
report information related to payments, gifts, and other items of value to physicians and other healthcare providers. Recently, states have enacted or are
considering legislation intended to make drug prices more transparent and deter significant price increases. These laws may affect our future sales,
marketing, and other promotional activities by imposing administrative and compliance burdens.
If our operations are found to be in violation of any of the laws or regulations described above or any other laws that apply to us, we may be subject
penalties or other enforcement actions, including criminal and significant civil monetary penalties, damages, fines, disgorgement, imprisonment, exclusion
from participation in government healthcare programs, corporate integrity agreements, suspension and debarment from government contracts, and refusal
of orders under existing government contracts, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our
operations, any of which could adversely affect our ability to operate our business and our results of operations.
To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for
instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance
programs and reporting of payments or transfers of value to healthcare professionals. In the European Union, the data privacy laws are generally perceived
to be stricter than those which apply in the United States and include specific requirements for the transfer of personal data outside the European Union to
the United States to ensure that European Union standards of data privacy will be applied to such data.
Coverage and reimbursement generally
The commercial success of our product candidates and our ability to commercialize any approved product candidates successfully will depend in part
on the extent to which governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers, and other
third-party payors, provide coverage for and establish adequate reimbursement levels for our product candidates. Government authorities, private health
insurers, and other organizations generally decide which therapeutics they will pay for and establish reimbursement levels for healthcare. Medicare is a
federally funded program managed by CMS through local fiscal intermediaries and carriers that administer coverage and reimbursement for certain
healthcare items and services furnished to the elderly and disabled. Medicaid is an insurance program for certain categories of patients whose income and
assets fall below state defined levels and who are otherwise uninsured that is both federally and state funded and managed by each state. The federal
government sets general guidelines for Medicaid and each state creates specific regulations that govern its individual program, including supplemental
rebate programs that restrict coverage to therapeutics on the state Preferred Drug List. Similarly, government laws and regulations establish the parameters
for coverage of prescription therapeutics by health plans participating in state exchanges and Tricare, the health care program for military personnel,
retirees, and related beneficiaries. Some states have also created pharmacy assistance programs for individuals who do not qualify for federal programs. In
the United States, private health insurers and other third-party payors often provide reimbursement for products and services based on the level at which the
government provides reimbursement through the Medicare or Medicaid programs for such products and services.
In the United States, the European Union, and other potentially significant markets for our product candidates, government authorities and third-party
payors are increasingly attempting to limit or regulate the price of medical products and services, particularly for new and innovative products and
therapies, which often has resulted in average selling prices lower than they would otherwise be and sometimes at or below the provider’s acquisition cost.
In the United States, it is also common for government and private health plans to use coverage determinations to leverage rebates from manufacturers in
order to reduce the plans’ net costs. These restrictions and limitations influence the purchase of healthcare services and products and lower the realization
on manufacturers’ sales of prescription therapeutics. Third-party payors are developing increasingly sophisticated methods of controlling healthcare costs.
Third-party payors may limit coverage to specific therapeutic products on an approved
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list, or formulary, which might not include all of the FDA-approved products for a particular indication or might impose high copayment amounts to
influence patient choice. Third-party payors also control costs by requiring prior authorization or imposing other dispensing restrictions before covering
certain products and by broadening therapeutic classes to increase competition. Third-party payors are increasingly challenging the price and examining the
medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. Absent clinical differentiators, third-party
payors may treat products as therapeutically equivalent and base formulary decisions on net cost. To lower the prescription cost, manufacturers frequently
rebate a portion of the prescription price to the third-party payors. Recently, purchasers and third-party payors have begun to focus on value of new
therapeutics and sought agreements in which price is based on achievement of performance metrics.
Federal programs also impose price controls through mandatory ceiling prices on purchases by federal agencies and federally funded hospitals and
clinics and mandatory rebates on retail pharmacy prescriptions paid by Medicaid and Tricare. These restrictions and limitations influence the purchase of
healthcare services and products. Legislative proposals to reform healthcare or reduce costs under government programs may result in lower reimbursement
for our product candidates or exclusion of our product candidates from coverage. In addition, government programs like Medicaid include substantial
penalties for increasing commercial prices over the rate of inflation. All of these conditions can affect realization and return on investment.
Private payors often rely on the lead of the governmental payors in rendering coverage and reimbursement determinations. Therefore, achieving
favorable CMS coverage and reimbursement is usually a significant gating issue for successful introduction of a new product. In addition, many
government programs as a condition of participation mandate fixed discounts or rebates from manufacturers regardless of formulary position or utilization,
and then rely on competition in the market to attain further price reductions, which can greatly reduce realization on the sale.
Further, the increased emphasis on managed healthcare in the United States and on country and regional pricing and reimbursement controls in the
European Union will put additional pressure on product pricing, reimbursement, and utilization, which may adversely affect our future product sales and
results of operations. These pressures can arise from rules and practices of managed care groups, competition within therapeutic classes, judicial decisions
and governmental laws and regulations related to Medicare, Medicaid, and healthcare reform, biopharmaceutical coverage and reimbursement policies, and
pricing in general. Patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party
payors to reimburse all or part of the associated healthcare costs. Sales of our product candidates will therefore depend substantially, both domestically and
abroad, on the extent to which the costs of our products will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare
management organizations, or reimbursed by government health administration authorities, such as Medicare and Medicaid, private health insurers, and
other third-party payors.
As a result of the above, we may need to conduct expensive pharmacoeconomic and/or health technology assessment studies in order to demonstrate
the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA and EMA approvals. Our product
candidates may not be considered medically necessary or cost-effective, or the rebate percentages required to secure coverage may not yield an adequate
margin over cost.
Moreover, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Adequate third-
party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in therapeutic
development. Legislative or regulatory proposals to reform healthcare or reduce costs under government insurance programs may result in lower
reimbursement for our products and product candidates or exclusion of our products and product candidates from coverage. The cost containment measures
that healthcare payors and providers are instituting and any healthcare reform could significantly reduce our revenues from the sale of any approved
product candidates. We cannot provide any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for our
product candidates in whole or in part.
The absence in Europe of any substantive harmonization of pricing and reimbursement regimes, including health technology assessment, means that
separate negotiations will need to take place with the relevant authorities in each member state and may include a variety of risk share agreements with
payors.
Healthcare reform measures
The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals designed to change
the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the United States and
elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality,
and expanding access. In the United States, the
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biopharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
For example, on November 27, 2020, CMS issued an interim final rule implementing a Most Favored Nation payment model under which
reimbursement for certain Medicare Part B drugs and biologicals will be based on a price that reflects the lowest per capita Gross Domestic Product-
adjusted (GDP-adjusted) price of any non-U.S. member country of the Organization for Economic Co-operation and Development (OECD) with a GDP per
capita that is at least sixty percent of the U.S. GDP per capita. Any reduction in reimbursement from Medicare and other government programs may result
in a similar reduction in payments from private payors.
Moreover, the ACA broadened access to health insurance, attempts to reduce or constrain the growth of healthcare spending, enhanced remedies
against fraud and abuse, added new transparency requirements for healthcare and health insurance industries, imposed new taxes and fees on the health care
industry, and imposed additional health policy reforms. The law expanded the eligibility criteria and mandatory eligibility categories for Medicaid
programs, thereby potentially increasing both the volume of sales and manufacturers’ Medicaid rebate liability. The law also expanded the 340B discount
program that mandates discounts to certain hospitals, community centers, and other qualifying providers, by expanding the categories of entities eligible to
purchase under the program. In addition, the ACA authorized civil monetary penalties for violating 340B pricing requirements, and regulations
implementing this authority became effective on January 1, 2019. The ACA revised the definition of “average manufacturer price”, or AMP, for reporting
purposes, which generally increased the amount of Medicaid rebates to states and created a separate AMP for certain categories of administered
therapeutics provided in non-retail outpatient settings. The law additionally extended manufacturer’s Medicaid rebate liability to covered therapeutics
dispensed to patients enrolled in Medicaid managed care organizations and increased the statutory minimum rebates a manufacturer must pay under the
Medicaid Drug Rebate program. The revisions to the AMP definition and Medicaid rebate formula can have the further effect of increasing the required
340B discounts. Further, the ACA required manufacturers of covered therapeutics to pay mandatory Medicare Part D coverage gap rebates, and the
Bipartisan Budget Act of 2018, increased the required percentage to 70% of the pharmacy charge to Medicare Part D patients while they are in the
coverage gap. Finally, the ACA imposes a significant annual fee on companies that manufacture or import branded prescription therapeutic products.
Substantial new provisions affecting compliance have also been enacted through the ACA and otherwise, including the reporting of therapeutic sample
distribution, which may require us to modify our business practices with healthcare practitioners. Although the ACA was recently amended to repeal the
individual insurance mandate, and efforts to repeal and replace portions of the law may continue, it is likely that pressure on biopharmaceutical pricing,
especially under the Medicare program, will continue, and may also increase our regulatory burdens and operating costs. Moreover, in the coming years,
additional changes could be made to governmental healthcare programs that could significantly impact the success of our product candidates.
The cost of biopharmaceuticals continues to generate substantial governmental and third-party payor interest. We expect that the biopharmaceutical
industry will experience pricing pressures due to the trend toward managed healthcare, the increasing influence of managed care organizations and
additional legislative proposals. Our results of operations could be adversely affected by current and future healthcare reforms.
Some third-party payors also require pre-approval of coverage for new or innovative devices or therapies before they will reimburse healthcare
providers that use such therapies. While we cannot predict whether any proposed cost-containment measures will be adopted or otherwise implemented in
the future, the announcement or adoption of these proposals could have a material adverse effect on our ability to obtain adequate prices for our product
candidates.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. The Budget Control Act of 2011, as amended,
created the Joint Select Committee on Deficit Reduction to recommend proposals in spending reductions to Congress. The Joint Select Committee on
Deficit Reduction did not achieve its targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic
reductions to several government programs. These reductions include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year.
The Bipartisan Budget Act of 2018 retained the federal budget “sequestration” Medicare payment reductions of 2%, at present that reduction has been
extended through 2030. The American Taxpayer Relief Act of 2012 further reduced Medicare payments to several categories of healthcare providers and
increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These and other healthcare
reform initiatives may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our financial
operations. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that
federal and state governments will pay for healthcare products and services, which could further limit the prices we are able to charge, or the amounts of
reimbursement available, for our product candidates once they are approved. The Bipartisan Budget Act also extended Manufacturer responsibility for
prescription costs in the Medicare Part D coverage gap to biosimilars, which had previously been exempt.
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The Foreign Corrupt Practices Act
The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of
anything of value, directly or indirectly, to any foreign official, political party, or candidate or representatives of international organizations for the purpose
of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business or obtaining an
improper advantage. The FCPA also obligates companies whose securities are listed in the United States to comply with books and records an accounting
control provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including
international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Activities that violate
the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight by compliance
monitors, and suspension and debarment from government contracts, and refusal of orders under existing government contracts.
Other foreign anti-corruption regimes are arguably of wider application. For instance, the U.K. Bribery Act 2010 applies to dealings with any decision
maker whether in the private or public sector in a position of trust.
Background on certain of our target indications
Set forth below is a description of certain of the target indications we currently intend to pursue with our product candidates.
Cutaneous squamous cell carcinoma
CSCC is the second most common form of skin cancer and is estimated to be responsible for at least 7,000 deaths each year in the United States. It
currently accounts for approximately 20% of all skin cancers in the U.S., with the number of newly diagnosed cases expected to rise annually. When CSCC
invades deeper layers of the skin or adjacent tissues, it is categorized as locally advanced. Once it spreads to other distant parts of the body, it is considered
metastatic. Cemiplimab was the first approved therapy in the United States for the treatment of locally advanced or metastatic CSCC and has subsequently
been approved in the European Union and Australia.
Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic
melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma
has been increasing steadily for the last 30 years. In the United States, 91,270 new diagnoses of melanoma and more than 9,320 related deaths were
estimated to have occurred in 2018. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308
related deaths. Melanoma is mostly curable when treated in its very early stages; however, survival rates are roughly halved if regional lymph nodes are
involved.
Human capital
As of March 31, 2022, we employed 206 employees, all of which are full-time employees. Of the 206 employees, 178 are in research and development
and 28 are in selling, general and administrative functions. We have never had a work stoppage, and none of our employees is represented by a labor
organization or under any collective bargaining arrangements. We consider our employee relations to be good.
We focus on identifying, attracting, retaining and developing highly talented and motivated employees. Our equity and cash incentive plans are aligned
to attract, retain and reward our employees through the granting of stock-based and cash-based compensation awards. We believe motivating our
employees to perform at their highest level and take pride in achieving company goals increases stockholder value.
The well-being, health and safety of our employees are integral to the success of our business. Early in the COVID-19 outbreak we proactively
implemented social distancing policies at our facilities, encouraged and implemented work-from-home policies for our employees, other than those in
working in our laboratory, those performing manufacturing functions and certain other employees as deemed appropriate from time to time, and restricted
employee travel. In addition, we provided a safety training for all employees and we established a task force focused on creating and keeping employees
well informed about our latest plans and guidance around COVID-19.
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In response to public health directives, and in an effort to protect the health and safety of our employees, we continue to monitor the pandemic, assess
our work-from-home, return-to-office, and other health and safety policies and, as applicable, follow local, state and federal guidelines.
Corporate information
We are a Delaware corporation organized in July 2017. Our principal executive offices are located at 500 Unicorn Park Drive, 3 Floor, Woburn, MA
rd
01801, and our telephone number is (781) 222-9600. Our website is www.replimune.com. Information that is contained on, or that can be accessed through,
our website is not incorporated by reference into this Annual Report on Form 10-K, and you should not consider information on our website to be part of
this Annual Report on Form 10-K.
Available information
We make available free of charge on the investor relations portion of our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K, Proxy Statements for our annual meetings of stockholders, and amendments to those reports, as soon as reasonably
practicable after we file such material with, or furnish it to, the Securities and Exchange Commission, or SEC. These filings are available for download free
of charge on the investor relations portion of our website located at https://ir.replimune.com. The SEC also maintains a website that contains reports, proxy
and information statements and other information about issuers, like us, that file electronically with the SEC. The address of that website is
https://www.sec.gov.
Item 1A. Risk factors
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with
all of the other information in this Annual Report on Form 10-K, including our audited consolidated financial statements and related notes and
“Management’s discussion and analysis of results of operations and financial condition.” If any of the following risks are realized, our business, financial
condition, operating results and prospects could be materially and adversely affected. In that event, the price of our common stock could decline, and you
could lose part or all of your investment. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not
presently known to us or that we currently believe to be immaterial may also adversely affect our business.
Summary of risk factors
Material risks that may affect our business, operating results and financial condition include, but are not necessarily limited to, those relating to:
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the timing, progress, and results of our preclinical studies and clinical trials for our product candidates, and the timing, scope or likelihood of
regulatory filings and approvals for any of our product candidates;
our ability to develop and advance any future product candidates based on our proprietary RPx platform and successfully complete clinical trials;
our ability to develop our product candidates for use in combination with other checkpoint blockade therapies, including anti-PD-1;
our ability to successfully commercialize any product candidate for which we receive regulatory approval and our expectations regarding the size
of the patient populations or the market acceptance of our product candidates if approved for commercial use;
our ability to compete with other biopharmaceutical companies, biotechnology companies and other third parties and risks associated with such
third parties developing or commercializing products more quickly or marketing them more successfully than us;
negative developments in the field of immuno-oncology including clinical or commercial developments that may be attributed to our product
candidates;
our history of losses, the likelihood that we will continue to incur substantial and increasing net losses in the future, and the likelihood that we will
require additional financing to achieve our goals;
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering
RP1 and our other product candidates, claims others may make regarding rights in our intellectual property, and any potential infringement,
misappropriation or other violation of any third-party intellectual property rights;
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our ability to successfully complete transfer of our product manufacturing to our in-house manufacturing facility from our contract manufacturers
including comparability analysis and to qualify, obtain approval for, and maintain successful operation, approval and qualification of our in-house
manufacturing operations;
our ability to obtain and maintain sufficient quantities of raw material supplies to build or maintain our product candidate supplies or otherwise
operate our in-house manufacturing facility;
the costs of operating our in-house manufacturing facility and our reliance on third-party collaborators and clinical trial service providers, which
may be single or of limited source;
our compliance with domestic and foreign laws, rules and regulations and the consequences in the event that we fail to comply with such laws,
rules and regulations;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
our competitive position, and developments and projections relating to our competitors and our industry;
the impact of the COVID-19 coronavirus, or COVID-19, as a global pandemic and related public health issues, including potential material
supplies and supply chain disruptions, hiring and retaining talent, and global or national economic impacts such as inflation; and
the ongoing military conflict between Russia and Ukraine and the impact on the global economy and related governmental imposed sanctions.
Risks related to product development
Our product candidates are in the early stages of development, are not approved for commercial sale and might never receive regulatory approval or
become commercially viable. We have never generated any revenue from product sales and may never be profitable.
All of our product candidates are in research or development. We have not generated any revenues from the sale of products and do not expect to do so
for at least the next several years. Our lead product candidate, RP1, and any other product candidates will require extensive preclinical and/or clinical
testing and regulatory approval prior to commercial use. Our research and development efforts may not be successful. Even if our clinical development
efforts result in positive data, our product candidates may not receive regulatory approval or be successfully introduced and marketed at prices that would
permit us to operate profitably.
An underlying problem with our proprietary RPx platform would adversely affect our business and may require us to discontinue development of
product candidates based on the same or similar therapeutic approaches.
Since all of the product candidates in our current pipeline are based on our proprietary RPx platform, if any of our product candidates fail in
development as a result of any underlying problem with our proprietary RPx platform, then we may be required to discontinue development of all product
candidates that are based on our therapeutic approach. If we were required to discontinue development of our product candidates that are based on our
therapeutics approach, or if any of them were to fail to receive regulatory approval or achieve sufficient market acceptance, we could be prevented from or
significantly delayed in achieving profitability. We can provide no assurance that we would be successful at developing other product candidates based on
an alternative therapeutic approach.
We will not be able to commercialize our product candidates if our preclinical studies do not produce successful results and/or our clinical trials do not
demonstrate the safety and efficacy of our product candidates.
Our product candidates are susceptible to the risks of failure inherent at any stage of product development, including the occurrence of unexpected or
unacceptable adverse events or the failure to demonstrate efficacy in clinical trials. Clinical development is expensive and can take many years to complete,
and its outcome is inherently uncertain.
The results of preclinical studies, preliminary study results, and early clinical trials of our product candidates may not be predictive of the results of
later stage clinical trials. Our product candidates may not perform as we expect, may ultimately have a different or no impact on tumors, may have a
different mechanism of action than we expect in humans, and may not ultimately prove to be safe and effective.
Preliminary and final results from preclinical studies and early stage trials, and trials in compounds that we believe are similar to ours, may not be
representative of results that are found in larger, controlled, blinded, and longer-term studies. Product candidates may fail at any stage of preclinical or
clinical development. Product candidates may fail to show the desired
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safety and efficacy traits even if they have progressed through preclinical studies or initial clinical trials. Preclinical studies and clinical trials may also
reveal unfavorable product candidate characteristics, including safety concerns. A number of companies in the biopharmaceutical industry have suffered
significant setbacks in clinical trials, notwithstanding promising results in earlier preclinical studies or clinical trials or promising mechanisms of action. In
some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to
numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and
adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. Moreover, should there be an issue with the design of a
clinical trial, our results may be impacted. We may not discover such a flaw until the clinical trial is at an advanced stage.
We may also experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing
approval or commercialize our product candidates, including:
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the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may
be slower than we anticipate or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than we anticipate, or may
elect to participate in alternative clinical trials sponsored by our competitors with product candidates that treat the same indications as our product
candidates;
regulators or institutional review boards, or IRBs, may not authorize us or our investigators to commence a clinical trial, conduct a clinical trial at
a prospective trial site, or amend trial protocols, or may require that we modify or amend our clinical trial protocols;
• we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective
trial sites and/or contract research organizations, or CROs;
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clinical trials of our product candidates may produce negative or inconclusive results, or our studies may fail to reach the necessary level of
statistical significance, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development
programs;
our third-party contractors may fail to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us
in a timely manner, or at all, or we may be required to engage in additional clinical trial site monitoring;
• we, regulators, or IRBs may require that we or our investigators suspend or terminate clinical research for various reasons, including
noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks, undesirable side
effects, or other unexpected characteristics of the product candidate, or due to findings of undesirable effects caused by a chemically or
mechanistically similar therapeutic or therapeutic candidate;
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changes in manufacturing facilities or the manufacturing process for our product candidates may impact how our product candidates perform in
clinical trials;
changes could be adopted in marketing approval policies during the development period, rendering our data insufficient to obtain marketing
approval;
statutes or regulations could be amended or new ones could be adopted, especially in light of the upcoming reauthorization of the Prescription
Drug User Fee Act;
changes could be adopted in the regulatory review process for submitted product applications;
the cost of clinical trials of our product candidates may be greater than we anticipate or we may have insufficient funds for a clinical trial or to pay
the substantial user fees required by the FDA upon the filing of a Biologics License Application, or BLA, or equivalent authorizations from
comparable foreign regulatory authorities;
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient
or inadequate or we may not be able to obtain them on favorable terms due to reasons, such as international trade policies and supply chain
disruptions;
• we may decide, or regulators may require us, to conduct or gather, as applicable, additional clinical trials, analyses, reports, data, or preclinical
trials, or we may abandon product development programs. By example, the FDA may determine that larger trials, Phase 3 trials, randomized and
controlled clinical trials, or clinical trials designed to replicate results found in our registrational or pivotal trials are required before we may file a
BLA or before the FDA will approve a marketing application;
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• we may fail to reach an agreement with regulators or IRBs regarding the scope, design, or implementation of our clinical trials, and the FDA or
comparable foreign regulatory authorities may require changes to our study designs that make further study impractical or not financially prudent;
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regulators may ultimately disagree with the design or our conduct of our preclinical studies or clinical trials, finding that they do not support
product candidate approval;
• we may have delays in adding new investigators or clinical trial sites, or we may experience a withdrawal of clinical trial sites;
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patients that enroll in our studies may misrepresent their eligibility or may otherwise not comply with the clinical trial protocol, resulting in the
need to drop the patients from the study or clinical trial, increase the needed enrollment size for the clinical trial or extend its duration;
there may be regulatory questions or disagreements regarding interpretations of data and results;
the FDA or comparable foreign regulatory authorities may disagree with our study design, including endpoints, or our interpretation of data from
preclinical studies and clinical trials or find that a product candidate’s benefits do not outweigh its safety risks;
the FDA or comparable foreign regulatory authorities may not accept data from studies with clinical trial sites in foreign countries;
the FDA or comparable foreign regulatory authorities may disagree with our intended indications;
the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing, testing, comparability
or quality processes or our manufacturing facilities for clinical and future commercial supplies;
the data collected from clinical trials, including our registration directed or registration intended trials, of our product candidates may not be
sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable
submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
The FDA may decide that our intended pathways, including accelerated approval, are not appropriate for our product candidates, requiring that we
conduct additional studies. By example, in recent years the accelerated approval pathway has come under significant FDA and public scrutiny.
Accordingly, depending on the results of our studies, the FDA may be more conservative in granting accelerated approval or, if granted, may be
more apt to withdrawal approval if clinical benefit is not confirmed. Even if accelerated approval is granted, payors, including governmental
payors, may be less welling to provide sufficient reimbursement for products approved via accelerated approval;
the FDA or comparable foreign regulatory authorities may take longer than we anticipate to make a decision on our product candidates or
necessary inspections before an approval can be issued may be delayed;
• we may not be able to demonstrate that a product candidate provides an advantage over current standards of care or current or future competitive
therapies in development; and
• we, the third parties on which we rely, and the FDA may have delays in the conduct of our respective operations as a result of the effects of the
COVID-19 pandemic, which could result in delays or prevent our ability to receive marketing approval or commercialize our product candidates.
Our development costs will also increase if we experience delays in testing or approvals, and we may not have sufficient funding to complete the
testing and approval process for any of our product candidates. We may be required to obtain additional funds to complete clinical trials and prepare for
possible commercialization of our product candidates. We do not know whether any preclinical tests or clinical trials beyond what we currently have
planned will be required, will begin as planned, will need to be restructured, or will be completed on schedule, or at all. Significant delays relating to any
preclinical or clinical trials also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow
our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates and may harm our
business and results of operations. In addition, many of the factors that cause, or lead to, delays in clinical trials may ultimately lead to the denial of
marketing approval of any of our product candidates. If any of these occur, our business, financial condition, results of operations, stock price and prospects
may be materially harmed.
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We anticipate that our product candidates will be used in combination with third-party drugs, some of which are still in development, and we have
limited or no control over the supply, regulatory status, or regulatory approval of such drugs.
Our product candidates may be administered in combination with checkpoint blockade drugs, a class of drugs that are intended to stop tumor cells
from “switching off” an immune system attack against themselves. We have entered into agreements with BMS for the supply of nivolumab, its anti-PD-1
therapy, for use in connection with our ongoing IGNYTE Phase 1/2 trials with RP1, our Phase 1/2 clinical trial with RP2 and our Phase 1 and Phase 2
clinical trials with RP3 where we decide to use nivolumab. We have also entered into a clinical collaboration agreement with Regeneron, which includes
the supply of cemiplimab, its anti-PD-1 therapy, for clinical trials conducted thereunder. We are enrolling patients in the CERPASS trial, our first planned
clinical trial under the Regeneron agreement. We may enter into additional agreements for the supply of anti-PD-1 products for use in combination with
and for the continued development of one or more of our product candidates. Our ability to develop and ultimately commercialize our product candidates
used in combination with nivolumab, cemiplimab or any other checkpoint blockade therapy will depend on our ability to access such drugs on
commercially reasonable terms for the clinical trials and their availability for use with the commercialized product, if approved. We cannot be certain that
current or potential future commercial relationships will provide us with a steady supply of such drugs on commercially reasonable terms or at all.
Any failure to maintain or enter into new successful commercial relationships, or the expense of purchasing checkpoint blockade therapies in the
market, may delay our development timelines, increase our costs and jeopardize our ability to develop our product candidates as commercially viable
therapies. If any of these occur, our business, financial condition, results of operations, stock price and prospects may be materially harmed.
Moreover, the development of our product candidates for use in combination with another product or product candidate may present challenges that are
not faced for single agent product candidates. While we have opened a clinical trial for use of RP1 as a monotherapy, we are generally developing RP1 and
our other product candidates for use in combination with anti-PD-1 or potentially anti-PD(L)-1 therapies and may develop RP1 or our other product
candidates for use with other therapies. Although we intend our IGNYTE anti-PD-1 failed melanoma cohort and our CERPASS trial to be registration
directed, the FDA may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to
any observed effects. It is possible that the results of these trials could show that any positive previous trial results are attributable to the therapy with which
our products were combined and not our product candidates. Moreover, following product approval, the FDA may require that products used in conjunction
with each other be cross-labeled for combined use. To the extent that we do not have rights to the other product, this may require us to work with a third
party to satisfy such a requirement. Moreover, developments related to the other product may impact our clinical trials for the combination as well as our
commercial prospects should we receive marketing approval. Such developments may include changes to the other product’s safety or efficacy profile,
changes to the availability of the approved product, and changes to the standard of care.
In the event that BMS, Regeneron or any future collaborator or supplier cannot continue to supply their products on commercially reasonable terms or
at all, we would need to identify alternatives for accessing an anti-PD-1 therapy. Additionally, should the supply of products from BMS, Regeneron or any
future collaborator or supplier be interrupted, delayed or otherwise be unavailable to us, our clinical trials may be delayed, interrupted or halted. In the
event we are unable to source a supply of an acceptable alternative anti-PD-1 therapy, or are unable to do so on commercially reasonable terms, our
business, financial condition, results of operations, stock price and prospects may be materially harmed.
If we fail to develop additional product candidates, our commercial opportunity could be limited.
Our lead product candidate is RP1. A key part of our strategy is to pursue clinical development of RP1 and additional product candidates, including
RP2 and RP3. Developing, obtaining marketing approval for, and commercializing additional product candidates will require substantial additional funding
and will be subject to the risks of failure inherent in medical product development. We cannot assure our shareholders that we will be able to successfully
advance any of these additional product candidates through the development process.
Even if we obtain approval from the FDA or comparable foreign regulatory authorities to market additional product candidates for the treatment of
solid tumors, we cannot assure our shareholders that any such product candidates will be successfully commercialized, widely accepted in the marketplace,
or more effective than other commercially available alternatives. If we are unable to successfully develop and commercialize additional product candidates,
our commercial opportunity may be limited and our business, financial condition, results of operations, stock price and prospects may be materially
harmed.
Risks related to regulatory approval
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Even if our development efforts are successful, we may not obtain regulatory approval for any of our product candidates in the United States or other
jurisdictions, which would prevent us from commercializing our product candidates. Even if we obtain regulatory approval for our product candidates,
any such approval may be subject to limitations, including with respect to the approved indications or patient populations, which could impair our
ability to successfully commercialize our product candidates.
We are not permitted to market or promote or sell any of our product candidates before we receive regulatory approval from the FDA or comparable
foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates. Securing marketing approval requires
the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the
product candidate’s safety and efficacy for that indication. Securing marketing approval also requires the submission of information about the product
manufacturing process to, and inspection of manufacturing facilities and clinical trial sites by, the regulatory authorities. If we do not receive approval from
the FDA and comparable foreign regulatory authorities for any of our product candidates, we will not be able to commercialize such product candidates in
the United States or in other jurisdictions. If significant delays in obtaining approval for and commercializing our product candidates occur in any
jurisdictions, our business, financial condition, results of operations, stock price and prospects will be materially harmed. Even if our product candidates
are approved, they may:
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be subject to limitations on the indicated uses or patient populations for which they may be marketed, distribution restrictions, or other conditions
of approval;
contain significant safety warnings, including boxed warnings, contraindications, and precautions;
not be approved with label statements necessary or desirable for successful commercialization; or
contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a risk evaluation and
mitigation strategy, or REMS, to monitor the safety or efficacy of the products.
We have not previously submitted a BLA to the FDA, or a similar marketing application to comparable foreign regulatory authorities, for any product
candidate, and we can provide no assurance that we will ultimately be successful in obtaining regulatory approval for claims that are necessary or desirable
for successful marketing, or at all.
The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently
unpredictable. If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our
product candidates as expected, and our ability to generate revenue may be materially impaired.
The time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years
following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In
addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product
candidate’s clinical development and may vary among jurisdictions and there may be varying interpretations of data obtained from preclinical studies or
clinical trials, any of which may cause delays or limitations in the approval or a decision not to approve an application. These regulatory requirements may
require us to amend our clinical trial protocols, conduct additional preclinical studies or clinical trials that may require regulatory or IRB approval, or
otherwise cause delays in the approval or rejection of an application. Any delay in obtaining or failure to obtain required approvals could materially
adversely affect our ability to generate revenue from the particular product candidate, which may materially harm our business, financial condition, results
of operations, stock price and prospects.
If we experience delays in obtaining approval, if we fail to obtain approval of a product candidate or if the label for a product candidate does not
include the labeling claims necessary or desirable for the successful commercialization of that product candidate, the commercial prospects for such
product candidate may be harmed and our ability to generate revenues from that product candidate may be materially impaired.
The FDA or a comparable foreign regulatory authority may determine that our product candidates have undesirable side effects that could delay or
prevent their regulatory approval or commercialization.
There can be no assurance that undesirable side effects or serious adverse events will not be caused by or associated with RP1 or our other product
candidates as they continue through or enter clinical development. Serious adverse events or undesirable side effects caused by our product candidates
could cause us, IRBs, and other reviewing entities or regulatory authorities to interrupt, delay, or halt clinical trials and could result in a more restrictive
label or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. For example, if concerns are raised regarding
the
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safety of a new therapeutic as a result of undesirable side effects identified during clinical or preclinical testing, the FDA or comparable foreign regulatory
authority may order us to cease further development, decline to approve the product candidate or issue a letter requesting additional data or information
prior to making a final decision regarding whether or not to approve the product candidate. The FDA or comparable foreign regulatory authorities, or IRBs
and other reviewing entities, may also require, or we may voluntarily develop, strategies for managing adverse events during clinical development, which
could include restrictions on our enrollment criteria, the use of stopping criteria, adjustments to a study’s design, or the monitoring of safety data by a data
monitoring committee, among other strategies. The FDA or comparable foreign regulatory authority requests for additional data or information could also
result in substantial delays in the approval of our product candidates.
Undesirable side effects caused by any of our product candidates could also result in denial of regulatory approval by the FDA or comparable foreign
regulatory authorities for any or all targeted indications or the inclusion of unfavorable information in our product labeling, such as limitations on the
indicated uses for which the products may be marketed or distributed, a label with significant safety warnings, including boxed warnings, contraindications,
and precautions, a label without statements necessary or desirable for successful commercialization, or may result in requirements for costly post-marketing
testing and surveillance, or other requirements, including REMS, to monitor the safety or efficacy of the products, and in turn prevent us from
commercializing and generating revenues from the sale of our product candidates. Undesirable side effects may limit the potential market for any approved
products or could result in the discontinuation of the sales and marketing of the product, or withdrawal of product approvals. Later discovered undesirable
side effects may further result in the imposition of a REMS, label revisions, post approval study requirements, or other testing and surveillance.
If any of our product candidates is associated with serious adverse events or undesirable side effects or have properties that are unexpected, we may
need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other
characteristics are less prevalent, less severe or more acceptable from a risk/benefit perspective. The therapeutic-related side effects could affect patient
recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may materially
harm our business, financial condition, results of operations, stock price and prospects.
Changes in product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates are developed through preclinical studies to later stage clinical trials towards approval and commercialization, it is common that
various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes
and results. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future
clinical trials conducted with the altered materials. Such changes may also require additional testing, or notification to, or approval by the FDA or a
comparable foreign regulatory authority. This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the
repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and/or jeopardize our ability to commence
product sales and generate revenue.
Regulatory approval by the FDA or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval
has been granted, and we may be subject to substantial fines, criminal penalties, injunctions, or other enforcement actions if we are determined to be
promoting the use of our products for unapproved or “off label” uses, resulting in damage to our reputation and business.
We must comply with requirements concerning advertising and promotion for any product candidates for which we obtain marketing approval.
Promotional communications with respect to therapeutics are subject to a variety of legal and regulatory restrictions and continuing review by the FDA,
Department of Justice, Department of Health and Human Services’ Office of Inspector General, state attorneys general, members of Congress, and the
public. When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to
those specific uses and indications for which a product is approved. If we are not able to obtain FDA approval for desired uses or indications for our
product candidates, we may not market or promote them for those indications and uses, referred to as off label uses, and our business, financial condition,
results of operations, stock price and prospects may be materially harmed. We also must sufficiently substantiate any claims that we make for our products,
including claims comparing our products to other companies’ products, and must abide by the FDA’s strict requirements regarding the content of promotion
and advertising.
While physicians may choose to prescribe products for uses that are not described in the product’s labeling and for uses that differ from those tested in
clinical trials and approved by the regulatory authorities, we are prohibited from marketing and promoting the products for indications and uses that are not
specifically approved by the FDA. These off label uses are common across medical specialties and may constitute an appropriate treatment for some
patients in varied circumstances. Regulatory authorities in the United States generally do not restrict or regulate the behavior of physicians in their choice
of treatment within
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the practice of medicine. Regulatory authorities do, however, restrict communications by biopharmaceutical companies concerning off label use.
If we are found to have impermissibly promoted any of our product candidates, we may become subject to significant liability and government fines.
The FDA and other agencies actively enforce the laws and regulations regarding product promotion, particularly those prohibiting the promotion of off
label uses, and a company that is found to have improperly promoted a product may be subject to significant sanctions. The federal government has levied
large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off label promotion.
The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or
curtailed.
In the United States, engaging in the impermissible promotion of our products, following approval, for off label uses can also subject us to false claims
and other litigation under federal and state statutes. These include fraud and abuse and consumer protection laws, which can lead to civil and criminal
penalties and fines and agreements with governmental authorities that materially restrict the manner in which we promote or distribute therapeutic products
and conduct our business. These restrictions could include corporate integrity agreements, suspension or exclusion from participation in federal and state
healthcare programs, and suspension and debarment from government contracts and refusal of orders under existing government contracts. These False
Claims Act lawsuits against manufacturers of drugs and biologics have increased significantly in volume and breadth. In addition, False Claims Act
lawsuits may expose manufacturers to follow-on claims by private payers based on fraudulent marketing practices. This growth in litigation has increased
the risk that a biopharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, as well as criminal and civil
penalties, agree to comply with burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid, or other federal and state
healthcare programs. If we do not lawfully promote our approved products, if any, we may become subject to such litigation and, if we do not successfully
defend against such actions, those actions may have a material adverse effect on our business, financial condition, results of operations, stock price and
prospects.
In the United States, the promotion of biopharmaceutical products is subject to additional FDA requirements and restrictions on promotional
statements. If after one or more of our product candidates obtains marketing approval the FDA determines that our promotional activities violate its
regulations and policies pertaining to product promotion, it could request that we modify our promotional materials or subject us to regulatory or other
enforcement actions, including issuance of warning letters or untitled letters, suspension or withdrawal of an approved product from the market, requests
for recalls, payment of civil fines, disgorgement of money, imposition of operating restrictions, injunctions or criminal prosecution, and other enforcement
actions. Similarly, industry codes in foreign jurisdictions may prohibit companies from engaging in certain promotional activities and regulatory agencies
in various countries may enforce violations of such codes with civil penalties. If we become subject to regulatory and enforcement actions our business,
financial condition, results of operations, stock price and prospects will be materially harmed.
Even if our product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may
result in significant additional expense and limit how we manufacture and market our products.
Any product candidate for which we obtain marketing approval will be subject to extensive and ongoing requirements of and review by the FDA and
comparable foreign regulatory authorities, including requirements related to the manufacturing processes, post approval clinical data, labeling, packaging,
distribution, adverse event reporting, shortage reporting, risk management plans, supply chain security, storage, recordkeeping, export, import, advertising,
marketing, and promotional activities for such product. These requirements further include submissions of safety and other post-marketing information,
including manufacturing deviations and reports, registration and listing requirements, the payment of annual fees, continued compliance with current Good
Manufacturing Practice, or cGMP, requirements relating to manufacturing, quality control, quality assurance, and corresponding maintenance of records
and documents, and good clinical practices, or GCPs, for any clinical trials that we conduct post approval.
The FDA and comparable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval. If the
FDA or comparable foreign regulatory authorities become aware of new safety information after approval of any of our product candidates, they may
withdraw approval, issue public safety alerts, require labeling changes or establishment of a REMS or similar strategy, impose significant restrictions on a
product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post approval studies or post-market surveillance. Any such
restrictions could limit sales of the product.
We and any of our suppliers or collaborators, including our contract manufacturers, could be subject to periodic unannounced inspections by the FDA
to monitor and ensure compliance with cGMPs and other FDA regulatory requirements.
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Application holders must further notify the FDA, and depending on the nature of the change, obtain FDA preapproval for product and manufacturing
changes.
In addition, later discovery of previously unknown adverse events or that the product is less effective than previously thought or other problems with
our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements both before and after approval, may yield
various negative results, including:
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restrictions on manufacturing, distribution, or marketing of such products;
restrictions on the labeling, including required additional warnings, such as black boxed warnings, contraindications, precautions, and restrictions
on the approved indication or use;
• modifications to promotional pieces;
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issuance of corrective information;
requirements to conduct post-marketing studies or other clinical trials;
clinical holds or termination of clinical trials;
requirements to establish or modify a REMS or similar strategy;
changes to the way the product candidate is administered;
liability for harm caused to patients or subjects;
reputational harm;
the product becoming less competitive;
• warning, untitled, or cyber letters;
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suspension of marketing or withdrawal of the products from the market;
regulatory authority issuance of safety alerts, Dear Healthcare Provider letters, press releases, or other communications containing warnings or
other safety information about the product candidate;
refusal to approve pending applications or supplements to approved applications that we submit;
recalls of products;
fines, restitution or disgorgement of profits or revenues;
suspension or withdrawal of marketing approvals;
refusal to permit the import or export of our products;
product seizure or detention;
FDA debarment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from
federal healthcare programs, consent decrees, or corporate integrity agreements; or
injunctions or the imposition of civil or criminal penalties, including imprisonment.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, or could
substantially increase the costs and expenses of commercializing such product, which in turn could delay or prevent us from generating significant revenues
from its marketing and sale. Any of these events could further have other material and adverse effects on our operations and business and could adversely
impact our business, financial condition, results of operations, stock price and prospects.
The FDA’s policies or those of comparable foreign regulatory authorities may change and additional government regulations may be enacted that could
prevent, limit or delay regulatory approval of our product candidates, limit the marketability of our product candidates, or impose additional regulatory
obligations on us. Changes in medical practice and standard of care may also impact the marketability of our product candidates.
If we are slow or unable to adapt to changes in existing requirements, standards of care, or the adoption of new requirements or policies, or if we are
not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and be subject to regulatory enforcement
action.
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Should any of the above actions take place, we could be prevented from or significantly delayed in achieving profitability. Further, the cost of
compliance with post approval regulations may have a negative effect on our operations and business and could adversely impact our business, financial
condition, results of operations, stock price and prospects.
Obtaining and maintaining marketing approval for our product candidates in one jurisdiction would not mean that we will be successful in obtaining
marketing approval of that product candidate in other jurisdictions, which could prevent us from marketing our products internationally.
Obtaining and maintaining marketing approval of our product candidates in one jurisdiction would not guarantee that we will be able to obtain or
maintain marketing approval in any other jurisdiction, while a failure or delay in obtaining marketing approval in one jurisdiction may have a negative
effect on the marketing approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable foreign
regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures
vary among jurisdictions and can involve requirements and administrative review periods different from and, in some cases, greater than, those in the
United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory
authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be
approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval. Additionally, with the
full departure of the United Kingdom from the European Union in January 2021, commonly referred to as Brexit, there is continuing regulatory uncertainty.
Since a significant proportion of the regulatory framework in the United Kingdom is derived from European Union directives and regulations, and the
degree to which the United Kingdom and European Union regulatory regimes align or diverge could materially impact the execution of our clinical trials or
approval of our product candidates in the United Kingdom or the European Union.
Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply
prior to marketing in those jurisdictions. Obtaining foreign marketing approvals and compliance with foreign regulatory requirements could result in
significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the
regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize
the full market potential of our product candidates will be harmed. If we obtain approval for any product candidate and ultimately commercialize that
product in foreign markets, we would be subject to additional risks and uncertainties, including the burden of complying with complex and changing
foreign regulatory, tax, accounting and legal requirements and the reduced protection of intellectual property rights in some foreign countries.
Risks related to commercialization
If we are unable to successfully commercialize any product candidate for which we receive regulatory approval, or experience significant delays in
doing so, our business will be materially harmed.
If we are successful in obtaining marketing approval from applicable regulatory authorities for RP1 or any of our other product candidates, our ability
to generate revenues from our product candidates will depend on our success in:
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launching commercial sales of our product candidates, whether alone or in collaboration with others;
receiving an approved label with claims that are necessary or desirable for successful marketing, and that does not contain safety or other
limitations that would impede our ability to market the product candidates;
creating market demand for our product candidates through marketing, sales and promotion activities;
hiring, training, and deploying a sales force or contracting with third parties to commercialize product candidates in the United States;
• manufacturing product candidates in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter;
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establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms;
creating partnerships with, or offering licenses to, third parties to promote and sell product candidates in foreign markets where we receive
marketing approval;
• maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;
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achieving market acceptance of our product candidates by patients, the medical community, and third-party payors;
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achieving appropriate reimbursement for our product candidates;
effectively competing with other therapies; and
• maintaining a continued acceptable safety profile of our product candidates following launch.
To the extent we are not able to do any of the foregoing, our business, financial condition, results of operations, stock price and prospects will be
materially harmed.
We face significant competition from other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and other
research organizations, which may result in others discovering, developing or commercializing products more quickly or marketing them more
successfully than us. If their product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or
eliminated.
The development and commercialization of cancer immunotherapy products is characterized by rapidly advancing technologies, intense competition
and a strong emphasis on proprietary rights. We face competition with respect to our current product candidates, and will face competition with respect to
any product candidates that we may seek to develop or commercialize in the future, from major biopharmaceutical companies, specialty biopharmaceutical
companies, and biotechnology companies worldwide. There are a number of large biopharmaceutical and biotechnology companies that currently market
and sell products or are pursuing the development of products for the treatment of solid tumors, including oncolytic immunotherapy and cancer vaccine
approaches. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct
research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization.
While our product candidates are intended to be used in combination with other drugs with different mechanisms of action, if and when marketed they
will still compete with a number of drugs that are currently marketed or in development that also target cancer. To compete effectively with these drugs, our
product candidates will need to demonstrate advantages in clinical efficacy and safety compared to these competitors when used alone or in combination
with other drugs.
Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,
have fewer or less severe side effects, are easier to administer or are less expensive alone or in combination with other therapies than any products that we
may develop alone or in combination with other therapies. Our competitors also may obtain FDA or comparable foreign regulatory authority approval for
their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are
able to enter the market. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors coverage decisions.
Certain of the companies with which we are competing or may compete in the future have significantly greater financial resources and expertise in
research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products
than we do. Mergers and acquisitions in the biopharmaceutical and biotechnology industries may result in even more resources being concentrated among a
smaller number of our competitors. Early stage companies may also prove to be significant competitors, particularly through collaborative arrangements
with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel and
establishing clinical trial sites and patient registration for clinical trials, as well as in developing or acquiring technologies complementary to, or necessary
for, our programs. If we are unable to successfully compete with these companies our business, financial condition, results of operations, stock price and
prospects may be materially harmed.
If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market and sell our
product candidates, if they are approved, the revenues that we generate may be limited and we may never become profitable.
We currently do not have a commercial infrastructure for the marketing, sale, and distribution of our product candidates. If and when our product
candidates receive marketing approval, we intend to commercialize our product candidates on our own in the United States and potentially with
pharmaceutical or biotechnology partners in other geographies. In order to commercialize our products, we must build our marketing, sales, and
distribution capabilities or make arrangements with third parties to perform these services. We may not be successful in doing so. Should we decide to
move forward in developing our own marketing capabilities, we may incur expenses prior to product launch or even approval in order to recruit a sales
force and develop a marketing and sales infrastructure. If a commercial launch is delayed as a result of FDA or comparable foreign regulatory authority
requirements or other reasons, we would incur these expenses prior to being able to realize any revenue from sales of our product candidates. Even if we
are able to effectively hire a sales force and develop a marketing and sales
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infrastructure, our sales force and marketing teams may not be successful in commercializing our product candidates. This may be costly, and our
investment would be lost if we cannot retain or reposition our sales and marketing personnel.
We may also or alternatively decide to collaborate with third-party marketing and sales organizations to commercialize any approved product
candidates in the United States, in which event, our ability to generate product revenues may be limited. To the extent we rely on third parties to
commercialize any products for which we obtain regulatory approval, we may receive less revenues than if we commercialized these products ourselves,
which could materially harm our prospects. In addition, we would have less control over the sales efforts of any other third parties involved in our
commercialization efforts, and could be held liable if they failed to comply with applicable legal or regulatory requirements.
We have no prior experience in the marketing, sale, and distribution of biopharmaceutical products, and there are significant risks involved in building
and managing a commercial infrastructure. The establishment and development of commercial capabilities, including compliance plans, to market any
products we may develop will be expensive and time consuming and could delay any product launch, and we may not be able to successfully develop this
capability. We will have to compete with other biopharmaceutical and biotechnology companies, including oncology-focused companies, to recruit, hire,
train, manage, and retain marketing and sales personnel, which is expensive and time consuming and could delay any product launch. Developing our sales
capabilities may also divert resources and management attention away from product development.
In the event we are unable to develop a marketing and sales infrastructure, we may not be able to commercialize our product candidates in the United
States or elsewhere, which could limit our ability to generate product revenues and materially harm our business, financial condition, results of operations,
stock price and prospects. Factors that may inhibit our efforts to commercialize our product candidates include:
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the inability to recruit, train, manage, and retain adequate numbers of effective sales and marketing personnel;
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe our product candidates;
our inability to effectively oversee a geographically dispersed sales and marketing team;
the costs associated with training sales and marketing personnel on legal and regulatory compliance matters and monitoring their actions;
an inability to secure adequate coverage and reimbursement by government and private health plans;
the clinical indications for which the products are approved and the claims that we may make for the products;
limitations or warnings, including distribution or use restrictions, contained in the products’ approved labeling;
any distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities or to which we agree as part of a mandatory
REMS or voluntary risk management plan;
liability for sales or marketing personnel who fail to comply with the applicable legal and regulatory requirements;
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with
more extensive product lines; and
unforeseen costs and expenses associated with creating an independent sales and marketing organization or engaging a contract sales organization.
Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product
candidate development.
We have concentrated all of our research and development efforts on product candidates based on our proprietary RPx platform, and our future success
depends on the successful development of this therapeutic approach. There can be no assurance that any development problems we experience in the future
will not cause significant delays or unanticipated costs, or that such development problems can be solved. Should we encounter development problems,
including unfavorable preclinical or clinical trial results, the FDA and foreign regulatory authorities may refuse to approve our product candidates, or may
require additional information, tests, or trials, which could significantly delay product development and significantly increase our development costs.
Moreover, even if we are able to provide the requested information or trials to the FDA, there would be no guarantee that the FDA would accept them or
approve our product candidates. We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process, or
developing or qualifying and validating product release assays, other testing and manufacturing methods, and our equipment and facilities in a timely
manner, which may prevent us from completing our clinical trials or commercializing our product candidates on a timely or profitable basis, if at all.
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In addition, the clinical trial requirements of the FDA and comparable foreign regulatory authorities and the criteria these regulators use to determine
the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential
products. The FDA and comparable foreign regulatory authorities have limited experience with the approval of oncolytic immunotherapies. Only one
oncolytic immunotherapy, T-Vec, has received FDA approval to date. Any product candidates that are approved may be subject to extensive post approval
regulatory requirements, including requirements pertaining to manufacturing, distribution, and promotion. We may need to devote significant time and
resources to compliance with these requirements.
If our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales may be limited, and we may never
become profitable.
We have never commercialized a product candidate for any indication. Even if our product candidates are approved by the appropriate regulatory
authorities for marketing and sale, they may not gain acceptance among physicians, patients, third-party payors, and others in the medical community. If
any product candidates for which we obtain regulatory approval do not gain an adequate level of market acceptance, we could be prevented from or
significantly delayed in achieving profitability. Market acceptance of our product candidates by the medical community, patients, and third party payors
will depend on a number of factors, some of which are beyond our control. For example, physicians are often reluctant to switch their patients and patients
may be reluctant to switch from existing therapies even when new and potentially more effective or safer treatments enter the market.
Efforts to educate the medical community and third party payors on the benefits of our product candidates may require significant resources and may
not be successful. If any of our product candidates is approved but does not achieve an adequate level of market acceptance, we could be prevented from or
significantly delayed in achieving profitability. The degree of market acceptance of any of our product candidates will depend on a number of factors,
including:
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the efficacy of our product candidates in combination with marketed checkpoint blockade drugs;
the commercial success of the checkpoint blockade drugs with which our products are co-administered;
the prevalence and severity of adverse events associated with our product candidates or those products with which they are co-administered;
the clinical indications for which the products are approved and the approved claims that we may make for the products;
limitations or warnings contained in the product’s FDA-approved labeling or those of comparable foreign regulatory authorities, including
potential limitations or warnings for our product candidates that may be more restrictive than other competitive products;
changes in the standard of care for the targeted indications for our product candidates, which could reduce the marketing impact of any claims that
we could make following FDA approval or approval by comparable foreign regulatory authorities, if obtained;
the relative convenience and ease of administration of our product candidates by direct injection into tumors, a less common method for the
administration of oncology therapies than systemic administration, which may result in slower adoption of our therapies;
the relative convenience and ease of administration of any products with which our product candidates are co-administered;
the cost of treatment compared with the economic and clinical benefit of alternative treatments or therapies;
the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by
government healthcare programs, including Medicare and Medicaid;
the price concessions required by third-party payors to obtain coverage;
the extent and strength of our marketing and distribution of our product candidates;
the safety, efficacy, and other potential advantages over, and availability of, alternative treatments already used or that may later be approved;
distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities with respect to our product candidates or to
which we agree as part of a REMS or voluntary risk management plan;
the timing of market introduction of our product candidates, as well as competitive products;
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our ability to offer our product candidates for sale at competitive prices;
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
the extent and strength of our manufacturing operations and our third-party manufacturer and supplier support;
the actions of companies that market any products with which our product candidates are co-administered;
the approval of other new products;
adverse publicity about our product candidates or any products with which they are co-administered, or favorable publicity about competitive
products; and
potential product liability claims.
The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for
our product candidates may be smaller than our estimates.
The potential market opportunities for our product candidates are difficult to estimate and will depend in large part on the drugs with which our
product candidates are co-administered and the success of competing therapies and therapeutic approaches. In particular, the market opportunity for
oncolytic immunotherapies is hard to estimate given that it is an emerging field with only one existing FDA-approved oncolytic immunotherapy, T-Vec,
which has yet to enjoy broad market acceptance. Our estimates of the potential market opportunities are predicated on many assumptions, which may
include industry knowledge and publications, third-party research reports, and other surveys. Although we believe that our internal assumptions are
reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain, and their
reasonableness has not been assessed by an independent source. If any of the assumptions proves to be inaccurate, the actual markets for our product
candidates could be smaller than our estimates of the potential market opportunities.
Negative developments in the field of immuno-oncology could damage public perception of our product candidates and negatively affect our business.
The commercial success of our product candidates will depend in part on public acceptance of the use of cancer immunotherapies. Adverse events in
clinical trials of RP1 or our other product candidates or in clinical trials of others developing similar products and the resulting publicity, as well as any
other negative developments in the field of immuno-oncology that may occur in the future, including in connection with competitor therapies, could result
in a decrease in demand for our product candidates. These events could also result in the suspension, discontinuation, or clinical hold of or modification to
our clinical trials. If public perception is influenced by claims that the use of cancer immunotherapies is unsafe, whether related to our therapies or those of
our competitors, our product candidates may not be accepted by the general public or the medical community and potential clinical trial subjects may be
discouraged from enrolling in our clinical trials. As a result, we may not be able to continue or may be delayed in conducting our development programs.
As our product candidates consist of a modified virus, adverse developments in antiviral vaccines or clinical trials of other oncolytic immunotherapy
products based on viruses may result in a disproportionately negative effect for our product candidates as compared to other products in the field of
immuno-oncology that are not based on viruses. Future negative developments in the field of immuno-oncology or the biopharmaceutical industry could
also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our products. Any
increased scrutiny could delay or increase the costs of obtaining marketing approval for our product candidates.
Risks related to our financial position and need for additional capital
We are a clinical stage biopharmaceutical company with a very limited operating history. We have incurred net losses since our inception and
anticipate that we will continue to incur substantial and increasing net losses in the foreseeable future. We may never achieve or sustain profitability.
We are a clinical stage biopharmaceutical company with a limited operating history, and we are early in our development efforts. We have no products
approved for commercial sale and have not generated any revenue from product sales to date, and we continue to incur significant research and
development and other expenses related to our ongoing operations. Investment in biopharmaceutical product development is highly speculative because it
entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an
acceptable safety profile, gain marketing approval and become commercially viable. We have financed our operations to date primarily through the sale of
equity securities, including the sale of our common stock and pre-funded warrants in our public offerings. Since our inception, most of our resources have
been dedicated to the preclinical and clinical development of our proprietary RPx
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platform, including our lead product candidate, RP1, and our other product candidates. The size of our future net losses will depend, in part, on our future
expenses and our ability to generate revenue, if any.
We are not profitable and have incurred losses in each period since our inception. For the years ended March 31, 2022 and 2021, we reported a net loss
of $118.0 million and $80.9 million, respectively. At March 31, 2022, we had an accumulated deficit of $311.2 million. We expect to continue to incur
significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek marketing
approvals for, RP1, our other product candidates and any additional product candidates we may develop.
Even if we succeed in receiving marketing approval for and commercialize RP1 or our other product candidates, we will continue to incur substantial
research and development and other expenditures to develop and market additional potential products. We may encounter unforeseen expenses, difficulties,
complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of
future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an
adverse effect on our stockholders’ equity and working capital.
We have never generated any revenue from product sales, and our ability to generate revenue from product sales and become profitable will depend
significantly on our success in achieving a number of goals.
We have no products approved for commercial sale, have not generated any revenue from product sales, and do not anticipate generating any revenue
from product sales until after we have received marketing approval for the commercial sale of a product candidate, if ever. Our ability to generate revenue
and achieve profitability depends significantly on our success in achieving a number of goals, including:
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completing research regarding, and preclinical and clinical development of, RP1 and our other product candidates;
obtaining marketing approvals for RP1 and our other product candidates for which we complete clinical trials;
developing a sustainable and scalable manufacturing process for RP1 and our other product candidates, including establishing and maintaining
commercially viable supply and manufacturing relationships with third parties;
launching and commercializing RP1 and our other product candidates for which we obtain marketing approvals, either directly or with a
collaborator or distributor;
obtaining market acceptance of RP1 and our other product candidates as viable treatment options;
addressing any competing technological and market developments;
identifying, assessing, acquiring and developing new product candidates;
negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter;
obtaining, maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and
attracting, hiring, and retaining qualified personnel.
Even if our product candidates or any future product candidates that we develop are approved for commercial sale, we anticipate incurring significant
costs associated with commercializing any such product candidate. Our expenses could increase beyond expectations if we are required by the FDA or
comparable foreign regulatory authorities to change our manufacturing processes or assays, or to perform clinical, nonclinical, or other types of studies in
addition to those that we currently anticipate.
If we are successful in obtaining regulatory approvals to market RP1 or our other product candidates, our revenue will be dependent, in part, upon the
size of the markets in the territories for which we gain marketing approval, the accepted price for the product, the ability to get reimbursement at any price,
and whether we own the commercial rights for that territory. If the number of our addressable patients is not as significant as we estimate, the indication
approved by regulatory authorities is narrower than we expect, the labels for our product candidates contain significant safety warnings, regulatory
authorities impose burdensome or restrictive distribution requirements, or the reasonably accepted patient population for treatment is narrowed by
competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. If we are not
able to generate revenue from the sale of any approved products, we could be prevented from or significantly delayed in achieving profitability.
We will require additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all,
could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
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Our operations have consumed substantial amounts of cash since inception. At March 31, 2022, our cash and cash equivalents and short-term
investments were $395.7 million. We expect to continue to spend substantial amounts to continue the clinical and preclinical development of RP1 and our
other product candidates. Accordingly, we will need to obtain additional funds to achieve our business objectives. If we are able to gain marketing approval
of any product candidate, we will require significant additional amounts of cash in order to launch and commercialize such product. In addition, other
unanticipated costs may arise.
Our future capital requirements depend on many factors, including:
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the scope, progress, results and costs of researching and developing RP1 and our other product candidates, and conducting preclinical studies and
clinical trials;
the timing of, and the costs involved in, obtaining marketing approvals for RP1 and our other product candidates if clinical trials are successful;
the success of any collaborations;
the cost of commercialization activities for any approved product, including marketing, sales and distribution costs;
the cost and timing of operating our manufacturing facility;
the cost of manufacturing RP1 and our other product candidates for clinical trials in preparation for marketing approval and commercialization;
our ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;
the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and
the outcome of such litigation;
the timing, receipt, and amount of sales of, or royalties on, our future products, if any; and
the emergence of competing cancer therapies and other adverse market developments.
We do not have any committed external source of funds or other support for our development efforts. Until we can generate sufficient product revenue
to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity
offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. Based on our
research and development plans, we expect that our existing cash and cash equivalents and short-term investments will enable us to fund our planned
operating expenses and capital expenditure requirements into the second half of calendar 2024. We have based this estimate on assumptions that may prove
to be wrong, and we could exhaust our available capital resources sooner than we expect. In addition, because the design and outcome of our planned and
anticipated clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and
commercialization of RP1 or our other product candidates.
Risks related to intellectual property
If we are unable to obtain, maintain and protect our intellectual property rights for our technology and product candidates, or if our intellectual
property rights are inadequate, our competitive position could be harmed.
Our commercial success will depend in part on our ability to obtain and maintain patent and other intellectual property protection in the United States
and other countries with respect to our technology and proprietary RPx platform, including our lead product candidate, RP1, and our other product
candidates. We rely on trade secret, patent, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third
parties, all of which offer only limited protection.
The patent positions of biotechnology and pharmaceutical companies generally are highly uncertain, involve complex legal and factual questions and
have in recent years been the subject of much litigation and subject to change with regulatory agencies and court decisions. As a result, the issuance, scope,
validity, enforceability and commercial value of our licensed patents and any patents we own in the future are highly uncertain. The steps we have taken to
protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information, use by third parties of our products or
infringement of our intellectual property rights, both inside and outside of the United States.
Our pending applications cannot be enforced against third parties practicing the inventions claimed in such applications unless and until a patent issues
from such applications. Because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our issued patents and
issued patents that we license from third parties or may own in the
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future may be challenged in the courts or patent offices in the United States and abroad. Further, the examination process may require us to narrow the
claims for our pending patent applications, which may limit the scope of patent protection that may be obtained if these applications issue. The scope of a
patent may also be interpreted or reinterpreted after issuance. The rights that may be granted under our future issued patents may not provide us with the
proprietary protection or competitive advantages we are seeking. Although we enter into nondisclosure and confidentiality agreements with parties who
have access to confidential or patentable aspects of our research and development output, such as our employees, collaborators, and other third parties, any
of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent
protection. In addition, the patent prosecution process is expensive, time consuming and complex, and we may not be able to file, prosecute, maintain,
enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. If we are unable to obtain and maintain patent
protection for our technology or inventions, or for RP1 or our other product candidates, or if the scope of the patent protection obtained is not sufficient,
our competitors could develop and commercialize products similar or superior to ours, and our ability to successfully commercialize RP1 or our other
product candidates and future technologies or inventions may be adversely affected.
Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and our product candidates for
which we intend to seek approval as biological products may face competition sooner than anticipated. Given the amount of time required for the
development, testing and regulatory review of our product candidates, such as RP1 and our other product candidates, patents protecting such product
candidates might expire before or shortly after such product candidates are commercialized.
Filing, prosecuting and defending patents on our technology or inventions in all countries throughout the world would be prohibitively expensive, and
our intellectual property rights in some countries or religions outside the United States can be less protective of our products than those in the United
States. In addition, the laws and practices of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in
the United States. Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing
our ability to protect RP1 and our other product candidates. Consequently, we may not be able to prevent third parties from practicing our inventions in all
countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
Competitors may use our technologies or inventions in jurisdictions where we have not obtained patent protection to develop and/or manufacture their own
products and may export otherwise infringing products to territories where we have patent protection but where enforcement is not as strong as that in the
United States. These products may compete with our products and our patent claims or other intellectual property rights may not be effective or sufficient
to prevent them from so competing.
Protecting against the unauthorized use of our patented inventions, trademarks and other intellectual property rights is expensive, time consuming,
difficult and in some cases may not be possible. In some cases, it may be difficult or impossible to detect third-party infringement or misappropriation of
our intellectual property rights, even in relation to issued patent claims, and proving any such infringement or misappropriation may be even more difficult.
If we are unable to obtain, maintain, and protect our intellectual property our competitive advantage could be harmed, and it could result in a material
adverse effect on our business, financial condition, results of operations, stock price and prospects.
In addition to seeking patent protection, we also rely on other proprietary rights, including protection of trade secrets, know-how and confidential and
proprietary information. Although we enter into confidentiality agreements with our employees, consultants, collaborators, suppliers, manufacturers and
other third parties who have access to our trade secrets, and our agreements with employees also provide that any inventions conceived by the individual in
the course of rendering services to us shall be our exclusive property, we may not obtain these agreements in all circumstances, and individuals with whom
we have these agreements may not comply with their terms or may have conflicting agreements with third parties. In addition, in the event of unauthorized
use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may not provide meaningful protection, particularly for
our trade secrets or other confidential information. To the extent that our employees, consultants or contractors use technology or know-how owned by
third parties in their work for us, disputes may arise between us and those third parties as to the rights in related inventions. If any of our trade secrets,
know-how or confidential or proprietary information were to be lawfully obtained, patented or independently developed by a competitor or other third
party, we would have no right to prevent them from using that technology or information to compete with us and may be blocked from using such trade
secrets, know-how or confidential or proprietary information ourselves. The disclosure of our trade secrets or the independent development of our trade
secrets by a competitor or other third party would impair our competitive position and may materially harm our business, financial condition, results of
operations, stock price and prospects.
Third parties may in the future initiate legal proceedings alleging that we are infringing their intellectual property rights, and we may become involved
in lawsuits or other administrative procedures to protect or enforce our intellectual property, which could be expensive, time consuming and
unsuccessful and have a material adverse effect on the success of our business.
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Our commercial success depends on our ability and the ability of our current or future collaborators to develop, manufacture, market and sell RP1 and
our other product candidates, and to use our related proprietary technologies without infringing, misappropriating or otherwise violating the intellectual
property and proprietary rights of third parties. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents
and other intellectual property rights. We may become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property
rights with respect to our current and any other future product candidates. Third parties may assert infringement or other intellectual property claims against
us based on existing patents or patents that may be filed and/or granted in the future. At times we may attempt to initiate litigation or other administrative
procedures to invalidate or otherwise limit the scope of a third party’s intellectual property and these attempts may not be successful. If we are found to
infringe a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such intellectual property rights are invalid, unenforceable
or otherwise not infringed, we could be required to obtain a license from such third-party to continue developing, manufacturing and commercializing RP1
and our other product candidates. Such a license may not be available on commercially reasonable terms, or at all. Even if we were able to obtain a license,
it could be nonexclusive, thereby giving our competitors and other third parties access to the same technologies and inventions licensed to us, and it could
require us to make substantial licensing and royalty payments. We also could be forced, including by court order, to cease developing, manufacturing, and
commercializing RP1 or our other product candidates or we could be found liable for significant monetary damages if we are found to have willfully
infringed a patent or other intellectual property right. Any of the foregoing could have a material adverse effect on our business, financial condition, results
of operations, stock price and prospects. Any claims by third parties that we have misappropriated their know-how, confidential or proprietary information
or trade secrets could have a similar material adverse effect on our business, financial condition, results of operations, stock price and prospects.
If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering any of our technology or inventions,
the defendant could counterclaim that the patent covering our product candidate is invalid or unenforceable. If a third party were to prevail on a legal
assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on RP1 and our other product
candidates. Such a loss of patent protection could have a material adverse impact on our business, financial condition, results of operations, stock price and
prospects.
Many of our employees, including our senior management team, were previously employed at, or consulted for, universities or other biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Although we take steps to ensure that our employees do not use, claim as
theirs, or misappropriate the intellectual property, confidential or proprietary information, know-how or trade secrets of others in their work for us, we may
be subject to claims that we or these employees have used, claimed as theirs, misappropriated or disclosed intellectual property, including trade secrets,
know-how or other confidential or proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend
against such claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or
personnel or sustain damages. Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such
third-party to commercialize our technology or products. Such a license may not be available on commercially reasonable terms, or at all.
In addition, we are developing certain of our product candidates in combination with nivolumab and cemiplimab, which are covered by patents or
licenses held by BMS and Regeneron, respectively, to which we do not have a license other than for use in connection with the applicable clinical trial. We
also may develop our product candidates in combination with products developed by additional companies that are covered by patents or licenses held by
those entities to which we do not have a license. In the event that a labeling instruction is required in product packaging recommending that combination,
we could be accused of, or held liable for, infringement of the third-party patents covering the product candidate or product recommended for
administration with RP1 or our other product candidates. In such a case, we could be required to obtain a license from the other company or institution to
use the required or desired package labeling, which license may not be available on commercially reasonable terms, or at all.
Competitors may infringe any future licensed patents or any patent we own in the future or misappropriate or otherwise violate our intellectual
property rights. We may also be required to defend against claims of infringement and our licensed patents and any patents we own in the future may
become involved in priority or other intellectual property related disputes. To counter infringement or unauthorized use, litigation may be necessary in the
future to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity and scope of our own intellectual
property rights or the proprietary rights of others.
These proceedings can be expensive and time consuming. Many of our current and potential competitors have the ability to dedicate substantially
greater resources to conduct intellectual property related litigations or proceedings than we can. We may not have sufficient financial or other resources to
conduct such litigation or proceedings adequately. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or
misappropriating our intellectual property. An adverse result in any litigation or other intellectual property related proceeding could put one or more of our
patents at risk of
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being invalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation in the United States, there is a risk that some of our trade secrets, know-how, or proprietary or confidential information could
be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim
proceedings or developments in any such proceedings. If securities analysts or investors perceive these results to be negative, it could have a material
adverse effect on the price of shares of our common stock. Any of the foregoing may have a material adverse effect on our business, financial condition,
results of operations, stock price and prospects.
Risks related to manufacturing and our reliance on third parties
We have agreements with BMS and Regeneron, and in the future may have agreements with other companies, to obtain the supply of anti-PD-1
therapies for the development of our product candidates. If our relationships with BMS, Regeneron, or any future collaborator or supplier are not
successful, we may be delayed in completing the development of our product candidates.
We have entered into arrangements with BMS and Regeneron as part of our clinical development for RP1, RP2 and RP3 for where nivolumab or
cemiplimab, respectively, are intended to be used for these clinical programs. BMS is providing nivolumab, its anti-PD-1 therapy, for use in our ongoing
IGNYTE Phase 1/2 trials with RP1, our Phase 1/2 clinical trial with RP2 and our Phase 1 and Phase 2 clinical trials with RP3 where we intend to use
nivolumab and may potentially do so for other clinical trials in the future; Regeneron is providing cemiplimab, its anti-PD-1 therapy, for use in our ongoing
CERPASS Phase 2 clinical trial and may potentially do so for other clinical trials in the future. We may also enter into agreements with additional
companies for the supply of anti-PD-1 therapies for use in the development of RP1 and our other product candidates. The outcome of these clinical trials is
dependent, in part, both on the performance of our partners’ products and product candidates and also on our partners’ ability to deliver sufficient quantities
of adequately produced product. Should any of our partners’ products or product candidates fail to produce the results that we anticipate, we may have to
re-run clinical trials for RP1 or our other product candidates or may otherwise be delayed in the commercialization of RP1 or our other product candidates.
Similarly, should any partner fail to provide us with a product or product candidate that suits our requirements, we may have to re-run clinical trials for RP1
or our other product candidates or may be otherwise delayed in the commercialization of RP1 or our other product candidates.
Our collaboration agreements with any future partners may not be successful, which could adversely affect our ability to develop and commercialize
our product candidates.
We may in the future seek collaboration arrangements with other parties for the development or commercialization of our product candidates. The
success of any collaboration arrangements may depend on the efforts and activities of our collaborators. Collaborators generally have significant discretion
in determining the efforts and resources that they will apply to these arrangements. Disagreements between parties to a collaboration arrangement regarding
clinical development and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate
and, in some cases, termination of the collaboration arrangement.
Collaborations with biopharmaceutical companies and other third parties often are terminated or allowed to expire by the other party. Any such
termination or expiration could adversely affect us financially and could harm our business reputation.
Any future collaborations we might enter into may pose a number of risks, including the following:
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collaborators may not perform their obligations as expected;
collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to
continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or
available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate,
repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
collaborators could fail to make timely regulatory submissions for a product candidate;
collaborators may not comply with all applicable regulatory requirements or may fail to report safety data in accordance with all applicable
regulatory requirements, which could subject them or us to regulatory enforcement actions;
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product
candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under
terms that are more economically attractive than ours;
product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or
products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;
a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit
sufficient resources to the marketing and distribution of such product candidate or product;
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development,
might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional
responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time consuming and
expensive;
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to
invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; and
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability.
If any collaborations we might enter into in the future do not result in the successful development and commercialization of products or if one of our
collaborators subsequently terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under such
potential future collaboration. If we do not receive the funding we expect under the agreements, our development of our product candidates could be
delayed and we may need additional resources to develop our product candidates and our product platform.
Additionally, if any future collaborator of ours is involved in a business combination, the collaborator might deemphasize or terminate development or
commercialization of any product candidate it licenses to us. If one of our collaborators terminates its agreement with us, we may find it more difficult to
attract new collaborators and our reputation in the business and financial communities could be adversely affected.
We face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for any collaboration will depend
upon, among other things, our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the
proposed collaborator’s evaluation of a number of factors.
If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the
development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential
commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization
activities at our own expense. If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional
expertise and additional capital, which may not be available to us on acceptable terms, or at all. If we fail to enter into collaborations and do not have
sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our product
candidates or bring them to market or continue to develop our product platform and our business may be materially and adversely affected.
We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third
parties do not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory
requirements, we may be unable to obtain regulatory approval for our product candidates or any other product candidates that we may develop in the
future.
We rely on third-party CROs, study sites, and others to conduct, supervise, and monitor our preclinical studies and clinical trials for our product
candidates and do not currently plan to independently conduct preclinical studies or clinical trials of any other potential product candidates. We expect to
continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions, and clinical investigators, to conduct our
preclinical studies and clinical trials. Although we have agreements governing their activities, we have limited influence over their actual performance and
control only certain aspects of their activities. The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines
could substantially harm our business because we may be delayed in completing or unable to complete the studies required to support future approval of
our product candidates, or we may not obtain marketing approval for or commercialize our product candidates in a timely manner or at all. Moreover, these
agreements might terminate for a variety of reasons,
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including a failure to perform by the third parties. If we need to enter into alternative arrangements our product development activities would be delayed
and our business, financial condition, results of operations, stock price and prospects may be materially harmed.
Our reliance on these third parties for development activities will reduce our control over these activities. Nevertheless, we are responsible for ensuring
that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on third parties
does not relieve us of our regulatory responsibilities. For example, we will remain responsible for ensuring that each of our trials is conducted in
accordance with the general investigational plan and protocols for the trial. We must also ensure that our preclinical trials are conducted in accordance with
the FDA’s Good Laboratory Practice, or GLP, regulations, as appropriate. Moreover, the FDA and comparable foreign regulatory authorities require us to
comply with standards, commonly referred to as GCPs for conducting, recording, and reporting the results of clinical trials to assure that data and reported
results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Regulatory authorities enforce these
requirements through periodic inspections of trial sponsors, clinical investigators, and trial sites. If we or any of our third parties fail to comply with
applicable GCPs or other regulatory requirements, we or they may be subject to enforcement or other legal actions, the data generated in our trials may be
deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional studies.
In addition, our clinical trials must be conducted with product candidates that were produced under cGMP regulations. Failure to comply with these
regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical studies or clinical trials in
accordance with regulatory requirements or our stated protocols, if they need to be replaced or if the quality or accuracy of the data they obtain is
compromised due to the failure to adhere to our protocols, regulatory requirements or for other reasons, our trials may be repeated, extended, delayed, or
terminated; we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates; we may not be able to, or may
be delayed in our efforts to, successfully commercialize our product candidates, or we or they may be subject to regulatory enforcement actions. As a
result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to
generate revenues could be delayed. To the extent we are unable to successfully identify and manage the performance of third-party service providers in the
future, our business, financial condition, results of operations, stock price and prospects may be materially harmed.
If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative providers or to do so on
commercially reasonable terms. Switching or adding additional third parties involves additional cost and may result in delays that could compromise our
ability to meet our desired development timelines.
We also rely on other third parties to store and distribute our products for the clinical trials that we conduct. Any performance failure on the part of our
distributors could delay clinical development, marketing approval, or commercialization of our product candidates, which could result in additional losses
and deprive us of potential product revenue.
If the manufacturers upon which we rely fail to produce our raw materials or product candidates in the volumes that we require on a timely basis, or
fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization
of, or be unable to meet demand for, our product candidates and may lose potential revenues.
We continue to rely on third-party contract manufacturers to manufacture our raw materials and clinical trial product supplies until our in-house
manufactured clinical trial product supplies are qualified for use in our clinical trials. As a result, there can be no assurance that our clinical development
will not be limited, interrupted, or of satisfactory quality or continue to be available at acceptable prices.
We currently have only one contract manufacturer for our product candidates for use in our clinical trials until our in-house materials are qualified for
use in our clinical trials. In addition, we do not have any long-term commitments from our suppliers of raw materials or clinical trial material or guaranteed
prices for our product candidates or their components. There are a limited number of manufacturers that operate under cGMP regulations and that are both
capable of manufacturing and filling our viral product for us and willing to do so. If our existing third-party manufacturers of raw materials or our product
candidates, or the third parties that we engage in the future, should cease to work with us, we likely would experience delays in obtaining sufficient
quantities of our product candidates for us to meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers.
Any replacement of our contract manufacturer could require significant effort and expertise because there may be a limited number of qualified
replacements. Any delays in obtaining adequate supplies of our raw materials or product candidates that meet the necessary quality standards may delay
our development or commercialization.
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If our manufacturers do not perform as agreed or encounter difficulties in production costs and yields, quality control, shortages of qualified personnel
or key raw materials, compliance with strictly enforced federal, state, and foreign regulations, or other difficulties, our ability to provide product candidates
to patients in our clinical trials could be jeopardized.
In addition, if our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory
requirements of the FDA or other regulatory authorities, they will not be able to secure or maintain regulatory approval for their manufacturing facilities.
Any such deviations may also require remedial measures that may be costly and/or time consuming for us or a third party to implement and that may
include the temporary or permanent suspension of a clinical trial or the temporary or permanent closure of a facility. Any such remedial measures imposed
upon us or third parties with whom we contract could materially harm our business. Any delays in obtaining raw materials, products or product candidates
that comply with the applicable regulatory requirements may result in delays to clinical trials, product approvals, and commercialization.
While we are ultimately responsible for the manufacturing of our product candidates and therapeutic substances, other than through our contractual
arrangements, we have little control over our manufacturers’ compliance with these regulations and standards. If the FDA or a comparable foreign
regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we
may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our
product candidates, if approved. We must also receive FDA approval for the use of any new manufacturers for clinical or commercial supply, including our
own manufacturing facility.
A failure to comply with the applicable regulatory requirements, including periodic regulatory inspections, may result in regulatory enforcement
actions against our manufacturers or us (including fines and civil and criminal penalties, including imprisonment) suspension or restrictions of production,
injunctions, delay or denial of product approval or supplements to approved products, clinical holds or termination of clinical trials, warning or untitled
letters, regulatory authority communications warning the public about safety issues with the product candidate, refusal to permit the import or export of the
products, product seizure, detention, or recall, operating restrictions, suits under the civil False Claims Act, corporate integrity agreements, consent decrees,
withdrawal of product approval, environmental or safety incidents and other liabilities. If the safety of any quantities supplied is compromised due to our
manufacturers’ failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize
our product candidates.
The transition of our manufacturing operations to our new facility may result in further delays or expenses, and we may not experience the anticipated
operating efficiencies.
Our approximately 63,000 square foot manufacturing facility in Framingham, Massachusetts is now fully operational. The process of transferring the
manufacturing of RP1 and RP2 from our third-party contract manufacturer is complete and the transfer of the manufacturing of RP3 from our third-party
contract manufacturer is nearly complete. Comparability analysis of RP1 produced at our Framingham facility with the contract manufacturer material used
in our clinical studies is complete and a report has been submitted to the FDA. Comparability studies of RP2 manufactured from our in-house facility to our
current clinical trial supply material manufactured from our third-party contract manufacturer are underway. This facility is intended to give us control over
key aspects of the supply chain for our products and product candidates. However, we may not experience the anticipated operating efficiencies as we
commence manufacturing operations at the new facility. Any such delays may disrupt or delay the supply of our product candidates if we have not
maintained a sufficient backup supply of our product candidates through third-party manufacturers. Moreover, changing manufacturing facilities may also
require that we conduct additional studies, make notifications to the regulatory authorities, make additional filings to the regulatory authorities, and obtain
regulatory authority approval for the new facilities, which may be delayed or which we may never receive. We will further need to comply with the FDA’s
and applicable foreign regulatory authorities’ cGMP requirements for the production of our product candidates for clinical trials and, if approved,
commercial supply, and will be subject to FDA and comparable foreign regulatory authority inspections. We may not be able to develop or acquire the
internal expertise and resources necessary for compliance with these requirements. If we are not able to comply with the applicable regulatory requirements
or produce product that meets our requirements and specifications, we will be subject to the same risks that we would be subject to should third party
manufacturers be unable to comply with the applicable regulatory requirements or produce product meeting our requirements or specifications, as described
above. If we fail to achieve the operating efficiencies that we anticipate, our manufacturing and operating costs may be greater than expected, which could
have a material adverse impact on our operating results.
In operating our own manufacturing facility, we may be forced to devote greater resources and management time than anticipated, particularly in areas
relating to operations, quality, raw material supply, regulatory, facilities and information technology. Further, should corrective or preventative actions be
required, we will be fully responsible for these. If we experience unanticipated employee turnover in any of these areas, we may not be able to effectively
manage our ongoing manufacturing operations and we may not achieve the operating efficiencies that we anticipate from the new facility, which
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may negatively affect our product development timeline, product candidate supplies and, if approved, our commercial product supplies. If we experience
any unanticipated shortages of key raw materials, or other difficulties related to our raw material supply, we may not be able to effectively manage our
ongoing manufacturing timelines and costs which may negatively affect our product development schedule and our ability to provide clinical trial supplies
to patients in our clinical trials, and if approved, commercial product supplies.
Any problems or delays we experience in preparing for commercial scale manufacturing of a product candidate or component may result in a delay in
product development timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability to
manufacture commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention, or impairment of
clinical development and commercialization of our product candidates and may materially harm our business, financial condition, results of operations,
stock price and prospects.
Any such problems could result in the delay, prevention, or impairment of clinical development and commercialization of our product candidates and
may materially harm our business, financial condition, results of operations, stock price and prospects.
Risks related to legal and compliance matters
We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the
commercialization of any approved products and/or our product candidates.
The use of our product candidates in clinical trials, and the sale of any product for which we obtain regulatory approval, exposes us to the risk of
product liability claims. We face inherent risk of product liability related to the testing of our product candidates in human clinical trials, including liability
relating to the actions and negligence of our investigators, and will face an even greater risk if we commercially sell any product candidates that we may
develop. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in
the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. Product liability claims
might be brought against us by consumers, healthcare providers or others using, administering or selling our products. If we cannot successfully defend
ourselves against these claims, we will incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful
defense would require significant financial and management resources. Regardless of merit or eventual outcome, liability claims may result in:
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loss of revenue from decreased demand for our products and/or product candidates;
impairment of our business reputation or financial stability;
costs of related litigation;
substantial monetary awards to patients or other claimants;
diversion of management attention;
• withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs;
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the inability to commercialize our product candidates;
significant negative media attention;
decreases in our stock price;
initiation of investigations and enforcement actions by regulators; and
product recalls, withdrawals or labeling, marketing or promotional restrictions, including withdrawal of marketing approval.
We believe we have sufficient insurance coverage in place for our business operations. However, our insurance coverage may not reimburse us or may
not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and, in the
future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. We
intend to expand our insurance coverage to include the sale of commercial products if we obtain FDA or comparable foreign regulatory approval for our
product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for
marketing, or at all. Failure to obtain and retain sufficient product liability insurance at an acceptable cost could prevent or inhibit the commercialization of
products we develop. A successful product liability claim or series of claims
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brought against us could cause our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash, and materially harm our
business, financial condition, results of operations, stock price and prospects.
We are subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and other anticorruption laws, as well as import and export control
laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or
criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, financial condition, results of operations,
stock price and prospects.
Our operations are subject to anticorruption laws, including the U.S. Foreign Corrupt Practices Act, or FCPA, the U.K. Bribery Act 2010, or the
Bribery Act, and other anticorruption laws that apply in countries where we do business. We also may participate in collaborations and relationships with
third parties whose actions, if noncompliant, could potentially subject us to liability under the FCPA, Bribery Act or local anticorruption laws.
We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the
United States and the United Kingdom and authorities in the European Union, including applicable import and export control regulations, economic
sanctions on countries and persons, anti-money laundering laws, customs requirements and currency exchange regulations, collectively referred to as the
trade control laws.
We can provide no assurance that we will be completely effective in ensuring our compliance with all applicable anticorruption laws or other legal
requirements, including trade control laws. If we are not in compliance with applicable anticorruption laws or trade control laws, we may be subject to
criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our
business, financial condition, results of operations, stock price and prospects. Likewise, any investigation of any potential violations of these anticorruption
laws or trade control laws by U.S., U.K. or other authorities could also have an adverse impact on our reputation, our business, financial condition, results
of operations, stock price and prospects.
If we fail to comply with federal and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we
could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.
We are subject to many federal and state healthcare laws, such as the federal Anti-Kickback Statute, the federal civil and criminal False Claims Acts,
the civil monetary penalties statute, the Medicaid Drug Rebate statute and other price reporting requirements, the Veterans Health Care Act of 1992, or
VHCA, the federal Health Insurance Portability and Accountability Act of 1996 (as amended by the Health Information Technology for Economics and
Clinical Health Act, or HITECH), or HIPAA, the FCPA, the ACA, and similar state laws. Even though we do not and will not control referrals of healthcare
services or bill directly to Medicare, Medicaid or other third-party payors, certain federal and state healthcare laws, and regulations pertaining to fraud and
abuse, reimbursement programs, government procurement, and patients’ rights are and will be applicable to our business. We would be subject to
healthcare fraud and abuse and patient privacy regulation by both the federal government and the states and foreign jurisdictions in which we conduct our
business. In the European Union, the data privacy laws are generally stricter than those that apply in the United States and include specific requirements for
the collection of personal data of European Union persons or the transfer of personal data outside of the European Union to the United States to ensure that
European Union standards of data privacy will be applied to such data.
If we or our operations are found to be in violation of any federal or state healthcare law, or any other laws or regulations that apply to us, we may be
subject to penalties, including civil, criminal, and administrative penalties, damages, fines, disgorgement, suspension and debarment from government
contracts, and refusal of orders under existing government contracts, exclusion from participation in U.S. federal or state health care programs, corporate
integrity agreements, and the curtailment or restructuring of our operations, any of which could materially adversely affect our ability to operate our
business and our financial results. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in
compliance with applicable laws, it may be subject to criminal, civil or administrative sanctions, including but not limited to, exclusions from participation
in government healthcare programs, which could also materially affect our business. Any action against us for violation of these laws, even if we
successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
We are subject to new legislation, regulatory proposals and healthcare payor initiatives that may increase our costs of compliance, and adversely affect
our ability to market our products, obtain collaborators, and raise capital.
In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post approval activities and affect our
ability to profitably sell any products for which we obtain marketing
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approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage
criteria and in additional downward pressure on the price that we may receive for any approved products, which could have a material adverse effect on
customers for our products, if approved, and, accordingly, on our results of operations.
Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private
payors. The implementation of cost containment measures or other healthcare reforms may prevent us from commercializing our products and being able to
generate revenue, and we could be prevented from or significantly delayed in achieving profitability.
Compliance with the federal track and trace requirements may increase our operational expenses and impose significant administrative burdens. As a
result of these and other new proposals, we may determine to change our current manner of operation, provide additional benefits or change our contract
arrangements, any of which could have a material adverse effect on our business, financial condition, results of operations, stock price and prospects.
Our employees, independent contractors, consultants, commercial partners, principal investigators, CMOs, or CROs may engage in misconduct or
other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our
business.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees, independent contractors, consultants, commercial
partners, principal investigators, CMOs, or CROs could include intentional, reckless, negligent, or unintentional failures to comply with FDA regulations,
comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing information required by federal
programs, report financial information or data accurately or disclose unauthorized activities to us. This misconduct could also involve the improper use or
misrepresentation of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.
Moreover, it is possible for a whistleblower to pursue a False Claims Act case against us even if the government considers the claim unmeritorious and
declines to intervene, which could require us to incur costs defending against such a claim. If any such actions are instituted against us, and we are not
successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of
operations, stock price and prospects, including the imposition of significant fines or other sanctions.
Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have
a material adverse effect on the success of our business.
We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures, the handling, use,
storage, treatment and disposal of hazardous materials and wastes and the cleanup of contaminated sites. Our operations involve the use of hazardous and
flammable materials, including chemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We would incur
substantial costs as a result of violations of or liabilities under environmental requirements in connection with our operations or property, including fines,
penalties and other sanctions, investigation and cleanup costs and third party claims. In the event of contamination or injury resulting from our use of
hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs
associated with civil or criminal fines and penalties.
Although we maintain workers’ compensation insurance to cover costs and expenses, we may incur due to injuries to our employees resulting from the
use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental
liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.
Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could
result in a material disruption of our development programs.
Our internal computer systems, and those of our CROs, CMOs, information technology suppliers and other contractors and consultants are vulnerable
to damage from computer viruses, cyber-attacks and other unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical
failures. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs. For
example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in delays in our regulatory approval efforts and
significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to
our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further
development of any of our product candidates could be delayed.
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Risks related to our operations
Our financial condition and results of operations could be adversely affected by the coronavirus disease-2019, or COVID-19, outbreak.
In December 2019, a novel strain of coronavirus, now referred to as COVID-19, surfaced in Wuhan, China. The virus and variants thereof continue to
spread globally, including in the United States, the United Kingdom and other countries in which we conduct clinical trials, and has been declared a
pandemic by the World Health Organization. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society,
which has resulted in and will likely continue to result in significant disruptions to the global economy and supply chains, as well as businesses and capital
markets around the world. In an effort to halt the outbreak of COVID-19, many countries, including the United States, the United Kingdom and certain
other countries in which we conduct clinical trials, placed significant restrictions on travel and business operations or issued shelter-in-place orders. These
restrictions and orders continue to remain in effect to varying degrees, the effect of which required, and in some instances, continue to require, certain of
our employees and clinical trial staff to work remotely and avoid unnecessary travel. These restrictions and orders have impacted the pace of enrollment in
our clinical trials, and if they continue, may affect our results and operations.
The COVID-19 pandemic is affecting the United States and global economies and has affected, and may continue to affect, our operations and those
of third parties on which we rely, including by causing disruptions in our raw material and anti-PD-1 supply, the manufacturing of our product candidates,
the access to laboratory and other supplies necessary for development and packaging of our product candidates, our commercialization processes and the
conduct and the enrollment of current and future clinical trials. Many manufacturers have experienced shortages of key equipment and ingredients needed
for product manufacturing. In addition, the COVID-19 pandemic has affected and may continue to affect the operations of the FDA and comparable foreign
regulatory authorities, which could result in delays of reviews and approvals, including with respect to RP1 and our other product candidates. By example,
we may be delayed in obtaining any necessary FDA inspections that are required for product approval following submission of a BLA. The evolving
COVID-19 pandemic has also directly or indirectly impacted, and is likely to continue to impact the pace of enrollment in our clinical trials as patients may
avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency, and clinical trial staff may no longer be
able to get to the clinic. Such facilities and offices have focused, and may continue to be required to focus, limited resources on non-clinical trial matters,
including treatment of COVID-19 patients, and may not be available, in whole or in part, for clinical trial services. In addition, employee disruptions and
remote working environments related to the COVID-19 pandemic and the federal, state and local responses to such virus, could materially impact the
efficiency and pace with which we work and develop our product candidates.
The COVID-19 pandemic and the government and public health response continues to rapidly evolve and fluctuation in infection rates in the regions in
which we operate has resulted in periodic changes in restrictions that vary from region to region and require vigilant attention and rapid response to new or
reinstated orders. In light of the COVID-19 pandemic, the FDA has issued a number of new guidance documents. Specifically, as a result of the potential
effect of the COVID-19 pandemic on many clinical trial programs in the United States and globally, the FDA issued guidance concerning potential impacts
on clinical trial programs, changes that may be necessary to such programs if they proceed, considerations regarding trial suspensions and discontinuations,
the potential need to consult with or make submissions to relevant ethics committees, IRBs, and the FDA, the use of alternative drug delivery methods, and
considerations with respect the outbreak’s impacts on endpoints, data collection, study procedures, and analysis. Additionally, in March 2020, the U.S.
Congress passed the Coronavirus Aid, Relief, and Economic Security Act, which includes a number of provisions that are applicable to the pharmaceutical
industry, and further acts, laws or regulations may be enacted or implemented in the future.
While the potential economic impact brought by, and the duration and severity of, the COVID-19 pandemic are difficult to assess or predict, the impact
of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact our short-term and
long-term liquidity. Additionally, the stock market has been unusually volatile during the COVID-19 pandemic and such volatility may continue. During
certain periods of the COVID-19 pandemic, our stock price fluctuated significantly, and such fluctuation may continue to occur. The ultimate impact of the
COVID-19 pandemic on our business will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence,
such as the emergence of new variants, ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in
the United States and other countries, business closures or business disruptions, the ultimate impact on financial markets and the global economy, and the
effectiveness of any COVID-19 vaccines and actions taken in the United States and other countries to contain and treat the disease. While vaccines for
COVID-19 are being, and have been developed, new variants may continue to emerge and there is no guarantee that any such vaccine will be effective,
work as expected, will be made available or will be accepted on a significant scale and in a timely manner.
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We do not yet know the full extent of the delays or impacts on our business, financing or clinical trial activities, healthcare systems or the global
economy as a whole. However, these effects could have a material impact on our liquidity, capital resources, operations and business and those of the third
parties on which we rely. To the extent the COVID-19 pandemic materially impacts our business and financial results, it may also have the effect of
significantly heightening many of the other risk described in this “Risk Factors” section.
We will need to expand the size of our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, sales, marketing,
financial and other personnel. Our future financial performance and our ability to commercialize RP1 and our other product candidates will depend, in part,
on our ability to effectively manage any future growth, which would impose significant additional responsibilities on members of management and may
divert their attention away from day-to-day activities.
We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants
to provide certain services. The services include substantially all aspects of clinical trial management and manufacturing, as well as support for our
financial reporting and accounting functions. If the services of independent organizations, advisors and consultants become unavailable to us or we are
unable to effectively manage our outsourced activities, or if the quality or accuracy of such services is compromised for any reason, our clinical trials may
be extended, delayed or terminated, we may not comply with our financial reporting and accounting obligations on a timely basis and we may not be able
to obtain marketing approval of RP1 and our other product candidates or otherwise advance our business.
If we are not able to effectively expand our organization by hiring qualified new employees and expanding our groups of consultants and contractors,
we may not be able to successfully implement the tasks necessary to further develop and commercialize RP1 and our other product candidates and,
accordingly, may not achieve our research, development and commercialization goals.
We are highly dependent on our key personnel, including Philip Astley-Sparke, our Chief Executive Officer; Robert Coffin, Ph.D., our President and
Chief Research & Development Officer; and Colin Love, Ph.D., our Chief Operating Officer. If we are not successful in attracting, motivating and
retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract, motivate and retain
highly qualified managerial, scientific and medical personnel. We are highly dependent on our management and particularly on the services of our
founders, as well as our other scientific, manufacturing, quality and medical personnel, including Philip Astley-Sparke, our Chief Executive Officer, Robert
Coffin, Ph.D., our President and Chief Research & Development Officer, and Colin Love, Ph.D., our Chief Operating Officer. The loss of the services of
our key personnel and any of our other executive officers, key employees, and scientific and medical advisors, and our inability to find suitable
replacements, could result in delays in product development and harm our business.
Additionally, competition for skilled personnel is intense and the turnover rate can be high, which may limit our ability to hire and retain highly
qualified personnel on acceptable terms or at all.
To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided stock option and restricted stock
unit grants that vest over time. The value to employees of these equity grants that vest over time may be significantly affected by movements in our stock
price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies. Although we have
employment agreements with our key employees, these employment agreements generally provide for at-will employment, which means that any of our
employees could leave our employment at any time, with or without notice.
If we fail to establish and maintain proper and effective internal control over financial reporting our ability to produce accurate and timely financial
statements could be impaired.
We are required to maintain internal control over financial reporting. We must perform system and process design evaluation and testing of the
effectiveness of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial
reporting, as required by Section 404 of the Sarbanes-Oxley Act. We continue to be engaged in a process to document and evaluate our internal control
over financial reporting, which is both costly and challenging. In this regard, we will need to continue to incur substantial professional fees and internal
costs for our accounting and finance functions, expend significant management efforts, continue to implement plans developed to address
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areas that we have identified as requiring improvement, validate through testing that controls are functioning as documented and implement a continuous
reporting and improvement process for internal control over financial reporting.
If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain proper
and effective internal controls over financial reporting, we may not be able to produce timely and accurate financial statements. If that were to happen, our
investors could lose confidence in our reported financial information, the market price of our stock could decline and we could be subject to sanctions or
investigations by the SEC, Nasdaq or other regulatory authorities.
We believe that any internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. We may discover weaknesses in our system of internal financial and accounting controls and procedures
that could result in a material misstatement of our consolidated financial statements. Our internal control over financial reporting will not prevent or detect
all errors and all fraud. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that
misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.
These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of simple error
or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized
override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be
detected.
Risks related to our common stock and general risks
An active trading market for our common stock may not be sustained.
Our common stock began trading on the Nasdaq Global Select Market on July 20, 2018. Given the limited trading history of our common stock, there
is a risk that an active trading market for shares of our common stock may not be sustained. In the absence of an active trading market for shares of our
common stock, our stockholders may not be able to sell their common stock at or above the price at which such stockholder acquired our common stock or
at the time that they would like to sell.
The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common
stock.
Our stock price has been and is likely to be volatile. The stock market in general and the market for biopharmaceutical companies in particular have
experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, you may not
be able to sell your common stock at or above the price at which it was acquired. The market price for our common stock may be influenced by many
factors, including:
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the success of competitive products or technologies;
results of clinical trials of RP1 and our other product candidates or those of our competitors;
regulatory or legal developments in the United States and other countries;
developments or disputes concerning patent applications, issued patents or other proprietary rights;
the recruitment or departure of key personnel;
the level of expenses related to the development of RP1 and our other product candidates or clinical development programs;
the results of our efforts to discover, develop, acquire or in-license additional product candidates or drugs;
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
variations in our financial results or those of companies that are perceived to be similar to us;
changes in the structure of healthcare payment systems;
• market conditions in the pharmaceutical and biotechnology sectors;
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general economic, industry and market conditions;
political and economic instability, including the impact of COVID-19, the possibility of an economic recession, international hostilities including,
but not limited to, the ongoing military conflict between Russia and Ukraine, acts of
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terrorism, governmental restrictions and sanctions, inflation, global supply chain disruptions, trade relationships and military and political
alliances; and
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the other factors described in this “Risk factors” section.
Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to
fall below expectations or our guidance.
Our quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult for us to predict our future operating
results. From time to time, we may enter into license or collaboration agreements with other companies that include development funding and significant
upfront and milestone payments and/or royalties, which may become an important source of our revenue. Accordingly, our revenue may depend on
development funding and the achievement of development and clinical milestones under current and any potential future license and collaboration
agreements and sales of our products, if approved. These upfront and milestone payments may vary significantly from period to period and any such
variance could cause a significant fluctuation in our operating results from one period to the next.
In addition, we measure compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the
award as determined by our board of directors, and recognize the cost as an expense over the employee’s requisite service period. As the variables that we
use as a basis for valuing these awards change over time, including, our underlying stock price and stock price volatility, the magnitude of the expense that
we must recognize may vary significantly.
Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to
predict, including the following:
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timing and cost of, and level of investment in, research and development activities relating to our current and any future product candidates, which
will change from time to time;
the total expenses we incur in connection with equipping and operating our manufacturing facility;
our ability to enroll patients in clinical trials and the timing of enrollment;
the cost of manufacturing our current and any future product candidates, which may vary depending on the FDA’s and comparable foreign
regulatory authorities’ guidelines and requirements, the quantity of production and the terms of any agreements with manufacturers;
expenditures that we will or may incur to acquire or develop additional product candidates and technologies;
the timing and outcomes of clinical and preclinical studies for RP1 and our other product candidates or competing product candidates;
competition from existing and potential future products that compete with RP1 and our other product candidates, and changes in the competitive
landscape of our industry, including consolidation among our competitors or partners;
any delays in regulatory review or approval of RP1 or our other product candidates;
the level of demand for RP1 and our other product candidates, if approved, which may fluctuate significantly and be difficult to predict;
the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future
products that compete with RP1 and our other product candidates;
our ability to commercialize RP1 and our other product candidates, if approved, inside and outside of the United States, either independently or
working with third parties;
the success of and our ability to establish and maintain collaborations, licensing or other arrangements;
our ability to adequately support future growth;
potential unforeseen business disruptions that increase our costs or expenses;
political and economic instability, including the impact of COVID-19, the possibility of an economic recession, international hostilities, including,
but not limited to, those resulting from the ongoing military conflict between Russia and Ukraine, acts of terrorism, governmental restrictions and
sanctions, inflation, global supply chain disruptions, trade relationships and military and political alliances;
future accounting pronouncements or changes in our accounting policies; and
the changing and volatile global economic environment.
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These factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating
results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.
This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any
period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the
forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a
stock price decline could occur even when we have met any previously publicly stated revenue and/or earnings guidance we may provide.
We have broad discretion in how we use our cash, cash equivalents and investments, and may not use these resources effectively, which could affect
our results of operations and cause our stock price to decline.
Our management has considerable discretion in the application of our cash, cash equivalents and investments. We intend to use our resources to fund
our preclinical and clinical development programs as well as for general corporate purposes, including working capital requirements and other operating
expenses. As a result, investors will be relying upon management’s judgment with only limited information about our specific intentions for the use of our
resources. We may use our resources for purposes that do not yield a significant return or any return at all for our stockholders. In addition, pending their
use, we may invest our cash, cash equivalents and investments in a manner that does not produce income or that loses value.
We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring
or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the appreciation of their stock, which may
never occur, as the only way to realize any return on their investment.
Our executive officers, directors, and stockholders and their affiliates who beneficially own more than 5% of our common stock exercise significant
influence over our company, which limits your ability to influence corporate matters and could delay or prevent a change in corporate control.
Based on the number of shares outstanding as of March 31, 2022, our executive officers, directors, holders of 5% or more of our capital stock and their
respective affiliates beneficially owned a significant portion of our voting stock and, accordingly, these stockholders will continue to have significant
influence over matters requiring stockholder approval. For example, these stockholders will continue to significantly influence elections of directors,
amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or
discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.
Conflicts of interest may arise because some members of our board of directors are representatives of our principal stockholders.
Certain of our principal stockholders or their affiliates are venture capital funds or other investment vehicles that could invest in entities that directly or
indirectly compete with us. As a result of these relationships, when conflicts arise between the interests of the principal stockholders or their affiliates and
the interests of other stockholders, members of our board of directors that are representatives of the principal stockholders may not be disinterested. Neither
the principal stockholders nor the representatives of the principal stockholders on our board of directors, by the terms of our amended and restated
certificate of incorporation, are required to offer us any transaction opportunity of which they become aware and could take any such opportunity for
themselves or offer it to their other affiliates, unless such opportunity is expressly offered to them solely in their capacity as members of our board of
directors.
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the expiration of
contractual or legal restrictions on resale lapse, the market price of our common stock could decline. These sales may make it more difficult for us to sell
equity or equity related securities in the future at a time and price that we deem appropriate, or to use equity as consideration for future acquisition.
In addition, a significant number of shares of common stock that are either subject to outstanding options and restricted stock units, reserved for future
issuance under our equity incentive plans or subject to outstanding warrants are eligible for sale in the public market to the extent permitted by the
provisions of various vesting schedules and Rule 144 and Rule 701 under the
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Securities Act, including our ESPP if activated. If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public
market, the market price of our common stock could decline.
Certain holders of shares of our common stock, or their permitted transferees, are entitled to rights with respect to the registration under the Securities
Act of shares of our common stock pursuant to the amended and restated investors’ rights agreement by and among us and certain of our stockholders.
Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except
for shares purchased by affiliates. Any sales of securities by these stockholders could have a material adverse effect on the market price of our common
stock.
We may sell up to $62.5 million of shares of our common stock in “at-the-market” offerings pursuant to the sales agreement entered into with SVB
Leerink LLC on August 11, 2020 and as amended on October 21, 2020. The sale of a substantial number of shares of our common stock pursuant to the
sales agreement, or anticipation of such sales, could cause the trading price of our common stock to decline or make it more difficult for us to sell equity or
equity-related securities in the future at a time and at a price that we might otherwise desire. In addition, issuances of any shares of our common stock sold
pursuant to the sales agreement will have a dilutive effect on our existing stockholders.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or
product candidates.
To the extent that we raise additional capital through the sale of common stock or securities convertible, exercisable or exchangeable into common
stock, our existing stockholders’ interest will be diluted. Debt financing, if available, would increase our fixed payment obligations and may involve
agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures
or declaring dividends.
If we are unable to raise additional funds through equity or debt financings when needed, we may be required to grant rights to develop and market one
or more of our product candidates or technologies that we would otherwise prefer to develop and market ourselves.
If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt
or assume contingent liabilities, and subject us to other risks.
We may evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights,
technologies, or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:
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increased operating expenses and cash requirements;
the assumption of additional indebtedness or contingent liabilities;
the issuance of our equity securities;
assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new
personnel;
the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;
retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;
risks and uncertainties associated with the other party to such a transaction, including the prospects of that party, their regulatory compliance
status, and their existing products or product candidates and marketing approvals; and
our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even
to offset the associated acquisition and maintenance costs.
In addition, if we undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire
intangible assets that could result in significant future amortization expense or intangible asset impairment charges. Moreover, we may not be able to locate
suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the
development of our business. Any of the foregoing may materially harm our business, financial condition, results of operations, stock price and prospects.
Unfavorable market and economic conditions may have serious adverse consequences on our business, financial condition, results of operations, stock
price and prospects.
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Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. The most recent
global financial crisis caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in
a variety of risks to our business, including a reduced ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining
economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all
of the ways in which the economic climate and financial market conditions could adversely impact our business.
Global financial markets have been experiencing extreme disruption in recent months, including, among other things, extreme volatility in securities
prices. We are unable to predict the likely duration and severity of the current disruptions in financial markets and adverse economic conditions throughout
the world. These economic developments affect businesses such as ours and those of third parties on which we rely in a number of ways that could result in
unfavorable consequences to us. Current economic conditions or a deepening economic downturn in the United States and elsewhere may reduce our
ability to access capital, which could negatively impact our short-term and long-term liquidity.
Although we are not aware of any downgrades, material losses, or other significant deterioration in the fair value of our cash equivalents or short-term
investments, we cannot assure you that deterioration of the global credit and financial markets would not negatively impact our current portfolio of cash
equivalents or short-term investments, or our ability to meet our financing objectives. Furthermore, our stock price may decline due, in part, to the volatility
of the stock market and general economic downturns.
Exchange rate fluctuations may materially affect our results of operations and financial conditions.
Owing to the international scope of our operations, fluctuations in exchange rates, particularly between the U.S. dollar and the British pound and the
euro, may adversely affect us. Although we are based in the United States, we have significant research and development operations in the United
Kingdom, and source third-party manufacturing, consulting and other services in the United Kingdom and the European Union. As a result, our business
and the price of our common stock may be affected by fluctuations in foreign exchange rates, which may have a significant impact on our results of
operations and cash flows from period to period. Currently, we do not have any exchange rate hedging arrangements in place.
Unfavorable global economic conditions and geopolitical events could adversely affect our business, financial condition or results of operations.
Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. The financial
markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the ongoing conflict
between Russia and Ukraine, terrorism or other geopolitical events. Sanctions imposed by the United States and other countries in response to such
conflicts may also adversely impact our clinical trials, the financial markets and the global economy, and any economic countermeasures by the affected
countries or others could exacerbate market and economic instability. A weak or declining economy or political disruption, including any international
trade disputes, could disrupt or otherwise adversely impact our operations and those of third parties upon which we rely. Although we do not currently
operate in Russia or Ukraine, if the conflict broadens it may impact countries or territories in which we do operate or intend to operate, which could have a
negative impact on our ability to achieve our objectives or timelines.
Item 1B. Unresolved staff comments
None.
Item 2. Properties
Our corporate headquarters are located in Woburn, Massachusetts, where we occupy approximately 18,712 square feet pursuant to a lease expiring in
2029, with an option to extend by an additional five years. Additionally, we also lease an approximately 12,000 square-foot facility in Oxfordshire, United
Kingdom, containing research and development, laboratory and office space. This lease expires in April 2031 and we have the right to terminate it in
April 2026. In October 2021, the Company entered into an additional agreement to lease approximately 2,951 square feet of research and development,
office and laboratory space in Abingdon, Oxfordshire, United Kingdom. The lease expires in October 2026.
In June 2018, we entered into an agreement to lease approximately 63,000 square feet of office, manufacturing and laboratory space in Framingham,
Massachusetts. Pursuant to the lease agreement, the lease term commenced in December 2018 and the rent commenced in August 2019. The initial lease
term is ten years from the rent commencement date and includes two optional five-year extensions.
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We believe that our current facilities are suitable and adequate to meet our current and planned needs. Our leases can be renewed, and we believe that
suitable alternative spaces will be available as needed in the future, on commercially reasonable terms. We do not own any real property.
Item 3. Legal proceedings
We are not currently a party to any material legal proceedings.
Item 4. Mine safety disclosures
Not applicable.
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Item 5. Market for registrant’s common equity, related stockholder matters and issuer purchases of equity securities
Our common stock has been listed on the Nasdaq Global Select Market under the symbol “REPL” since July 20, 2018. Prior to that date, there was no
PART II
public trading market for our common stock.
Holders of common stock
As of the close of business on May 16, 2022, there were approximately 18 holders of record of our common stock. This number does not reflect
beneficial owners whose shares are held in street name.
Dividend policy
We have never declared or paid any dividends on our capital stock. We currently intend to retain all available funds and any future earnings for use in
the operation of our business and do not anticipate paying any dividends on our common stock in the foreseeable future. Any future determination to
declare dividends will be made at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements,
contractual restrictions, business prospects, general business conditions and other factors that our board of directors may deem relevant.
Securities authorized for issuance under equity compensation plans
Information regarding our equity compensation plans and the securities authorized for issuance thereunder is set forth herein under Part III, Item 12
below.
Recent sales of unregistered securities
None.
Use of proceeds from registered securities
Shares of our common stock began trading on the Nasdaq Global Select market on July 20, 2018. The offer and sale of all the shares in the initial
public offering, or IPO, were registered under the Securities Act pursuant to a registration statement on Form S-1 (File No. 333-225846), which was
declared effective by the SEC on July 19, 2018. There has been no material change in the planned use of proceeds from our IPO as described in the
Prospectus filed with the SEC pursuant to Rule 424(b) under the Securities Act on July 23, 2018.
Purchases of equity securities by the Issuer and affiliated purchasers
None.
Item 6. Reserved
Item 7. Management’s discussion and analysis of financial condition and results of operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated
financial statements and related notes and other financial information included elsewhere in this Annual Report on Form 10-K. In addition to historical
information, some of the statements contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including
information with respect to our plans and strategy for our business, constitute forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. We have based these
forward-looking statements on our current expectations and projections about future events. The following information and any forward-looking statements
should be considered in light of factors discussed elsewhere in this Annual Report on Form 10-K, particularly including those risks identified in Part I,
Item 1A “Risk factors” and our other filings with the Securities Exchange Commission, or SEC.
We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition
and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Annual
Report on Form 10-K. Statements made herein are as of the date of the filing of this Annual Report on Form 10-K with the SEC and should not be relied
upon as of any subsequent date. Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate
are consistent with the forward-looking statements contained in this Annual Report on Form 10-K, they may not be predictive of
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results or developments in future periods. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or
revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based
or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Overview
We are a clinical-stage biotechnology company committed to applying our leading expertise in the field of oncolytic immunotherapy to transform the
lives of cancer patients through our novel tumor-directed oncolytic immunotherapies. Our proprietary tumor-directed oncolytic immunotherapy product
candidates are designed and intended to maximally activate the immune system against cancer.
Oncolytic immunotherapy is an emerging drug class, which we intend to establish as the second cornerstone of immune-based cancer treatments,
alongside checkpoint blockade. Oncolytic immunotherapy exploits the ability of certain viruses to selectively replicate in and directly kill tumors, as well
as induce a potent, patient-specific, anti-tumor immune response. Our product candidates incorporate multiple mechanisms of action into a practical “off-
the-shelf” approach that is intended to maximize the immune response against a patient’s cancer and to offer significant advantages over other approaches
of inducing anti-tumor immunity, including personalized vaccine approaches. We believe that the bundling of multiple approaches for the treatment of
cancer into single therapies will simplify the development path of our product candidates, while also improving patient outcomes at a lower cost to the
healthcare system than the use of multiple different drugs.
Financial
Since our inception, we have devoted substantially all of our resources to developing our proprietary RPx platform, building our intellectual property
portfolio, conducting research and development of our product candidates, business planning, raising capital and providing selling, general and
administrative support for our operations. To date, we have financed our operations primarily with proceeds from the sale of equity securities and to a lesser
extent the proceeds from the issuance of debt securities. We do not have any products approved for sale and have not generated any revenue from product
sales.
Since commencement of our initial public offering, or IPO, on July 20, 2018, we have raised an aggregate of approximately $569.0 million in net
proceeds to fund our operations, of which $101.2 million was from our IPO, $463.4 million was from three separate follow-on offerings, or the Public
Offerings, that we closed in November 2019, June 2020 and October 2020, respectively, and $4.4 million was from at-the-market offerings. We sold
7,407,936 shares of common stock in our IPO, an aggregate of 13,619,822 shares of our common stock and pre-funded warrants to purchase 5,284,238
shares of our common stock in the Public Offerings, and 287,559 shares of common stock through our at-the-market facility.
Funds affiliated with two separate institutional investors hold all of our outstanding pre-funded warrants. Other than as set forth in Notes 8, 9 and 10 of
the "Notes to Consolidated Financial Statements" contained in Part II, Item 8 of this Annual Report on From 10-K, the shares of our common stock into
which our outstanding pre-funded warrants are exercisable are not included in the number of issued and outstanding shares of our common stock set forth
in this Annual Report on Form 10-K.
In addition, on August 8, 2019, we entered into a Loan and Security Agreement with Hercules Capital, Inc., or Hercules, which we refer to as the
Hercules Loan Agreement, pursuant to which we borrowed $10.0 million under a secured term loan facility in the amount of $30.0 million. The Hercules
Loan Agreement was subsequently amended on June 1, 2020, in order to, among other things, increase the secured term loan facility from $30.0 million to
$40.0 million. On December 15, 2020, we paid a total of $10.8 million, representing the outstanding principal, accrued and unpaid interest, fees, costs and
expenses due and owing under the Hercules Loan Agreement and related loan documents, in repayment of all of our outstanding obligations thereunder,
and thereby terminated the Hercules Loan Agreement and the related loan documents.
Since our inception, we have incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will
depend on the successful development and eventual commercialization of one or more of our product candidates. Our net losses were $118.0 million and
$80.9 million for the years ended March 31, 2022 and 2021, respectively. As of March 31, 2022, we had an accumulated deficit of $311.2 million. These
losses have resulted primarily from costs incurred in connection with research and development activities and selling, general and administrative costs
associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
We anticipate that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly as we
advance the clinical trials, development and pre-commercial activities related to our RPx platform product candidates, and if and as we:
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conduct our current and future clinical trials with RP1, RP2 and RP3;
further preclinical development of our RPx platform;
qualify, operate or maintain our own in-house manufacturing facility;
seek to identify and develop additional product candidates;
seek marketing approvals for any of our product candidates that successfully complete clinical trials, if any;
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
until our manufacturing facility is fully validated, continued limited manufacturing by third parties for clinical development;
• maintain, expand and protect our intellectual property portfolio;
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hire and retain additional clinical, quality control, scientific and selling, general and administration personnel;
acquire or in-license other drugs and technologies; and
add operational, financial and management information systems and personnel, including personnel to support our research and development
programs, any future commercialization efforts and operations as a public company.
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for
RP1 or our other product candidates. If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization
partnership in any jurisdiction, we expect to incur significant expenses related to developing our internal commercialization capability to support product
sales, marketing, and distribution.
As a result, we will need additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate
significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, lines of
credit, collaborations, strategic alliances, and marketing, distribution, or licensing arrangements. We may be unable to raise additional funds or enter into
such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when,
needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of one or more of our product candidates.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or
amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not
become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our
operations at planned levels and be forced to reduce or terminate our operations.
As of March 31, 2022, we had cash and cash equivalents and short-term investments of $395.7 million. We believe that our existing cash and cash
equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements through at least 12 months from
the issuance of the consolidated financial statements included in this Annual Report on Form 10-K.
See “— Liquidity and capital resources” and “Risk factors — Risks related to our financial position and need for additional capital.”
The COVID-19 pandemic
We are continuing to monitor the global outbreak and spread of COVID-19 and, throughout the pandemic, have implemented measures designed to
comply with applicable federal, state and local guidelines, as well as care for our employee's health and well-being. We will continue to examine our
protocols as the pandemic and health guidance evolves. The COVID-19 pandemic continues to affect the United States and global economies and has
affected and may continue to affect our operations and those of third parties on which we rely, including by causing disruptions in our raw material and
anti-PD-1 supply, the manufacturing of our product candidates and our commercialization processes. In addition, timing of patient enrollment and treatment
in certain of our ongoing clinical studies has been impacted by the pandemic. However, the extent of these delays is currently unknown and has and will
likely continue to vary by clinical study. In addition, we may incur unforeseen costs as a result of disruptions in raw material supplies, clinical product
supplies, and preclinical studies or clinical trial delays. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business,
results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including
new
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information that may emerge concerning COVID-19, the actions taken in an effort to contain it or to potentially treat or continue to vaccinate against
COVID-19 and the economic impact on local, regional, national and international markets. We continue to actively monitor this situation and the possible
effects on our financial condition, liquidity, operations, suppliers, supplies, industry and workforce. For additional information, see “Risk Factors — Our
financial condition and results of operations could be adversely affected by the coronavirus disease-2019, or COVID-19, outbreak.” in Part I, Item 1A of
this Annual Report on Form 10-K.
Components of our results of operations
Revenue
To date, we have not generated any revenue from product sales as we do not have any approved products and do not expect to generate any revenue
from the sale of products in the near future. If our development efforts for RP1 or any other product candidates that we may develop in the future are
successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future
from a combination of product sales or payments from those collaborations or license agreements.
Operating expenses
Research and development expenses
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development
of our product candidates, and include:
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expenses incurred under agreements with third parties, including clinical research organizations, or CROs, that conduct research, preclinical
activities and clinical trials on our behalf as well as contract manufacturing organizations, or CMOs, that manufacture our product candidates for
use in our preclinical and clinical trials;
salaries, benefits and other related costs, including stock-based compensation expense, for personnel engaged in research and development
functions;
costs of outside consultants engaged in research and development functions, including their fees, stock-based compensation and related travel
expenses;
the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials;
costs related to compliance with regulatory requirements in connection with the development of our product candidates; and
facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating
costs.
These costs will be partially offset by our agreement with Regeneron related to our CERPASS trial.
We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to
completion of specific tasks using information provided to us by our service providers. Payments for these activities are based on the terms of the
individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued
research and development expenses.
Our direct external research and development expenses are tracked on a program-by-program basis and consist of costs, such as fees paid to
consultants, contractors, CMOs, and CROs in connection with our preclinical and clinical development activities. We do not allocate personnel costs, costs
associated with our discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific product development
programs because these costs are deployed across multiple product development programs and, as such, are not separately classified. All non-employee
costs associated with our manufacturing facility have been fully burdened to our RP1 program.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher
development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We
expect that our research and development expenses will continue to increase for the foreseeable future as we continue enrollment and initiate additional
clinical trials and continue to discover and develop additional product candidates. The successful development and commercialization of our product
candidates is highly
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uncertain. This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following:
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the scope, rate of progress, expense and results of our ongoing clinical trials, as well as future clinical trials or other product candidates and other
research and development activities that we may conduct;
the number and scope of preclinical and clinical programs we decide to pursue;
our ability to maintain our current research and development programs and to establish new ones;
uncertainties in clinical trial design;
the rate of enrollment in clinical trials;
the successful completion of clinical trials with safety, tolerability, and efficacy profiles that are satisfactory to the FDA or any comparable foreign
regulatory authority;
the receipt of regulatory approvals from applicable regulatory authorities;
our success in operating our manufacturing facility, or securing manufacturing supply through relationships with third parties;
our ability to obtain and maintain patents, trade secret protection, and regulatory exclusivity, both in the United States and internationally;
our ability to maintain, expand and protect our rights in our intellectual property portfolio;
the commercialization of our product candidates, if and when approved;
the acceptance of our product candidates, if approved, by patients, the medical community, and third-party payors;
our ability to successfully develop our product candidates for use in combination with third-party products or product candidates;
negative developments in the field of immuno-oncology;
competition with other products; and
significant and changing government regulation and regulatory guidance.
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs
and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to
conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we
experience significant trial delays due to patient enrollment or other reasons, we could be required to expend significant additional financial resources and
time on the completion of clinical development. We may never succeed in obtaining regulatory approval for any of our product candidates.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in
our executive, finance, corporate, commercial, and business development and administrative functions. Selling, general and administrative expenses also
include professional fees for legal, patent, accounting, auditing, tax and consulting services, pre-commercial planning, travel expenses, and facility-related
expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
We expect that our selling, general and administrative expenses will continue to increase in the future as we increase our selling, general and
administrative headcount to support our continued research and development and pre-launch activities to prepare for potential commercialization of our
product candidates. We also expect to continue to incur increased expenses, including accounting, audit, legal, regulatory and tax-related services
associated with maintaining compliance with exchange listing and SEC requirements; director and officer insurance costs; and investor and public relations
costs.
Other income (expense), net
Research and development incentives
Research and development incentives consists of reimbursements of research and development expenditures. We participate, through our subsidiary in
the United Kingdom, in the research and development program provided by the United
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Kingdom tax relief program, such that a percentage of up to 14.5% of our qualifying research and development expenditures are reimbursed by the United
Kingdom government, and such incentives are reflected as other income.
Investment income
Investment income consists of income earned on our cash and cash equivalents and short-term investments.
Interest expense on finance lease liability
Interest expense on finance lease liability consists of amortization of finance charges under our financing lease.
Interest expense on debt obligations
Interest expense on debt obligations consists of the amortization of debt discount and cash paid for interest under the term loan facility with Hercules.
Loss on extinguishment of debt
Loss on extinguishment of debt consists of the loss from extinguishment of debt obligations under the term loan facility with Hercules.
Other income (expense), net
Other income (expense), net consists primarily of realized and unrealized foreign currency transaction gains and losses.
Income taxes
Since our inception and through March 31, 2022, we have not recorded any income tax benefits for the net losses we incurred in each jurisdiction in
which we operate, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards
will not be realized.
Results of operations
Comparison of the years ended March 31, 2022 and 2021
The following table summarizes our results of operations for the years ended March 31, 2022 and 2021:
Operating expenses:
Research and development
Selling, general and administrative
Total operating expenses
Loss from operations
Other income (expense):
Research and development incentives
Investment income
Interest expense on finance lease liability
Loss on extinguishment of debt
Interest expense on debt obligations
Other (expense) income
Total other income (expense), net
Year Ended March 31,
Change
2022
2021
$
%
(Amounts in thousands)
$
79,545 $
56,754 $
38,769
118,314
(118,314)
3,170
390
(2,223)
—
—
(1,059)
278
23,201
79,955
(79,955)
2,807
916
(2,242)
(913)
(818)
(665)
(915)
22,791
15,568
38,359
(38,359)
363
(526)
19
913
818
(394)
1,193
Net loss
(118,036)
(80,870)
(37,166)
60
40 %
67 %
48 %
48 %
13 %
(57)%
(1)%
(100)%
(100)%
59 %
(130)%
46 %
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Research and development expenses
Research and development expenses for the year ended March 31, 2022 were $79.5 million, compared to $56.8 million for the year ended March 31,
2021. The following table summarizes our research and development expenses for the years ended March 31, 2022 and 2021:
Direct research and development expenses by program:
RP1
RP2
RP3
Unallocated research and development expenses:
Personnel related (including stock-based compensation)
Other
Total research and development expenses
$
Year Ended March 31,
Change
2022
2021
$
%
16,291
13,958
1,227
37,528
10,541
79,545 $
27,517
3,004
—
22,939
3,294
56,754 $
(11,226)
10,954
1,227
—
14,589
7,247
22,791
(41)%
365 %
100 %
64 %
220 %
40 %
The change in our direct research and development expenses between our product candidates is associated with technology transfer, process
development, qualification and comparability of our in-house manufactured materials compared to our third-party manufactured materials in readiness for
utilizing our product candidates made at our in-house manufacturing facility in our clinical development programs and preparation for potential commercial
manufacture, if approved. Manufacturing continued to focus on RP2 and RP3 technology transfers and process development during the fourth quarter, as
well as continued readiness for clinical trial development of these product candidates made at our in-house facility.
The increase of $21.8 million in our unallocated expenses was due primarily to a $14.6 million increase in personnel-related costs, including a $11.6
million increase in payroll and fringe benefits and a stock-based compensation increase of $2.8 million. The increase in personnel-related costs largely
reflected the hiring of additional personnel in our research and development functions as we expand the development plan in multiple indications.
Personnel related costs for the years ended March 31, 2022 and 2021 included stock-based compensation expense of $8.6 million and $5.7 million,
respectively. Additionally, the increase in other expenses is largely driven by $3.2 million of increased costs related to our manufacturing facility and
related lease costs, as well as an increase of $1.9 million in research costs and an increase of $0.9 million in lab supplies.
Selling, general and administrative expenses
Selling, general and administrative expenses were $38.8 million for the year ended March 31, 2022, compared to $23.2 million for the year ended
March 31, 2021. The increase of $15.6 million is primarily the result of an increase of $13.1 million in personnel related costs, including a stock-based
compensation increase of $9.6 million, an increase of $3.2 million in payroll and fringe benefits and a $0.3 million increase in travel and entertainment.
The increase in personnel related costs was driven by the continued hiring of additional personnel in our selling, general and administrative functions,
including the addition of commercial personnel associated with pre-launch commercial planning and initial build of the Company's commercial
infrastructure, which accounts for approximately $1.7 million of the increase compared to prior year, as we expand our operations.
Total other income (expense), net
Other income (expense) for the year ended March 31, 2022 was $0.3 million compared to $(0.9) million for the year ended March 31, 2021. The net
change of $1.2 million is primarily attributable to a decrease in expense of $0.9 million as a result of a loss related to the extinguishment of debt in the prior
year which did not recur in the current year, as well as a decrease in expense of $0.8 million as a result of interest expense on the aforementioned debt
obligations in the prior year which did not recur during the current year. Furthermore, the Company earned approximately $0.5 million more in interest
income on investments in the prior year as compared to the current year, and there is an increase in expense of $0.4 million in the current year due to the
changes in foreign exchange rates of the Great British Pound to United States Dollar.
Liquidity and capital resources
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from
our operations. We have not yet commercialized any of our product candidates, which are in
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various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for the foreseeable future, if at
all.
Sources of liquidity
To date, we have financed our operations primarily with proceeds from the sale of equity securities and, to a lesser extent, proceeds from the issuance
of debt. Through March 31, 2022, we had received net proceeds of $655.8 million from our sales of equity securities and $10.0 million from our incurrence
of debt under the term loan facility with Hercules, which was repaid in full in December 2020. As of March 31, 2022, we had cash and cash equivalents
and short-term investments of $395.7 million.
In July 2018, we completed our IPO and issued and sold 7,407,936 shares of our common stock at a public offering price of $15.00 per share, resulting
in net proceeds of $101.2 million after deducting underwriting discounts, commissions and other offering expenses of approximately $9.9 million. In the
fourth calendar quarter of 2019, we closed a registered public offering for the issuance and sale of 4,516,561 shares of our common stock at a public
offering price of $13.61 per share and pre-funded warrants to purchase 2,200,000 shares of our common stock at a purchase price of $13.6099 per pre-
funded warrant, which was equal to the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded
warrant. We received aggregate net proceeds of approximately $85.6 million after deducting underwriting discounts, commissions and other offering
expenses of approximately $5.8 million. In June 2020, we closed a second registered public offering for the issuance and sale of 3,478,261 shares of our
common stock at a public offering price of $23.00 per share and pre-funded warrants to purchase 1,521,738 shares of our common stock at a purchase price
of $22.9999 per pre-funded warrant, which was equal to the public offering price per share of common stock less the $0.0001 per share exercise price of
each pre-funded warrant. We received aggregate net proceeds of approximately $107.8 million after deducting underwriting discounts, commissions and
other offering expenses of approximately $7.2 million. In October 2020, we closed a third registered public offering for the issuance and sale of 5,625,000
shares of our common stock at a public offering price of $40.00 per share and pre-funded warrants to purchase 1,562,500 shares of our common stock at a
purchase price of $39.9999 per pre-funded warrant, the public offering price per share of common stock less the $0.0001 per share exercise price of each
pre-funded warrant. We received aggregate net proceeds of approximately $270.0 million after deducting underwriting discounts, commissions and other
offering expenses of approximately $17.5 million.
In addition to registered public equity offerings, we also established an at-the-market offering program pursuant to a sales agreement that we entered
into with SVB Leerink LLC, or the Agent, on August 8, 2019, or the 2019 Sales Agreement. Under the 2019 Sales Agreement, and prior to its amendment
in June 2020, we could sell from time to time, at our option, up to an aggregate of $75.0 million of shares of our common stock. In June 2020, we amended
the 2019 Sales Agreement to reduce the aggregate offering amount thereunder from $75.0 million to $30.0 million. We sold 287,559 shares of our common
stock under the 2019 Sales Agreement for net proceeds of approximately $4.4 million. On August 11, 2020, in connection with our entry into separate sales
agreement with the Agent, or the 2020 Sales Agreement, we and the Agent mutually agreed to terminate the 2019 Sales Agreement. Under the 2020 Sales
Agreement, and prior to its amendment in October 2020, we could sell from time to time, at our option, up to an aggregate of $75.0 million of shares of our
common stock. In October 2020, we amended the 2020 Sales Agreement to reduce the aggregate offering amount thereunder from $75.0 million to
$62.5 million. We did not issue or sell any shares of our common stock under the 2020 Sales Agreement during the year ended March 31, 2022. For
additional information, see Note 17, Subsequent events, of the "notes to Consolidated Financial Statements" contained in Part II, Item 8 of this Annual
Report on Form 10-K.
Our incurrence of debt was conducted entirely under the Hercules Loan Agreement, as amended, pursuant to which we borrowed $10.0 million of a
maximum of $40.0 million. On December 15, 2020, we entered into a Payoff Letter with Hercules and paid a total of $10.8 million to Hercules in
connection therewith, representing the outstanding principal, accrued and unpaid interest, fees, costs and expense due and owed to Hercules, thereby
terminating the Hercules Loan Agreement and the related loan documents.
Cash flows
The following table summarizes our cash flows for each of the periods presented:
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Net cash used in operating activities
Net cash (used in) provided by investing activities
Net cash provided by financing activities
Effect of exchange rate changes on cash and cash equivalents
Net (decrease) increase in cash and cash equivalents
Operating activities
Year Ended March 31,
2022
2021
(Amounts in thousands)
(82,180) $
(1,806)
6,598
818
(61,389)
(188,776)
372,462
721
(76,570) $
123,018
$
$
During the year ended March 31, 2022, net cash used in operating activities was $82.2 million, primarily resulting from our net loss of $118.0 million,
partially offset by non-cash charges of $28.6 million, consisting of stock-based compensation expense of $24.3 million and $4.4 million of expense related
to depreciation and amortization and net amortization of premiums and discounts on short-term investments, and an increase in cash of $7.2 million related
to changes in our operating assets and liabilities. Changes in our operating assets and liabilities for the year ended March 31, 2022 consisted primarily of a
$4.7 million increase in accrued expenses and other current liabilities, a net $2.5 million change in operating and financing right-of-use assets and lease
liabilities, a $1.1 million increase in accounts payable and a $0.8 million increase in prepaid expenses and other current assets, as well as a $0.2 million
increase in research and development incentives receivable from the United Kingdom government due to the timing and amount of qualifying expenditures.
During the year ended March 31, 2021, net cash used in operating activities was $61.4 million, primarily resulting from our net loss of $80.9 million,
partially offset by an increase in non-cash charges of $16.0 million, primarily consisting of stock-based compensation expense, and an increase in cash of
$3.5 million related to changes in our operating assets and liabilities. Changes in our operating assets and liabilities for the year ended March 31, 2021
consisted primarily of a $3.4 million increase in accrued expenses and other current liabilities, a net $2.5 million change in operating and financing right-
of-use assets and lease liabilities, a $1.7 million decrease in prepaid expenses and other current assets, a $1.0 million decrease in accounts payable and a
$0.3 million decrease in research and development incentives receivable from the United Kingdom government due to the timing and amount of our
qualifying expenditures. The changes in accounts payable were primarily due to the timing of vendor invoicing and payments.
Investing activities
During the year ended March 31, 2022, net cash used in investing activities was $1.8 million, consisting of $255.7 million in purchases of available for
sale securities and $2.3 million in purchases of property, plant and equipment, offset by $256.3 million in proceeds from sales and maturities of short-term
investments.
During the year ended March 31, 2021, net cash used in investing activities was $188.8 million, consisting of $392.4 million in purchases of available
for sale securities which were primarily driven by the receipt of proceeds from two registered public offerings during the fiscal year ended March 31, 2021,
as well as $2.4 million in purchases of property, plant and equipment, partially offset by $206.1 million in proceeds from sales and maturities of short-term
investments.
Financing Activities
During the year ended March 31, 2022, net cash provided by financing activities was $6.6 million, consisting primarily of $6.9 million in proceeds
from the exercise of stock options.
During the year ended March 31, 2021, net cash provided by financing activities was $372.5 million, consisting of $286.1 million from the issuance of
common stock, $91.7 million from the issuance of pre-funded warrants to purchase common stock, $5.7 million in proceeds from the exercise of stock
options, partially offset by $10.0 million in debt payments under the Hercules Loan Agreement and $0.8 million of fees associated with the extinguishment
of the obligations under the Hercules Loan Agreement.
Hercules Loan Agreement
On August 8, 2019 and as amended on June 1, 2020, we and certain of our affiliates entered into the Hercules Loan Agreement with Hercules, which
provided for aggregate borrowings of up to $40 million in the form of term loans. We borrowed $10.0 million at closing under the Hercules Loan
Agreement in August 2019 and subject to the achievement of certain milestones, had the ability to borrow the unused $30.0 million available in three
separate $10.0 million advances
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between October 1, 2020 and December 15, 2020, July 1, 2020 and June 30, 2021, and July 1, 2021 and December 15, 2021, respectively.
On December 15, 2020, we entered into a Payoff Letter with respect to the Hercules Loan Agreement. Pursuant to the Payoff Letter, we paid a total of
$10.8 million to Hercules, representing the outstanding principal, accrued and unpaid interest, fees, costs and expenses due and owed to Hercules under the
Hercules Loan Agreement. Upon the execution of the Payoff Letter, in repayment of all of our outstanding obligations thereunder, the Hercules Loan
Agreement and the related loan documents were terminated.
Borrowings under the Hercules Loan Agreement bore interest at a rate per annum equal to 8.75%. Under the Hercules Loan Agreement, we were
required to make monthly interest-only payments through September 1, 2022. As of March 31, 2022, there was no amount outstanding under the Hercules
Loan Agreement due and owing.
The Term Loan Facility with Hercules was secured by substantially all of our assets, excluding our intellectual property, and subject to certain
exceptions and exclusions. All liens on our assets held by Hercules were released in connection with the execution of the Payoff Letter.
Funding requirements
Our plan of operation is to continue implementing our business strategy, continue research and development of RP1 and our other product candidates
and continue to expand our research pipeline and our internal research and development capabilities. We expect our expenses to increase substantially in
connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our product candidates and if and as we:
•
•
•
•
•
•
•
conduct our current and future clinical trials with RP1, RP2 and RP3;
further preclinical development of our RPx platform;
operate, qualify and maintain our own in-house manufacturing facility;
seek to identify and develop additional product candidates;
seek marketing approvals for any of our product candidates that successfully complete clinical trials, if any;
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
until our planned manufacturing facility is fully validated, continued limited manufacturing by third parties for clinical development.
• maintain, expand and protect our intellectual property portfolio;
•
•
acquire or in-license other drugs and technologies; and
add operational, financial and management information systems and personnel, including personnel to support our research and development
programs, any future commercialization efforts and operations as a public company.
As of March 31, 2022, we had cash and cash equivalents and short-term investments of $395.7 million. We believe that our existing cash, cash
equivalents and short-term investments as of March 31, 2022, will enable us to fund our overall operations into the second half of calendar 2024, excluding
any confirmatory trial required by the FDA or other regulatory body. We have based these estimates on assumptions that may prove to be wrong, and we
could utilize our available capital resources sooner than we expect.
Because of the numerous risks and uncertainties associated with the development of RP1 and other product candidates and programs, and because the
extent to which we may enter into collaborations with third parties for development of our product candidates is unknown, we are unable to estimate the
timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product
candidates. Our future capital requirements will depend on many factors, including those described in this section and above under “— Operating expenses
— Research and development expenses.”
Developing novel biopharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and
uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any
product candidates or generate revenue from the sale of any products for which we may obtain marketing approval. In addition, our product candidates, if
approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of therapies that we do not expect to be
commercially
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available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
Adequate additional funds may not be available to us on acceptable terms, or at all. We do not currently have any committed external source of funds.
To the extent that we raise additional capital through the sale of our equity or convertible debt securities, our shareholders’ interest may be diluted, and the
terms of these securities may include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of our common
stockholder. Additional debt or preferred equity financing, if available, may involve agreements that include restrictive covenants that may limit our ability
to take specific actions, such as incurring debt adversely impact our ability to conduct our business, and may require the issuance of warrants, which could
potentially dilute your ownership interest.
If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish
valuable rights to our technology, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to
us. If we are unable to raise additional funds through equity or debt financings or collaborations, strategic alliances or licensing arrangements with third
parties when needed, we may be required to delay, limit, reduce and/or terminate our product development programs or any future commercialization
efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Contractual obligations and commitments
We have entered into arrangements that contractually obligate us to make payments that will affect our liquidity and cash flows in future periods. Our
contractual obligations primarily consist of our obligations under our operating and financing leases, as well as costs associated with contracts entered into
in the normal course of business with CROs, CMOs and other third parties for clinical trials and preclinical research studies and testing.
As of March 31, 2022, the aggregate amount of future lease payments is approximately $60.0 million, with $3.6 million due within one year. For
additional information on our leases and timing of future payments, see Note 12 Commitments and contingencies, of the "notes to Consolidated Financial
Statements" contained in Part II, Item 8 of this Annual Report on Form 10-K.
Manufacturing and research commitments include agreements that are enforceable and legally binding on us and that specify all significant terms,
including fixed or minimum quantities to be purchased; fixed, minimum or variable price provisions; and the approximate timing of the transaction. As of
March 31, 2022, the aggregate amount of non-cancelable purchase obligations related to such manufacturing commitments are approximately $2.0 million
and all of this balance is due within one year.
Collaborations
BMS
In February 2018, we entered into a Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb Company, or BMS. Pursuant to the
agreement, BMS is providing to us, at no cost, nivolumab, its anti-PD-1 therapy, for use in combination with RP1 in our ongoing Phase 1/2 clinical trial.
Under the agreement, we will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon protocol. BMS granted us a non-exclusive,
non-transferrable, royalty-free license (with a right to sublicense) under its intellectual property to use nivolumab in the clinical trial and has agreed to
supply nivolumab, at no cost to us, for use in the clinical trial. Both parties will own the study data produced in the clinical trial, other than study data
related solely to nivolumab, which will belong solely to BMS, or study data related solely to RP1, which will belong solely to us. In January 2020, this
agreement was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed melanoma.
Unless earlier terminated, the agreement will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data have been
delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the clinical trial protocol or any analysis
otherwise agreed upon by the parties. The agreement may be terminated by either party (x) in the event of an uncured material breach by the other party,
(y) in the event the other party is insolvent or in bankruptcy proceedings or (z) for safety reasons. Upon termination, the licenses granted to us to use
nivolumab in the clinical trial will terminate. The agreement contains representations, warranties, undertakings and indemnities customary for a transaction
of this nature.
In April 2019, we entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to
which BMS will provide, at no cost to us, nivolumab for use in our Phase 1 clinical trial of RP2 in combination with nivolumab.
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Regeneron
In May 2018, we entered into a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals, Inc., or Regeneron.
Pursuant to the agreement we agreed to undertake one or more clinical trials with Regeneron for the administration of our product candidates in
combination with cemiplimab, an anti-PD-1 therapy developed by Regeneron, across multiple solid tumor types, the first of which is our ongoing Phase 2
clinical trial testing RP1 in combination with cemiplimab versus cemiplimab alone in patients with CSCC. Each clinical trial will be conducted pursuant to
an agreed study plan which, among other things, will identify the name of the sponsor and which party will manage the particular study, and include the
protocol, the budget and a schedule of clinical obligations. The first study plan related to the Phase 2 clinical trial in CSCC has been agreed.
Pursuant to the terms of the agreement, each party granted the other party a non-exclusive license of their respective intellectual property and agreed to
contribute the necessary resources needed to fulfill their respective obligations, in each case, under the terms of agreed study plans. Development costs of a
particular clinical trial will be split equally. The agreement contains representations, warranties, undertakings and indemnities customary for a transaction
of this nature. The agreement also contains certain time-based covenants that restrict us from entering into a third-party arrangement with respect to the use
of our product candidates in combination with an anti-PD-1 therapy and that restrict Regeneron from entering into a third-party arrangement with respect to
the use of cemiplimab in combination with an HSV-1 virus, in each case, for the treatment of a tumor type that is the subject of a clinical trial to which the
covenants apply. Unless otherwise mutually agreed in a future study plan, these covenants are only applicable to our ongoing Phase 2 clinical trial in
CSCC.
The agreement may be terminated by either party if (i) there is no active study plan for which a final study report has not been completed and the
parties have not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most recent final study report or
(ii) in the event of a material breach.
Critical accounting policies and estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which
have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our consolidated financial
statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and
expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience,
known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on
an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in greater detail in Note 2 to our consolidated financial statements appearing elsewhere in this
Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the
preparation of our consolidated financial statements.
Accrued research and development expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.
This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on
our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise
notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when
contractual milestones are met; however, some require advanced payments. We make estimates of our accrued expenses as of each balance sheet date in the
consolidated financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development
expenses include fees paid to:
•
•
•
•
•
CROs in connection with performing research activities and conducting preclinical studies and clinical trials on our behalf;
CMOs in connection with the production of preclinical and clinical trial materials;
investigative sites or other service providers in connection with clinical trials;
vendors in connection with preclinical and clinical development activities; and
vendors related to product manufacturing and development and distribution of preclinical and clinical supplies.
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We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes
and contracts with multiple CMOs and CROs that supply, conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of
these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which
payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these
contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we
estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance
of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect
our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the
actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date,
there have not been any material adjustments to our prior estimates of accrued research and development expenses.
Stock-based compensation
We issue stock-based awards to employees, directors, consultants and non-employees in the form of stock options and restricted stock units. We
measure such stock-based awards in accordance with ASC 718, Compensation — Stock Compensation, which requires all stock-based awards to be
recognized in the consolidated statements of operations and comprehensive loss based on their fair value on the date of the grant and the related
compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. We
have, to date, only issued stock-based awards with service-based vesting conditions and record the expense for these awards using the straight-line method.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on
certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that
approximates the expected term of the option, and our expected dividend yield. See Note 9 of the "Notes to Consolidated Financial Statements" contained
in Part II, Item 8 of this Annual Report on Form 10-K for more information. Forfeitures are accounted for as they occur. The fair value of each stock-based
award is estimated on the date of grant based on the fair value of our common stock on that same date.
We classify stock-based compensation expense in our consolidated statements of operations in the same manner in which the award recipient’s payroll
costs are classified or in which the award recipient’s service payments are classified.
Recently issued accounting pronouncements
Refer to Note 2, summary of significant accounting policies of the “Notes to Consolidated Financial Statements” contained in Part II, Item 8 of this
Annual Report on Form 10-K for a description of recent accounting pronouncements that are applicable to our business and may potentially have an impact
on our financial position and results of operations
Emerging growth company status
As an “emerging growth company,” the Jumpstart Our Business Startups Act of 2012 permits us to take advantage of an extended transition period to
comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We
have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to
be adopted by public companies that are not emerging growth companies.
Item 7A. Quantitative and qualitative disclosures about market risks
Interest rate sensitivity
As of March 31, 2022, we had cash and cash equivalents and short-term investments of $395.7 million, which consisted of cash equivalents, U.S.
Treasury securities and U.S. government agency securities. Interest income is sensitive to changes in the general level of interest rates; however, due to the
nature of these investments, an immediate 10% change in interest rates would not have a material effect on the fair market value of our investment
portfolio.
Foreign currency exchange risk
Our headquarters are located in the United States, where the majority of our selling, general and administrative expenses are incurred in U.S. dollars.
The majority of our research and development costs are incurred by our subsidiary in Oxfordshire, United Kingdom, whose functional currency is the
British pound. We are exposed to foreign exchange rate risk. During the years ended March 31, 2022 and 2021, we recognized net foreign currency
transaction losses of $1.1 million and $0.7
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million, respectively. These losses are primarily related to unrealized and realized foreign currency gains and losses as a result of transactions entered into
by our United Kingdom subsidiary in currencies other than the British pound, primarily the euro. These foreign currency transaction losses were recorded
as a component of other income (expense), net in our consolidated statements of operations. We believe that a 10% change in the exchange rate between the
British pound and the euro would not have a material impact on our financial position or results of operations.
As we continue to grow our business, our results of operations and cash flows will be subject to fluctuations due to changes in foreign currency
exchange rates, which could adversely impact our results of operations. To date, we have not entered into any foreign currency hedging contracts to
mitigate our exposure to foreign currency exchange risk.
Item 8. Financial statements and supplementary data
See the consolidated financial statements filed as part of this Annual Report on Form 10-K as listed under Item 15 below.
Item 9. Changes in and disagreements with accountants on accounting and financial disclosures
None.
Item 9A. Controls and procedures
Evaluation of disclosure controls and procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures
that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded,
processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its
principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Under the supervision and with
the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of
our disclosure controls and procedures as of March 31, 2022. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2022.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how
well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.
Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions;
over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate.
Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Management’s report on internal control over financial reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-
15(f) under the Exchange Act). Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and
includes those policies and procedures that:
(i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
(ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally
accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management
and directors; and
(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have
a material effect on our financial statements.
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Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
Management of the Company has assessed the effectiveness of the Company’s internal control over financial reporting as of March 31, 2022. In
making its assessment of internal control over financial reporting, management used the criteria established in Internal Control — Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this evaluation, management concluded that
our internal control over financial reporting was effective as of March 31, 2022.
This annual report does not include an audit report of the Company’s registered public accounting firm regarding internal control over financial
reporting. Management’s report was not subject to audit by the Company’s registered public accounting firm pursuant to rules of the Securities and
Exchange Commission that permit the Company to provide only management’s report in this Annual Report on Form 10-K.
Changes in internal control over financial reporting
There have been no changes in our internal control over financial reporting during the fourth quarter of the fiscal year ended March 31, 2022 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
None.
Item 9C. Disclosure Regarding Jurisdictions That Prevent Inspections
Not Applicable.
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Item 10. Directors, executive officers and corporate governance
PART III
The text of our Code of Business Conduct and Ethics, which applies to our directors and employees (including our principal executive officer,
principal financial officer, and principal accounting officer or controller, and persons performing similar functions), is posted in the “Corporate
Governance” section of our website, www.replimune.com. A copy of the Code of Business Conduct and Ethics can be obtained free of charge on our
website. We intend to disclose on our website any amendments to, or waivers from, our Code of Business Conduct and Ethics that are required to be
disclosed pursuant to the rules of the Securities and Exchange Commission and Nasdaq. The information contained on our website is not considered part
of, or incorporated by reference into, this Annual Report on Form 10-K or any other filing that we make with the Securities and Exchange Commission.
The remaining information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A,
which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended March 31,
2022.
Item 11. Executive compensation
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which
proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31, 2022.
Item 12. Security ownership of certain beneficial owners and management and related stockholder matters
Securities authorized for issuance under equity compensation plans
The following table provides information as of March 31, 2022, regarding our common stock that may be issued under (1) the 2017 Equity
Compensation Plan, or the 2017 Plan; (2) the 2018 Omnibus Incentive Compensation Plan, or the 2018 Plan; or (3) the Employee Stock Purchase Plan, or
the ESPP.
Equity compensation plans approved by stockholders
Plan Category:
2017 Plan
2018 Plan
(1)
ESPP
Total
Number of Securities to be
Issued Upon Exercise of
Outstanding Options,
Warrants and Rights
Weighted-Average Exercise
Price of Outstanding Options,
Warrants and Rights
Number of Securities Available
for Future Issuance Under
Equity Compensation Plans
1,224,136
5,903,078
7,127,214
3.10
19.54
—
1,933,300
1,550,375
3,483,675
_________________
(1) Includes 737,880 shares of common stock subject to outstanding restricted stock units.
The remaining information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A,
which proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31,
2022.
Item 13. Certain relationships and related transactions, and director independence
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which
proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31, 2022.
Item 14. Principal accountant fees and services
The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which
proxy statement will be filed with the Securities and Exchange commission not later than 120 days after the close of our fiscal year ended March 31, 2022.
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Item 15. Exhibits and financial statement schedules
(a) 1. Consolidated financial statements.
PART IV
For a list of the consolidated financial statements included herein, see Index on page F-1 of this report.
2.
Financial statement schedules.
All required information is included in the financial statements or notes thereto.
3.
List of exhibits.
The documents listed in the exhibit index immediately preceding the signature page of this Annual Report on Form 10-K are incorporated by reference
or are filed or furnished with this Annual Report on Form 10-K, in each case as indicated therein.
Item 16. 10-K summary
None.
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REPLIMUNE GROUP, INC.
Financial Statements
For the Years Ended March 31, 2022 and 2021
Report of independent registered public accounting firm (PCAOB ID 238)
Consolidated balance sheets
Consolidated statements of operations
Consolidated statements of comprehensive loss
Consolidated statements of stockholders’ equity
Consolidated statements of cash flows
Notes to consolidated financial statements
F - 1
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-8
TABLE OF CONTENTS
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Replimune Group, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Replimune Group, Inc. and its subsidiaries (the “Company”) as of March 31, 2022
and 2021, and the related consolidated statements of operations, of comprehensive loss, of stockholders’ equity and of cash flows for the years then ended,
including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present
fairly, in all material respects, the financial position of the Company as of March 31, 2022 and 2021, and the results of its operations and its cash flows for
the years then ended in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the
Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we
plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether
due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As
part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on
the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or
fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and
disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis
for our opinion.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
May 19, 2022
We have served as the Company’s auditor since 2018.
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REPLIMUNE GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
Assets
Current assets:
Cash and cash equivalents
Short-term investments
Research and development incentives receivable
Prepaid expenses and other current assets
Total current assets
Property, plant and equipment, net
Restricted cash
Right-to-use asset – operating leases
Right-to-use asset – financing leases
Total assets
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Operating lease liabilities, current
Financing lease liabilities, current
Total current liabilities
Operating lease liabilities, non-current
Financing lease liabilities, non-current
Total liabilities
Commitments and contingencies (Note 12)
Stockholders’ equity:
Common stock, $0.001 par value; 150,000,000 shares authorized as of March 31, 2022 and March 31, 2021;
47,338,660 and 46,566,481 shares issued and outstanding as of March 31, 2022 and March 31, 2021,
respectively
Additional paid-in capital
Accumulated deficit
Accumulated other comprehensive loss
Total stockholders’ equity
Total liabilities and stockholders’ equity
March 31,
2022
March 31,
2021
$
105,948 $
$
$
289,707
3,055
5,267
403,977
7,933
1,636
5,552
42,094
461,192 $
3,732 $
13,392
1,070
2,562
20,756
4,801
24,406
49,963
182,518
293,784
2,953
4,492
483,747
7,442
1,636
5,751
44,522
543,098
2,355
8,735
970
2,487
14,547
5,078
24,745
44,370
47
723,359
(311,204)
(973)
411,229
461,192 $
$
47
692,243
(193,168)
(394)
498,728
543,098
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
Operating expenses:
Research and development
Selling, general and administrative
Total operating expenses
Loss from operations
Other income (expense):
Research and development incentives
Investment income
Interest expense on finance lease liability
Interest expense on debt obligations
Loss on extinguishment of debt
Other (expense) income
Total other income (expense), net
Net loss
Net loss per common share, basic and diluted
Year Ended March 31,
2022
2021
$
79,545 $
38,769
118,314
(118,314)
3,170
390
(2,223)
—
—
(1,059)
278
$
$
(118,036) $
(2.26) $
56,754
23,201
79,955
(79,955)
2,807
916
(2,242)
(818)
(913)
(665)
(915)
(80,870)
(1.75)
Weighted average common shares outstanding, basic and diluted
52,212,269
46,248,969
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands)
Net loss
Other comprehensive loss:
Foreign currency translation gain
Net unrealized loss on short-term investments, net of tax of $0
Comprehensive loss
Year Ended March 31,
2022
2021
(118,036) $
(80,870)
748
(1,327)
866
(278)
(118,615) $
(80,282)
$
$
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Amounts in thousands, except share amounts)
Balances as of March 31, 2020
36,668,743 $
37 $
296,961 $
(112,298) $
(982) $
183,718
Common stock
Shares
Amount
Additional paid-in
capital
Accumulated
deficit
Accumulated other
comprehensive loss
Total
stockholders’
equity
Issuance of prefunded warrants to purchase
common stock, net of $5,850 issuance costs
Issuance of common stock, net of issuance costs
and underwriter fees of $18,892
Foreign currency translation adjustment
Unrealized loss on short-term investments
Exercise of stock options
Stock-based compensation expense
Net loss
9,103,261
—
—
794,477
—
—
—
8
—
—
2
—
—
91,650
286,099
—
—
5,743
11,790
—
—
—
—
—
—
—
(80,870)
Balances as of March 31, 2021
46,566,481 $
47 $
692,243 $
(193,168) $
(394) $
Foreign currency translation adjustment
Unrealized loss on short-term investments
Exercise of stock options
Vesting of restricted stock units
Stock-based compensation expense
Net loss
—
—
768,186
3,993
—
—
—
—
—
—
—
—
—
—
6,862
—
24,254
—
—
—
—
—
—
(118,036)
748
(1,327)
—
—
—
—
—
91,650
—
866
(278)
—
—
—
286,107
866
(278)
5,745
11,790
(80,870)
498,728
748
(1,327)
6,862
—
24,254
(118,036)
Balances as of March 31, 2022
47,338,660 $
47 $
723,359 $
(311,204) $
(973) $
411,229
The accompanying notes are an integral part of these consolidated financial statements.
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REPLIMUNE GROUP, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
Depreciation and amortization
Net amortization of premiums and discounts on short-term investments
Noncash interest expense
Loss on extinguishment of debt
Changes in operating assets and liabilities:
Research and development incentives receivable
Prepaid expenses and other current assets
Operating lease, right-of-use-asset
Finance lease, right-of-use-asset
Accounts payable
Accrued expenses and other current liabilities
Operating lease liabilities
Net cash used in operating activities
Cash flows from investing activities:
Purchases of property, plant and equipment
Purchase of short-term investments
Proceeds from sales and maturities of short-term investments
Net cash (used in) investing activities
Cash flows from financing activities:
Proceeds from issuance of common stock in follow-on public offering, net of underwriting fees and discounts
Proceeds from issuance of prefunded warrants to purchase common stock, net of underwriting fees and discounts
Proceeds from exercise of stock options
Payment of debt issuance costs
Principal payment of finance lease obligation
Principal payment of long-term debt
Payment of long-term debt extinguishment costs
Net cash provided by financing activities
Effect of exchange rate changes on cash, cash equivalents and restricted cash
Net (decrease) increase in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period
Cash, cash equivalents and restricted cash at end of period
Supplemental disclosure of cash flow information:
Cash paid during the period for interest
Cash paid for income taxes, net
Supplemental disclosure of non-cash investing and financing activities:
Purchases of property and equipment included in accounts payable
Lease assets obtained in exchange for new operating lease liabilities
Year Ended March 31,
2022
2021
$
(118,036) $
(80,870)
24,254
2,147
2,220
—
—
(247)
(815)
99
2,428
1,118
4,725
(73)
11,790
1,711
1,376
181
913
325
(1,707)
447
2,403
(1,031)
3,413
(340)
(82,180)
(61,389)
(2,336)
(255,720)
256,250
(1,806)
—
—
6,862
—
(264)
—
—
6,598
818
(76,570)
184,154
107,584 $
— $
55
415 $
363 $
(2,392)
(392,434)
206,050
(188,776)
286,107
91,650
5,745
(100)
(145)
(10,000)
(795)
372,462
721
123,018
61,136
184,154
636
—
98
1,580
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
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1. Nature of the business
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
Replimune Group, Inc. (the “Company”) is a clinical-stage biotechnology company focused on the development of oncolytic immunotherapies to treat
cancer. Replimune Group, Inc., whose predecessor was founded in 2015, is the parent company of its wholly owned, direct and indirect subsidiaries:
Replimune Limited (“Replimune UK”); Replimune, Inc. (“Replimune US”); Replimune Securities Corporation; and Replimune (Ireland) Limited.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to,
development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with
government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require
significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These
efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance and reporting capabilities. Even if
the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Basis of presentation
The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the
satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since its inception, including net
losses of $118.0 million and $80.9 million for the years ended March 31, 2022 and 2021, respectively. In addition, as of March 31, 2022, the Company had
an accumulated deficit of $311.2 million. The Company expects to continue to generate operating losses for the foreseeable future. As of the issuance date
of these consolidated financial statements, the Company expects that its cash and cash equivalents and short-term investments will be sufficient to fund its
operating expenses and capital expenditure requirements through at least 12 months from the issuance of the consolidated financial statements.
Impact of COVID-19
In December 2019, a novel strain of coronavirus, which causes the disease known as COVID-19, was reported to have surfaced in Wuhan, China.
Since then, COVID-19 coronavirus has spread globally. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic and
the U.S. government imposed travel restrictions on travel between the United States, Europe and certain other countries. The impact of this pandemic has
been, and will likely continue to be, extensive in many aspects of society, which has resulted, and will likely continue to result, in significant disruption to
the global economy as well as businesses and capital markets around the world.
In response to public health directives and orders and to help minimize the risk of the virus to employees, the Company has taken precautionary
measures including establishing and maintaining an internal COVID-19 task force to ensure timely communication and decision-making in response to
COVID-19, establishing work-from home policies and return-to-office policies as well as other measures to respond and adapt to the COVID-19 impact.
For those employees working from our offices, laboratories and manufacturing facilities, we have implemented stringent safety measures designed to
comply with applicable federal, state and local guidelines instituted in response to the COVID-19 pandemic and we continue to examine our protocols as
the pandemic and health guidance evolves. The Company has taken these and other precautionary steps while maintaining business continuity in order to
continue to progress its programs. While there has been no prolonged material disruption to the Company’s business to date, the impact of the virus,
including work-from-home policies, may negatively impact productivity, disrupt the Company’s business, and delay its preclinical research and clinical
trial activities and its development program timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other
limitations on the Company’s ability to conduct its business in the ordinary course. Other impacts to the Company’s business may include disruptions of its
suppliers or material supplies and disruptions or restrictions on its employees’ ability to travel. Any prolonged material disruption to the Company’s
employees, suppliers or supply could adversely impact the Company’s preclinical research and clinical trial activities, financial condition and results of
operations, including its ability to obtain financing.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
2.
Summary of significant accounting policies
Principles of consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United
States of America, or GAAP, and include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Replimune UK, Replimune
US, Replimune Securities Corporation and Replimune (Ireland) Limited after elimination of all intercompany accounts and transactions.
Use of estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the
reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements
include, but are not limited to, the accrual for research and development expenses and the valuation of stock-based awards. The Company bases its
estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the
circumstances.
The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition,
including, expenses, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain,
including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. We have made
estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods.
Estimates are periodically reviewed in light of reasonable changes in circumstances, facts and experience. Changes in estimates are recorded in the
period in which they become known. Actual results could differ from those estimates or assumptions.
Foreign currency and currency translation
The functional currency for the Company’s wholly owned foreign subsidiary, Replimune UK, is the British pound. Assets and liabilities of Replimune
UK are translated into United States dollars at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average
exchange rate in effect during the period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment, which is included in
the consolidated statements of stockholders’ equity as a component of accumulated other comprehensive loss. Adjustments that arise from exchange rate
changes on transactions denominated in a currency other than the local currency are included in other income (expense), net in the consolidated statements
of operations as incurred.
Concentrations of credit risk and of significant suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents as well as
short-term investments. The Company deposits its cash in financial institutions in amounts that may exceed federally insured limits, and has not
experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with
commercial banking relationships.
The Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and raw materials for its development
programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials.
Cash and cash equivalents
The Company considers all highly liquid investments with original maturities of three months or less at date of purchase to be cash equivalents. Cash
equivalents consisted of money market funds as of March 31, 2022 and 2021, respectively. As of March 31, 2022 and 2021, the amount of cash equivalents
included in cash and cash equivalents totaled $75,117 and $150,734, respectively.
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REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
2. Summary of significant accounting policies (Continued)
Restricted cash
The Company holds restricted cash in segregated bank accounts in connection with a letter of credit. As of March 31, 2022 and 2021, restricted cash
consisted of $1,636, held for the benefit of the landlords in connection with our leases. These amounts have been classified as non-current assets on the
Company’s consolidated balance sheets.
Short-term investments
The Company’s short-term debt security investments are classified as available-for-sale and are carried at fair value, with the unrealized gains and
losses reported as a component of accumulated other comprehensive loss in stockholders’ equity. Realized gains and losses and declines in value
determined to be other than temporary are based on the specific identification method and are included as a component of other income (expense), net in
the consolidated statements of operations.
The Company evaluates its short-term debt security investments with unrealized losses for other-than-temporary impairment. When assessing short-
term debt security investments for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the
decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s
ability and intent to retain the short-term debt security investment for a period of time sufficient to allow for any anticipated recovery in fair value and
market conditions in general. If any adjustment to fair value reflects a decline in the value of the short-term debt security investment that the Company
considers to be “other than temporary,” the Company reduces the short-term debt security investment to fair value through a charge to the consolidated
statements of operations. No such adjustments were necessary during the periods presented.
The Company’s short-term investments as of March 31, 2022 and 2021 had maturities of less than two years.
Property, plant and equipment
Property, plant and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation and amortization expense is recognized
using the straight-line method over the estimated useful lives of the respective assets as follows:
Office equipment
Computer equipment and software
Plant, manufacturing and laboratory equipment
Leasehold improvements
Estimated Useful life
5 years
3 years
5 years
Lesser of lease term or 10 years
Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines
once placed into service. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts
and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred.
Impairment of long-lived assets
Long-lived assets consist of property, plant and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or
changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in
deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative
industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-
lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition
of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to
result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the
impaired asset group over its fair value, determined based on discounted cash flows. To date, the Company has not recorded any impairment losses on
long-lived assets.
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
2. Summary of significant accounting policies (Continued)
Fair value measurements
Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received
for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and
minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three
levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
•
•
•
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted
prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by
observable market data.
Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or
liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
The Company’s short-term investments and cash equivalents are carried at fair value, determined according to the fair value hierarchy described above
(see Note 3). The carrying values of research and development incentives receivable, prepaid expenses and other current assets, accounts payable and
accrued expenses and other current liabilities approximate their fair values due to the short-term nature of these assets and liabilities.
Debt issuance costs
Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as
interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is canceled or forfeited, or if
the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s
consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that
debt liability.
Segment information
The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions. The
Company’s current focus is on developing oncolytic immunotherapies for the treatment of cancer.
Research and development costs
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and
development activities, including salaries, stock-based compensation and benefits, facilities costs and laboratory supplies, depreciation and external costs of
outside vendors engaged to conduct preclinical development, clinical development activities and clinical trials as well as to manufacture clinical trial
materials. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and
capitalized. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected
that the goods will be delivered or the services rendered. Upfront payments for materials and supplies acquired for particular research and development
activities that have no alternative future use in other research and development projects or otherwise, and therefore have no separate economic value, are
expensed as research and development costs at the time the costs are incurred.
Research contract costs and accruals
The Company has entered into various research and development-related contracts with companies both inside and outside of the United States. These
agreements are generally cancellable, and related costs are recorded as research and development expenses as incurred. The Company records accruals for
estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials,
including the phase or completion of
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
2. Summary of significant accounting policies (Continued)
events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any
reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different
from the actual costs.
Patent costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the
recovery of the expenditure. Amounts incurred are classified as selling, general and administrative expenses.
Stock-based compensation
The Company accounts for share-based payment awards granted to employees, consultants, and non-employees and directors using the fair value of
the Company’s common stock on the grant date and compensation expense is recognized for those awards over the requisite service period, which is
generally the vesting period of the respective award. The grant date fair value is utilized for time-vested restricted stock units (“RSUs”) and the fair value
of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective
assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the
expected term of the option, and the Company’s expected dividend yield (see Note 9). Forfeitures are accounted for as they occur. To date, the Company
has issued stock-based awards with only service-based vesting conditions and records the expense for these awards using the straight-line method.
The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award
recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Research and development incentives and receivable
The Company, through its subsidiary in the United Kingdom, receives reimbursements of certain research and development expenditures as part of a
United Kingdom government’s research and development tax reliefs program. Under the program, a percentage of qualifying research and development
expenses incurred by the Company’s subsidiary in the United Kingdom are reimbursed up to 14.5%.
Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are
likely to be eligible under the research and development incentive program described above. At each period end, management estimates the reimbursement
available to the Company based on available information at the time.
The Company recognizes income from the research and development incentives when the relevant expenditure has been incurred, the associated
conditions have been satisfied and there is reasonable assurance that the reimbursement will be received. The Company records these research and
development incentives as other income. The research and development incentives receivable represents an amount due in connection with the above
program. The Company recorded other income from research and development incentives of $3,170 and $2,807 during the years ended March 31, 2022 and
2021, respectively, in the consolidated statements of operations and a research and development incentives receivable of $3,055 and $2,953 as of March 31,
2022 and 2021, respectively, on the consolidated balance sheets.
Comprehensive loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than
those with stockholders. For the year ended March 31, 2022, comprehensive loss included $748 of foreign currency translation adjustments and $1,327 of
unrealized losses on short-term investments, net of tax. For the year ended March 31, 2021, comprehensive loss included $866 of foreign currency
translation adjustments and $278 of unrealized losses on short-term investments, net of tax.
Income taxes
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
2. Summary of significant accounting policies (Continued)
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for
the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred
tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities
using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in
the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the
extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be
realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by
estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.
The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to
determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon
external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to
determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest
amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any
resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
Net income (loss) per share
Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock
outstanding for the period. Diluted net income (loss) per common share is computed by dividing the diluted net income (loss) by the weighted average
number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock
equivalents.
In periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are
not assumed to have been issued if their effect is anti-dilutive.
Recently adopted accounting pronouncements
In December 2019, the Financial Accounting Standards Board ("FASB") issued ASU No. 2019-12 Income Taxes (Topic 740)-Simplifying the
Accounting for Income Taxes (ASU 2019-12), which is intended to simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions
related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax
liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of
GAAP. The new standard was effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. We adopted ASU
2019-12 effective April 1, 2021. The adoption of ASU 2019-12 did not have a material impact on our consolidated financial statements.
Recently issued accounting pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326). The standard changes how entities will measure
credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. Financial assets measured at
amortized cost will be presented at the net amount expected to be collected by using an allowance for credit losses. In April 2019, the FASB issued ASU
No. 2019-4, Codification Improvements to Topic 326, Financial Instruments — Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825,
Financial Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended Topics. Additionally,
in May 2019, the FASB issued ASU No. 2019-5, Financial Instruments — Credit Losses (Topic 326), which provides an option to irrevocably elect to
measure certain individual financial assets at fair value instead of amortized cost. The standard is effective for fiscal years and interim periods beginning
after December 15, 2022. Early adoption is permitted for all periods beginning after December 15, 2018. The adoption of ASU 2016-13 is not expected to
have a material impact on the Company’s consolidated financial statements.
3. Fair value of financial assets and liabilities
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
3. Fair value of financial assets and liabilities (Continued)
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis:
Assets
Money market funds
US Government Agency bonds
US Treasury bonds
Assets
Money market funds
US Government Agency bonds
US Treasury bonds
Fair Value Measurements as of March 31, 2022 Using:
Level 1
Level 2
Level 3
Total
— $
75,117 $
—
—
26,688
263,019
— $
364,824 $
— $
—
—
— $
75,117
26,688
263,019
364,824
Fair Value Measurements as of March 31, 2021 Using:
Level 1
Level 2
Level 3
Total
— $
150,734 $
—
—
67,012
226,772
— $
444,518 $
— $
—
—
— $
150,734
67,012
226,772
444,518
$
$
$
$
The underlying securities held in the money market funds held by the Company are all government backed securities. During the years ended
March 31, 2022 and 2021, there were no transfers between levels.
Valuation of cash equivalents and short-term investments
Money market funds, U.S. Treasury bonds and U.S. Government Agency bonds were valued by the Company using quoted prices in active markets for
similar securities, which represent a Level 2 measurement within the fair value hierarchy. Cash equivalents consisted of money market funds at March 31,
2022 and March 31, 2021.
4. Short-term investments
As of March 31, 2022 and 2021, the Company's available-for-sale investments by type, consisted of the following:
US Government agency bonds
US Treasury bonds
US Government agency bonds
US Treasury bonds
March 31, 2022
Amortized cost
Gross unrealized gains
Gross unrealized
losses
Fair value
26,827 $
264,162
290,989 $
— $
—
— $
(139) $
(1,143)
(1,282) $
26,688
263,019
289,707
March 31, 2021
Amortized cost
Gross unrealized gains
Gross unrealized
losses
Fair value
67,017 $
226,722
293,739 $
12 $
55
67 $
(17) $
(5)
(22) $
67,012
226,772
293,784
$
$
$
$
As of March 31, 2022 and 2021, available-for-sale securities consisted of investments that mature within one year, with the exception of certain U.S.
Government agency bonds and U.S. Treasury bonds which have maturities between one and two years and an aggregate fair value of $7.6 million and
$54.2 million, respectively.
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
5. Property, plant and equipment, net
Property, plant and equipment, net consisted of the following:
Office equipment
Computer equipment
Plant and laboratory equipment
Leasehold improvements
Construction in progress
Less: Accumulated depreciation and amortization
March 31,
2022
March 31,
2021
$
937 $
1,667
7,720
785
1,619
12,728
(4,795)
$
7,933 $
830
1,695
6,369
784
412
10,090
(2,648)
7,442
Depreciation and amortization expense was $2.1 million and $1.7 million for the years ended March 31, 2022 and 2021, respectively, and recorded
within research and development and selling, general and administrative expenses in the consolidated statement of operations.
6. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following:
Accrued research and development costs
Accrued compensation and benefits costs
Accrued professional fees
Other
7. Long-term debt
Hercules Loan Agreement
March 31,
2022
March 31,
2021
$
$
5,882 $
5,569
621
1,320
13,392 $
3,862
3,952
407
514
8,735
On August 8, 2019, (the “Closing Date”) the Company and certain of its affiliates entered into a Loan and Security Agreement (as amended, the
“Hercules Loan Agreement”) with Hercules Capital, Inc. (“Hercules”) pursuant to which Hercules agreed to make available to the Company a secured term
loan facility in the amount of $30,000 (the “Term Loan Facility”), subject to certain terms and conditions. The Company borrowed $10,000 under the
Hercules Loan Agreement in one advance as a single tranche term Loan on the Closing Date upon which the Company paid a $225 facility charge and
incurred $130 in additional closing and legal fees.
On June 1, 2020, the Company entered into the First Amendment to the Hercules Loan Agreement (the “Hercules First Amendment”), to, among other
things, increase the aggregate principal amount of the secured term loan facility from $30,000 to $40,000. Pursuant to the Hercules First Amendment,
subject to the achievement of certain milestones, the Company could have borrowed three tranches of up to $10,000 between October 1, 2020 and
December 15, 2020, July 1, 2020 and June 30, 2021, and July 1, 2021 and December 15, 2021, respectively. The Company incurred $100 in additional
closing and legal fees in connection with Hercules First Amendment which were capitalized and will be amortized as part of the effective yield.
On December 15, 2020, the Company entered into a Payoff Letter with respect to the Hercules Loan Agreement, which resulted in a loss on
extinguishment of debt of $913 including both cash and non-cash expense. Pursuant to the Payoff Letter, the Company paid a total of $10,839 to Hercules,
representing $10,000 in outstanding principal, $495 end of term charge, $300
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TABLE OF CONTENTS
7. Long-term debt (Continued)
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
early termination fee due and $44 in accrued interest owed to Hercules under the Hercules Loan Agreement. In connection with the execution of the Payoff
Letter and the repayment of the Company’s outstanding obligations under the Hercules Loan Agreement, the Hercules Loan Agreement and the related loan
documents were terminated.
The Term Loan Facility was secured by substantially all of the Company’s assets, but excluding its intellectual property, and subject to certain
exceptions and exclusions. All liens on the Company’s assets held by Hercules were released in connection with the execution of the Payoff Letter.
In connection with entering into the Hercules Loan Agreement the Company paid Hercules $355 and $100 of upfront fees, respectively. Such upfront
fees included closing costs and legal fees associated with entering into the respective agreements, and were recorded as a debt discount.
The Company recognized aggregate interest expense under the Hercules Loan Agreement of $818 during the year ended March 31, 2021, which
included non-cash interest expense of $181. Non-cash interest expense included the amortization of the debt discount of $82 and the accretion of the final
payment of $99, respectively.
There were no principal payments due or paid under the Hercules Loan Agreement during the year ended March 31, 2022.
8. Stockholders’ Equity
Common stock
As of March 31, 2022 and 2021, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to
150,000,000 shares of common stock, par value $0.001 per share.
As of March 31, 2022 and 2021, the Company had reserved 16,605,804 and 14,572,115 shares of common stock for the exercise of outstanding stock
options and the vesting of restricted share units, the number of shares remaining available for grant under the Company’s 2018 Omnibus Incentive
Compensation Plan and the Company’s Employee Stock Purchase Plan (see Note 9) and the exercise of the outstanding warrants to purchase shares of
common, respectively.
Undesignated preferred stock
As of March 31, 2022, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 10,000,000 shares
of undesignated preferred stock, par value $0.001 per share. There were no undesignated preferred shares issued or outstanding as of March 31, 2022.
ATM program
In August 2019, the Company entered into a Sales Agreement (as amended, the “Sales Agreement”) with SVB Leerink LLC (the “Agent”), pursuant to
which the Company could sell, from time to time, at its option, up to an aggregate amount of $75,000 of shares of the Company’s common stock, $0.001
par value per share through the Agent, as the Company’s sales agent. In June 2020, the 2019 Sales Agreement was amended to reduce the aggregate
offering amount under the 2019 Sales Agreement from $75,000 of shares to $30,000 of shares.
On August 11, 2020, the 2019 Sales Agreement was terminated by the execution by the Company and the Agent of a new sales agreement, which was
subsequently amended on October 21, 2020 (as amended, the “2020 Sales Agreement”). Under the 2020 Sales Agreement the Company may sell, from
time to time, at its option, up to an aggregate of $62,500 of shares of the Company’s common stock, $0.001 par value per share (the “Shares”), through the
Agent, as the Company’s sales agent.
Any Shares to be offered and sold under the 2020 Sales Agreement will be issued and sold (i) by methods deemed to be an “at the market offering”
(“ATM”), as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended or in negotiated transactions, if authorized by the
Company, and (ii) pursuant to, and only upon the effectiveness of, a registration statement on Form S-3 filed by the Company with the Securities and
Exchange Commission on August 11, 2020 for an offering of up to $350,000 of various securities, including shares of the Company’s common stock,
preferred stock, debt securities, warrants and/or units for sale to the public in one or more public offerings.
Subject to the terms of the 2020 Sales Agreement, the Agent will use reasonable efforts to sell the Shares from time to time, based upon the
Company’s instructions (including any price, time or size limits or other customary parameters or
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
8. Stockholders’ Equity(Continued)
conditions the Company may impose). The Company cannot provide any assurances that it will issue any additional Shares pursuant to the 2020 Sales
Agreement. The Company will pay the Agent a commission of up to 3.0% of the gross proceeds from the sale of the Shares. The Company has also agreed
to provide the Agent with customary indemnification rights.
The Company did not issue or sell any shares under the 2020 Sales Agreement during the year ended March 31, 2022. For additional information, see
Note 17 to these consolidated financial statements.
Equity offerings
In November 2019, pursuant to an underwriting agreement (the “November 2019 Underwriting Agreement”) with J.P. Morgan Securities LLC and
SVB Leerink LLC, as representatives of the several underwriters named therein (the “November 2019 Underwriters”), the Company issued and sold to the
November 2019 Underwriters (a) 4,516,561 shares of the Company’s common stock (the “November 2019 Shares”), inclusive of the November 2019
Underwriters partially exercised 30-day option and purchased an additional 838,530 shares of the Company’s common stock, and (b) pre-funded warrants
to purchase 2,200,000 shares of the Company’s common stock (the “November 2019 Pre-Funded Warrants”). The November 2019 shares were sold to the
November 2019 Underwriters (the “November 2019 Offering”) at the public offering price of $13.61 per share and the pre-funded warrants were sold at a
public offering price of $13.6099 per November 2019 Pre-Funded Warrant, which represented the per share public offering price for November 2019
Shares less a $0.0001 per share exercise price for each such November 2019 Pre-Funded Warrant. The Company received aggregate net proceeds of
approximately $85,598 in the November 2019 Offering, after deducting underwriting discounts, commissions and other offering expenses payable by the
Company of approximately $5,814.
Funds affiliated with Redmile Group, LLC purchased all of the November 2019 Pre-Funded Warrants. The November 2019 Pre-Funded Warrants are
exercisable at any time after the date of issuance. A holder of November 2019 Pre-Funded Warrants may not exercise the November 2019 Pre-Funded
Warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of the Company’s common stock
outstanding immediately after giving effect to such exercise.
In June 2020, pursuant to an underwriting agreement (the “June 2020 Underwriting Agreement”) with J.P. Morgan Securities LLC and SVB Leerink
LLC, as representatives of the several underwriters named therein (“the June 2020 Underwriters”), the Company sold to the June 2020 Underwriters
(a) 3,478,261 shares of the Company’s common stock (the “June 2020 Shares”), inclusive of the underwrites 30-day option to purchase up to an additional
652,173 shares of the Company’s commons stock, and (b) pre-funded warrants to purchase 1,521,738 shares of the Company’s common stock (the
“June 2020 Pre-Funded Warrants”).The June 2020 Shares of the Company’s common stock were sold to the June 2020 Underwriters at the public offering
price of $23.00 per share and the June 2020 Pre-Funded Warrants were sold at a public offering price of $22.9999 per June 2020 Pre-Funded Warrant,
which represented the per share public offering price for the June 2020 shares less a $0.0001 per share exercise price for each such June 2020 Pre-Funded
Warrant. The Company received aggregate net proceeds of approximately $107,782 after deducting underwriting discounts, commissions and other
offering expenses payable by the Company of approximately $7,217.
Funds affiliated with Redmile Group, LLC and funds affiliated with a second institutional investor purchased all of the June 2020 Pre-Funded
Warrants. The June 2020 Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of June 2020 Pre-Funded Warrants may not
exercise the June 2020 Pre-Funded Warrants if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of
the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of June 2020 Pre-Funded Warrants may increase or
decrease this percentage up to 19.99% by providing at least 61 days’ prior notice to the Company.
In October 2020, pursuant to an underwriting agreement with J.P. Morgan Securities LLC and SVB Leerink LLC, as representatives of the several
underwriters named therein, the Company issued and sold to the underwriters (a) 5,625,000 shares of the Company’s common stock, inclusive of the
underwriters 30-day option to purchase up to an additional 937,500 shares of the Company’s common stock, and (b) pre-funded warrants to purchase
1,562,500 shares of the Company’s common stock (the “October 2020 Pre-Funded Warrants”). The shares of the Company’s common stock were sold to
the underwriters at the public offering price of $40.00 per share and the pre-funded warrants were sold at a public offering price of $39.9999 per October
2020 Pre-Funded Warrant, which represented the per share public offering price for the Company’s common stock less a $0.0001 per share exercise price
for each such pre-funded warrant. The Company received aggregate net proceeds of
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
8. Stockholders’ Equity(Continued)
approximately $269,975 after deducting underwriting discounts, commissions and other offering expenses payable by the Company of approximately
$17,525.
Funds affiliated with Redmile Group, LLC and funds affiliated with a second institutional investor purchased all of the October 2020 Pre-Funded
Warrants. The October 2020 Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of October 2020 Pre-Funded Warrants
may not exercise the October 2020 Pre-Funded Warrants if the holder, together with its affiliates, would beneficially own more than 9.99% of the number
of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. A holder of October 2020 Pre-Funded Warrants
may increase or decrease this percentage up to 19.99% by providing at least 61 days’ prior notice to the Company.
Other than as set forth in Note 9 and Note 10 to these consolidated financial statements, the 5,284,238 Pre-Funded Warrants are not included in the
number of issued and outstanding shares of the Company’s common stock set forth herein. As of March 31, 2022, none of the November 2019 Pre-Funded
Warrants, the June 2020 Pre-Funded Warrants, or the October 2020 Pre-Funded Warrants had been exercised.
9. Stock-based compensation
Stock-based compensation expense
The following table summarizes the classification of stock-based compensation expense in the consolidated statements of operations for the years
ended March 31, 2022 and 2021 as follows:
Research and development
Selling, general and administrative
Twelve Months Ended
March 31,
2022
2021
$
$
8,568 $
15,686
24,254 $
5,749
6,041
11,790
The following table summarizes stock-based compensation expense by award type for the years ended March 31, 2022 and 2021 as follows:
Stock options
Restricted stock units
Twelve Months Ended
March 31,
2022
2021
$
$
19,160 $
5,094
24,254 $
11,778
12
11,790
2015 Enterprise Management Incentive Share Option Plan
The 2015 Enterprise Management Incentive Share Option Plan of Replimune UK (the “2015 Plan”) provided for Replimune UK to grant incentive
stock options, non-statutory stock options, stock awards, stock units, stock appreciation rights and other stock-based awards. Incentive stock options are
granted only to the Company’s employees, including officers and directors who are also employees. Non-statutory stock options are granted to employees,
members of the board of directors, outside advisors and consultants of the Company.
2017 Equity Compensation Plan
In July 2017, in conjunction with reorganization by Replimune Limited, pursuant to which each shareholder thereof exchanged their outstanding shares
in Replimune Limited for shares in Replimune Group, Inc., on a one-for-one basis (the "Reorganization"), the 2015 Plan was terminated, and all awards
were cancelled with replacement awards issued under the 2017 Equity Compensation Plan (the “2017 Plan”). Subsequent to the Reorganization, no
additional grants have been or will be made under the 2015 Plan and any outstanding awards under the 2015 Plan have continued, and will continue with
their original terms. The Company concluded that the cancellation of the 2015 Plan and issuance of replacement awards under the 2017 Plan
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TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
9. Stock-based compensation (Continued)
was a modification with no change in the material rights and preferences and therefore no recorded change in the fair value of each respective award.
The Company’s 2017 Plan provides for the Company to grant incentive stock options or non-statutory stock options, stock awards, stock units, stock
appreciation rights and other stock-based awards. Incentive stock options were granted under the 2017 Plan only to the Company’s employees, including
officers and directors who were also employees. Restricted stock awards and non-statutory stock options were granted under the 2017 Plan to employees,
officers, members of the board of directors, advisors and consultants of the Company. The maximum number of common shares that may be issued under
the 2017 Plan was 2,659,885, of which none remained available for future grants as of March 31, 2022. Shares with respect to which awards have expired,
terminated, surrendered or cancelled under the 2017 Plan without having been fully exercised will be available for future awards under the 2018 Plan
referenced below. In addition, shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of
shares of common stock available for the grant of awards.
2018 Omnibus Incentive Compensation Plan
On July 9, 2018, the Company’s board of directors adopted, and the Company’s stockholders approved the 2018 Omnibus Incentive Compensation
Plan (the “2018 Plan”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s initial public
offering. The 2018 Plan provides for the issuance of incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation
rights and other stock-based awards. The number of shares initially reserved for issuance under the 2018 Plan is 3,617,968 shares. If any options or stock
appreciation rights, including outstanding options and stock appreciation rights granted under the 2017 Plan (up to 2,520,247 shares), terminate, expire, or
are canceled, forfeited, exchanged, or surrendered without having been exercised, or if any stock awards, stock units or other stock-based awards, including
outstanding awards granted under the 2017 Plan, are forfeited, terminated, or otherwise not paid in full in shares of common stock, the shares of the
Company’s common stock subject to such grants will be available for purposes of our 2018 Plan. The number of shares reserved for issuance under the
2018 Plan will increase automatically on the first day of each April equal to 4.0% of the total number of shares of Company stock outstanding on the last
trading day in the immediately preceding fiscal year, which includes for these purposes, the number of shares issuable upon exercise of the November 2019
Pre-Funded Warrants, the June 2020 Pre-Funded Warrants, and the October 2020 Pre-Funded Warrants, or such lesser amount as determined by the Board.
On April 1, 2021, the number of shares reserved for issuance under the 2018 Plan automatically increased by 2,074,028 shares pursuant to the terms of the
2018 Plan and based on total number of shares of Company stock outstanding on March 31, 2021. On April 1, 2020, the number of shares reserved for
issuance under the 2018 Plan automatically increased by 1,466,749 shares pursuant to the terms of the 2018 Plan. As of March 31, 2022, 1,933,300 shares
remained available for future grants under the 2018 Plan.
The 2015 Plan, the 2017 Plan and the 2018 Plan are administered by the board of directors or, at the discretion of the board of directors, by a
committee of the board of directors. However, the board of directors shall administer and approve all grants made to non-employee directors. The exercise
prices, vesting and other restrictions are determined at the discretion of the board of directors, except that the exercise price per share of incentive stock
options may not be less than 100% of the fair market value of the common stock on the date of grant (or 110% of fair value in the case of an award granted
to employees who hold more than 10% of the total combined voting power of all classes of stock at the time of grant) and the term of stock options may not
be greater than five years for an incentive stock option granted to a 10% stockholder and greater than ten years for all other options granted. Stock options
awarded under both plans expire ten years after the grant date, unless the board of directors sets a shorter term. Vesting periods for both plans are
determined at the discretion of the board of directors. Incentive stock options granted to employees and non-statutory options granted to employees,
officers, members of the board of directors, advisors, and consultants of the Company typically vest over four years. In 2021 the board of directors initiated
the award of restricted stock units ("RSUs"), under the 2018 Plan in addition to stock option awards available as part of the Company’s equity incentive for
employees, officers, advisors and consultants of the Company. The RSUs typically vest over four approximately equal annual installments with the first
such installment occurring on a designated vesting date that is approximately on the one year anniversary date of the date of grant and the subsequent
installments occurring on the subsequent three annual anniversaries of the designated vesting date.
Employee Stock Purchase Plan
F - 19
TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
9. Stock-based compensation (Continued)
On July 9, 2018, the Company’s board of directors adopted and the Company’s stockholders approved the Employee Stock Purchase Plan (the
“ESPP”), which became effective immediately prior to the effectiveness of the registration statement for the Company’s IPO. The total shares of common
stock initially reserved for issuance under the ESPP is limited to 348,612 shares. In addition, as of the first trading day of each fiscal year during the term of
the ESPP (excluding any extensions), an additional number of shares of the Company’s common stock equal to 1% of the total number of shares
outstanding on the last trading day in the immediately preceding fiscal year, which includes for these purposes, the number of shares issuable upon exercise
of the November 2019 Pre-Funded Warrants, the June 2020 Pre-Funded Warrants, and the October 2020 Pre-Funded Warrants, or 697,224 shares,
whichever is less (or such lesser amount as determined by the Company’s board of directors) will be added to the number of shares authorized under the
ESPP. In accordance with the terms of the ESPP, on April 1, 2021 and 2020, the number of shares reserved for issuance under the ESPP automatically
increased by 518,507 and 366,687 shares, respectively, for a total of 1,550,375 shares reserved for the ESPP. If the total number of shares of common stock
to be purchased pursuant to outstanding purchase rights on any particular date exceed the number of shares then available for issuance under the ESPP, then
the plan administrator will allocate the available shares pro-rata and refund any excess payroll deductions or other contributions to participants. The
Company’s ESPP is not currently active.
Out-of-Plan Inducement Grant
In May 2021, the Company granted an equity award to a newly hired executive as a material inducement to enter into employment with the Company.
The grant constitutes an "employment inducement grant" in accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules and was issued outside of the
2018 Plan and each of the other stock incentive plans described above. The inducement grant included a nonqualified stock option to purchase up to
125,000 shares of the Company's common stock, as well as a restricted stock unit grant representing 88,333 shares of the Company's common stock. These
stock option and restricted stock unit inducement grants have terms and conditions consistent with those set forth under the 2018 Plan and vest under the
same respective vesting schedules as stock option and restricted stock unit awards granted under the 2018 Plan. The inducement grant is included in the
stock option and RSU award tables below.
Stock option valuation
The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. As the Company has limited company-specific
historical and implied volatility information, the expected stock volatility is based on a combination of Replimune volatility and the historical volatility of a
publicly traded set of peer companies. For options with service-based vesting conditions, the expected term of the Company’s stock options has been
determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-
employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in
effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact
that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
The following table presents, on a weighted-average basis, the assumptions that the Company used to determine the grant-date fair value of stock
options granted to employees and directors:
Risk-free interest rate
Expected term (in years)
Expected volatility
Expected dividend yield
F - 20
Twelve Months Ended
March 31,
2022
2021
1.18 %
6.0
79.8 %
0 %
0.93 %
6.3
75.4 %
0 %
TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
9. Stock-based compensation (Continued)
Stock options
A summary of stock option activity under the Company’s equity incentive plans for the year ended March 31, 2022 is as follows:
Outstanding as of March 31, 2021
Granted
Exercised
Cancelled
Outstanding as of March 31, 2022
Options exercisable as of March 31, 2021
Options exercisable as of March 31, 2022
Number of Shares
6,460,184 $
1,573,862
(768,186)
(751,526)
6,514,334
2,698,708 $
3,645,749 $
Weighted Average
Exercise Price
13.26
31.29
8.93
24.93
16.78
8.38
10.85
Weighted Average
Contractual Term
(Years)
7.95
7.26
6.79
6.31
$
$
$
$
Aggregate Intrinsic
Value
116,193
30,358
59,717
24,875
As of March 31, 2022, there was $37.9 million of unrecognized compensation cost related to unvested common stock options, which is expected to be
recognized over a weighted average period of 2.51 years.
The weighted average grant-date fair value of stock options granted during the years ended March 31, 2022 and 2021 was $21.40 and $12.03,
respectively. The aggregate intrinsic value of stock options exercised during the years ended March 31, 2022 and 2021 was $16.2 million and $24.9
million, respectively.
Restricted stock units
A summary of the changes in the Company’s RSUs during the year ended March 31, 2022 is as follows:
Outstanding as of March 31, 2021
Granted
Vested
Cancelled
Outstanding as of March 31, 2022
Number of Restricted
Shares
Weighted Average
Grant Date Fair Value
15,975 $
868,016
(3,993)
(53,785)
826,213 $
34.15
31.37
34.15
31.95
31.38
At March 31, 2022, there was $21.0 million of total unrecognized compensation cost related to unvested RSUs, which will be recognized over a
weighted-average period of 3.3 years.
10. Net loss per share
The following table sets forth the computation of the Company’s basic and diluted net loss per share attributable to common stockholders (in
thousands, except per share amounts):
Numerator:
Net loss
Denominator:
Weighted average common shares outstanding, basic and diluted
Net loss per share, basic and diluted
F - 21
Twelve Months Ended
March 31,
2022
2021
$
$
(118,036) $
(80,870)
52,212,269
46,248,969
(2.26) $
(1.75)
TABLE OF CONTENTS
10. Net loss per share (Continued)
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
The November 2019 Pre-Funded Warrants, the June 2020 Pre-Funded Warrants and October 2020 Pre-Funded Warrants are included as outstanding
common stock in the calculation of basic and diluted net loss per share.
The Company’s potentially dilutive securities, which include stock options and warrants to purchase common stock have been excluded from the
computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares
outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential common shares,
presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including
them would have had an anti-dilutive effect:
Options to purchase common stock
Warrants to purchase common stock
11. Significant agreements
Agreement with Bristol-Myers Squibb Company
Twelve Months Ended
March 31,
2022
2021
6,514,334
497,344
7,011,678
6,476,159
497,344
6,973,503
In February 2018, the Company entered into an agreement with Bristol-Myers Squibb Company (“BMS”). Pursuant to the agreement, BMS will
provide to the Company, at no cost, a compound for use in the Company’s ongoing clinical trial of RP1. Under the agreement, the Company will sponsor,
fund and conduct the clinical trial in accordance with an agreed-upon protocol. BMS granted the Company a non-exclusive, non-transferrable, royalty-free
license (with a right to sublicense) under its intellectual property to its compound in the clinical trial and agreed to supply its compound, at no cost to the
Company, for use in the clinical trial. In January 2020, this agreement was expanded to cover an additional cohort of 125 patients with anti-PD-1 failed
melanoma.
Unless earlier terminated, the agreement will remain in effect until (i) the completion of the clinical trial, (ii) all related clinical trial data have been
delivered to both parties and (iii) the completion of any statistical analyses and bioanalyses contemplated by the clinical trial protocol or any analysis
otherwise agreed upon by the parties. The agreement may be terminated by either party (x) in the event of an uncured material breach by the other party,
(y) in the event the other party is insolvent or in bankruptcy proceedings or (z) for safety reasons. Upon termination, the licenses granted to the Company to
use BMS’s compound in the clinical trial will terminate.
In April 2019, the Company entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above,
pursuant to which BMS will provide to the Company, at no cost, nivolumab for use in the Company’s Phase 1 clinical trial of RP2 in combination with
nivolumab.
Agreement with Regeneron Pharmaceuticals, Inc.
In May 2018, the Company entered into an agreement with Regeneron Pharmaceuticals, Inc. (“Regeneron”). The Company and Regeneron are each
independently developing compounds for the treatment of certain tumor types. Pursuant to the agreement, the Company and Regeneron will undertake one
or more clinical trials using a combination of the compounds being developed by each entity. Under the agreement, each study will be conducted under
terms set out in a separately agreed upon study plan that will identify the name of the sponsor and which party will manage the particular clinical trial, and
include the protocol, the budget and a schedule of clinical obligations. In June 2018, under the terms of the agreement between the Company and
Regeneron, the parties agreed to the first study plan. The Company and Regeneron have agreed to the protocol, budget, sample testing and clinical
obligations schedule under the study plan. Development and supply costs associated with the study plan will be split equally between the Company and
Regeneron.
Pursuant to the terms of the agreement, each party granted the other party a non-exclusive license under its respective intellectual property and agreed
to contribute the necessary resources needed to fulfill its respective obligations, in each case,
F - 22
TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
11. Significant agreements (Continued)
under the terms of the agreed-upon or to-be agreed upon study plans. Development costs of a particular clinical trial will be split equally between the
Company and Regeneron in accordance with the agreed upon study plan.
The agreement may be terminated by either party if (i) there is no active study plan for which a final study report has not been completed and the
parties have not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most recent final study report or
(ii) in the event of a material breach.
The agreement with Regeneron is accounted for under ASC 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants and
each party pays its own compound costs and share equally in development costs. The Company will account for costs incurred as part of the study,
including costs to supply compounds for use in the study, as research and development expenses within the consolidated statement of operations. The
Company will recognize any amounts received from Regeneron in connection with this agreement as an offset to research and development expense within
the consolidated statement of operations.
Under the terms of the agreement, on a quarterly basis the Company and Regeneron true-up costs of the study and make corresponding payments to the
party that incurred the majority of the costs. During the years ended March 31, 2022 and 2021, the Company did not make any payments under the terms of
the agreement to Regeneron. During the years ended March 31, 2022 and 2021, the Company received payments under the terms of the agreement from
Regeneron of $6.1 million and $5.1 million, respectively. As of March 31, 2022 and 2021, the Company recorded $2.0 million and $1.3 million of
receivables from Regeneron in connection with this agreement in prepaid expenses and other current assets in the consolidated balance sheet, respectively.
12. Commitments and contingencies
Leases
The Company leases real estate assets and equipment, and determination if an arrangement is a lease occurs at inception. For leases with terms greater
than 12 months, the Company records a related right-of-use (“ROU”) asset and lease liability at the present value of lease payments over the term. Many
leases include fixed rental escalation clauses, renewal options and/or termination options that are factored into the determination of lease payments when
appropriate. The Company’s leases do not provide an implicit rate, and thus the Company estimated the incremental borrowing rate in calculating the
present value of the lease payments. The Company has elected not to record a ROU asset and lease obligation for short-term leases (with terms less than
12 months) or separate non-lease components from associated lease components for its real estate lease assets. As a result, all contract consideration is
allocated to the single lease component.
In October 2021, the Company entered into an agreement to lease approximately 2,951 square feet of research and development, office and laboratory
space in Abingdon, Oxfordshire, United Kingdom. Pursuant to the lease agreement, the lease term commenced on November 1, 2021 with rental payments
scheduled to commence on February 1, 2022. The lease term is for five years with no option for renewal. Annual lease payments are approximately
$0.1 million. The Company recorded a right-of-use asset and a lease liability of approximately $0.4 million upon commencement of the lease and the lease
is classified as an operating lease.
The Company’s leases have remaining lease terms of eight years to seventeen years. Some of our leases include one or more options to renew with
renewal terms that can extend the lease for additional years, or options to terminate the leases, both at the Company’s discretion. The Company’s lease
terms include options to extend or terminate leases when the Company concludes it is reasonably certain that it would exercise those options. Lease
expense for minimum lease payments is recognized on a straight-line basis based on the fixed components of a lease arrangement. The Company amortizes
this expense over the term of the lease beginning with the date of initial possession, which is the date the Company can enter the leased space and begin to
make improvements in preparation for its intended use. Variable lease components represent amounts that are not fixed in nature and are not tied to an
index or rate, and are recognized as incurred.
F - 23
TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
12. Commitments and contingencies (Continued)
The table below presents the lease-related costs which are included in the consolidated statements of operations for the years ended as of March 31,
2022 and 2021:
Lease cost
Finance lease costs:
Amortization of right-to-use asset
Interest on lease liabilities
Operating lease costs
Total lease cost
Twelve Months Ended March 31,
2022
2021
$
$
2,428 $
2,223
1,003
5,654 $
2,428
2,242
948
5,618
The following table summarizes the classification of lease costs in the consolidated statement of operations for the years ended March 31, 2022 and
2021 as follows:
Finance Lease Costs
Research and development
Selling, general and administrative
Other income (expense)
Operating Lease Costs
Research and development
Selling, general and administrative
Total lease cost
Twelve Months Ended March 31,
2022
2021
$
$
2,070 $
358
2,223
407
596
5,654 $
2,070
358
2,242
352
596
5,618
The following table summarizes the maturity of the Company’s lease liabilities on an undiscounted cash flow basis and a reconciliation to the
operating and financing lease liabilities recognized on our balance sheet as of March 31, 2022:
2023
2024
2025
2026
2027
Thereafter
Total lease payments
Less: interest
Total lease liabilities
Operating leases
March 31, 2022
Financing lease
Total
$
$
1,070 $
1,079
1,088
1,098
1,062
2,978
8,375
2,504
5,871 $
2,562 $
2,639
2,718
2,799
2,883
38,022
51,623
24,655
26,968 $
3,632
3,718
3,806
3,897
3,945
41,000
59,998
27,159
32,839
F - 24
TABLE OF CONTENTS
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
12. Commitments and contingencies (Continued)
The following table provides lease disclosure as of and for the year ended March 31, 2022:
March 31, 2022
March 31, 2021
Leases
Right-to-use operating lease asset
Right-to-use finance lease asset
Total lease assets
Operating lease liabilities, current
Finance lease liabilities, current
Operating lease liabilities, non-current
Finance lease liabilities, non-current
Total lease liabilities
Other information
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
Operating cash flows from finance leases
Financing cash flows from finance leases
Right-to-use asset obtained in exchange for new operating lease liabilities
Right-to-use asset obtained in exchange for new financing lease liabilities
Weighted-average remaining lease term – operating leases
Weighted-average remaining lease term – financing leases
Weighted-average discount rate – operating leases
Weighted-average discount rate – financing leases
$
$
$
$
$
$
$
$
$
$
$
$
5,552
42,094
47,646
1,070
2,562
4,801
24,406
32,839
$
968
2,223
264
363
—
$
$
$
$
$
7.7 years
17.3 years
10.1 %
8.3 %
5,751
44,522
50,273
970
2,487
5,078
24,745
33,280
823
2,240
145
1,580
—
8.9 years
18.3 years
9.8 %
8.3 %
The variable lease costs and short-term lease costs were insignificant for the years ended March 31, 2022 and 2021, respectively.
Manufacturing commitments
The Company has entered into an agreement with a contract manufacturing organization to provide clinical trial products. As of March 31, 2022 and
2021, the Company had committed to minimum payments under these arrangements totaling $1,951 and $1,651 through March 31, 2022.
Indemnification agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and
other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property
infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its executive
management team and its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise
by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make
under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such
indemnifications. The Company is not aware of any claims under indemnification arrangements, and therefore it has not accrued any liabilities related to
such obligations in its consolidated financial statements as of March 31, 2022 or 2021.
Legal proceedings
The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities.
F - 25
TABLE OF CONTENTS
13. Benefit plans
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
The Company established a defined-contribution savings plan under Section 401(k) of the Code (the “401(k) Plan”). The 401(k) Plan covers
substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a
pre-tax basis. Matching contributions to the 401(k) Plan may be made at the discretion of the Company’s board of directors. During the years ended
March 31, 2022 and 2021, the Company made contributions totaling $1.1 million and $0.7 million, respectively, to the 401(k) Plan.
We provide a pension contribution plan for our employees in the United Kingdom, pursuant to which we match our employees’ contributions each year
in amounts up to 8% of their annual base salary.
14. Income taxes
During the years ended March 31, 2022 and 2021, the Company recorded no income tax benefits for the net losses incurred due to the uncertainty of
the realization of such losses. The Company’s net loss before income taxes were generated in the United States and the United Kingdom.
Net loss before income taxes for the years ended March 31, 2022 and 2021 were as follows:
United States
Foreign (United Kingdom)
Total
Year Ended March 31,
2022
2021
(28,985)
(89,051)
(118,036)
(22,775)
(58,095)
(80,870)
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate for the years ended March 31, 2022 and 2021
is as follows:
U.S. Federal statutory income tax rate
State taxes, net of federal benefit
Research and development credits
Research and development expenses
Return to provision
Stock compensation
Foreign tax rate differential
Change in tax rates
Change in valuation allowance
Other
Year Ended March 31,
2022
2021
-21.0 %
-0.3 %
0.0 %
1.0 %
-0.2 %
-2.1 %
1.5 %
-10.6 %
31.1 %
0.6 %
0.0 %
-21.0 %
-2.4 %
-0.8 %
1.9 %
0.0 %
-3.9 %
0.0 %
0.0 %
25.9 %
0.3 %
0.0 %
F - 26
TABLE OF CONTENTS
14. Income taxes(Continued)
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
Components of the Company’s deferred tax assets as of March 31, 2022 and 2021 were as follows:
Deferred tax assets:
Federal net operating loss carryforwards
Foreign net operating loss carryforwards
State net operating loss carryforwards
Research & development credits
Property, plant and equipment
Capitalized start-up costs
Stock compensation
Accrued expense
Lease liability
Other
Total deferred tax assets
Valuation allowance
Net deferred tax assets
Deferred tax liabilities:
Right of Use Asset
Other
Total deferred tax liabilities
Net deferred tax assets (liabilities)
Year Ended March 31,
2022
2021
$
9,827 $
48,588
2,697
1,000
4,367
1,286
8,922
1,452
7,309
310
85,758
(74,892)
10,866
(10,866)
—
(10,866)
$
— $
7,083
22,195
2,358
787
5,068
1,597
4,838
739
8,462
—
53,127
(40,028)
13,099
(13,090)
(9)
(13,099)
—
As of March 31, 2022, the Company had federal and foreign net operating loss carryforwards of approximately $46,797 and $194,354, respectively,
which can be carried forward indefinitely. As of March 31, 2022, the Company had state net operating loss carryforwards of $42,710, which will begin to
expire in 2039.
As of March 31, 2022, the Company had federal and state research and development carryforwards of approximately $709 and $367, respectively,
which will begin to expire in 2041 and 2036, respectively.
Utilization of the U.S. federal and state net operating loss carryforwards may be subject to a substantial annual limitation under Section 382 of the
Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, due to ownership changes that have occurred previously or that
could occur in the future. These ownership changes may limit the amount of net operating loss carryforwards that can be utilized annually to offset future
taxable income and tax liabilities, respectively. The Company has not completed a study to assess whether a change of ownership has occurred, or whether
there have been multiple ownership changes since its formation, due to the significant cost and complexity associated with such a study. Any limitation
may result in expiration of a portion of the net operating loss carryforwards before utilization. Further, until a study is completed by the Company and any
limitation is known, no amounts are being presented as an uncertain tax position.
F - 27
TABLE OF CONTENTS
14. Income taxes(Continued)
REPLIMUNE GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Amounts in thousands, except share and per share amounts)
Changes in the valuation allowance for deferred tax assets during the years ended March 31, 2022 and 2021 related primarily to the increase in net
operating loss carryforwards were as follows:
Valuation allowance as of beginning of year
Increases recorded to income tax provision
(Decreases) increases recorded to income tax provision for equity
Valuation allowance as of end of year
Year Ended March 31,
2022
2021
$
$
$
40,028 $
36,679
(1,815) $
74,892 $
17,329
22,624
76
40,028
As of March 31, 2022 and 2021, the Company had not recorded any amounts for unrecognized tax benefits. The Company’s policy is to record interest
and penalties related to income taxes as part of its income tax provision. As of March 31, 2022 and 2021, the Company had no accrued interest or penalties
related to uncertain tax positions and no amounts had been recognized in the Company’s consolidated statements of operations and comprehensive loss.
The Company files income tax returns in the United States, Massachusetts and the United Kingdom as prescribed by the tax laws of the jurisdictions in
which it operates. In the normal course of business, the Company is subject to examination by U.S. federal, state and foreign jurisdictions, where
applicable. There are currently no pending tax examinations. The Company is open to future tax examination in the U.S. under statute from 2019 to the
present and in the United Kingdom from 2017 to the present. Although, with respect to the U.S. federal jurisdictions, carryforward attributes that were
generated prior to 2019 may still be adjusted upon examination if they either have been or will be used in a future period.
As of March 31, 2022 and 2021, income taxes on undistributed earnings of the Company’s subsidiary have not been provided for as the Company
planned to indefinitely reinvest these amounts, had the ability to do so, and the cumulative undistributed foreign earnings were in an overall deficit.
During the second quarter of 2021, the Finance Act 2021 (the Act) was enacted in the United Kingdom. The Act increases the corporate income tax
rate from 19% to 25% effective April 1, 2023 and enhances the first-year capital allowance on qualifying new plant and machinery assets effective April 1,
2021. The effects on the Company’s existing deferred tax balances have been recorded and is offset by the valuation allowance maintained against the
Company’s U.K. net deferred tax assets.
15. Geographic information
The Company operates in two geographic regions: the United States (Massachusetts) and the United Kingdom (Oxfordshire). Information about the
Company’s long-lived assets held in different geographic regions is presented in the tables below:
United States
United Kingdom
16 Subsequent Events
March 31, 2022
March 31, 2021
$
$
6,318 $
1,615
7,933 $
6,866
576
7,442
Between April 1, 2022 and May 19, 2022, the Company settled transactions that occurred pursuant to the 2020 Sales Agreement, whereby the
Company issued and sold an aggregate of 1,686,438 shares of its common stock between April 7, 2022 and April 19, 2022, resulting in gross proceeds of
$32.0 million, before deducting fees of $1.0 million.
F - 28
TABLE OF CONTENTS
Exhibit index
Exhibit Number
Exhibit Description
3.1
3.2
4.1
4.2
4.3*
4.4
4.5
4.6
10.1†
10.2†
10.3*
10.4†
10.5†
10.6†
10.7†
10.8†
10.9†
10.10†
10.11†*
10.12†*
10.13†*
10.14†*
Third Amended and Restated Certificate of Incorporation of the Registrant
(conformed to include the Certificate of Amendment to the Third Amended
and Restated Certificate of Incorporation filed on September 9, 2019).
Amended and Restated By-laws of the Registrant.
Form of Common Stock Certificate of the Registrant.
Amended and Restated Investors’ Rights Agreement, dated July 10, 2017, by
and among the Registrant and the investors set forth therein.
Description of the Registrant’s Securities registered pursuant to Section 12 of
the Securities Exchange Act of 1934.
Form of Pre-Funded Warrant (2019).
Form of Pre-Funded Warrant (2020).
Form of Indenture to be entered into between the Registrant and a trustee
acceptable to the Registrant.
Form of Indemnification Agreement by and between the Registrant and its
directors and officers.
2017 Equity Compensation Plan and Sub-Plan for U.K. Employees and
forms of agreements thereunder.
2018 Omnibus Incentive Compensation Plan and Sub-Plan for U.K.
Employees and forms of agreements thereunder.
Employee Stock Purchase Plan.
Amended and Restated Employment Agreement, dated as of November 2,
2021, by and between Robert Coffin and Replimune, Inc.
Amended and Restated Employment Agreement, dated as of November 2,
2021, by and between Philip Astley-Sparke and Replimune, Inc.
Employment Agreement, effective as of November 1, 2015, by and between
Pamela Esposito and Replimune, Inc.
Employment Agreement, dated as of September 16, 2015, by and between
Colin Love and Replimune Limited.
Employment Agreement, dated as of November 27, 2019, by and between
Jean Franchi and Replimune, Inc.
Employment Agreement, dated as of May 25, 2020, by and between Andrea
Pirzkall and Replimune, Inc.
Amended and Restated Employment Agreement, dated as of May 3, 2021, by
and between Sushil Patel and Replimune, Inc.
Employment Agreement, dated as of May 10, 2021, by and between Tanya
Lewis and Replimune, Inc.
Stock Option Grant Agreement, effective as of May 3, 2021, by and between
Sushil Patel and the Registrant.
Restricted Stock Unit Grant Agreement, effective as of May 3, 2021, by and
between Sushil Patel and the Registrant.
Form
10-K
8-K
S-1/A
S-1
8-K
8-K
S-3
S-1/A
S-1/A
S-1/A
10-Q
10-Q
S-1
S-1/A
8-K
10-Q
10-K
10-K
10-K
10-K
Incorporated by Reference
Date
Number
June 3, 2020
July 24, 2018
July 10, 2018
June 22, 2018
November 18, 2019
June 10, 2020
August 8, 2019
July 10, 2018
June 26, 2018
July 10, 2018
November 4, 2021
November 4, 2021
June 22, 2018
July 10, 2018
December 9, 2019
August 7, 2020
3.1
3.2
4.1
4.2
4.1
4.1
4.4
10.1
10.2
10.4
10.2
10.1
10.7
10.9
10.1
10.1
May 20, 2021
10.11
May 20, 2021
10.12
May 20, 2021
10.13
May 20, 2021
10.14
TABLE OF CONTENTS
Exhibit Number
Exhibit Description
Form
Date
Number
Incorporated by Reference
10-Q
10-K
S-1
S-1
10-Q
S-1/A
S-1/A
S-1
8-K
10-Q
10-K
February 13, 2020
10.2
June 3, 2020
10.13
June 22, 2018
June 22, 2018
August 7, 2020
10.8
10.9
10.3
July 10, 2018
10.12
July 17, 2018
10.13
June 22, 2018
10.12
June 13, 2019
February 4, 2021
10.1
10.1
June 3, 2020
10.22
10-Q
February 3, 2022
10.3
10.15†
10.16†
10.17
10.18
10.19
10.20‡
10.21‡
10.22
10.23
10.24
10.25
10.26
10.27†*
21.1*
23.1*
31.1*
31.2*
Separation Agreement and Release, dated as of December 23, 2019, by and
between Howard Kaufman and Replimune, Inc.
Separation Agreement and Release, dated as of April 3, 2020, by and
between Stephen Gorgol and Replimune, Inc.
Lease, dated as of April 1, 2016, by and between Cummings Properties, LLC
and the Registrant.
Lease, dated as of April 4, 2016, by and between MEPC Milton Park No. 1
Limited and MEPC Milton Park No. 2 Limited, and Replimune Limited.
Deed of Variation, dated June 29, 2020, by and among MEPC Milton Park
No. 1 Limited and MEPC Milton Park No. 2 Limited, and Replimune
Limited.
Clinical Trial Collaboration and Supply Agreement, dated as of February 26,
2018, by and between Bristol-Myers Squibb Company and the Registrant.
Master Clinical Trial Collaboration and Supply Agreement, dated as of
May 29, 2018, by and between Regeneron Pharmaceuticals, Inc. and the
Registrant.
Indenture of Lease, dated as of June 22, 2018, by and between CRP/King 33
NY Ave. Owner, L.L.C. and the Registrant.
Lease, dated as of June 7, 2019, by and between ND/CR Unicorn LLC and
the Registrant.
Payoff Letter to Loan and Security Agreement by and among the Registrant,
Replimune, Inc., Replimune Limited and Hercules Capital, Inc., dated
December 15, 2020.
Clinical Trial Collaboration and Supply Agreement (RP-2), dated as of
April 12, 2019, by and between Bristol-Myers Squibb Company and
Replimune, Inc.
Lease Agreement, dated as of October 29, 2021, by and among Replimune
Limited, MEPC Milton Park No. 1 Limited, and MEPC Milton Park No. 2
Limited.
Separation Agreement and Release, dated as of August 25, 2021, by and
between Andrea Pirzkall and Replimune, Inc., as amended.
Subsidiaries of the Registrant.
Consent of PricewaterhouseCoopers LLP, Independent Registered Public
Accounting Firm.
Certification of the Chief Executive Officer, as required by Section 302 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
Certification of the Chief Financial Officer, as required by Section 302 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
32.1**
Certification of the Chief Executive Officer, as required by Section 906 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
TABLE OF CONTENTS
Exhibit Number
32.2**
Exhibit Description
Form
Date
Number
Incorporated by Reference
Certification of the Chief Financial Officer, as required by Section 906 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
101.INS*
Inline XBRL Instance Document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
___________________
* Filed herewith.
** Furnished and not filed herewith.
† Indicates management contract or compensatory plan.
‡ Indicates confidential treatment has been requested with respect to specific portions of this exhibit. Omitted portions have been filed with the Securities
and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
TABLE OF CONTENTS
Pursuant to the requirements of Section 13 or 15(d) of the Securities Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Signatures
Date: May 19, 2022
REPLIMUNE GROUP, INC.
By:
/s/ PHILIP ASTLEY-SPARKE
Philip Astley-Sparke
Chief Executive Officer and Director
Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons in the capacities and on the dates
indicated.
/s/ PHILIP ASTLEY-SPARKE
Name
Philip Astley-Sparke
/s/ JEAN FRANCHI
Jean Franchi
/s/ ROBERT COFFIN
Robert Coffin
/s/ KAPIL DHINGRA
Kapil Dhingra
/s/ HYAM LEVITSKY
Hyam Levitsky
/s/ CHRISTY OLIGER
Christy Oliger
/s/ PAOLO PUCCI
Paolo Pucci
/s/ JASON RHODES
Jason Rhodes
/s/ JOSEPH SLATTERY
Joseph Slattery
/s/ SANDER SLOOTWEG
Sander Slootweg
/s/ DIETER WEINAND
Dieter Weinand
Title
Chief Executive Officer and Director
(Principal Executive Officer)
Chief Financial Officer and Treasurer,
(Principal Financial and Accounting Officer)
Date
May 19, 2022
May 19, 2022
President and Chief Research & Development Officer and Director
May 19, 2022
Director
Director
Director
Director
Director
Director
Director
Director
May 19, 2022
May 19, 2022
May 19, 2022
May 19, 2022
May 19, 2022
May 19, 2022
May 19, 2022
May 19, 2022
DESCRIPTION OF THE REGISTRANT’S SECURITIES
REGISTERED PURSUANT TO SECTION 12 OF THE
SECURITIES EXCHANGE ACT OF 1934
The following description sets forth certain material terms and provisions of Replimune Group, Inc.’s (“we,” “us,” and “our”) securities that are
registered under Section 12 of the Securities Exchange Act of 1934, as amended.
DESCRIPTION OF CAPITAL STOCK
The following description is a summary and does not purport to be complete. It is subject to, and qualified in its entirety by reference to, our Third
Amended and Restated Certificate of Incorporation, as amended (our “Certificate of Incorporation”), and our Amended and Restated By-laws (our
“Bylaws”), each of which are incorporated by reference or filed as an exhibit to our Annual Report on Form 10-K of which this Exhibit 4.3 is a part. The
terms of these securities also may be affected by the Delaware General Corporation Law (the “DGCL”).
Authorized Capital Stock
The Company’s authorized capital stock consists of 150,000,000 shares of common stock, par value $0.001 per share, and 10,000,000 shares of
undesignated preferred stock, par value $0.001 per share.
Common Stock
Subject to any preferential rights that may be applicable to any outstanding shares of preferred stock from time to time, holders of our common
stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The holders of our common stock do not have any
cumulative voting rights. Holders of our common stock are entitled to receive ratably any dividends declared by our board of directors out of funds legally
available for that purpose, subject to any preferential dividend rights of any outstanding preferred stock. Our common stock has no preemptive rights,
conversion rights or other subscription rights or redemption or sinking fund provisions.
In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in all assets remaining
after payment of all debts and other liabilities and any liquidation preference of any outstanding preferred stock.
Preferred Stock
Pursuant to our Certificate of Incorporation, our board of directors has the authority, without further action by our stockholders, to designate up to
10,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof. These rights, preferences
and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the
number of shares constituting, or the designation of, such series, any or all of which may be greater than the rights of common stock.
The DGCL provides that the holders of preferred stock will have the right to vote separately as a class on any proposal involving fundamental
changes in the rights of holders of that preferred stock. This right is in addition to any voting rights that may be provided for in the applicable certificate of
designation.
Pre-Funded Warrants
In November 2019, we issued and sold pre-funded warrants to purchase an aggregate of 2,200,000 shares of our common stock at an offering price
of $13.6099 per pre-funded warrant in an underwritten public offering pursuant to a shelf registration on Form S-3. In June 2020, we issued and sold pre-
funded warrants to purchase an aggregate of 1,521,738 shares of our common stock at an offering price of $22.999 per pre-funded warrant and, in October
2020, we issued and sold pre-funded warrants to purchase an aggregate of 1,562,500 shares of our common stock at an offering price of $39.999 per pre-
funded warrant, in each case, in an underwritten public offering pursuant to a shelf registration on Form S-3 (the “2020 Pre-Funded Warrants”).
Each pre-funded warrant entitles the holder to purchase one share of our common stock at an exercise price of $0.0001 per share. The pre-funded
warrants do not expire and may be exercised at any time after their original issuance. Under the pre-funded warrants, we may not effect the exercise of any
pre-funded warrant, and a holder will not be entitled to exercise any portion of any pre-funded warrant, which, upon giving effect to such exercise,
would cause (i) the aggregate number of shares of our common stock beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the
number of shares of our common stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of our securities
beneficially owned by the holder of the pre-funded warrant (together with its affiliates) to exceed 9.99% of the combined voting power of all of our
securities then outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the
pre-funded warrants. However, any holder may increase or decrease such percentage to any other percentage upon at least 61 days’ prior notice from the
holder to us; provided, that a holder of a 2020 Pre-Funded Warrant may not increase such percentage to a percentage in excess of 19.99%.The exercise
price of the pre-funded warrants and the number of shares of our common stock issuable upon exercise of the pre-funded warrants is subject to appropriate
adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our
common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders. The exercise price will not be adjusted
below the par value of our common stock.
Anti-Takeover Effects of Provisions of Delaware Law and Our Certificate of Incorporation and Bylaws
The provisions of Delaware law and of our Certificate of Incorporation and Bylaws may have the effect of discouraging, delaying or preventing a
change in control or an unsolicited acquisition proposal that a stockholder might consider favorable, including a proposal that might result in the payment
of a premium over the market price for the shares held by stockholders. These provisions are summarized in the following paragraphs.
Classified Board of Directors. Our Certificate of Incorporation and Bylaws provide that our board of directors is divided into three classes of
directors, with the directors in each class serving staggered three-year terms and with the number of directors in each class to be as nearly equal as possible.
The classification of our board of directors has the effect of requiring at least two annual stockholder meetings, instead of one, to replace a majority of the
members of our board of directors.
Authorized but Unissued or Undesignated Capital Stock. Our authorized capital stock consists of 150,000,000 shares of common stock and
10,000,000 shares of preferred stock. The authorized but unissued (and in the case of preferred stock, undesignated) stock may be issued by our board of
directors in one or more transactions. In this regard, our Certificate of Incorporation grants our board of directors broad power to establish the rights and
preferences of authorized and unissued preferred stock. The issuance of shares of preferred stock pursuant to our board of directors’ authority described
above could decrease the amount of earnings and assets available for distribution to holders of common stock and adversely affect the rights and powers,
including voting rights, of such holders and may have the effect of delaying, deferring or preventing a change in control. Our board of directors does not
currently intend to seek stockholder approval prior to any issuance of preferred stock, unless otherwise required by law.
Special Meetings of Stockholders. Our Certificate of Incorporation provides that special meetings of the stockholders may be called only by or at
the direction of our board of directors. Our Bylaws prohibit the conduct of any business at a special meeting other than as specified in the notice for such
meeting.
Requirements for Advance Notification of Stockholder Nominations and Proposals. Our Bylaws establish advance notice procedures with respect
to stockholder proposals and the nomination of candidates for election as directors, other than nominations made by or at the direction of our board of
directors or a committee of our board of directors. In order for any matter to be “properly brought” before a meeting, a stockholder will have to comply
with advance notice requirements and provide us with certain information. Additionally, vacancies and newly created directorships may be filled only by a
vote of a majority of the directors then in office, even though less than a quorum, and not by the stockholders. Our Bylaws allow the presiding officer at a
meeting of the stockholders to adopt rules and regulations for the conduct of meetings which may have the effect of precluding the conduct of certain
business at a meeting if the rules and regulations are not followed. These provisions may also defer, delay or discourage a potential acquirer from
conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company.
Stockholder Action by Written Consent. Our Certificate of Incorporation prohibits the taking of any action of our stockholders by written consent
without a meeting.
Amendments to Our Certificate of Incorporation and Bylaws. The DGCL provides that, unless a corporation’s certificate of incorporation provides
otherwise, the affirmative vote of holders of shares constituting a majority of the votes of all shares entitled to vote may approve amendments to the
certificate of incorporation. Our Certificate of Incorporation and Bylaws provide that the affirmative vote of holders of at least 75% of the outstanding
shares of capital stock, voting together as a single class, and entitled to vote in the election of directors, will be required to amend, alter, change or repeal
our Certificate of Incorporation and Bylaws. This requirement of a
supermajority vote to approve amendments to our Certificate of Incorporation and Bylaws could enable a minority of our stockholders to exercise veto
power over such amendments.
No Cumulative Voting. The DGCL provides that stockholders are not entitled to cumulate votes in the election of directors unless the corporation’s
certificate of incorporation provides otherwise. Our Certificate of Incorporation does not expressly provide for cumulative voting.
Delaware Anti-Takeover Statute. We are governed by the provisions of Section 203 of the Delaware General Corporation Law. In general,
Section 203 prohibits a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years
after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.
A “business combination” includes mergers, asset sales or other transactions resulting in a financial benefit to the stockholder. An “interested stockholder”
is a person who, together with affiliates and associates, owns, or within three years of the date on which it is sought to be determined whether such person
is an interested stockholder, did own, 15% or more of the corporation’s outstanding voting stock. These provisions may have the effect of delaying,
deferring, or preventing a change in our control.
Registration Rights
Certain holders of our common stock, or their transferees, are entitled to registration rights with respect to registration of the resale of such shares
under the Securities Act of 1933, as amended, pursuant to the amended and restated investors’ rights agreement, by and among us and certain of our
investors.
Stock Exchange Listing
Our common stock is listed on the Nasdaq Global Select Market under the symbol “REPL.”
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Computershare Trust Company, N.A.
REPLIMUNE GROUP, INC.
2018 OMNIBUS INCENTIVE COMPENSATION PLAN
Effective as of the Effective Date (as defined below), the Replimune Group, Inc. 2018 Omnibus Incentive Compensation Plan
(the “Plan”) is hereby established.
The purpose of the Plan is to provide employees of Replimune Group, Inc. (the “Company”) and its subsidiaries, certain
consultants and advisors who perform services for the Company or its subsidiaries, and non-employee members of the Board of
Directors of the Company with the opportunity to receive grants of incentive stock options, nonqualified stock options, stock
appreciation rights, stock awards, stock units and other stock-based awards.
The Company believes that the Plan will encourage the participants to contribute materially to the growth of the Company,
thereby benefitting the Company’s stockholders, and will align the economic interests of the participants with those of the
stockholders.
The Plan is a successor to the Replimune Group, Inc. 2017 Equity Compensation Plan (the “Prior Plan”). No additional grants
shall be made under the Prior Plan after the Effective Date. Outstanding grants under the Prior Plan shall continue in effect
according to their terms, consistent with the Prior Plan.
Definitions
Section 1.
The following terms shall have the meanings set forth below for purposes of the Plan:
(a)
“Board” shall mean the Board of Directors of the Company.
(b)
“Cause” shall have the meaning ascribed to such term in any written employment agreement, offer letter or
severance agreement between the Employer and the Participant, or in a severance plan or policy sponsored by the Employer and
applicable to the Participant, to the extent applicable, or if no such agreement, plan or policy applies to the Participant or if such
term is not defined therein, and unless otherwise defined in the Grant Instrument, “Cause” shall mean a finding by the Committee
that the Participant (i) has breached his or her employment or service contract with the Employer, (ii) has engaged in disloyalty to
the Employer, including, without limitation, fraud, embezzlement, theft, commission of a felony or proven dishonesty, (iii) has
disclosed trade secrets or confidential information of the Employer to persons not entitled to receive such information, (iv) has
breached any written non-competition, non-solicitation, invention assignment or confidentiality agreement between the
Participant and the Employer or (v) has engaged in such other behavior detrimental to the interests of the Employer as the
Committee determines.
(c)
(d)
“CEO” shall mean the Chief Executive Officer of the Company.
A “Change of Control” shall be deemed to have occurred if:
(i)
Any “person” (as such term is used in sections 13(d) and 14(d) of the Exchange Act) becomes a
“beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company
representing more than 50% of the voting power of the then outstanding securities of the Company; provided that a Change of
Control shall not be deemed to occur as a result of a transaction in which the Company becomes a subsidiary of another
corporation and in which the stockholders of the Company, immediately
EU1/ 54974591.6
prior to the transaction, will beneficially own, immediately after the transaction, shares entitling such stockholders to more than
50% of all votes to which all stockholders of the parent corporation would be entitled in the election of directors.
(ii)
The consummation of (A) a merger or consolidation of the Company with another corporation
where, immediately after the merger or consolidation, the stockholders of the Company, immediately prior to the merger or
consolidation, will not beneficially own, in substantially the same proportion as ownership immediately prior to the merger or
consolidation, shares entitling such stockholders to more than 50% of all votes to which all stockholders of the surviving
corporation would be entitled in the election of directors, or where the members of the Board, immediately prior to the merger or
consolidation, will not, immediately after the merger or consolidation, constitute a majority of the board of directors of the
surviving corporation or (B) a sale or other disposition of all or substantially all of the assets of the Company.
(iii)
A change in the composition of the Board over a period of 12 consecutive months or less such that
a majority of the Board members ceases, by reason of one or more contested elections, or threatened election contests, for Board
membership, to be comprised of individuals who either (A) have been Board members continuously since the beginning of such
period or (B) have been elected or nominated for election as Board members during such period by at least a majority of the
Board members described in clause (A) who were still in office at the time the Board approved such election or nomination.
(iv)
The consummation of a plan of complete dissolution or liquidation of the Company.
Notwithstanding the foregoing, if a Grant constitutes deferred compensation subject to section 409A of the Code and the Grant
provides for payment upon a Change of Control, then, for purposes of such payment provisions, no Change of Control shall be
deemed to have occurred upon an event described in items (i) – (iv) above unless the event would also constitute a change in
ownership or effective control of, or a change in the ownership of a substantial portion of the assets of, the Company under
section 409A of the Code.
thereunder.
(e)
“Code” shall mean the Internal Revenue Code of 1986, as amended, and the regulations promulgated
(f)
“Committee” shall mean the Compensation Committee of the Board or another committee appointed by
the Board to administer the Plan. The Committee shall also consist of directors who are “non-employee directors” as defined
under Rule 16b-3 promulgated under the Exchange Act and “independent directors,” as determined in accordance with the
independence standards established by the stock exchange on which the Company Stock is at the time primarily traded.
(g)
(h)
(i)
“Company” shall mean Replimune Group, Inc. and shall include its successors.
“Company Stock” shall mean common stock of the Company.
“Disability” or “Disabled” shall mean, unless otherwise set forth in the Grant Instrument, a Participant’s
becoming disabled within the meaning of the Employer’s long-term disability plan applicable to the Participant, or, if there is no
such plan, a physical or mental
-2-
condition that prevents the Participant from performing the essential functions of the Participant’s position (with or without
reasonable accommodation) for a period of six consecutive months.
(j)
“Dividend Equivalent” shall mean an amount determined by multiplying the number of shares of Company
Stock subject to a Stock Unit or Other Stock-Based Award by the per-share cash dividend paid by the Company on its
outstanding Company Stock, or the per-share Fair Market Value of any dividend paid on its outstanding Company Stock in
consideration other than cash. If interest is credited on accumulated divided equivalents, the term “Dividend Equivalent” shall
include the accrued interest.
(k)
“Effective Date” shall mean the date on which the registration statement for the initial public offering of
the Company Stock is declared effective by the Securities and Exchange Commission and the Company Stock is priced for the
initial public offering of such Company Stock, subject to approval of the Plan by the stockholders of the Company.
(l)
“Employee” shall mean an employee of the Employer (including an officer or director who is also an
employee), but excluding any person who is classified by the Employer as a “contractor” or “consultant,” no matter how
characterized by the Internal Revenue Service, other governmental agency or a court. Any change of characterization of an
individual by the Internal Revenue Service or any court or government agency shall have no effect upon the classification of an
individual as an Employee for purposes of this Plan, unless the Committee determines otherwise.
(m)
“Employed by, or providing service to, the Employer” shall mean employment or service as an Employee,
Key Advisor or member of the Board (so that, for purposes of exercising Options and SARs and satisfying conditions with
respect to Stock Awards, Stock Units and Other Stock-Based Awards, a Participant shall not be considered to have terminated
employment or service until the Participant ceases to be an Employee, Key Advisor and member of the Board), unless the
Committee determines otherwise. If a Participant’s relationship is with a subsidiary of the Company and that entity ceases to be a
subsidiary of the Company, the Participant will be deemed to cease employment or service when the entity ceases to be a
subsidiary of the Company, unless the Participant transfers employment or service to an Employer.
(n)
(o)
(p)
“Employer” shall mean the Company and its subsidiaries.
“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended.
“Exercise Price” shall mean the per share price at which shares of Company Stock may be purchased under
an Option, as designated by the Committee.
(q)
“Fair Market Value” shall mean:
(i)
If the Company Stock is publicly traded, the Fair Market Value per share shall be determined as
follows: (A) if the principal trading market for the Company Stock is a national securities exchange, the closing sales price
during regular trading hours on the relevant date or, if there were no trades on that date, the latest preceding date upon which a
sale was reported, or (B) if the Company Stock is not principally traded on any such exchange, the
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last reported sale price of a share of Company Stock during regular trading hours on the relevant date, as reported by the OTC
Bulletin Board.
transactions as set forth above, the Fair Market Value per share shall be determined by the Committee through any reasonable
valuation method authorized under the Code.
(ii)
If the Company Stock is not publicly traded or, if publicly traded, is not subject to reported
If a Grant is made effective on the date that the registration statement for the initial public offering
of the Company Stock is declared effective by the Securities and Exchange Commission and the Company Stock is priced for the
initial public offering of such Company Stock, then the Fair Market Value per share shall be equal to the per share price of
Company Stock offered to the public in such initial public offering.
(iii)
(r)
“GAAP” shall mean United States Generally Accepted Accounting Principles.
(s)
“Good Reason” shall have the meaning ascribed to such term in any written employment agreement, offer
letter or severance agreement between the Employer and the Participant, or in a severance plan or policy sponsored by the
Employer and applicable to the Participant, to the extent applicable. For the avoidance of doubt, if no such agreement, plan or
policy applies to the Participant or if such term is not defined therein, then Good Reason shall not apply to the Participant.
(t)
“Grant” shall mean an Option, SAR, Stock Award, Stock Unit or Other Stock-Based Award granted under
the Plan.
(u)
including all amendments thereto.
“Grant Instrument” shall mean the written agreement that sets forth the terms and conditions of a Grant,
(v)
“Incentive Stock Option” shall mean an Option that is intended to meet the requirements of an incentive
stock option under section 422 of the Code.
(w)
“Key Advisor” shall mean a consultant or advisor of the Employer.
(x)
“Non-Employee Director” shall mean a member of the Board who is not an Employee.
option under section 422 of the Code.
(y)
“Nonqualified Stock Option” shall mean an Option that is not intended to be taxed as an incentive stock
(z)
“Option” shall mean an option to purchase shares of Company Stock, as described in Section 6.
(aa)
“Other Stock-Based Award” shall mean any Grant based on, measured by or payable in Company Stock
(other than an Option, Stock Unit, Stock Award, or SAR), as described in Section 10.
(ab)
“Participant” shall mean an Employee, Key Advisor or Non-Employee Director designated by the
Committee to participate in the Plan.
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(ac)
“Performance Goals” shall mean performance goals that may be based on one or more of the following
criteria: cash flow; free cash flow; earnings (including gross margin, earnings before interest and taxes, earnings before taxes,
earnings before interest, taxes, depreciation, amortization and charges for stock-based compensation, earnings before interest,
taxes, depreciation and amortization, adjusted earnings before interest, taxes, depreciation and amortization and net earnings);
earnings per share; growth in earnings or earnings per share; book value growth; stock price; return on equity or average
stockholder equity; total stockholder return or growth in total stockholder return either directly or in relation to a comparative
group; return on capital; return on assets or net assets; revenue, growth in revenue or return on sales; sales; expense reduction or
expense control; expense to revenue ratio; income, net income or adjusted net income; operating income, net operating income,
adjusted operating income or net operating income after tax; operating profit or net operating profit; operating margin; gross
profit margin; return on operating revenue or return on operating profit; regulatory filings; regulatory approvals, litigation and
regulatory resolution goals; other operational, regulatory or departmental objectives; budget comparisons; growth in stockholder
value relative to established indexes, or another peer group or peer group index; development and implementation of strategic
plans and/or organizational restructuring goals; development and implementation of risk and crisis management programs;
improvement in workforce diversity; compliance requirements and compliance relief; safety goals; productivity goals; workforce
management and succession planning goals; economic value added (including typical adjustments consistently applied from
generally accepted accounting principles required to determine economic value added performance measures); measures of
customer satisfaction, employee satisfaction or staff development; development or marketing collaborations, formations of joint
ventures or partnerships or the completion of other similar transactions intended to enhance the Corporation’s revenue or
profitability or enhance its customer base; merger and acquisitions; and other similar criteria consistent with the foregoing.
Performance goals applicable to a Grant shall be determined by the Committee, and may be established on an absolute or relative
basis and may be established on a corporate-wide basis or with respect to one or more business units, divisions, subsidiaries or
business segments. Relative performance may be measured against a group of peer companies, a financial market index or other
objective and quantifiable indices.
(ad)
from time to time.
“Plan” shall mean this Replimune Group, Inc. 2018 Omnibus Incentive Compensation Plan, as in effect
(ae)
“Prior Plan” shall mean Replimune Group, Inc. 2017 Equity Compensation Plan.
(af)
“Restriction Period” shall have the meaning given that term in Section 7(a).
(ag)
“SAR” shall mean a stock appreciation right, as described in Section 9.
(ah)
“Stock Award” shall mean an award of Company Stock, as described in Section 7.
in Section 8.
(ai)
“Stock Unit” shall mean an award of a phantom unit representing a share of Company Stock, as described
(aj)
“Substitute Awards” shall have the meaning given that term in Section 4(b).
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Section 2.
Administration
(a)
Committee. The Plan shall be administered and interpreted by the Committee; provided, however, that any
Grants to members of the Board must be authorized by a majority of the Board. The Committee may delegate authority to one or
more subcommittees, as it deems appropriate. Subject to compliance with applicable law and the applicable stock exchange rules,
the Board, in its discretion, may perform any action of the Committee hereunder. To the extent that the Board, a subcommittee or
the CEO, as described below administers the Plan, references in the Plan to the “Committee” shall be deemed to refer to the
Board or such subcommittee or the CEO.
(b)
Delegation to CEO. Subject to compliance with applicable law and applicable stock exchange
requirements, the Committee may delegate all or part of its authority and power to the CEO, as it deems appropriate, with respect
to Grants to Employees or Key Advisors who are not executive officers or directors under section 16 of the Exchange Act.
(c)
Committee Authority. The Committee shall have the sole authority to (i) determine the individuals to
whom Grants shall be made under the Plan, (ii) determine the type, size, terms and conditions of the Grants to be made to each
such individual, (iii) determine the time when the Grants will be made and the duration of any applicable exercise or restriction
period, including the criteria for exercisability and the acceleration of exercisability, (v) amend the terms of any previously issued
Grant, subject to the provisions of Section 17 below, and (vi) deal with any other matters arising under the Plan.
(d)
Committee Determinations. The Committee shall have full power and express discretionary authority to
administer and interpret the Plan, to make factual determinations and to adopt or amend such rules, regulations, agreements and
instruments for implementing the Plan and for the conduct of its business as it deems necessary or advisable, in its sole
discretion. The Committee’s interpretations of the Plan and all determinations made by the Committee pursuant to the powers
vested in it hereunder shall be conclusive and binding on all persons having any interest in the Plan or in any awards granted
hereunder. All powers of the Committee shall be executed in its sole discretion, in the best interest of the Company, not as a
fiduciary, and in keeping with the objectives of the Plan and need not be uniform as to similarly situated individuals.
(e)
Indemnification. No member of the Committee or the Board, and no employee of the Company shall be
liable for any act or failure to act with respect to the Plan, except in circumstances involving his or her bad faith or willful
misconduct, or for any act or failure to act hereunder by any other member of the Committee or employee or by any agent to
whom duties in connection with the administration of this Plan have been delegated. The Company shall indemnify members of
the Committee and the Board and any agent of the Committee or the Board who is an employee of the Company or a subsidiary
against any and all liabilities or expenses to which they may be subjected by reason of any act or failure to act with respect to
their duties on behalf of the Plan, except in circumstances involving such person’s bad faith or willful misconduct.
Section 3.
Grants
Grants under the Plan may consist of Options as described in Section 6, Stock Awards as described in Section 7, Stock
Units as described in Section 8, SARs as described in Section 9 and Other Stock-Based Awards as described in Section 10. All
Grants shall be subject to the terms
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and conditions set forth herein and to such other terms and conditions consistent with this Plan as the Committee deems
appropriate and as are specified in writing by the Committee to the individual in the Grant Instrument. All Grants shall be made
conditional upon the Participant’s acknowledgement, in writing or by acceptance of the Grant, that all decisions and
determinations of the Committee shall be final and binding on the Participant, his or her beneficiaries and any other person
having or claiming an interest under such Grant. Grants under a particular Section of the Plan need not be uniform as among the
Participants.
Section 4.
Shares Subject to the Plan
(a)
Shares Authorized. Subject to adjustment as described below in Sections 4(b) and 4(e), the maximum
aggregate number of shares of Company Stock that may be issued or transferred under the Plan shall be equal to the sum of the
following: (i) 3,486,118 shares, plus (ii) the number of shares of Company Stock reserved for issuance under the Prior Plan that
remain available for grant under the Prior Plan as of the Effective Date (not to exceed 131,850 shares of Company Stock). In
addition, and subject to adjustment as provided in Sections 4(b) and 4(e) below, shares of Company Stock subject to outstanding
grants under the Prior Plan as of the Effective Date that terminate, expire or are cancelled, forfeited, exchanged or surrendered on
or after the Effective Date without having been exercised, vested or paid in shares of Company Stock under the Prior Plan prior to
the Effective Date (up to 2,520,247 shares) shall be added to the share reserve under the Plan. In addition, as of the first trading
day of each fiscal year during the term of the Plan (excluding any extensions), an additional positive number of shares of
Company Stock shall be added to the number of shares of Company Stock authorized to be issued or transferred under the Plan,
equal to 4% of the total number of shares of Company Stock outstanding on the last trading day in the immediately preceding
fiscal year, or such lesser amount as determined by the Board. Subject to adjustment as described below in Sections 4(b) and 4(e),
the aggregate number of shares of Company Stock that may be issued or transferred under the Plan pursuant to Incentive Stock
Options shall not exceed the lesser of the maximum aggregate number of shares of Company Stock available for issuance or
transfer under the Plan and 16,000,000 shares of Company Stock.
(b)
Source of Shares; Share Counting. Shares issued or transferred under the Plan may be authorized but
unissued shares of Company Stock or reacquired shares of Company Stock, including shares purchased by the Company on the
open market for purposes of the Plan. If and to the extent Options or SARs granted under the Plan or options granted under the
Prior Plan terminate, expire or are canceled, forfeited, exchanged or surrendered without having been exercised, or if any Stock
Awards, Stock Units or Other Stock-Based Awards are forfeited, terminated or otherwise not paid in full, the shares subject to
such Grants shall again be available for purposes of the Plan. Shares of Company Stock surrendered in payment of the Exercise
Price of an Option (including an option granted under the Prior Plan that is exercised on or after the Effective Date) shall not be
available for re-issuance under the Plan. Shares of Company Stock withheld or surrendered for payment of withholding taxes
with respect to Grants (including options granted under the Prior Plan) shall not be available for re-issuance under the Plan. If
SARs are granted, the full number of shares subject to the SARs shall be considered issued under the Plan, without regard to the
number of shares issued upon exercise of the SARs. To the extent any Grants are paid in cash, and not in shares of Company
Stock, any shares previously subject to such Grants shall again be available for issuance or transfer under the Plan. For the
avoidance of doubt, if shares are repurchased by the Company on the open market with the proceeds of the Exercise Price of
Options (including options granted under the Prior Plan), such shares may not again be made available for issuance under the
Plan.
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(c)
Substitute Awards. Shares issued or transferred under Grants made pursuant to an assumption, substitution
or exchange for previously granted awards of a company acquired by the Company in a transaction (“Substitute Awards”) shall
not reduce the number of shares of Company Stock available under the Plan and available shares under a stockholder approved
plan of an acquired company (as appropriately adjusted to reflect the transaction) may be used for Grants under the Plan and shall
not reduce the Plan’s share reserve (subject to applicable stock exchange listing and Code requirements).
(d)
Individual Limits. Subject to adjustment as described below in Section 4(e), the following Grant
limitations shall apply:
(i)
For Options, SARs, Stock Awards, Stock Units and Other Stock-Based Awards (whether payable in
Company Stock, cash or a combination of the two), the maximum number of shares of Company Stock for which such Grants
may be made to any Employee or Key Advisor in any calendar year shall not exceed 1,641,235 shares of Company Stock in the
aggregate.
(ii)
The maximum aggregate grant date value of shares of Company Stock subject to Grants granted to
any Non-Employee Director during any calendar year for services rendered as a Non-Employee Director, taken together with any
cash fees earned by such Non-Employee Director for services rendered as a Non-Employee Director during the calendar year,
shall not exceed $750,000 in total value, provided that the maximum aggregate grant date value of shares of Company Stock
subject to Grants granted to any Non-Employee Director during the calendar year in which the Non-Employee Director is first
appointed to the Board for services rendered as a Non-Employee Director for such calendar year, taken together with any cash
fees earned by such Non-Employee Director for services rendered as a Non-Employee Director during such calendar year, shall
not exceed $1,000,000 in total value. For purposes of these limits, the value of such Grants shall be calculated based on the grant
date fair value of such Grants for financial reporting purposes.
(e)
Adjustments. If there is any change in the number or kind of shares of Company Stock outstanding by
reason of (i) a stock dividend, spinoff, recapitalization, stock split, reverse stock split or combination or exchange of shares, (ii) a
merger, reorganization or consolidation, (iii) a reclassification or change in par value, or (iv) any other extraordinary or unusual
event affecting the outstanding Company Stock as a class without the Company’s receipt of consideration, or if the value of
outstanding shares of Company Stock is substantially reduced as a result of a spinoff or the Company’s payment of an
extraordinary dividend or distribution, the maximum number and kind of shares of Company Stock available for issuance under
the Plan, the maximum number and kind of shares of Company Stock for which any individual may receive Grants in any year,
the number and kind of shares covered by outstanding Grants, the number and kind of shares issued and to be issued under the
Plan, and the price per share or the applicable market value of such Grants shall be equitably adjusted by the Committee to reflect
any increase or decrease in the number of, or change in the kind or value of, the issued shares of Company Stock to preclude, to
the extent practicable, the enlargement or dilution of rights and benefits under the Plan and such outstanding Grants; provided,
however, that any fractional shares resulting from such adjustment shall be eliminated. In addition, in the event of a Change of
Control, the provisions of Section 12 of the Plan shall apply. Any adjustments to outstanding Grants shall be consistent with
section 409A or 424 of the Code, to the extent applicable. Subject to Section 17(b), the adjustments of Grants under this Section
4(e) shall include adjustment of shares, Exercise Price of Stock Options, base amount of SARs, Performance Goals or other terms
and conditions, as the Committee deems appropriate. The Committee shall have
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the sole discretion and authority to determine what appropriate adjustments shall be made and any adjustments determined by the
Committee shall be final, binding and conclusive.
Section 5.
Eligibility for Participation
(a)
Eligible Persons. All Employees and Non-Employee Directors shall be eligible to participate in the Plan.
Key Advisors shall be eligible to participate in the Plan if the Key Advisors render bona fide services to the Employer, the
services are not in connection with the offer and sale of securities in a capital-raising transaction and the Key Advisors do not
directly or indirectly promote or maintain a market for the Company’s securities.
(b)
Selection of Participants. The Committee shall select the Employees, Non-Employee Directors and Key
Advisors to receive Grants and shall determine the number of shares of Company Stock subject to a particular Grant in such
manner as the Committee determines.
Section 6.
Options
The Committee may grant Options to an Employee, Non-Employee Director or Key Advisor upon such terms as the
Committee deems appropriate. The following provisions are applicable to Options:
(a)
Number of Shares. The Committee shall determine the number of shares of Company Stock that will be
subject to each Grant of Options to Employees, Non-Employee Directors and Key Advisors.
(b)
Type of Option and Exercise Price.
(i)
The Committee may grant Incentive Stock Options or Nonqualified Stock Options or any
combination of the two, all in accordance with the terms and conditions set forth herein. Incentive Stock Options may be granted
only to employees of the Company or its parent or subsidiary corporations, as defined in section 424 of the Code. Nonqualified
Stock Options may be granted to Employees, Non-Employee Directors and Key Advisors.
(ii)
The Exercise Price of Company Stock subject to an Option shall be determined by the Committee
and shall be equal to or greater than the Fair Market Value of a share of Company Stock on the date the Option is granted.
However, an Incentive Stock Option may not be granted to an Employee who, at the time of grant, owns stock possessing more
than 10% of the total combined voting power of all classes of stock of the Company, or any parent or subsidiary corporation of
the Company, as defined in section 424 of the Code, unless the Exercise Price per share is not less than 110% of the Fair Market
Value of a share of Company Stock on the date of grant.
(c)
Option Term. The Committee shall determine the term of each Option. The term of any Option shall not
exceed ten years from the date of grant. However, an Incentive Stock Option that is granted to an Employee who, at the time of
grant, owns stock possessing more than 10% of the total combined voting power of all classes of stock of the Company, or any
parent or subsidiary corporation of the Company, as defined in section 424 of the Code, may not have a term that exceeds five
years from the date of grant. Notwithstanding the foregoing, in the event that on the last business day of the term of an Option
(other than an Incentive Stock
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Option), the exercise of the Option is prohibited by applicable law, including a prohibition on purchases or sales of Company
Stock under the Company’s insider trading policy, the term of the Option shall be extended for a period of 30 days following the
end of the legal prohibition, unless the Committee determines otherwise.
(d)
Exercisability of Options. Options shall become exercisable in accordance with such terms and conditions,
consistent with the Plan, as may be determined by the Committee and specified in the Grant Instrument. Subject to the limitations
in Section 12, the Committee may accelerate the exercisability of any or all outstanding Options at any time for any reason.
(e)
Grants to Non-Exempt Employees. Notwithstanding the foregoing, Options granted to persons who are
non-exempt employees under the Fair Labor Standards Act of 1938, as amended, may not be exercisable for at least six months
after the date of grant (except that such Options may become exercisable, as determined by the Committee, upon the Participant’s
death, Disability or retirement, or upon a Change of Control or other circumstances permitted by applicable regulations).
(f)
Termination of Employment or Service. Except as provided in the Grant Instrument, an Option may only
be exercised while the Participant is employed by, or providing services to, the Employer. The Committee shall determine in the
Grant Instrument under what circumstances and during what time periods a Participant may exercise an Option after termination
of employment or service.
(g)
Exercise of Options. A Participant may exercise an Option that has become exercisable, in whole or in
part, by delivering a notice of exercise to the Company. The Participant shall pay the Exercise Price for an Option as specified by
the Committee (i) in cash or by check, (ii) unless the Committee determines otherwise, by delivering shares of Company Stock
owned by the Participant and having a Fair Market Value on the date of exercise at least equal to the Exercise Price or by
attestation (in accordance with procedures prescribed by the Company) to ownership of shares of Company Stock having a Fair
Market Value on the date of exercise at least equal to the Exercise Price, (iii) by payment through a broker in accordance with
procedures permitted by Regulation T of the Federal Reserve Board, (iv) if permitted by the Committee, by withholding shares of
Company Stock subject to the exercisable Option, which have a Fair Market Value on the date of exercise equal to the Exercise
Price, or (v) by such other method as the Committee may approve. Shares of Company Stock used to exercise an Option shall
have been held by the Participant for the requisite period of time necessary to avoid adverse accounting consequences to the
Company with respect to the Option. Payment for the shares to be issued or transferred pursuant to the Option, and any required
withholding taxes, must be received by the Company by the time specified by the Committee depending on the type of payment
being made, but in all cases prior to the issuance or transfer of such shares.
(h)
Limits on Incentive Stock Options. Each Incentive Stock Option shall provide that, if the aggregate Fair
Market Value of the Company Stock on the date of the grant with respect to which Incentive Stock Options are exercisable for the
first time by a Participant during any calendar year, under the Plan or any other stock option plan of the Company or a parent or
subsidiary, exceeds $100,000, then the Option, as to the excess, shall be treated as a Nonqualified Stock Option.
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Section 7.
Stock Awards
The Committee may issue or transfer shares of Company Stock to an Employee, Non-Employee Director or Key Advisor
under a Stock Award, upon such terms as the Committee deems appropriate. The following provisions are applicable to Stock
Awards:
(a)
General Requirements. Shares of Company Stock issued or transferred pursuant to Stock Awards may be
issued or transferred for consideration or for no consideration, and subject to restrictions or no restrictions, as determined by the
Committee. The Committee may, but shall not be required to, establish conditions under which restrictions on Stock Awards shall
lapse over a period of time or according to such other criteria as the Committee deems appropriate, including, without limitation,
restrictions based upon the achievement of specific Performance Goals. The period of time during which the Stock Awards will
remain subject to restrictions will be designated in the Grant Instrument as the “Restriction Period.”
transferred pursuant to a Stock Award and the restrictions applicable to such shares.
(b)
Number of Shares. The Committee shall determine the number of shares of Company Stock to be issued or
(c)
Requirement of Employment or Service. If the Participant ceases to be employed by, or provide service to,
the Employer during a period designated in the Grant Instrument as the Restriction Period, or if other specified conditions are not
met, the Stock Award shall terminate as to all shares covered by the Grant as to which the restrictions have not lapsed, and those
shares of Company Stock must be immediately returned to the Company. Subject to the limitations in Section 12, the Committee
may, however, provide for complete or partial exceptions to this requirement as it deems appropriate.
(d)
Restrictions on Transfer and Legend on Stock Certificate. During the Restriction Period, a Participant may
not sell, assign, transfer, pledge or otherwise dispose of the shares of a Stock Award except under Section 15 below. Unless
otherwise determined by the Committee, the Company will retain possession of certificates for shares of Stock Awards until all
restrictions on such shares have lapsed. Each certificate for a Stock Award, unless held by the Company, shall contain a legend
giving appropriate notice of the restrictions in the Grant. The Participant shall be entitled to have the legend removed from the
stock certificate covering the shares subject to restrictions when all restrictions on such shares have lapsed. The Committee may
determine that the Company will not issue certificates for Stock Awards until all restrictions on such shares have lapsed.
(e)
Right to Vote and to Receive Dividends. Unless the Committee determines otherwise, during the
Restriction Period, the Participant shall have the right to vote shares of Stock Awards and to receive any dividends or other
distributions paid on such shares, subject to any restrictions deemed appropriate by the Committee, including, without limitation,
the achievement of specific Performance Goals. Dividends with respect to Stock Awards that vest based on performance shall
vest if and to the extent that the underlying Stock Award vests, as determined by the Committee.
(f)
Lapse of Restrictions. All restrictions imposed on Stock Awards shall lapse upon the expiration of the
applicable Restriction Period and the satisfaction of all conditions, if any, imposed by the Committee. The Committee may
determine, as to any or all Stock Awards, that the restrictions shall lapse without regard to any Restriction Period.
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Section 8.
Stock Units
The Committee may grant Stock Units, each of which shall represent one hypothetical share of Company Stock, to an
Employee, Non-Employee Director or Key Advisor upon such terms and conditions as the Committee deems appropriate. The
following provisions are applicable to Stock Units:
(a)
Crediting of Units. Each Stock Unit shall represent the right of the Participant to receive a share of
Company Stock or an amount of cash based on the value of a share of Company Stock, if and when specified conditions are met.
All Stock Units shall be credited to bookkeeping accounts established on the Company’s records for purposes of the Plan.
(b)
Terms of Stock Units. The Committee may grant Stock Units that vest and are payable if specified
Performance Goals or other conditions are met, or under other circumstances. Stock Units may be paid at the end of a specified
performance period or other period, or payment may be deferred to a date authorized by the Committee. Subject to the limitations
set forth in Section 12, the Committee may accelerate vesting or payment, as to any or all Stock Units at any time for any reason,
provided such acceleration complies with section 409A of the Code. The Committee shall determine the number of Stock Units
to be granted and the requirements applicable to such Stock Units.
(c)
Requirement of Employment or Service. If the Participant ceases to be employed by, or provide service to,
the Employer prior to the vesting of Stock Units, or if other conditions established by the Committee are not met, the
Participant’s Stock Units shall be forfeited. The Committee may, however, provide for complete or partial exceptions to this
requirement as it deems appropriate.
(d)
Payment With Respect to Stock Units. Payments with respect to Stock Units shall be made in cash,
Company Stock or any combination of the foregoing, as the Committee shall determine.
Section 9.
Stock Appreciation Rights
The Committee may grant SARs to an Employee, Non-Employee Director or Key Advisor separately or in tandem with
any Option. The following provisions are applicable to SARs:
(a)
General Requirements. The Committee may grant SARs to an Employee, Non-Employee Director or Key
Advisor separately or in tandem with any Option (for all or a portion of the applicable Option). Tandem SARs may be granted
either at the time the Option is granted or at any time thereafter while the Option remains outstanding; provided, however, that, in
the case of an Incentive Stock Option, SARs may be granted only at the time of the grant of the Incentive Stock Option. The
Committee shall establish the base amount of the SAR at the time the SAR is granted. The base amount of each SAR shall be
equal to or greater than the Fair Market Value of a share of Company Stock as of the date of grant of the SAR. The term of any
SAR shall not exceed ten years from the date of grant. Notwithstanding the foregoing, in the event that on the last business day of
the term of a SAR, the exercise of the SAR is prohibited by applicable law, including a prohibition on purchases or sales of
Company Stock under the Company’s insider trading policy, the term shall be extended for a period of 30 days following the end
of the legal prohibition, unless the Committee determines otherwise.
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(b)
Tandem SARs. In the case of tandem SARs, the number of SARs granted to a Participant that shall be
exercisable during a specified period shall not exceed the number of shares of Company Stock that the Participant may purchase
upon the exercise of the related Option during such period. Upon the exercise of an Option, the SARs relating to the Company
Stock covered by such Option shall terminate. Upon the exercise of SARs, the related Option shall terminate to the extent of an
equal number of shares of Company Stock.
(c)
Exercisability. An SAR shall be exercisable during the period specified by the Committee in the Grant
Instrument and shall be subject to such vesting and other restrictions as may be specified in the Grant Instrument. Subject to the
limitations set forth in Section 12, the Committee may accelerate the exercisability of any or all outstanding SARs at any time for
any reason. SARs may only be exercised while the Participant is employed by, or providing service to, the Employer or during
the applicable period after termination of employment or service as specified by the Committee. A tandem SAR shall be
exercisable only during the period when the Option to which it is related is also exercisable.
(d)
Grants to Non-Exempt Employees. Notwithstanding the foregoing, SARs granted to persons who are non-
exempt employees under the Fair Labor Standards Act of 1938, as amended, may not be exercisable for at least six months after
the date of grant (except that such SARs may become exercisable, as determined by the Committee, upon the Participant’s death,
Disability or retirement, or upon a Change of Control or other circumstances permitted by applicable regulations).
(e)
Value of SARs. When a Participant exercises SARs, the Participant shall receive in settlement of such
SARs an amount equal to the value of the stock appreciation for the number of SARs exercised. The stock appreciation for an
SAR is the amount by which the Fair Market Value of the underlying Company Stock on the date of exercise of the SAR exceeds
the base amount of the SAR as described in subsection (a).
(f)
Form of Payment. The appreciation in an SAR shall be paid in shares of Company Stock, cash or any
combination of the foregoing, as the Committee shall determine. For purposes of calculating the number of shares of Company
Stock to be received, shares of Company Stock shall be valued at their Fair Market Value on the date of exercise of the SAR.
Section 10.
Other Stock-Based Awards
The Committee may grant Other Stock-Based Awards, which are awards (other than those described in Sections 6, 7, 8
and 9 of the Plan) that are based on or measured by Company Stock, to any Employee, Non-Employee Director or Key Advisor,
on such terms and conditions as the Committee shall determine. Other Stock-Based Awards may be awarded subject to the
achievement of Performance Goals or other criteria or other conditions and may be payable in cash, Company Stock or any
combination of the foregoing, as the Committee shall determine.
Section 11.
Dividend Equivalents
The Committee may grant Dividend Equivalents in connection with Stock Units or Other Stock-Based Awards. Dividend
Equivalents may be paid currently or accrued as contingent cash obligations and may be payable in cash or shares of Company
Stock, and upon such terms and conditions as the Committee shall determine. Dividend Equivalents with respect to Stock Units
or Other Stock-Based Awards that vest based on performance shall vest and be paid only if and to the extent the underlying Stock
Units or Other Stock-Based Awards vest and are paid, as
-13-
determined by the Committee. For the avoidance of doubt, no dividends or Dividend Equivalents will be granted in connection
with Stock Options or SARs.
Section 12.
Consequences of a Change of Control
(a)
Assumption of Outstanding Grants. Upon a Change of Control where the Company is not the surviving
corporation (or survives only as a subsidiary of another corporation), all outstanding Grants that are not exercised or paid at the
time of the Change of Control shall be assumed by, or replaced with grants that have comparable terms by, the surviving
corporation (or a parent or subsidiary of the surviving corporation). In the event that the surviving corporation (or a parent or
subsidiary of the surviving corporation) does not assume or replace Grants with grants that have comparable terms, outstanding
Stock Options and SARs shall automatically accelerate and become fully exercisable and the restrictions and conditions on
outstanding Stock Awards, Stock Units, Other Stock-Based Awards and Dividend Equivalents shall immediately lapse; provided
that if the vesting of any such Grants is based, in whole or in part, on performance, the applicable Grant Instrument shall specify
how the portion of the Grant that becomes vested pursuant to this Section 12(a) shall be calculated. After a Change of Control,
references to the “Company” as they relate to employment matters shall include the successor employer in the transaction,
subject to applicable law.
(b)
Vesting Upon Certain Terminations of Employment. If Grants are assumed by, or replaced with grants that
have comparable terms by, the surviving corporation (or a parent or subsidiary of the surviving corporation) and if a Participant’s
employment or service is terminated by the Employer without Cause or by the Participant for Good Reason (if applicable) upon
or within 12 months following a Change of Control, the Participant’s outstanding Grants shall become fully vested as of the date
of such termination; provided that if the vesting of any such Grants is based, in whole or in part, on performance, the applicable
Grant Instrument shall specify how the portion of the Grant that becomes vested pursuant to this Section 12(b) shall be
calculated. Notwithstanding the foregoing in this Section 12(b), the Committee may provide for more beneficial vesting terms
upon a termination of employment in connection with a Change of Control, as set forth in the applicable Grant Instrument or
otherwise.
(c)
Other Alternatives. In the event of a Change of Control, if any outstanding Grants are not assumed by, or
replaced with grants that have comparable terms by, the surviving corporation (or a parent or subsidiary of the surviving
corporation), the Committee may take any of the following actions with respect to any or all outstanding Grants, without the
consent of any Participant: (i) the Committee may determine that Participants shall receive a payment in settlement of
outstanding Stock Units, Other Stock-Based Awards or Dividend Equivalents, in such amount and form as may be determined by
the Committee; (ii) the Committee may require that Participants surrender their outstanding Stock Options and SARs in exchange
for a payment by the Company, in cash or Company Stock as determined by the Committee, in an amount equal to the amount, if
any, by which the then Fair Market Value of the shares of Company Stock subject to the Participant’s unexercised Stock Options
and SARs exceeds the Stock Option Exercise Price or SAR base amount, and (iii) after giving Participants an opportunity to
exercise all of their outstanding Stock Options and SARs, the Committee may terminate any or all unexercised Stock Options and
SARs at such time as the Committee deems appropriate. Such surrender, termination or payment shall take place as of the date of
the Change of Control or such other date as the Committee may specify. Without limiting the foregoing, if the per share Fair
Market Value of the Company Stock does not exceed the per
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share Stock Option Exercise Price or SAR base amount, as applicable, the Company shall not be required to make any payment
to the Participant upon surrender of the Stock Option or SAR.
Section 13.
Deferrals
The Committee may permit or require a Participant to defer receipt of the payment of cash or the delivery of shares that
would otherwise be due to such Participant in connection with any Grant. If any such deferral election is permitted or required,
the Committee shall establish rules and procedures for such deferrals and may provide for interest or other earnings to be paid on
such deferrals. The rules and procedures for any such deferrals shall be consistent with applicable requirements of section 409A
of the Code.
Section 14. Withholding of Taxes
(a)
Required Withholding. All Grants under the Plan shall be subject to applicable United States federal
(including FICA), state and local, foreign country or other tax withholding requirements. The Employer may require that the
Participant or other person receiving Grants or exercising Grants pay to the Employer an amount sufficient to satisfy such tax
withholding requirements with respect to such Grants, or the Employer may deduct from other wages and compensation paid by
the Employer the amount of any withholding taxes due with respect to such Grants.
(b)
Share Withholding. The Committee may permit or require the Employer’s tax withholding obligation with
respect to Grants paid in Company Stock to be satisfied by having shares withheld up to an amount that does not exceed the
Participant’s applicable withholding tax rate for United States federal (including FICA), state and local, foreign country or other
tax liabilities. The Committee may, in its discretion, and subject to such rules as the Committee may adopt, allow Participants to
elect to have such share withholding applied to all or a portion of the tax withholding obligation arising in connection with any
particular Grant. Unless the Committee determines otherwise, share withholding for taxes shall not exceed the Participant’s
minimum applicable tax withholding amount.
Section 15.
Transferability of Grants
(a)
Nontransferability of Grants. Except as described in subsection (b) below, only the Participant may
exercise rights under a Grant during the Participant’s lifetime. A Participant may not transfer those rights except (i) by will or by
the laws of descent and distribution or (ii) with respect to Grants other than Incentive Stock Options, pursuant to a domestic
relations order. When a Participant dies, the personal representative or other person entitled to succeed to the rights of the
Participant may exercise such rights. Any such successor must furnish proof satisfactory to the Company of his or her right to
receive the Grant under the Participant’s will or under the applicable laws of descent and distribution.
(b)
Transfer of Nonqualified Stock Options. Notwithstanding the foregoing, the Committee may provide, in a
Grant Instrument, that a Participant may transfer Nonqualified Stock Options to family members, or one or more trusts or other
entities for the benefit of or owned by family members, consistent with the applicable securities laws, according to such terms as
the Committee may determine; provided that the Participant receives no consideration for the transfer of an Option and the
transferred Option shall continue to be subject to the same terms and conditions as were applicable to the Option immediately
before the transfer.
-15-
Section 16.
Requirements for Issuance or Transfer of Shares
No Company Stock shall be issued or transferred in connection with any Grant hereunder unless and until all legal
requirements applicable to the issuance or transfer of such Company Stock have been complied with to the satisfaction of the
Committee. The Committee shall have the right to condition any Grant on the Participant’s undertaking in writing to comply with
such restrictions on his or her subsequent disposition of the shares of Company Stock as the Committee shall deem necessary or
advisable, and certificates representing such shares may be legended to reflect any such restrictions. Certificates representing
shares of Company Stock issued or transferred under the Plan may be subject to such stop-transfer orders and other restrictions as
the Committee deems appropriate to comply with applicable laws, regulations and interpretations, including any requirement that
a legend be placed thereon.
Section 17.
Amendment and Termination of the Plan
(a)
Amendment. The Board may amend or terminate the Plan at any time; provided, however, that the Board
shall not amend the Plan without stockholder approval if such approval is required in order to comply with the Code or other
applicable law, or to comply with applicable stock exchange requirements.
(b)
No Repricing of Options or SARs. Except in connection with a corporate transaction involving the
Company (including, without limitation, any stock dividend, distribution (whether in the form of cash, Company Stock, other
securities or property), stock split, extraordinary cash dividend, recapitalization, change in control, reorganization, merger,
consolidation, split-up, spin-off, combination, repurchase or exchange of shares of Company Stock or other securities, or similar
transactions), the Company may not, without obtaining stockholder approval, (i) amend the terms of outstanding Stock Options
or SARs to reduce the Exercise Price of such outstanding Stock Options or base price of such SARs, (ii) cancel outstanding Stock
Options or SARs in exchange for Stock Options or SARs with an Exercise Price or base price, as applicable, that is less than the
Exercise Price or base price of the original Stock Options or SARs or (iii) cancel outstanding Stock Options or SARs with an
Exercise Price or base price, as applicable, above the current stock price in exchange for cash or other securities.
(c)
Termination of Plan. The Plan shall terminate on the day immediately preceding the tenth anniversary of
its Effective Date, unless the Plan is terminated earlier by the Board or is extended by the Board with the approval of the
stockholders.
(d)
Termination and Amendment of Outstanding Grants. A termination or amendment of the Plan that occurs
after a Grant is made shall not materially impair the rights of a Participant unless the Participant consents or unless the
Committee acts under Section 18(f) below. The termination of the Plan shall not impair the power and authority of the Committee
with respect to an outstanding Grant. Whether or not the Plan has terminated, an outstanding Grant may be terminated or
amended under Section 18(f) below or may be amended by agreement of the Company and the Participant consistent with the
Plan; provided that, the Participant’s consent is not required if any termination or amendment to the Participant’s outstanding
Grant does not materially impair the rights or materially increase the obligations of the Participant.
-16-
Section 18. Miscellaneous
(a)
Grants in Connection with Corporate Transactions and Otherwise. Nothing contained in the Plan shall be
construed to (i) limit the right of the Committee to make Grants under the Plan in connection with the acquisition, by purchase,
lease, merger, consolidation or otherwise, of the business or assets of any corporation, firm or association, including Grants to
employees thereof who become Employees, or (ii) limit the right of the Company to grant stock options or make other awards
outside of the Plan. The Committee may make a Grant to an employee of another corporation who becomes an Employee by
reason of a corporate merger, consolidation, acquisition of stock or property, reorganization or liquidation involving the
Company, in substitution for a stock option or stock award granted by such corporation. Notwithstanding anything in the Plan to
the contrary, the Committee may establish such terms and conditions of the new Grants as it deems appropriate, including setting
the Exercise Price of Options or the base price of SARs at a price necessary to retain for the Participant the same economic value
as the prior options or rights.
(b)
Governing Document. The Plan shall be the controlling document. No other statements, representations,
explanatory materials or examples, oral or written, may amend the Plan in any manner. The Plan shall be binding upon and
enforceable against the Company and its successors and assigns.
special or separate fund or to make any other segregation of assets to assure the payment of any Grants under the Plan.
(c)
Funding of the Plan. The Plan shall be unfunded. The Company shall not be required to establish any
(d)
Rights of Participants. Nothing in the Plan shall entitle any Employee, Non-Employee Director, Key
Advisor or other person to any claim or right to receive a Grant under the Plan. Neither the Plan nor any action taken hereunder
shall be construed as giving any individual any rights to be retained by or in the employ of the Employer or any other
employment rights.
(e)
No Fractional Shares. No fractional shares of Company Stock shall be issued or delivered pursuant to the
Plan or any Grant. Except as otherwise provided under the Plan, the Committee shall determine whether cash, other awards or
other property shall be issued or paid in lieu of such fractional shares or whether such fractional shares or any rights thereto shall
be forfeited or otherwise eliminated.
(f)
Compliance with Law.
(i)
The Plan, the exercise of Options and SARs and the obligations of the Company to issue or transfer
shares of Company Stock under Grants shall be subject to all applicable laws and regulations, and to approvals by any
governmental or regulatory agency as may be required. With respect to persons subject to section 16 of the Exchange Act, it is
the intent of the Company that the Plan and all transactions under the Plan comply with all applicable provisions of Rule 16b-3 or
its successors under the Exchange Act. In addition, it is the intent of the Company that Incentive Stock Options comply with the
applicable provisions of section 422 of the Code, and that, to the extent applicable, Grants comply with the requirements of
section 409A of the Code. To the extent that any legal requirement of section 16 of the Exchange Act or section 422 or 409A of
the Code as set forth in the Plan ceases to be required under section 16 of the Exchange Act or section 422 or 409A of the Code,
that Plan provision shall cease to apply. The Committee may revoke any Grant if it is contrary to law or modify a
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Grant to bring it into compliance with any valid and mandatory government regulation. The Committee may also adopt rules
regarding the withholding of taxes on payments to Participants. The Committee may, in its sole discretion, agree to limit its
authority under this Section.
(ii)
The Plan is intended to comply with the requirements of section 409A of the Code, to the extent
applicable. Each Grant shall be construed and administered such that the Grant either (A) qualifies for an exemption from the
requirements of section 409A of the Code or (B) satisfies the requirements of section 409A of the Code. If a Grant is subject to
section 409A of the Code, (I) distributions shall only be made in a manner and upon an event permitted under section 409A of the
Code, (II) payments to be made upon a termination of employment or service shall only be made upon a “separation from
service” under section 409A of the Code, (III) unless the Grant specifies otherwise, each installment payment shall be treated as a
separate payment for purposes of section 409A of the Code, and (IV) in no event shall a Participant, directly or indirectly,
designate the calendar year in which a distribution is made except in accordance with section 409A of the Code.
(iii)
Any Grant that is subject to section 409A of the Code and that is to be distributed to a Key
Employee (as defined below) upon separation from service shall be administered so that any distribution with respect to such
Grant shall be postponed for six months following the date of the Participant’s separation from service, if required by section
409A of the Code. If a distribution is delayed pursuant to section 409A of the Code, the distribution shall be paid within 15 days
after the end of the six-month period. If the Participant dies during such six-month period, any postponed amounts shall be paid
within 90 days of the Participant’s death. The determination of Key Employees, including the number and identity of persons
considered Key Employees and the identification date, shall be made by the Committee or its delegate each year in accordance
with section 416(i) of the Code and the “specified employee” requirements of section 409A of the Code.
(iv)
Notwithstanding anything in the Plan or any Grant agreement to the contrary, each Participant shall
be solely responsible for the tax consequences of Grants under the Plan, and in no event shall the Company or any subsidiary or
affiliate of the Company have any responsibility or liability if a Grant does not meet any applicable requirements of section 409A
of the Code. Although the Company intends to administer the Plan to prevent taxation under section 409A of the Code, the
Company does not represent or warrant that the Plan or any Grant complies with any provision of federal, state, local or other tax
law.
(g)
Establishment of Subplans. The Board may from time to time establish one or more sub-plans under the
Plan for purposes of satisfying applicable blue sky, securities or tax laws of various jurisdictions. The Board shall establish such
sub-plans by adopting supplements to the Plan setting forth (i) such limitations on the Committee’s discretion under the Plan as
the Board deems necessary or desirable and (ii) such additional terms and conditions not otherwise inconsistent with the Plan as
the Board shall deem necessary or desirable. All supplements adopted by the Board shall be deemed to be part of the Plan, but
each supplement shall apply only to Participants within the affected jurisdiction and the Employer shall not be required to provide
copies of any supplement to Participants in any jurisdiction that is not affected.
(h)
Clawback Rights. Subject to the requirements of applicable law, the Committee may provide in any Grant
Instrument that, if a Participant breaches any restrictive covenant agreement between the Participant and the Employer (which
may be set forth in any Grant Instrument) or otherwise engages in activities that constitute Cause either while employed
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by, or providing service to, the Employer or within a specified period of time thereafter, all Grants held by the Participant shall
terminate, and the Company may rescind any exercise of an Option or SAR and the vesting of any other Grant and delivery of
shares upon such exercise or vesting (including pursuant to dividends and Dividend Equivalents), as applicable on such terms as
the Committee shall determine, including the right to require that in the event of any such rescission, (i) the Participant shall
return to the Company the shares received upon the exercise of any Option or SAR and/or the vesting and payment of any other
Grant (including pursuant to dividends and Dividend Equivalents) or, (ii) if the Participant no longer owns the shares, the
Participant shall pay to the Company the amount of any gain realized or payment received as a result of any sale or other
disposition of the shares (or, in the event the Participant transfers the shares by gift or otherwise without consideration, the Fair
Market Value of the shares on the date of the breach of the restrictive covenant agreement (including a Participant’s Grant
Instrument containing restrictive covenants) or activity constituting Cause), net of the price originally paid by the Participant for
the shares. Payment by the Participant shall be made in such manner and on such terms and conditions as may be required by the
Committee. The Employer shall be entitled to set off against the amount of any such payment any amounts otherwise owed to the
Participant by the Employer. In addition, all Grants under the Plan shall be subject to any applicable clawback or recoupment
policies, share trading policies and other policies that may be implemented by the Board from time to time.
(i)
Governing Law. The validity, construction, interpretation and effect of the Plan and Grant Instruments
issued under the Plan shall be governed and construed by and determined in accordance with the laws of the State of Delaware,
without giving effect to the conflict of laws provisions thereof.
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REPLIMUNE GROUP, INC.
2018 OMNIBUS INCENTIVE COMPENSATION PLAN
NONQUALIFIED STOCK OPTION GRANT AGREEMENT
U.S. Form
Participant:
Date of Grant:
Shares subject to the Option:
Option Price:
%%FIRST_NAME%-% %%LAST_NAME%-%
%%OPTION_DATE,'Month DD, YYYY'%-%
%%TOTAL_SHARES_GRANTED,'999,999,999'%-%
%%OPTION_PRICE,'$999,999,999.99'%-%
RECITALS
The Replimune Group, Inc. 2018 Omnibus Incentive Compensation Plan (the “Plan”) provides for the grant of stock
options to purchase shares of Replimune Group, Inc. (the “Company”) common stock (“Company Stock”). The Committee has
decided to make this nonqualified stock option grant as an inducement for the Participant to promote the best interests of the
Company and its stockholders. The Participant hereby acknowledges the receipt of a copy of the official prospectus for the Plan,
which is available by accessing the Company’s intranet at [INSERT LINK]. Paper copies of the Plan and the official Plan
prospectus are available by contacting the [INSERT TITLE] of the Company at [INSERT PHONE NUMBER] , or emailing
[INSERT EMAIL ADDRESS]. This Agreement is made pursuant to the Plan and is subject in its entirety to all applicable
provisions of the Plan. Capitalized terms used herein and not otherwise defined will have the meanings set forth in the Plan.
1.
Grant of Option. Subject to the terms and conditions set forth in this Nonqualified Stock Option Grant Agreement (this
“Agreement”) and in the Plan, the Company hereby grants to the Participant a nonqualified stock option (the “Option”) to
purchase the number of shares of Company Stock (“Shares”) at the Exercise Price per Share, as set forth above. The Option shall
become exercisable according to Section 2 below.
2.
Exercisability of Option.
(a)
The Option shall become vested and exercisable according to the vesting table in Exhibit A, detailing the vesting
dates (each, an individual “Vesting Date”), provided that the Participant continues to be employed by, or provide service to, the
Employer from the Date of Grant until the applicable Vesting Date.
(b)
The vesting and exercisability of the Option is cumulative, but shall not exceed 100% of the Shares subject to the
Option.
(c)
If the Participant’s employment or service terminates on account of the Participant’s death or Disability before the
last Vesting Date, any unvested and unexercisable portion of the Option shall become fully vested and exercisable upon such
termination of employment or service.
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(d)
In the event of a Change of Control, the provisions of the Plan applicable to a Change of Control shall apply to the
Option, and, in the event of a Change of Control, the Committee may take such actions as it deems appropriate pursuant to the
Plan.
In addition, if the Company is not the surviving corporation (or survives only as a subsidiary of another corporation) as a
result of the Change of Control and the Option is assumed by, or replaced with an award with comparable terms by, the surviving
corporation (or parent or subsidiary of the surviving corporation) and the Participant’s employment or service is terminated by the
Employer without Cause or by the Participant for Good Reason (if applicable) upon or within 12 months following a Change of
Control and before the Option is fully vested and exercisable in accordance with the vesting schedule set forth in Section 2(a)
above, any unvested and unexercisable portion of the Option shall become fully vested and exercisable upon such termination of
employment or service. In the event that the surviving corporation (or a parent or subsidiary of the surviving corporation) does
not assume or replace the Option with a grant that has comparable terms, and the Participant is employed by, or providing
services to, the Employer on the date of the Change of Control, any unvested and unexercisable portion of the Option shall
become fully vested and exercisable upon the date of the Change of Control.
3.
Term of Option.
(a)
The Option shall have a term of ten years from the Date of Grant and shall terminate at the expiration of that
period, unless it is terminated at an earlier date pursuant to the provisions of this Agreement or the Plan. Notwithstanding the
foregoing, in the event that on the last business day of the term of the Option, the exercise of the Option is prohibited by
applicable law, including a prohibition on purchases or sales of Company Stock under the Company’s insider trading policy, the
term of the Option shall be extended for a period of 30 days following the end of the legal prohibition, unless the Committee
determines otherwise.
(b)
The Option shall automatically terminate upon the happening of the first of the following events:
(i)
The expiration of the 90-day period after the Participant ceases to be employed by, or provide service to,
the Employer, if the termination is for any reason other than Disability, death or Cause.
(ii)
The expiration of the one-year period after the Participant ceases to be employed by, or provide service to,
the Employer on account of the Participant’s Disability.
(iii)
The expiration of the one-year period after the Participant ceases to be employed by, or provide service to,
the Employer, if the Participant dies while employed by, or providing service to, the Employer or the Participant dies
within 90 days after the Participant ceases to be so employed or to provide services to the Employer for any reason other
than Disability, death or Cause.
(iv)
The date on which the Participant ceases to be employed by, or provide service to, the Employer for Cause.
In addition, notwithstanding the prior provisions of this Section 3, if the Participant engages in conduct that constitutes
Cause after the Participant’s employment or service terminates, the Option shall immediately terminate.
-21-
Notwithstanding the foregoing, in no event may the Option be exercised after the date that is immediately before the tenth
anniversary of the Date of Grant, except as provided under Section 3(a) above. Any portion of the Option that is not exercisable
at the time the Participant ceases to be employed by, or provide service to, the Employer shall immediately terminate.
4.
Exercise Procedures.
(a)
Subject to the provisions of Sections 2 and 3 above, the Participant may exercise part or all of the exercisable
Option by giving the Company or its delegate written notice of intent to exercise, specifying the number of Shares as to which the
Option is to be exercised and such other information as the Company or its delegate may require.
The Participant shall pay the Exercise Price (i) in cash or check, (ii) unless the Committee determines otherwise, by
delivering shares of Company Stock owned by the Participant, which shall be valued at their Fair Market Value on the date of
exercise, or by attestation (in accordance with procedures prescribed by the Company) to ownership of shares of Company Stock
having a Fair Market Value on the date of exercise at least equal to the Exercise Price, (iii) if permitted by the Committee, by
payment through a broker in accordance with procedures permitted by Regulation T of the Federal Reserve Board, or (iv) by such
other method as the Committee may approve, to the extent permitted by applicable law. The Committee may impose from time to
time such limitations as it deems appropriate on the use of shares of Company Stock to exercise the Option.
(b)
The obligation of the Company to deliver Shares upon exercise of the Option shall be subject to all applicable
laws, rules, and regulations and such approvals by governmental agencies as may be deemed appropriate by the Committee,
including such actions as Company counsel shall deem necessary or appropriate to comply with relevant securities laws and
regulations.
(c)
All obligations of the Company under this Agreement shall be subject to the rights of the Employer as set forth in
the Plan to withhold amounts required to be withheld for any taxes, if applicable. The Participant shall be required to pay to the
Employer, or make other arrangements satisfactory to the Employer to provide for the payment of, any federal, state, local or
other taxes that the Employer is required to withhold with respect to the Option.
(d)
Upon exercise of the Option (or portion thereof), the Option (or portion thereof) will terminate and cease to be
outstanding.
5.
Restrictions on Exercise. Except as the Committee may otherwise permit pursuant to the Plan, only the Participant may
exercise the Option during the Participant’s lifetime and, after the Participant’s death, the Option shall be exercisable (subject to
the limitations specified in the Plan) solely by the legal representatives of the Participant, or by the person who acquires the right
to exercise the Option by will or by the laws of descent and distribution, to the extent that the Option is exercisable pursuant to
this Agreement.
Grant Subject to Plan Provisions. This grant is made pursuant to the Plan, the terms of which are incorporated herein by
6.
reference, and in all respects shall be interpreted in accordance with the Plan. The grant and exercise of the Option are subject to
the provisions of the Plan and to interpretations, regulations and determinations concerning the Plan established from time to time
by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining to (a) rights
and obligations with respect to withholding taxes, (b) the
-22-
registration, qualification or listing of the Shares, (c) changes in capitalization of the Company and (d) other requirements of
applicable law. The Committee may amend the terms of this Option to the extent permitted by the Plan. The Committee shall
have the authority to interpret and construe the Option pursuant to the terms of the Plan, and its decisions shall be conclusive as
to any questions arising hereunder.
No Employment or Other Rights. The grant of the Option shall not confer upon the Participant any right to be retained by
7.
or in the employ or service of any Employer and shall not interfere in any way with the right of any Employer to terminate the
Participant’s employment or service at any time. The right of any Employer to terminate at will the Participant’s employment or
service at any time for any reason is specifically reserved.
No Stockholder Rights. Neither the Participant, nor any person entitled to exercise the Participant’s rights in the event of
8.
the Participant’s death, shall have any of the rights and privileges of a stockholder with respect to the Shares subject to the
Option, until certificates for Shares have been issued upon the exercise of the Option.
Assignment and Transfers. Except as the Committee may otherwise permit pursuant to the Plan, the rights and interests of
9.
the Participant under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the
death of the Participant, by will or by the laws of descent and distribution. In the event of any attempt by the Participant to
alienate, assign, pledge, hypothecate, or otherwise dispose of the Option or any right hereunder, except as provided for in this
Agreement, or in the event of the levy or any attachment, execution or similar process upon the rights or interests hereby
conferred, the Company may terminate the Option by notice to the Participant, and the Option and all rights hereunder shall
thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or assigns
of the Company and to the Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the Company
without the Participant’s consent.
10.
construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions thereof.
Applicable Law. The validity, construction, interpretation and effect of this Agreement shall be governed by and
11.
Notice. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the
[INSERT TITLE] at the corporate headquarters of the Company, and any notice to the Participant shall be addressed to such
Participant at the current address shown on the payroll of the Employer, or to such other address as the Participant may designate
to the Employer in writing. Any notice shall be delivered by hand or enclosed in a properly sealed envelope addressed as stated
above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service or by
the postal authority of the country in which the Participant resides or to an internationally recognized expedited mail courier.
12.
Company Policies. The Participant agrees that payment by the Participant shall be made in such manner and on such
terms and conditions as may be required by the Committee and the Employer shall be entitled to set off against the amount of any
such payment any amounts otherwise owed to the Participant by the Employer. In addition, the Participant agrees that the Option
shall be subject to any applicable clawback or recoupment policies, share trading policies and other policies that may be
implemented by the Board or imposed under applicable rule or regulation from time to time.
-23-
Application of Section 409A of the Code. This Agreement is intended to be exempt from section 409A of the Code and to
13.
the extent this Agreement is subject to section 409A of the Code, it will in all respects be administered in accordance with section
409A of the Code.
By electronic acceptance, the Participant hereby accepts the Option described in this Agreement, and agrees to be bound by the
terms of the Plan and this Agreement. The Participant hereby agrees that all decisions and determinations of the Committee with
respect to the Option shall be final and binding.
-24-
Shares Vesting
Vesting Date
Exhibit A
Vesting Schedule
-25-
-26-
REPLIMUNE GROUP, INC.
2018 OMNIBUS INCENTIVE COMPENSATION PLAN
NONQUALIFIED STOCK OPTION GRANT AGREEMENT
U.K. Form
Participant:
Date of Grant:
Shares subject to the Option:
Option Price:
%%FIRST_NAME%-% %%LAST_NAME%-%
%%OPTION_DATE,'Month DD, YYYY'%-%
%%TOTAL_SHARES_GRANTED,'999,999,999'%-%
%%OPTION_PRICE,'$999,999,999.99'%-%
RECITALS
The Replimune Group, Inc. 2018 Omnibus Incentive Compensation Plan and the Sub-Plan for U.K. Employees
thereunder (together, the “Plan”) provides for the grant of stock options to purchase shares of Replimune Group, Inc. (the
“Company”) common stock (“Company Stock”). The Committee has decided to make this nonqualified stock option grant as an
inducement for the Participant to promote the best interests of the Company and its stockholders. The Participant hereby
acknowledges the receipt of a copy of the official prospectus for the Plan, which is available by accessing the Company’s intranet
at [INSERT LINK]. Paper copies of the Plan and the official Plan prospectus are available by contacting the [INSERT TITLE]
of the Company at [INSERT PHONE NUMBER], or emailing [INSERT EMAIL ADDRESS]. This Agreement is made
pursuant to the Plan and is subject in its entirety to all applicable provisions of the Plan. Capitalized terms used herein and not
otherwise defined will have the meanings set forth in the Plan.
14.
Grant of Option. Subject to the terms and conditions set forth in this Nonqualified Stock Option Grant Agreement (this
“Agreement”) and in the Plan, the Company hereby grants to the Participant a stock option, which is a nonqualified stock option
for U.S. federal tax purposes (the “Option”) to purchase the number of shares of Company Stock (“Shares”) at the Exercise Price
per Share, as set forth above. The Option shall become exercisable according to Section 2 below.
15.
Exercisability of Option.
(a)
The Option shall become vested and exercisable according to the vesting table in Exhibit A, detailing the vesting
dates (each, an individual “Vesting Date”), provided that the Participant continues to be employed by, or provide service to, the
Employer from the Date of Grant until the applicable Vesting Date.
(b)
The vesting and exercisability of the Option is cumulative, but shall not exceed 100% of the Shares subject to the
Option.
(c)
If the Participant’s employment or service terminates on account of the Participant’s death or Disability before the
last Vesting Date, any unvested and unexercisable portion of the Option shall become fully vested and exercisable upon such
termination of employment or service.
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(d)
In the event of a Change of Control, the provisions of the Plan applicable to a Change of Control shall apply to the
Option, and, in the event of a Change of Control, the Committee may take such actions as it deems appropriate pursuant to the
Plan.
In addition, if the Company is not the surviving corporation (or survives only as a subsidiary of another corporation) as a
result of the Change of Control and the Option is assumed by, or replaced with an award with comparable terms by, the surviving
corporation (or parent or subsidiary of the surviving corporation) and the Participant’s employment or service is terminated by the
Employer without Cause or by the Participant for Good Reason (if applicable) upon or within 12 months following a Change of
Control and before the Option is fully vested and exercisable in accordance with the vesting schedule set forth in Section 2(a)
above, any unvested and unexercisable portion of the Option shall become fully vested and exercisable upon such termination of
employment or service. In the event that the surviving corporation (or a parent or subsidiary of the surviving corporation) does
not assume or replace the Option with a grant that has comparable terms, and the Participant is employed by, or providing
services to, the Employer on the date of the Change of Control, any unvested and unexercisable portion of the Option shall
become fully vested and exercisable upon the date of the Change of Control.
(e)
For purposes of this Agreement, the Participant’s employment or service will be deemed to terminate on the date
that the Participant ceases to be actively employed by, or providing services to, the Employer and shall not be extended by any
notice period mandated or implied under local law (i) during or for which the Participant receives pay in lieu of notice or
severance pay or is on garden or similar leave or (ii) during which the Participant remains employed or providing services, but is
not actively working. The Company shall have the sole discretion to determine when the Participant is no longer in active
employment or service for purposes of this Agreement, without reference to any other agreement, written or oral, including the
Participant’s contract of employment or service.
(f)
The exercisability of the Option pursuant to this Section 2 shall be subject in all respects to the exercise
procedures and requirements set forth in Section 4 below.
16.
Term of Option.
(a)
The Option shall have a term of ten years from the Date of Grant and shall terminate at the expiration of that
period, unless it is terminated at an earlier date pursuant to the provisions of this Agreement or the Plan. Notwithstanding the
foregoing, in the event that on the last business day of the term of the Option, the exercise of the Option is prohibited by
applicable law, including a prohibition on purchases or sales of Company Stock under the Company’s insider trading policy, the
term of the Option shall be extended for a period of 30 days following the end of the legal prohibition, unless the Committee
determines otherwise or otherwise prohibited under applicable law.
(b)
The Option shall automatically terminate upon the happening of the first of the following events:
(i)
The expiration of the 90-day period after the Participant ceases to be employed by, or provide service to,
the Employer, if the termination is for any reason other than Disability, death or Cause.
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(ii)
The expiration of the one-year period after the Participant ceases to be employed by, or provide service to,
the Employer on account of the Participant’s Disability.
(iii)
The expiration of the one-year period after the Participant ceases to be employed by, or provide service to,
the Employer, if the Participant dies while employed by, or providing service to, the Employer or the Participant dies
within 90 days after the Participant ceases to be so employed or to provide services to the Employer for any reason other
than Disability, death or Cause.
(iv)
The date on which the Participant ceases to be employed by, or provide service to, the Employer for Cause.
In addition, notwithstanding the prior provisions of this Section 3, if the Participant engages in conduct that constitutes
Cause after the Participant’s employment or service terminates, the Option shall immediately terminate.
Notwithstanding the foregoing, in no event may the Option be exercised after the date that is immediately before the tenth
anniversary of the Date of Grant, except as provided under Section 3(a) above. Any portion of the Option that is not exercisable
at the time the Participant ceases to be employed by, or provide service to, the Employer shall immediately terminate.
17.
Exercise Procedures.
(a)
Subject to the provisions of Sections 2 and 3 above, the Participant may exercise part or all of the exercisable
Option by giving the Company or its delegate written notice of intent to exercise, specifying the number of Shares as to which the
Option is to be exercised and such other information as the Company or its delegate may require.
The Participant shall pay the Exercise Price (i) in cash or check, (ii) unless the Committee determines otherwise, by
delivering shares of Company Stock owned by the Participant, which shall be valued at their Fair Market Value on the date of
exercise, or by attestation (in accordance with procedures prescribed by the Company) to ownership of shares of Company Stock
having a Fair Market Value on the date of exercise at least equal to the Exercise Price, (iii) if permitted by the Committee, by
payment through a broker in accordance with procedures permitted by Regulation T of the Federal Reserve Board, or (iv) by such
other method as the Committee may approve, to the extent permitted by applicable law. The Committee may impose from time to
time such limitations as it deems appropriate on the use of shares of Company Stock to exercise the Option.
(b)
The obligation of the Company to deliver Shares upon exercise of the Option shall be subject to all applicable
laws, rules, and regulations and such approvals by governmental agencies as may be deemed appropriate by the Committee,
including such actions as Company counsel shall deem necessary or appropriate to comply with relevant securities laws and
regulations.
(c)
All obligations of the Company under this Agreement shall be subject to the rights of the Employer as set forth in
the Plan to withhold amounts required to be withheld, collected or accounted for with respect to any income tax (including U.S.
federal, state, and local tax and/or foreign income tax), employment tax (including FICA), payroll tax, social security tax, social
insurance, national insurance and other contributions, payment on account obligations, national and local tax or other amounts
required to be withheld, collected or accounted for by the Employer in connection with any taxable event with respect to the
Option (the “Withholding
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Taxes”), if applicable. The Participant shall be required to pay to the Employer, or make other arrangements satisfactory to the
Employer to provide for the payment of Withholding Taxes.
(d)
Regardless of any action the Employer takes with respect to any such Withholding Taxes, the Participant
acknowledges that the ultimate liability for all such Withholding Taxes legally due by the Participant is and remains the
Participant’s responsibility and may exceed the amount withheld by the Employer. The Participant further acknowledges that the
Employer (i) makes no representations or undertakings regarding the treatment of any Withholding Taxes in connection with any
aspect of the Option, including the grant, vesting or exercise of the Option and the subsequent sale of any Shares acquired upon
exercise; and (ii) does not commit to, and is under no obligation to, structure the terms of the grant or any aspect of the Option to
reduce or eliminate the Participant’s liability for Withholding Taxes. Further, if the Participant has become subject to tax in more
than one jurisdiction between the date of grant and the date of any relevant taxable event, then the Participant acknowledges that
the Employer may be required to collect, withhold or account for Withholding Taxes in more than one jurisdiction.
(e)
Employer NICs. As a condition to participation in the Plan and the exercise of the Option, the Participant hereby
agrees to accept all liability for and pay all secondary Class 1 National Insurance Contributions which would otherwise be
payable by the Company (or any successor or any subsidiary employing or retaining or previously employing or retaining the
Participant) with respect to the exercise of the Option or any other event giving rise to taxation in respect of the Option (the
“Employer NICs”). The Participant agrees that to the extent requested by the Company, the Participant will execute, within the
time period specified by the Company, a joint election, and any other consent or elections required to effect the transfer of the
Employer NICs. The Participant further agrees to execute such other joint elections as may be required between the Participant
and any successor to the Company and/or the Participant’s employer. The Participant further agrees that the Company and/or the
Participant’s employer may collect the Employer NICs by any of the means set forth in this Agreement.
(f)
Upon exercise of the Option (or portion thereof), the Option (or portion thereof) will terminate and cease to be
outstanding.
18.
Restrictions on Exercise. Except as the Committee may otherwise permit pursuant to the Plan, only the Participant may
exercise the Option during the Participant’s lifetime and, after the Participant’s death, the Option shall be exercisable (subject to
the limitations specified in the Plan) solely by the legal representatives of the Participant, or by the person who acquires the right
to exercise the Option by will or by the laws of descent and distribution, to the extent that the Option is exercisable pursuant to
this Agreement.
19.
Grant Subject to Plan Provisions. This grant is made pursuant to the Plan, the terms of which are incorporated herein by
reference, and in all respects shall be interpreted in accordance with the Plan. The grant and exercise of the Option are subject to
the provisions of the Plan and to interpretations, regulations and determinations concerning the Plan established from time to time
by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining to (a) rights
and obligations with respect to withholding taxes, (b) the registration, qualification or listing of the Shares, (c) changes in
capitalization of the Company and (d) other requirements of applicable law. The Committee may amend the terms of this Option
to the extent permitted by the Plan. The Committee shall have the authority to interpret and construe the Option pursuant to the
terms of the Plan, and its decisions shall be conclusive as to any questions arising hereunder.
-30-
No Employment or Other Rights. The grant of the Option shall not confer upon the Participant any right to be retained by
20.
or in the employ or service of any Employer and shall not interfere in any way with the right of any Employer to terminate the
Participant’s employment or service at any time. Subject to the terms of any employment agreement between the Participant and
the Employer and applicable law, the right of any Employer to terminate at will the Participant’s employment or service at any
time for any reason is specifically reserved.
21.
No Stockholder Rights. Neither the Participant, nor any person entitled to exercise the Participant’s rights in the event of
the Participant’s death, shall have any of the rights and privileges of a stockholder with respect to the Shares subject to the
Option, until certificates for Shares have been issued upon the exercise of the Option.
Assignment and Transfers. Except as the Committee may otherwise permit pursuant to the Plan, the rights and interests of
22.
the Participant under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the
death of the Participant, by will or by the laws of descent and distribution. In the event of any attempt by the Participant to
alienate, assign, pledge, hypothecate, or otherwise dispose of the Option or any right hereunder, except as provided for in this
Agreement, or in the event of the levy or any attachment, execution or similar process upon the rights or interests hereby
conferred, the Company may terminate the Option by notice to the Participant, and the Option and all rights hereunder shall
thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or assigns
of the Company and to the Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the Company
without the Participant’s consent.
Applicable Law. The validity, construction, interpretation and effect of this Agreement shall be governed by and
23.
construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions thereof.
Notice. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the
24.
[INSERT TITLE] at the corporate headquarters of the Company, and any notice to the Participant shall be addressed to such
Participant at the current address shown on the payroll of the Employer, or to such other address as the Participant may designate
to the Employer in writing. Any notice shall be delivered by hand or enclosed in a properly sealed envelope addressed as stated
above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service or by
the postal authority of the country in which the Participant resides or to an internationally recognized expedited mail courier.
25.
Company Policies. The Participant agrees that payment by the Participant shall be made in such manner and on such
terms and conditions as may be required by the Committee and the Employer shall be entitled to set off against the amount of any
such payment any amounts otherwise owed to the Participant by the Employer. In addition, the Participant agrees that the Option
shall be subject to any applicable clawback or recoupment policies, share trading policies and other policies that may be
implemented by the Board or imposed under applicable rule or regulation from time to time.
26.
Application of Section 409A of the Code. This Agreement is intended to be exempt from section 409A of the Code and to
the extent this Agreement is subject to section 409A of the Code, it will in all respects be administered in accordance with section
409A of the Code.
-31-
27.
Agreement, the Participant acknowledges the following:
No Entitlement or Claims for Compensation. In connection with the acceptance of the grant of the Option under this
(a)
the Plan is established voluntarily by the Company, the grant of the Option under the Plan is made at the discretion
of the Committee and the Plan may be modified, amended, suspended or terminated by the Company at any time;
(b)
the grant of the Option under the Plan is voluntary and occasional and does not create any contractual or other
right to receive future grants of equity awards, or benefits in lieu of them, even if equity awards have been granted repeatedly in
the past;
(c)
(d)
all decisions with respect to future grants of awards, if any, will be at the sole discretion of the Committee;
the Participant is voluntarily participating in the Plan;
(e)
the Option and any Shares acquired under the Plan are extraordinary items that do not constitute compensation of
any kind for services of any kind rendered to the Employer and which are outside the scope of the Participant’s employment
contract, if any;
(f)
the Option and any Shares acquired under the Plan are not to be considered part of the Participant’s normal or
expected compensation or salary for any purpose, including, but not limited to, calculating any severance, resignation,
termination, payment in lieu of notice, redundancy, end of service payments, bonuses, long-service awards, pension or retirement
or welfare benefits or similar payments;
(g)
the Option and the Shares subject to the Option are not intended to replace any pension rights or compensation;
(h)
the grant of the Option and the Participant’s participation in the Plan will not be interpreted to form an
employment contract or relationship with the Employer;
(i)
the future value of the underlying Shares is unknown and cannot be predicted with certainty. If the Participant
exercises the Option and acquires Shares, the value of the acquired Shares may increase or decrease including below the Exercise
Price;
(j)
the Participant understands that the Company is not responsible for any foreign exchange fluctuation between the
United States Dollar and the Participant’s local currency that may affect the value of the Option or the Shares;
(k)
the Participant shall have no rights, claim or entitlement to compensation or damages as a result of the
Participant’s cessation of employment or service for any reason whatsoever, whether or not in breach of contract or local labor
law, insofar as these rights, claim or entitlement arise or may arise from the Participant’s ceasing to have rights under or be
entitled to exercise the Option as a result of such cessation or loss or diminution in value of the Option or any of the Shares
purchased through exercise of the Option as a result of such cessation, and the Participant irrevocably releases his or her
Employer from any such rights, entitlement or claim that may arise. If, notwithstanding the foregoing, any such right or claim is
found by a court of competent jurisdiction to have arisen, then, by signing this Agreement, the Participant shall be deemed to
have irrevocably waived his or her entitlement to pursue such rights or claim;
-32-
(l)
the Participant has no right to compensation or damages on account of any loss in respect of this Option where the
loss arises or is claimed to arise in whole or part from: (i) the termination of Participant’s office or employment; or (ii) notice to
terminate Participant’s office or employment. This exclusion of liability shall apply however termination of office or
employment, or the giving of notice, is caused, and however compensation or damages are claimed. For the purpose of the Plan,
the implied duty of trust and confidence is expressly excluded.
28.
Data Privacy.
(a)
The Participant hereby acknowledges and understands the collection, use, disclosure and transfer, in
electronic or other form, of his or her personal data as described in this Agreement by and among, as applicable, his or
her employer, the Company and its affiliates for the exclusive purpose of implementing, administering and managing his
or her participation in the Plan.
(b)
The Participant understands that the Company and its affiliates (including his or her employer), as
applicable, hold certain personal information about him or her regarding the Participant’s employment, the nature and
amount of the Participant’s compensation and the fact and conditions of the Participant’s participation in the Plan,
including, but not limited to, his or her name, home address, telephone number and e-mail address, date of birth, social
insurance number or other identification number, salary, nationality, job title, any equity or directorships held in the
Company and its affiliates, details of all options or any other entitlement to equity awarded, canceled, exercised, vested,
unvested or outstanding in his or her favor, for the purpose of implementing, administering and managing the Plan (the
“Data”).
(c)
The Participant understands that the Data may be transferred to the Company, its affiliates and any third
parties assisting in the implementation, administration, and management of the Plan, that these recipients may be located
in his or her country, or elsewhere, and that the recipient’s country may have a lower standard of data privacy laws and
protections than the Participant’s country of residence. The Participant understands that he or she may request a list with
the names and addresses of any potential recipients of the Data by contacting the Participant’s local human resources
representative. The Participant understands that the recipients receive, possess, use, retain and transfer the Data, in
electronic or other form, for the purposes of implementing, administering and managing his or her participation in the
Plan, including any requisite transfer of such Data as may be required to a broker or other third party. The Participant
understands that the Data will be held only as long as is necessary to implement, administer and manage his or her
participation in the Plan. The Participant understands that he or she may, at any time, view the Data, request additional
information about the storage and processing of the Data, require any necessary amendments to the Data, object to or
request restriction of the processing of his or her Data or refuse or withdraw any consents provided to the Company
herein, in any case without cost, by contacting in writing his or her local human resources representative. The Participant
understands, however, that objecting to or requesting the restriction of the processing of his or her Data may affect his or
her ability to participate in the Plan. For more information on the processing of his or her Data and other personal data,
the Participant is referred to the Privacy Notice provided to him or her by his or her employer.
-33-
By electronic acceptance, the Participant hereby accepts the Option described in this Agreement, and agrees to be bound
by the terms of the Plan and this Agreement. The Participant hereby agrees that all decisions and determinations of the
Committee with respect to the Option shall be final and binding.
-34-
Shares Vesting
Vesting Date
Exhibit A
Vesting Schedule
-35-
-36-
REPLIMUNE GROUP, INC.
2018 OMNIBUS INCENTIVE COMPENSATION PLAN
RESTRICTED STOCK UNIT GRANT AGREEMENT
U.S. Form
Participant:
Date of Grant:
Restricted Units Granted:
%%FIRST_NAME%-% %%LAST_NAME%-%
%%OPTION_DATE,'Month DD, YYYY'%-%
%%TOTAL_SHARES_GRANTED,'999,999,999'%-%
RECITALS
The Replimune Group, Inc. 2018 Omnibus Incentive Compensation Plan (the “Plan”) provides for the grant of restricted
stock units. The Committee has decided to make this grant of restricted stock units as an inducement for the Participant to
promote the best interests of the Replimune Group, Inc. (the “Company”) and its stockholders. The Participant hereby
acknowledges the receipt of a copy of the official prospectus for the Plan, which is available by accessing the Company’s intranet
at [INSERT LINK]. Paper copies of the Plan and the official Plan prospectus are available by contacting the [INSERT TITLE]
of the Company at [INSERT PHONE NUMBER], or emailing [INSERT EMAIL ADDRESS]. This Agreement is made
pursuant to the Plan and is subject in its entirety to all applicable provisions of the Plan. Capitalized terms used herein and not
otherwise defined will have the meanings set forth in the Plan.
29.
Grant of Stock Units. Subject to the terms and conditions set forth in this Restricted Stock Unit Grant Agreement (this
“Agreement”) and in the Plan, the Company hereby grants the Participant the number of restricted stock units set forth above,
subject to the restrictions set forth below and in the Plan (the “Stock Units”). Each Stock Unit represents the right of the
Participant to receive a share of common stock of the Company (“Company Stock”) on the applicable payment date set forth in
Section 5 below.
30.
Stock Unit Account. Stock Units represent hypothetical shares of Company Stock, and not actual shares of stock. The
Company shall establish and maintain a Stock Unit account, as a bookkeeping account on its records, for the Participant and shall
record in such account the number of Stock Units granted to the Participant. No shares of Company Stock shall be issued to the
Participant at the time the grant is made, and the Participant shall not be, and shall not have any of the rights or privileges of, a
stockholder of the Company with respect to any Stock Units recorded in the Stock Unit account. The Participant shall not have
any interest in any fund or specific assets of the Company by reason of this award or the Stock Unit account established for the
Participant.
31.
Vesting.
(a)
The Stock Units are anticipated to become vested over a period of four (4) years, with 25% of the Stock Units
vesting on the Designated Vesting Date (as defined in the following table), and 25% of the Stock Units subject to this Agreement
vesting on the yearly anniversaries of the Designated Vesting Date thereafter for the next three (3) consecutive years (each, a
-37-
“Vesting Date”); provided that the Participant continues to be employed by, or provide service to, the Employer from the Date of
Grant until the applicable Vesting Date:
Date of Grant
Designated Vesting Date*
January 1 – March 31
April 1 – June 30
July 1 – September 30
October 1 – December 30
th
th
February 15 of the next calendar year
May 15 of the next calendar year
August 15 of the next calendar year
November 15 of the next calendar year
th
th
* If a Designated Vesting Date falls on a weekend, federal holiday or any other day the Nasdaq Global Market is closed for trading, such
Designated Vesting Date will become the next active trading day of the Company’s common stock.
(b)
The vesting of the Stock Units shall be cumulative, but shall not exceed 100% of the Stock Units. If the foregoing
schedule would produce fractional Stock Units, the number of Stock Units that vest shall be rounded down to the nearest whole
Stock Unit and the fractional Stock Units will be accumulated so that the resulting whole Stock Units will be included in the
number of Stock Units that become vested on the last Vesting Date.
(c)
If the Participant’s employment or service terminates on account of the Participant’s death or Disability before the
last Vesting Date, any unvested Stock Units shall become fully vested upon such termination of employment or service.
(d)
If the Company is not the surviving corporation (or survives only as a subsidiary of another corporation) as a
result of a Change of Control and the Stock Units are assumed by, or replaced with an award with comparable terms by, the
surviving corporation (or parent or subsidiary of the surviving corporation) and the Participant’s employment or service is
terminated by the Employer without Cause or by the Participant for Good Reason (if applicable) upon or within 12 months
following a Change of Control and before the Stock Units are fully vested in accordance with the vesting schedule set forth in
Section 3(a) above, any unvested Stock Units shall become fully vested upon such termination of employment or service. In the
event that the surviving corporation (or a parent or subsidiary of the surviving corporation) does not assume or replace the Stock
Units with an award with comparable terms, and the Participant is employed by, or providing services to, the Employer on the
date of the Change of Control, any unvested Stock Units shall become fully vested upon the date of the Change of Control.
32.
Termination of Stock Units. If the Participant ceases to be employed by, or provide service to, the Employer for any
reason before all of the Stock Units vest, any unvested Stock Units shall automatically terminate and shall be forfeited as of the
date of the Participant’s termination of employment or service. No payment shall be made with respect to any unvested Stock
Units that terminate as described in this Section 4.
33.
Payment of Stock Units.
(a)
If and when the Stock Units vest, the Company shall issue to the Participant one share of Company Stock for each
vested Stock Unit, subject to applicable Withholding Taxes (as defined below). Payment shall be made within 30 days after the
applicable Vesting Date.
(b)
All obligations of the Company under this Agreement shall be subject to the rights of the Employer as set forth in
the Plan to withhold amounts required by law to be withheld for any federal (including FICA), state, local and other taxes with
respect to the
-38-
payment of the Stock Units (“Withholding Taxes”). The Participant irrevocably (i) has elected, as of the Date of Grant to sell
shares of Company Stock in an amount having an aggregate Fair Market Value equal to the Withholding Taxes, and to allow the
Company’s designated broker (the “Broker”) to remit the cash proceeds of such sale to the Employer (a “Sell to Cover”) and (ii)
directs the Employer to make a cash payment to satisfy the Withholding Taxes from the cash proceeds of such sale directly to the
appropriate taxing authorities. To the extent the Sell to Cover does not cover all Withholding Taxes due, the Participant shall be
required to pay to the Employer, or make other arrangements satisfactory to the Employer to provide for the payment of, any
Withholding Taxes that the Employer is required to withhold with respect to the Stock Units.
(c)
The obligation of the Company to deliver Company Stock following vesting of the Stock Units shall be subject to
all applicable laws, rules, and regulations and such approvals by governmental agencies as may be deemed appropriate by the
Committee, including such actions as Company counsel shall deem necessary or appropriate to comply with relevant securities
laws and regulations.
34.
No Stockholder Rights. Neither the Participant, nor any person entitled to receive payment in the event of the Participant’s
death, shall have any of the rights and privileges of a stockholder with respect to shares of Company Stock, including voting,
dividend rights or dividend equivalent rights, until certificates for shares have been issued upon payment of Stock Units. The
Participant acknowledges that no election under Section 83(b) of the Code is available with respect to Stock Units.
35.
Grant Subject to Plan Provisions. This grant is made pursuant to the Plan, the terms of which are incorporated herein by
reference, and in all respects shall be interpreted in accordance with the Plan. The grant and payment of the Stock Units are
subject to the provisions of the Plan and to interpretations, regulations and determinations concerning the Plan established from
time to time by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining
to (a) rights and obligations with respect to Withholding Taxes, (b) the registration, qualification or listing of the shares of
Company Stock, (c) changes in capitalization of the Company and (d) other requirements of applicable law. The Committee shall
have the authority to interpret and construe the Stock Units pursuant to the terms of the Plan, and its decisions shall be conclusive
as to any questions arising hereunder.
36.
No Employment or Other Rights. The grant of the Stock Units shall not confer upon the Participant any right to be
retained by or in the employ or service of any Employer and shall not interfere in any way with the right of any Employer to
terminate the Participant’s employment or service at any time. The right of any Employer to terminate at will the Participant’s
employment or service at any time for any reason is specifically reserved.
37.
Assignment and Transfers. Except as the Committee may otherwise permit pursuant to the Plan, the rights and interests of
the Participant under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the
death of the Participant, by will or by the laws of descent and distribution. In the event of any attempt by the Participant to
alienate, assign, pledge, hypothecate, or otherwise dispose of the Stock Units or any right hereunder, except as provided for in
this Agreement, or in the event of the levy or any attachment, execution or similar process upon the rights or interests hereby
conferred, the Company may terminate the Stock Units by notice to the Participant, and the Stock Units and all rights hereunder
shall thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or
assigns of the Company and to the
-39-
Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the Company without the Participant’s
consent.
38.
Applicable Law; Jurisdiction. The validity, construction, interpretation and effect of this Agreement shall be governed by
and construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions
thereof. Any action arising out of, or relating to, any of the provisions of this Agreement shall be brought only in the United
States District Court for the District of Massachusetts, or if such court does not have jurisdiction or will not accept jurisdiction, in
any court of general jurisdiction in Boston, Massachusetts, and the jurisdiction of such court in any such proceeding shall be
exclusive. Notwithstanding the foregoing sentence, on and after the date a Participant receives shares of Company Stock
hereunder, the Participant will be subject to the jurisdiction provision set forth in the Company’s bylaws.
39.
Notice. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the
[INSERT TITLE] at the corporate headquarters of the Company, and any notice to the Participant shall be addressed to such
Participant at the current address shown on the payroll of the Employer, or to such other address as the Participant may designate
to the Employer in writing. Any notice shall be delivered by hand, or enclosed in a properly sealed envelope addressed as stated
above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service or by
the postal authority of the country in which the Participant resides or to an internationally recognized expedited mail courier.
40.
Company Policies. The Participant agrees that payment to the Participant shall be made in such manner and on such terms
and conditions as may be required by the Committee and the Employer shall be entitled to set off against the amount of any such
payment any amounts otherwise owed to the Participant by the Employer, to the extent permitted by applicable law. In addition,
the Participant agrees that the Stock Units shall be subject to any applicable clawback or recoupment policies, share trading
policies and other policies that may be implemented by the Board or imposed under applicable rule or regulation from time to
time.
41.
Application of Section 409A of the Code. This Agreement is intended to be exempt from section 409A of the Code under
the “short-term deferral” exception and to the extent this Agreement is subject to section 409A of the Code, it will in all respects
be administered in accordance with section 409A of the Code.
By electronic acceptance, the Participant hereby accepts the award of Stock Units described in this Agreement, and agrees
to be bound by the terms of the Plan and this Agreement. The Participant hereby agrees that all decisions and determinations of
the Committee with respect to the Stock Units shall be final and binding.
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REPLIMUNE GROUP, INC.
2018 OMNIBUS INCENTIVE COMPENSATION PLAN
RESTRICTED STOCK UNIT GRANT AGREEMENT
U.K. Form
Participant:
Date of Grant:
Restricted Units Granted:
%%FIRST_NAME%-% %%LAST_NAME%-%
%%OPTION_DATE,'Month DD, YYYY'%-%
%%TOTAL_SHARES_GRANTED,'999,999,999'%-%
RECITALS
The Replimune Group, Inc. 2018 Omnibus Incentive Compensation Plan and the Sub-Plan for U.K. Employees
thereunder (together, the “Plan”) provides for the grant of restricted stock units. The Committee has decided to make this grant of
restricted stock units as an inducement for the Participant to promote the best interests of the Replimune Group, Inc. (the
“Company”) and its stockholders. The Participant hereby acknowledges the receipt of a copy of the official prospectus for the
Plan, which is available by accessing the Company’s intranet at [INSERT LINK]. Paper copies of the Plan and the official Plan
prospectus are available by contacting the [INSERT TITLE] of the Company at [INSERT PHONE NUMBER], or emailing
[INSERT EMAIL ADDRESS]. This Agreement is made pursuant to the Plan and is subject in its entirety to all applicable
provisions of the Plan. Capitalized terms used herein and not otherwise defined will have the meanings set forth in the Plan.
42.
Grant of Stock Units. Subject to the terms and conditions set forth in this Restricted Stock Unit Grant Agreement (this
“Agreement”) and in the Plan, the Company hereby grants the Participant the number of restricted stock units set forth above,
subject to the restrictions set forth below and in the Plan (the “Stock Units”). Each Stock Unit represents the right of the
Participant to receive a share of common stock of the Company (“Company Stock”) on the applicable payment date set forth in
Section 5 below.
43.
Stock Unit Account. Stock Units represent hypothetical shares of Company Stock, and not actual shares of stock. The
Company shall establish and maintain a Stock Unit account, as a bookkeeping account on its records, for the Participant and shall
record in such account the number of Stock Units granted to the Participant. No shares of Company Stock shall be issued to the
Participant at the time the grant is made, and the Participant shall not be, and shall not have any of the rights or privileges of, a
stockholder of the Company with respect to any Stock Units recorded in the Stock Unit account. The Participant shall not have
any interest in any fund or specific assets of the Company by reason of this award or the Stock Unit account established for the
Participant.
44.
Vesting.
(a)
The Stock Units are anticipated to become vested over a period of four (4) years, with 25% of the Stock Units
vesting on the Designated Vesting Date (as defined in the following table), and 25% of the Stock Units subject to this Agreement
vesting on the yearly anniversaries of the Designated Vesting Date thereafter for the next three (3) consecutive years (each, a
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“Vesting Date”); provided that the Participant continues to be employed by, or provide service to, the Employer from the Date of
Grant until the applicable Vesting Date:
Date of Grant
Designated Vesting Date*
January 1 – March 31
April 1 – June 30
July 1 – September 30
October 1 – December 30
th
th
February 15 of the next calendar year
May 15 of the next calendar year
August 15 of the next calendar year
November 15 of the next calendar year
th
th
* If a Designated Vesting Date falls on a weekend, federal holiday or any other day the Nasdaq Global Market is closed for trading,
such Designated Vesting Date will become the next active trading day of the Company’s common stock.
(b)
The vesting of the Stock Units shall be cumulative, but shall not exceed 100% of the Stock Units. If the foregoing
schedule would produce fractional Stock Units, the number of Stock Units that vest shall be rounded down to the nearest whole
Stock Unit and the fractional Stock Units will be accumulated so that the resulting whole Stock Units will be included in the
number of Stock Units that become vested on the last Vesting Date.
(c)
If the Participant’s employment or service terminates on account of the Participant’s death or Disability before the
last Vesting Date, any unvested Stock Units shall become fully vested upon such termination of employment or service.
(d)
If the Company is not the surviving corporation (or survives only as a subsidiary of another corporation) as a
result of a Change of Control and the Stock Units are assumed by, or replaced with an award with comparable terms by, the
surviving corporation (or parent or subsidiary of the surviving corporation) and the Participant’s employment or service is
terminated by the Employer without Cause or by the Participant for Good Reason (if applicable) upon or within 12 months
following a Change of Control and before the Stock Units are fully vested in accordance with the vesting schedule set forth in
Section 3(a) above, any unvested Stock Units shall become fully vested upon such termination of employment or service. In the
event that the surviving corporation (or a parent or subsidiary of the surviving corporation) does not assume or replace the Stock
Units with an award with comparable terms, and the Participant is employed by, or providing services to, the Employer on the
date of the Change of Control, any unvested Stock Units shall become fully vested upon the date of the Change of Control.
(e)
For purposes of this Agreement, the Participant’s employment or service will be deemed to terminate on the date
that the Participant ceases to be actively employed by, or providing services to, the Employer and shall not be extended by any
notice period mandated or implied under local law (i) during or for which the Participant receives pay in lieu of notice or
severance pay or is on garden or similar leave or (ii) during which the Participant remains employed or providing services, but is
not actively working. The Company shall have the sole discretion to determine when the Participant is no longer in active
employment or service for purposes of this Agreement, without reference to any other agreement, written or oral, including the
Participant’s contract of employment or service.
45.
Termination of Stock Units. If the Participant ceases to be employed by, or provide service to, the Employer for any
reason before all of the Stock Units vest, any unvested Stock Units shall automatically terminate and shall be forfeited as of the
date of the Participant’s termination of employment or service. No payment shall be made with respect to any unvested Stock
Units that terminate as described in this Section 4.
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46.
Payment of Stock Units.
(a)
If and when the Stock Units vest, the Company shall issue to the Participant one share of Company Stock for each
vested Stock Unit, subject to applicable Withholding Taxes (as defined below). Payment shall be made within 30 days after the
applicable Vesting Date.
(b)
All obligations of the Company under this Agreement shall be subject to the rights of the Employer as set forth in
the Plan to withhold amounts required by law to be withheld, collected or accounted for with respect to any income tax (including
U.S. federal, state, and local tax and/or foreign income tax), employment tax (including FICA), payroll tax, social security tax,
social insurance, national insurance and other contributions, payment on account obligations, national and local tax or other
amounts required to be withheld, collected or accounted for by the Employer in connection with any taxable event with respect to
the payment of the Stock Units (“Withholding Taxes”). The Participant irrevocably (i) has elected, as of the Date of Grant, to sell
shares of Company Stock in an amount having an aggregate Fair Market Value equal to the Withholding Taxes, and to allow the
Company’s designated broker (the “Broker”) to remit the cash proceeds of such sale to the Employer (a “Sell to Cover”) and (ii)
directs the Employer to make a cash payment to satisfy the Withholding Taxes from the cash proceeds of such sale directly to the
appropriate taxing authorities. To the extent the Sell to Cover does not cover all Withholding Taxes due, the Participant shall be
required to pay to the Employer, or make other arrangements satisfactory to the Employer to provide for the payment of, any
Withholding Taxes that the Employer is required to withhold with respect to the Stock Units.
(c)
Regardless of any action the Employer takes with respect to any such Withholding Taxes, the Participant
acknowledges that the ultimate liability for all such Withholding Taxes legally due by the Participant is and remains the
Participant’s responsibility and may exceed the amount withheld by the Employer. The Participant further acknowledges that the
Employer (i) makes no representations or undertakings regarding the treatment of any Withholding Taxes in connection with any
aspect of the Stock Units, including the grant, vesting or payment of the Stock Units and the subsequent sale of any shares of
Company Stock acquired upon payment of the Stock Units and (ii) does not commit to, and is under no obligation to, structure
the terms of the grant or any aspect of the Stock Units to reduce or eliminate the Participant’s liability for Withholding Taxes.
Further, if the Participant has become subject to tax in more than one jurisdiction between the date of grant and the date of any
relevant taxable event, then the Participant acknowledges that the Employer may be required to collect, withhold or account for
Withholding Taxes in more than one jurisdiction.
(d)
As a condition to participation in the Plan and the grant of the Stock Units, the Participant hereby agrees to accept
all liability for and pay all secondary Class 1 National Insurance Contributions which would otherwise be payable by the
Company (or any successor or any subsidiary employing or retaining or previously employing or retaining the Participant) with
respect to the payment of the Stock Units or any other event giving rise to taxation in respect of the Stock Units (the “Employer
NICs”). The Participant agrees that to the extent requested by the Company, the Participant will execute, within the time period
specified by the Company, a joint election, and any other consent or elections required to effect the transfer of the Employer
NICs. The Participant further agrees to execute such other joint elections as may be required between the Participant and any
successor to the Company and/or the Participant’s employer. The Participant further agrees that the Company and/or the
Participant’s employer may collect the Employer NICs by any of the means set forth in this Agreement.
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(e)
The Participant indemnifies the Company and the Employer for any Withholding Taxes that may be payable with
respect to the full number of shares of Company Stock vested and issued (including those shares of Company Stock that are
deemed issued).
(f)
The obligation of the Company to deliver Company Stock following vesting of the Stock Units shall be subject to
all applicable laws, rules, and regulations and such approvals by governmental agencies as may be deemed appropriate by the
Committee, including such actions as Company counsel shall deem necessary or appropriate to comply with relevant securities
laws and regulations.
47.
No Stockholder Rights. Neither the Participant, nor any person entitled to receive payment in the event of the Participant’s
death, shall have any of the rights and privileges of a stockholder with respect to shares of Company Stock, including voting,
dividend rights or dividend equivalent rights, until certificates for shares have been issued upon payment of Stock Units. The
Participant acknowledges that no election under Section 83(b) of the Code is available with respect to Stock Units.
Grant Subject to Plan Provisions. This grant is made pursuant to the Plan, the terms of which are incorporated herein by
48.
reference, and in all respects shall be interpreted in accordance with the Plan. The grant and payment of the Stock Units are
subject to the provisions of the Plan and to interpretations, regulations and determinations concerning the Plan established from
time to time by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining
to (a) rights and obligations with respect to Withholding Taxes, (b) the registration, qualification or listing of the shares of
Company Stock, (c) changes in capitalization of the Company and (d) other requirements of applicable law. The Committee shall
have the authority to interpret and construe the Stock Units pursuant to the terms of the Plan, and its decisions shall be conclusive
as to any questions arising hereunder.
No Employment or Other Rights. The grant of the Stock Units shall not confer upon the Participant any right to be
49.
retained by or in the employ or service of any Employer and shall not interfere in any way with the right of any Employer to
terminate the Participant’s employment or service at any time. Subject to the terms of any employment agreement between the
Participant and the Employer and applicable law, the right of any Employer to terminate at will the Participant’s employment or
service at any time for any reason is specifically reserved.
50.
Assignment and Transfers. Except as the Committee may otherwise permit pursuant to the Plan, the rights and interests of
the Participant under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the
death of the Participant, by will or by the laws of descent and distribution. In the event of any attempt by the Participant to
alienate, assign, pledge, hypothecate, or otherwise dispose of the Stock Units or any right hereunder, except as provided for in
this Agreement, or in the event of the levy or any attachment, execution or similar process upon the rights or interests hereby
conferred, the Company may terminate the Stock Units by notice to the Participant, and the Stock Units and all rights hereunder
shall thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or
assigns of the Company and to the Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the
Company without the Participant’s consent.
51.
Applicable Law; Jurisdiction. The validity, construction, interpretation and effect of this Agreement shall be governed by
and construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions
thereof. Any action arising out
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of, or relating to, any of the provisions of this Agreement shall be brought only in the United States District Court for the District
of Massachusetts, or if such court does not have jurisdiction or will not accept jurisdiction, in any court of general jurisdiction in
Boston, Massachusetts, and the jurisdiction of such court in any such proceeding shall be exclusive. Notwithstanding the
foregoing sentence, on and after the date a Participant receives shares of Company Stock hereunder, the Participant will be
subject to the jurisdiction provision set forth in the Company’s bylaws.
52.
Notice. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the
[INSERT TITLE] at the corporate headquarters of the Company, and any notice to the Participant shall be addressed to such
Participant at the current address shown on the payroll of the Employer, or to such other address as the Participant may designate
to the Employer in writing. Any notice shall be delivered by hand, or enclosed in a properly sealed envelope addressed as stated
above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service or by
the postal authority of the country in which the Participant resides or to an internationally recognized expedited mail courier.
53.
Company Policies. The Participant agrees that payment to the Participant shall be made in such manner and on such terms
and conditions as may be required by the Committee and the Employer shall be entitled to set off against the amount of any such
payment any amounts otherwise owed to the Participant by the Employer, to the extent permitted by applicable law. In addition,
the Participant agrees that the Stock Units shall be subject to any applicable clawback or recoupment policies, share trading
policies and other policies that may be implemented by the Board or imposed under applicable rule or regulation from time to
time.
54.
Application of Section 409A of the Code. This Agreement is intended to be exempt from section 409A of the Code under
the “short-term deferral” exception and to the extent this Agreement is subject to section 409A of the Code, it will in all respects
be administered in accordance with section 409A of the Code.
55.
Agreement, the Participant acknowledges the following:
No Entitlement or Claims for Compensation. In connection with the acceptance of the grant of the Stock Units under this
(a)
the Plan is established voluntarily by the Company, the grant of the Stock Units under the Plan is made at the
discretion of the Committee and the Plan may be modified, amended, suspended or terminated by the Company at any time;
(b)
the grant of the Stock Units under the Plan is voluntary and occasional and does not create any contractual or other
right to receive future grants of equity awards, or benefits in lieu of them, even if equity awards have been granted repeatedly in
the past;
(c)
(d)
all decisions with respect to future grants of awards, if any, will be at the sole discretion of the Committee;
the Participant is voluntarily participating in the Plan;
(e)
the Stock Units and any shares of Company Stock acquired under the Plan are extraordinary items that do not
constitute compensation of any kind for services of any kind rendered to the Employer or any affiliate and which are outside the
scope of the Participant’s employment contract, if any;
-45-
(f)
the Stock Units and any shares of Company Stock acquired under the Plan are not to be considered part of the
Participant’s normal or expected compensation or salary for any purpose, including, but not limited to, calculating any severance,
resignation, termination, payment in lieu of notice, redundancy, end of service payments, bonuses, long-service awards, pension
or retirement or welfare benefits or similar payments;
(g)
the Stock Units and the shares of Company Stock underlying the Stock Units are not intended to replace any
pension rights or compensation;
(h)
the grant of the Stock Units and the Participant’s participation in the Plan will not be interpreted to form an
employment contract or relationship with the Employer;
(i)
the future value of the shares of Company Stock underlying the Stock Units is unknown and cannot be predicted
with certainty. If the Stock Units are paid pursuant to this Agreement, the value of the acquired shares of Company Stock may
increase or decrease;
(j)
the Participant understands that the Company is not responsible for any foreign exchange fluctuation between the
United States Dollar and the Participant’s local currency that may affect the value of the Stock Units or the underlying shares of
Company Stock;
(k)
the Participant shall have no rights, claim or entitlement to compensation or damages as a result of the
Participant’s cessation of employment or service for any reason whatsoever, whether or not in breach of contract or local labor
law, insofar as these rights, claim or entitlement arise or may arise from the Participant’s ceasing to have rights under or be
entitled to the Stock Units as a result of such cessation or loss or diminution in value of the Stock Units or any of the shares
received upon payment of the Stock Units as a result of such cessation, and the Participant irrevocably releases his or her
Employer from any such rights, entitlement or claim that may arise. If, notwithstanding the foregoing, any such right or claim is
found by a court of competent jurisdiction to have arisen, then, by signing this Agreement, the Participant shall be deemed to
have irrevocably waived his or her entitlement to pursue such rights or claim; and
(l)
the Participant has no right to compensation or damages on account of any loss in respect of the Stock Units where
the loss arises or is claimed to arise in whole or part from: (i) the termination of Participant’s office or employment; or (ii) notice
to terminate Participant’s office or employment. This exclusion of liability shall apply however termination of office or
employment, or the giving of notice, is caused, and however compensation or damages are claimed. For the purpose of the Plan,
the implied duty of trust and confidence is expressly excluded.
56.
Data Privacy.
(a)
The Participant hereby acknowledges and understands the collection, use, disclosure and transfer, in
electronic or other form, of his or her personal data as described in this Agreement by and among, as applicable, his or
her employer, the Company and its affiliates for the exclusive purpose of implementing, administering and managing his
or her participation in the Plan.
(b)
The Participant understands that the Company and its affiliates (including his or her employer), as
applicable, hold certain personal information about him or her regarding the Participant’s employment, the nature and
amount of the Participant’s
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compensation and the fact and conditions of the Participant’s participation in the Plan, including, but not limited to, his
or her name, home address, telephone number and e-mail address, date of birth, social insurance number or other
identification number, salary, nationality, job title, any equity or directorships held in the Company and its affiliates,
details of all stock units or any other entitlement to equity awarded, canceled, exercised, vested, unvested or outstanding
in his or her favor, for the purpose of implementing, administering and managing the Plan (the “Data”).
(c)
The Participant understands that the Data may be transferred to the Company, its affiliates and any third
parties assisting in the implementation, administration, and management of the Plan, that these recipients may be located
in his or her country, or elsewhere, and that the recipient’s country may have a lower standard of data privacy laws and
protections than the Participant’s country of residence. The Participant understands that he or she may request a list with
the names and addresses of any potential recipients of the Data by contacting the Participant’s local human resources
representative. The Participant understands that the recipients receive, possess, use, retain and transfer the Data, in
electronic or other form, for the purposes of implementing, administering and managing his or her participation in the
Plan, including any requisite transfer of such Data as may be required to a broker or other third party. The Participant
understands that the Data will be held only as long as is necessary to implement, administer and manage his or her
participation in the Plan. The Participant understands that he or she may, at any time, view the Data, request additional
information about the storage and processing of the Data, require any necessary amendments to the Data, object to or
request restriction of the processing of his or her Data or refuse or withdraw any consents provided to the Company
herein, in any case without cost, by contacting in writing his or her local human resources representative. The Participant
understands, however, that objecting to or requesting restriction of the processing of his or her Data may affect his or her
ability to participate in the Plan. For more information on the processing of his or her Data and other personal data, the
Participant is referred to the Privacy Notice provided to him or her by his or her employer.
By electronic acceptance, the Participant hereby accepts the award of Stock Units described in this Agreement, and agrees
to be bound by the terms of the Plan and this Agreement. The Participant hereby agrees that all decisions and determinations of
the Committee with respect to the Stock Units shall be final and binding.
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REPLIMUNE GROUP, INC.
2018 OMNIBUS INCENTIVE COMPENSATION PLAN (THE “PLAN”)
SUB-PLAN FOR U.K. EMPLOYEES (THE “SUB-PLAN”)
This Sub-Plan is a sub-plan of the Plan, and has been created and approved in accordance with the provisions of Section 18(g) of
the Plan. Terms defined in the Plan shall have the same meanings in this Sub-Plan unless otherwise defined in this Sub-Plan.
SECTION 1 Definitions. As used in this Sub-Plan and/or any Grant Instrument under this Sub-Plan, the
following terms shall have the meanings set forth below.
(a) “Employer’s NICs” means the amount of secondary Class 1 national insurance contributions payable in respect of any
Grant;
(b) “FPO” means the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 of the United
Kingdom;
(c) “FSMA” means the Financial Services and Markets Act 2000 of the United Kingdom (as amended).
(d) “Group” has the meaning given to that term under FSMA;
(e) “U.K. Employee” means an employee of the Company or of any subsidiary (provided that such subsidiary is a
member of the Company’s Group) who is resident in the United Kingdom.
SECTION 2 Purpose.
(a) The purpose of this Sub-Plan is primarily to establish a sub-plan under the auspices of the Plan which will apply to
Grants to be made to U.K. Employees. As a result:
(i)
All Grants to U.K. Employees shall be made under this Sub-Plan;
(ii) No Grants shall be made under this Sub-Plan to any person other than a U.K. Employee, and this Sub-Plan
shall not apply to any Grants made under the Plan to any such other person; and
(iii) Section 5 of the Plan shall be deemed amended accordingly insofar as it applies to this Sub-Plan.
(b) The provisions of the Sub-Plan vary from those applicable under the Plan so as to
(i)
enable the Sub-Plan (and any Grants made or proposed to be made under the Sub-Plan, and
communications concerning those Grants) to take advantage of certain exemptions available in the United
Kingdom from certain prohibitions and restrictions which might otherwise apply to such grants and
communications in the United Kingdom under the regulatory regime established under FSMA; and
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(ii)
take account of United Kingdom tax treatment of the Grants.
(b) No Grant shall be granted under this Sub-Plan unless such Grant relates to a type of investment set out or referred to
in Article 60(1) of the FPO. Section 3 of the Plan shall be deemed amended accordingly insofar as it applies to this
Sub-Plan.
SECTION 3 Interaction With The Plan.
(a) This Sub-Plan should be read in conjunction with the Plan and is subject to the terms and conditions of the Plan
except to the extent that the terms and conditions of the Plan differ from or conflict with the terms set out in this Sub-
Plan, in which event, the terms set out in this Sub-Plan shall prevail.
(b) Subject to the other provisions of this Sub-Plan, the provisions of the Plan will apply to this Sub-Plan as if references
therein to the Plan were references to this Sub-Plan.
SECTION 4 Taxes
(a) Section 14 of the Plan shall not apply to this Sub-Plan.
(b) All Grants under this Sub-Plan shall be subject to applicable United Kingdom taxes and national insurance
contributions. As a condition to the issuance, vesting, exercise or settlement of any Grant, the Participant shall be
required to pay to the Company or any relevant Employer, or make other arrangements satisfactory to the Company or
the relevant Employer to provide for the payment of, any national, federal, state or local or other taxes, social security
and employee’s United Kingdom national insurance contributions (“Employment Taxes”) that the Company or the
relevant Employer is required to withhold, or in respect of which the Company or the relevant Employer is required to
account to any tax authority including HM Revenue & Customs (“HMRC”), with respect to any income or gains
arising or deemed to arise to the Participant in connection with any Grant (including for the avoidance of doubt in
connection with the holding or disposal of any Company Stock received pursuant to any Grant). The Committee, in
its discretion, may permit the satisfaction of such Employment Taxes by having Company Stock withheld from
delivery with respect to any Grant up to a value that does not exceed the relevant required amount of Employment
Taxes. The Company or the relevant Employer is authorised to withhold from any Grant made, any payment relating
to a Grant under this Sub-Plan, including from a distribution of Company Stock, or any payroll or other payment to a
Participant, amount of required Employment Taxes due or potentially payable in connection with any transaction
involving a Grant under this Sub-Plan to the maximum extent permitted by law and regulation. To the extent any
amount is withheld by the Company in accordance with such section, such amount shall either be remitted to the
actual employer of the Participant on behalf of the Participant, or deemed to have been so remitted where the amount
is paid to a relevant tax authority on behalf of such actual employer.
(c) The Participant may be required as a condition precedent to acquiring or exercising any Option or Company Stock to
enter into a joint election under Section 431(1) of the United Kingdom Income Tax (Earnings and Pensions) Act 2003
for the full disapplication of Chapter 2 of Part 7 of that Act.
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(d) In accepting any relevant Grant the Participant shall, if so required by the Company and to the extent lawful, agree
with and undertake to the Company and any Employer which is a “secondary contributor” in respect of Class I
national insurance contributions payable in respect of the Grant (or any Company Stock award in connection
therewith) that the Company or relevant Employer may recover from the Participant the whole or part of any
Employer’s NICs; and shall either (i) (if so required the Company) join with the Company or relevant Employer in
making an election (in such terms and such form and subject to such approval by HMRC as provided in paragraph 3B
of Schedule 1 to the Social Security Contributions and Benefits Act 1992) for the whole or part of any liability of the
Company or relevant Employer to Employer’s NICs to be transferred to the Participant, or (ii) enter into a joint
agreement with the Company or relevant Employer at the time of the Grant to arrange for the reimbursement of the
Company or relevant Employer for such Employer’s NICs.
SECTION 5 General.
(a) The Sub-Plan, and any Grants granted hereunder, shall be governed, construed and administered in accordance with
the laws of the State of Delaware, without reference to its conflict of laws provisions.
(b) The terms and conditions provided in this Sub-Plan are severable and if (despite the provisions of Section 4(a) of this
Sub-Plan) any one or more provisions (or the effect of any such provision) are determined to be subject to any laws of
the United Kingdom (or any constituent part thereof) and to be illegal or otherwise unenforceable under, such laws, in
whole or in part, the remaining provisions shall nevertheless be binding and enforceable.
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Replimune Inc
500 Unicorn Park Dr.
Woburn, MA 01801
PERSONAL & CONFIDENTIAL August 25, 2021
(revised September 30, 2021)
Andrea Pirzkall
17927 Mollypop Lane
Cornelius NC 28031
RE: Separation Agreement and Release
Dear Andrea:
This letter of agreement and general release (“Agreement”) confirms our mutual agreement regarding the terms and conditions of
your separation from employment with Replimune, Inc. (the “Company”) without Cause. You and the Company (the “Parties”)
agree as follows:
1.
Last Day of Employment. Your last day of employment with the Company was September 24, 2021 (“Last Day of
Employment”). You will receive your current base salary and benefits through the Last Day of Employment. Additionally,
you will receive your salary and other amounts earned, accrued and owing but not yet paid through your Last Day of
Employment, including any benefits accrued and due under any applicable benefit plans and programs of the Company
(“Accrued Obligations”), pursuant to your Employment Agreement with the Company dated May 22, 2020 (the
“Employment Agreement”), regardless of whether you execute or revoke this Agreement. You will also receive payment
for approved expenses provided you submitted for such expenses by September 24, 2021. Your employment and your
participation in and eligibility for the Company’s employee benefit plans and programs terminated on your Last Day of
Employment. Effective as of the Last Day of Employment, you were automatically deemed to resign from all Company-
related positions, including as an officer and director of the Company and its parents, subsidiaries and affiliates, as
applicable, and shall execute all documentation necessary to effectuate such resignation(s).
2.
Consideration in Exchange for Release. In consideration of your execution of this Agreement (provided you do not revoke
it), and provided that you otherwise comply with your obligations under this Agreement and your continuing obligations
under Sections 15 of your Employment Agreement, attached hereto as Exhibit A, the Company will:
(a)
Pay you an amount equal to $325,125, which is nine months of your current base salary as of immediately prior to
your Last Day of Employment. Payment shall be made over the nine-month period following the Last Day of
Employment in installments in accordance with the Company’s normal payroll practices, commencing within 60
days following the Last Day of Employment. Any installments not paid between the Last Day of Employment and
the date of the first payment will be paid with the first payment.
DB1/ 124613904.6
(b)
During the period beginning on the Last Day of Employment and ending on the earliest of (i) the date on which
you first become covered by any other “group health plan” as described in Section 4980B(g)(2) of the Internal
Revenue Code of 1986, as amended (the “Code”), (ii) June 24, 2022, or (iii) the date you cease to be eligible for
continued coverage under the Consolidated Omnibus Budget Reconciliation Act (“COBRA”) for any reason,
including your ceasing to pay the applicable COBRA premiums (such period, the “Coverage Period”), if you
timely elect to receive continued health coverage under the Company’s health plan pursuant to COBRA at a level
of coverage at your level of coverage in effect on the Last Day of Employment, the Company will reimburse you
on a monthly basis for the COBRA premiums you pay for yourself and your eligible dependents (“COBRA
Reimbursements”). You agree to promptly notify the Company of your coverage under an alternative health plan
upon becoming covered by such alternative plan, or your other ineligibility for continued coverage under COBRA
upon becoming ineligible. The COBRA health care continuation coverage period under Section 4980B of the
Code shall run concurrently with the Coverage Period.
3.
Release.
(a)
In consideration of the compensation and benefits set forth in Section 2 hereof, to the fullest extent permitted by
law you waive, release, and forever discharge the Company and each of its past and current parents, subsidiaries,
affiliates, and each of its and their respective past and current directors, officers, members, trustees, employees,
representatives, agents, attorneys, employee benefit plans and such plans’ administrators, fiduciaries, trustees,
recordkeepers and service providers, and each of its and their respective successors and assigns, each and all of
them in their personal and representative capacities (collectively the “Company Releasees”) from any and all
claims legally capable of being waived, agreements, causes of action, attorneys’ fees, costs, damages, or any right
to any monetary recovery or any other personal relief, whether known or unknown, in law or in equity, by
contract, tort, law of trust or pursuant to federal, state or local statute, regulation, ordinance or common law, which
you now have, ever have had, or may hereafter have, whether known or unknown to you, arising at any time up to
the date of execution of this Agreement, arising out of or relating in any way to your employment with the
Company or the termination thereof.
Without limiting the generality of the foregoing, this waiver, release, and discharge includes any claim or right, to
the extent legally capable of being waived, based upon or arising under any federal, state or local fair employment
practices or equal opportunity laws, including, but not limited to, the Age Discrimination in Employment Act
(“ADEA”) (29 U.S.C. Section 621, et seq.), 42 U.S.C. Section 1981, Title VII of the Civil Rights Act of 1964, the
Equal Pay Act, the Employee Retirement Income Security Act (“ERISA”) (including, but not limited to, claims
for breach of fiduciary duty under ERISA), the Americans With Disabilities Act, the Family and Medical Leave
Act of 1993, the
DB1/ 124613904.6
2
Massachusetts Fair Employment Practices Act, the Massachusetts Civil Rights Act, the Massachusetts Equal
Rights Act, the Massachusetts Parental Leave Act, the Massachusetts Labor and Industries Act, the Massachusetts
right of privacy law, the Massachusetts Wage Act (as further explained below), the Massachusetts Earned Sick
Time law, the Massachusetts Equal Pay Act, the Massachusetts Minimum Fair Wage Law, the North Carolina
Equal Employment Practices Act, including age and sexual harassment claims, the North Carolina Persons with
Disabilities Protection Act, the North Carolina Civil Rights Law, the North Carolina Lawful Products Use Law,
the North Carolina Hemoglobin/Genetic Information Anti-Discrimination Law, the North Carolina Retaliatory
Employment Discrimination Act, the North Carolina Leave for Parent Involvement in Schools Law, as well as any
claim or right under your Employment Agreement unless as provided herein.
This waiver, release, and discharge includes any claims arising under any employment agreement you have had
with the Company and any amendments thereto.
Massachusetts Wage Act Waiver. By signing this Agreement, you acknowledge that this waiver includes any
claims against the Company Releasees under Mass. Gen. Laws ch. 149, § 148 et seq.,—the Massachusetts Wage
Act. These claims include, but are not limited to, claims for failure to pay earned wages, failure to pay overtime,
failure to pay earned commissions, failure to timely pay wages, failure to pay accrued vacation or holiday pay,
failure to furnish appropriate pay stubs, improper wage deductions, and failure to provide proper check-cashing
facilities.
Notwithstanding the generality of the foregoing, nothing herein constitutes a release or waiver by you of, or
prevents you from making or asserting: (i) any claim or right you may have under COBRA; (ii) any claim or right
you may have for unemployment insurance or workers’ compensation benefits (other than for retaliation under
workers’ compensation laws); (iii) any claim to vested benefits under the written terms of a qualified employee
pension benefit plan; (iv) any claim for indemnity pursuant to Section 25 of your Employment Agreement, which
is incorporated herein by reference; (v) any medical claim incurred during your employment that is payable under
applicable medical plans or an employer-insured liability plan; (vi) any claim or right that may arise after the
execution of this Agreement; (vii) any claim or right you may have under this Agreement; or (viii) any claim that
is not otherwise able to be waived under applicable law.
In addition, nothing herein shall prevent you from filing a charge or complaint with the Equal Employment
Opportunity Commission (“EEOC”) or similar federal or state fair employment practices agency or interfere with
your ability to participate in any investigation or proceeding conducted by such agency; provided, however, that
pursuant to Section 3(a), you are waiving any right to recover monetary damages or any other form of personal
relief from the Company Releasees to the extent any such charge, complaint, investigation or proceeding asserts a
claim subject to the release in Section 3(a) above. To the extent you
(b)
(c)
DB1/ 124613904.6
3
4.
5.
6.
7.
receive any such personal or monetary relief in connection with any such charge, complaint, investigation or
proceeding, the Company will be entitled to an offset for the payment made pursuant to Section 2 of this
Agreement.
No Additional Entitlements. You agree and represent that other than as provided for in this Agreement, you have received
all entitlements due from the Company relating to your employment with the Company or under your Employment
Agreement, including but not limited to, all wages earned, including without limitation all commissions and bonuses, sick
pay, vacation pay, overtime pay, and any paid and unpaid personal leave for which you were eligible and entitled, and that
no other entitlements are due to you other than as set forth in this Agreement. Additionally, the Company agrees not to
contest any claim for unemployment benefits you may file; provided, however, that the Company may respond to any
inquiry from the unemployment compensation board to the extent you make any allegations of wrongdoing by the
Company. Except as expressly provided for herein, your Employment Agreement with the Company is hereby terminated.
Protection of Confidential Information. Except as expressly permitted in Section 7 of this Agreement or if otherwise
required by law, you agree that you will not at any time, directly or indirectly, use or disclose any trade secret, confidential
or proprietary information you have learned by reason of your employment with the Company and will continue to abide
by your confidentiality obligations pursuant to Section 15 of your Employment Agreement.
Non-Disparagement. Except as expressly permitted in Section 7 of this Agreement, the Parties agree that they shall not at
any time make any written or oral comments or statements of a defamatory or disparaging nature regarding each other,
and they shall not take any action that would cause or contribute to their being held in disrepute. For the purposes of this
Paragraph, the obligations on behalf of the Company extend to Philip Astley-Sparke, Dr. Robert Coffin, and Tanya Lewis.
Your obligations extend to the Company and the Company Releasees, including their individual capacities, as appropriate.
Reports to Government Entities. Nothing in this Agreement restricts or prohibits you from initiating communications
directly with, responding to any inquiries from, providing testimony before, providing confidential information to,
reporting possible violations of law or regulation to, or from filing a claim or assisting with an investigation directly with
a self-regulatory authority or a government agency, or from making other disclosures that are protected under the
whistleblower provisions of federal, state, or local law or regulation. You do not need the prior authorization of the
Company to engage in conduct protected by this Section, and you do not need to notify the Company that you have
engaged in such conduct. Please take notice that federal law provides criminal and civil immunity to federal and state
claims for trade secret misappropriation to individuals who disclose a trade secret to their attorney, a court, or a
government official in certain, confidential circumstances that are set forth at 18 U.S.C. §§ 1833(b)(1) and 1833(b)(2),
related to the reporting or investigation of a suspected violation of the law, or in connection with a lawsuit for retaliation
for reporting a suspected violation of the law.
DB1/ 124613904.6
4
8.
9.
10.
11.
Non-Admission. It is understood and agreed that neither the execution of this Agreement nor the terms of this Agreement
constitute an admission of liability to you by the Company or the Company Releasees, and such liability is expressly
denied. It is further understood and agreed that no person shall use the Agreement, or the consideration paid pursuant
thereto, as evidence of an admission of liability, in as much as such liability is expressly denied.
Cooperation. You agree that upon the Company’s reasonable notice to you, and a reasonable request, you shall cooperate
with the Company and its counsel (including, if necessary, preparation for and appearance at depositions, hearings, trials
or other proceedings) with regard to matters that relate to or arise out of matters you have knowledge about or have been
involved with during your employment with the Company. In the event that such cooperation is required, you will be
reimbursed for any reasonable travel expenses incurred in connection therewith.
Confidentiality of the Agreement. Except as permitted in Section 7 of this Agreement, as may be required pursuant to the
Securities Exchange Act of 1934, as amended, and the rules and regulations thereof, to enforce the terms of this
Agreement or if otherwise required by law, the parties, including the Company, shall not disclose the terms of this
Agreement, or the circumstances giving rise to this Agreement, to any person other than their respective attorneys,
immediate family members, accountants, financial advisors or corporate employees who have a business need to know
such terms in order to approve or implement such terms.
Continuing Obligations. Subject to Section 7 of this Agreement, you reaffirm and agree that you remain bound by
Sections 15-17 of your Employment Agreement, which is incorporated herein by reference. The Employment Agreement
remains binding and in full force and effect in accordance with its terms except modified as follows:
(a)
(b)
(c)
(d)
You may engage in a Competitive Business in the Restricted Area during the Restriction Period, i.e. section 15(a)
of the Employment Agreement is waived.
You may hire or attempt to hire any former employee, consultant, or independent contractor of the Company or its
Affiliates. For the purposes of this Paragraph, “former employee, consultant, or independent contractor” means
any person who is no longer an employee, consultant, or independent contractor of the Company or its Affiliates.
For the purposes of Section 15(c) of your Employment Agreement, “business partner” and “prospective business
partner” means any actual or prospective customer, client, or supplier of Replimune that you were aware of during
your employment.
Notwithstanding the foregoing, you agree and acknowledge that you must still comply with the remaining
provisions of the Employment Agreement and this Agreement, including but not limited to Sections 5 (Protection
of Confidential Information) and 6 (Non-Disparagement) above.
12.
Return of Company Property. By no later than September 30, 2021, you must (i) send to Camilo Garcia by overnight
FedEx (for delivery by October 1, 2021) all originals and
DB1/ 124613904.6
5
copies of all documents and property of the Company or an affiliate that is in your possession or under your control or to
which you may have access, (ii) deliver to Camilo Garcia all Company property, including keys, key cards, access cards,
identification cards, security devices, employer credit cards, network access devices, computers, cell phones,
smartphones, PDAs, pagers, fax machines, equipment, manuals, reports, files, books, compilations, work product, e-mail
messages, recordings, disks, thumb drives or other removable information storage devices, hard drives, and data, and (iii)
to the extent that you made use of your personal electronics (e.g., laptop, iPad, telephone, thumb drives, etc.) during your
employment with the Company, permit the Company to delete all Company property and information from such personal
devices.
13.
Acknowledgments. You hereby acknowledge that:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
The Company advises you to consult with an attorney before signing this Agreement;
You have obtained independent legal advice from an attorney of your own choice with respect to this Agreement,
or you have knowingly and voluntarily chosen not to do so;
You freely, voluntarily and knowingly entered into this Agreement after due consideration;
You have had a minimum of twenty-one (21) days to review and consider this Agreement;
You and the Company agree that changes to the Company’s offer contained in this Agreement, whether material or
immaterial, will not restart the twenty-one (21) day consideration period provided for in Section 13(d) above;
You have a right to revoke this Agreement by notifying the undersigned representative in writing, via hand
delivery, facsimile or electronic mail, within seven (7) business days of your execution of this Agreement;
In exchange for your waivers, releases and commitments set forth herein, including your waiver and release of all
claims arising under the ADEA, the payments, benefits and other considerations that you are receiving pursuant to
this Agreement exceed any payment, benefit or other thing of value to which you would otherwise be entitled, and
are just and sufficient consideration for the waivers, releases and commitments set forth herein; and
No promise or inducement has been offered to you, except as expressly set forth herein, and you are not relying
upon any such promise or inducement in entering into this Agreement.
14. Medicare Disclaimer. You acknowledge that you are not a Medicare Beneficiary as of the time you enter into this
Agreement. To the extent that you are a Medicare Beneficiary, you agree to contact a Company Human Resources
Representative for further instruction.
DB1/ 124613904.6
6
15. Miscellaneous.
(a)
(b)
(c)
Entire Agreement. This Agreement, together with the expressly incorporated provisions of your Employment
Agreement, sets forth the entire agreement between you and the Company and replaces any other oral or written
agreement between you and the Company relating to the subject matter of this Agreement, including, without
limitation, any prior offer letters and/or employment agreements.
Governing Law. This Agreement shall be construed, performed, enforced and in all respects governed in
accordance with the laws of the Commonwealth of Massachusetts, without giving effect to the principles of
conflicts of law thereof. Additionally, all disputes arising from or related to this Agreement shall be brought in a
state or federal court situated in the Commonwealth of Massachusetts, Suffolk County, and the parties hereby
expressly consent to the jurisdiction of such courts for all purposes related to resolving such disputes.
Severability. Should any provision of this Agreement be held to be void or unenforceable, the remaining
provisions shall remain in full force and effect, to be read and construed as if the void or unenforceable provisions
were originally deleted.
(d) Withholding. All payments under this Agreement shall be made subject to applicable tax withholding, and the
Company shall withhold from any payments under this Agreement all federal, state, and local taxes as the
Company is required to withhold pursuant to any law or governmental rule or regulation. You shall bear all
expense of, and be solely responsible for, all federal, state, and local taxes due with respect to any payment
received under this Agreement.
(e)
Section 409A. This Agreement is intended to comply with Section 409A of the Code, and its corresponding
regulations, or an exemption thereto, and payments may only be made under this Agreement upon an event and in
a manner permitted by Section 409A of the Code, to the extent applicable. Severance benefits under this
Agreement are intended to be exempt from Section 409A of the Code under the “short-term deferral” exception, to
the maximum extent applicable, and then under the “separation pay” exception, to the maximum extent applicable.
All payments to be made upon a termination of employment under this Agreement may only be made upon a
“separation from service.” For purposes of Section 409A of the Code, each payment hereunder shall be treated as
a separate payment, and the right to a series of installment payments under this Agreement shall be treated as a
right to a series of separate payments. In no event may you, directly or indirectly, designate the calendar year of a
payment. Notwithstanding any provision of this Agreement to the contrary, in no event shall the timing of your
execution of this Agreement, directly or indirectly, result in your designating the calendar year of payment of any
amounts of deferred compensation subject to Section 409A of the Code. All reimbursements and in-kind benefits
provided
DB1/ 124613904.6
7
(f)
(g)
under this Agreement shall be made or provided in accordance with the requirements of Section 409A of the
Code.
Amendments. This Agreement may not be modified or amended, except upon the express written consent of both
you and the Company.
Breach. You acknowledge that if you breach your commitments to the Company agreed upon in Sections 5, 6, 8, 9,
10, 11 or 12 you will forfeit the severance benefits set forth in Section 2 and be subject to suit by the Company for
damages and equitable relief relating to such breach. You further acknowledge that any breach by you of Sections
5, 6, 8, 9, 10, 11 or 12 will cause irreparable damage to the Company and that in the event of such breach the
Company shall have, in addition to any and all remedies at law, the right to an injunction, specific performance or
other equitable relief to prevent the violation of your obligations hereunder. The Company acknowledges that any
breach by it of Sections 2 or 6 may cause irreparable damage to you and that in the event of such breach you shall
have, in addition to any and all remedies at law, the right to an injunction, specific performance or other equitable
relief to prevent the violation of your obligations hereunder.
(h) Waiver. A waiver by either party hereto of a breach of any term or provision of the Agreement shall not be
construed as a waiver of any subsequent breach.
(i)
(j)
Counterparts. This Agreement may be executed in one or more counterparts, and be transmitted by facsimile or
pdf, each of which shall be deemed an original, but all of which together shall constitute one and the same
agreement.
Assignment. In the event of a change of control, the Company will assign any surviving obligations in this
Agreement to the appropriate entity to the extent permitted by law. This Agreement shall inure to the benefit of the
Company and permitted successors and assigns. However, you may not assign this Agreement or any part hereof.
Any purported assignment by you shall be null and void from the initial date of purported assignment.
DB1/ 124613904.6
8
(k)
Effective Date. This Agreement will become effective and enforceable upon the expiration of the seven (7)
business day revocation period provided for in Section 13(f) above (the “Effective Date”). If you fail to return an
executed original by September 30, 2021 (or otherwise revoke this Agreement pursuant to Section 13(f) above),
this Agreement, including but not limited to the obligation of the Company to provide the compensation and
benefits provided in Section 2 above, shall be deemed automatically null and void.
[Signature Page Follows]
9
DB1/ 124613904.6
If the above accurately states our agreement, including the separation, waiver and release, kindly sign below and return the
original Agreement to me no later than September 30, 2021.
Sincerely,
Replimune Inc.
By:
Date:
UNDERSTOOD, AGREED TO AND ACCEPTED WITH THE INTENTION TO
BE LEGALLY BOUND:
______________________________________
Andrea Pirzkall
Date: ______________________________
Signature Page to Separation and Release Agreement
DB1/ 124613904.6
EXHIBIT A
EMPLOYMENT AGREEMENT
DB1/ 124613904.6
Subsidiaries of Replimune Group, Inc.
Name of Subsidiary
EXHIBIT 21.1
Jurisdiction
Delaware
United Kingdom
Massachusetts
Ireland
Replimune, Inc.
Replimune Limited
Replimune Securities Corporation
Replimune (Ireland) Limited
EU1/ 55029326.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-244386) and Form S-8 (Nos. 333-
226323 and 333-256314) of Replimune Group, Inc. of our report dated May 19, 2022 relating to the financial statements, which appears in
this Form 10-K.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
May 19, 2022
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED
Exhibit 31.1
PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Philip Astley-Sparke, certify that:
1.
2.
I have reviewed this Annual Report on Form 10-K of Replimune Group, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal
control over financial reporting.
Date: May 19, 2022
By:
/s/ PHILIP ASTLEY-SPARKE
Philip Astley-Sparke
Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED
Exhibit 31.2
PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Jean Franchi, certify that:
1.
I have reviewed this Annual Report on Form 10-K of Replimune Group, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal
control over financial reporting.
Date: May 19, 2022
By:
/s/ JEAN FRANCHI
Jean Franchi
Chief Financial Officer
(Principal Financial Officer)
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report on Form 10-K of Replimune Group, Inc. (the "Company") for the fiscal year ended March 31, 2022, as filed
with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, Philip Astley-Sparke, Chief Executive Officer of the
Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of
his knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 19, 2022
By:
/s/ PHILIP ASTLEY-SPARKE
Philip Astley-Sparke
Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report on Form 10-K of Replimune Group, Inc. (the "Company") for the fiscal year ended March 31, 2022, as filed
with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, Jean Franchi, Chief Financial Officer of the Company,
hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his
knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 19, 2022
By:
/s/ JEAN FRANCHI
Jean Franchi
Chief Financial Officer
(Principal Financial Officer)