UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended April 30, 2021
OR
☐
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 001-36830
KalVista Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its Charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
55 Cambridge Parkway
Suite 901 East
Cambridge, Massachusetts
(Address of principal executive offices)
20-0915291
(I.R.S. Employer
Identification No.)
02142
(Zip Code)
Title of Each Class
Common Stock, $0.001 par value per share
Trading Symbol
KALV
Name of Exchange on Which Registered
The Nasdaq Stock Market LLC
Registrant’s telephone number, including area code: (857) 999-0075
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐NO ☒
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 ☒ 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 ☒ NO ☐
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definition of “large accelerated filer,”
“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Non-accelerated filer
☐
☒
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. ☐
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 Exchange Act). YES ☐ NO ☒
The aggregate market value of common stock held by non-affiliates of the registrant calculated based on the closing price of $17.21 of the registrant’s common stock as reported on The NASDAQ Global Market on October 31,
2020, the last business day of the registrant’s most recently completed second quarter, was $282,204,641.
The number of shares of Registrant’s Common Stock outstanding as of July 2, 2021 was 24,436,492.
DOCUMENTS INCORPORATED BY REFERENCE
Information required in responses to Part III of Form 10-K is hereby incorporated by reference to portions of the Registrant’s Proxy Statement for the Annual Meeting of Stockholders to be held in 2021. The Proxy Statement
will be filed by the Registrant with the Securities and Exchange Commission no later than 120 days after the end of the Registrant’s fiscal year ended April 30, 2021.
Table of Contents
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
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
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 Accounting Fees and Services
Exhibits, Financial Statement Schedules
Form 10-K Summary
Index to Consolidated Financial Statements
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
Signatures
Page
1
23
50
50
50
51
52
52
54
60
61
61
61
62
63
63
63
64
64
65
67
68
F-1
i
PART I
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical fact are “forward-looking
statements” for purposes of this Annual Report on Form 10-K. These forward-looking statements may include, but are not limited to, statements regarding
our current and future nonclinical, preclinical and clinical development activities, anticipated impacts of the COVID-19 pandemic, our future results of
operations and financial position, business strategy, market size, potential growth opportunities, the efficacy and safety profile of our product candidates,
expected timing and results of our clinical trials, and receipt and timing of potential regulatory designations, approval and commercialization of product
candidates. In some cases, forward-looking statements may be identified by terminology such as “believe,” “may,” “will,” “should,” “predict,” “goal,”
“strategy,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect,” “seek” and similar expressions and
variations thereof. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we
believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial
needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors”
section and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment, and new risks
emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to
which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may
make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual
results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in
the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after
the date of this report to conform these statements to actual results or to changes in our expectations, except as required by law.
As used in this Annual Report on Form 10-K, the terms “KalVista,” “the Company,” “we,” “us,” and “our” refer to KalVista Pharmaceuticals, Inc.
and, where appropriate, its consolidated subsidiaries, unless the context indicates otherwise.
Item 1. Business.
Overview
We are a clinical stage pharmaceutical company focused on the discovery, development and commercialization of small molecule protease inhibitors
for diseases with significant unmet need. We apply our insights into the chemistry and biology of proteases to develop orally delivered, small molecule
inhibitors with high selectivity, potency and bioavailability that we believe will make them successful treatments for diseases. We have used these capabilities
to develop a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors targeting hereditary angioedema (“HAE”) and diabetic macular edema
(“DME”). In late 2020, we also announced a novel, oral Factor XIIa (“Factor XIIa”) inhibitor program, which initially is being advanced to provide a next
generation of HAE therapeutics and which also offers the opportunity for expansion into other high unmet need indications in the future.
Our primary focus is currently on developing oral plasma kallikrein inhibitors for HAE, for which we have two drug program candidates in clinical
trials. HAE is a rare and potentially life-threatening condition with symptoms that include episodes of debilitating and often painful swelling in the skin,
gastrointestinal tract or airways. Despite having multiple therapies approved, we believe HAE patients are in need of alternatives that better meet their
objectives for quality of life and ease of disease control. Other than one therapy recently approved for
1
prophylaxis, currently marketed therapies are all administered by injection, which patients can find challenging despite their efficacy because they can be
painful, time consuming to deliver and difficult to store. We anticipate that there will be strong interest in safe and effective, orally delivered, small molecule
treatments, and our strategy is to develop oral drug candidates for both on-demand and prophylactic use with the goal of providing patients with a complete
set of oral options to treat their disease.
Our strategy is based upon extensive patient, physician and payer research to identify the key needs in the market. According to our market research,
oral therapy remains the highest unmet need, with 93% of patients surveyed by KalVista expressing a willingness to switch to oral therapy for both on-
demand and prophylactic use. Importantly however, the survey data shows that patients are not prepared to accept significantly reduced efficacy or safety
with a switch to oral therapy, and so we place a high degree of emphasis on advancing program candidates that we believe can compare favorably to existing
approved therapies in both those dimensions.
We have advanced our candidate KVD900 into later stage clinical development as a potential oral, on-demand therapy for HAE attacks. In February
2021 we announced data from a Phase 2 efficacy trial in which KVD900 demonstrated statistically and clinically significant responses across all primary and
secondary endpoints. KVD900-201 was a double blind, placebo-controlled, crossover trial investigating the safety and efficacy of a single dose of 600 mg
KVD900 as an on-demand treatment for HAE attacks in patients with Type 1 or Type 2 HAE. Following an open label phase, in which pharmacokinetic
samples were collected over four hours, all patients progressed into the randomized phase of the trial. In this “at home” part of the trial, patients treated two
attacks, one with 600 mg KVD900 and one with placebo in a randomized sequence. Patients administered treatment for each attack within one hour of attack
onset, following confirmation with their physician, and then recorded symptoms and, if needed, the time to use of rescue (the patient’s conventional attack
treatment). The time to use of rescue treatment within 12 hours was the primary outcome of the trial. Secondary outcomes included assessment of attack
severity using categorical (“PGI-S”) and visual analogue scale (“VAS”) measures and the patient’s global impression of change (“PGI-C”).
The trial planned to complete at least 50 patients and enrolled 68 patients of which 53 completed the trial by treating two attacks. One patient
withdrew consent and 14 patients were discontinued due to completion of the trial. No patients withdrew due to adverse events.
The trial met its primary endpoint comparing the time to use of rescue treatment within 12 hours on KVD900 versus placebo (p=0.001) with rates of
use at 12 hours of 15.1% following treatment with KVD900 versus 30.2% after placebo. The trial also met all secondary endpoints: reduced worsening of
attacks (p<0.0001; based on PGI-S or use of rescue) and reduced time to onset of symptom relief measured using both PGI-C (p<0.0001) and VAS
(p<0.0001). The trial included 126 administrations of KVD900 and 55 of placebo. During the uncontrolled, open label phase, 5 of 68 patients dosed reported
8 adverse events suspected to be related to treatment. During the randomized, placebo-controlled phase, 5 patients reported adverse events suspected to be
treatment-related (3 of 58 dosed with KVD900 and 2 of 55 dosed with placebo). We have scheduled an end-of-phase 2 meeting with the FDA to confirm our
plans for the Phase 3 program, following which we are prepared to commence the trial rapidly in the US. We also intend for this trial to be conducted in a
number of other countries, with commencement in those locations to follow approval by their respective regulatory authorities. KVD900 has received Fast
Track designation from the FDA. A Pediatric Investigational Plan (“PIP”) has also been approved by the European Medicines Agency (“EMA”) for KVD900.
KVD824 is our oral product candidate being developed for potential prophylactic treatment of HAE. Our work to optimize the exposure profile of
KVD824 has yielded a formulation that maintains the plasma concentrations we believe are required to deliver efficacy that will compete with approved
injectable therapies. Twice-daily dosing of this formulation of KVD824 up to 14 days has shown what we believe to be an encouraging safety and tolerability
profile.
In April 2021 we announced that the FDA has placed a clinical hold our Investigational New Drug Application (“IND”) for a Phase 2 clinical trial of
KVD824. The FDA letter request further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned Phase 2
trial. Refinements were also proposed to the intended KVD824 Phase 2 study protocol. No new studies were requested nor was it suggested that new data be
generated to initiate the Phase 2 trial. We are currently working to provide the additional
2
information and analysis requested by the FDA while also progressing regulatory filings for other countries where we also plan to initiate sites for the Phase
2. We currently intend to submit our response to the FDA in the third calendar quarter of 2021.
We initially evaluated KVD824 in a three-part first-in-human study in which 84 healthy male, adult subjects received at least one dose of KVD824.
The study evaluated single doses up to 1,280 mg, multiple doses up to 640 mg, and the effect of food on KVD824 pharmacokinetics. We have also completed
a study in healthy adult subjects assessing different formulations of KVD824 and believe that twice-daily dosing maintains concentrations sufficient to deliver
meaningful clinical efficacy.
To date, a total of 121 subjects have been exposed to treatment with KVD824 as single doses up to 1,280 mg and up to 14 days of twice-daily dosing
of 600 mg and 900 mg. In the first-in-human study adverse event rates were similar in placebo and active arms, no subjects withdrew from the study and no
serious adverse events were reported. All reported adverse events have been mild and no subjects withdrew from the trial.
Our oral Factor XIIa inhibitor program represents what we believe is a major breakthrough in development of a therapeutic against an important
target. Factor XIIa is an enzyme that plays a key role in HAE as the most upstream mechanism in the biochemical pathway that initiates HAE attacks. For this
reason, we believe that inhibition of Factor XIIa will block the underlying causes of HAE attacks, including the uncontrolled generation of both plasma
kallikrein and bradykinin, which cause swelling and pain. Clinical studies of an injectable Factor XIIa-inhibitory antibody have demonstrated a high degree of
efficacy in preventing HAE attacks, and there are no known safety implications of long-term inhibition of this enzyme. We believe that our program has the
potential to be the first orally delivered Factor XIIa inhibitor to enter clinical development, initially for HAE and over time for additional indications that are
supported by scientific evidence.
Our internal research team has discovered multiple series of low nanomolar potency Factor XIIa inhibitors that are both selective and orally
bioavailable. We are pursuing comprehensive intellectual property protection for this advanced medicinal chemistry program that is currently in lead
optimization. We anticipate initiating IND-enabling studies for potential drug candidates in 2021.
The second indication we are pursuing is DME. DME is the leading cause of moderate vision loss in most developed countries and diabetes, the
underlying cause of DME, is the leading cause of blindness among American adults according to the Center for Disease Control and Prevention. Our DME
program to date has been focused on the development of an intravitreally administered small molecule plasma kallikrein inhibitor, KVD001, which completed
a Phase 2 trial. We believe intravitreal plasma kallikrein inhibitors may be an effective alternative therapy to vascular endothelial growth factor (“VEGF”)
inhibitors and further improve visual acuity and decrease macular thickening. We also intend to develop oral therapies for DME, which we believe would
represent a substantial enhancement to the therapeutic options with this disease. We are currently evaluating our development strategy in this indication and
expect to provide further updates when appropriate.
Strategy
Key elements of our strategy include:
•
•
Apply our deep scientific expertise in the area of serine proteases to develop novel oral therapies for indications with high unmet need. Our
core scientific team has decades of experience working on protease inhibitors and developing compounds with high potency, selectivity and
bioavailability. We have assembled a team of chemists and biologists who have demonstrated the ability to design and formulate multiple
drug candidate programs from a broad variety of chemical classes, as indicated by our extensive intellectual property portfolio. Our initial
focus is specifically on development of plasma kallikrein inhibitors for HAE and DME; however, we believe our scientific capabilities also
can be applied to other proteases to develop therapies for diseases with high unmet need and orphan indications.
Develop multiple HAE product candidates to provide a full set of therapeutic options for patients. We intend to develop best-in-class oral
therapies for HAE and, to accomplish that goal, we plan to develop drug candidates for both on-demand and prophylactic use to provide
patients with a complete set of oral
3
options to treat their disease. Our most advanced program for HAE is KVD900, which is being developed as a potential oral, on-demand
therapy for treatment of HAE attacks. In February 2021 we announced data from a Phase 2 efficacy trial in which KVD900 demonstrated
statistically and clinically significant responses across all primary and secondary endpoints, and we are currently preparing for an FDA
meeting following which we intend to commence a Phase 3 trial. KVD824 is our next oral candidate to be developed as a potential oral
prophylactic treatment for HAE. In April 2021 we announced that the FDA placed a clinical hold on our IND for a Phase 2 clinical trial of
KVD824. We are currently working to provide the additional information and analysis requested by the FDA and intend to commence the
planned Phase 2 study once such clearance is provided. With our recently announced Factor XIIa inhibitor program, we believe we may be
able to offer patients a next generation of HAE therapies that may further enhance their options.
•
•
Continue to advance our DME programs, including developing an oral therapy. KVD001, our first product candidate to treat DME,
completed a Phase 2 clinical trial in 2019. We also intend to develop an oral therapy for this indication, which we believe could dramatically
improve the standard of care for patients, since all current therapies are delivered by injection into the eye.
Grow our capabilities internally as well as through strategic partnerships. We intend to retain ownership and control of our pipeline
programs to key milestones and in certain markets. For certain indications, such as HAE, that can be addressed by a focused organization, we
intend to keep all program rights and develop internal sales and marketing capabilities. For programs that address larger markets or require
greater infrastructure or resources, we may seek a partner that can provide those capabilities. Decisions on whether, and when, to engage in
partnerships or collaborations will be based upon our evaluations of the relative risks and rewards of those collaborations at each point in the
development cycle.
Plasma Kallikrein in HAE and DME
Plasma kallikrein is a serine protease enzyme that is a key early mediator of inflammation and edema. The body modulates the inflammatory effects
of plasma kallikrein through a circulating inhibitor protein called C1-esterase inhibitor (“C1-INH”). Most patients with HAE have genetic mutations that lead
to C1-INH deficiency, which results in an inability to control activated plasma kallikrein in affected tissues. This excessive activation leads to inflammation,
edema, and pain.
Published laboratory work has shown that the vitreous fluid of the eye is also a site of increased plasma kallikrein in DME. In diabetic patients, the
retina is one of a few tissues in which edema develops. Under normal circumstances the eye is protected from the diffusion of plasma proteins by an effective
blood vessel barrier. In diabetes this barrier becomes less effective and allows plasma proteins such as plasma kallikrein to enter the retina and vitreous. While
C1-INH can also to enter by the same route, animal models of DME have shown that the concentration of C1-INH in the vitreous fluid is insufficient to fully
suppress the effects of plasma kallikrein on retinal edema. Over time, this edema leads to retinal damage that causes blindness.
Hereditary Angioedema
Disease Overview
HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people, according to published
information from an HAE patient advocacy group. Excessive plasma kallikrein activation that is not sufficiently controlled by C1-INH leads to HAE attacks,
which can vary with regard to the affected tissue or organ and severity. HAE attacks include episodes of intense swelling usually in the skin, gastrointestinal
tract or airways. They often lead to temporary disfiguration of various body parts including the hands, feet, face, body trunk, and genitals. In addition, patients
often have bouts of excruciating abdominal pain, nausea and vomiting that is caused by swelling in the intestinal wall. Airway swelling is particularly
dangerous and can lead to death by asphyxiation.
Attacks can occur spontaneously although they often are associated with anxiety, stress, minor trauma, surgery, or illnesses. Commonly patients are
alerted to an impending attack by prodromal symptoms which include
4
rash, fatigue, and muscle aches. Trauma to the oral cavity caused by dental procedures makes HAE patients particularly vulnerable to airway attacks. The
frequency of HAE attacks is highly variable, with some patients having attacks several times per week and others very infrequently. Population studies have
shown that the median number of attacks per month for patients is approximately one, and approximately 90% of patients have two or fewer attacks per
month. Although life-threatening airway swelling is rare, at least half of HAE patients have experienced at least one such attack and airway attacks remain a
major cause of mortality in HAE patients. The severity of attacks is unpredictable and not related to their underlying frequency. A patient with only one attack
per year can nevertheless be at risk of suffering a laryngeal attack.
HAE is an autosomal dominant disease, meaning that a defect in only one copy of the gene leads to symptoms and that it occurs at similar rates in
both males and females. The most common cause of HAE is a defect or mutation in the gene responsible for the production of C1-INH. While HAE most
often results from the inheritance of a defective gene from a parent, it is estimated that up to 25% of cases also arise from spontaneous mutations. Patients
with C1-INH-related disease are classified as Type 1 or Type 2; Type 1 is the most common form and results in low levels of circulating C1-INH and Type 2
results in production of a low function protein. An additional form of HAE, sometimes called normal C1-INH HAE, can occur in patients with normal levels
of C1-INH for a variety of reasons including mutations in genes for Factor 12, plasminogen or angiopoetin. Moreover, bradykinin-induced acute attacks of
angioedema can occur idiopathically in individuals for which a hereditary cause has not yet been identified. Excessive formation of bradykinin can also be
caused by increased circulation of estrogens, reduced elimination of bradykinin, or through use of drugs such as ACE inhibitors.
C1-INH is a natural plasma-borne protein that is an inhibitor of multiple serine proteases in both the complement and kallikrein kinin systems. C1-INH is
the predominant physiological inhibitor of plasma kallikrein, and thereby suppresses the generation of bradykinin, a potent hormone produced by plasma
kallikrein, that activates its receptors on blood vessels to increase vascular leakage. Uncontrolled plasma kallikrein activity leads to the edema that is the hallmark
of HAE. Selective plasma kallikrein inhibitors and a bradykinin receptor antagonist are approved therapies for HAE. As such, plasma kallikrein is a clinically
validated target for HAE and previous studies have demonstrated that plasma kallikrein inhibition can both treat and prevent HAE attacks.
Current Treatments and Market Opportunities
There are a number of marketed and development stage therapeutics for HAE which provide evidence that inhibition of plasma kallikrein activity will
give therapeutic benefit in HAE. Takyzyro® is a monoclonal antibody against plasma kallikrein indicated for prophylaxis to prevent attacks of HAE. The
prescribing information recommends subcutaneous administration every two weeks, though dosing at more extended intervals may be considered in some
patients. Ecallantide (Kalbitor®) is a small protein inhibitor of plasma kallikrein that is approved for treatment of acute attacks of HAE. While effective,
ecallantide has been associated with cases of anaphylaxis and its approval by the FDA includes a black box warning limiting its administration to healthcare
professionals. Other therapies provide C1-INH replacement to control plasma kallikrein levels. Marketed C1-INH replacement therapies include Cinryze®
and Haegarda® for prophylaxis, and Berinert® for treatment of acute attacks, all of which are purified from human plasma, and Ruconest® which is a
recombinant product also for treatment of acute attacks. Icatibant (Firazyr®) is a synthetic peptide-based antagonist that blocks the activity of bradykinin and
is indicated for treatment of acute attacks. All of these products are administered by injection, which is typically less convenient for patients and has the
potential to reduce compliance. Berotralstat (ORLADEYOTM) is a newly approved oral prophylactic treatment which in clinical trials had inferior efficacy
when compared to injectables. As a result of the lifelong nature of HAE and the challenges related to taking many of the injected therapies, patient surveys
consistently indicate an overwhelming desire of patients for an oral therapy. We believe that a safe and effective oral agent has the potential to transform
treatment for this disease. We also believe that opportunities exist for both acute and prophylactic treatments, and we intend to develop drug candidates for
both on-demand and prophylactic use, with the goal of providing patients with a complete set of oral options to treat their disease.
We believe a further future market opportunity may exist in treatment of normal C1-INH HAE. Estimates of the size of this patient population vary
widely, but we believe that the nature of normal C1-INH HAE disease may make prophylaxis less attractive for these patients than a safe and rapidly effective
on-demand plasma kallikrein inhibitor therapy.
5
Our Portfolio of HAE Programs
Our strategy is to evaluate and develop multiple oral molecules in pursuit of best-in-class therapies for HAE patients, with an initial focus on
treatment of Type 1 and Type 2 HAE. The first of these product candidates being evaluated in later stage clinical trials is KVD900. A positive Phase 2 clinical
trial for KVD900 as a potential on-demand treatment for HAE attacks was completed in February 2021. Our second oral treatment in development for
potential prophylactic treatment for HAE is KVD824.
KVD900
The first clinical study of KVD900 was a multi-part trial consisting of a single ascending dose phase, a formulation cross-over phase, and
investigation of food effect in 84 healthy, male volunteers. Doses up to 600 mg were tested in this study using both capsule and tablet formulation, with the
tablet as the intended formulation for future development. Data from the single ascending dose phase of the study showed that KVD900 tablets were rapidly
absorbed into the bloodstream and achieved blood levels that we believe are sufficient for efficacy within as little as 10 minutes at the higher dose levels, and
essentially complete inhibition of plasma kallikrein was observed within 30 minutes. Food effect studies showed little impact of fed state on the
pharmacodynamic profile of KVD900 tablets, delivering 95% inhibition within 30 minutes. There were no severe adverse events (“SAE”) reported and single
doses of KVD900 up to 600 mg were generally well-tolerated in this study.
Evidence from studies using therapies approved for the treatment of acute HAE attacks shows that earlier treatment has a powerful impact on the
efficacy outcomes. Despite clear evidence that early treatment markedly reduces attack duration, treatment is often delayed. In one outcome study of 207
HAE attacks, attack duration was 2.75-fold shorter when treatment was administered within 1 hour of attack onset (6.1 hours versus 16.8 hours (p<0.001)),
yet treatment was administered more than 1 hour after attack onset in nearly 60% of attacks, and for 30% of attacks treatment was administered more than
five hours after attack onset. We believe this delay in administration is due to many factors including the inconvenience of preparation and administration as
well as the discomfort of injectable therapies. An oral therapy has the potential to overcome these and lower the barrier for treatment for patients. The
combination of the rapid uptake of KVD900 to very high blood levels and the likelihood of earlier dosing by patients, could lead to much better disease
management and prevention of attacks reaching the critical stage of significant swelling and discomfort. We therefore believe that a safe, oral on-demand
treatment has the potential to become a preferred alternative for patients currently using injectable treatments, including both acute and prophylactic therapies.
In 2020 we completed a multiple dose study of KVD900 that was designed to explore the safety and pharmacokinetics of repeat dosing over differing
timeframes. A total of 42 healthy male and female subjects were included in the study, consisting of 30 active and 12 placebo. Study subjects received a total
dose of 1800 mg KVD900 given as 3x600 mg doses at intervals of 8 hours (6 active, 2 placebo), 4 hours (6 active, 2 placebo) or 2 hours (18 active and 8
placebo).
The study showed that dosing every two hours achieved maximum concentrations of KVD900 approximately three times the maximum concentration
of a single 600 mg dose. All reported AEs were mild and resolved without intervention. The incidence of adverse events was similar between KVD900-
treated and placebo-treated cohorts. The protocol also included continuous cardiac monitoring of subjects. There was no clinically significant effect of
KVD900 treatment on any electrocardiogram parameters.
In February 2021 we announced data from a Phase 2 efficacy trial in which KVD900 demonstrated statistical and clinically significant responses
across all primary and secondary endpoints. KVD900-201 was a double blind, placebo-controlled, crossover trial investigating the safety and efficacy of a
single dose of 600 mg KVD900 as an on-demand treatment for HAE attacks in patients with Type 1 or Type 2 HAE. Following an open label phase, in which
pharmacokinetic samples were collected over four hours, all patients progressed into the randomized phase of the trial. In this “at home” part of the trial,
patients treated two attacks, one with 600 mg KVD900 and one with placebo in a randomized sequence. Patients administered treatment for each attack
within one hour of attack onset, following confirmation with their physician, and then recorded symptoms and, if needed, the time to use of rescue (the
patient’s conventional attack treatment). The time to rescue treatment within 12 hours was the primary outcome
6
of the trial. Secondary outcomes included assessment of attack severity using categorical (PGI-S) and visual analogue scale (VAS) measures and the patient’s
global impression of change (PGI-C).
The trial planned to complete at least 50 patients and enrolled 68 patients of which 53 completed the trial by treating two attacks. One patient
withdrew consent and 14 patients were discontinued due to completion of the trial. No patients withdrew due to adverse events.
The trial met its primary endpoint comparing the time to use of rescue treatment within 12 hours on KVD900 versus placebo (p=0.001) with rates of
use at 12 hours of 15.1% following treatment with KVD900 versus 30.2% after placebo. The trial also met all secondary endpoints: reduced worsening of
attacks (p<0.0001; PGI-S or use of rescue) and reduced time to onset of symptom relief measured using both PGI-C (p<0.0001) and VAS (p<0.0001). The
trial included 126 administrations of KVD900 and 55 of placebo. During the uncontrolled, open label phase, 5 of 68 patients dosed reported 8 adverse events
suspected to be related to treatment. During the randomized, placebo-controlled phase, 5 patients reported adverse events suspected to be treatment-related (3
of 58 dosed with KVD900 and 2 of 55 dosed with placebo). We have scheduled an end-of-phase 2 meeting with the U.S. Food and Drug Administration
(“FDA”) to confirm our plans for the Phase 3 program, following which we are prepared to commence the trial rapidly in the US. We also intend for this trial
to be conducted in a number of other countries, with commencement in those locations to follow approval by their respective regulatory authorities. KVD900
has received Fast Track designation from the FDA. A Pediatric Investigational Plan (“PIP”) has also been approved by the European Medicines Agency
(“EMA”) for KVD900.
KVD824
KVD824 is our oral product candidate which is being developed for potential prophylactic treatment of HAE. Our work to optimize the exposure
profile of KVD824 has yielded a formulation that maintains the plasma concentrations we believe are required to deliver efficacy that will compete with
approved injectable therapies. Twice-daily dosing of this formulation of KVD824 up to 14 days has shown what we believe to be an encouraging safety and
tolerability profile.
We initially evaluated KVD824 in a three-part first-in-human study in which 84 healthy male, adult subjects received at least one dose of KVD824.
The study evaluated single doses up to 1,280 mg, multiple doses up to 640 mg, and the effect of food on KVD824 pharmacokinetics. We have also completed
a study in healthy adult subjects assessing different formulations of KVD824 and believe that twice-daily dosing maintains concentrations sufficient to deliver
meaningful clinical efficacy.
To date, a total of 121 subjects have been exposed to treatment with KVD824 as single doses up to 1,280 mg and up to 14 days of twice-daily dosing
of 600 mg and 900 mg. In the first-in-human study adverse event rates were similar in placebo and active arms, no subjects withdrew from the study and no
serious adverse events were reported. All reported adverse events have been mild and no subjects withdrew from the trial.
All of our initial clinical development related to KVD824 was conducted in the U.K. To conduct our planned Phase 2 clinical trial in the US, we filed
our first US IND for KVD824 in early 2021. In April 2021 we announced that the FDA placed a clinical hold on our IND. The FDA letter request further
information and analysis related to certain preclinical studies of KVD824 submitted to support the planned Phase 2 trial. Refinements were also proposed to
the intended KVD824 Phase 2 study protocol. No new studies were requested nor was it suggested that new data be generated to initiate the Phase 2 trial. We
are currently working to provide the additional information and analysis requested by the FDA while also continuing to make regulatory filings in other
countries where we plan to initiate sites for the Phase 2. We currently intend to submit our response to the FDA in the third calendar quarter of 2021.
7
Factor XIIa
Our recently announced oral Factor XIIa inhibitor program represents what we believe is a major breakthrough in development of a therapeutic
against an important target. Factor XIIa is an enzyme that plays a key role in HAE as the most upstream mechanism in the biochemical pathway that initiates
HAE attacks. For this reason, we believe that inhibition of Factor XIIa will block the underlying causes of HAE attacks, including the uncontrolled generation
of both plasma kallikrein and bradykinin, which cause swelling and pain. Clinical studies of an injectable Factor XIIa-inhibitory antibody have demonstrated
efficacy in preventing HAE attacks, and there are no known safety implications of long-term inhibition of this enzyme. We believe that our program has the
potential to be the first orally delivered Factor XIIa inhibitor to enter clinical development, initially for HAE and over time for additional indications that are
supported by scientific evidence.
Our internal research team has discovered multiple series of low nanomolar potency Factor XIIa inhibitors that are selective and orally bioavailable.
We are currently in the lead optimization phase of compounds that display pharmacokinetic profiles consistent with our target for once-daily oral dosing that
we believe can lead to clinical candidates. In parallel with advancing medicinal chemistry for our Factor XIIa inhibitors, we are characterizing the PK/PD
properties of certain of our compounds in preclinical models of angioedema. ACE inhibitor captopril-induced vascular leakage of Evans blue dye is a well-
characterized model of bradykinin-mediated angioedema in mice. Captopril increases vascular leakage in the larynx (3.4 fold) and colon (3.1 fold) in mice
compared with controls receiving saline. Factor XII knockout mice are fully protected from captopril-induced vascular leakage, demonstrating that Factor XII
is required for vascular permeability in this model. We show that treatment of mice with our selective small molecule Factor XIIa inhibitor KV998083 at 0.3,
1 or 3 mg/kg reduced captopril induced leakage in larynx by 65% (p=0.013), 84% (p=0.001) and 104% (p<0.001), compared to captopril alone. In the colon,
this dosing regimen reduced captopril induced leakage by 27% (n.s), 50% (p=0.027) and 112% (p<0.001). These results demonstrate that Factor XIIa
inhibition with KV998083 protects against bradykinin-mediated angioedema an established preclinical model.
We have not yet determined whether KV998083 will be advanced as a program candidate, as we have multiple preclinical compounds under
evaluation and we have established a strict set of criteria for candidate selection. We anticipate initiating IND-enabling studies for one or more of those
potential Factor XIIa inhibitor program candidates in 2021.
8
Diabetic Macular Edema
Disease Overview
DME occurs as a complication of diabetes and is caused by the breakdown of the endothelial barrier function in the retina, resulting in the
accumulation of fluid in the macula. This leads to edematous thickening of the macula region of the retina and loss of visual acuity, potentially leading to
blindness. DME is a major complication associated with diabetes, affecting an estimated 26% of type 1 diabetic patients after 14 years of the disease, and an
estimated 29% over their lifetime; 17% of type 1 diabetic patients were estimated to develop clinically significant macular edema over their lifetime.
Approximately 900,000 patients in the United States have active DME and are at serious risk of vision loss, according to a study published in 2015.
The current standard of care for DME in the United States is therapy directed against VEGF, a hypoxia-induced protein that stimulates the growth of
blood vessels in the retina. FDA approved anti-VEGF therapies for DME are ranibizumab (Lucentis®) and aflibercept (Eylea®). Both of these products are
administered via intravitreal injection at roughly monthly intervals. In addition to treatment by these two products, a large fraction of patients is treated with
bevacizumab (Avastin®), another therapy that works through the same mechanism of binding to VEGF but has not been approved for ophthalmic use.
Bevacizumab is priced based on its application in oncology and off-label use by retinal specialists typically results in treatment at a fraction of the cost seen
with both ranibizumab and aflibercept. Patients are also treated with laser therapy in some circumstances, as well as a number of other drug therapies
including corticosteroid anti-inflammatories.
In a recent large, multi-center clinical trial in DME patients, anti-VEGF therapy led to approximately 20% of patients improving their visual acuity by
15 letters or more after a median of 9 or 10 intravitreal injections, leaving a significant portion of the patients with inadequate control of their disease. Further,
in one study conducted for an approved anti-VEGF, 40% of patients displayed minimal improvement in visual acuity following anti-VEGF therapy after
months of treatment. Certain corticosteroid treatments have led to 15-letter improvements in visual acuity in approximately 20-30% of patients. However,
corticosteroid treatments are associated with a dramatic increase in cataract formation and a rise in intraocular pressure, reducing the attractiveness of these
agents as potential therapies in many patients.
Research into the biology underlying DME by our scientific team has identified plasma kallikrein as a potential novel target for this indication.
KalVista scientists were the first to identify increased concentrations of plasma kallikrein in vitreous fluid samples obtained from individuals with diabetic
retinopathy and DME and have pioneered the development of plasma kallikrein inhibitors for the treatment of this disease. Our group has established
preclinical models to investigate the role of plasma kallikrein in both VEGF-independent and VEGF-mediated DME as well as for underlying pathologies
associated with diabetic retinopathy. We have used this in-depth knowledge of the plasma kallikrein system, diabetic retinopathy, and clinical ophthalmology
to evaluate the effects of orally available plasma kallikrein inhibitors for the treatment of DME. Using a pharmacology platform, originally developed and
validated using plasma kallikrein knockout mice at the Joslin Diabetes Center and Harvard Medical School, we have screened and characterized the
pharmacodynamic effects of KalVista’s oral plasma kallikrein inhibitors. We were the first to demonstrate that plasma kallikrein inhibition and gene knockout
are protective against VEGF-induced retinal edema.
Using subcutaneously implanted osmotic pumps we have quantified the dose-dependent pharmacodynamic effect of plasma kallikrein inhibitors on
VEGF-induced retinal edema and have correlated these effects with both plasma and retinal drug concentrations. Moreover, using gavage we have
characterized the pharmacokinetic and pharmacodynamics effects of orally administered plasma kallikrein inhibitors on retinal edema. These models and
protocols have enabled detailed characterization and comparison of the effects of multiple oral plasma kallikrein inhibitors on retinal edema.
9
KVD001
Our first potential DME therapy is KVD001. KVD001 is a potent inhibitor of human plasma kallikrein with a Ki of approximately 10 nM and a high
degree of selectivity against a broad range of other proteases. We have developed KVD001 for intravitreal injection because we believe that trials using this
delivery modality will provide a relatively early and direct proof-of-concept since the molecule is delivered directly to the site of edema. Since other products
such as anti-VEGF therapies are also delivered intravitreally, we believe this will be accepted by both physicians and patients and will not lead to any
competitive disadvantages. Another inherent advantage of intravitreal administration is that there is very limited systemic exposure, thus reducing potential
systemic safety concerns.
In December 2019 we announced data from a Phase 2 trial for KVD001. This study evaluated the safety and efficacy of two dose levels (3μg and
6μg) of KVD001 compared to a sham control in 129 DME patients who had previously been treated with anti-VEGF therapy, and still had significant edema
and reduced visual acuity. The primary efficacy endpoint of change in best corrected visual acuity (“BCVA”) at 16 weeks compared to sham was not met. No
significant differences were observed in the secondary endpoints of central subfield thickness or the diabetic retinopathy severity scale. KVD001 was
generally safe and well tolerated with no drug-related serious adverse events. In the overall study population, KVD001 demonstrated a protection against
vision loss. In the sham treated group 54.5% of patients experienced a reduction in vision compared to 32.5% in the 6μg dose (p=0.042). The study also
included a pre-specified subgroup analysis investigating the impact of baseline visual acuity on response. After excluding those patients with the most severe
vision loss (visual acuity of <55 letters at baseline), the remaining 70% of the total patient population showed a difference in BCVA compared to sham of 4.9
letters (p=0.056) at the 6μg dose.
We continue to believe that the results of the KVD001 Phase 2 study suggest a patient population in which plasma kallikrein inhibition may yield
vision benefits, and we intend to explore further development opportunities for this and oral DME programs over time.
Potential for Oral DME Therapies
In parallel with the clinical development of our intravitreal product candidate KVD001, we intend to identify and advance plasma kallikrein inhibitors
as oral therapies for DME. We believe that a safe and effective oral therapy has the potential to transform the treatment of DME which to date has been
dominated by drug therapies that must be injected intravitreally. Future trials in DME with oral plasma kallikrein inhibitors may focus on the treatment of
earlier stage disease, a stage at which intravitreal injections are not a desirable solution due to their inherently invasive nature and consequent risk of adverse
reactions.
Competition
In treating HAE, we expect to face competition from several FDA-approved therapeutics, including Takhzyro and Cinryze, marketed by Takeda
Pharmaceuticals Company Limited (“Takeda”) in the United States and Europe for the prevention of angioedema attacks in adults and adolescents; Firazyr,
marketed by Takeda in the United States, Europe and certain other geographic territories for the treatment of acute angioedema attacks in adult patients;
Kalbitor, an injectable plasma kallikrein inhibitor marketed by Takeda for the resolution of acute attacks in adolescent and adult HAE patients; Berinert,
marketed by CSL Behring for treatment of acute abdominal, facial or laryngeal attacks of HAE in adults and adolescents, and Haegarda, also marketed by
CSL Behring, for prophylaxis; Ruconest, marketed by Pharming Group for the treatment of acute angioedema attacks in adult patients; and Orladeyo, an oral
prophylactic treatment marketed by BioCryst Pharmaceuticals, Inc. We are also aware of other companies that are engaged in the clinical development of
other HAE treatments, including Pharvaris GmbH, Intellia Therapeutics, Inc. and Ionis Pharmaceuticals, Inc. We are aware of several other companies in
preclinical development of potential HAE therapies.
In treating DME, we expect to face competition from several FDA-approved therapeutics, including anti-VEGF therapies Lucentis, marketed by
Roche Holding AG (“Roche”) and Novartis International AG (“Novartis”), Eylea, marketed by Regeneron Pharmaceuticals (“Regeneron”), and off-label use
of Avastin from Roche. We also face competition from various corticoid steroids including extended release formulations lluvien, marketed by
10
Alimera Sciences, Inc., and Ozurdex, marketed by Allergan plc. We further expect to compete with generic corticosteroids such as fluocinolone acetonide,
and dexamethasone and we are aware of a number of other companies that have product candidates in clinical trials, including Novartis, GlaxoSmithKline
plc, Boehringer Ingelheim, Roche, Regeneron, Ohr Pharmaceutical, Inc., Aerpio Therapeutics, Oxurion NV and Allegro Ophthalmics, LLC.
Intellectual Property
Our success substantially depends on our ability to obtain and maintain patents and other forms of intellectual property rights for our product
candidates, methods used to manufacture our product candidates and methods for treating patients using our product candidates, as well as our ability to
preserve our trade secrets, to prevent third parties from infringing upon our proprietary rights and to operate without infringing upon the proprietary rights of
others. Our patent portfolio includes patents and patent applications covering plasma kallikrein inhibitors (“the plasma kallikrein portfolio), and patent
applications covering factor XIIa (FXIIa) inhibitors (“the FXIIa portfolio”).
In the plasma kallikrein portfolio, as of April 30, 2021, we are the owner of fifteen U.S. patents expiring between 2023 and 2037, absent any
extensions, as well as eleven pending U.S. patent applications and five pending US provisional applications. Any patents issuing from the foregoing U.S.
patent applications are expected to expire in between 2034 and 2038, absent any adjustments or extensions. In the plasma kallikrein portfolio, as of April 30,
2021, we owned a total of 198 pending foreign applications and 332 patents in foreign jurisdictions. Any issued patents, or those issuing from these foreign
patent applications, are expected to expire between 2023 and 2041, absent any adjustments or extensions. In the plasma kallikrein portfolio, as of April 30,
2021, we also controlled five pending international applications that, if issued, are expected to expire between 2039 and 2040, absent any adjustments or
extensions.
KVD001, an intravitreally administered plasma kallikrein inhibitor, is covered by U.S. patents and U.S. patent applications covering composition of
matter, methods of treatment, solid form and clinical formulations. The anticipated expiration dates of these patents, or patents arising from applications,
range from 2032 to 2040, absent any adjustments or extensions. KVD001 is also covered by European patents with the European Patent Office (“EPO”) and
European patent applications, covering composition of matter, medical use, solid form and clinical formulations. The anticipated expiration dates of these
European patents, or European patents arising from applications, range from 2032 to 2040 absent any extensions.
Our portfolio of oral plasma kallikrein inhibitors, including KVD900 and KVD824, is covered by U.S. patents, U.S. patent applications and U.S.
provisional applications, and pending international applications covering composition of matter, methods of treatment, solid form and clinical formulations
and the anticipated expiration dates of these patents, patents arising from those applications, or patents arising from applications claiming priority from
provisional applications range from 2035 to 2042, absent any adjustments or extensions. Our portfolio of oral plasma kallikrein inhibitors, including KVD900
and KVD824, is also covered by EPO patents, European patent applications, and expected European patent applications claiming priority from U.S.
provisional applications, covering composition of matter, medical use, solid form and clinical formulations. The anticipated expiration dates of these
European patents, or European patents arising from applications, range from 2035 to 2042 absent any extensions.
In the FXIIa portfolio, as of April 30, 2021, we are the owner of four pending U.S. provisional applications, six pending international applications,
and sixteen pending foreign applications in multiple jurisdictions. Any patents issuing from the foregoing applications in the FXIIa portfolio are expected to
expire in between 2039 and 2041, absent any adjustments or extensions.
Patents extend for varying periods according to the date of patent filing or grant and the legal term of patents in various countries where patent
protection is obtained. The actual protection afforded by a patent, which can vary from country to country, depends on the type of patent, the scope of its
coverage and the availability of legal remedies in the country.
We also use other forms of protection, such as trademark, copyright and trade secret protection for our intellectual property, particularly where we do
not believe patent protection is appropriate or obtainable. We require
11
our employees, consultants, contractors and other advisors to execute nondisclosure and assignment of invention agreements upon commencement of their
respective employment or engagement. In addition, we also require confidentiality or service agreements from third parties that receive confidential
information or materials.
Government Regulation and Product Approval
Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the United
Kingdom and European Union, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval,
packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export
of pharmaceutical products. The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with
subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial
resources.
FDA approval process
In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act, and other
federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval,
labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure
to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as clinical hold, FDA refusal to
approve pending new drug applications (“NDA”), warning or untitled letters, product recalls, product seizures, total or partial suspension of production or
distribution, injunctions, fines, civil penalties, and criminal prosecution.
Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves preclinical
laboratory and animal tests, the submission to the FDA of an Investigational New Drug (“IND”) application, which must become effective before clinical
testing may commence in the United States, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each
indication for which FDA approval is sought. Satisfaction of FDA approval requirements prior to marketing a pharmaceutical product 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 tests include laboratory evaluation of product chemistry, formulation and manufacturing process, as well as toxicity studies in animals to
assess the characteristics and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and
requirements, including good laboratory practices and good manufacturing practice (“cGMP”). The results of preclinical testing are submitted to the FDA as
part of an IND along with the information on product chemistry, manufacturing and controls, and a proposed clinical trial protocol. For the initial IND
submission, a 30-day waiting period after the submission of the IND is required prior to the commencement of the clinical trial in humans. If the FDA has
neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin. For subsequent clinical trial
protocols submitted to the IND, there is no mandated review time for FDA. Longer duration pre-clinical studies, for example animal tests of reproductive
toxicology and carcinogenicity, if required, will be conducted and submitted to the IND throughout the development of the product until sufficient data is
available to support submission of an NDA. Clinical trials involve the administration of the investigational drug to healthy volunteers or patients under the
supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical
practice (“GCP”), an international standard designed to protect the rights, safety and well-being of trial subjects and to define the roles of clinical trial
sponsors, administrators and monitors; as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and
the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA
as part of the IND.
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. The trial
protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board (“IRB”), for
12
approval prior to the start of the clinical trial. 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 may impose other conditions.
Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase 1, the
initial introduction of the drug into healthy human subjects or patients, the product is tested to assess metabolism, pharmacokinetics, pharmacological actions,
side effects associated with increasing doses, and, if possible, early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population to
determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dose, and to identify common adverse effects and safety
risks. If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain
the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit
the FDA to evaluate the overall benefit risk relationship of the drug and to provide adequate information for the labeling of the product. In most cases, the
FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug. A single Phase 3 trial may be sufficient in rare
instances, including (1) where the trial is a large multicenter trial demonstrating internal consistency and a statistically persuasive finding of a clinically
meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious or life-threatening outcome and confirmation of the
result in a second trial would be practically or ethically impossible or (2) when in conjunction with other confirmatory evidence.
The manufacturer of an investigational drug in a Phase 2 or 3 clinical trial for a serious or life- threatening disease is required to make available, such
as by posting on its website, its policy on evaluating and responding to requests for expanded access to such investigational drug.
After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before
marketing of the product may begin in the United States. The NDA must include the results of all preclinical and clinical data, including pharmacology and
toxicology results, and the results of other testing and a compilation of data relating to the product’s chemistry, manufacture and controls. The cost of
preparing and submitting an NDA is substantial. The submission of most NDAs is additionally subject to an application user fee, and once approved, the
NDA is also subject to annual product and establishment user fees. These fees are typically increased annually. The FDA has 60 days from its receipt of an
NDA to determine whether the application will be filed based on the agency’s threshold determination that it is sufficiently complete to permit substantive
review. Once the submission is filed, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of NDAs. Most
such applications for standard review drug products are reviewed within ten months of the date the FDA files the NDA; most applications for priority review
drugs are reviewed within six months of the date the FDA files the NDA. Priority review can be applied to a drug that the FDA determines has the potential to
treat a serious or life-threatening condition and, if approved, would be a significant improvement in safety or effectiveness compared to available therapies.
The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted
information, or information intended to clarify information already provided in the submission.
After the FDA evaluates the NDA and the compliance of manufacturing facilities with GMP, it issues either an approval letter or a complete response
letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order
for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction, the FDA will issue an approval letter.
The FDA has committed to reviewing such additional data in two or six months depending on the type of information included. An approval letter authorizes
commercial marketing of the drug with specific prescribing information for the indication being supported. As a condition of NDA approval, the FDA may
require a risk evaluation and mitigation strategy (“REMS”) if it is considered that additional measures are needed to ensure that the benefits of the drug
outweigh the potential risks. REMS can include the use of medication guides and communication plans for healthcare professionals, and elements to assure
safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain
circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of
the product. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the product’s safety or efficacy.
13
Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following
initial marketing. Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing
processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA
supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions
in reviewing NDA supplements as it does in reviewing NDAs.
Foreign clinical studies to support an NDA
The FDA will accept as support for marketing approval of a product (NDA) well-designed, well-conducted, clinical studies conducted outside of the
United States if the studies have been conducted in accordance with the exact same standards of GCP, as required in the United States, and the protocol was
submitted to the IND. FDA may validate the data from the study through an onsite inspection, if necessary. Clinical studies conducted outside the United
States are subject to the same rigorous regulatory controls as the United States (see “— Europe / rest of world government regulation” below).
A sponsor or applicant who wishes to rely on a non-IND foreign clinical study to support an IND must submit documentation to the FDA to
demonstrate compliance with GCP. The FDA may also request to inspect a foreign clinical study site to confirm compliance.
Orphan drug designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation if a compound has the potential to treat a rare disease or condition,
generally a disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United
States, if there is no reasonable expectation that the cost of developing and making a product available in the United States for such disease or condition will
be recovered from sales of the product.
Orphan drug designation must be requested prior to submitting an NDA. After the FDA grants orphan drug designation, the generic identity of the
compound and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration
of, the regulatory review and approval process of an NDA. The first NDA applicant to receive FDA approval for a drug product containing a compound that
has FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the United States for that drug product for that orphan indication.
During the seven-year exclusivity period, the FDA may not approve any other applications to market a drug product containing the same active moiety for the
same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. A product is clinically
superior if it is safer, more effective or makes a major contribution to patient care. Orphan drug exclusivity does not prevent the FDA from approving a drug
product containing a different active moiety for the same disease or condition, or the same drug product for a different disease or condition. Among the other
benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA user fee.
Fast Track Designation and Priority Review
The FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or life-threatening
disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Fast track
designation may be granted for products that are intended to treat a serious or life-threatening disease or condition for which there is no effective treatment
and preclinical or clinical data demonstrate the potential to address unmet medical needs for the condition. Fast track designation applies to both the product
and the specific indication for which it is being studied. Any product submitted to FDA for marketing, including under a fast track program, may be eligible
for other types of FDA programs intended to expedite development and review, such as priority review.
Priority review may be granted for products that are intended to treat a serious or life-threatening condition and, if approved, would provide a
significant improvement in safety and effectiveness compared to available therapies. FDA will attempt to direct additional resources to the evaluation of an
application designated for priority review in an effort to facilitate the review.
14
Disclosure of clinical trial information
Sponsors of clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information on the
website www.clinicaltrials.gov. Information related to the product, patient population, phase of investigation, trial sites and investigators, and other aspects of
the clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss the results of their clinical trials after completion.
Disclosure of the results of these trials can be delayed in certain circumstances for up to two years after the date of completion of the trial. Competitors may
use this publicly available information to gain knowledge regarding the progress of clinical development programs as well as clinical trial design.
Pediatric information
Under the Pediatric Research Equity Act (“PREA”) NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the
drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which
the drug product is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by
regulation, PREA does not apply to any drug product for an indication for which orphan designation has been granted.
Post-approval requirements
Once an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval
marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific
and educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved indications and in accordance with
the provisions of the approved labeling.
Adverse event reporting and submission of periodic reports is required following FDA approval of an NDA. The FDA also may require post-
marketing testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved product, or the FDA may place conditions on an
approval that could restrict the distribution or use of the product. In addition, quality control, drug product manufacture, packaging, and labeling procedures
must continue to conform to cGMPs after approval. Drug manufacturers and certain of their subcontractors are required to register their establishments with
the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency
inspects manufacturing facilities to assess compliance with cGMPs. Accordingly, manufacturers must continue to expend time, money, and effort in the areas
of production and quality-control to maintain compliance with cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a
company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are
subsequently discovered.
Other U.S. healthcare laws and compliance requirements
In the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including
but not limited to, the Centers for Medicare and Medicaid Services (“CMS”), other divisions of the U.S. Department of Health and Human Services (such as
the Office of Inspector General), the U.S. Department of Justice (“DOJ”), and individual U.S. Attorney offices within the DOJ, and state and local
governments. For example, sales, marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions of the
Social Security Act, the federal false claims laws, the privacy and security provisions of the Health Insurance Portability and Accountability Act (“HIPAA”),
and similar state laws, each as amended, as applicable.
The federal Anti-Kickback Statute 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,
recommending or arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare
programs. The term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has
15
been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and/or formulary managers on the
other. There are a number of statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory
sanctions. The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce
prescribing, purchasing or recommending 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 its facts and circumstances. Practices
may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor. In addition, the statutory exceptions and
regulatory safe harbors are subject to change.
Additionally, the intent standard under the Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act, as amended by the
Health Care and Education Affordability Reconciliation Act (collectively, the “ACA”) 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 codified case law that a claim
including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal
False Claims Act (discussed below).
The civil monetary penalties statute imposes penalties against any person or entity who, among other things, is determined to have presented or
caused to be presented a claim to a federal health 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.
Federal false claims laws, including the federal civil False Claims Act, prohibit, among other things, any person or entity from knowingly presenting,
or causing to be presented, a false claim for payment to, or approval by, the federal government or 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. As a result of a modification made by the Fraud Enforcement and
Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition, manufacturers can be
held liable under the civil False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission
of false or fraudulent claims. Pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly
providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been
prosecuted for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus generally non-reimbursable,
uses and purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes.
HIPAA created additional federal criminal statutes that prohibit 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 money or property owned by, or under the control or custody of, any
healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device,
a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or
services. Similar to the Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order
to have committed a violation.
Also, many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state
programs, or, in several states, apply regardless of the payor.
16
Data privacy and security regulations by both the federal government and the states in which business is conducted may also be applicable. HIPAA,
as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations, imposes
requirements relating to the privacy, security and transmission of individually identifiable health information. HIPAA requires covered entities to limit the use
and transmission of individually identifiable health information. HIPAA requires covered entities to limit the use and disclosure of protected health
information to specifically authorized situations and requires covered entities to implement security measures to protect health information that they maintain
in electronic form. Among other things, HITECH made HIPAA’s security standards directly applicable to business associates, independent contractors or
agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH
also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, 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
attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in
specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Additionally, the federal Physician Payments Sunshine Act within the ACA, and its implementing regulations, require that certain manufacturers of
drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with
certain exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians and teaching
hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain
ownership and investment interests held by physicians and their immediate family members. Moreover, the Drug Supply Chain Security Act imposes new
obligations on manufacturers of pharmaceutical products related to product tracking and tracing. Legislative and regulatory proposals have been made to
expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.
In order to distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors
of drug products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or
distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of
product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing
product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish
marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other
activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician
prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices.
Certain local jurisdictions also require drug manufacturers to report information related to payments and other transfers of value to physicians and other
healthcare providers or marketing expenditures. Sales and marketing activities are also potentially subject to federal and state consumer protection and unfair
competition laws.
If our operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations
that apply to us, we may be subject to penalties, including without limitation, significant civil, criminal and/or administrative penalties, damages, fines,
disgorgement, exclusion from participation in government programs, such as Medicare and Medicaid, imprisonment, injunctions, private “qui tam” actions
brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages,
reputational harm, administrative burdens, 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.
Coverage, pricing and reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. In the
United States and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the
extent to which third party payors
17
provide coverage, and establish adequate reimbursement levels for such products. In the United States, third party payors include federal and state healthcare
programs, private managed care providers, health insurers and other organizations. The process for determining whether a third party payor will provide
coverage for a product may be separate from the process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay
for the product. Third party payors may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the
FDA-approved products for a particular indication. Third party payors are increasingly challenging the price, examining the medical necessity and reviewing
the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. We may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of its products, in addition to the costs required to obtain the
FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor’s decision to provide coverage for a product
does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure
that other payors will also provide coverage for the product. Adequate third party reimbursement may not be available to enable us to maintain price levels
sufficient to realize an appropriate return on its investment in product development.
Different pricing and reimbursement schemes exist in other countries. In the EU, governments influence the price of pharmaceutical products through
their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers. Some
jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain
reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular
product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control
company profits. The downward pressure on health care costs has become intense. As a result, increasingly high barriers are being erected to the entry of new
products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third
party payors fail to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased and we expect
will continue to increase the pressure on healthcare pricing. Coverage policies and third party reimbursement rates may change at any time. Even if favorable
coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and
reimbursement rates may be implemented in the future.
U.S. Healthcare reform
In the United States there have been, and continue to be, proposals by the federal government, state governments, regulators and third-party payors to
control or manage the increased costs of health care and, more generally, to reform the U.S. healthcare system. For example, in March 2010, the presidential
administration signed into law the ACA, which substantially changed healthcare financing and delivery by both governmental and private insurers, and
significantly impacted the pharmaceutical and biotechnology industry.
Among the ACA provisions of importance to the pharmaceutical industries, in addition to those otherwise described above, are the following:
•
•
•
subjected therapeutic biologics to potential competition by lower-cost biosimilars by creating a licensure framework for follow-on biologic
products;
proscribed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs
and therapeutic biologics that are inhaled, infused, instilled, implanted, or injected;
increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program
to individuals enrolled in Medicaid managed care organizations;
18
•
•
•
•
•
•
established annual fees and taxes on manufacturers of certain branded prescription drugs and therapeutic biologics;
established a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer point-of-sale discounts (now 70%)
off negotiated prices of applicable brand drugs and therapeutic biologics to eligible beneficiaries during their coverage gap period, as a
condition for the manufacturer’s outpatient drugs and therapeutic biologics to be covered under Medicare Part D;
expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional
individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level,
thereby potentially increasing manufacturers’ Medicaid rebate liability;
expanded the entities eligible for discounts under the Public Health Service program;
created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness
research, along with funding for such research; and
established a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and
Medicaid spending, potentially including prescription drug spending.
In the United States, there have also been legislative and judicial efforts to modify, repeal, or otherwise invalidate all, or certain provisions of, the
ACA. Following January 2017, the presidential administration issued two executive orders and other directives designed to delay the implementation of
certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. For example, on October 12,
2017, the presidential administration issued an executive order that expands the use of association health plans and allows anyone to purchase short-term
health plans that provide temporary, limited insurance. This executive order also called for the halt of federal payments to health insurers for cost-sharing
reductions previously available to lower-income Americans to afford coverage. There is still uncertainty with respect to the impact this executive order could
have on coverage and reimbursement for healthcare items and services covered by plans that were authorized by the ACA. Concurrently, Congress has
considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, two
bills affecting the implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017, among other things,
includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to
maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. It is uncertain how healthcare measures
of the current presidential administration will impact the ACA and our business. There is still uncertainty with respect to the impact the current presidential
administration and the Congress may have, if any, and any changes will likely take time to unfold, and could have an impact on coverage and reimbursement
for healthcare items and services covered by plans that were authorized by the ACA. However, we cannot predict the ultimate content, timing or effect of any
healthcare reform legislation or the impact of potential legislation on us.
In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, in August 2011,
the President signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to
recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at
least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate
reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013, and due to subsequent
legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through December
31, 2021 due to the COVID-19 pandemic, unless additional Congressional action is taken. Additionally, in January 2013, the American Taxpayer Relief Act
of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals and imaging centers. These
new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our
products, if approved, and, accordingly, our financial operations.
19
There has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription
drugs. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other
things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government
program reimbursement methodologies for products. At the federal level, the former presidential administration used several means to propose or implement
drug pricing reform, including through federal budget proposals, executive orders, and policy initiatives. It is unclear whether the current administration will
work to reverse those measures or pursue similar policy initiatives. On March 11, 2021, the President signed the American Rescue Plan Act of 2021 into law,
which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator
multiple source drugs, beginning January 1, 2024. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to
control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing
cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Any reduction in
reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. The implementation of cost
containment measures or other healthcare reforms may prevent the generation revenue, attainment profitability, or commercialization of products. In addition,
it is possible that there will be further legislation or regulation that could harm the business, financial condition and results of operations.
The Foreign Corrupt Practices Act
The Foreign Corrupt Practices Act (“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 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. The FCPA also obligates companies whose securities are listed in the
United States to comply with accounting provisions requiring us 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.
Additional regulation
In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety
and Health Act, the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect our business. These and other laws govern the use,
handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If our operations result in
contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines. We believe that we
are in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our
business. We cannot predict, however, how changes in these laws may affect our future operations.
Europe / rest of world government regulation
In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing, among other things, clinical
trials and any commercial sales and distribution of our products. Whether or not we obtain FDA approval of a product, we must obtain the requisite approvals
from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries
outside of the United States have a similar process that requires the submission of a clinical trial application much like the IND prior to the commencement of
human clinical trials. In the European Union, for example, a clinical trial application must be submitted to each country’s national health authority and an
independent ethics committee, much like the FDA and IRB, respectively. Once the clinical trial application is approved in accordance with a country’s
requirements, clinical trial development may proceed. The requirements and process governing the conduct of clinical trials, product licensing, pricing and
reimbursement vary from country to country in the European Union. In all cases, the clinical trials are conducted in accordance with GCP and the applicable
regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
20
To obtain regulatory approval of a drug product under European Union regulatory systems, we must submit a marketing authorization application
(“MAA”). The documentation submitted to the FDA in support of an NDA in the United States is almost identical to that required in the European Union,
with the exception of, among other things, country-specific document requirements. For other countries outside of the European Union, such as countries in
Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from
country to country. In all cases, again, the clinical trials are conducted in accordance with GCP and the applicable regulatory requirements and the ethical
principles that have their origin in the Declaration of Helsinki.
If we or our potential collaborators fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines,
suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
Other regulations
We are subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental
protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and
regulations now or in the future.
Human Capital Resources
As of April 30, 2021, we had a total of 70 full-time employees, of whom 28 were located in the United States, 41 were located in the United
Kingdom, and 1 was located in Switzerland. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We
have not experienced any work stoppages and consider our relations with employees to be good. We believe that our future success largely depends upon our
continued ability to attract and retain highly skilled employees. We emphasize a number of measures and objectives in managing our human capital assets,
and we provide our employees with competitive salaries and bonuses, opportunities for equity ownership, development programs that enable continued
learning and growth and a robust employment package that promotes well-being across all aspects of their lives, including health care, retirement planning
and paid time off. In July 2021, the Company adopted an Equity Inducement Plan in order to provide incentives to attract and motivate employees through the
grant of stock options and restricted share units.
Corporate Information
Our principal executive offices are located at 55 Cambridge Parkway, Suite 901 East, Cambridge, MA 02142, and our telephone number is (857) 999-
0075. Our website address is www.kalvista.com. The information contained on, or that can be accessed through, our website is not a part of this report. We
have included our website address in this report solely as an inactive textual reference.
Available Information
We file annual, quarterly, and current reports, proxy statements, and other documents with the Securities and Exchange Commission (“SEC”) under
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are available on our corporate website at www.kalvista.com as soon as
reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Also, the SEC maintains an Internet website that contains
reports, proxy and information statements, and other information regarding issuers, including us, that file electronically with the SEC. The public can obtain
any documents that we file with the SEC at www.sec.gov. The information posted on or accessible through these websites are not incorporated into this filing.
21
Item 1A.
Summary of Risk Factors
An investment in our common stock involves various risks, and prospective investors are urged to carefully consider the matters discussed in the section titled
“Risk Factors” prior to making an investment in our common stock. These risks include, but are not limited to, the following:
•
•
•
•
•
•
•
•
•
•
•
The novel strain of coronavirus, SARS-CoV-2 (“COVID-19”) outbreak has caused, and has the potential to further cause, disruptions in
our business, financial condition and results of operations, including the execution of our clinical development activities and the use and
sufficiency of our existing cash.
We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or
maintain profitability.
Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.
We will need substantial additional funding. If we are unable to raise capital when needed, we may need to delay, reduce or eliminate our
product development programs or commercialization efforts.
We are early in our development efforts. If we are unable to successfully develop and commercialize one or more of our compounds, or
if we experience significant delays in doing so, the business will be materially harmed.
Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or
experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could
be delayed or prevented and expenses for development of our product candidates could increase.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our
product candidates, and our ability to generate revenue will be materially impaired.
We may seek orphan drug exclusivity for some of our product candidates, and we may be unsuccessful.
A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process and does not
increase the likelihood that our product candidates will receive marketing approval.
Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
22
•
•
•
•
•
•
•
•
•
•
•
•
Even if any of our product candidates receives marketing approval, we may fail to achieve the degree of market acceptance by
physicians, patients, third party payors and others in the medical community necessary for commercial success.
We face substantial competition, which may result in others discovering, developing or commercializing competing products before or
more successfully than we do.
The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate
coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to
generate revenue.
We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and we expect to continue
to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product
candidates or products at an acceptable cost and quality, which could delay, prevent or impair our development or commercialization
efforts.
If we are unable to obtain and maintain intellectual property protection for our technology and products or if the scope of the intellectual
property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar
or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment
and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-
compliance with these requirements.
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution
capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
Our stock price is volatile and our stockholders may not be able to resell shares of our common stock at or above the price they paid.
Shareholder activism could cause material disruption to our business.
Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and
may lead to entrenchment of management.
Unstable or unfavorable global market and economic conditions may have adverse consequences on our business, financial condition
and stock price.
Risk Factors
Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with
all of the other information in this Annual Report on Form 10-K,
23
including the consolidated financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” included elsewhere in this Annual Report on Form 10-K before deciding whether to invest in shares of our common stock. The risks
and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of or that we deem immaterial may
also become important factors that adversely affect our business. If any of the following risks actually occur, our business, financial condition, results of
operations and future prospects could be materially and adversely affected. In that event, the market price of our stock could decline, and you could lose part
or all of your investment.
Risks Related to Our Business
The novel strain of coronavirus, SARS-CoV-2 (“COVID-19”) outbreak has caused, and has the potential to further cause, disruptions in our business,
financial condition and results of operations, including the execution of our clinical development activities and the use and sufficiency of our existing
cash.
The COVID-19 global pandemic has disrupted many of our operating activities, including our recently completed Phase 2 trial for KVD900. We may
continue to experience delays or difficulties with respect to our clinical trials as a result of delays in clinical site initiations and the enrollment of patients in
our future clinical trials, including difficulties in recruiting clinical site investigators and clinical site staff due to the COVID-19 pandemic. Any such delays to
our planned clinical trial timelines could also impact the use and sufficiency of our existing cash reserves, and we may be required to raise additional capital
earlier than we had previously planned. We may be unable to raise additional capital if and when needed, which may result in further delays or suspension of
our development plans. If we are able to raise additional capital, challenging and uncertain economic conditions can make capital raising costly and dilutive.
Further, the extent to which the COVID-19 pandemic impacts our ability to procure resources, raw materials or components necessary for our
research studies or preclinical or clinical development will depend on unpredictable future developments, including new information that may emerge about
the severity of the coronavirus and the actions to contain the coronavirus or treat its effects, among others.
Additionally, our operations have been, and may continue to experience disruptions, such as due to temporary closure of our offices or those of our
suppliers and suspension of services, which may materially and adversely affect our development timelines, and our business, financial condition and results
of operations.
The spread of COVID-19, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place by
businesses and governments, may have a material adverse effect on our business. While the potential economic impact brought by, and the duration of, the
COVID-19 pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial
markets and the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-
19 pandemic, which may reduce our ability to access capital either at all or on favorable terms.
The ultimate impact of the current COVID-19 pandemic, or any other health epidemic, is highly uncertain and subject to change. We do not yet know
the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems or the global economy as a whole. However, these effects
could have a material adverse impact on our operations, and we will continue to monitor the situation closely.
We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain
profitability.
Since inception, we have incurred significant operating losses as we focused on our discovery efforts and developing our product candidates. We
expect that it will be many years, if ever, before we have a product candidate ready for commercialization. To date, we have financed our operations primarily
through sales of our stock and a previous option agreement with Merck and associated private placement. We expect to continue to incur significant
24
expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
•
•
•
•
•
•
•
•
•
•
continue clinical development of our current product candidates;
seek to identify additional product candidates;
acquire or in-license other products and technologies or enter into collaboration arrangements with regards to product discovery;
initiate clinical trials for additional product candidates;
seek marketing approvals for our product candidates that successfully complete clinical trials;
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
maintain, expand and protect our intellectual property portfolio;
hire additional personnel;
add operational, financial and management information systems and personnel, including personnel to support our product development and
planned future commercialization efforts; and
continue to incur increased costs as a result of operating as a public company.
To become and remain profitable, we must develop and eventually commercialize a product or products with significant market potential. This will
require us to be successful in a range of challenging activities, including completing clinical trials of our product candidates, obtaining marketing approval for
these product candidates and manufacturing, marketing and selling those products for which we may obtain marketing approval. We may never succeed in
these activities and, even if we do, we may never generate revenues that are significant or large enough to achieve profitability. If we do achieve profitability,
we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of
our business and could impair our ability to raise capital, maintain our discovery and preclinical development efforts, expand our business or continue our
operations and may require us to raise additional capital that may dilute the ownership interest of common stockholders. A decline in the value of our
business could also cause stockholders to lose all or part of their investment.
Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.
We are a clinical stage company and our operations to date have been limited to organizing and staffing, business planning, raising capital, acquiring
and developing the technology, identifying potential product candidates, and undertaking up to Phase 2 clinical studies of our most advanced product
candidates. We have not yet demonstrated our ability to successfully complete large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a
commercial scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product
commercialization. Substantial time is required to develop a new medicine from the time it is discovered to when it is available for treating patients.
Consequently, any predictions made about our future success or viability based on our limited operating history to date may not be as accurate as they could
be if we had a longer operating history.
In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. Upon regulatory
approval of our product candidates, we will need to transition from a company with a research focus to a company capable of supporting and scaling
commercial activities. We may not be successful in such a transition.
25
We will need substantial additional funding. If we are unable to raise capital when needed, we may need to delay, reduce or eliminate our product
development programs or commercialization efforts.
We expect our expenses to increase in parallel with our ongoing activities, particularly as we continue our discovery and preclinical development
collaborations to identify new clinical candidates and initiate clinical trials of, and seek marketing approval for, our product candidates. In addition, if we
obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing,
manufacturing and distribution. Accordingly, we will need to obtain substantial additional funding for our continuing operations. If we are unable to raise
capital when needed or on attractive terms, we may be forced to delay, reduce or eliminate our discovery and preclinical development programs or any future
commercialization efforts.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product
candidates.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity
offerings and debt financings. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity
or convertible debt securities, the ownership interest of common stockholders will be diluted, and the terms of these securities may include liquidation or
other preferences that adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available, 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.
Risks Related to the Discovery and Development of Our Product Candidates
We are early in our development efforts. If we are unable to successfully develop and commercialize one or more of our compounds, or if we experience
significant delays in doing so, the business will be materially harmed.
We currently do not have any products that have gained regulatory approval. We have invested substantially all of our efforts and financial resources
in identifying potential drug candidates and funding our preclinical and clinical studies. Our ability to generate product revenues, which we do not expect will
occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of our clinical stage product candidates.
We have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new
and rapidly evolving fields, particularly in the biopharmaceutical area. For example, to execute our business plan, we will need to successfully:
•
•
•
•
•
•
•
execute ongoing clinical development activities;
successfully complete any clinical trials beyond Phase 2;
move other product candidates into development;
obtain required regulatory approvals for the development and commercialization of one or more of our product candidates;
maintain, leverage and expand our intellectual property portfolio;
manufacture a commercial scale product or arrange for a third party to do so on our behalf;
build and maintain robust sales, distribution and marketing capabilities for successful product commercialization, either on our own or in
collaboration with strategic partners;
26
•
•
•
gain market acceptance for one or more of our product candidates;
develop and maintain any strategic relationships we elect to enter into; and
manage our spending as costs and expenses increase due to drug discovery, preclinical development, clinical trials, regulatory approvals and
commercialization.
If we are unsuccessful in accomplishing these objectives, we may not be able to successfully develop and commercialize KVD900, KVD824 or other
product candidates, and our business will suffer.
Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in
completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
We have not yet commercialized our product candidates and the historical failure rate in clinical drug development of product candidates in our
industry is high. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical
development and then conduct extensive clinical trials to demonstrate the safety and efficacy of its product candidates in humans. Clinical testing is
expensive, difficult to design and implement and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time
during the clinical trial process. Further, the results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results
of later-stage clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often
susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical
studies and clinical trials have nonetheless failed to obtain marketing approval of their products. It is impossible to predict when or if any of our product
candidates will prove effective or safe in humans or will receive regulatory approval.
We may experience delays in our clinical trials and we do not know whether planned clinical trials will begin or enroll subjects on time, need to be
redesigned or be completed on schedule, if at all. For example, in April 2021 we announced that the FDA placed a clinical hold on our IND for KVD824 that
we currently are working to resolve. There can be no assurance that the FDA, Medicines & Healthcare products Regulatory Agency (the “MHRA”), the U.K.
regulatory authority, or the European Medicines Agency (the “EMA”) will not put any of our product candidates on clinical hold in the future. We may
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. Clinical trials may be delayed, suspended or prematurely terminated for a variety of reasons, such as:
•
•
•
•
•
•
•
•
delay or failure in reaching agreement with the FDA, MHRA, EMA or a comparable foreign regulatory authority on a trial design that we
want to execute;
delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority
regarding the scope or design of a clinical study;
delays in reaching, or failure to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
inability, delay, or failure in identifying and maintaining a sufficient number of trial sites, many of which may already be engaged in other
clinical programs;
delay or failure in recruiting and enrolling suitable subjects to participate in a trial, including due to the COVID-19 pandemic;
delay or failure in having subjects complete a trial or return for post-treatment follow-up, including due to the COVID-19 pandemic;
clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, or
dropping out of a trial;
the withdrawal of the United Kingdom from the European Union could materially impact the regulatory regime with respect to clinical trials
in the United Kingdom or the European Union;
27
•
•
•
•
•
•
•
•
•
•
•
lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to
conduct additional clinical studies and increased expenses associated with the services of its clinical research organizations (“CROs”) and
other third parties;
clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us to
conduct additional clinical trials or abandon product development programs;
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 at a higher rate than we anticipate;
we may experience delays or difficulties in the enrollment of patients that our product candidates are designed to target;
our third party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or
at all;
we may have difficulty partnering with experienced CROs that can identify patients that our product candidates are designed to target and run
our clinical trials effectively;
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;
the cost of clinical trials of our product candidates may be greater than we anticipate;
there may be political factors surrounding the approval process, such as government shutdowns, political instability or global pandemics such
as the COVID-19 pandemic;
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, including due to the COVID-19 pandemic; or
there may be changes in governmental regulations or administrative actions.
If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are
unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only
modestly positive or if there are safety concerns, we may:
•
•
•
•
•
•
be delayed in obtaining marketing approval for our product candidates;
not obtain marketing approval at all;
obtain approval for indications or patient populations that are not as broad as intended or desired;
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings that would reduce the potential
market for our products or inhibit our ability to successfully commercialize our products;
be subject to additional post-marketing restrictions and/or testing requirements; or
have the product removed from the market after obtaining marketing approval.
Our product development costs will also increase if we experience delays in testing or marketing approvals. We do not know whether any of our
preclinical studies or clinical trials will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical trial delays 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.
28
If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or
prevented and expenses for development of our product candidates could increase.
We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible
patients to participate in these trials to demonstrate safety and efficacy. We are conducting clinical trials of KVD900 and KVD824, and we do not know
whether planned or ongoing clinical trials will enroll subjects in a timely fashion, require redesign of essential trial elements or be completed on our projected
schedule. In particular, because we are focused on patients with HAE, which is a rare disease, our ability to enroll eligible patients in trials may be limited or
may result in slower enrollment than we anticipate. In addition, competitors have ongoing clinical trials for product candidates that treat the same indications
as our product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product
candidates. Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays and could require us to abandon one
or more clinical trials altogether. The ongoing COVID-19 pandemic could also negatively affect site initiation, as well as recruitment and retention, at sites in
a region or city whose health care system becomes overwhelmed as a result.
Patient enrollment is affected by many factors including:
•
•
•
•
•
•
•
•
•
•
•
the eligibility criteria for the study in question;
the perceived risks and benefits of the product candidate under study;
the efforts to facilitate timely enrollment in clinical trials;
the inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs,
including some that may be for the same disease indication;
the patient referral practices of physicians;
the proximity and availability of clinical trial sites for prospective patients;
any delays and difficulties in enrollment due to the COVID-19 pandemic;
ambiguous or negative interim results of our clinical trials, or results that are inconsistent with earlier results;
feedback from the FDA, MHRA, EMA, IRBs, data safety monitoring boards, or a comparable foreign regulatory authority, or results from
earlier stage or concurrent preclinical and clinical studies, that might require modifications to the protocol;
decisions by the FDA, MHRA, EMA, IRBs, a comparable foreign regulatory authority or us, or recommendations by data safety monitoring
boards, to suspend or terminate clinical trials at any time for safety issues or for any other reason; and
unacceptable risk-benefit profile or unforeseen safety issues or adverse effects.
Enrollment delays in our clinical trials may result in increased development costs for our product candidates, which would cause the value of the
company to decline and limit our ability to obtain additional financing.
If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed
and, as a result, our stock price may decline.
From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development
goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and
the submission of regulatory filings. From time to time, we may publicly announce the expected timing of some of these milestones. All of these milestones
are and will be based on numerous assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for
reasons beyond our control. If we do not meet these milestones as publicly announced, or at all, the commercialization of our products may be delayed or
never achieved and, as a result, our stock price may decline.
29
If serious adverse events or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit
the development of some of our product candidates.
If our product candidates are associated with undesirable effects in preclinical or clinical trials or have characteristics that are unexpected, we may
need to interrupt, delay or abandon their development or limit development to more narrow 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. Our HAE programs, including KVD900 and KVD824,
are still in the early stage of clinical testing and we have not yet determined what, if any, significant side effects may occur from dosing. Additional or more
severe side effects may be identified for all our programs through further clinical studies. These or other drug-related side effects could affect patient
recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Any of these occurrences may significantly
harm our business, financial condition and prospects.
Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product
candidates, and our ability to generate revenue will be materially impaired.
Our product candidates must be approved by the FDA pursuant to an NDA in the United States and by the EMA and similar regulatory authorities
outside the United States prior to commercialization. The process of obtaining marketing approvals, both in the United States and abroad, is expensive and
takes many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the
product candidates involved. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We
have not received approval to market any of our product candidates from regulatory authorities in any jurisdiction. We have no experience in filing and
supporting the applications necessary to gain marketing approvals and expect to rely on third party CROs to assist us in this process. 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. Securing marketing approval also requires the submission of information about the product
manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our product candidates may not be effective, may be only
moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us from obtaining
marketing approval or prevent or limit commercial use. Regulatory authorities have substantial discretion in the approval process and may refuse to accept
any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying
interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Changes in
marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review
for each submitted product application, may also cause delays in or prevent the approval of an application.
For example, the United Kingdom formally left the European Union on January 31, 2020, often referred to as Brexit, and the transition period ended
on December 31, 2020. Brexit has caused uncertainty in the current regulatory framework in Europe. For instance, Brexit has resulted in the European
Medicines Agency, or the EMA, moving from the United Kingdom to the Netherlands. In the United Kingdom, Brexit may cause disruption in the
administrative and medical scientific links between the EMA and MHRA. In April 2021, the United Kingdom adopted legislation giving effect to the trade
and cooperation agreement with the E.U. The trade and cooperation agreement sets out certain procedures for approval and recognition of medical products in
each jurisdiction. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of the trade and cooperation agreement or otherwise,
could prevent us from commercializing any product candidates in the United Kingdom and/or the European Union and restrict our ability to generate revenue
and achieve and sustain profitability. If any of these outcomes occur, we may be forced to restrict or delay efforts to seek regulatory approval in the United
Kingdom and/or European Union for any product candidates, which could significantly and materially harm our business. The current lack of detail and
resolution with regard to the Brexit implementation may result in a disruption of the manufacturing and supply of components of our product candidates in
the U.K. and we are unable to confidently predict the effects of such disruption to the regulatory framework in Europe. Any adjustments we make to our
business and operations as a result of Brexit could result in significant delays and additional expense.
30
Any of the foregoing factors could have a material adverse effect on our business, results of operations, or financial condition.
Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved
product not commercially viable.
If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product
candidates may be harmed and our ability to generate revenues will be materially impaired.
We may seek orphan drug exclusivity for some of our product candidates, and we may be unsuccessful.
Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as
orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition,
which is generally defined as a disease with a patient population of fewer than 200,000 individuals in the United States.
Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such
designation, the product is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application
for the same drug for the same indication during the period of exclusivity. The applicable period is seven years in the United States and ten years in Europe.
The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently
profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for
designation was materially defective, if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease
or condition.
Even if we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from competition
because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve a different drug
for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major
contribution to patient care.
A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process and does not increase the likelihood
that our product candidates will receive marketing approval.
The FDA has granted fast track designation for KVD900 for the treatment of HAE. We may also seek fast track designation for other indications or
for some of our other product candidates. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the
potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA fast track designation. The FDA has broad discretion
whether or not to grant this designation. Even if we believe a particular product candidate is eligible for this designation, we cannot assure that the FDA
would decide to grant it. Even though we have received fast track designation for KVD900 for the treatment of HAE, or even if we receive fast track
designation for other indications or for our other product candidates, we may not experience a faster development process, review or approval compared to
conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our
clinical development program. Many drugs that have received fast track designation have failed to obtain drug approval.
Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
In order to market and sell our products in the European Union and many other jurisdictions, we or our third party collaborators must obtain separate
marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve
additional testing. The time required to obtain approval may differ substantially from that required to obtain MHRA or FDA approval. The regulatory
approval process outside the United Kingdom and United States generally includes all of the risks associated with obtaining, respectively, MHRA or FDA
approval. In addition, in many countries outside the United States, it is
31
required that the product be approved for reimbursement before the product can be approved for sale in that country. We, or these third parties, may not obtain
approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the MHRA or FDA does not ensure approval by
regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by
regulatory authorities in other countries or jurisdictions or by the FDA. We may not be able to file for marketing approvals and may not receive necessary
approvals to commercialize our products in any market.
Any product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and could be subject
to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we
experience unanticipated problems with our products, when and if any of them are approved.
Our product candidates and the activities associated with their development and commercialization, including their testing, manufacture,
recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA, MHRA, and
other regulatory authorities. In the United States, these requirements include submissions of safety and other post-marketing information and reports,
registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of
records and documents, including periodic inspections by the FDA and other regulatory authority, requirements regarding the distribution of samples to
physicians and recordkeeping.
The FDA, or other regulatory authorities, may also impose requirements for costly post-marketing studies or clinical trials and surveillance to
monitor the safety or efficacy of the product. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed
only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’
communications regarding use of their products and if we promote our products beyond their approved indications, we may be subject to enforcement action
for off-label promotion. Violations of the Federal Food, Drug, and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations
alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.
In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, or
failure to comply with regulatory requirements, may yield various results, including:
•
•
•
•
•
•
•
•
•
•
•
•
•
restrictions on such products, manufacturers or manufacturing processes;
restrictions on the labeling or marketing of a product;
restrictions on product distribution or use;
requirements to conduct post-marketing studies or clinical trials;
warning or untitled letters;
withdrawal of the products from the market;
refusal to approve pending applications or supplements to approved applications that we submit;
recall 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
injunctions or the imposition of civil or criminal penalties.
32
Non-compliance with European Union requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the
development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the European Union’s
requirements regarding the protection of personal information can also lead to significant penalties and sanctions.
Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product
candidates and affect the prices we may obtain.
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 product candidates for which we obtain marketing approval.
As an example, the ACA, was signed into law in 2010 but has been the subject of legislative and judicial efforts to modify, repeal or otherwise
invalidate all or certain aspects of its provisions. The ACA included a substantial number of major changes to the healthcare system that impact our business,
and several other legislations since then, as well as ongoing efforts, have continued to create a complicated planning and operating environment for
companies in our industry.
We expect that the ACA, 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 receive for any approved product. Any reduction in reimbursement from Medicare or other
government 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 being able to generate revenue, attain profitability, or commercialize our products.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for
pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or
interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition,
increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more
stringent product labeling and post-marketing testing and other requirements.
Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In
these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain
reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product
candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory
levels, our business could be materially harmed.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could
harm our business.
We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling,
use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including
chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these
materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from its
use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed its resources. We also could incur significant
costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.
33
Although we maintain workers’ compensation insurance to cover us for 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 the storage or disposal of biological, hazardous or radioactive
materials.
In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These
current or future laws and regulations may impair our discovery, preclinical development or production efforts. Our failure to comply with these laws and
regulations also may result in substantial fines, penalties or other sanctions.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
As with all companies, we are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional
failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we may establish, comply with
federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In
particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud,
kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and
promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of
information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to
identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or
unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with
such laws or regulations. 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 material and adverse effect on our business, financial condition, results of operations and prospects, including the imposition of significant civil,
criminal and administrative penalties, damages, fines, disgorgement, imprisonment, the curtailment or restructuring of our operations, loss of eligibility to
obtain approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement or other government programs, including
Medicare and Medicaid, integrity oversight and reporting obligations, or reputational harm.
Risks Related to the Commercialization of Our Product Candidates
Even if any of our product candidates receives marketing approval, we may fail to achieve the degree of market acceptance by physicians, patients, third
party payors and others in the medical community necessary for commercial success.
If any of our product candidates receives marketing approval, we may nonetheless fail to gain sufficient market acceptance by physicians, patients,
third party payors and others in the medical community. In addition, physicians, patients and third party payors may prefer other novel products to ours. If our
product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The
degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:
•
•
•
•
•
the efficacy and safety and potential advantages and disadvantages compared to alternative treatments;
the ability to offer our products for sale at competitive prices;
the convenience and ease of administration compared to alternative treatments;
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
the strength of our marketing and distribution support;
34
•
•
•
•
the availability of third party coverage and adequate reimbursement, including patient cost-sharing programs such as copays and deductibles;
the ability to develop or partner with third-party collaborators to develop companion diagnostics;
the prevalence and severity of any side effects; and
any restrictions on the use of our products together with other medications.
In addition, in order to commercialize any product candidates, we must build marketing, sales, distribution, managerial and other non-technical
capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. If we are unable to enter into such
arrangements when needed on acceptable terms or at all, we may not be able to successfully commercialize any of our product candidates that receive
regulatory approval or any such commercialization may experience delays or limitations. If we are not successful in commercializing our product candidates,
either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant additional
losses. Our estimates of the potential market opportunities for our products are informed by work that is not definitive and future analyses may lead to
estimates that are higher or lower than these estimates than those provided at any given time, with respect to addressable patient populations. If our market
opportunity is lower than anticipated, our business may suffer.
We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully
than we do.
The development and commercialization of new drug products is highly competitive. 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
pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and
biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for
which we are developing our product candidates. Some of these competitive products and therapies are based on scientific approaches that are the same as or
similar to our approach, and others are based on entirely different 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.
Our commercial opportunity 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 more convenient or are less expensive than any products that we may develop. In addition, our ability to compete
may be affected in many cases by insurers or other third party payors seeking to encourage the use of generic products. Generic products are expected to
become available over the coming years, potentially creating pricing pressure. If our product candidates achieve marketing approval, we expect that they will
be priced at a significant premium over competitive generic products.
Many of the companies against which we are competing or we 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 pharmaceutical and biotechnology industries may result in even more resources being concentrated among a
smaller number of our competitors. Smaller and other 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, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for,
our programs.
35
The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and
reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford expensive
treatments. Sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates
will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health
administration authorities, private health coverage insurers and other third party payors. If reimbursement is not available, or is available only to limited
levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not
be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.
There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal
decisions about reimbursement for new medicines are typically made by the CMS, an agency within the U.S. Department of Health and Human Services, as
CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors tend to follow CMS to a substantial
degree. It is difficult to predict what CMS will decide with respect to reimbursement for fundamentally novel products such as ours, as there is no body of
established practices and precedents for these new products. Reimbursement agencies in Europe may be more conservative than CMS. Outside the United
States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing
emphasis on cost-containment initiatives in Europe, Canada, and other countries has and will continue to put pressure on the pricing and usage of our product
candidates. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. In general,
the prices of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for
medicines, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we
are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced
compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.
Moreover, increasing efforts by governmental and third party payors, in the United States and abroad, to cap or reduce healthcare costs may cause
such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or provide adequate
payment for our product candidates. We expect to experience pricing pressures in connection with the sale of any of our product candidates, due to the trend
toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on
healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly
high barriers are being erected to the entry of new products into the healthcare market.
In addition, many private payors contract with commercial vendors who sell software that provide guidelines that attempt to limit utilization of, and
therefore reimbursement for, certain products deemed to provide limited benefit to existing alternatives. Such organizations may set guidelines that limit
reimbursement or utilization of our products.
Our ability to obtain services, reimbursement or funding may be impacted by possible reductions in federal spending in the United States as well as
globally.
U.S. federal government agencies currently face potentially significant spending reductions. Under the Budget Control Act of 2011, the failure of
Congress to enact deficit reduction measures of at least $1.2 trillion for the years 2013 through 2021 triggered automatic cuts to most federal programs. These
cuts would include aggregate reductions to Medicare payments to providers of up to two percent per fiscal year, which went into effect beginning on April 1,
2013 and will stay in effect through 2030 unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012, which was enacted on
January 1, 2013, among other things, reduced Medicare payments to several providers, including hospitals and imaging centers. The full impact on our
business of these automatic cuts is uncertain. Additionally, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act enacted in 2020 provides
financial support and resources to individuals and businesses affected by the COVID-19
36
pandemic, suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2020, and extended the sequester policy by one year, through
2030, in order to offset the added expense of the 2020 cancellation. The Consolidated Appropriations Act, 2021 extended the suspension of the 2% Medicare
sequester through March 31, 2021. Moreover, the American Taxpayer Relief Act of 2012 among other things, further reduced Medicare payments to several
types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to
recover overpayments to providers from three to five years.
If government spending is reduced, anticipated budgetary shortfalls may also impact the ability of relevant agencies, such as the FDA or the National
Institutes of Health to continue to function at current levels. Amounts allocated to federal grants and contracts may be reduced or eliminated. These reductions
may also impact the ability of relevant agencies to timely review and approve drug research and development, manufacturing, and marketing activities, which
may delay our ability to develop, market and sell any products we may develop. Any reductions in government spending in countries outside the United
States may also impact us negatively, such as by limiting the functioning of international regulatory agencies in countries outside the United States or by
eliminating programs on which we may rely.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even
greater risk if we commercially sell any products that we may develop. If we cannot successfully defend against claims that our product candidates or
products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
•
•
•
•
•
•
•
•
decreased demand for any product candidates or products that we may develop;
injury to our reputation and significant negative media attention;
withdrawal of clinical trial participants;
significant costs to defend the related litigation;
substantial monetary awards to trial participants or patients;
loss of revenue;
reduced resources of our management to pursue our business strategy; and
the inability to commercialize any products that we may develop.
We currently hold $10,000,000 in product liability insurance coverage in the aggregate, with a per incident limit of $10,000,000, which may not be
adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand our clinical trials or if we commence
commercialization of our product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a
reasonable cost or in an amount adequate to satisfy any liability that may arise.
37
Risks Related to Our Dependence on Third Parties
We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and we expect to continue to do so for
commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products at an
acceptable cost and quality, which could delay, prevent or impair our development or commercialization efforts.
We do not own or operate facilities for the manufacture of our product candidates, and we do not have any manufacturing personnel. We currently
have no plans to build our own clinical or commercial scale manufacturing capabilities. We rely, and expect to continue to rely, on third parties for the
manufacture of our product candidates for preclinical and clinical testing and we do not have backup sources of supply established for our candidates. We
review the manufacturing process for each of our candidates and assess the risk to supply and, as appropriate, establish multiple manufacturers and/or
establish stock levels to support future activities and do not believe we are currently substantially dependent on any one third party. Despite the drug
substance and product risk management, this reliance on third parties presents a risk that we will not have sufficient quantities of our product candidates or
products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. Furthermore,
if any third-party in the supply chain for materials used in the production of our product candidates are adversely impacted by restrictions resulting from the
COVID-19 pandemic, our supply chain may be disrupted, limiting the ability of our third-party manufacturers to manufacture our product candidates for our
clinical trials. If our third-party manufacturers were to encounter any manufacturing difficulties or delays due to resource constraints as a result of COVID-19
pandemic, our ability to provide our product candidates to patients in clinical trials, or to provide product for treatment of patients once approved, would be
jeopardized.
Any performance failure on the part of our existing or future manufacturers of drug substance or drug products could delay clinical development or
marketing approval. If current suppliers cannot supply us with our Phase 2 requirements as agreed, we may be required to identify alternative manufacturers,
which would lead us to incur added costs and delays in identifying and qualifying any such replacement.
The formulation used in early studies frequently is not a final formulation for commercialization. Additional changes may be required by the FDA or
other regulatory authorities on specifications and storage conditions. These may require additional studies and may delay our clinical trials.
We expect to rely on third party manufacturers or third party collaborators for the manufacture of commercial supply of any other product candidates
for which our collaborators or we obtain marketing approval.
We also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our
distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, producing additional
losses and depriving us of potential product revenue.
We may be unable to establish any agreements with third party manufacturers or to do so on acceptable terms. Even if we are able to establish
agreements with third party manufacturers, reliance on third party manufacturers entails additional risks, including:
•
•
•
•
reliance on the third party for regulatory compliance and quality assurance;
the possible breach of the manufacturing agreement by the third party;
the possible misappropriation of our proprietary information, including trade secrets and know-how; and
the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
38
Third party manufacturers may not be able to comply with cGMP, regulations or similar regulatory requirements outside the United States. Our
failure, or the failure of our third party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical
holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or
products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.
Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing
facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.
Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future
profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.
We may not successfully engage in strategic transactions, including any additional collaborations we seek, which could adversely affect our ability to
develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management.
The terms of any collaborations may also have impacts on other aspects of our business.
From time to time, we may consider strategic transactions, such as collaborations, acquisitions of companies, asset purchases and out- or in-licensing
of product candidates or technologies that we believe will complement or augment our existing business. In particular, we will evaluate and, if strategically
attractive, seek to enter into additional collaborations, including with major biotechnology or biopharmaceutical companies. The competition for collaborators
is intense, and the negotiation process is time-consuming and complex. Any new collaboration may be on terms that are not optimal for us, and we may not
be able to maintain any new collaboration if, for example, development or approval of a product candidate is delayed, sales of an approved product candidate
do not meet expectations or the collaborator terminates the collaboration. In addition, there have been a significant number of recent business combinations
among large pharmaceutical companies that have resulted in a reduced number of potential future strategic partners. Our ability to reach a definitive
agreement for a collaboration will depend, among other things, upon our assessment of the strategic partner’s resources and expertise, the terms and
conditions of the proposed collaboration and the proposed strategic partner’s evaluation of a number of factors. These factors may include the design or
results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject
product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the
existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of
the challenge, and industry and market conditions generally. Moreover, even if we acquire assets with promising markets or technologies, we may not be able
to realize the benefit of acquiring such assets due to an inability to successfully integrate them with our existing technologies and we may encounter
numerous difficulties in developing, manufacturing and marketing any new products resulting from a strategic acquisition that delay or prevent us from
realizing their expected benefits or enhancing our business.
We cannot assure you that following any such collaboration, or other strategic transaction, we will achieve the expected synergies to justify the
transaction. For example, such transactions may require us to incur non-recurring or other charges, increase our near- and long-term expenditures and pose
significant integration or implementation challenges or disrupt our management or business. These transactions would entail numerous operational and
financial risks, including exposure to unknown liabilities, disruption of our business and diversion of our management’s time and attention in order to manage
a collaboration or develop acquired products, product candidates or technologies, incurrence of substantial debt or dilutive issuances of equity securities to
pay transaction consideration or costs, higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment
charges, increased amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired
business, impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership
and the inability to retain key employees of any acquired business. Also, such strategic alliance, joint venture or acquisition may be prohibited. Collaborations
may also have potential impact on other aspects of our business.
39
Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any
transactions that we do complete may be subject to the foregoing or other risks that would have a material and adverse effect on our business, financial
condition, results of operations and prospects.
We have entered, and may in the future seek to enter, into collaborations with third parties for the development and commercialization of our product
candidates. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential
of our product candidates.
Biopharmaceutical companies are our prior and likely future collaborators for any marketing, distribution, development, licensing or broader
collaboration arrangements. For example, in 2017, we entered into a collaboration with Merck, under which we granted to Merck an option to acquire
KVD001 through a period following completion of a Phase 2 clinical trial, as well as an option to our planned future oral DME programs; those options
expired in February 2020. We expect that in any future collaboration agreements, we would have limited control over the amount and timing of resources that
our collaborators dedicate to the development or commercialization of our product candidates. Moreover, our ability to generate revenues from these
arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements. We face significant
competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for any collaboration will depend, among other things, upon 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 our development program or one or more of our other development programs, delay our potential
development schedule or reduce the scope of research activities, or increase our expenditures and undertake discovery or preclinical development activities
at our own expense. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development
activities, we may not be able to further develop our product candidates or continue to develop our product candidates and our business may be materially and
adversely affected.
Future collaborations we may enter into may involve the following risks:
•
•
•
•
•
•
•
•
•
collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations;
collaborators may not perform their obligations as expected;
changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, may divert resources or
create competing priorities;
collaborators may delay discovery and preclinical development, provide insufficient funding for product development of targets selected
by us, stop or abandon discovery and preclinical development for a product candidate, repeat or conduct new discovery and preclinical
development for a product candidate;
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 than our products;
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 development of its product candidates;
collaborators may not properly maintain or defend their intellectual property rights or intellectual property rights licensed to us or may
use their 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;
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and
collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional
capital to pursue further development or commercialization of the applicable product candidates.
40
Additionally, subject to its contractual obligations to us, if a collaborator is involved in a business combination, the collaborator might deemphasize
or terminate the development of any of our product candidates. If one of our collaborators terminates its agreement with us, we may find it more difficult to
attract new collaborators and the perception of us in the business and financial communities could be adversely affected.
If our collaborations do not result in the successful development of products or product candidates, product candidates could be delayed and we may
need additional resources to develop product candidates. All of the risks relating to product development, regulatory approval and commercialization
described in this proxy statement also apply to the activities of our collaborators.
Risks Related to Our Intellectual Property
If we are unable to obtain and maintain intellectual property protection for our technology and products or if the scope of the intellectual property
protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and
our ability to successfully commercialize our technology and products may be impaired.
Our success depends in large part on our ability to obtain and maintain patent protection in the United States, the European Union, and other countries
with respect to our proprietary technology and products. We seek to protect our proprietary position by filing patent applications in the United States and
abroad related to our novel technologies and product candidates. This patent portfolio includes issued patents and pending patent applications covering
compositions of matter and methods of use.
The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent
applications at a reasonable cost or in a timely manner. We may choose not to seek patent protection for certain innovations and may choose not to pursue
patent protection in certain jurisdictions, and under the laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited
in scope. It is also possible that we will fail to identify patentable aspects of our discovery and preclinical development output before it is too late to obtain
patent protection. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to
maintain the patents, covering technology that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in
a manner consistent with the best interests of our business.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and
has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of
the United States. For example, India and China do not allow patents for methods of treating the human body. Publications of discoveries in the scientific
literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18
months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our
owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. If a third party has also filed
a United States patent application prior to the effective date of the relevant provisions of the America Invents Act (i.e. before March 16, 2013) covering our
product candidates or a similar invention, we may have to participate in an adversarial proceeding, known as an interference, declared by the USPTO to
determine priority of invention in the United States. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are
highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in
part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of
the patent laws in the European Union, the United States and other countries may diminish the value of our patents or narrow the scope of our patent
protection.
Moreover, we may be subject to a third party preissuance submission of prior art to the USPTO, or become involved in opposition, derivation,
reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. An adverse
determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize
41
our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without
infringing third party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could
dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection,
prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned
or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be
challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent
claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing
similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time required
for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such
candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from
commercializing products similar or identical to ours.
The risks described elsewhere pertaining to our patents and other intellectual property rights also apply to the intellectual property rights that we
license, and any failure to obtain, maintain and enforce these rights could have a material adverse effect on our business. In some cases we may not have
control over the prosecution, maintenance or enforcement of the patents that we license, and our licensors may fail to take the steps that we believe are
necessary or desirable in order to obtain, maintain and enforce the licensed patents. Any inability on our part to protect adequately our intellectual property
may have a material adverse effect on our business, operating results and financial position.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other
requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these
requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the
USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. We employ an
outside firm and rely on our outside counsel to pay these fees due to non-U.S. patent agencies. The USPTO and various non-U.S. governmental patent agencies
require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ
reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in
accordance with the applicable rules. However, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market
and this circumstance would have a material adverse effect on our business.
We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and
unsuccessful.
Because competition in our industry is intense, competitors may infringe or otherwise violate our issued patents, patents of our licensors or other
intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time
consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringed their
patents. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the
patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in
question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. We may also
elect to enter into license agreements in order to settle patent infringement claims or to resolve disputes
42
prior to litigation, and any such license agreements may require us to pay royalties and other fees that could be significant. Furthermore, because of the
substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be
compromised by disclosure.
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain
and could have a material adverse effect on the success of our business.
Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our product
candidates and use our proprietary technologies without infringing the proprietary rights of third parties. There is considerable intellectual property litigation
in the biotechnology and pharmaceutical industries. We may become party to, or threatened with, future adversarial proceedings or litigation regarding
intellectual property rights with respect to our products and technology, including interference or derivation proceedings before the USPTO. Third parties may
assert infringement claims against us based on existing patents or patents that may be granted in the future.
If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue
developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at
all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We
could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary
damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from
commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have
misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for some of our technology and product candidates, we also rely on trade secrets, including unpatented know-how,
technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-
disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific
collaborators, contract manufacturers, consultants, advisors and other third parties. We seek to protect our confidential proprietary information, in part, by
entering into confidentiality and invention or patent assignment agreements with our employees and consultants, however, we cannot be certain that such
agreements have been entered into with all relevant parties. Moreover, to the extent we enter into such agreements, any of these parties may breach the
agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is
unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets
were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate them,
from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor,
our competitive position would be harmed.
Risks Related to Employee Matters, Facilities, Managing Growth and Macroeconomic Conditions
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
We are highly dependent on the research and development, clinical and business development expertise of the principal members of our management,
scientific and clinical team. Although we have entered into employment letter agreements with our executive officers, each of them may terminate their
employment with us at any time. We do not maintain “key person” insurance for any of our executives or other employees. The loss of the services of any of
our management team, other key employees and other scientific and medical advisors, including due to illness
43
resulting from COVID-19, and our inability to find suitable replacements, could result in delays in product development and harm our business.
Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success. The loss of the
services of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectives and
seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and
may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to
successfully develop, gain regulatory approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable to
hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies
for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition,
we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our discovery and preclinical development and
commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or
advisory contracts with other entities that may limit their availability to provide services to us. If we are unable to continue to attract and retain high quality
personnel, our ability to pursue our growth strategy will be limited.
We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result,
we may encounter difficulties in managing our growth, which could disrupt our operations.
We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug
development, regulatory affairs and, if any of our product candidates receive marketing approval, sales, marketing and distribution. To manage our anticipated
future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit
and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company
with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.
The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage
growth could delay the execution of our business plans or disrupt our operations.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our operations, and those of our CROs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications
failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, such as the COVID-19 pandemic, and other
natural or man-made disasters or business interruptions, for which we may not have insurance coverage. The occurrence of any of these business disruptions
could seriously harm our operations and financial condition and increase our costs and expenses. In particular, the potential effects on our business due to
the COVID-19 pandemic may be significant and could materially harm our business, operating results and financial condition. We rely on third-party
manufacturers to produce and process our product candidates. Our ability to obtain supplies of our product candidates could be disrupted if the operations of
these suppliers are affected by a man-made or natural disaster or other business interruption. Our operations and financial condition could suffer in the event
of a natural or man-made disaster near our headquarters in Cambridge, Massachusetts or our research facility in Porton Down, United Kingdom.
Our business and operations would suffer in the event of system failures, cyberattacks or a deficiency in our cybersecurity.
Our internal computer systems and those of our CROs, collaborators and third parties on whom we rely are vulnerable to damage from computer
viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Furthermore, we have little or no control over the
security measures and computer systems of our third party collaborators. The risk of a security breach or disruption, particularly through cyberattacks or
cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has
44
generally increased as the number, intensity, and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the
prevalent use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential
information or other intellectual property. The costs to us or our CROs or other contractors or consultants we may utilize to mitigate network security
problems, bugs, viruses, worms, phishing attempts, malicious software programs and security vulnerabilities could be significant, and while we have
implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful,
and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. In May
2019, we were notified by one of our vendors that they suffered a security breach and some of our data was among the information stolen by an unknown
third party. We have taken certain actions in response to that theft and we do not anticipate significant disruption to our business or future prospects. However,
in the future, if such an event were to occur and lead to exposure of sensitive information or cause interruptions in our operations or our third party
collaborators, it could result in a material disruption of our drug development programs and potential financial losses. For example, the loss of research data
could delay development of our product candidates and the loss of clinical trial data from completed or ongoing or planned clinical trials could result in
delays in our regulatory approval efforts and we may incur substantial costs to attempt to recover or reproduce the data. If any disruption or security breach
resulted in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability
and/or the further development of our product candidates could be delayed or impaired.
In addition, such a breach may require notification to governmental agencies, the media or individuals pursuant to various federal and state privacy
and security laws, if applicable, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information
Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing rules and regulations, as well as regulations promulgated by the
Federal Trade Commission and state breach notification laws. We would also be exposed to a risk of loss or litigation and potential liability under laws,
regulations and contracts that protect the privacy and security of personal information. We would also be exposed to a risk of loss or litigation and potential
liability, which could materially adversely affect our business, reputation, results of operations, financial condition and prospects.
We also depend on our information technology infrastructure for communications among our personnel, contractors, consultants and vendors. System
failures or outages, including any potential disruptions due to significantly increased global demand on certain cloud based systems during the COVID-19
pandemic, could also compromise our ability to perform these functions in a timely manner, which could harm our ability to conduct business or delay our
financial reporting.
Risks Related to Ownership of Our Common Stock
Our stock price is volatile and our stockholders may not be able to resell shares of our common stock at or above the price they paid.
The trading price of our common stock is highly volatile and could be subject to wide fluctuations in response to various factors, many of which are
beyond our control. In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the
COVID-19 pandemic. Factors affecting the market price of our common stock include those discussed in this “Risk Factors” section of this Annual Report on
Form 10-K and others such as:
•
•
•
•
•
announcement of a strategic transaction or other significant events for us or our competitors;
our decision to initiate a clinical trial or not to initiate a clinical trial;
announcements of significant changes in our business or operations, including the decision not to pursue drug development programs;
additions or departures of key personnel;
adverse results or delays in clinical trials;
45
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
changes in reimbursement or third party coverage of treatments for HAE or DME, or changes to treatment recommendations or guidelines
applicable to the treatment of HAE or DME;
announcements relating to collaboration partnerships or other strategic transactions undertaken by us;
announcements of therapeutic innovations or new products by us or our competitors;
adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities;
changes or developments in laws or regulations applicable to any of our product candidates;
any adverse changes to our relationship with any manufacturers or suppliers;
the success of our testing and clinical trials;
the success of our efforts to acquire or license or discover additional product candidates;
any intellectual property infringement actions in which we may become involved;
announcements concerning our competitors or the pharmaceutical industry in general;
achievement of expected product sales and profitability;
manufacture, supply or distribution shortages;
actual or anticipated fluctuations in our operating results;
FDA or other regulatory actions affecting us or our industry or other healthcare reform measures in the United States, the United Kingdom or
the European Union;
changes in financial estimates or recommendations by securities analysts;
trading volume of our common stock;
sales of our common stock by us, our executive officers and directors or our stockholders in the future;
general economic and market conditions and overall fluctuations in the United States equity markets, including due to global pandemics such as
COVID-19; and
other events or factors, many of which are beyond our control.
In addition, the stock markets in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have
experienced extreme volatility that may have been unrelated to the operating performance of the issuer. These broad market fluctuations may adversely affect
the trading price or liquidity of our common stock. In the past, when the market price of a stock has been volatile, holders of that stock have sometimes
instituted securities class action litigation against the issuer. If any of our stockholders were to bring such a lawsuit against us, we could incur substantial costs
defending the lawsuit and the attention of our management would be diverted from the operation of our business, which could seriously harm our financial
position. Any adverse determination in litigation could also subject us to significant liabilities.
We incur significant costs as a result of operating as a public company, and our management devotes substantial time to compliance initiatives. We may
fail to comply with the rules that apply to public companies, including Section 404 of the Sarbanes-Oxley Act of 2002, which could result in sanctions or
other penalties that would harm our business.
We incur significant legal, accounting and other expenses as a public company, including costs resulting from public company reporting obligations
under the Exchange Act, and regulations regarding corporate governance practices. The listing requirements of The NASDAQ Global Market require that we
satisfy certain corporate governance requirements relating to director independence, distributing annual and interim reports, stockholder meetings, approvals
and voting, soliciting proxies, conflicts of interest and a code of conduct. Our management and other personnel have devoted, and will continue to need to
devote, a substantial amount of time to ensure that we comply with all of these requirements. Moreover, the reporting requirements, rules and regulations
increase our legal and financial compliance costs and make some activities more time consuming and costly. Any changes we
46
make to comply with these obligations may not be sufficient to allow us to satisfy our obligations as a public company on a timely basis, or at all. These
reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also
make it more difficult for us to attract and retain qualified persons to serve on our board of directors or board committees or to serve as executive officers, or
to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.
We are subject to Section 404 of The Sarbanes-Oxley Act of 2002 (“Section 404”), and the related rules of the SEC which generally require our
management and independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting. Section 404 requires
an annual management assessment of the effectiveness of our internal control over financial reporting. Effective April 27, 2020, the SEC adopted amendments to
the “accelerated filer” and “large accelerated filer” definitions in Rule 12b-2 under the Securities and Exchange Act of 1934. The amendments exclude from the
“accelerated filer” and “large accelerated filer” definitions an issuer that is eligible to be a smaller reporting company and that had annual revenues of less than
$100 million in the most recent fiscal year for which audited financial statements are available. We determined that our Company does not meet the accelerated or
large accelerated filer definitions as of April 30, 2021. For so long as we remain a smaller reporting company and a non-accelerated filer, we intend to take
advantage of certain exemptions from various reporting requirements that are applicable to public companies, including, but not limited to, not being required as a
non-accelerated filer to comply with the auditor attestation requirements of Section 404(b). An independent assessment by our independent registered public
accounting firm of the effectiveness of internal control over financial reporting could detect problems that our management’s assessment might not. Undetected
material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of
remediation.
During the course of the review and testing of our internal control for the purpose of providing the reports required by these rules, we may identify
deficiencies and be unable to remediate them before we must provide the required reports. Furthermore, if we have a material weakness in our internal control
over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated. We or our independent
registered public accounting firm may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, which
could harm our operating results, cause investors to lose confidence in our reported financial information and cause the trading price of our stock to fall. In
addition, as a public company we are required to file accurate and timely quarterly and annual reports with the SEC under the Exchange Act. Any failure to
report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from The NASDAQ Global Market or
other adverse consequences that would materially harm our business.
In addition, if we lose our status as a “non-accelerated filer,” we will be required to have our independent registered public accounting firm attest to
the effectiveness of internal control over financial reporting. If our independent registered public accounting firm is unable to express an opinion as to the
effectiveness of our internal control over financial reporting once we are an accelerated filer or a large accelerated filer, investors may lose confidence in the
accuracy and completeness of our financial reports, and the market price of our common stock could be negatively affected.
Shareholder Activism Could Cause Material Disruption to Our Business.
Publicly traded companies have increasingly become subject to campaigns by activist investors advocating corporate actions such as actions related
to environment, social and governance (“ESG”) matters, financial restructuring, increased borrowing, dividends, share repurchases or even sales of assets or
the entire company. Responding to proxy contests and other actions by such activist investors or others in the future could be costly and time-consuming,
disrupt our operations and divert the attention of our board of directors and senior management from the pursuit of our business strategies, which could
adversely affect our results of operations and financial condition.
Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to
entrenchment of management.
47
Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could significantly reduce the value
of our shares to a potential acquirer or delay or prevent changes in control or changes in our management without the consent of our board of directors. The
provisions in our charter documents include the following:
•
•
•
•
•
•
•
•
•
•
a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a
majority of our board of directors;
no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the
resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
the required approval of at least 66 2/3% of the shares entitled to vote to remove a director for cause, and the prohibition on removal of
directors without cause;
the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the price and other terms of those
shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a
hostile acquirer;
the ability of our board of directors to alter our bylaws without obtaining stockholder approval;
the required approval of at least 66 2/3% of the shares entitled to vote at an election of directors to adopt, amend or repeal certain provisions
of our bylaws and our amended and restated certificate of incorporation regarding the election and removal of directors;
a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our
stockholders;
the requirement that a special meeting of stockholders may be called only by or at the direction of our board of directors pursuant to a resolution
adopted by a majority of the total number of directors that our board of directors would have if there were no vacancies, which may delay the
ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and
advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters
to be acted upon at a stockholders’ meeting, which may discourage or deter 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 us. In addition, these provisions would apply even if we
were to receive an offer that some stockholders may consider beneficial.
We are also subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law. Under Section 203, a
corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for
three years or, among other exceptions, the board of directors has approved the transaction.
Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third party claims against us and may
reduce the amount of money available to us.
Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will indemnify our directors and officers, in
each case to the fullest extent permitted by Delaware law.
In addition, as permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws and our indemnification
agreements that we have entered into with our directors and officers provide that:
•
we will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the
fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith
and in a manner such person
48
reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable
cause to believe such person’s conduct was unlawful.
•
•
•
•
•
we may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.
we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such
directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
we will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that
person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a
right to indemnification.
the rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements
with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
we may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers,
employees and agents.
Our ability to use our net operating losses to offset future taxable income, if any, may be subject to certain limitations.
In general, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change”
(generally defined as a greater than 50-percentage-point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year
period) is subject to limitations on its ability to utilize its pre-change net operating losses, or NOLs, to offset future taxable income. We have experienced
ownership changes that substantially limit our use of the NOLs available to us for U.S. federal income tax purposes. If we undergo additional ownership changes
(some of which changes may be outside our control), our ability to utilize our NOLs could be further limited by Section 382 of the Code. Our NOLs may also be
impaired under state law. Accordingly, we may not be able to utilize a material portion of our NOLs. Furthermore, our ability to utilize our NOLs is conditioned
upon our attaining profitability and generating U.S. federal taxable income. We have incurred net losses since our inception and anticipate that we will continue to
incur significant losses for the foreseeable future; thus, we do not know whether or when we will generate the U.S. federal taxable income necessary to utilize our
NOLs.
The Tax Cuts and Jobs Act of 2017, or the TCJA, changed both the federal deferred tax value of the net operating loss carryforwards and the rules of
utilization of federal net operating loss carryforwards. Under the TCJA, net operating loss carryforwards generated in years after 2017 will only be available to
offset 80% of future taxable income in any single year but will not expire. However, the CARES Act temporarily repealed the 80% taxable income limitation for
tax years beginning before January 1, 2021; net operating loss carried forward generated from 2018 or later and carryforwards to taxable years beginning after
December 31, 2020 will be subject to the 80% limitation. Also, under the CARES Act, net operating losses arising in 2018, 2019 and 2020 can be carried back 5
years.
General Risk Factors
Unstable or unfavorable global market and economic conditions may have adverse consequences on our business, financial condition and stock price.
Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. Global credit
and financial markets have experienced extreme volatility and disruptions in the past several years, including severely diminished liquidity and credit
availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. We
cannot assure you that further deterioration in credit and financial markets and confidence in economic conditions will not occur. Our general business
strategy and stock price may be adversely affected by any such economic downturn, volatile business environment or large-scale unpredictable or unstable
market conditions, including a prolonged government shutdown or as a result of a global pandemic such as the COVID-19 pandemic. While the potential
economic impact brought by and the duration of the pandemic may be difficult to assess or
49
predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access
capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the spread of COVID-19
could materially and adversely affect our business and the value of our common stock.
If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive.
Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial
performance and stock price and could require us to delay or abandon development plans. In addition, there is a risk that one or more of our current service
providers, manufacturers and other partners may not survive these difficult economic times, which could directly affect our ability to attain our operating
goals on schedule and on budget.
If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse opinion regarding our stock, our stock
price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our
business. If any analysts who cover us issue an adverse regarding us, our business model, our intellectual property or our stock performance, or if our clinical
trials and operating results fail to meet the expectations of analysts, our stock price may decline. If any of these analysts cease coverage of us or fail to publish
reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
We do not currently intend to pay dividends on our common stock, and, consequently, our stockholders’ ability to achieve a return on their investment will
depend on appreciation in the price of our common stock.
We do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We currently intend to invest our future
earnings, if any, to fund our growth. Therefore, our stockholders are not likely to receive any dividends on their common stock for the foreseeable future.
Since we do not intend to pay dividends, our stockholders’ ability to receive a return on their investment will depend on any future appreciation in the market
value of our common stock. There is no guarantee that our common stock will appreciate or even maintain the price at which our holders have purchased it.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Our corporate headquarters is located in Cambridge, Massachusetts where we occupy approximately 8,300 square feet of office space under a lease
agreement that runs through September 2028. We maintain approximately 13,400 square feet of office and research laboratory space in Porton Down, United
Kingdom, under a lease agreement that runs through April 2028. We also maintain approximately 1,000 square feet of leased research laboratory space in
Boston, Massachusetts.
We believe that our current and planned facilities are adequate to meet our needs for the foreseeable future, and that, should it be needed, suitable
additional space will be available to accommodate any such expansion of our operations.
Item 3. Legal Proceedings.
From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. We are
currently not aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or
operating results.
50
Item 4. Mine Safety Disclosures.
Not Applicable.
51
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
PART II
Market Information
Our common stock is traded on the NASDAQ Global Market under the symbol “KALV.”
Holders
As of July 2, 2021, there were 24 holders of record of our common stock. The actual number of holders is greater than this number of record holders
and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
Dividends
We have never declared or paid cash dividends on our capital stock. We do not expect to pay dividends on our common stock for the foreseeable
future. Instead, we anticipate that all of our earnings, if any, will be used for the operation and growth of our business. Any future determination to declare
cash dividends would be subject to the discretion of our board of directors and would depend upon various factors, including our results of operations,
financial condition and capital requirements, restrictions that may be imposed by applicable law and our contracts and other factors deemed relevant by our
board of directors.
Recent Sales of Unregistered Securities
None.
Securities Authorized for Issuance under Equity Compensation Plans
The information required by this item regarding equity compensation plan information is set forth in Item 12 of this Annual Report on Form 10-K
and incorporated herein by reference.
Item 6. Selected Financial Data.
The following selected financial data should be read in conjunction with the Consolidated Financial Statements and the Notes thereto and the section
captioned “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included elsewhere in this Annual Report on Form 10-
K.
52
The Balance Sheet Data at April 30, 2021 and 2020 and the Statement of Operations Data for each of the three years ended April 30, 2021, 2020, and
2019 have been derived from the audited Consolidated Financial Statements for such years, included elsewhere in this Annual Report on Form 10-K. The
Balance Sheet Data at April 30, 2019, 2018, and 2017, and the Statement of Operations Data for each of the periods ended April 30, 2018 and 2017 have been
derived from audited consolidated financial statements for such years not included in this Annual Report on Form 10-K.
Consolidated Statement of Operations Data:
Revenue
Operating expenses
Research and development
General and administrative
Total operating expenses
Operating loss
Total other income
Loss before income taxes
Income tax (benefit) expense
Net loss
Net loss per share, basic and diluted
Weighted average common shares outstanding, basic and diluted
Consolidated Balance Sheet Data:
Cash and cash equivalents
Marketable securities
Property and equipment, net
Working capital
Total assets
Total liabilities
Stockholders' equity (deficit)
2021
For the Years Ended April 30,
2018
2019
2020
(in thousands, except share and per share data)
2017
$
— $
12,690 $
16,127 $
8,394 $
1,504
41,286
16,637
57,923
(57,923)
11,679
(46,244)
—
(46,244) $
40,194
13,029
53,223
(40,533)
11,293
(29,240)
(124)
(29,116) $
35,021
10,926
45,947
(29,820)
9,128
(20,692)
124
(20,816) $
18,237
8,862
27,099
(18,705)
2,900
(15,805)
—
(15,805) $
$
(1.53) $
$
19,094,440 17,748,666 15,080,863 10,321,780
(1.64) $
(2.42) $
(1.38) $
12,666
11,177
23,843
(22,339)
3,736
(18,603)
—
(18,603)
(4.47)
4,646,764
2021
2020
April 30,
2019
(in thousands)
2018
2017
$
50,592 $
198,337
1,791
254,490
272,013
14,820
257,193
15,789 $
51,925
2,043
80,976
92,529
8,777
83,752
32,006 $
68,805
2,413
97,494
118,132
21,394
96,738
51,055 $
—
1,836
36,164
61,389
34,136
27,253
30,950
—
97
31,180
34,345
3,018
31,327
53
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis should be read in conjunction with our audited consolidated financial statements and the related notes that
appear elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Exchange Act. These statements are often identified by the use of words
such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue,” and similar expressions or variations. These
statements are based on the belief and assumptions of our management based on information currently available to management, reflecting our current
expectations that involve risks and uncertainties. Actual results and the timing of certain events may differ materially from those discussed or implied in these
forward-looking statements due to a number of factors, including, but not limited to, the impact of the current COVID-19 pandemic on our business and
future financial performance, and those set forth in the section entitled “Risk Factors” and elsewhere in this Annual Report on Form 10-K. You should review
the risk factors for a more complete understanding of the risks associated with an investment in our securities. For further information regarding forward-
looking statements, please refer to the “Special Note Regarding Forward-Looking Statements” at the beginning of Part I of this Annual Report on Form 10-
K. Our fiscal year end is April 30, and references throughout this Annual Report to a given fiscal year are to the twelve months ended on that date.
Management Overview
We are a clinical stage pharmaceutical company focused on the discovery, development and commercialization of small molecule protease inhibitors
for diseases with significant unmet need. We apply our insights into the chemistry and biology of proteases to develop orally delivered, small molecule
inhibitors with high selectivity, potency and bioavailability that we believe will make them successful treatments for diseases. We have used these capabilities
to develop a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors targeting hereditary angioedema (“HAE”) and diabetic macular edema
(“DME”). In late 2020, we also announced a novel, oral Factor XIIa (“Factor XIIa”) inhibitor program, which initially is being advanced to provide a next
generation of HAE therapeutics and which also offers the opportunity for expansion into other high unmet need indications in the future.
Our most advanced program for HAE is KVD900, which is being developed as a potential on-demand oral therapy for treatment of HAE attacks. In
February 2021 we announced positive data from a Phase 2 clinical trial of KVD900 and have scheduled an end-of-phase 2 meeting with the FDA to confirm
our plans for the Phase 3 program. KVD824 is our next oral program to be developed as a twice-daily potential oral prophylactic treatment for HAE.
KVD001, our first product candidate to treat DME, completed a Phase 2 clinical trial in December 2019. We also intend to develop an oral therapy
for this indication, which we believe could dramatically improve the standard of care for patients, since all current therapies are delivered by injection into the
eye. We continue to believe that the results of the KVD001 Phase 2 study suggest a patient population in which plasma kallikrein inhibition may yield vision
benefits, and we intend to explore further development opportunities for this and oral DME programs over time.
We have devoted substantially all our efforts to research and development, including clinical trials of our product candidates. We have not completed
the development of any product candidates. Pharmaceutical drug product candidates, like those being developed by us, require approvals from the FDA or
foreign regulatory agencies prior to commercial sales. There can be no assurance that any product candidates will receive the necessary approvals and any
failure to receive approval or delay in approval may have a material adverse impact on our business and financial results. We are subject to a number of risks
and uncertainties similar to those of other life science companies developing new products, including, among others, the risks related to the necessity to
obtain adequate additional financing, to successfully develop product candidates, to obtain regulatory approval of product candidates, to comply with
government regulations, to successfully commercialize our potential products, to the protection of proprietary technology and to our dependence on key
individuals.
The COVID-19 pandemic and its adverse effects continue to affect the locations where we, our manufacturers, suppliers or third-party business
partners conduct business. Although we have continued our operations and clinical trials to date, we have experienced, and if there are renewed or continued
closures of business in the European Union, the United States or the United Kingdom, or other impacted areas, we may continue to experience, further
54
delays in our preclinical studies or planned clinical trials, which could materially adversely impact our business, results of operations and overall financial
performance in future periods. In addition, we may experience impact from changes in how we and companies worldwide conduct business due to the
COVID-19 pandemic, including but not limited to continued restrictions on travel and in-person meetings, delays in future site activations and future
enrollment of clinical trials, prioritization of hospital resources toward the COVID-19 pandemic effort, delays in review by the FDA and comparable foreign
regulatory agencies, and disruptions in our supply chain for our product candidates. As of the filing date of this Annual Report on Form 10-K, the extent to
which COVID-19 may impact our financial condition, results of operations or guidance is uncertain. The effect of the COVID-19 pandemic will not be fully
reflected in our results of operations and overall financial performance until future periods. See the section entitled “Risk Factors” included elsewhere in this
report for further discussion of the possible impact of the COVID-19 pandemic on our business.
In February 2021, we completed a public offering of our common stock and issued 6,181,250 shares at a price of $36.00 per share (“the Offering”),
including the underwriters’ full exercise of their option to purchase 806,250 additional shares of common stock. The total net proceeds to us were $209.2
million, after deducting underwriting discounts, commissions, and other offering expenses.
On May 21, 2021, we entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co. (the “Sales Agreement”), which
established an at-the-market offering program pursuant to which we may offer and sell shares of our common stock from time to time. The Sales Agreement
provides for the sale of shares of our common stock having an aggregate offering price of up to $100.0 million.
We have funded operations primarily through the issuance of capital stock, including from the Offering in February 2021. As of April 30, 2021, we
had an accumulated deficit of $167.8 million and $248.9 million of cash, cash equivalents and available for sale securities. Our working capital is anticipated
to fund our operations for at least the next twelve months from the date the audited consolidated financial statements are issued.
Financial Overview
Revenue
We have not generated any revenue in the current fiscal year. Our revenue recognized in the prior fiscal year consists of up-front fees from the
option agreement with Merck Sharpe & Dohme Corp. which was entered into in 2017 (the “Merck Option Agreement”) and expired in February 2020.
Research and Development Expenses
Research and development expenses primarily consist of costs associated with our research activities, including the preclinical and clinical
development of product candidates. We contract with clinical research organizations to manage our clinical trials under agreed upon budgets for each study,
with oversight by our clinical program managers. All research and development costs are expensed as incurred.
Costs for certain research and development activities, such as manufacturing development activities and clinical studies are recognized based on the
contracted amounts adjusted for the percentage of work completed to date. Payments for these activities are based on the terms of the contractual
arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid or accrued expenses. We
defer and capitalize non-refundable advance payments made for research and development activities until the related goods are delivered or the related
services are performed.
We expect to continue to incur substantial expenses related to development activities for the foreseeable future as we conduct clinical development,
manufacturing and toxicology studies. 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, additional drug manufacturing requirements, and
later stage toxicology studies such as carcinogenicity studies. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory
approval is costly and time consuming. The probability of success for each product candidate is affected by numerous factors, including preclinical data,
clinical
55
data, competition, manufacturing capability and commercial viability. Accordingly, we may never succeed in achieving marketing approval for any of our
product candidates.
Completion dates and costs for clinical development programs as well as our research program can vary significantly for each current and future
product candidate and are difficult to predict. As a result, we cannot estimate with any degree of certainty the costs associated with development of our
product candidates at this point in time. We anticipate making determinations as to which programs and product candidates to pursue and how much funding
to direct to each program and product candidate on an ongoing basis in response to the scientific success of early research programs, results of ongoing and
future clinical trials, our ability to enter into collaborative agreements with respect to programs or potential product candidates, as well as ongoing
assessments as to the commercial potential of each current or future product candidate.
General and Administrative Expenses
General and administrative expenses consist primarily of the costs associated with general management, obtaining and maintaining our patent
portfolio, professional fees for accounting, auditing, consulting and legal services, and general overhead expenses.
We expect ongoing general and administrative expenses to increase in the future as we expand our operating activities, maintain and expand the
patent portfolio and incur additional costs associated with the management of a public company and maintain compliance with exchange listing and
requirements of the SEC. These potential increases will likely include management costs, legal fees, accounting fees, directors’ and officers’ liability
insurance premiums and expenses associated with investor relations, among others.
Other Income
Other income consists of bank and investment interest, research and development tax credits from the United Kingdom government’s tax incentive
programs set up to encourage research and development in the United Kingdom, and realized and unrealized exchange rate gains/losses on cash held in
foreign currencies and transactions settled in foreign currencies.
Income Taxes
We historically have incurred net losses and had no corporation tax liabilities. We file U.S. Federal tax returns, as well as certain state returns. We
also file tax returns in the United Kingdom. Under the U.K. government’s research and development tax incentive scheme, we have incurred qualifying
research and development expenses and filed claims for research and development tax credits in accordance with the relevant tax legislation. The research and
development tax credits are paid out to us in cash and reported as other income.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have
prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of our financial statements
requires us 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 our financial statements and the reported revenue and expenses during the reported periods. We evaluate these estimates and judgments, including
those described below, on an ongoing basis. We base our estimates on historical experience, known trends and events, contractual milestones 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 value of
assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
See also Note 2, Summary of Significant Accounting Policies to our Consolidated Financial Statements included in this Annual Report on Form 10-K, which
discusses the significant assumptions used in applying our accounting policies. Those accounting policies and estimates that we deem to be critical are as
follows:
56
Preclinical and Clinical Trial Accruals
We base our accrued expenses related to clinical trials on estimates of patient enrollment and related expenses at clinical investigator sites as well as
estimates for services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations that conduct
and manage clinical trials on our behalf. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts
and circumstances known to us and based on contracted amounts applied to the level of patient enrollment and activity according to the clinical trial protocol.
If timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we modify our estimates of accrued
expenses accordingly on a prospective basis.
If we do not identify costs that we have begun to incur, or if we underestimate or overestimate the level of services performed or the costs of these
services, our actual expenses could differ from our estimates.
Results of Operations
This section of this Annual Report on Form 10-K generally discusses fiscal years 2021 and 2020 items and year-to-year comparisons between fiscal
years 2021 and 2020. Discussions of fiscal years 2020 items and year-to-year comparisons between fiscal years 2020 and 2019 that are not included in this
Annual Report on Form 10-K can be found in Part II, Item 7 of our Annual Report on Form 10-K for the fiscal year ended April 30, 2020, which was filed
with the SEC on July 1, 2020.
Year Ended April 30, 2021 Compared to Year Ended April 30, 2020
The following table sets forth the key components of our results of operations for the years ended April 30, 2021 and 2020:
Income
Revenue
Operating Expenses
Research and development expenses
General and administrative expenses
Other income
Interest, exchange rate gain and other income
Years Ended
April 30,
2021
2020
(in thousands)
Increase
(Decrease)
$
— $
12,690
$
(12,690)
41,286
16,637
40,194
13,029
1,092
3,608
11,679
11,293
386
Revenue. No revenue was recognized in the year ended April 30, 2021 compared to $12.7 million in the prior year. The $12.7 million of revenue in
the prior year was attributable to the revenue recognized from the up-front payment from the Merck Option Agreement and the decrease in the current year
was due to the expiration of that agreement in February 2020.
Research and Development Expenses. Research and development expenses were $41.3 million in the year ended April 30, 2021 compared to
$40.2 million in the prior year. The increase of $1.1 million was primarily due to an increase of $4.4 million in spending on the KVD824 program and an
increase of $2.1 million in spending on the KVD900 program. The increased costs were offset by a decrease of $4.5 million related to the KVD001 program
and a $0.9 million decrease related to preclinical activities compared to the prior year. The impact of exchange rates on research and development expenses
was an increase of approximately $1.2 million compared to the prior year, which is reflected in the figures above.
57
Research and development expenses by major programs or categories were as follows:
Years Ended
April 30,
2021
2020
Increase
(Decrease)
KVD001
KVD900
KVD824
Preclinical activities
Total
$
$
$
(in thousands)
253
12,530
9,255
19,248
41,286
$
4,719 $
10,441
4,857
20,177
40,194 $
(4,466)
2,089
4,398
(929)
1,092
-95%
20%
91%
-5%
3%
Expenses for the KVD001 program decreased primarily due to the completion of the KVD001 Phase 2 clinical trial. We anticipate that expenses for
the KVD001 program will remain low at current levels as we determine next steps for the KVD001 program.
Expenses for the KVD900 program increased primarily due to the Phase 2 clinical trial which was completed in December. We anticipate that these
expenses will increase above current levels as we initiate the Phase 3 clinical trial for KVD900.
Expenses for the KVD824 program increased primarily due to an increase in clinical trial expenses. We anticipate that the expenses for the KVD824
program will increase above current levels as we initiate the Phase 2 clinical trial for KVD824.
Expenses for preclinical activities decreased primarily due to a decrease in manufacturing expenses. We anticipate that expenses will increase from
current levels as we continue to advance our oral Factor XIIa inhibitor program towards the clinical stage of development.
General and Administrative Expenses. General and administrative expenses were $16.6 million in the year ended April 30, 2021 compared to $13.0
million in the prior fiscal year. The increase of $3.6 million was primarily due to an increase of $2.8 million in compensation related expenses, an increase of
$0.4 million in professional fees, an increase of $0.3 million in insurance costs, an increase of $0.2 million in facility costs, and an increase of $0.1 million in
other administrative expenses, offset by a decrease of $0.2 million in travel costs, compared to the prior year. We anticipate that expenses will continue at or
above current levels as we continue to support the growth of the Company.
Other Income. Other income was $11.7 million for the year ended April 30, 2021 compared to $11.3 million in the prior fiscal year. The increase of
$0.4 million was primarily due to an increase in foreign currency exchange rate gains of $1.2 million from transactions denominated in foreign currencies in
our U.K. subsidiary, and an increase of $0.3 million in income from research and development tax credits, offset by a decrease in interest income of $0.9
million, and a decrease in realized gains from available for sale securities of $0.2 million, compared to the prior year.
Liquidity and Capital Resources
We have incurred losses since inception and cash outflows from operating activities for the years ended April 30, 2021 and 2020. We have funded
operations primarily through the issuance of capital stock, including our February 2021 Offering that generated net proceeds of $209.2 million. We had an
accumulated deficit of $167.8 million as of April 30, 2021. We anticipate that we will continue to incur net losses for the foreseeable future as we continue the
research and development efforts on our product candidates, hire additional staff, including clinical, scientific, operational, and financial and management
personnel.
58
Cash Flows
The following table shows a summary of the net cash flow activity for the years ended April 30, 2021 and 2020:
Cash flows used in operating activities
Cash flows provided by (used in) investing activities
Cash flows provided by financing activities
Effect of exchange rate changes on cash
Net increase (decrease) in cash and cash equivalents
Net cash used in operating activities
Years Ended
April 30,
2021
2020
(in thousands)
$
$
(30,171) $
(147,654)
212,117
511
34,803 $
(44,816)
16,753
11,584
262
(16,217)
Net cash used in operating activities was $30.2 million for the year ended April 30, 2021 and primarily consisted of a net loss of $46.2 million
adjusted for stock-based compensation of $7.1 million, cash flow favorable increases from the research and development tax credit receivable of $7.5 million,
and other changes in net working capital. The research and development tax credit receivable decreased due to the timing of the receipt of prior year tax
credits offset by new tax credit deferrals compared to the prior year. Net cash used in operating activities was $44.8 million for the year ended April 30, 2020
and primarily consisted of a net loss of $29.1 million adjusted for stock-based compensation of $4.4 million, an increase in the research and development tax
credit receivable of $5.8 million, a decrease in deferred revenue of $12.7 million, and other changes in net working capital. The increase in cash used in
operating activities was due to increased spending on operating expenses compared to the prior year.
Net cash provided by (used in) investing activities
Net cash used in investing activities was $147.7 million for the year ended April 30, 2021 and consisted of purchases of marketable securities of
$201.2 million and acquisitions of property and equipment of $0.1 million offset by sales and maturities of marketable securities of $53.6 million. Net cash
provided by investing activities was $16.8 million for the year ended April 30, 2020 and consisted of sales and maturities of marketable securities of $66.8
million offset by purchases of marketable securities of $49.8 million and acquisitions of property and equipment of $0.2 million.
Net cash provided by financing activities
Net cash provided by financing activities was $212.1 million for the year ended April 30, 2021 and primarily consisted of the net proceeds received
in the February 2021 public offering of common stock. Net cash provided by financing activities was $11.6 million for the year ended April 30, 2020 and
primarily consisted of the sale of common stock pursuant to an existing at-the-market sales agreement.
Operating Capital Requirements
To date, we have not generated any revenues from the sale of products, and we do not have any products that have been approved for
commercialization. We do not expect to generate significant product revenue unless and until we obtain regulatory approval for, and commercialize, one of
our current or future product candidates. We anticipate that we will continue to incur losses for the foreseeable future, and we expect the losses to increase as
we continue the development of, and seek regulatory approvals for, product candidates, and begin to commercialize any approved products. We are subject to
all of the risks inherent in the development of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and
other unknown factors that may adversely affect our business. We currently anticipate that, based upon our operating plans and existing capital resources, we
have sufficient funding to operate for at least the next 12 months.
Until such time, if ever, as we can generate substantial revenues, we expect to finance our cash needs through a combination of equity and debt
financings, collaborations, strategic partnerships and licensing arrangements. To
59
the extent that additional capital is raised through the sale of stock or convertible debt securities, the ownership interest of existing stockholders will be
diluted, and the terms of these newly issued securities may include liquidation or other preferences that adversely affect the rights of common stockholders.
Debt financing, if available, may involve agreements that include increased fixed payment obligations and covenants limiting or restricting our ability to take
specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, selling or licensing intellectual property rights and other
operating restrictions that could adversely impact our ability to conduct business. Additional fundraising through collaborations, strategic partnerships or
licensing arrangements with third parties may require us to relinquish valuable rights to product candidates, including our other technologies, future revenue
streams or research programs, or grant licenses on terms that may not be favorable. If we are unable to raise additional funds when needed, we may be
required to delay, limit, reduce or terminate product development or future commercialization efforts or grant rights to develop and commercialize other
product candidates even if we would otherwise prefer to develop and commercialize such product candidates internally.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in the rules and regulations of the SEC.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows
is disclosed in Note 2 to our consolidated financial statements.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
Because of the short-term nature of the bank deposit arrangements and the very low interest rates prevailing in the United Kingdom and the United
States, a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operations. We do
not believe that our cash or cash equivalents have significant risk of default or illiquidity.
We invest in marketable securities in accordance with our investment policy. The primary objectives of our investment policy are to preserve capital,
maintain proper liquidity to meet operating needs and maximize yields. We invest our excess cash in securities issued by financial institutions, commercial
companies, and government agencies that management believes to be of high credit quality in order to limit the amount of credit exposure. Some of the
securities we invest in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to
fluctuate.
Our investment exposure to market risk for changes in interest rates relates to the increase or decrease in the amount of interest income we can earn
on our portfolio, changes in the market value due to changes in interest rates and other market factors as well as the increase or decrease in any realized gains
and losses. Our investment portfolio includes only marketable securities and instruments with active secondary or resale markets to help ensure portfolio
liquidity. An increase or decrease in interest rates along the entire interest rate yield curve would not significantly affect the fair value of our interest sensitive
financial instruments, but may affect our future earnings and cash flows. We generally intend to hold our fixed income investments to maturity and therefore
do not expect that our operating results, financial position or cash flows will be materially impacted due to a sudden change in interest rates. However, our
future investment income may fall short of expectations due to changes in interest rates, or we may suffer losses in principal if forced to sell securities which
have declined in market value due to changes in interest rates or other factors, such as changes in credit risk related to the securities’ issuers. To minimize this
risk, we schedule our investments to have maturities that coincide with our expected cash flow needs, thus avoiding the need to redeem an investment prior to
its maturity date. Accordingly, we do not believe that we have material exposure to interest rate risk arising from our investments. We have not realized any
significant losses from our investments.
60
Foreign Exchange Rate Risk
We maintain cash balances primarily in both U.S. Dollars (“USD”) and British Pound Sterling (“GBP”) to fund ongoing operations and manage
foreign exchange risk. Cash, cash equivalents and marketable securities as of April 30, 2021 was composed of $50.6 million in cash and cash equivalents
which consisted of readily available checking and bank deposit accounts held primarily in both USD and GBP and $198.3 million of USD denominated
marketable securities. As of April 30, 2021, 69% of cash and cash equivalents were held in USD and 31% in GBP. We currently incur significant expense
denominated in foreign currencies, primarily in GBP. We do not currently engage in exchange rate hedging or other similar activities to address our exchange
rate risk. A 10% change in the exchange rate would result in an immaterial net gain or loss.
Effects of Inflation
We do not believe that inflation and changing prices had a significant impact on the results of operations for any periods presented herein.
Item 8. Financial Statements and Supplementary Data.
The financial statements required to be filed are listed in Item 15 of this Annual Report on Form 10-K and incorporated herein by reference.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) under the Exchange Act of 1934, our management, under the supervision and with the participation of our Chief
Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of
April 30, 2021. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and
other procedures of a company 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 information required to be disclosed by a company in the reports that
it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal
financial officers, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in
evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of April 30,
2021 our Chief Executive Officer and Chief Financial Officer have concluded that, as of April 30, 2021, our disclosure controls and procedures were effective
at the reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial
reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, our principal
executive and principal financial officers and effected by our board of directors, management and other personnel to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our internal control over
financial reporting includes those policies and procedures that:
•
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;
61
•
•
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S.
GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
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.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems
determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. 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.
Our management, with the participation of our principal executive officer and principal financial officer, assessed the effectiveness of our internal
control over financial reporting as of April 30, 2021. In making this assessment, management used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in its 2013 Internal Control – Integrated Framework. Based on our assessment, our management has
concluded that, as of April 30, 2021, our internal control over financial reporting is effective based on those criteria.
This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over
financial reporting. Effective April 27, 2020, the SEC adopted amendments to the “accelerated filer” and “large accelerated filer” definitions in Rule 12b-2
under the Exchange Act. The amendments exclude from the accelerated and large accelerated filer definitions an issuer that is eligible to be a smaller
reporting company and that had annual revenues of less than $100 million in the most recent fiscal year for which audited financial statements are available.
We determined that our Company does not meet the accelerated or large accelerated filer definitions as of April 30, 2021. For as long as we remain a non-
accelerated filer, we intend to take advantage of the exemption permitting us not to comply with the requirement under Section 404(b) of the Sarbanes-Oxley
Act of 2002 that our independent registered public accounting firm provide an attestation on the management’s assessment of the effectiveness of our internal
control over financial reporting.
Changes in Internal Controls over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the quarter ended April 30, 2021 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
None.
62
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by the Item is set forth in our 2021 Proxy Statement to be filed with the SEC within 120 days of April 30, 2021, and is
incorporated by reference into this Annual Report on Form 10-K.
Item 11. Executive Compensation.
The information required by the Item is set forth in our 2021 Proxy Statement to be filed with the SEC within 120 days of April 30, 2021, and is
incorporated by reference into this Annual Report on Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by Item 403 of Regulation S-K is set forth in our 2021 Proxy Statement to be filed with the SEC within 120 days of April
30, 2021, and is incorporated by reference into this Annual Report on Form 10-K.
Securities Authorized for Issuance under Equity Compensation Plans
The following table provides information as of April 30, 2021, with respect to the shares of our common stock that may be issued under our existing
equity compensation plans.
Number of
Securities to
be Issued
upon
Exercise of
Outstanding
Options,
Warrants
and Rights
(a)
2,816,543 $
20,055 $
2,836,598
Weighted-
average
Exercise
Price of
Outstanding
Options,
Warrants
and Rights
(b)
13.24
10.21
Number of
Securities
Remaining
Available for
Future
Issuance
Under Equity
Compensation
Plans
(excluding
securities
reflected in
column (a))
(c)
1,302,038
—
1,302,038
Plan Category
Equity compensation plans approved by stockholders (1)(2)
Equity compensation plans not approved by stockholders (3)
Total
(1)
Includes 111,866 shares subject to options issued pursuant to the Carbylan 2015 Incentive Plan, 100,263 shares subject to options issued
pursuant to the Enterprise Management Incentives Plan and 2,604,414 shares subject to options issued pursuant to the 2017 Equity Incentive
Plan. The 2017 Equity Incentive Plan contains provisions that provide for automatic increases to the authorized number of shares as of
January 1st of each year of the first ten calendar years during the term of such plan, by the lesser of (a) 4% of the issued and outstanding
shares of stock on the last day of the immediately preceding calendar year and (b) such number of shares as approved by our board of
directors. There are 853,743 shares available for future issuance under the 2017 Equity Incentive Plan as of April 30, 2021. In January 2019,
the board of directors authorized the first offering period under the 2017 Employee Stock Purchase Plan to run from February 15, 2019 to
June 30, 2019. All subsequent offering periods will run for six month periods ending June 30 and December 31 of each year. The 2017
Employee Stock Purchase Plan contains provisions that provide for automatic increases to the authorized number of shares as of January 1st
for the first ten calendar years after the first Offering Date (as defined therein) by the number of shares equal to one percent of the total
number of outstanding shares of common stock on the immediately preceding December 31 (rounded down to the nearest whole share) or a
lesser number of shares determined by our board of directors. There are 448,295 shares of common stock available for future issuance under
the 2017 Employee Stock Purchase Plan as of April 30, 2021.
63
(2)
Shares reserved for issuance under the 2017 Equity Incentive Plan may be granted as restricted stock, restricted share units and other equity
awards, as well as for grants of stock options and stock appreciation rights.
(3)
Consists of options issued pursuant to inducement grants.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by the Item is set forth in our 2020 Proxy Statement to be filed with the SEC within 120 days of April 30, 2021, and is
incorporated by reference into this Annual Report on Form 10-K.
Item 14. Principal Accounting Fees and Services.
The information required by the Item is set forth in our 2021 Proxy Statement to be filed with the SEC within 120 days of April 30, 2021, and is
incorporated by reference into this Annual Report on Form 10-K.
64
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a)
The following documents are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K:
(1)
(2)
(3)
Consolidated Financial Statements. See Index to Financial Statements beginning on page F-1 of this Annual Report, which are
incorporated by reference.
Financial Statement Schedules. All schedules have been omitted because the information required to be presented in them is not
applicable or is shown in the financial statements or related notes.
Exhibits. We have filed, or incorporated into this Annual Report on Form 10-K by reference, the exhibits listed on the accompanying
Exhibit Index.
(b)
Exhibits.
Incorporated by reference
Description of Document
Amended and Restated Certificate of Incorporation.
Certificate of Amendment to the Restated Certificate of
Incorporation.
Certificate of Amendment (Name Change) to the
Restated Certificate of Incorporation.
Amended and Restated Bylaws, as amended as of June
24, 2021.
Form of Common Stock Certificate.
Description of Registrant’s Securities
Form
8-K
8-K
8-K
8-K
File
No.
001-36830
001-36830
001-36830
001-36830
S-1/A
10-K
333-201278
001-36830
Form of Indemnification Agreement.
S-1
333-201278
Filed
Herewith
Exhibit
3.1
3.1
3.2
3.1
4.2
10.24
10.14
10.3
Filing Date
April 16, 2015
November 23,
2016
November 23,
2016
June 30, 2021
January 23, 2015
July 16, 2019
December 29,
2014
January 23, 2015
Carbylan 2015 Incentive Plan and forms of award
agreements.
2017 Equity Incentive Plan.
S-1/A
333-201278
DEF 14A
001-36830
Appendix A
March 2, 2017
2017 Employee Stock Purchase Plan.
Amended and Restated Employment Agreement
between the Registrant and T. Andrew Crockett, dated
June 26, 2019.
Amended and Restated Employment Agreement
between the Registrant and Benjamin L. Palleiko, dated
June 26, 2019.
Forms of Equity Agreements under the 2017 Equity
Incentive Plan.
Office Lease Agreement by and between the Registrant
and 55 Cambridge Parkway, LLC, dated May 30, 2017.
Underlease by and between the Registrant and
Wiltshire Council, dated April 30, 2018.
DEF 14A
10-K
001-36830
001-36830
Appendix B March 2, 2017
10.5
July 16, 2019
10-K
001-36830
10.6
July 16, 2019
8-K
001-36830
99.1
June 29, 2018
10-K
001-36830
10.12
July 27, 2017
8-K
001-36830
10.1
May 2, 2018
65
Exhibit
Number
3.1
3.2
3.3
3.4
4.1
4.2
10.1#
10.2#
10.3#
10.4#
10.5#
10.6#
10.7#
10.8
10.9
Exhibit
Number
10.10#
10.11#
10.12#
10.13#
10.14#
10.15#
10.16#
10.17#
10.18#
10.19
10.20
10.21
21.1
23.1
24.1
31.1
Description of Document
Amended and Restated Executive Employment
Agreement dated June 26, 2019, by and between the
Registrant and Andreas Maetzel.
Enrollment/Change Form under the 2017 Employee
Stock Purchase Plan.
Service Agreement dated November 1, 2015, by and
between KalVista. Pharmaceuticals Ltd and Dr.
Christopher M. Yea.
Amendment, dated January 31, 2019, to the Service
Agreement dated November 1, 2015 by and between
KalVista. Pharmaceuticals Ltd and Dr. Christopher M.
Yea.
Equity Acceleration Letter, dated March 11, 2019 by
and between KalVista Pharmaceuticals Ltd and Dr.
Christopher M. Yea.
Amended and Restated Executive Employment
Agreement by and between Registrant and Edward
Feener.
Executive Employment Agreement by and between
Registrant and Michael Smith.
Amendment, dated June 26, 2019, to the Service
Agreement dated November 1, 2015 by and between
KalVista. Pharmaceuticals Ltd and Dr. Christopher M.
Yea.
Executive Employment Agreement by and between
Registrant and Dr. Paul K. Audhya, MD
First Amendment of Lease, dated November 20, 2020,
to the Office Lease Agreement by and between the
Registrant and 55 Cambridge Parkway, LLC, dated
May 19, 2017
Controlled Equity Offering Sales Agreement, dated
May 21, 2021, between the Registrant and Cantor
Fitzgerald & Co.
2021 Equity Inducement Plan and forms of agreement
Subsidiaries of the Registrant.
Consent of Deloitte & Touche LLP.
Power of Attorney. (See signature page hereto.)
Certification of Principal Executive Officer, pursuant to
Rule 13a-14(a)/15d-14(a), as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
Incorporated by reference
Form
10-K
File
No.
001-36830
Exhibit
10.13
Filing Date
July 16, 2019
Filed
Herewith
S-8
333-237059
99.4
March 10, 2020
10-K
001-36830
10.15
July 30, 2018
10-Q
001-36830
10.1
March 14, 2019
10-Q
001-36830
10.2
March 14, 2019
10-K
001-36830
10.21
July 16, 2019
10-K
10-K
001-36830
001-36830
10.22
10.23
July 16, 2019
July 16, 2019
10-Q
001-36830
10.1
December 10,
2020
S-3
333-256378
1.2
May 21, 2021
10-K
001-36830
21.1
July 1, 2020
66
X
X
X
X
X
Exhibit
Number
31.2
32.1*
32.2*
101.INS
101.SCH
101.CAL
101.DEF
101.LAB
101.PRE
Description of Document
Certification of Principal Financial Officer, pursuant to
Rule 13a-14(a)/15d-14(a), as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Chief Executive Officer, pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
Certification of Chief Financial Officer, pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
XBRL Instance Document.
XBRL Taxonomy Extension Schema Document.
XBRL Taxonomy Extension Calculation Linkbase
Document.
XBRL Taxonomy Extension Definition Linkbase
Document.
XBRL Taxonomy Extension Labels Linkbase
Document.
XBRL Taxonomy Extension Presentation Linkbase
Document.
Form
File
No.
Exhibit
Filing Date
Incorporated by reference
Filed
Herewith
X
X
X
X
X
X
X
X
X
#
*
Management contract or compensatory plan or arrangement.
This certification is deemed not filed for purpose of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be
deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
Item 16. Form 10-K Summary.
None.
67
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Annual
Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
Date: July 13, 2021
Date: July 13, 2021
KalVista Pharmaceuticals, Inc.
By:
By:
/s/ T. Andrew Crockett
T. Andrew Crockett
Chief Executive Officer
/s/ Benjamin L. Palleiko
Benjamin L. Palleiko
Chief Business Officer and Chief Financial Officer
POWER OF ATTORNEY
Each person whose individual signature appears below hereby authorizes and appoints Thomas Andrew Crockett and Benjamin L. Palleiko, and each
of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act
in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any
and all amendments to this annual report on Form 10-K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and
every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do
or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on
behalf of the Registrant in the capacities and on the dates indicated.
Name
/s/ T. Andrew Crockett
T. Andrew Crockett
/s/ Benjamin L Palleiko
Benjamin L. Palleiko
/s/ Martin Edwards
Martin Edwards, M.D.
/s/ Albert Cha
Albert Cha, M.D., Ph.D.
/s/ Brian J.G. Pereira
Brian J.G. Pereira, M.D.
/s/ Daniel Soland
Daniel Soland
/s/Nancy Stuart
Nancy Stuart
/s/ Edward W. Unkart
Edward W. Unkart
Title
Chief Executive Officer and Director
(Principal Executive Officer)
Chief Business Officer and Chief Financial Officer
(Principal Financial and Accounting Officer)
Director and Chairman
Director
Director
Director
Director
Director
68
Date
July 13, 2021
July 13, 2021
July 13, 2021
July 13, 2021
July 13, 2021
July 13, 2021
July 13, 2021
July 13, 2021
KALVISTA PHARMACEUTICALS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Loss
Consolidated Statements of Changes in Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F-1
F-2
F-3
F-4
F-5
F-6
F-7
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of KalVista Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of KalVista Pharmaceuticals, Inc. and subsidiaries (the "Company") as of April 30, 2021 and
2020, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the three years in
the period ended April 30, 2021, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present
fairly, in all material respects, the financial position of the Company as of April 30, 2021 and 2020, and the results of its operations and its cash flows for each
of the three years in the period ended April 30, 2021, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's 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 in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the 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 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
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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to
the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
July 13, 2021
We have served as the Company's auditor since 2016.
F-2
KALVISTA PHARMACEUTICALS, INC.
Consolidated Balance Sheets
April 30, 2021 and 2020
(in thousands except share and per share amounts)
Assets
Current assets:
Cash and cash equivalents
Marketable securities
Research and development tax credit receivable
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Right of use assets
Other assets
Total assets
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
Accrued expenses
Lease liability - current portion
Total current liabilities
Long-term liabilities:
Lease liability - net of current portion
Total long-term liabilities
Commitments and contingencies (Note 8)
Stockholders’ equity:
Common stock, $0.001 par value, 100,000,000 authorized
Shares issued and outstanding: 24,422,531 and 17,845,599 at April 30, 2021 and 2020, respectively
Additional paid-in capital
Accumulated deficit
Accumulated other comprehensive loss
Total stockholders’ equity
Total liabilities and stockholders’ equity
See notes to consolidated financial statements.
F-3
2021
2020
$
$
$
$
50,592 $
198,337
10,418
4,917
264,264
1,791
5,758
200
272,013 $
1,981 $
6,930
863
9,774
5,046
5,046
24
426,437
(167,836)
(1,432)
257,193
272,013 $
15,789
51,925
16,527
4,455
88,696
2,043
1,612
178
92,529
1,677
5,455
588
7,720
1,057
1,057
18
207,208
(121,592)
(1,882)
83,752
92,529
KALVISTA PHARMACEUTICALS, INC.
Consolidated Statements of Operations and Comprehensive Loss
Years Ended April 30, 2021, 2020 and 2019
(in thousands, except share and per share amounts)
Revenue
Operating expenses:
Research and development
General and administrative
Total operating expenses
Operating loss
Other income:
Interest income
Foreign currency exchange gain (loss)
Other income
Total other income
Loss before income taxes
Income tax (benefit) expense
Net loss
Other comprehensive income (loss):
Foreign currency translation adjustments
Unrealized holding gain (loss) on available-for-sale securities
Reclassification adjustment for realized (gain) on available for sale securities included
in net loss
Total other comprehensive income (loss):
Comprehensive loss
Net loss per share, basic and diluted
Weighted average common shares outstanding, basic and diluted
2021
2020
2019
$
— $
12,690 $
16,127
41,286
16,637
57,923
(57,923)
903
847
9,929
11,679
(46,244)
—
(46,244)
1,076
(473)
$
40,194
13,029
53,223
(40,533)
1,830
(367)
9,830
11,293
(29,240)
(124)
(29,116)
59
285
(153)
450 $
$
(2.42) $
(45,794)
19,094,440
(300)
44
(29,072)
(1.64)
17,748,666
$
$
$
$
35,021
10,926
45,947
(29,820)
1,397
49
7,682
9,128
(20,692)
124
(20,816)
(1,257)
440
—
(817)
(21,633)
(1.38)
15,080,863
$
$
$
$
See notes to consolidated financial statements.
F-4
KALVISTA PHARMACEUTICALS, INC.
Consolidated Statements of Changes in Stockholders’ Equity
Years Ended April 30, 2021, 2020 and 2019
(in thousands, except share and per share amounts)
Balance at May 1, 2018
Issuance of common stock
Issuance of common stock from exercise of stock
options
Stock-based compensation expense
Net loss
Foreign currency translation adjustment
Unrealized holding gains from available-for-sale
securities, net of reclassification for realized gains
Balance at April 30, 2019
Issuance of common stock, net of issuance costs of
$123
Issuance of common stock from exercise of stock
options
Stock-based compensation expense
Net loss
Foreign currency translation adjustment
Unrealized holding gains from available for sale
securities
Reclassification adjustment for realized (gain) on
available-for-sale securities included in net loss
Balance at April 30, 2020
Common Stock
Shares
Amount
Paid-in
Capital
Accumulated
Deficit
Additional
Accumulated
Other
Comprehensive
Loss
Total
Stockholders’
Equity
10,799,895 $
6,382,320
11 $
6
100,011 $
87,904
(71,660) $
—
(1,109) $
—
27,253
87,910
95,535
—
—
—
—
17,277,750
—
—
—
—
—
17
242
2,966
—
—
—
—
(20,816)
—
—
191,123
—
(92,476)
—
—
—
(1,257)
440
(1,926)
242
2,966
(20,816)
(1,257)
440
96,738
527,221
1
11,421
—
—
11,422
40,628
—
—
—
—
—
—
—
216
4,448
—
—
—
—
(29,116)
—
—
—
—
59
216
4,448
(29,116)
59
—
—
—
—
285
285
—
17,845,599
—
18
—
207,208
—
(121,592)
(300)
(1,882)
(300)
83,752
Issuance of common stock from public offering, net of
issuance costs of $239
Issuance of common shares under an at-the-market
sales agreement, net of issuance costs of $132
Issuance of common stock from equity incentive plans
Stock-based compensation expense
Net loss
Foreign currency translation adjustment
Unrealized holding losses from available for sale
securities
Reclassification adjustment for realized (gain) on
available-for-sale securities included in net loss
Balance at April 30, 2021
6,181,250
6
208,928
—
—
208,934
97,332
298,350
—
—
—
—
—
—
—
—
1,648
1,535
7,118
—
—
—
—
—
(46,244)
—
—
—
—
—
1,076
1,648
1,535
7,118
(46,244)
1,076
—
—
—
—
(473)
(473)
—
24,422,531 $
—
24 $
—
426,437 $
—
(167,836) $
(153)
(1,432) $
(153)
257,193
See notes to consolidated financial statements.
F-5
KALVISTA PHARMACEUTICALS, INC.
Consolidated Statements of Cash Flows
Years Ended April 30, 2021, 2020 and 2019
(in thousands)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
2021
2020
2019
$
(46,244) $
(29,116) $
(20,816)
Depreciation and amortization
Stock-based compensation expense
Realized gain from sale of marketable securities
Non-cash operating lease expense
Amortization of premium on available for sale securities
Foreign currency exchange (gain) loss
Changes in operating assets and liabilities:
Research and development tax credit receivable
Prepaid expenses and other current assets
Other assets
Accounts payable
Accrued expenses
Deferred revenue
Net cash used in operating activities
Cash flows from investing activities:
Purchases of available for sale securities
Sales and maturities of available for sale securities
Acquisition of property and equipment
Net cash provided by (used in) investing activities
Cash flows from financing activities:
Issuance of common stock, net of offering expenses
Issuance of common stock from equity incentive plans
Finance lease principal payments
Net cash provided by financing activities
Effect of exchange rate changes on cash and cash equivalents
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents, beginning year
Cash and cash equivalents, end of year
Supplemental disclosures of cash flow information:
Right of use assets obtained in exchange for operating lease liabilities
$
$
See notes to consolidated financial statements.
F-6
537
7,118
(153)
114
685
(574)
7,457
(222)
(22)
150
983
—
(30,171)
(201,210)
53,638
(82)
(147,654)
210,582
1,535
—
212,117
511
34,803
15,789
50,592 $
512
4,448
(300)
13
193
74
(5,781)
(1,112)
(5)
(1,004)
(48)
(12,690)
(44,816)
(49,797)
66,770
(220)
16,753
11,422
216
(54)
11,584
262
(16,217)
32,006
15,789 $
378
2,966
(23)
—
—
(80)
(4,883)
(1,979)
—
1,534
2,665
(16,127)
(36,365)
(79,889)
11,548
(1,081)
(69,422)
87,910
242
(209)
87,943
(1,205)
(19,049)
51,055
32,006
4,784 $
309 $
—
KALVISTA PHARMACEUTICALS, INC.
Notes to Consolidated Financial Statements
Note 1. Description of Business and Basis of Presentation
KalVista Pharmaceuticals, Inc. (together with its subsidiaries, “KalVista” or the “Company”) is a clinical stage pharmaceutical company focused on
the discovery, development and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The Company’s first
product candidates are inhibitors of plasma kallikrein being developed for two indications: hereditary angioedema (“HAE”) and diabetic macular edema
(“DME”). The Company applies its insights into the chemistry of proteases and, with current programs, the biology of the plasma kallikrein system, to
develop small molecule inhibitors with high selectivity, potency and bioavailability that it believes will make them successful treatments for HAE and DME.
KalVista has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and advanced multiple drug candidates into clinical trials in
order to create best-in-class oral therapies for both HAE and DME. In February 2021 the Company announced positive data from a Phase 2 clinical study of
KVD900 as a potential on-demand therapy for acute HAE attacks. KVD824 is KalVista’s next oral program to be developed for HAE, currently being
developed as a twice-daily potential oral prophylactic treatment for HAE. In the case of DME, KVD001, an intravitreally delivered plasma kallikrein inhibitor
in development for potential treatment of DME, completed a Phase 2 clinical trial in 2019.
The Company’s headquarters is located in Cambridge, Massachusetts, with additional offices and research activities located in Porton Down, United
Kingdom, Salt Lake City, Utah and Boston, Massachusetts.
The Company has devoted substantially all of its efforts to research and development, including clinical trials of its product candidates. The Company
has not completed the development of any product candidates. Pharmaceutical drug product candidates, like those being developed by the Company, require
approvals from the U.S. Food and Drug Administration (“FDA”) or foreign regulatory agencies prior to commercial sales. There can be no assurance that any
product candidates will receive the necessary approvals and any failure to receive approval or delay in approval may have a material adverse impact on the
Company’s business and financial results. The Company has not yet commenced commercial operations. The Company is subject to a number of risks and
uncertainties similar to those of other life science companies developing new products, including, among others, the risks related to the necessity to obtain
adequate additional financing, to successfully develop product candidates, to obtain regulatory approval of product candidates, to comply with government
regulations, to successfully commercialize its potential products, to the protection of proprietary technology and to the dependence on key individuals.
The Company has funded its operations primarily through the issuance of stock. As of April 30, 2021, the Company had an accumulated deficit of
$167.8 million and cash, cash equivalents and marketable securities totaling $248.9 million. The Company’s working capital, primarily cash, cash equivalents
and marketable securities, is anticipated to fund the Company’s operations for at least 12 months beyond the date of issuance of the consolidated financial
statements.
The Company will need to expend substantial resources for research and development, including costs associated with the clinical testing of its
product candidates and will need to obtain additional financing to fund its operations and to conduct trials for its product candidates. The Company will seek
to finance future cash needs through equity offerings, future grants, corporate partnerships and product sales.
F-7
The Company has never been profitable and has incurred significant operating losses in each year since inception. Cash requirements may vary
materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and
technical advances, patent developments, regulatory changes or other developments. Additional financing will be required to continue operations after the
Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance
that any such financing can be obtained by the Company, or if obtained, what the terms thereof may be, or that any amount that the Company is able to raise
will be adequate to support the Company’s working capital requirements until it achieves profitable operations. If adequate additional working capital is not
secured when needed, the Company may be required to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible
and/or suspend or curtail planned research programs. Any of these actions could materially harm the Company’s business and prospects.
The outbreak of COVID-19 has evolved into a global pandemic. The extent of the impact of COVID-19 on the Company’s operational and financial
performance will depend on certain developments, including the duration and spread of the outbreak, impact on clinical studies, employee or industry events,
and effect on suppliers and manufacturers, or impact on the healthcare systems, all of which are uncertain and cannot be predicted. The Company has
experienced and may continue to experience constrained supplies of product candidates or, with respect to the Company’s clinical trials, delays in enrollment,
site initiation, participant dosing, distribution of clinical trial materials, study monitoring and data analysis that could materially adversely impact the
Company’s business, results of operations and overall financial performance in future periods. Any such delays to the Company’s planned clinical timelines
for KVD900 and KVD824 could also impact the use and sufficiency of existing cash reserves, and the Company may be required to raise additional capital
earlier than previously planned. The Company may be unable to raise additional capital if and when needed, which may result in further delays or suspension
of our development plans. The extent to which COVID-19 may impact the Company’s financial condition, results of operations or cash flows is uncertain.
The impact of COVID-19 could have a material adverse impact on the Company’s operations and will continue to be monitored closely.
Note 2. Summary of Significant Accounting Policies
Principles of consolidation: The accompanying consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Use of estimates: The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles (“U.S.
GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets
and liabilities, at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual
results could differ from these estimates.
Foreign currency: The functional currency of the Company’s U.K. subsidiary is the British Pound Sterling. Assets and liabilities of the foreign
subsidiary are translated using the exchange rate existing on each respective balance sheet date. Revenues and expenses are translated using average exchange
rates prevailing throughout the year. The translation adjustments resulting from this process are included as a component of the accumulated other
comprehensive loss. In addition, the Company engages in transactions and holds balances denominated and settled in currencies other than the functional
currency, and transaction gains or losses are recorded in the consolidated statement of operations.
Segment Reporting: The chief operating decision maker, the CEO, manages the Company’s operations as a single operating segment for the
purposes of assessing performance and making operating decisions.
Recent Accounting Pronouncements: In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments, which amends the impairment model by requiring entities to use a forward-looking approach on
expected losses to estimate credit losses on certain financial instruments, including trade receivables and available-for-sale debt securities. The new guidance
is effective for the Company as of May 1, 2023. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position,
results of operations, and cash flows.
F-8
Cash and cash equivalents: Cash and cash equivalents consist of bank deposits and money market accounts. Cash equivalents are carried at cost
which approximates fair value due to their short-term nature. The Company considers all highly liquid investments with an original maturity of 90 days or
less to be cash equivalents.
The Company maintains its cash and cash equivalent balances with financial institutions that management believes are of high credit quality. The
Company’s cash and cash equivalent accounts at times may exceed federally insured limits. The Company has not experienced any losses in such accounts.
The Company believes it is not exposed to any significant credit risk of cash and cash equivalents.
Research and development tax credit receivable: The research and development tax credit receivable consists of research and development
expenses that have been claimed as research and development tax credits in accordance with the relevant U.K. tax legislation. These refundable tax credits are
payable to the Company in cash and are carried on the consolidated balance sheet at the amount claimed and expected to be received from the U.K.
government within the next 12 months.
Property and equipment: Property and equipment are stated at cost less accumulated depreciation. Expenditures for repairs and maintenance are
charged to expense as incurred. Upon retirement or sale, the costs of the assets disposed of and the related accumulated depreciation are eliminated from the
accounts and any resulting gain or loss is reflected in the statement of operations. Depreciation is provided using the straight-line method over the estimated
useful lives of the assets, which are as follows:
Asset Classification
Machinery and equipment
Computer equipment
Leasehold improvements
Estimated Useful Life
1-5 Years
3-4 Years
15 Years or term of lease, if shorter
The Company assesses the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying value of such
assets, or asset groups, may not be recoverable. Whenever events or changes in circumstances suggest that the carrying amount of long-lived assets may not
be recoverable, the future undiscounted cash flows expected to be generated by the asset, or asset groups, from its use or eventual disposition is estimated. If
the sum of the expected future undiscounted cash flows is less than the carrying amount of those assets, or asset groups, an impairment loss is recognized
based on the excess of the carrying amount over the fair value of the assets, or asset groups.
Revenue recognition: The Company recognizes revenue from research and development arrangements. In accordance with Accounting Standards
Codification (“ASC”) 606, “Revenue from Contracts with Customers,” revenue is recognized when a customer obtains control of promised goods or services.
The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these goods and services.
Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both
capable of being distinct, whereby the customer can benefit from the good or service either on its own or together with other available resources, and are
distinct in the context of the contract, whereby the transfer of the good or service is separately identifiable from other promises in the contract. To the extent a
contract includes multiple promised goods and services, the Company must apply judgment to determine whether promised goods and services are capable of
being distinct and distinct in the context of the contract. If these criteria are not met, the promised goods and services are accounted for as a combined
performance obligation.
The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services
to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should
be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable
consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of
cumulative revenue under the contract will not occur.
F-9
Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that
contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative standalone selling price
basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of
a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative standalone
selling prices.
The Company satisfies performance obligations either over time or at a point in time. Revenue is recognized over time if either: (1) the customer
simultaneously receives and consumes the benefits provided by the entity’s performance, (2) the entity’s performance creates or enhances an asset that the
customer controls as the asset is created or enhanced or (3) the entity’s performance does not create an asset with an alternative use to the entity and the entity
has an enforceable right to payment for performance completed to date. If the entity does not satisfy a performance obligation over time, the related
performance obligation is satisfied at a point in time by transferring the control of a promised good or service to a customer. ASC 606 requires the Company
to select a single revenue recognition method for the performance obligation that faithfully depicts the Company’s performance in transferring control of the
goods and services. The guidance allows for two methods to measure progress toward complete satisfaction of a performance obligation, depending on the
facts and circumstances:
Output methods - recognize revenue on the basis of direct measurements of the value to the customer of the goods or services transferred to date
relative to the remaining goods or services promised under the contract (e.g., surveys of performance completed to date, appraisals of results achieved,
milestones reached, time elapsed, and units of produced or units delivered); and
Input methods - recognize revenue on the basis of the entity’s efforts or inputs to the satisfaction of a performance obligation (e.g., resources
consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation.
Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance
obligations identified in the arrangement, the Company must consider the nature of the intellectual property to which the customer will have rights (i.e.,
access at a point in time or benefit of intellectual property enhancements over time). The Company recognizes revenue from non-refundable, up-front fees
allocated to the license at a point in time/over the period the license is transferred to the customer and the customer is able to use and benefit from the license.
For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine
whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for
purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress at each reporting period and, if
necessary, adjusts the measure of performance and related revenue recognition.
Milestone payments: At the inception of each arrangement that includes development and regulatory milestone payments for promised goods and
services, the Company evaluates the circumstances of whether the milestones will be reached and estimates the amount to be included in the transaction price
that will not cause a significant revenue reversal.
Up-front payments: Up-front payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue
recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as
accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing
component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services
to the customer will be one year or less.
Merck Arrangement: On October 6, 2017, the Company entered into an Option Agreement with a customer to acquire certain intellectual property
that was in development and granted that customer a non-exclusive license to
F-10
use the compounds solely for research purposes, while the Company was required to use its diligent efforts to develop the intellectual property through the
completion of Phase 2 clinical trials. Under the terms of this arrangement, the Company received an upfront fee of $37 million in November 2017, which was
recognized as a contract liability upon receipt. The Company evaluated the revenue arrangement and determined that there were two performance obligations
and the amounts allocated to each performance obligation were recognized as revenue using an input method. On February 10, 2020, the Company announced
that the arrangement had expired, and the Company concluded that the performance obligations were completed in the fourth quarter of the fiscal year ended
April 30, 2020. For the fiscal years ended April 30, 2020 and 2019, the Company recognized $12.7 million and $16.1 million, respectively.
Contract balances: The Company recognizes a contract asset when the Company transfers goods or services to a customer before the customer pays
consideration or before payment is due, excluding any amounts presented as a receivable (i.e., accounts receivable). A contract asset is an entity’s right to
consideration in exchange for goods or services that the entity has transferred to a customer. The contract liabilities (i.e., deferred revenue) primarily relate to
contracts where the Company has received payment but has not yet satisfied the related performance obligations. The advance consideration received from
customers for research and development services and/or licenses is a contract liability, recorded as deferred revenue, until the underlying performance
obligations are transferred to the customer.
Research and development: Research and development costs are expensed as incurred and include, but are not limited to:
•
•
•
Employee-related expenses including salaries, benefits, travel, and share-based compensation expense for research and development
personnel;
Costs associated with preclinical and development activities;
Costs associated with regulatory operations.
Costs for certain research and development activities, such as manufacturing development activities and clinical studies are recognized based on the
contracted amounts adjusted for the percentage of work completed to date. Payments for these activities are based on the terms of the contractual
arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid or accrued expenses. The
Company defers and capitalizes non-refundable advance payments made by the Company for research and development activities until the related goods are
delivered or the related services are performed.
Income taxes: The Company accounts for income taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities
are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities
and their respective income tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. The Company evaluates the realizability of its deferred tax assets and establishes
a valuation allowance when it is more likely than not that all or a portion of deferred tax assets will not be realized. The Company has provided a full
valuation allowance on its deferred tax assets.
Relative to accounting for uncertainties in tax positions, the Company recognizes the tax benefit of tax positions to the extent that the benefit will
more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the
tax position as well as consideration of the available facts and circumstances. For those tax positions where it is more likely than not that a tax benefit will be
sustained, the Company records the largest amount of tax benefit with a greater than 50% likelihood of being realized upon ultimate settlement with a taxing
authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be
sustained, the Company does not recognize a tax benefit in the financial statements.
The Company recognizes interest and penalties related to uncertain tax positions, if any, as a component of income tax expense. As the Company has
no uncertain tax positions, there were no interest or penalties charges recognized in the statement of operations for any years.
F-11
Stock-based compensation: The Company accounts for stock-based compensation arrangements at fair value. The fair value is recognized over the
period during which the recipient is required to provide services (usually the vesting period), on a straight-line basis. Forfeitures are recognized as they are
incurred.
Net loss per share: Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding
during the period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common shares and the number
of potential dilutive common share equivalents outstanding during the period. Potential dilutive common share equivalents consist of the incremental
common shares issuable upon the exercise of share options and awards.
Potential dilutive common share equivalents consist of:
Stock options and awards
2021
April 30,
2020
2019
2,836,598 2,320,677 1,784,338
In computing diluted earnings per share, common share equivalents are not considered in periods in which a net loss is reported, as the inclusion of
the common share equivalents would be anti-dilutive. As a result, there is no difference between the Company’s basic and diluted loss per share in the periods
presented.
Fair value measurement: The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure
fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs
used to measure fair value are as follows: Level 1, quoted market prices in active markets for identical assets or liabilities; Level 2, observable inputs other
than quoted market prices included in Level 1, such as quoted market prices for similar instruments or for markets that are not active or other inputs that are
observable or can be corroborated by observable market data; and Level 3, unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use
significant unobservable inputs. These fair values are obtained from independent pricing services, which utilize Level 1 and Level 2 inputs.
The following tables summarize the cash equivalents and marketable securities measured at fair value on a recurring basis as of April 30, 2021 and
2020:
Level 1
Level 2
Level 3
Balance at April 30, 2021
2,985
$
—
$
—
$
Cash equivalents
Marketable securities:
Corporate debt securities
U.S. government agency securities
Cash equivalents
Marketable securities:
Corporate debt securities
U.S. government agency securities
$
$
$
$
—
—
—
$
2,985
157,873
40,464
201,322
Level 3
Balance at April 30, 2020
—
$
—
—
—
$
650
39,216
12,709
52,575
—
—
2,985
157,873
40,464
$ 198,337
Level 1
Level 2
650
$
—
—
—
650
39,216
12,709
51,925
$
$
$
$
F-12
Note 3. Marketable Securities
The objectives of the Company’s investment policy are to ensure the safety and preservation of invested funds, as well as to maintain liquidity
sufficient to meet cash flow requirements. The Company invests its excess cash in securities issued by financial institutions, commercial companies, and
government agencies that management believes to be of high credit quality in order to limit the amount of its credit exposure. The Company has not realized
any significant losses from its investments.
The Company classifies all of its investments as available for sale. Unrealized gains and losses on investments are recognized in accumulated
comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The
Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent
temporary declines primarily resulting from interest rate changes. Realized gains and losses are included in other income in the consolidated statements of
operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a trade date basis.
The following tables summarize the fair value of the Company’s investments by type as of April 30, 2021 and 2020:
Corporate debt securities
Obligations of the U.S. Government and its agencies
Total investments
Corporate debt securities
Obligations of the U.S. Government and its agencies
Total investments
April 30, 2021
Amortized
Unrealized
Unrealized
Cost
158,063
40,473
198,536
$
$
Gains
Losses
55
7
62
$
$
(245)
(16)
(261)
April 30, 2020
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
38,922
12,534
51,456
$
$
295
175
470
$
$
(1)
—
(1)
$
$
$
$
Fair
Value
157,873
40,464
198,337
Fair
Value
39,216
12,709
51,925
$
$
$
$
The following table summarizes the scheduled maturity for the Company’s investments at April 30, 2021:
Maturing in one year or less
Maturing after one year through two years
Maturing after two years through four years
Total investments
F-13
April 30,
2021
129,235
50,542
18,560
198,337
$
$
Note 4. Property and Equipment
At April 30, 2021 and 2020, property and equipment consisted of (in thousands):
Laboratory equipment
Office equipment
Furniture & fixtures
Leasehold improvements
Total property and equipment at cost
Less: Accumulated depreciation
Property and equipment, net
2021
2020
$
$
1,748 $
45
215
1,872
3,880
(2,089)
1,791 $
1,543
36
185
1,647
3,411
(1,368)
2,043
For the years ended April 30, 2021, 2020 and 2019, depreciation expense was $537,000, $512,000 and $378,000, respectively.
Note 5. Accrued Expenses
At April 30, 2021 and 2020, accrued expenses consisted of (in thousands):
Accrued research expense
Accrued compensation
Accrued professional fees
Other accrued expenses
Total accrued expenses
$
$
2021
2020
2,476 $
3,507
557
390
6,930 $
2,821
2,333
173
128
5,455
Note 6. Stockholder’s Equity
Public Offering of Common Stock
On February 16, 2021, the Company completed a public offering of 6,181,250 shares of its common stock at a price of $36.00 per share, including
the underwriters’ full exercise of their option to purchase 806,250 additional shares of common stock. The total net proceeds to the Company were $209.2
million, after deducting underwriting discounts, commissions, and other offering expenses payable by the Company.
On May 21, 2021, the Company filed a shelf registration statement pursuant to which the Company may offer and sell securities having an aggregate
public offering price of up to $300 million. In connection with the filing of the Registration Statement, the Company also entered into a sales agreement with
a sales agent, pursuant to which the Company may issue and sell shares of its common stock under an at-the-market (the “ATM”) offering program.
Note 7. Stock-Based Compensation
The Company has three plans that provide for equity-based compensation. Two are legacy plans for which no further grants are to be made. As of
April 30, 2021, 853,743 stock options remain available for grant under the 2017 Equity Incentive Plan (“2017 Plan”). There are 3,690,341 shares of the
Company’s common stock that are reserved for issuance upon exercise or settlement of stock options or other awards under these plans. Initial awards
generally vest 25% after one year and then ratably on a monthly basis over the next three years. Recurring grants typically vest on a monthly basis over four
years. Stock option grants expire after ten years.
The Company also has in place the 2017 Employee Stock Purchase Plan (“ESPP”), under which employees have the option to purchase the
Company’s common stock at a discount of 15% from the market price during predetermined offering periods each year. There are 448,295 shares available
for future issuance under the ESPP as of April 30, 2021. Activity under the ESPP was not significant in the periods presented.
F-14
The Company recognizes stock-based compensation expense over the requisite service period based on the grant date fair value of the award. The
Company has elected to use the Black-Scholes option pricing model to determine the fair value of awards granted. The determination of the fair value of stock-
based awards utilizing the Black-Scholes model is affected by the share price and a number of assumptions, including expected volatility, expected life, risk-free
interest rate and expected dividends. Due to insufficient history of the Company’s stock price, the stock-price volatility assumption is based on the historical
volatility of a peer group of publicly traded companies. The expected life of the awards is estimated based on the simplified method. The risk-free interest rate
assumption is based on observed interest rates appropriate for the terms of the awards. The dividend yield assumption is based on history and expectation of
paying no dividends. Forfeitures have not been material in the periods presented.
The fair value of the share-based awards was measured with the following weighted-average assumptions for the fiscal years ended April 30:
Risk-free interest rate
Expected life of the options
Expected volatility of the underlying stock
Expected dividend rate
2021
0.47%
6.25 years
81.7%
0%
2020
2.06%
6.25 years
81.1%
0%
2019
2.90%
6.25 years
77.2%
0%
Stock-based compensation was reflected in the Company’s consolidated statement of operations and comprehensive loss as follows (in thousands):
Research and development
General and administrative
Total stock-based compensation expense
2021
Year ended April 30,
2020
2019
$
$
3,174 $
3,944
7,118 $
1,944 $
2,504
4,448 $
2,005
961
2,966
A summary of option activity for the year ended April 30, 2021 and changes during the years then ended is presented below:
Outstanding at May 1, 2020
Exercised
Granted
Cancelled
Outstanding at April 30, 2021
Exercisable at April 30, 2021
Vested and expected to vest at April 30, 2021
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Life
Aggregate
Intrinsic
Value
13.27
7.71
11.82
18.85
13.22
11.40
13.22
7.83 $
4,899
7.60 $
6.73 $
7.60 $
33,514
19,661
33,514
Shares
2,300,677 $
(246,575)
835,500
(53,004)
2,836,598 $
1,446,403 $
2,836,598 $
The weighted-average grant date fair value of stock options granted during the years ended April 30, 2021, 2020 and 2019 was $8.24, $15.76, and
$9.62, respectively. The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised during the
years ended April 30, 2021, 2020 and 2019 was $4,200,000, $431,000 and $950,000, respectively. The total cash received by the Company as a result of
employee stock option exercises during the years ended April 30, 2021, 2020 and 2019 was $1,535,000, $216,000, and $242,000, respectively.
During the fiscal year ended April 30, 2021, the Company recognized $0.4 million of compensation expense related to the vesting of 45,000
performance stock units that were granted in 2018. As of April 30, 2021, there are no additional performance stock units remaining.
F-15
As of April 30, 2021, there was $13.0 million of unrecognized compensation expense related to unvested awards, which is expected to be recognized
over a weighted-average period of 2.6 years.
Note 8. Commitments and Contingencies
Clinical Studies: The Company enters into contractual agreements with contract research organizations in connection with preclinical and toxicology
studies and clinical trials. Amounts due under these agreements are invoiced to the Company on predetermined schedules during the course of the studies and
clinical trials and are not refundable regardless of the outcome. The Company has a contractual obligation related to the expected future costs to be incurred
to complete the ongoing preclinical studies and clinical trials. The remaining commitments, which have cancellation provisions, totaled $32.2 million as of
April 30, 2021.
Indemnification: In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and
warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may
be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its
indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. No amounts associated
with such indemnifications have been recorded to date.
Contingencies: From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The
Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
There were no contingent liabilities requiring accrual at April 30, 2021 and 2020.
As a result of the terms of grant income received in prior years, upon successful regulatory approval and following the first commercial sale of certain
products, the Company will be required to pay royalty fees of up to $1 million within 90 days of the first commercial sale of the product subject to certain
caps and follow on payments depending upon commercial success and type of product. Given the stage of development of the current pipeline of products it
is not possible to predict with certainty the amount, if any or timing of any such liability.
Note 9. Leases
The Company has a lease agreement for approximately 2,700 square feet of space for its headquarters located in Cambridge, Massachusetts that
commenced in September 2017 and runs through September 2028. In November 2021, the Company expanded the Cambridge headquarter premises by
approximately 5,600 additional square feet, the lease for which also runs through September 2028.
The Company has lease agreements for approximately 13,400 square feet of office and research laboratory space located in Porton Down, United
Kingdom that runs through April 2028, with an option to terminate in April 2023. The Company is reasonably certain that it will not terminate the lease in
April 2023, therefore the entire lease terms are included in the calculation of the lease liabilities. Options to renew a lease are not included in the Company’s
assessment unless there is reasonable certainty that the Company will renew.
The Company is also party to several operating leases for office and laboratory space as well as certain lab equipment. Total rent expense was
$926,000, $743,000 and $677,000 for the years ended April 30, 2021, 2020 and 2019, respectively and is reflected in general and administrative expenses and
research and development expenses as determined by the underlying activities.
Incremental borrowing rate – The Company’s lease agreements do not provide an implicit rate. The Company estimated the incremental borrowing
rate based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term and economic
environment.
Lease and non-lease components – The Company has elected the practical expedient which allows non-lease components to be combined with lease
components for all existing asset classes and will therefore include any fixed
F-16
additional rent amounts in its lease payments. Any variable lease payments are excluded from the lease liability and are recognized in the period incurred.
The following table summarizes lease costs included in research and development and general and administrative expense for the years ended April
30, 2021 and 2020 (in thousands):
Operating lease costs
Finance Lease Costs
Short-term lease costs
Variable lease costs
Total lease costs
2021
2020
$
$
926 $
—
13
149
1,088 $
743
54
13
47
857
The following table summarizes the undiscounted payments due under lease liabilities and the present value of those liabilities as of April 30, 2021
(in thousands):
Years ending April 30,
2022
2023
2024
2025
2026
Thereafter
Total lease payments
Less: imputed interest
Total lease liabilities
Current lease liabilities
Long-term lease liabilities
Operating
Leases
1,310
1,107
971
991
1,012
2,470
7,861
1,952
5,909
863
5,046
$
$
The following table summarizes the lease term and discount rate as of April 30, 2021 and 2020:
Weighted-average remaining lease term (years)
Weighted-average discount rate
2021
2020
6.8
9.0%
4.8
9.0%
The following table summarizes the cash paid for amounts included in the measurement of lease liabilities for the years ended April 30, 2021 and
2020 (in thousands):
Cash paid for amounts included in the measurement of operating
lease liabilities
Cash paid for amounts included in the measurement of finance
lease liabilities
$
$
696 $
— $
708
54
2021
2020
Note 10. Income Taxes
The components of the Company’s loss before income taxes for the years ended April 30 consisted of the following (in thousands):
F-17
Domestic
Foreign
2021
2020
2019
$
$
(10,909) $
(35,335)
(46,244) $
(6,337) $
(22,903)
(29,240) $
(5,006)
(15,686)
(20,692)
For the year ended April 30, 2021, the Company did not record any U.S. Federal income tax benefit or expense. For the years ended April 30, 2020
and 2019, the Company recorded a U.S. Federal income tax benefit of $124,000 and a U.S. Federal income tax expense of $124,000, respectively.
A reconciliation between the effective tax rates and statutory rates for the years ended April 30 is as follows:
Income tax benefit at U.S. federal statutory
rate
Foreign rate differential
Nondeductible expenses - UK R&D credit
Other
Globl Intangible Low-Taxed Income ("GILTI")
Valuation allowance
2021
2020
2019
21.0%
(1.6)%
(8.3)%
0.4%
—
(11.5)%
—
21.0%
(1.6)%
(12.1)%
(0.5)%
—
(6.6)%
0.2%
21.0%
(0.9)%
(5.9)%
(0.9)%
(7.6)%
(6.3)%
(0.6)%
The tax effect of significant temporary differences representing deferred tax assets and liabilities as of April 30 is as follows (in thousands):
Net operating loss (“NOL”) carryforwards
Other
Valuation allowance
Net deferred tax asset
2021
2020
$
$
14,410 $
2,620
(17,030)
— $
7,367
2,162
(9,529)
—
Management of the Company has determined it is not more likely than not that the Company will recognize the benefits of net deferred tax assets, the
majority of which are NOLs, and has provided a valuation allowance for the full amount of deferred tax assets as of April 30, 2021 and 2020, respectively.
During the years ended April 30, 2021, 2020 and 2019 the valuation allowance changed by $7.5 million, $1.1 million and $1.6 million, respectively.
Realization of deferred tax assets is dependent upon the generation of future taxable income.
The ability to utilize the Company’s domestic net operating losses is limited due to changes in ownership as defined by Section 382 of the Internal
Revenue Code (the “Code”). Under the provisions of Sections 382 and 383 of the Code, a change of control, as defined in the Code, imposes an annual
limitation on the amount of the Company’s net operating loss and tax credit carryforwards, and other tax attributes that can be used to reduce future tax
liabilities. The Company determined that ownership changes occurred as a result of public offerings in December 2005, a transaction in November 2016 and a
public offering in September 2018.
As of April 30, 2021, the Company has NOL carryforwards for U.S. federal income taxes of $6 million that expire in 2036 and $6 million that can be
carried forward indefinitely. The $6 million of NOL expiring in 2036 is subject to an annual 382 limitation of $0.3 million. The $6 million of indefinite NOL
is not currently subject to an annual 382 limitation. The Company also has NOL carryforwards for state income taxes of $14 million that begin to expire in
2036 and NOL carryforwards for U.K. income taxes of $58 million that do not expire.
In addition, the Company has $77 million of NOLs subject to 382 limitation arising from the aforementioned ownership changes. It is estimated that
the effect of Section 382 will substantially limit the amount of the net operating loss carryforwards that are available to offset future taxable income. Due to
the limitations, the Company expects these NOL to go unutilized and are not recognized.
F-18
The Company recognizes the financial statement effects of a tax position when it becomes more likely than not, based upon the technical merits, that
the position will be sustained upon examination. The Company files U.S. Federal tax returns, as well as certain state returns. The Company also files returns
in the United Kingdom. The Company is subject to U.S. Federal, state, and U.K. income tax examinations by authorities for tax years ending after 2016.
There are currently no federal, state, or U.K. audits in process. Management has analyzed the Company’s tax positions taken for all open tax years and has
concluded that no provision for unrecognized tax benefits from uncertain tax positions is required in the Company’s consolidated financial statements.
Note 11. Defined Contribution Plans
Participation in a personal pension plan is available to all U.K. based employees of the Company upon commencement of their employment.
Employer contributions are made in accordance with the terms and conditions of the employment contract. Employees may contribute additionally in
accordance with the prevailing statutory limitations. Employees of the U.S. parent company are eligible to participate in the Company's 401(k) Plan. The
Company matches up to 4% of employee contributions to the Plan. Total employer contributions to both plans for the years ended April 30, 2021, 2020 and
2019 were $388,000, $314,000 and $237,000 respectively.
Note 12. Other Income
As of April 30, 2021 and 2020, the Company had research and development tax credits receivable totaling $10.4 million and $16.5 million,
respectively. This tax credit is related to a tax scheme for small and medium enterprises in the United Kingdom as well as an R&D expenditure credit system
that allows the Company to file a claim for cash credit in proportion to the Company’s R&D expenditure for the year. This amount is included in other
income, as it is a refundable credit that does not depend on the Company’s ongoing tax status or position. The Company recognized $9.8 million, $9.5 million
and $7.6 million related to these programs in the years ended April 30, 2021, 2020 and 2019, respectively. For the years ended April 30, 2021, 2020 and 2019
other income also included $0.2 million, $0.3 million, and $0.1 million of realized gains from the sale of available for sale securities, respectively.
F-19
EXECUTIVE EMPLOYMENT AGREEMENT
Exhibit 10.18
This Executive Employment Agreement (“Agreement”) is made and entered into on this 12th day of April, 2021 by and between
KalVista Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and Paul K. Audhya, MD (hereinafter, the “Executive”).
RECITALS
WHEREAS, the Company desires to employ the Executive and the Executive desires to be employed by the Company on the terms
herein described.
NOW, THEREFORE, in consideration of the premises and mutual covenants set forth herein, and for other good and valuable
consideration, the receipt and sufficiency of which are mutually acknowledged, the Company and the Executive hereby agree as follows:
1.
Employment. The Company hereby agrees to employ the Executive and the Executive hereby agrees to serve the
Company during the Term of Employment on the terms and conditions set forth herein.
2.
Position and Duties of Executive. During the Term of Employment, the Executive shall be employed and serve as the
Chief Medical Officer of the Company, and shall have such duties typically associated with such title, including, without limitation supervising
operations and management of the Company and its subsidiaries. The Executive shall faithfully and diligently perform all services as may be
assigned to him by the CEO, and shall exercise such power and authority as may from time to time be delegated to him by the CEO. The
Executive shall devote his full business time, attention and efforts to the performance of his duties under this Agreement, render such services
to the best of his ability, and use his reasonable best efforts to promote the interests of the Company. The Executive shall not engage in any
other business or occupation during the Term of Employment, including, without limitation, any activity that (i) conflicts with the interests of
the Company or its subsidiaries, (ii) interferes with the proper and efficient performance of his duties for the Company, or (iii) interferes with
the exercise of his judgment in the Company’s best interests. Notwithstanding the foregoing or any other provision of this Agreement, it shall
not be a breach or violation of this Agreement for the Executive to (w) serve on up to two outside corporate or scientific advisory boards with
prior notice to the Company, (x) serve on civic or charitable boards or committees, (y) deliver lectures or fulfill speaking engagements, or (z)
manage personal investments, so long as any such activities do not interfere with or detract from the performance of the Executive’s
responsibilities to the Company in accordance with this Agreement.
3.
Compensation and Benefits.
(a)
Base Salary. The Executive shall receive a Base Salary at the annual rate of $420,000.00 during the Term of
Employment, with such Base Salary payable in installments consistent with the Company’s normal payroll schedule, subject to applicable
withholding and other taxes. The Base Salary shall be reviewed, at least annually, for merit increases and may, by action and in the discretion
of the Board (or its Compensation Committee), be increased at any time or from time to time, but may not be decreased from the then current
Base Salary.
(b)
Bonuses. During the Term of Employment, the Executive shall participate in the Company’s annual incentive
compensation plan, program and/or arrangements applicable to senior-level executives, as established and modified from time to time by the
Compensation Committee of the Board in its sole discretion. During the Term of Employment, the Executive shall have a target bonus
opportunity under such plan or program equal to 40% of his current Base Salary (the “Target Bonus”), based on satisfaction of performance
criteria to be established by the Compensation Committee of the Board within the first three months of each fiscal year that begins during the
Term of Employment. Payment of any earned bonus for fiscal year 2021 will be pro-rated based upon the number of days Executive is
employed during such year. Payment of annual incentive compensation awards shall be made in the same manner and at the same time that
other senior-level
executives receive their annual incentive compensation awards, but in no event later than 2 ½ months following the last day of the applicable
Company fiscal year, and, except as otherwise provided herein, will be subject to the Executive’s continued employment through the last day of
the applicable Company fiscal year.
(c)
Compensation/Benefit Programs. During the Term of Employment, the Executive shall be entitled to
participate in all medical, dental, hospitalization, accidental death and dismemberment, disability, travel and life insurance plans, 401(k) plans
and any and all other plans as are presently and hereinafter offered by the Company to its executive personnel, subject to the general eligibility
and participation provisions set forth in such plans.
(d)
Equity Awards. Subject to the approval of the Board (or its Compensation Committee), Executive will be
granted an option (the “Initial Option”) to purchase 100,000 shares of the Company’s common stock (the “Shares”) at an exercise price per
share equal to the closing price per share of Company Common Stock as reported on The Nasdaq Global Market on the date of grant, as
determined by the Board (or its Compensation Committee). The Initial Option shall vest over a four (4) year period, with (i) 25% of the Shares
subject to the Initial Option vesting on the one (1) year anniversary of the date of grant (such one year anniversary, the “First Vesting Date”)
and (ii) thereafter, 1/48th of the Shares subject to the Initial Option vesting on each successive monthly anniversary of the First Vesting Date,
subject to the terms and conditions of the Company’s 2017 Equity Incentive Plan, the applicable award agreement evidencing the Initial Option
and Executive’s continued service through each applicable vesting date. Thereafter, during the Term of Employment, the Executive shall be
eligible to be granted Equity Awards. The number and type of such Equity Awards, and the terms and conditions thereof, shall be determined
by the Board (or its Compensation Committee), in its discretion.
Employment, in accordance with and subject to the terms of the Company’s then effective vacation or paid time off policy.
(e)
Vacation. The Executive shall be entitled to 25 days of paid vacation each calendar year during the Term of
(f)
Reimbursement of Reasonable Business Expenses. Subject to submission of proper substantiation by the
Executive, and subject to such rules and guidelines as the Company may from time to time adopt with respect to the reimbursement of
reasonable business expenses of executive personnel, the Company shall reimburse the Executive for all reasonable expenses actually paid or
incurred by the Executive during the Term of Employment in the course of and pursuant to the business of the Company. The Executive shall
account to the Company in writing for all expenses for which reimbursement is sought and shall supply to the Company copies of all relevant
invoices, receipts or other evidence reasonably requested by the Company.
4.
Termination.
(a)
General. The Term of Employment shall terminate upon the earliest to occur of (i) the Executive’s death, (ii) a
termination by the Company by reason of the Executive’s Disability, (iii) a termination by the Company with or without Cause, or (iv) a
termination by Executive with or without Good Reason. Upon any termination of Executive’s employment for any reason, except as may
otherwise be requested by the Company in writing and agreed upon in writing by Executive, the Executive shall resign from any and all
directorships, committee memberships or any other positions Executive holds with the Company or any of its Related Entities.
(b)
Termination by the Company for Cause. The Company shall at all times have the right, upon written notice to
the Executive, to terminate the Term of Employment for Cause. In no event shall a termination of the Executive’s employment for Cause occur
unless the Company gives written notice to the Executive in accordance with this Agreement stating with reasonable specificity the events or
actions that constitute Cause. In the event that the Term of Employment is terminated by the Company for Cause, Executive shall be entitled
only to the Accrued Obligations.
Employment upon written notice to the Executive at any time during which the Executive
(c)
Disability. The Company shall have the option, in accordance with applicable law, to terminate the Term of
2
is suffering from a Disability. In the event that the Term of Employment is terminated due to the Executive’s Disability, the Executive shall be
entitled to (i) the Accrued Obligations and (ii) any insurance benefits to which he and his beneficiaries are entitled as a result of his Disability.
Death. In the event that the Term of Employment is terminated due to the Executive’s death, the Executive’s
estate shall be entitled to (i) the Accrued Obligations and (ii) any insurance benefits to which he and his beneficiaries are entitled as a result of
his death.
(d)
(e)
Termination Without Cause outside of a Change in Control of the Company or Resignation With Good
Reason outside of a Change in Control of the Company. The Company may terminate the Term of Employment without Cause, and the
Executive may terminate the Term of Employment for Good Reason, at any time upon written notice. If the Term of Employment is terminated
by the Company without Cause (other than due to the Executive’s death or Disability) or by the Executive for Good Reason, in either case prior
to the date of a Change in Control or more than two years after a Change in Control, the Executive shall be entitled to the following:
(i)
(ii)
The Accrued Obligations;
A lump sum payment equal to 12 months of Executive’s then-current Base Salary;
(iii)
Provided that the Executive timely elects continued coverage under COBRA, the Company will
reimburse the Executive for the monthly COBRA cost of continued health and dental coverage of the Executive and his qualified beneficiaries
paid by the Executive under the health and dental plans of the Company, less the amount that the Executive would be required to contribute for
health and dental coverage if the Executive were an active employee of the Company, for 12 months (or, if less, for the duration that such
COBRA coverage is available to Executive). Notwithstanding the above, if the Company determines in its sole discretion that it cannot provide
the COBRA benefits described herein without violating applicable law (including, without limitation, Section 2716 of the Public Health Service
Act), the Company shall in lieu thereof provide Executive with a taxable lump sum payment in an amount equal to the then-unreimbursed
monthly COBRA premiums.
(f)
Termination by Executive Without Good Reason. The Executive may terminate his employment without Good
Reason by providing the Company 30 days’ written notice of such termination. In the event of a termination of employment by the Executive
under this Section 4(f), the Executive shall be entitled only to the Accrued Obligations. In the event of termination of the Executive’s
employment under this Section 4(f), the Company may, in its sole and absolute discretion, by written notice, accelerate such date of termination
and still have it treated as a termination without Good Reason.
(g)
Termination Without Cause in connection with a Change in Control of the Company or Resignation With
Good Reason in connection with a Change in Control of the Company. If the Executive’s employment is terminated by the Company (or any
entity to which the obligations and benefits under this Agreement have been assigned pursuant to Section 9(b)) without Cause or by the
Executive for Good Reason, in either case during the two year period immediately following a Change in Control, then the Executive shall be
entitled to the following:
(i)
(ii)
(iii)
Termination Date occurs;
3
The Accrued Obligations;
A lump sum payment equal to 12 months of Executive’s then-current Base Salary;
A lump sum payment equal to the Executive’s full Target Bonus for the fiscal year in which the
(iv)
Provided that the Executive timely elects continued coverage under COBRA, the Company will
reimburse the Executive for the monthly COBRA cost of continued health and dental coverage of the Executive and his qualified beneficiaries
paid by the Executive under the health and dental plans of the Company, less the amount that the Executive would be required to contribute for
health and dental coverage if the Executive were an active employee of the Company, for 12 months (or, if less, for the duration that such
COBRA coverage is available to Executive). Notwithstanding the above, if the Company determines in its sole discretion that it cannot provide
the COBRA benefits described herein without violating applicable law (including, without limitation, Section 2716 of the Public Health Service
Act), the Company shall in lieu thereof provide Executive with a taxable lump sum payment in an amount equal to the then-unreimbursed
monthly COBRA premiums.
(v)
All then-unvested Equity Awards will vest in full.
(h)
Release. All rights, payments and benefits due to the Executive under this Section 4 (other than the Accrued
Obligations) shall be conditioned on the Executive’s execution of a general release of claims against the Company and its affiliates substantially
in the form attached hereto as Exhibit B (the “Release”) and on that Release becoming irrevocable within 60 days following the Termination
Date. The severance described in this Section 4 (other than Accrued Obligations) shall be paid no later than the first business day following the
sixtieth (60th) day following the termination of employment of Executive and in compliance with the timeframe required under Section 409A
as set forth herein, and the first payment will include the payments due and owing prior to that payment date but for the application of this
sentence. If the Straddle Period (as defined below) spans two (2) calendar years, then the cash payments under this Section 4 (other than
Accrued Obligations) shall first be made on the first business day in the second calendar year that occurs after the expiration of the sixty (60)-
day period in which the Release must be delivered and effective, as described in this Section 4. The “Straddle Period” shall mean the sixty
(60)-day period following a termination of employment in which the Release is to be executed and become irrevocable pursuant to this Section
4.
(i)
Section 280G Certain Reductions of Payments by the Company.
(1)
Anything in this Agreement to the contrary notwithstanding, in the event it shall be determined that
any payment or distribution by the Company to or for the benefit of the Executive, whether paid or payable or distributed or distributable
pursuant to the terms of this Agreement or otherwise (a “Payment”), would be nondeductible by the Company for Federal income tax purposes
because of Section 280G of the Code, then the aggregate present value of amounts payable or distributable to or for the benefit of the Executive
pursuant to this Agreement (such payments or distributions pursuant to this Agreement are hereinafter referred to as “Agreement Payments”)
shall be reduced to the Reduced Amount. The “Reduced Amount” shall be an amount expressed in present value that avoids any Payment
being nondeductible by the Company because of Section 280G of the Code. To the extent necessary to avoid imposition of the Excise Tax, the
amounts payable or benefits to be provided to the Executive shall be reduced such that the reduction of compensation to be provided to the
Executive is minimized. In applying this principle, the reduction shall be made in a manner consistent with the requirements of Section 409A
of the Code, and where two economically equivalent amounts are subject to reduction but payable at different times, such amounts shall be
reduced on a pro rata basis (but not below zero). Anything to the contrary notwithstanding, if the Reduced Amount is zero and it is determined
further that any Payment which is not an Agreement Payment would nevertheless be nondeductible by the Company for Federal income tax
purposes because of Section 280G of the Code, then the aggregate present value of Payments which are not Agreement Payments shall also be
reduced (but not below zero) to an amount expressed in present value which maximizes the aggregate present value of Payments without
causing any Payment to be nondeductible by the Company because of Section 280G of the Code. If a reduction of any Payment is required
pursuant to this Section 4(i), such reduction shall occur to the amounts in the order that results in the greatest economic present value of all
payments and benefits actually made or provided to the Executive. For purposes of this Section 4(i), present value shall be determined in
accordance with Section 280G(d)(4) of the Code.
compensation consulting firm of national reputation selected by the Company (the “Consulting Firm”),
(2)
All determinations required to be made under this Section 4(i) shall be made by a tax or
4
which shall provide detailed supporting calculations both to the Company and the Executive within 20 business days of the date of termination
or such earlier time as is requested by the Company and an opinion to the Executive that he has substantial authority not to report any excise tax
on his Federal income tax return with respect to any Payments. Any such determination by the Consulting Firm shall be binding upon the
Company and the Executive. Within five business days thereafter, the Company shall pay to or distribute to or for the benefit of the Executive
such amounts as are then due to the Executive under this Agreement. All fees and expenses of the Consulting Firm incurred in connection with
the determinations contemplated by this Section 4(i) shall be borne by the Company.
(3)
As a result of the uncertainty in the application of Section 280G of the Code at the time of the initial
determination by the Consulting Firm hereunder, it is possible that Payments will have been made by the Company which should not have been
made (“Overpayment”) or that additional Payments which will not have been made by the Company could have been made
(“Underpayment”), in each case, consistent with the calculations required to be made hereunder. In the event that the Consulting Firm, based
upon the assertion of a deficiency by the Internal Revenue Service against the Executive which the Consulting Firm believes has a high
probability of success, determines that an Overpayment has been made, any such Overpayment paid or distributed by the Company to or for the
benefit of the Executive shall be promptly repaid to the Company by the Executive. In the event that the Consulting Firm, based upon
controlling precedent or other substantial authority, determines that an Underpayment has occurred, any such Underpayment shall be promptly
paid by the Company to or for the benefit of the Executive together with interest at the applicable federal rate provided for in Section 7872(f)(2)
of the Code.
(j)
Cooperation. Following the Term of Employment, the Executive shall give his assistance and cooperation
willingly, upon reasonable advance notice with due consideration for his other business or personal commitments, in any matter relating to his
position with the Company, or his expertise or experience as the Company may reasonably request, including his attendance and truthful
testimony where deemed appropriate by the Company, with respect to any investigation or the Company’s defense or prosecution of any
existing or future claims or litigations or other proceedings relating to matters in which he was involved or potentially had knowledge by virtue
of his employment with the Company. In no event shall his cooperation materially interfere with his services for a subsequent employer or
other similar service recipient. To the extent permitted by law, the Company agrees that (i) it shall promptly reimburse the Executive for his
reasonable and documented expenses in connection with his rendering assistance and/or cooperation under this Section 4(j) upon his
presentation of documentation for such expenses and (ii) the Executive shall be reasonably compensated for any continued material services as
required under this Section 4(j).
(k)
Return of Company Property. Following the Termination Date, the Executive or his personal representative
shall return all Company property in his possession, including but not limited to all computer equipment (hardware and software), telephones,
facsimile machines, cell phones and other communication devices, credit cards, office keys, security access cards, badges, identification cards
and all copies (including drafts) of any documentation or information (however stored) relating to the business of the Company, its customers
and clients or its prospective customers and clients.
(l)
Compliance with Section 409A.
General. It is the intention of both the Company and the Executive that the benefits and rights to
which the Executive could be entitled pursuant to this Agreement comply with Section 409A of the Code and the Treasury Regulations and
other guidance promulgated or issued thereunder (“Section 409A”), to the extent that the requirements of Section 409A are applicable thereto,
and the provisions of this Agreement shall be construed in a manner consistent with that intention.
(i)
Section 409A, no payment or benefit required to be paid under this Agreement on account
(ii)
Distributions on Account of Separation from Service. If and to the extent required to comply with
5
of termination of the Executive’s employment shall be made unless and until the Executive incurs a “separation from service” within the
meaning of Section 409A.
(iii)
Six Month Delay for Specified Employees. If the Executive is a “specified employee” (within the
meaning of Section 409A(a)(2)(B)(i) of the Code), then no payment or benefit that is payable on account of the Executive’s “separation from
service”, as that term is defined for purposes of Section 409A, shall be made before the date that is six months after the Executive’s “separation
from service” (or, if earlier, the date of the Executive’s death) if and to the extent that such payment or benefit constitutes deferred
compensation (or may be nonqualified deferred compensation) under Section 409A and such deferral is required to comply with the
requirements of Section 409A. Any payment or benefit delayed by reason of the prior sentence shall be paid out or provided in a single lump
sum at the end of such required delay period in order to catch up to the original payment schedule.
Treatment of Each Installment as a Separate Payment. For purposes of applying the provisions of
Section 409A to this Agreement, each separately identified amount to which the Executive is entitled under this Agreement shall be treated as a
separate payment. In addition, any series of installment payments under this Agreement shall be treated as a right to a series of separate
payments.
(iv)
(v)
Taxable Reimbursements and In-Kind Benefits.
Any reimbursements by the Company to the Executive of any eligible expenses under this
Agreement that are not excludable from the Executive’s income for Federal income tax purposes (the “Taxable Reimbursements”) shall be
made by no later than the last day of the taxable year of the Executive following the year in which the expense was incurred.
(A)
The amount of any Taxable Reimbursements, and the value of any in-kind benefits to be
provided to the Executive, during any taxable year of the Executive shall not affect the expenses eligible for reimbursement, or in-kind benefits
to be provided, in any other taxable year of the Executive.
(B)
liquidation or exchange for another benefit.
(C)
The right to Taxable Reimbursement, or in-kind benefits, shall not be subject to
(vi)
Section 409A Compliance. Notwithstanding the foregoing, the Company does not make any
representation to the Executive that the payments or benefits provided under this Agreement are exempt from, or satisfy, the requirements of
Section 409A, and the Company shall have no liability or other obligation to indemnify or hold harmless the Executive or any beneficiary of
the Executive for any tax, additional tax, interest or penalties that the Executive or any beneficiary of the Executive may incur in the event that
any provision of this Agreement, or any amendment or modification thereof, or any other action taken with respect thereto, is deemed to violate
any of the requirements of Section 409A.
5.
Restrictive Covenants.
Employee Invention Assignment, Confidentiality and Non-Competition Agreement (the “EIIA”) as provided therein.
(a)
Confidential Information. The Executive shall execute and agree to be bound by the terms of the Company’s
trading policies with respect to the securities of the Company as now in effect or hereafter adopted or amended.
(b)
Insider Trading Policies. Executive agrees that he shall comply with and be bound by the Company’s insider
the Company, as now in effect or hereafter adopted or amended, and all applicable laws
(c)
Clawback Provisions. All incentive and equity awards and payments shall be subject to the clawback policy of
6
and rules and regulations of the stock exchanges and public market on which the securities of the Company are traded.
(d)
Injunction. It is recognized and hereby acknowledged by the parties hereto that a breach by the Executive of
any of the covenants contained in this Section 5 or the EIIA may cause irreparable harm and damage to the Company, and its Related Entities,
the monetary amount of which may be virtually impossible to ascertain. As a result, the Executive recognizes and hereby acknowledges that
the Company and its Related Entities shall be entitled to seek an injunction from any court of competent jurisdiction enjoining and restraining
any violation of any or all of the covenants contained in this Section 5 or the EIIA by the Executive or any of his affiliates, associates, partners
or agents, either directly or indirectly, and that such right to injunction shall be cumulative and in addition to whatever other remedies the
Company may possess.
6.
Representations and Warranties of Executive. The Executive represents and warrants to the Company that:
party or otherwise may be bound;
(a)
The Executive’s employment will not conflict with or result in his breach of any agreement to which he is a
non-solicitation, non-competition or other similar covenant or agreement of a prior employer by which he is or may be bound; and
(b)
The Executive has not violated, and in connection with his employment with the Company will not violate, any
information that he may have obtained in connection with employment with any prior employer; and
(c)
In connection with Executive’s employment with the Company, he will not use any confidential or proprietary
7.
Indemnification. Subject to limitations imposed by law, the Company shall indemnify and hold harmless the Executive
to the fullest extent permitted by law from and against any and all claims, damages, expenses (including attorneys’ fees), judgments, penalties,
fines, settlements, and all other liabilities incurred or paid by him in connection with the investigation, defense, prosecution, settlement or
appeal of any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative and to which
the Executive was or is a party or is threatened to be made a party by reason of the fact that the Executive is or was an officer, employee or
agent of the Company, or by reason of anything done or not done by the Executive in any such capacity or capacities, provided that the
Executive acted in good faith, in a manner that was not grossly negligent or constituted willful misconduct and in a manner he reasonably
believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had no reasonable
cause to believe his conduct was unlawful. Executive will be named as an insured on the director and officer liability insurance policy
currently maintained by the Company, or as may be maintained by the Company from time to time, and will be subject to indemnification as
required by the Company’s Bylaws and the Indemnification Agreement to be entered into between Executive and the Company.
8.
Definitions. When used in this Agreement, the following terms shall have the following meanings:
(a)
Accrued Obligations” means:
(i)
(ii)
all accrued but unpaid Base Salary through the end of the Term of Employment;
any unpaid or unreimbursed expenses incurred in accordance with Company policy to the extent
incurred during the Term of Employment;
(iii)
any accrued but unpaid benefits provided under the Company’s employee benefit plans, subject to
and in accordance with the terms of those plans;
7
the Term of Employment; and
(iv)
any unpaid Bonus with respect to any completed fiscal year that has ended on or prior to the end of
(v)
any accrued but unused vacation pay.
pursuant to Section 3(a) hereof.
(b)
“Base Salary” means the salary provided for in Section 3(a) hereof or any increased salary granted to Executive
promulgated under the Securities Exchange Act of 1934, as amended.
(c)
“Beneficial Owner” and “Beneficial Ownership” shall have the meaning ascribed to such terms in Rule 13d-3
(d)
(e)
(f)
“Board” means the Board of Directors of the Company.
“Bonus” means any bonus payable to the Executive pursuant to Section 3(b) hereof.
“Cause” means any of the following:
turpitude;
(i)
(ii)
Executive’s conviction of or plea of nolo contendere to a felony or to any crime involving moral
willful misconduct or gross negligence by the Executive resulting, in either case, in material
economic or reputational harm to the Company or any of Related Entities;
failure by the Executive to remedy the failure within thirty (30) days after receipt of written notice of same, by the CEO;
(iii)
a willful failure by the Executive to carry out the reasonable and lawful directions of the CEO and
fraud, embezzlement, theft or dishonesty of a material nature by the Executive against the Company
or any Related Entity, or a willful material violation by the Executive of a policy or procedure of the Company or any Related Entity, resulting,
in any case, in material, reputational or economic harm to the Company or any Related Entity; or
(iv)
the Executive to remedy the material breach within 30 days after receipt of written notice of same, by the CEO.
(v)
a willful material breach by the Executive of this Agreement and failure by
(g)
“CEO” means the Chief Executive Officer of the Company.
(h)
“Change in Control” means the occurrence of any of the following events: (i) any Person becomes the
Beneficial Owner, directly or indirectly, of securities of the Company representing more than fifty percent (50%) of the total voting power
represented by the Company’s then-outstanding voting securities; provided, however, that for purposes of this subclause (i) the acquisition of
additional securities by any one Person who is considered to own more than fifty percent (50%) of the total voting power of the securities of the
Company will not be considered a Change in Control; (ii) the consummation of the sale or disposition by the Company of all or substantially all
of the Company’s assets; (iii) the consummation of a merger or consolidation of the Company with any other corporation, other than a merger
or consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent
(either by remaining outstanding or by being converted into voting securities of the surviving entity or its parent) at least fifty percent (50%) of
the total voting power represented by the voting securities of the Company or such surviving entity or its parent outstanding immediately after
such merger or consolidation; or (iv) a change in the effective control of the Company that occurs on the date that a majority of members of the
Board is replaced during any twelve (12) month period by members of the Board whose appointment or election is not endorsed by a majority
of the members of the Board prior to the date of the appointment or election. For purpose of this subclause (iv), if any Person is considered to
be in effective control of the Company, the acquisition of additional control of the
8
Company by the same Person will not be considered a Change in Control. For purposes of this definition, Persons will be considered to be
acting as a group if they are owners of a corporation that enters into a merger, consolidation, purchase or acquisition of stock, or similar
business transaction with the Company.
(i)
(j)
(k)
“COBRA” means the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended from time to time.
“Code” means the Internal Revenue Code of 1986, as amended.
“Commencement Date” means May 3, 2021.
“Disability” means the Executive’s inability, or failure, to perform the essential functions of his position, with or
without reasonable accommodation, for any period of six months or more in any 12 month period, by reason of any medically determinable
physical or mental impairment.
(l)
phantom stock or other equity based awards granted by the Company to the Executive.
(m)
“Equity Awards” means any stock options, restricted stock, restricted stock units, stock appreciation rights,
penalties imposed with respect thereto, or any interest or penalties are incurred by the Executive with respect to any such excise tax.
(n)
“Excise Tax” means any excise tax imposed by Section 4999 of the Code, together with any interest and
(o)
express written consent:
“Good Reason” means the occurrence of any of the following events or conditions, without the Executive’s
a material diminution in the Executive’s authority, duties, or responsibilities, provided, however, that
the mere acquisition or merger of the Company by itself shall not constitute a material diminution in the Executive’s authority, duties, or
responsibilities;
(i)
a material reduction by the Company in the Executive’s annual Base Salary (which for purposes
hereof is deemed to constitute a reduction of greater than 10%, unless such reduction applies as part of a salary reduction program and such
program includes similar reductions to all of the Executive’s direct reports); or
(ii)
from the Executive’s principal place of employment immediately prior to the Executive’s termination.
(iii)
the relocation of the Executive’s principal place of employment to a location more than 50 miles
With respect to each of subsection (i), (ii) and (iii) above, the Executive must provide notice to the Company of the condition giving rise to
“Good Reason” within 30 days of the initial existence of such condition, and the Company will have 30 days following such notice to remedy
such condition. The Executive must resign the Executive’s employment no later than 30 days following the Company’s failure to cure the
Good Reason or written notice to the Executive that it will decline to do so.
(p)
(q)
“Group” shall have the meaning ascribed to such term in Section 13(d) of the Securities Exchange Act of 1934.
“Person” shall have the meaning ascribed to such term in Section 3(a)(9) of the Securities Exchange Act of
1934 and used in Sections 13(d) and 14(d) thereof.
“Related Entity” means any Person controlling, controlled by or under common control with the Company or
any of its subsidiaries. For this purpose, the terms “controlling,” “controlled by” and “under common control with” mean the possession,
directly or indirectly, of the power to direct or cause the direction of
(r)
9
the management and policies of a Person, whether through the ownership of voting securities, as trustee or executor, by contract or otherwise,
including (without limitation) the ownership, directly or indirectly, of securities having the power to elect a majority of the board of directors or
similar body governing the affairs of such Person.
(s)
“Target Bonus” has the meaning described in Section 3(b).
“Term of Employment” means the period during which the Executive shall be employed by the Company
pursuant to the terms of this Agreement, which period shall begin on the Commencement Date and continue until terminated in accordance
with Section 4 hereof.
(t)
(u)
“Termination Date” means the date on which the Term of Employment ends.
9.
Miscellaneous Provisions.
Taxes. All payments or transfers of property made by the Company to the Executive or his estate or
beneficiaries shall be subject to the withholding of such amounts relating to taxes as the Company may reasonably determine it should withhold
pursuant to any applicable law or regulation.
(a)
(b)
Assignment. The Company shall have the right to assign this Agreement and its rights and obligations
hereunder in whole, but not in part, to any corporation or other entity with or into which the Company may hereafter merge or consolidate or to
which the Company may transfer all or substantially all of its assets, if in any such case said corporation or other entity shall by operation of
law or expressly in writing assume all obligations of the Company hereunder as fully as if it had been originally made a party hereto, but may
not otherwise assign this Agreement or its rights and obligations hereunder. The Executive may not assign or transfer this Agreement or any
rights or obligations hereunder.
(c)
Governing Law and At-will nature of Employment. Except as expressly set forth herein, this letter agreement
and the rights and obligations of the parties hereto shall be construed in accordance with the laws of the Commonwealth of Massachusetts,
without giving effect to the principles of conflict of laws. Executive’s employment with the Company is employment at-will, which means
either Executive or the Company may terminate Executive’s employment at any time and for any reason subject to the provisions of Section 4
of this Agreement.
(d)
Arbitration and Class Action Waiver. Executive and the Company agree to submit to mandatory binding
arbitration any and all claims arising out of or related to Executive’s employment with the Company and the termination thereof, including, but
not limited to, claims for unpaid wages, wrongful termination, torts, stock or stock options or other ownership interest in the Company, and/or
discrimination (including harassment), except as set forth below, based upon any federal, state or local ordinance, statute, regulation or
constitutional provision except that each party may, at its, his or her option, seek injunctive relief in court related to the improper use, disclosure
or misappropriation of a party’s private, proprietary, confidential or trade secret information (collectively, “Arbitrable Claims”). Further, to
the fullest extent permitted by law, Executive and the Company agree that no class or collective actions can be asserted in arbitration or
otherwise. All claims, whether in arbitration or otherwise, must be brought solely in Executive’s or the Company’s individual capacity, and not
as a plaintiff or class member in any purported class or collective proceeding.
THE PARTIES HEREBY WAIVE ANY RIGHTS THEY MAY HAVE TO TRIAL BY JURY IN REGARD TO ARBITRABLE
CLAIMS. THE PARTIES FURTHER WAIVE ANY RIGHTS THEY MAY HAVE TO PURSUE OR PARTICIPATE IN A CLASS OR
COLLECTIVE ACTION PERTAINING TO ANY ARBITRABLE CLAIMS BETWEEN YOU AND THE COMPANY.
Notwithstanding anything to the contrary herein, nothing in this Arbitration and Class Action Waiver section restricts
Executive’s right to pursue claims in court (a) on a representative action basis
10
under applicable law or (b) for any alleged sexual harassment or any alleged unlawful discriminatory practices related to sexual
harassment.
This Agreement does not restrict Executive’s right to file administrative claims Executive may bring before any government agency
where, as a matter of law, the parties may not restrict the employee’s ability to file such claims (including, but not limited to, the National Labor
Relations Board, the Equal Employment Opportunity Commission and the Department of Labor). However, the parties agree that, to the fullest
extent permitted by law, arbitration shall be the exclusive remedy for the subject matter of such administrative claims. The arbitration shall be
conducted in Boston, Massachusetts through JAMS before a single neutral arbitrator, in accordance with the JAMS employment arbitration
rules then in effect. The JAMS rules may be found and reviewed at http://www.jamsadr.com/rules-employment-arbitration. If Executive is
unable to access these rules, please let the Company know and Executive will be provided with a hardcopy. The arbitrator shall issue a written
decision that contains the essential findings and conclusions on which the decision is based. Executive and the Company agree that this
Arbitration and Class Action Waiver Provision shall be governed by the Federal Arbitration Act. Should any portion of this provision be found
unenforceable, it shall be severed and the remaining provisions shall remain in full force and effect.
(e)
Entire Agreement. This Agreement, together with the exhibit attached hereto, constitutes the entire agreement
between the patties hereto with respect to the subject matter hereof and, upon its effectiveness, shall supersede all prior agreements,
understandings and arrangements, both oral and written, between the Executive and the Company (or any of its Related Entities) with respect to
such subject matter. This Agreement may not be modified in any way unless by a written instrument signed by both the Company and the
Executive.
(f)
Notices. All notices required or permitted to be given hereunder shall be in writing and shall be personally
delivered by courier, sent by registered or certified mail, return receipt requested or sent by confirmed facsimile transmission addressed as set
forth herein. Notices personally delivered, sent by facsimile or sent by overnight courier shall be deemed given on the date of delivery and
notices mailed in accordance with the foregoing shall be deemed given upon receipt by the addressee, as evidenced by the return receipt
thereof. Notice shall be sent (i) if to the Company, addressed to the Company’s headquarters, Attention: the Company’s CEO, and (ii) if to the
Executive, to his address as reflected on the payroll records of the Company, or to such other address as either party shall request by notice to
the other in accordance with this provision.
Benefits; Binding Effect. This Agreement shall be for the benefit of and binding upon the parties hereto and
their respective heirs, personal representatives, legal representatives, successors and, where permitted and applicable, assigns, including,
without limitation, any successor to the Company, whether by merger, consolidation, sale of stock, sale of assets or otherwise.
(g)
Right to Consult with Counsel. The Executive acknowledges having read and considered all of the provisions
of this Agreement carefully, and having had the opportunity to consult with counsel of his own choosing, and, given this, the Executive agrees
that the obligations created hereby are not unreasonable.
(h)
(i)
Severability. The invalidity of any one or more of the words, phrases, sentences, clauses, provisions, sections or
articles contained in this Agreement shall not affect the enforceability of the remaining portions of this Agreement or any part thereof, all of
which are inserted conditionally on their being valid in law, and, in the event that any one or more of the words, phrases, sentences, clauses,
provisions, sections or articles contained in this Agreement shall be declared invalid, this Agreement shall be construed as if such invalid word
or words, phrase or phrases, sentence or sentences, clause or clauses, provisions or provisions, section or sections or article or articles had not
been inserted. If such invalidity is caused by length of time or size of area, or both, the otherwise invalid provision will be considered to be
reduced to a period or area which would cure such invalidity.
11
shall not operate nor be construed as a waiver of any subsequent breach or violation.
(j)
Waivers. The waiver by either party hereto of a breach or violation of any term or provision of this Agreement
Damages; Attorneys’ Fees. Nothing contained herein shall be construed to prevent the Company or the
Executive from seeking and recovering from the other damages sustained by either or both of them as a result of its or his breach of any term or
provision of this Agreement. Each party shall bear its own costs and attorneys’ fees.
(k)
(l)
No Set-off or Mitigation. The Company’s obligation to make the payments provided for in this Agreement and
otherwise to perform its obligations hereunder shall not be affected by any set off, counterclaim, recoupment, defense or other claim, right or
action which the Company may have against the Executive or others. In the event of any termination of the Executive’s employment under this
Agreement, he shall be under no obligation to seek other employment or otherwise in any way to mitigate the amount of any payment provided
for hereunder.
purposes only and shall not affect in any way the meaning or interpretation of this Agreement.
(m)
Section Headings. The article, section and paragraph headings contained in this Agreement are for reference
(n)
No Third Party Beneficiary. The Related Entities are intended third party beneficiaries of this
Agreement. Otherwise, nothing expressed or implied in this Agreement is intended, or shall be construed, to confer upon or give any person
other than the Company, the parties hereto and their respective heirs, personal representatives, legal representatives, successors and permitted
assigns, any rights or remedies under or by reason of this Agreement.
be an original but all of which together shall constitute one and the same instrument and agreement.
(o)
Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed to
[Signature Page to Executive Employment Agreement Follows]
12
IN WITNESS WHEREOF, the undersigned have executed this Agreement on the date first above written.
KalVista Pharmaceuticals, Inc.
Executive
/s/T. Andrew Crockett
Print Name: T. Andrew Crockett
Title: Chief Executive Officer
/s/ Paul K. Audhya, MD
Paul K. Audhya, MD
[Signature Page to Executive Employment Agreement]
13
Exhibit B
General Release of Claims
1.
Paul K. Audhya, MD (“Executive”), for himself and his family, heirs, executors, administrators, legal representatives and
their respective successors and assigns, in exchange for the consideration received pursuant to Section [4(e)] [4(g)] of the Executive
Employment Agreement (the “Severance Benefits”) to which this release is attached as Exhibit B (the “Employment Agreement”), does
hereby release and forever discharge KalVista Pharmaceuticals, Inc. (the “Company”), its subsidiaries, affiliated companies, successors and
assigns, and its current or former directors, officers, employees, shareholders or agents in such capacities (collectively with the Company, the
“Released Parties”) from any and all actions, causes of action, suits, controversies, claims and demands whatsoever, for or by reason of any
matter, cause or thing whatsoever, whether known or unknown including, but not limited to, all claims under any applicable laws arising under
or in connection with Executive’s employment or termination thereof, whether for tort, breach of express or implied employment contract,
wrongful discharge, intentional infliction of emotional distress, or defamation or injuries incurred on the job or incurred as a result of loss of
employment. Without limiting the generality of the release provided above, Executive expressly waives any and all claims under the Age
Discrimination in Employment Act (“ADEA”) that he may have as of the date hereof. Executive further understands that, by signing this
General Release of Claims, he is in fact waiving, releasing and forever giving up any claim under the ADEA as well as all other laws within the
scope of this paragraph 1 that may have existed on or prior to the date hereof. Notwithstanding anything in this paragraph 1 to the contrary, this
General Release of Claims shall not apply to (i) any rights to receive any payments or benefits to which the Executive is entitled under
COBRA, (ii) any rights or claims that may arise as a result of events occurring after the date this General Release of Claims is executed, (iii)
any indemnification and advancement rights Executive may have as a former employee, officer or director of the Company or its subsidiaries or
affiliated companies (including any rights under Section 7 of the Employment Agreement), (iv) any claims for benefits under any directors’ and
officers’ liability policy maintained by the Company or its subsidiaries or affiliated companies in accordance with the terms of such policy, (v)
rights to vested benefits under the Company’s 401(k) plan, and (vi) any rights as a holder of equity securities of the Company.
2.
Executive understands that nothing in this Release shall in any way limit or prohibit Executive from engaging in any
Protected Activity. For purposes of this Release, “Protected Activity” shall mean filing a charge, complaint, or report with, or otherwise
communicating, cooperating, or participating in any investigation or proceeding that may be conducted by, any federal, state or local
government agency or commission, including the Securities and Exchange Commission, the Equal Employment Opportunity Commission, the
Occupational Safety and Health Administration, and the National Labor Relations Board (“Government Agencies”). Executive understands
that in connection with such Protected Activity, Executive is permitted to disclose documents or other information as permitted by law, and
without giving notice to, or receiving authorization from, the Company. Notwithstanding the foregoing, Executive agrees to take all reasonable
precautions to prevent any unauthorized use or disclosure of any information that may constitute Company confidential information to any
parties other than the Government Agencies. Executive further understands that “Protected Activity” does not include the disclosure of any
Company attorney-client privileged communications. In addition, pursuant to the Defend Trade Secrets Act of 2016, Executive is notified that
an individual will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that (i) is
made in confidence to a federal, state, or local government official (directly or indirectly) or to an attorney solely for the purpose of reporting or
investigating a suspected violation of law, or (ii) is made in a complaint or other document filed in a lawsuit or other proceeding, if (and only if)
such filing is made under seal. In addition, an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of
law may disclose the trade secret to the individual’s attorney and use the trade secret information in the court proceeding, if the individual files
any document containing the trade secret under seal and does not disclose the trade secret, except pursuant to court order. This Release does
not limit Executive’s right to receive an award for information provided to any Government Agencies.
14
3.
Executive represents that he has not filed against the Released Parties any complaints, charges, or lawsuits arising out of
his employment, or any other matter arising on or prior to the date of this General Release of Claims, and covenants and agrees that he will
never individually or with any person file, or commence the filing of any lawsuits, complaints or proceedings with any governmental agency, or
against the Released Parties with respect to any of the matters released by Executive pursuant to paragraph 1 hereof; provided, that nothing
herein shall prevent Executive from filing a charge or complaint with the Equal Employment Opportunity Commission (“EEOC”) or similar
federal or state agency or the Executive’s ability to participate in any investigation or proceeding conducted by such agency. Nothing in this
paragraph shall serve to limit, restrain or impair Executive’s rights under paragraph 2 above.
4.
Executive acknowledges that, in the absence of his execution of this General Release of Claims, the Severance Benefits
would not otherwise be due to him.
5.
Executive acknowledges and agrees that he received adequate consideration in exchange for agreeing to the covenants
contained in Section 5 of the Employment Agreement and the EIAA (as defined therein), that such covenants remain reasonable and necessary
to protect the legitimate business interests of the Company and its affiliates and that he will continue to comply with those covenants.
6.
Executive hereby acknowledges that the Company has informed him that he has up to 21 days to sign this General Release
of Claims and he may knowingly and voluntarily waive that 21 day period by signing this General Release of Claims earlier. Executive also
understands that he shall have seven days following the date on which he signs this General Release of Claims within which to revoke it by
providing a written notice of his revocation to the Company.
7.
Executive acknowledges and agrees that this General Release of Claims will be governed by and construed and enforced in
accordance with the internal laws of the State of Massachusetts applicable to contracts made and to be performed entirely within such State.
8.
Executive acknowledges that he has read this General Release of Claims, that he has been advised that he should consult
with an attorney before he executes this general release of claims, and that he understands all of its terms and executes it voluntarily and with
full knowledge of its significance and the consequences thereof.
9.
This General Release of Claims shall become irrevocable on the eighth day following Executive’s execution of this
General Release of Claims, unless previously revoked in accordance with paragraph 6, above.
Intending to be legally bound hereby, Executive has executed this General Release of Claims on April 12, 2021.
Executive
/s/ Paul K. Audhya, MD
Paul K. Audhya, MD
15
KALVISTA PHARMACEUTICALS, INC. 2021
EQUITY INDUCEMENT PLAN
Exhibit 10.21
PURPOSE. The purpose of this Plan is to provide incentives to attract and motivate eligible
1.
employees whose potential contributions are important to the success of the Company, and any Parents,
Subsidiaries and Affiliates that exist now or in the future, by offering them an opportunity to participate in the
Company’s future performance through the grant of Awards. Capitalized terms not defined elsewhere in the text
are defined in Section 22.
2.
SHARES SUBJECT TO THE PLAN.
2.1.
Number of Shares Available. Subject to Sections 2.4 and 15 and any other
applicable provisions hereof, the total number of Shares reserved and available for grant and issuance pursuant
to this Plan as of the date of adoption of the Plan by the Board, is Three Hundred Fifty Thousand (350,000)
Shares.
2.2.
Lapsed, Returned Awards. Shares subject to Awards, and Shares issued under
the Plan under any Award, will again be available for grant and issuance in connection with subsequent Awards
under this Plan to the extent such Shares: (a) are subject to issuance upon exercise of an Option granted under
this Plan but which cease to be subject to the Option for any reason other than exercise of the Option; (b) are
subject to Awards granted under this Plan that are forfeited or are repurchased by the Company at the original
issue price; or (c) are subject to Awards granted under this Plan that otherwise terminate without such Shares
being issued. To the extent an Award under the Plan is paid out in cash rather than Shares, such cash payment will
not result in reducing the number of Shares available for issuance under the Plan. Shares used to pay the exercise
price of an Award or withheld to satisfy the tax withholding obligations related to an Award will become available
for future grant or sale under the Plan.
2.3.
Minimum Share Reserve. At all times the Company shall reserve and keep
available a sufficient number of Shares as shall be required to satisfy the requirements of all outstanding
Awards granted under this Plan.
2.4.
Adjustment of Shares. If the number of outstanding Shares is changed by a
stock dividend, extraordinary dividends or distributions (whether in cash, shares or other property, other than a
regular cash dividend) recapitalization, stock split, reverse stock split, subdivision, combination, consolidation,
reclassification, spin-off or similar change in the capital structure of the Company, without consideration, then
(a) the number and class of Shares reserved for issuance and future grant under the Plan set forth in Section 2.1,
(b) the Exercise Prices of and number and class of Shares subject to outstanding Options, and (c) the number and
class of Shares subject to other outstanding Awards, , shall be proportionately adjusted, subject to any required
action by the Board or the stockholders of the Company and in compliance with applicable securities laws;
provided that fractions of a Share will not be issued.
If, by reason of an adjustment pursuant to this Section 2.4, a Participant’s Award Agreement or other agreement
related to any Award or the Shares subject to such Award covers additional or different shares of stock or
securities, then such additional or different shares, and the Award
Agreement or such other agreement in respect thereof, shall be subject to all of the terms, conditions and
restrictions which were applicable to the Award or the Shares subject to such Award prior to such adjustment.
3.
ELIGIBILITY. Awards may be granted only to persons who, are being hired by the
Company or any Subsidiary as an Employee and such Award is a material inducement to such person being
hired.
4.
ADMINISTRATION.
4.1.
Committee Composition; Authority. This Plan will be administered by the
Committee or by the Board acting as the Committee. Subject to the general purposes, terms and conditions of
this Plan, and to the direction of the Board, the Committee will have full power to implement and carry out this
Plan. The Committee will have the authority to:
(a)
construe and interpret this Plan, any Award Agreement and
any other agreement or document executed pursuant to this Plan;
(b)
prescribe, amend and rescind rules and regulations relating to this Plan or
any Award;
(c)
(d)
select persons to receive Awards;
determine the form and terms and conditions, not inconsistent with the
terms of the Plan, of any Award granted hereunder. Such terms and conditions include, but are not limited to, the
exercise price, the time or times when Awards may vest and be exercised (which may be based on performance
criteria) or settled, any vesting acceleration or waiver of forfeiture restrictions, the method to satisfy tax
withholding obligations or any other tax liability legally due and any restriction or limitation regarding any
Award or the Shares relating thereto, based in each case on such factors as the Committee will determine;
(e)
determine the number of Shares or other consideration subject to Awards;
(f)
determine the Fair Market Value in good faith and interpret the
applicable provisions of this Plan and the definition of Fair Market Value in connection with circumstances that
impact the Fair Market Value, if necessary;
(g)
in
combination with, in tandem with, or as alternatives to, other Awards under this Plan or any other incentive or
compensation plan of the Company or any Parent, Subsidiary or Affiliate;
determine whether Awards will be granted singly,
(h)
(i)
(j)
grant waivers of Plan or Award conditions;
determine the vesting, exercisability and payment of Awards;
correct any defect, supply any omission or reconcile any
inconsistency in this Plan, any Award or any Award Agreement;
2
(k)
(l)
determine whether an Award has been vested and/or earned;
adjust Performance Factors;
(m)
reduce or waive any criteria with respect to Performance Factors;
(n)
adopt terms and conditions, rules and/or procedures (including
the adoption of any subplan under this Plan) relating to the operation and administration of the Plan to
accommodate requirements of local law and procedures outside of the United States or to qualify Awards for
special tax treatment under laws of jurisdictions other than the United States;
(o)
administration of this Plan; and
make all other determinations necessary or advisable for the
(p)
delegate any of the foregoing to a subcommittee or to one more
executive officers pursuant to a specific delegation as permitted by applicable law.
4.2.
Committee Interpretation and Discretion. Any determination made by the
Committee with respect to any Award shall be made in its sole discretion at the time of grant of the Award or,
unless in contravention of any express term of the Plan or Award, at any later time, and such determination shall
be final and binding on the Company and all persons having an interest in any Award under the Plan. Any
dispute regarding the interpretation of the Plan or any Award Agreement shall be submitted by the Participant or
Company to the Committee for review. The resolution of such a dispute by the Committee shall be final and binding
on the Company and the Participant. The Committee may delegate to one or more executive officers the authority
to review and resolve disputes with respect to Awards held by Participants who are not Insiders, and such
resolution shall be final and binding on the Company and the Participant.
4.3.
Section 16 of the Exchange Act. Awards granted to Participants who are
subject to Section 16 of the Exchange Act must be approved by two or more “non-employee directors” (as
defined in the regulations promulgated under Section 16 of the Exchange Act).
4.4.
Documentation. The Award Agreement for a given Award, the Plan and any
other documents may be delivered to, and accepted by, a Participant or any other person in any manner
(including electronic distribution or posting) that meets applicable legal requirements.
4.5.
Foreign Award Recipients. Notwithstanding any provision of the Plan to the
contrary, in order to comply with the laws and practices in other countries in which the Company, its Subsidiaries
and Affiliates operate or have Employees eligible for Awards, the Committee, in its sole discretion, shall have
the power and authority to: (a) determine which Subsidiaries and Affiliates shall be covered by the Plan; (b)
determine which Employees outside the United States are eligible to participate in the Plan; (c) modify the terms
and conditions of any Award granted to Employees outside the United States or foreign nationals to comply with
applicable foreign laws, policies, customs and practices; (d) establish subplans and modify exercise procedures,
vesting conditions, and other terms and procedures, to the extent the Committee determines such actions to be
necessary or advisable (and such subplans and/or modifications shall be attached to this Plan as appendices, if
necessary); provided, however, that no such subplans and/or modifications shall increase the share limitations
contained in Section 2.1 hereof; and (e) take any action, before or
3
after an Award is made, that the Committee determines to be necessary or advisable to obtain approval or
comply with any local governmental regulatory exemptions or approvals. Notwithstanding the foregoing, the
Committee may not take any actions hereunder, and no Awards shall be granted, that would violate the Exchange
Act or any other applicable United States securities law, the Code, or any other applicable United States
governing statute or law.
5.
OPTIONS. An Option is the right but not the obligation to purchase a Share, subject to
certain conditions, if applicable. The Committee may grant Nonqualified Stock Options (“NSOs”) to eligible
Employees and the Committee and will determine the number of Shares subject to the Option, the Exercise
Price of the Option, the period during which the Option may vest and be exercised, and all other terms and
conditions of the Option, subject to the following terms of this section.
5.1.
Option Grant. Each Option granted under this Plan will be an NSO. An
Option may be, but need not be, awarded upon satisfaction of such Performance Factors during any
Performance Period as are set out in advance in the Participant’s individual Award Agreement. If the Option is
being earned upon the satisfaction of Performance Factors, then the Committee will:
(a) determine the nature, length and starting date of any Performance Period for each Option; and
(b)
select from among the Performance Factors to be used to measure the performance, if any.
Performance Periods may overlap and Participants may participate simultaneously with respect to Options that
are subject to different performance goals and other criteria.
5.2.
Date of Grant. The date of grant of an Option will be the date on which the
Committee makes the determination to grant such Option, or a specified future date. The Award Agreement will
be delivered to the Participant within a reasonable time after the granting of the Option.
5.3.
Exercise Period. Options may be vested and exercisable within the times or
upon the conditions as set forth in the Award Agreement governing such Option; provided, however, that no
Option will be exercisable after the expiration of ten (10) years from the date the Option is granted. The
Committee also may provide for Options to become exercisable at one time or from time to time, periodically or
otherwise, in such number of Shares or percentage of Shares as the Committee determines.
5.4.
Exercise Price. The Exercise Price of an Option will be determined by the
Committee when the Option is granted; provided that the Exercise Price of an Option will be not less than one
hundred percent (100%) of the Fair Market Value of the Shares on the date of grant. Payment for the Shares
purchased may be made in accordance with Section 7 and the Award Agreement and in accordance with any
procedures established by the Company.
5.5.
Method of Exercise. Any Option granted hereunder will be vested and
exercisable according to the terms of the Plan and at such times and under such conditions as determined by the
Committee and set forth in the Award Agreement. An Option may not be exercised for a fraction of a Share. An
Option will be deemed exercised when the Company receives: (a) notice of exercise (in such form as the
Committee may specify from time to time) from the person entitled to exercise the Option (and/or via electronic
execution through the authorized third party administrator), and (b) full payment for the Shares with respect to
which the Option is exercised
4
(together with applicable withholding taxes). Full payment may consist of any consideration and method of
payment authorized by the Committee and permitted by the Award Agreement and the Plan. Shares issued upon
exercise of an Option will be issued in the name of the Participant. Until the Shares are issued (as evidenced by
the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no
right to vote or receive dividends or any other rights as a stockholder will exist with respect to the Shares,
notwithstanding the exercise of the Option. The Company will issue (or cause to be issued) such Shares
promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the
record date is prior to the date the Shares are issued, except as provided in Section 2.4 of the Plan. Exercising an
Option in any manner will decrease the number of Shares thereafter available, both for purposes of the Plan and
for sale under the Option, by the number of Shares as to which the Option is exercised.
5.6.
Termination of Service. If the Participant’s Service terminates for any reason
except for Cause or the Participant’s death or Disability, then the Participant may exercise such Participant’s
Options only to the extent that such Options would have been exercisable by the Participant on the date
Participant’s Service terminates no later than three (3) months after the date Participant’s Service terminates (or
such shorter or longer time period as may be determined by the Committee), but in any event no later than the
expiration date of the Options.
(a)
Death. If the Participant’s Service terminates because of the
Participant’s death (or the Participant dies within three (3) months after Participant’s Service terminates other
than for Cause or because of the Participant’s Disability), then the Participant’s Options may be exercised only to
the extent that such Options would have been exercisable by the Participant on the date Participant’s Service
terminates and must be exercised by the Participant’s legal representative, or authorized assignee, no later than
twelve (12) months after the date Participant’s Service terminates (or such shorter time period or longer time
period as may be determined by the Committee), but in any event no later than the expiration date of the Options.
(b)
Disability. If the Participant’s Service terminates because of the
Participant’s Disability, then the Participant’s Options may be exercised only to the extent that such Options
would have been exercisable by the Participant on the date Participant’s Service terminates and must be
exercised by the Participant (or the Participant’s legal representative or authorized assignee) no later than twelve
(12) months after the date Participant’s Service terminates (or such shorter time period or longer time period as
may be determined by the Committee), but in any event no later than the expiration date of the Options.
(c)
Cause. If the Participant’s Service terminates for Cause, then
Participant’s Options shall expire on such Participant’s date of termination of Service, or at such later time and on
such conditions as are determined by the Committee, but in any event no later than the expiration date of the
Options. Unless otherwise provided in an employment agreement or an Award Agreement, Cause shall have the
meaning set forth in the Plan.
5.7.
Limitations on Exercise. The Committee may specify a minimum number of
Shares that may be purchased on any exercise of an Option, provided that such minimum number will not
prevent any Participant from exercising the Option for the full number of Shares for which it is then exercisable.
5
5.8.
Modification, Extension or Renewal. The Committee may, in accordance
with NASDAQ 5635(c)(4), modify, extend or renew outstanding Options and authorize the grant of new
Options in substitution therefor, provided that any such action may not, without the written consent of a
Participant, impair any of such Participant’s rights under any Option previously granted.
6.
RESTRICTED STOCK UNITS. A Restricted Stock Unit (“RSU”) is an award to an eligible
Employee covering a number of Shares that may be settled in cash, or by issuance of those Shares (which may
consist of restricted Shares). All RSUs shall be made pursuant to an Award Agreement.
6.1.
Terms of RSUs. The Committee will determine the terms of an RSU
including, without limitation: (a) the number of Shares subject to the RSU; (b) the time or times during which the
RSU may be settled; (c) the consideration to be distributed on settlement; and (d) the effect of the Participant’s
termination of Service on each RSU; provided that no RSU shall have a term longer than ten (10) years. An
RSU may be awarded upon satisfaction of such performance goals based on Performance Factors during any
Performance Period as are set out in advance in the Participant’s Award Agreement. If the RSU is being earned
upon satisfaction of Performance Factors, then the Committee will: (x) determine the nature, length and starting
date of any Performance Period for the RSU; (y) select from among the Performance Factors to be used to
measure the performance, if any; and (z) determine the number of Shares deemed subject to the RSU.
Performance Periods may overlap and Participants may participate simultaneously with respect to RSUs that are
subject to different Performance Periods and different performance goals and other criteria.
6.2.
Form and Timing of Settlement. Payment of earned RSUs shall be made as
soon as practicable after the date(s) determined by the Committee and set forth in the Award Agreement. The
Committee, in its sole discretion, may settle earned RSUs in cash, Shares, or a combination of both. The
Committee may also permit a Participant to defer payment under a RSU to a date or dates after the RSU is
earned provided that the terms of the RSU and any deferral satisfy the requirements of Section 409A of the
Code to the extent applicable.
6.3.
Termination of Service. Except as may be set forth in the Participant’s Award
Agreement, vesting ceases on such date Participant’s Service terminates (unless determined otherwise by the
Committee).
7.
PAYMENT FOR SHARE PURCHASES. Payment from a Participant for Shares purchased
pursuant to this Plan may be made in cash or by check or, where approved for the Participant by the Committee
and where permitted by law (and to the extent not otherwise set forth in the applicable Award Agreement):
(a)
by cancellation of indebtedness of the Company to the Participant;
(b)
by surrender of Shares held by the Participant that have a Fair
Market Value on the date of surrender equal to the aggregate exercise price of the Shares as to which said Award
will be exercised or settled;
6
(c)
by waiver of compensation due or accrued to the Participant for
services rendered or to be rendered to the Company or a Parent, Subsidiary or Affiliate;
(d)
by consideration received by the Company pursuant to a broker-
assisted or other form of cashless exercise program implemented by the Company in connection with the Plan;
(e)
(f)
by any combination of the foregoing; or
by any other method of payment as is permitted by applicable law.
8.
WITHHOLDING TAXES.
8.1.
Withholding Generally. Whenever Shares are to be issued in satisfaction of
Awards granted under this Plan or a tax event occurs, the Company may require the Participant to remit to the
Company, or to the Parent, Subsidiary or Affiliate, as applicable, employing the Participant, an amount
sufficient to satisfy applicable U.S. federal, state, local and international tax or any other tax or social insurance
liability (the “Tax-Related Items”) required to be withheld from the Participant prior to the delivery of Shares
pursuant to exercise or settlement of any Award. Whenever payments in satisfaction of Awards granted under
this Plan are to be made in cash, such payment will be net of an amount sufficient to satisfy applicable
withholding obligations for Tax- Related Items. Unless otherwise determined by the Committee, the Fair Market
Value of the Shares will be determined as of the date that the taxes are required to be withheld and such Shares
will be valued based on the value of the actual trade or, if there is none, the Fair Market Value of the Shares as
of the previous trading day.
8.2.
Stock Withholding. The Committee, or its delegate(s), as permitted by
applicable law, in its sole discretion and pursuant to such procedures as it may specify from time to time and to
limitations of local law, may require or permit a Participant to satisfy such Tax Related Items legally due from
the Participant, in whole or in part by (without limitation) (a) paying cash,
(b)
having the Company withhold otherwise deliverable cash or Shares having a Fair Market Value
equal to the Tax-Related Items to be withheld, (c) delivering to the Company already-owned shares of common
stock having a Fair Market Value equal to the Tax-Related Items to be withheld or (d) withholding from the
proceeds of the sale of otherwise deliverable Shares acquired pursuant to an Award either through a voluntary sale
or through a mandatory sale arranged by the Company. The Company may withhold or account for these Tax-
Related Items by considering applicable statutory withholding rates or other applicable withholding rates,
including up to (but not in excess of) the maximum permissible statutory tax rate for the applicable tax
jurisdiction, to the extent consistent with applicable laws.
9.
TRANSFERABILITY. Unless determined otherwise by the Committee, an Award may not
be sold, pledged, assigned, hypothecated, transferred, or disposed of in any manner other than by will or by the
laws of descent or distribution. If the Committee makes an Award transferable, including, without limitation, by
instrument to an inter vivos or testamentary trust in which the Awards are to be passed to beneficiaries upon the
death of the trustor (settlor) or by gift or by domestic relations order to a Permitted Transferee, such Award will
contain such additional terms and conditions as the Committee deems appropriate. All Awards shall be
exercisable: (a) during
7
the Participant’s lifetime only by (i) the Participant, or (ii) the Participant’s guardian or legal representative; (b)
after the Participant’s death, by the legal representative of the Participant’s heirs or legatees; and (c) by a
Permitted Transferee.
10.
PRIVILEGES OF STOCK OWNERSHIP; RESTRICTIONS ON SHARES.
10.1.
Voting and Dividends. No Participant will have any of the rights of a
stockholder with respect to any Shares until the Shares are issued to the Participant, except for any Dividend
Equivalent Rights permitted by an applicable Award Agreement. Any Dividend Equivalent Rights shall be subject
to the same vesting or performance conditions as the underlying Award. After Shares are issued to the
Participant, the Participant will be a stockholder and have all the rights of a stockholder with respect to such
Shares, including the right to vote and receive all dividends or other distributions made or paid with respect to
such Shares; provided, that if such Shares are Restricted Stock, then any new, additional or different securities
the Participant may become entitled to receive with respect to such Shares by virtue of a stock dividend, stock
split or any other change in the corporate or capital structure of the Company will be subject to the same
restrictions as the Restricted Stock; provided, further, that the Participant will have no right to retain such stock
dividends or stock distributions with respect to Shares that are repurchased at the Participant’s Purchase Price or
Exercise Price, as the case may be, pursuant to Section 10.2. The Committee, in its discretion, may provide in the
Award Agreement evidencing any Award that the Participant shall be entitled to Dividend Equivalent Rights
with respect to the payment of cash dividends on Shares underlying an Award during the period beginning on
the date the Award is granted and ending, with respect to each Share subject to the Award, on the earlier of the
date on which the Award is exercised or settled or the date on which it is forfeited. Such Dividend Equivalent
Rights, if any, shall be credited to the Participant in the form of additional whole Shares as of the date of payment
of such cash dividends on Shares Notwithstanding the foregoing, dividends and Dividend Equivalent Rights
may accrue with respect to unvested Awards, but will not be paid or issued until such Award is fully vested and
the Shares are issued to Participant and such Shares are no longer subject to any vesting requirements or
repurchase rights on behalf of the Company.
10.2.
Restrictions on Shares. At the discretion of the Committee, the Company
may reserve to itself and/or its assignee(s) a right to repurchase (a “Right of Repurchase”) a portion of any or all
Unvested Shares held by a Participant following such Participant’s termination of Service at any time within
ninety (90) days (or such longer or shorter time determined by the Committee) after the later of the date
Participant’s Service terminates and the date the Participant purchases Shares under this Plan, for cash and/or
cancellation of purchase money indebtedness, at the Participant’s Purchase Price or Exercise Price, as the case
may be.
11.
CERTIFICATES. All Shares or other securities whether or not certificated, delivered under
this Plan will be subject to such stock transfer orders, legends and other restrictions as the Committee may
deem necessary or advisable, including restrictions under any applicable U.S. federal, state or foreign securities
law, or any rules, regulations and other requirements of the SEC or any stock exchange or automated quotation
system upon which the Shares may be listed or quoted and any non-U.S. exchange controls or securities law
restrictions to which the Shares are subject.
8
12.
ESCROW; PLEDGE OF SHARES. To enforce any restrictions on a Participant’s Shares,
the Committee may require the Participant to deposit all certificates representing Shares, together with stock
powers or other instruments of transfer approved by the Committee, appropriately endorsed in blank, with the
Company or an agent designated by the Company to hold in escrow until such restrictions have lapsed or
terminated, and the Committee may cause a legend or legends referencing such restrictions to be placed on the
certificates. Any Participant who is permitted to execute a promissory note as partial or full consideration for
the purchase of Shares under this Plan will be required to pledge and deposit with the Company all or part of
the Shares so purchased as collateral to secure the payment of the Participant’s obligation to the Company under
the promissory note; provided, however, that the Committee may require or accept other or additional forms of
collateral to secure the payment of such obligation and, in any event, the Company will have full recourse
against the Participant under the promissory note notwithstanding any pledge of the Participant’s Shares or
other collateral. In connection with any pledge of the Shares, the Participant will be required to execute and
deliver a written pledge agreement in such form as the Committee will from time to time approve. The Shares
purchased with the promissory note may be released from the pledge on a pro rata basis as the promissory note
is paid.
SECURITIES LAW AND OTHER REGULATORY COMPLIANCE. An Award will not
13.
be effective unless such Award is in compliance with all applicable U.S. and foreign federal and state securities
and exchange control laws, rules and regulations of any governmental body, and the requirements of any stock
exchange or automated quotation system upon which the Shares may then be listed or quoted, as they are in
effect on the date of grant of the Award and also on the date of exercise or other issuance. Notwithstanding any
other provision in this Plan, the Company will have no obligation to issue or deliver certificates for Shares
under this Plan prior to: (a) obtaining any approvals from governmental agencies that the Company determines
are necessary or advisable; and/or (b) completion of any registration or other qualification of such Shares under
any state or federal or foreign law or ruling of any governmental body that the Company determines to be
necessary or advisable. The Company will be under no obligation to register the Shares with the SEC or to
effect compliance with the registration, qualification or listing requirements of any foreign or state securities
laws, exchange control laws, stock exchange or automated quotation system, and the Company will have no
liability for any inability or failure to do so.
14.
NO OBLIGATION TO EMPLOY. Nothing in this Plan or any Award granted under this
Plan will confer or be deemed to confer on any Participant any right to continue in the employ of, or to continue
any other relationship with, the Company or any Parent, Subsidiary or Affiliate or limit in any way the right of
the Company or any Parent, Subsidiary or Affiliate to terminate Participant’s Service at any time.
15.
CORPORATE TRANSACTIONS. In the event of a Corporate Transaction any or all
outstanding Awards may be assumed or replaced by the successor corporation, which assumption or replacement
shall be binding on all Participants. In the alternative, the successor corporation may substitute equivalent
Awards or provide substantially similar consideration to Participants as was provided to stockholders (after
taking into account the existing provisions of the Awards). The successor corporation may also issue, in place of
outstanding Shares of the Company held by the Participant, substantially similar shares or other property subject
to repurchase restrictions no
9
less favorable to the Participant. In the event such successor or acquiring corporation (if any) refuses to assume,
convert, replace or substitute Awards, as provided above, pursuant to a Corporate Transaction, then
notwithstanding any other provision in this Plan to the contrary, such Awards will expire on such transaction at
such time and on such conditions as the Board will determine, provided, however, that the Board (or, the
Committee, if so designated by the Board) may, in its sole discretion, accelerate the vesting of such Awards in
connection with a Corporate Transaction. In addition, in the event such successor or acquiring corporation (if
any) refuses to assume, convert, replace or substitute Awards, as provided above, pursuant to a Corporate
Transaction, the Committee will notify the Participant in writing or electronically that such Award will be
exercisable for a period of time determined by the Committee in its sole discretion, and such Award will
terminate upon the expiration of such period. Awards need not be treated similarly in a Corporate Transaction
16.
ADOPTION. This Plan was adopted by the Board on the Effective Date.
17.
TERM OF PLAN/GOVERNING LAW. Unless earlier terminated as provided herein, this
Plan will become effective on the Effective Date and will terminate ten (10) years from the date this Plan is
adopted by the Board. This Plan and all Awards granted hereunder shall be governed by and construed in
accordance with the laws of the State of Delaware (excluding its conflict of law rules).
18.
AMENDMENT OR TERMINATION OF PLAN. The Board may at any time terminate or
amend this Plan in any respect, including, without limitation, amendment of any form of Award Agreement or
instrument to be executed pursuant to this Plan; provided, however, that the Board will not, without the approval
of the stockholders of the Company, amend this Plan in any manner that requires such stockholder approval;
provided further, that a Participant’s Award shall be governed by the version of this Plan then in effect at the
time such Award was granted. No termination or amendment of the Plan or any outstanding Award may
adversely affect any then outstanding Award without the consent of the Participant, unless such termination or
amendment is necessary to comply with applicable law, regulation or rule.
19.
NONEXCLUSIVITY OF THE PLAN. Neither the adoption of this Plan by the Board, nor
any provision of this Plan will be construed as creating any limitations on the power of the Board to adopt such
additional compensation arrangements as it may deem desirable, including, without limitation, the granting of
stock awards and bonuses otherwise than under this Plan, and such arrangements may be either generally
applicable or applicable only in specific cases.
INSIDER TRADING POLICY. Each Participant who receives an Award shall comply
20.
with any policy adopted by the Company from time to time covering transactions in the Company’s securities by
Employees, officers and/or directors of the Company, as well as with any applicable insider trading or market
abuse laws to which the Participant may be subject.
ALL AWARDS SUBJECT TO COMPANY CLAWBACK OR RECOUPMENT
21.
POLICY. All Awards, subject to applicable law, shall be subject to clawback or recoupment pursuant to any
compensation clawback or recoupment policy adopted by the Board or required by law during the term of
Participant’s employment or other service with the Company that is applicable to Employees, directors or other
service providers of the Company, and in addition to
10
any other remedies available under such policy and applicable law, may require the cancellation of outstanding
Awards and the recoupment of any gains realized with respect to Awards.
22.
herein, the following terms will have the following meanings:
DEFINITIONS.
As used in this Plan, and except as elsewhere defined
22.1.
“Affiliate” means (i) any entity that, directly or indirectly, is controlled by,
controls or is under common control with, the Company and (ii) any entity in which the Company has a
significant equity interest, in either case as determined by the Committee, whether now or hereafter existing.
22.2.
“Award” means any award under the Plan, including any Option or Restricted Stock
Unit .
22.3.
“Award Agreement” means, with respect to each Award, the written or electronic
agreement between the Company and the Participant setting forth the terms and conditions of the Award, and
country-specific appendix thereto for grants to non-U.S. Participants, which shall be in substantially a form
(which need not be the same for each Participant) that the Committee (or in the case of Award agreements that
are not used for Insiders, the Committee's delegate(s)) has from time to time approved, and will comply with
and be subject to the terms and conditions of this Plan.
22.4.
“Board” means the Board of Directors of the Company.
22.5.
“Cause” means (a) Participant’s willful failure substantially to perform his
or her duties and responsibilities to the Company or deliberate violation of a Company policy; (b) Participant’s
commission of any act of fraud, embezzlement, dishonesty or any other willful misconduct that has caused or is
reasonably expected to result in material injury to the Company;
(c)
unauthorized use or disclosure by Participant of any proprietary information or trade secrets of the
Company or any other party to whom the Participant owes an obligation of nondisclosure as a result of his or her
relationship with the Company; or (d) Participant’s willful breach of any of his or her obligations under any
written agreement or covenant with the Company. The determination as to whether a Participant is being
terminated for Cause shall be made in good faith by the Company and shall be final and binding on the
Participant. The foregoing definition does not in any way limit the Company’s ability to terminate a Participant’s
employment or consulting relationship at any time as provided in Section 14 above, and the term “Company”
will be interpreted to include any Subsidiary or Parent, as appropriate. The foregoing definition of “Cause” may, in
part or in whole, be modified or replaced in each individual employment agreement, Award Agreement or other
applicable agreement with any Participant, provided that such document supersedes the definition provided in
this Section 22.5.
22.6.
“Code” means the United States Internal Revenue Code of 1986, as
amended, and the regulations promulgated thereunder.
22.7.
“Committee” means the Compensation Committee of the Board or those
persons to whom administration of the Plan, or part of the Plan, has been delegated as permitted by law.
22.8.
“Common Stock” means common stock of the Company.
11
22.9.
“Company” means KalVista Pharmaceuticals, Inc., or any successor corporation.
22.10.
“Consultant” means any natural person, including an advisor or
independent contractor, engaged by the Company or a Parent, Subsidiary or Affiliate to render services to such
entity.
22.11.
“Corporate Transaction” means the occurrence of any of the following
events: (a) any “Person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes the
“beneficial owner” (as defined in Rule 13d-3 of the Exchange Act), directly or indirectly, of securities of the
Company representing more than fifty percent (50%) of the total voting power represented by the Company’s
then-outstanding voting securities; provided, however, that for purposes of this subclause (a) the acquisition of
additional securities by any one Person who is considered to own more than fifty percent (50%) of the total
voting power of the securities of the Company will not be considered a Corporate Transaction; (b) the
consummation of the sale or disposition by the Company of all or substantially all of the Company’s assets; (c)
the consummation of a merger or consolidation of the Company with any other corporation, other than a merger or
consolidation which would result in the voting securities of the Company outstanding immediately prior thereto
continuing to represent (either by remaining outstanding or by being converted into voting securities of the
surviving entity or its parent) at least fifty percent (50%) of the total voting power represented by the voting
securities of the Company or such surviving entity or its parent outstanding immediately after such merger or
consolidation; (d) any other transaction which qualifies as a “corporate transaction” under Section 424(a) of the
Code wherein the stockholders of the Company give up all of their equity interest in the Company (except for
the acquisition, sale or transfer of all or substantially all of the outstanding shares of capital stock of the
Company) or (e) a change in the effective control of the Company that occurs on the date that a majority of
members of the Board is replaced during any twelve (12) month period by members of the Board whose
appointment or election is not endorsed by a majority of the members of the Board prior to the date of the
appointment or election. For purpose of this subclause (e), if any Person is considered to be in effective control
of the Company, the acquisition of additional control of the Company by the same Person will not be considered a
Corporate Transaction. For purposes of this definition, Persons will be considered to be acting as a group if they
are owners of a corporation that enters into a merger, consolidation, purchase or acquisition of stock, or similar
business transaction with the Company. Notwithstanding the foregoing, to the extent that any amount
constituting deferred compensation (as defined in Section 409A of the Code) would become payable under this
Plan by reason of a Corporate Transaction, such amount shall become payable only if the event constituting a
Corporate Transaction would also qualify as a change in ownership or effective control of the Company or a
change in the ownership of a substantial portion of the assets of the Company, each as defined within the meaning
of Code Section 409A, as it has been and may be amended from time to time, and any proposed or final Treasury
Regulations and IRS guidance that has been promulgated or may be promulgated thereunder from time to time.
22.12.
“Disability” means that the Participant is unable to engage in any substantial
gainful activity by reason of any medically determinable physical or mental impairment that can be expected to
result in death or can be expected to last for a continuous period of not less than 12 months.
12
22.13.
“Dividend Equivalent Right” means the right of a Participant, granted at
the discretion of the Committee or as otherwise provided by the Plan, to receive a credit for the account of such
Participant in an amount equal to the cash, stock or other property dividends in amounts equal equivalent to
cash, stock or other property dividends for each Share represented by an Award held by such Participant.
22.14.
“Effective Date” means [, 2021], the date the Plan was adopted by the
Board.
22.15.
“Employee” means any person, including Officers and Directors, providing
services as an employee to the Company or any Parent, Subsidiary or Affiliate. Neither service as a member of
the Board nor payment of a director’s fee by the Company will be sufficient to constitute “employment” by the
Company.
22.16.
1934, as amended.
“Exchange Act” means the United States Securities Exchange Act of
22.17.
“Exercise Price” means, with respect to an Option, the price at which a
holder may purchase the Shares issuable upon exercise of an Option.
22.18.
“Fair Market Value” means, as of any date, the value of a share of the
Company’s Common Stock determined as follows:
(a)
if such Common Stock is publicly traded and is then listed on a
national securities exchange, its closing price on the date of determination on the principal national securities
exchange on which the Common Stock is listed or admitted to trading as reported in The Wall Street Journal or
such other source as the Committee deems reliable;
(b)
if such Common Stock is publicly traded but is neither listed
nor admitted to trading on a national securities exchange, the average of the closing bid and asked prices on the
date of determination as reported in The Wall Street Journal or such other source as the Committee deems reliable;
or
good faith.
(c)
if none of the foregoing is applicable, by the Board or the Committee in
22.19.
“Insider” means an officer or director of the Company or any other person
whose transactions in the Company’s Common Stock are subject to Section 16 of the Exchange Act.
22.20.
“IRS” means the United States Internal Revenue Service.
22.21.
“Option” means an award of an option to purchase Shares pursuant to Section 5.
22.22.
“Parent” means any corporation (other than the Company) in an unbroken
chain of corporations ending with the Company if each of such corporations other than the Company owns stock
possessing fifty percent (50%) or more of the total combined voting power of all classes of stock in one of the
other corporations in such chain.
13
22.23.
“Participant” means a person who holds an Award under this Plan.
22.24.
“Performance Factors” means any of the factors selected by the
Committee and specified in an Award Agreement, from among the following objective measures, either
individually, alternatively or in any combination, applied to the Company as a whole or any business unit or
Subsidiary, either individually, alternatively, or in any combination, on a GAAP or non-GAAP basis, and
measured, to the extent applicable on an absolute basis or relative to a pre-established target, to determine
whether the performance goals established by the Committee with respect to applicable Awards have been
satisfied:
Profit Before Tax;
Billings;
Revenue;
Net revenue;
(a)
(b)
(c)
(d)
(e)
Earnings (which may include earnings before interest and
taxes, earnings before taxes, net earnings, stock-based compensation expenses, depreciation and amortization);
(f)
(g)
(h)
(i)
(j)
(k)
(l)
Operating income;
Operating margin;
Operating profit;
Controllable operating profit, or net operating profit;
Net Profit;
Gross margin;
Operating expenses or operating expenses as a percentage of revenue;
(m)
Net income;
(n)
(o)
(p)
(q)
(r)
(s)
Earnings per share;
Total stockholder return;
Market share;
Return on assets or net assets;
The Company’s stock price;
Growth in stockholder value relative to a pre-determined index;
14
(t)
(u)
(v)
Return on equity;
Return on invested capital;
Cash Flow (including free cash flow or operating cash flows);
(w)
Cash conversion cycle;
(x)
(y)
(z)
Economic value added;
Individual confidential business objectives;
Contract awards or backlog;
(aa)
other expense reduction;
(bb)
(cc)
implementation; (dd)
plan development and implementation;
(ee)
diversity;
(ff)
and/or satisfaction;
(gg)
invention or innovation;
(hh)
Overhead or
Credit rating;
Strategic plan development and
Succession
Improvement in workforce
Customer indicators
New product
Attainment of research and development milestones;
(ii)
in productivity;
(jj)
(kk)
employee metrics; (ll)
(mm) Expenses;
Improvements
Bookings;
Attainment of objective operating goals and
Sales;
(nn)
marketable securities; (oo)
identified special project;
(pp)
corporate transaction; (qq)
satisfaction and/or retention;
(rr)
Balance of cash, cash equivalents and
Completion of an
Completion of a joint venture or other
Employee
Research and development expenses;
15
(tt)
Any other metric that is capable of measurement as determined by the
Working-
Committee.
(ss)
capital targets and
changes in working
capital; and
The Committee may, in recognition of unusual or non-recurring items such as acquisition- related
activities or changes in applicable accounting rules, provide for one or more equitable adjustments (based on
objective standards) to the Performance Factors to preserve the Committee’s original intent regarding the
Performance Factors at the time of the initial award grant. It is within the sole discretion of the Committee to
make or not make any such equitable adjustments.
22.25.
“Performance Period” means one or more periods of time, which may be
of varying and overlapping durations, as the Committee may select, over which the attainment of one or more
Performance Factors will be measured for the purpose of determining a Participant’ right to, and the payment of,
an Award subject to Performance Factors.
22.26.
“Permitted Transferee” means any child, stepchild, grandchild, parent,
stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in- law,
daughter-in-law, brother-in-law, or sister-in-law (including adoptive relationships) of the Employee, any person
sharing the Employee’s household (other than a tenant or employee), a trust in which these persons (or the
Employee) have more than 50% of the beneficial interest, a foundation in which these persons (or the
Employee) control the management of assets, and any other entity in which these persons (or the Employee)
own more than 50% of the voting interests.
22.27.
“Plan” means this KalVista Pharmaceuticals, Inc. 2021 Equity Inducement Plan.
22.28.
“Purchase Price” means the price to be paid for Shares acquired under the
Plan, other than Shares acquired upon exercise of an Option.
22.29.
“Restricted Stock Unit” means an Award granted pursuant to Section 6 of the Plan.
22.30.
“SEC” means the United States Securities and Exchange Commission.
22.31.
“Securities Act” means the United States Securities Act of 1933, as amended.
22.32.
“Service” shall mean service as an Employee, Consultant or member of the
Board to the Company or a Parent, Subsidiary or Affiliate, subject to such further limitations as may be set forth
in the Plan or the applicable Award Agreement. An Employee will not be deemed to have ceased to provide
Service in the case of (a) sick leave, (b) military leave, or (c) any other leave of absence approved by the
Company; provided, that such leave is for a period of not more than 90 days unless reemployment upon the
expiration of such leave is guaranteed by contract or statute. Notwithstanding anything to the contrary, an
Employee will not be deemed to have ceased to provide Service if a formal policy adopted from time to time by
the Company and issued and promulgated to employees in writing provides otherwise. In the case of any
Employee on an approved leave of absence or a reduction in hours worked (for illustrative purposes only, a
change in schedule from that of full-time to part-time), the Committee may make such provisions
16
respecting suspension or modification of vesting of the Award while on leave from the employ of
17
the Company or a Parent, Subsidiary or Affiliate or during such change in working hours as it may deem
appropriate, except that in no event may an Award be exercised after the expiration of the term set forth in the
applicable Award Agreement. In the event of military or other protected leave, if required by applicable laws,
vesting shall continue for the longest period that vesting continues under any other statutory or Company
approved leave of absence and, upon a Participant’s returning from military leave, he or she shall be given
vesting credit with respect to Awards to the same extent as would have applied had the Participant continued to
provide Service to the Company throughout the leave on the same terms as he or she was providing Service
immediately prior to such leave. An Employee shall have terminated employment as of the date he or she ceases to
provide Service (regardless of whether the termination is in breach of local employment laws or is later found to
be invalid) and employment shall not be extended by any notice period or garden leave mandated by local law,
provided however, that a change in status from an Employee to a Consultant, or a member of the Board (or vice
versa) shall not terminate Participant’s Service, unless determined by the Committee, in its discretion or to the
extent set forth in the applicable Award Agreement. The Committee will have sole discretion to determine
whether a Participant has ceased to provide Service and the effective date on which the Participant ceased to
provide Service.
22.33.
“Shares” means shares of Common Stock and the common stock of any successor
entity.
22.34.
“Subsidiary” means any corporation (other than the Company) in an unbroken
chain of corporations beginning with the Company if each of the corporations other than the last corporation in
the unbroken chain owns stock possessing fifty percent (50%) or more of the total combined voting power of all
classes of stock in one of the other corporations in such chain.
22.35.
“Treasury Regulations” means regulations promulgated by the United
States Treasury Department.
22.36.
“Unvested Shares” means Shares that have not yet vested or are subject to
a right of repurchase in favor of the Company (or any successor thereto).
18
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN NOTICE OF
GLOBAL STOCK OPTION GRANT
Unless otherwise defined herein, the terms defined in the KalVista Pharmaceuticals, Inc. 2021 Equity Inducement
Plan (the “Plan”) will have the same meanings in this Notice of Stock Option Grant and the electronic representation of
this Notice of Global Stock Option Grant established and maintained by the Company or a third party designated by the
Company (this “Notice”).
Name:
Address:
You (“Participant”) have been granted an option to purchase shares of Common Stock of the Company under the
Plan subject to the terms and conditions of the Plan, this Notice and the Stock Option Award Agreement (the “Option
Agreement”), including any applicable country-specific provisions in the appendix attached hereto (the “Appendix”)
which constitutes part of the Option Agreement.
Grant Number:
Date of Grant:
Vesting Commencement Date:
Exercise Price per Share: Total Number of
Shares:
Type of Option:
Non-Qualified Stock Option
Expiration Date:
, 20 . This Option expires earlier if
Participant’s Service terminates earlier, as described in the Option Agreement.
Vesting Schedule:
Notice, the Plan
Subject to the limitations set forth in this
and the Agreement, the Options will vest in accordance with the
following schedule: [insert applicable vesting schedule, which
may be time- and/or performance- based]
By accepting (whether in writing, electronically or otherwise) the Option, Participant acknowledges and agrees to the
following:
Participant understands that Participant’s Service with the Company or a Parent or Subsidiary or Affiliate is for an
unspecified duration, can be terminated at any time (i.e., is “at-will”), except where otherwise prohibited by applicable
law and that nothing in this Notice, the Option Agreement or the Plan changes the nature of that relationship.
[Signature Page Follows]
Participant acknowledges that the vesting of the Option pursuant to this Notice is earned only by continuing
Service (as defined in the Plan). Furthermore, the period during which Participant may exercise the Option after such
termination of Service will commence on the date Participant ceases to actively provide Service and will not be extended
by any notice period mandated under employment laws in the jurisdiction where Participant is employed or terms of
Participant’s employment agreement.
Participant agrees and acknowledges that the Vesting Schedule may change prospectively in the event that
Participant’s service status changes between full- and part-time status in accordance with Company policies relating to
work schedules and vesting of awards. Participant also understands that this Notice is subject to the terms and conditions of
both the Option Agreement and the Plan, both of which are incorporated herein by reference.
Participant has read the Company’s Insider Trading Policy, and agrees to comply with such policy, as it may be
amended from time to time, whenever Participant acquires or disposes of the Company’s securities.
Participant has read both the Option Agreement and the Plan. By accepting this Option, Participant consents to
electronic delivery as set forth in the Option Agreement.
PARTICIPANT
By:
Signature:
KALVISTA PHARMACEUTICALS, INC.
Print
Name:
Its:
[Signature Page to 2021 Equity Inducement Plan Notice of Global Stock Option Grant]
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN STOCK
OPTION AWARD AGREEMENT
Unless otherwise defined in this Stock Option Award Agreement (this “Option Agreement”), any capitalized terms
used herein will have the meaning ascribed to them in the KalVista Pharmaceuticals, Inc. 2021 Equity Inducement Plan (the
“Plan”).
Participant has been granted an option to purchase Shares (the “Option”) of KalVista Pharmaceuticals, Inc. (the
“Company”), subject to the terms and conditions of the Plan, the Notice of Stock Option Grant (the “Notice”) and this
Option Agreement, including any applicable country-specific provisions in the appendix attached hereto (the “Appendix”)
which constitutes part of this Option Agreement.
1.
Vesting Rights. Subject to the applicable provisions of the Plan and this Option
Agreement, this Option may be exercised, in whole or in part, in accordance with the schedule set forth in the Notice.
Participant acknowledges and agrees that the Vesting Schedule may change prospectively in the event Participant’s service
status changes between full and part-time status and/or in the event Participant is on an approved leave of absence in
accordance with Company policies relating to work schedules and vesting of awards or as determined by the Committee.
Participant acknowledges that the vesting of the Shares pursuant to this Notice and Agreement is earned only by continued
Service.
2.
Grant of Option. Participant has been granted an Option for the number of Shares set
forth in the Notice at the exercise price per Share in U.S. Dollars set forth in the Notice (the “Exercise Price”). In the
event of a conflict between the terms and conditions of the Plan and the terms and conditions of this Option Agreement, the
terms and conditions of the Plan shall prevail.
3.
Termination Period.
(a)
General Rule. If Participant’s Service terminates for any reason
except death or Disability, and other than for Cause, then this Option will expire at the close of business at Company
headquarters on the date three (3) months after Participant’s Termination Date (or such shorter time period not less than
thirty (30) days or longer time period as may be determined by the Committee). If Participant’s Service is terminated for
Cause, this Option will expire upon the date of such termination. The Company determines when Participant’s Service
terminates for all purposes under this Option Agreement.
(b)
Death; Disability. If Participant dies before Participant’s Service
terminates (or Participant dies within three months of Participant’s termination of Service other than for Cause (as defined
in the Plan)), then this Option will expire at the close of business at Company headquarters on the date 12 months after the
date of death (or such shorter time period not less than six (6) months or longer time period as may be determined by the
Committee, subject to the expiration details in Section 6). If Participant’s Service terminates because of Participant’s
Disability, then this Option will expire at the close of business at Company headquarters on the date 12 months after
Participant’s Termination Date (or such shorter time period not less than six (6) months or longer time period as may be
determined by the Committee, subject to the expiration details in Section 6).
(c)
No Notice. Participant is responsible for keeping track of these
exercise periods following Participant’s termination of Service for any reason. The Company will not provide further notice
of such periods. In no event shall this Option be exercised later than the Expiration Date set forth in the Notice.
(d)
Termination. For purposes of this Option, Participant’s Service will
be considered terminated as of the date Participant is no longer providing Services to the Company, its Parent or one of its
Subsidiaries or Affiliates (regardless of the reason for such termination and whether or not later found to be invalid or in
breach of employment laws in the jurisdiction where Participant is employed or the terms of Participant’s employment
agreement, if any) (the “Termination Date”). The Committee shall have the exclusive discretion to determine when
Participant is no longer actively providing services for purposes of Participant’s Option (including whether Participant
may still be considered to be providing services while on an approved leave of absence). Unless otherwise provided in this
Option Agreement or determined by the Company, Participant’s right to vest in this Option under the Plan, if any, will
terminate as of the Termination Date and will not be extended by any notice period (e.g., Participant’s period of services
would not include any contractual notice period or any period of “garden leave” or similar period mandated under
employment laws in the jurisdiction where Participant is employed or the terms of Participant’s employment agreement, if
any). Following the Termination Date, Participant may exercise the Option only as set forth in the Notice and this Section,
provided that the period (if any) during which Participant may exercise the Option after the Termination Date, if any, will
commence on the date Participant ceases to provide services and will not be extended by any notice period mandated
under employment laws in the jurisdiction where Participant is employed or terms of Participant’s employment
agreement, if any. If Participant does not exercise this Option within the termination period set forth in the Notice or the
termination periods set forth above, the Option shall terminate in its entirety. In no event, may any Option be exercised
after the Expiration Date of the Option as set forth in the Notice.
4.
Exercise of Option.
(a)
Right to Exercise. This Option is exercisable during its term in
accordance with the Vesting Schedule set forth in the Notice and the applicable provisions of the Plan and this Option
Agreement. In the event of Participant’s death, Disability, termination for Cause or other cessation of Service, the
exercisability of the Option is governed by the applicable provisions of the Plan, the Notice and this Option Agreement.
This Option may not be exercised for a fraction of a Share.
(b)
Method of Exercise. This Option is exercisable by delivery of an
exercise notice in a form specified by the Company (the “Exercise Notice”), which will state the election to exercise the
Option, the number of Shares in respect of which the Option is being exercised (the “Exercised Shares”), and such other
representations and agreements as may be required by the Company pursuant to the provisions of the Plan. The Exercise
Notice will be delivered in person, by mail, via electronic mail or facsimile or by other authorized method to the Secretary
of the Company or other person designated by the Company. The Exercise Notice will be accompanied by payment of the
aggregate Exercise Price as to all Exercised Shares together with any Tax- Related Items (as defined in Section 8 below).
This Option will be deemed to be exercised upon receipt by the Company of such fully executed Exercise Notice
accompanied by such aggregate Exercise Price and payment of any Tax-Related Items. No Shares will be issued pursuant
to the exercise of this Option unless such issuance and exercise complies with all relevant provisions of law and the
requirements of any stock exchange or quotation service upon which the Shares are then listed. Assuming such
compliance, for income tax purposes the Exercised Shares will be considered transferred to Participant on the date the
Option is exercised with respect to such Exercised Shares.
(c)
Exercise by Another. If another person wants to exercise this Option
after it has been transferred to him or her in compliance with this Agreement, that person must prove to the Company’s
satisfaction that he or she is entitled to exercise this Option. That person must also complete the proper Exercise Notice
form (as described above) and pay the Exercise Price (as described below) and any applicable tax withholding due upon
exercise of the Option (as described below).
2
5.
Method of Payment. Payment of the aggregate Exercise Price will be by any of
the following, or a combination thereof, at the election of Participant:
cashier’s check;
(a)
Participant’s personal check (or readily available funds), wire transfer, or a
(b)
certificates for shares of Company stock that Participant owns, along
with any forms needed to effect a transfer of those shares to the Company; the value of the shares, determined as of the
effective date of the Option exercise, will be applied to the Option exercise price. Instead of surrendering shares of
Company stock, Participant may attest to the ownership of those shares on a form provided by the Company and have the
same number of shares subtracted from the Option shares issued to Participant. However, Participant may not surrender, or
attest to the ownership of, shares of Company stock in payment of the exercise price of Participant’s Option if
Participant’s action would cause the Company to recognize compensation expense (or additional compensation expense)
with respect to this Option for financial reporting purposes;
(c)
cashless exercise through irrevocable directions to a securities broker
approved by the Company to sell all or part of the Shares covered by this Option and to deliver to the Company from the
sale proceeds an amount sufficient to pay the Option exercise price and any withholding taxes. The balance of the sale
proceeds, if any, will be delivered to Participant. The directions must be given by signing a special notice of exercise form
provided by the Company; or
(d)
other method authorized by the Company.
6.
Non-Transferability of Option. This Option may not be sold, assigned, transferred,
pledged, hypothecated, or otherwise disposed of other than by will or by the laws of descent or distribution or court order
and may be exercised during the lifetime of Participant only by Participant or unless otherwise permitted by the Committee
on a case-by-case basis. The terms of the Plan and this Option Agreement will be binding upon the executors,
administrators, heirs, successors and assigns of Participant.
7.
Term of Option. This Option will in any event expire on the expiration date set forth
in the Notice, which date is 10 years after the Date of Grant.
8.
Tax Consequences.
(a)
Exercising the Option. Participant acknowledges that, regardless of
any action taken by the Company or a Parent or Subsidiary or Affiliate employing or retaining Participant (the
“Employer”), the ultimate liability for all income tax, social insurance, payroll tax, fringe benefits tax, payment on
account or other tax related items related to Participant’s participation in the Plan and legally applicable to Participant
(“Tax-Related Items”) is and remains Participant’s responsibility and may exceed the amount actually withheld by the
Company or the Employer. Participant further acknowledges that the Company and/or the Employer (i) make no
representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of this
Option, including, but not limited to, the grant, vesting or exercise of this Option, the subsequent sale of Shares acquired
pursuant to such exercise and the receipt of any dividends; and (ii) do not commit to and are under no obligation to
structure the terms of the grant or any aspect of this Option to reduce or eliminate Participant’s liability for Tax-Related
Items or achieve any particular tax result. Further, if Participant is subject to Tax-Related Items in more than one
jurisdiction between the Date of Grant and the date of any relevant taxable or tax withholding event, as applicable,
Participant acknowledges that the Company and/or the Employer (or former employer, as applicable) may be required to
withhold or account for Tax-Related Items in more than one jurisdiction. PARTICIPANT SHOULD CONSULT A TAX
ADVISER APPROPRIATELY QUALIFIED IN THE
3
COUNTRY OR COUNTRIES IN WHICH PARTICIPANT RESIDES OR IS SUBJECT TO TAXATION BEFORE
EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
Prior to the relevant taxable or tax withholding event, as applicable, Participant agrees to make adequate
arrangements satisfactory to the Company and/or the Employer to satisfy all Tax-Related Items. In this regard, Participant
authorizes the Company and/or the Employer, or their respective agents, at their discretion, to satisfy the obligations with
regard to all Tax- Related Items by one or a combination of the following:
(i)
(ii)
(iii)
(iv)
withholding from Participant’s wages or other cash compensation paid to Participant
by the Company and/or the Employer; or
withholding from proceeds of the sale of Shares acquired at exercise of this Option
either through a voluntary sale or through a mandatory sale arranged by the
Company (on Participant’s behalf pursuant to this authorization) without further
consent; or
withholding in Shares to be issued upon exercise of the Option, provided the
Company only withholds from the amount of Shares necessary to satisfy the
applicable statutory withholding amount;
Participant’s payment of a cash amount (including by check representing readily
available funds or a wire transfer); or
(v)
any other arrangement approved by the Committee;
all under such rules as may be established by the Committee and in compliance with the Company’s Insider Trading Policy
and 10b5-1 Trading Plan Policy, if applicable; provided however, that if Participant is a Section 16 officer of the Company
under the Exchange Act, then the Committee (as constituted in accordance with Rule 16b-3 under the Exchange Act) shall
establish the method of withholding from alternatives (i)-(v) above, and the Committee shall establish the method prior to
the Tax- Related Items withholding event.
Depending on the withholding method, the Company may withhold or account for Tax- Related Items by
considering applicable statutory withholding amounts or other applicable withholding rates, including maximum
applicable rates, in which case Participant will receive a refund of any over- withheld amount in cash and will have no
entitlement to the Common Stock equivalent. If the obligation for Tax-Related Items is satisfied by withholding in Shares,
for tax purposes, Participant is deemed to have been issued the full member of Shares issued upon exercise of the Options;
notwithstanding that a member of the Shares are held back solely for the purpose of paying the Tax-Related Items. The Fair
Market Value of these Shares, determined as of the effective date of the Option exercise, will be applied as a credit against
the Tax-Related Items withholding.
Finally, Participant agrees to pay to the Company or the Employer any amount of Tax- Related Items that
the Company or the Employer may be required to withhold or account for as a result of Participant’s participation in the
Plan that cannot be satisfied by the means previously described. The Company may refuse to issue or deliver the Shares or
the proceeds of the sale of Shares, if Participant fails to comply with his or her obligations in connection with the Tax-
Related Items.
9.
and agrees that:
4
Nature of Grant. By accepting the Option, Participant acknowledges, understands
the Plan is established voluntarily by the Company, it is discretionary
in nature, and may be amended, suspended or terminated by the Company at any time, to the extent permitted by the Plan;
(a)
(b)
the grant of the Option is voluntary and occasional and does not
create any contractual or other right to receive future grants of options, or benefits in lieu of options, even if options have
been granted in the past;
(c)
all decisions with respect to future Option or other grants, if any, will
be at the sole discretion of the Company;
(d)
the Option grant and Participant’s participation in the Plan will not
create a right to employment or be interpreted as forming an employment or service contract with the Company, the
Employer or any Parent or Subsidiary or Affiliate;
(e)
Participant is voluntarily participating in the Plan;
(f)
the Option and any Shares acquired under the Plan are not intended to
replace any pension rights or compensation;
(g)
the Option and any Shares acquired under the Plan and the income
and value of same, are not part of normal or expected compensation for purposes of calculating any severance,
resignation, termination, redundancy, dismissal, end-of-service payments, bonuses, long-service awards, pension or
retirement or welfare benefits or similar payments;
(h)
the future value of the Shares underlying the Option is unknown,
indeterminable, and cannot be predicted with certainty;
(i)
if the underlying Shares do not increase in value, the Option will have no value;
(j)
if Participant exercises the Option and acquires Shares, the value of
such Shares may increase or decrease in value, even below the Exercise Price;
(k)
no claim or entitlement to compensation or damages will arise from
forfeiture of the Option resulting from Participant ceasing to provide employment or other services to the Company or the
Employer (for any reason whatsoever, whether or not later found to be invalid or in breach of employment laws in the
jurisdiction where Participant is employed or the terms of Participant’s employment agreement, if any), and in
consideration of the grant of the Option to which Participant is otherwise not entitled, Participant irrevocably agrees never
to institute any claim against the Company, any Parent or Subsidiary or Affiliate or the Employer, waives his or her ability,
if any, to bring any such claim, and releases the Company, any Parent or Subsidiary or Affiliate and the Employer from any
such claim; if, notwithstanding the foregoing, any such claim is allowed by a court of competent jurisdiction, then, by
participating in the Plan, Participant will be deemed irrevocably to have agreed not to pursue such claim and agrees to
execute any and all documents necessary to request dismissal or withdrawal of such claim;
(l)
unless otherwise provided in the Plan or by the Company in its
discretion, the Option and the benefits evidenced by this Option Agreement do not create any entitlement to have the
Option or any such benefits transferred to, or assumed by, another company nor to be exchanged, cashed out or substituted
for, in connection with any corporate transaction affecting the Shares; and
5
United States:
(m)
the following provisions apply only if Participant is providing services outside the
(i)
(ii)
the Option and the Shares subject to the Option are not part of normal or expected
compensation or salary for any purpose;
Participant acknowledges and agrees that neither the Company, the Employer nor
any Parent or Subsidiary or Affiliate will be liable for any foreign exchange rate
fluctuation between Participant’s local currency and the United States Dollar that may
affect the value of the Option or of any amounts due to Participant pursuant to the
exercise of the Option or the subsequent sale of any Shares acquired upon exercise.
10.
No Advice Regarding Grant. The Company is not providing any tax, legal or
financial advice, nor is the Company making any recommendations regarding Participant’s participation in the Plan, or
Participant’s acquisition or sale of the underlying Shares. Participant is hereby advised to consult with his or her own
personal tax, legal and financial advisors regarding his or her participation in the Plan before taking any action related to the
Plan.
11.
Data Privacy. Participant hereby explicitly and unambiguously consents to the
collection, use and transfer, in electronic or other form, of Participant’s personal data as described in this Option
Agreement and any other Option grant materials by and among, as applicable, the Employer, the Company and any
Parent or Subsidiary or Affiliate of for the exclusive purpose of implementing, administering and managing
Participant’s participation in the Plan.
Participant understands that the Company and the Employer may hold certain personal information
about Participant, including, but not limited to, Participant’s name, home address and telephone number, date of birth,
social insurance number or other identification number, salary, nationality, job title, any shares of stock or
directorships held in the Company, details of all Options or any other entitlement to shares of stock awarded, canceled,
exercised, vested, unvested or outstanding in Participant’s favor (“Data”), for the exclusive purpose of implementing,
administering and managing the Plan.
Participant understands that Data will be transferred to the stock plan service provider as may be
designated by the Company from time to time or its affiliates or such other stock plan service provider as may be
selected by the Company in the future, which is assisting the Company with the implementation, administration and
management of the Plan. Participant understands that the recipients of the Data may be located in the United States or
elsewhere, and that the recipient’s country (e.g., the United States) may have different data privacy laws and protections
than Participant’s country. Participant understands that if he or she resides outside the United States, he or she may
request a list with the names and addresses of any potential recipients of the Data by contacting his or her local human
resources representative. Participant authorizes the Company, the stock plan service provider as may be designated by
the Company from time to time, and its affiliates, and any other possible recipients which may assist the Company
(presently or in the future) with implementing, administering and managing the Plan to receive, possess, use, retain and
transfer the Data, in electronic or other form, for the sole purposes of implementing, administering and managing
Participant’s participation in the Plan. Participant understands that Data will be held only as long as is necessary to
implement, administer and manage Participant’s participation in the Plan. Participant understands that if he or she
resides outside the United States, he or she may, at any time, view Data, request additional information about the storage
and processing of Data, require any necessary amendments to Data or refuse or withdraw the consents herein, in any
case without cost, by contacting in writing his or her local human resources representative.
6
Further, Participant understands that he or she is providing the consents herein on a purely voluntary basis. If
Participant does not consent, or if Participant later seeks to revoke his or her consent, his or her employment status or
service and career with the Employer will not be adversely affected; the only adverse consequence of refusing or
withdrawing Participant’s consent is that the Company would not be able to grant Participant options or other equity
awards or administer or maintain such awards. Therefore, Participant understands that refusing or withdrawing his or
her consent may affect Participant’s ability to participate in the Plan. For more information on the consequences of
Participant’s refusal to consent or withdrawal of consent, Participant understands that he or she may contact his or
her local human resources representative.
12.
Language. If Participant has received this Option Agreement, or any other document
related to the Option and/or the Plan translated into a language other than English and if the meaning of the translated
version is different than the English version, the English version will control.
13.
Appendix. Notwithstanding any provisions in this Option Agreement, the Option
grant will be subject to any special terms and conditions set forth in any appendix to this Option Agreement for
Participant’s country. Moreover, if Participant relocates to one of the countries included in the Appendix, the special terms
and conditions for such country will apply to Participant, to the extent the Company determines that the application of
such terms and conditions is necessary or advisable for legal or administrative reasons. The Appendix constitutes part of
this Option Agreement.
14.
Imposition of Other Requirements. The Company reserves the right to impose
other requirements on Participant’s participation in the Plan, on the Option and on any Shares purchased upon exercise of
the Option, to the extent the Company determines it is necessary or advisable for legal or administrative reasons, and to
require Participant to sign any additional agreements or undertakings that may be necessary to accomplish the foregoing.
15.
Acknowledgement. The Company and Participant agree that the Option is granted
under and governed by the Notice, this Option Agreement and by the provisions of the Plan (incorporated herein by
reference). Participant
and
(a)
(b)
(c)
acknowledges receipt of a copy of the Plan and the Plan prospectus;
represents that Participant has carefully read and is familiar with their provisions;
hereby accepts the Option subject to all of the terms and conditions set
forth herein and those set forth in the Plan and the Notice.
16.
Entire Agreement; Enforcement of Rights. This Option Agreement, the Plan and
the Notice constitute the entire agreement and understanding of the parties relating to the subject matter herein and
supersede all prior discussions between them. Any prior agreements, commitments or negotiations concerning the
purchase of the Shares hereunder are superseded. No modification of or amendment to this Option Agreement, nor any
waiver of any rights under this Option Agreement, will be effective unless in writing and signed by the parties to this
Option Agreement. The failure by either party to enforce any rights under this Option Agreement will not be construed as a
waiver of any rights of such party.
17.
Compliance with Laws and Regulations. The issuance of Shares and any restriction
on the sale of Shares will be subject to and conditioned upon compliance by the Company and Participant with all applicable
state, federal and local laws and regulations and with all applicable requirements of any stock exchange or automated
quotation system on which the Company’s Shares may be listed or quoted at the
7
time of such issuance or transfer. Participant understands that the Company is under no obligation to register or qualify the
Common Stock with any state, federal or foreign securities commission or to seek approval or clearance from any
governmental authority for the issuance or sale of the Shares. Further, Participant agrees that the Company shall have
unilateral authority to amend the Plan and this Option Agreement without Participant’s consent to the extent necessary to
comply with securities or other laws applicable to issuance of Shares. Finally, the Shares issued pursuant to this Option
Agreement shall be endorsed with appropriate legends, if any, determined by the Company.
18.
Severability. If one or more provisions of this Option Agreement are held to be
unenforceable, the parties agree to renegotiate such provision in good faith. In the event that the parties cannot reach a
mutually agreeable and enforceable replacement for such provision, then (a) such provision will be excluded from this
Option Agreement, (b) the balance of this Option Agreement will be interpreted as if such provision were so excluded and
(c) the balance of this Option Agreement will be enforceable in accordance with its terms.
19.
Governing Law and Venue. This Option Agreement and all acts and transactions
pursuant hereto and the rights and obligations of the parties hereto will be governed, construed and interpreted in
accordance with the laws of the State of Delaware, without giving effect to principles of conflicts of law.
Any and all disputes relating to, concerning or arising from this Option Agreement, or relating to,
concerning or arising from the relationship between the parties evidenced by the Plan or this Option Agreement, will be
brought and heard exclusively in the United States District Court for the District of Delaware or the Delaware Superior
Court, New Castle County. Each of the parties hereby represents and agrees that such party is subject to the personal
jurisdiction of said courts; hereby irrevocably consents to the jurisdiction of such courts in any legal or equitable
proceedings related to, concerning or arising from such dispute, and waives, to the fullest extent permitted by law, any
objection which such party may now or hereafter have that the laying of the venue of any legal or equitable proceedings
related to, concerning or arising from such dispute which is brought in such courts is improper or that such proceedings
have been brought in an inconvenient forum.
20.
No Rights as Employee, Director or Consultant. Nothing in this Option Agreement
will affect in any manner whatsoever the right or power of the Company, or a Parent or Subsidiary or Affiliate, to terminate
Participant’s Service, for any reason, with or without Cause.
21.
Consent to Electronic Delivery of all Plan Documents and Disclosures. By
Participant’s signature and the signature of the Company’s representative on the Notice, Participant and the Company agree
that this Option is granted under and governed by the terms and conditions of the Plan, the Notice and this Option
Agreement. Participant has reviewed the Plan, the Notice and this Option Agreement in their entirety, has had an
opportunity to obtain the advice of counsel prior to executing the Notice, and fully understands all provisions of the Plan,
the Notice and this Option Agreement. Participant hereby agrees to accept as binding, conclusive and final all decisions or
interpretations of the Committee upon any questions relating to the Plan, the Notice and the Option Agreement.
Participant further agrees to notify the Company upon any change in the residence address indicated on the Notice. By
acceptance of this Option, Participant agrees to participate in the Plan through an on-line or electronic system established
and maintained by the Company or a third party designated by the Company and consents to the electronic delivery of the
Notice, this Option Agreement, the Plan, account statements, Plan prospectuses required by the U.S. Securities and
Exchange Commission, U.S. financial reports of the Company, and all other documents that the Company is required to
deliver to its security holders (including, without limitation, annual reports and proxy statements) or other communications
or information related to the Option and current or future participation in the Plan. Electronic delivery may include the
delivery of
8
a link to the Company intranet or the internet site of a third party involved in administering the Plan, the delivery of the
document via e- mail or such other delivery determined at the Company’s discretion. Participant acknowledges that
Participant may receive from the Company a paper copy of any documents delivered electronically at no cost if
Participant contacts the Company by telephone, through a postal service or electronic mail to Stock Administration.
Participant further acknowledges that Participant will be provided with a paper copy of any documents delivered
electronically if electronic delivery fails; similarly, Participant understands that Participant must provide on request to the
Company or any designated third party a paper copy of any documents delivered electronically if electronic delivery fails.
Also, Participant understands that Participant’s consent may be revoked or changed, including any change in the electronic
mail address to which documents are delivered (if Participant has provided an electronic mail address), at any time by
notifying the Company of such revised or revoked consent by telephone, postal service or electronic mail through Stock
Administration. Finally, Participant understands that Participant is not required to consent to electronic delivery if local
laws prohibit such consent.
22.
Insider Trading Restrictions/Market Abuse Laws. Participant acknowledges that,
depending on Participant’s country, Participant may be subject to insider trading restrictions and/or market abuse laws,
which may affect Participant’s ability to acquire or sell the Shares or rights to Shares under the Plan during such times as
Participant is considered to have “inside information” regarding the Company (as defined by the laws in Participant’s
country). Any restrictions under these laws or regulations are separate from and in addition to any restrictions that may be
imposed under any applicable Company insider trading policy. Participant acknowledges that it is Participant’s
responsibility to comply with any applicable restrictions, and Participant is advised to speak to Participant’s personal
advisor on this matter.
23.
Award Subject to Company Clawback or Recoupment. To the extent permitted by
applicable law, the Option shall be subject to clawback or recoupment pursuant to any compensation clawback or
recoupment policy adopted by the Board or required by law during the term of Participant’s employment or other Service
that is applicable to Participant. In addition to any other remedies available under such policy, applicable law may require
the cancellation of Participant’s Option (whether vested or unvested) and the recoupment of any gains realized with
respect to Participant’s Option.
BY ACCEPTING THIS OPTION, PARTICIPANT AGREES TO ALL OF THE TERMS AND
CONDITIONS DESCRIBED ABOVE AND IN THIS PLAN.
9
APPENDIX
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN STOCK
OPTION AWARD AGREEMENT
COUNTRY SPECIFIC PROVISIONS FOR EMPLOYEES OUTSIDE THE U.S.
Terms and Conditions
This Appendix includes additional terms and conditions that govern the Option granted to Participant under the
Plan if Participant resides and/or works in one of the countries below. This Appendix forms part of the Option Agreement.
Any capitalized term used in this Appendix without definition will have the meaning ascribed to it in the Notice, the
Option Agreement or the Plan, as applicable.
If Participant is a citizen or resident of a country, or is considered resident of a country, other than the one in which
Participant is currently working, or Participant transfers employment and/or residency between countries after the Date of
Grant, the Company will, in its sole discretion, determine to what extent the additional terms and conditions included herein
will apply to Participant under these circumstances.
Notifications
This Appendix also includes information relating to exchange control and other issues of which Participant should
be aware with respect to Participant’s participation in the Plan. The information is based on the securities, exchange control
and other laws in effect in the respective countries as of July 2021, if applicable. Such laws are often complex and change
frequently. As a result, the Company strongly recommends that Participant not rely on the information herein as the only
source of information relating to the consequences of Participant’s participation in the Plan because the information may
be out of date at the time that Participant exercises the Option or sells Shares acquired under the Plan.
In addition, the information is general in nature and may not apply to Participant’s particular situation, and the
Company is not in a position to assure Participant of any particular result. Accordingly, Participant is advised to seek
appropriate professional advice as to how the relevant laws in Participant’s country may apply to Participant’s situation.
Finally, if Participant is a citizen or resident of a country, or is considered resident of a country, other than the one
in which Participant is currently working, or Participant transfers employment and/or residency after the Date of Grant, the
information contained herein may not apply to Participant in the same manner.
A-1
There are no country-specific provisions.
UNITED STATES
A-2
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN NOTICE OF
RESTRICTED STOCK UNIT AWARD
GRANT NUMBER:
Unless otherwise defined herein, the terms defined in the KalVista Pharmaceuticals, Inc. 2021 Equity Inducement
Plan (the “Plan”) will have the same meanings in this Notice of Restricted Stock Unit Award and the electronic
representation of this Notice of Restricted Stock Unit Award established and maintained by the Company or a third party
designated by the Company (this “Notice”).
Name:
Address:
You (“Participant”) have been granted an award of Restricted Stock Units (“RSUs”) under the Plan subject to the
terms and conditions of the Plan, this Notice and the attached Restricted Stock Unit Award Agreement (hereinafter the
“Agreement”), including any applicable country-specific provisions in the appendix attached hereto (the “Appendix”),
which constitutes part of this Agreement.
Number of RSUs:
Date of Grant:
Vesting Commencement Date:
Expiration Date:
Vesting Schedule:
Notice, the Plan
The earlier to occur of: (a) the date on which settlement of all RSUs
granted hereunder occurs and (b) the tenth anniversary of the Date
of Grant. This RSU expires earlier if Participant’s Service
terminates earlier, as described in the Agreement.
Subject to the limitations set forth in this
and the Agreement, the RSUs will vest in accordance with the
following schedule: [insert applicable vesting schedule, which
may be time- and/or performance- based]
By accepting (whether in writing, electronically or otherwise) the RSUs, Participant acknowledges and agrees to
the following:
Participant understands that Participant’s employment with the Company or a Parent or Subsidiary or Affiliate is
for an unspecified duration, can be terminated at any time (i.e., is “at-will”), except where otherwise prohibited by
applicable law and that nothing in this Notice, the Agreement or the Plan changes the nature of that relationship.
Participant acknowledges that the vesting of the RSUs pursuant to this Notice is earned only by continuing Service (as
defined in the Plan) . Participant agrees and acknowledges that the Vesting Schedule may change prospectively in the
event that Participant’s service status changes between full- and part-time status and/or in the event Participant is on a
leave of absence, in accordance with Company policies relating to work schedules and vesting of awards or as determined
by the Committee
[Signature Page Follows]
to the extent permitted by applicable law. Participant also understands that this Notice is subject to the terms and
conditions of both the Agreement and the Plan, both of which are incorporated herein by reference. Participant has read
both the Agreement and the Plan. By accepting the RSUs, Participant consents to electronic delivery as set forth in the
Agreement.
Participant has read the Company’s Insider Trading Policy, and agrees to comply with such policy, as it may be
amended from time to time, whenever Participant acquires or disposes of the Company’s securities.
PARTICIPANT
By:
Signature:
KALVISTA PHARMACEUTICALS, INC.
Print
Name:
Its:
[Signature Page to 2021 Equity Inducement Plan Notice of Restricted Stock Unit Award]
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN RESTRICTED
STOCK UNIT AWARD AGREEMENT
Unless otherwise defined herein, the terms defined in the KalVista Pharmaceuticals, Inc. 2021 Equity Inducement
Plan (the “Plan”) will have the same defined meanings in this Restricted Stock Unit Award Agreement (this
“Agreement”).
Participant has been granted Restricted Stock Units (“RSUs”) subject to the terms, restrictions and conditions of the
Plan, the Notice of Restricted Stock Unit Award (the “Notice”) and this Agreement, including any applicable country-
specific provisions in the appendix attached hereto (the “Appendix”), which constitutes part of this Agreement.
1.
Settlement. Settlement of RSUs will be made within 30 days following the applicable
date of vesting under the vesting schedule set forth in the Notice. Settlement of RSUs will be in Shares. No fractional
RSUs or rights for fractional Shares shall be created pursuant to this Agreement.
2.
No Stockholder Rights. Unless and until such time as Shares are issued in settlement
of vested RSUs, Participant will have no ownership of the Shares allocated to the RSUs and will have no rights to dividends
or to vote such Shares.
3.
credited to Participant.
Dividend Equivalents. Dividends, if any (whether in cash or Shares), will not be
4.
Non-Transferability of RSUs. The RSUs and any interest therein will not be sold,
assigned, transferred, pledged, hypothecated, or otherwise disposed of in any manner other than by will or by the laws of
descent or distribution or court order or unless otherwise permitted by the Committee on a case- by-case basis.
5.
Termination. If Participant’s Service terminates for any reason, all unvested RSUs
will be forfeited to the Company forthwith, and all rights of Participant to such RSUs will immediately terminate without
payment of any consideration to Participant. Participant’s Service will be considered terminated as of the date Participant
is no longer providing services (regardless of the reason for such termination and whether or not later found to be invalid
or in breach of employment laws in the jurisdiction where Participant is employed or the terms of Participant’s
employment agreement, if any) and will not, subject to the laws applicable to Participant’s Award, be extended by any
notice period mandated under local laws (e.g., Service would not include a period of “garden leave” or similar period).
Participant acknowledges and agrees that the Vesting Schedule may change prospectively in the event Participant’s service
status changes between full- and part-time status and/or in the event Participant is on an approved leave of absence in
accordance with Company policies relating to work schedules and vesting of awards or as determined by the Committee.
Participant acknowledges that the vesting of the Shares pursuant to this Notice and Agreement is earned only by continued
Service. In case of any dispute as to whether termination of Service has occurred, the Committee will have sole discretion to
determine whether such termination of Service has occurred and the effective date of such termination (including whether
Participant may still be considered to be providing services while on an approved leave of absence).
6.
Withholding Taxes. Participant acknowledges that, regardless of any action taken by
the Company or, if different, Participant’s employer (the “Employer”) the ultimate liability for all income tax, social
insurance, payroll tax, fringe benefits tax, payment on account or other tax-related items related to Participant’s
participation in the Plan and legally applicable to Participant (“Tax-Related Items”), is and
remains Participant’s responsibility and may exceed the amount actually withheld by the Company or the Employer.
Participant further acknowledges that the Company and/or the Employer (1) make no representations or undertakings
regarding the treatment of any Tax-Related Items in connection with any aspect of the RSUs, including, but not limited to,
the grant, vesting or settlement of the RSUs and the subsequent sale of Shares acquired pursuant to such settlement and the
receipt of any dividends; and (2) do not commit to and are under no obligation to structure the terms of the grant or any
aspect of the RSUs to reduce or eliminate Participant’s liability for Tax-Related Items or achieve any particular tax result.
Further, if Participant is subject to Tax-Related Items in more than one jurisdiction between the date of grant and the date
of any relevant taxable or tax withholding event, as applicable, Participant acknowledges that the Company and/or the
Employer (or former employer, as applicable) may be required to withhold or account for Tax-Related Items in more than
one jurisdiction.
Prior to any relevant taxable or tax withholding event, as applicable, Participant agrees to make adequate
arrangements satisfactory to the Company and/or the Employer to satisfy all Tax-Related Items. In this regard, Participant
authorizes the Company and/or the Employer, or their respective agents, at their discretion, to satisfy the obligations with
regard to all Tax-Related Items by one or a combination of the following:
(i)
(ii)
(iii)
(iv)
withholding from Participant’s wages or other cash compensation paid to Participant
by the Company and/or the Employer; or
withholding from proceeds of the sale of Shares acquired upon settlement of the
RSUs either through a voluntary sale or through a mandatory sale arranged by the
Company (on Participant’s behalf pursuant to this authorization); or
withholding in Shares to be issued upon settlement of the RSUs, provided the
Company only withholds the amount of Shares necessary to satisfy the applicable
statutory withholding amounts;
Participant’s payment of a cash amount (including by check representing readily
available funds or a wire transfer); or
(v)
any other arrangement approved by the Committee;
all under such rules as may be established by the Committee and in compliance with the Company’s Insider Trading Policy
and 10b5-1 Trading Plan Policy, if applicable; provided however, that if Participant is a Section 16 officer of the Company
under the Exchange Act, then the Committee (as constituted in accordance with Rule 16b-3 under the Exchange Act) shall
establish the method of withholding from alternatives (i)-(v) above, and the Committee shall establish the method prior to
the Tax-Related Items withholding event.
Depending on the withholding method, the Company may withhold or account for Tax-Related Items by considering
applicable statutory withholding amounts, including maximum applicable rates, in which case Participant will receive a
refund of any over-withheld amount in cash and will have no entitlement to the Common Stock equivalent. If the
obligation for Tax- Related Items is satisfied by withholding in Shares, for tax purposes, Participant is deemed to have
been issued the full number of Shares subject to the vested RSUs, notwithstanding that a number of the Shares are held
back solely for the purpose of paying the Tax- Related Items. The Fair Market Value of these Shares, determined as of the
effective date when taxes otherwise would have been withheld in cash, will be applied as a credit against the Tax-Related
Items withholding.
2
Finally, Participant agrees to pay to the Company or the Employer any amount of Tax-Related Items that the
Company or the Employer may be required to withhold or account for as a result of Participant’s participation in the Plan
that cannot be satisfied by the means previously described. The Company may refuse to issue or deliver the Shares or the
proceeds of the sale of Shares, if Participant fails to comply with Participant’s obligations in connection with the Tax-
Related Items.
7.
and agrees that:
Nature of Grant. By accepting the RSUs, Participant acknowledges, understands
(a)
the Plan is established voluntarily by the Company, it is discretionary
in nature and it may be modified, amended, suspended or terminated by the Company at any time, to the extent permitted by
the Plan;
(b)
the grant of the RSUs is voluntary and occasional and does not create
any contractual or other right to receive future grants of RSUs, or benefits in lieu of RSUs, even if RSUs have been
granted in the past;
(c)
all decisions with respect to future RSU or other grants, if any, will
be at the sole discretion of the Company;
(d)
the RSU grant and Participant’s participation in the Plan will not
create a right to employment or be interpreted as forming an employment or services contract with the Company, the
Employer or any Parent or Subsidiary or Affiliate;
(e)
Participant is voluntarily participating in the Plan;
(f)
the RSUs and the Shares subject to the RSUs are not intended to
replace any pension rights or compensation;
(g)
the RSUs and the Shares subject to the RSUs, and the income and
value of same, are not part of normal or expected compensation for purposes of calculating any severance, resignation,
termination, redundancy, dismissal, end-of- service payments, bonuses, long-service awards, pension or retirement or
welfare benefits or similar payments;
(h)
the future value of the underlying Shares is unknown, indeterminable
and cannot be predicted with certainty;
(i)
no claim or entitlement to compensation or damages will arise from
forfeiture of the RSUs resulting from Participant’s termination of Service, and in consideration of the grant of the RSUs to
which Participant is otherwise not entitled, Participant irrevocably agrees never to institute any claim against the
Company, or any Parent or Subsidiary or Affiliate or the Employer, waives his or her ability, if any, to bring any such
claim, and releases the Company, any Parent or Subsidiary or Affiliate and the Employer from any such claim; if,
notwithstanding the foregoing, any such claim is allowed by a court of competent jurisdiction, then, by participating in the
Plan, Participant will be deemed irrevocably to have agreed not to pursue such claim and agrees to execute any and all
documents necessary to request dismissal or withdrawal of such claim;
(j)
unless otherwise provided in the Plan or by the Company in its
discretion, the RSUs and the benefits evidenced by this Agreement do not create any entitlement to have the RSUs or any
such benefits transferred to, or assumed by, another company nor to be exchanged, cashed out or substituted for, in
connection with any Corporate Transaction affecting the Shares; and
3
United States:
(k)
the following provisions apply only if Participant is providing services outside the
(i)
(ii)
the RSUs and the Shares subject to the RSUs are not part of normal or expected
compensation or salary for any purpose;
Participant acknowledges and agrees that neither the Company, the Employer nor
any Parent or Subsidiary or Affiliate will be liable for any foreign exchange rate
fluctuation between Participant’s local currency and the United States Dollar that may
affect the value of the RSUs or of any amounts due to Participant pursuant to the
settlement of the RSUs or the subsequent sale of any Shares acquired upon
settlement.
8.
No Advice Regarding Grant. The Company is not providing any tax, legal or
financial advice, nor is the Company making any recommendations regarding Participant’s participation in the Plan, or
Participant’s acquisition or sale of the underlying Shares. Participant is hereby advised to consult with his or her own
personal tax, legal and financial advisors regarding his or her participation in the Plan before taking any action related to the
Plan.
9.
Data Privacy. Participant hereby explicitly and unambiguously consents to the
collection, use and transfer, in electronic or other form, of Participant’s personal data as described in this Agreement and
any other RSU grant materials by and among, as applicable, the Employer, the Company and any Parent or Subsidiary or
Affiliate for the exclusive purpose of implementing, administering and managing Participant’s participation in the Plan.
Participant understands that the Company and the Employer may hold certain personal information
about Participant, including, but not limited to, Participant’s name, home address and telephone number, date of birth,
social insurance number or other identification number, salary, nationality, job title, any shares of stock or
directorships held in the Company, details of all RSUs or any other entitlement to shares of stock awarded, canceled,
exercised, vested, unvested or outstanding in Participant’s favor (“Data”), for the exclusive purpose of implementing,
administering and managing the Plan.
Participant understands that Data will be transferred to the stock plan service provider as may be
designated by the Company from time to time, which is assisting the Company with the implementation, administration
and management of the Plan. Participant understands that the recipients of the Data may be located in the United
States or elsewhere, and that the recipients’ country (e.g., the United States) may have different data privacy laws and
protections than Participant’s country. Participant understands that if he or she resides outside the United States, he or
she may request a list with the names and addresses of any potential recipients of the Data by contacting his or her local
human resources representative. Participant authorizes the Company, the stock plan service provider as may be
designated by the Company from time to time, and any other possible recipients which may assist the Company
(presently or in the future) with implementing, administering and managing the Plan to receive, possess, use, retain
and transfer the Data, in electronic or other form, for the sole purpose of implementing, administering and managing
his or her participation in the Plan. Participant understands that Data will be held only as long as is necessary to
implement, administer and manage Participant’s participation in the Plan. Participant understands if he or she resides
outside the United States, he or she may, at any time, view Data, request additional information about the storage and
processing of Data, require any necessary amendments to Data or refuse or withdraw the consents herein, in any case
without cost, by contacting in writing his or her local human resources representative. Further, Participant understands
that he or she is providing the consents herein on a purely voluntary
4
basis. If Participant does not consent, or if Participant later seeks to revoke his or her consent, his or her employment
status or service and career with the Employer will not be adversely affected; the only adverse consequence of refusing
or withdrawing Participant’s consent is that the Company would not be able to grant Participant RSUs or other equity
awards or administer or maintain such awards. Therefore, Participant understands that refusing or withdrawing his or
her consent may affect Participant’s ability to participate in the Plan. For more information on the consequences of
Participant’s refusal to consent or withdrawal of consent, Participant understands that he or she may contact his or
her local human resources representative.
10.
Language. If Participant has received this Agreement or any other document related
to the Plan translated into a language other than English and if the meaning of the translated version is different than the
English version, the English version will control.
11.
Appendix. Notwithstanding any provisions in this Agreement, the RSU grant will be
subject to any special terms and conditions set forth in any appendix to this Agreement for Participant’s country.
Moreover, if Participant relocates to one of the countries included in the Appendix, the special terms and conditions for
such country will apply to Participant, to the extent the Company determines that the application of such terms and
conditions is necessary or advisable for legal or administrative reasons. The Appendix constitutes part of this Agreement.
12.
Imposition of Other Requirements. The Company reserves the right to impose
other requirements on Participant’s participation in the Plan, on the RSUs and on any Shares acquired under the Plan, to
the extent the Company determines it is necessary or advisable for legal or administrative reasons, and to require
Participant to sign any additional agreements or undertakings that may be necessary to accomplish the foregoing.
13.
Acknowledgement. The Company and Participant agree that the RSUs are granted
under and governed by the Notice, this Agreement and the provisions of the Plan. Participant: (a) acknowledges receipt of
a copy of the Plan and the Plan prospectus, (b) represents that Participant has carefully read and is familiar with their
provisions, and (c) hereby accepts the RSUs subject to all of the terms and conditions set forth herein and those set forth in
the Plan and the Notice.
14.
Entire Agreement; Enforcement of Rights. This Agreement, the Plan and the
Notice constitute the entire agreement and understanding of the parties relating to the subject matter herein and supersede
all prior discussions between them. Any prior agreements, commitments or negotiations concerning the purchase of the
Shares hereunder are superseded. No modification of or amendment to this Agreement, nor any waiver of any rights under
this Agreement, will be effective unless in writing and signed by the parties to this Agreement. The failure by either party
to enforce any rights under this Agreement will not be construed as a waiver of any rights of such party.
15.
Compliance with Laws and Regulations. The issuance of Shares will be subject to
and conditioned upon compliance by the Company and Participant with all applicable state and federal laws and
regulations and with all applicable requirements of any stock exchange or automated quotation system on which the
Company’s Common Stock may be listed or quoted at the time of such issuance or transfer. Participant understands that
the Company is under no obligation to register or qualify the Common Stock with any state, federal or foreign securities
commission or to seek approval or clearance from any governmental authority for the issuance or sale of the Shares.
Further, Participant agrees that the Company shall have unilateral authority to amend the Plan and this RSU Agreement
without Participant’s consent to the extent necessary to comply with securities or other laws applicable to issuance of
Shares. Finally, the Shares issued pursuant to this RSU Agreement shall be endorsed with appropriate legends, if any,
determined by the Company.
5
16.
Severability. If one or more provisions of this Agreement are held to be
unenforceable under applicable law, the parties agree to renegotiate such provision in good faith. In the event that the
parties cannot reach a mutually agreeable and enforceable replacement for such provision, then (a) such provision will be
excluded from this Agreement, (b) the balance of this Agreement will be interpreted as if such provision were so excluded
and (c) the balance of this Agreement will be enforceable in accordance with its terms.
17.
Governing Law and Venue. This Agreement and all acts and transactions pursuant
hereto and the rights and obligations of the parties hereto will be governed, construed and interpreted in accordance with the
laws of the State of Delaware, without giving effect to principles of conflicts of law.
Any and all disputes relating to, concerning or arising from this Agreement, or relating to, concerning or
arising from the relationship between the parties evidenced by the Plan or this Agreement, will be brought and heard
exclusively in the United States District Court for the District of New Delaware or the Delaware Superior Court, New
Castle County. Each of the parties hereby represents and agrees that such party is subject to the personal jurisdiction of
said courts; hereby irrevocably consents to the jurisdiction of such courts in any legal or equitable proceedings related to,
concerning or arising from such dispute, and waives, to the fullest extent permitted by law, any objection which such party
may now or hereafter have that the laying of the venue of any legal or equitable proceedings related to, concerning or
arising from such dispute which is brought in such courts is improper or that such proceedings have been brought in an
inconvenient forum.
18.
No Rights as Employee, Director or Consultant. Nothing in this Agreement will
affect in any manner whatsoever the right or power of the Company, or a Parent or Subsidiary or Affiliate of the Company,
to terminate Participant’s Service, for any reason, with or without Cause.
19.
Consent to Electronic Delivery of All Plan Documents and Disclosures. By
Participant’s acceptance (whether in writing, electronically or otherwise) of the Notice, Participant and the Company agree
that the RSUs are granted under and governed by the terms and conditions of the Plan, the Notice and this Agreement.
Participant has reviewed the Plan, the Notice and this Agreement in their entirety, has had an opportunity to obtain the
advice of counsel prior to executing this Agreement, and fully understands all provisions of the Plan, the Notice and this
Agreement. Participant hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the
Committee upon any questions relating to the Plan, the Notice and this Agreement. Participant further agrees to notify the
Company upon any change in Participant’s residence address. By acceptance of the RSUs, Participant agrees to participate
in the Plan through an on-line or electronic system established and maintained by the Company or a third party designated
by the Company and consents to the electronic delivery of the Notice, this Agreement, the Plan, account statements, Plan
prospectuses required by the U.S. Securities and Exchange Commission,
U.S. financial reports of the Company, and all other documents that the Company is required to deliver to its security
holders (including, without limitation, annual reports and proxy statements) or other communications or information
related to the RSUs and current or future participation in the Plan. Electronic delivery may include the delivery of a link to
a Company intranet or the internet site of a third party involved in administering the Plan, the delivery of the document
via e- mail or such other delivery determined at the Company’s discretion. Participant acknowledges that Participant may
receive from the Company a paper copy of any documents delivered electronically at no cost if Participant contacts the
Company by telephone, through a postal service or electronic mail to Stock Administration. Participant further
acknowledges that Participant will be provided with a paper copy of any documents delivered electronically if electronic
delivery fails; similarly, Participant understands that Participant must provide on request to the Company or any
designated third party a paper copy of any documents delivered electronically if electronic delivery fails. Also, Participant
understands that Participant’s consent may be revoked or changed, including any change in the electronic mail address to
which documents are delivered
6
(if Participant has provided an electronic mail address), at any time by notifying the Company of such revised or revoked
consent by telephone, postal service or electronic mail through Stock Administration. Finally, Participant understands that
Participant is not required to consent to electronic delivery if local laws prohibit such consent.
20.
Insider Trading Restrictions/Market Abuse Laws. Participant acknowledges that,
depending on Participant’s country, Participant may be subject to insider trading restrictions and/or market abuse laws,
which may affect Participant’s ability to acquire or sell the Shares or rights to Shares under the Plan during such times as
Participant is considered to have “inside information” regarding the Company (as defined by the laws in Participant’s
country). Any restrictions under these laws or regulations are separate from and in addition to any restrictions that may be
imposed under any applicable Company insider trading policy. Participant acknowledges that it is Participant’s
responsibility to comply with any applicable restrictions, and Participant is advised to speak to Participant’s personal
advisor on this matter.
21.
Code Section 409A. For purposes of this Agreement, a termination of employment
will be determined consistent with the rules relating to a “separation from service” as defined in Section 409A of the
Internal Revenue Code and the regulations thereunder (“Section 409A”). Notwithstanding anything else provided herein,
to the extent any payments provided under this RSU Agreement in connection with Participant’s termination of
employment constitute deferred compensation subject to Section 409A, and Participant is deemed at the time of such
termination of employment to be a “specified employee” under Section 409A, then such payment shall not be made or
commence until the earlier of (i) the expiration of the six-month period measured from Participant’s separation from
service from the Company or (ii) the date of Participant’s death following such a separation from service; provided,
however, that such deferral shall only be effected to the extent required to avoid adverse tax treatment to Participant
including, without limitation, the additional tax for which Participant would otherwise be liable under Section 409A(a)(1)
(B) in the absence of such a deferral. To the extent any payment under this RSU Agreement may be classified as a “short-
term deferral” within the meaning of Section 409A, such payment shall be deemed a short-term deferral, even if it may also
qualify for an exemption from Section 409A under another provision of Section 409A. Payments pursuant to this section are
intended to constitute separate payments for purposes of Section 1.409A-2(b)(2) of the Treasury Regulations.
22.
Award Subject to Company Clawback or Recoupment. The RSUs shall be subject
to clawback or recoupment pursuant to any compensation clawback or recoupment policy adopted by the Board or
required by law during the term of Participant’s employment or other Service that is applicable to executive officers,
Employees, directors or other service providers of the Company, and in addition to any other remedies available under
such policy and applicable law may require the cancellation of Participant’s RSUs (whether vested or unvested) and the
recoupment of any gains realized with respect to Participant’s RSUs.
BY ACCEPTING THIS AWARD OF RSUS, PARTICIPANT AGREES TO ALL OF THE TERMS AND
CONDITIONS DESCRIBED ABOVE AND IN THE PLAN.
7
APPENDIX
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN RESTRICTED
STOCK UNIT AWARD AGREEMENT
COUNTRY SPECIFIC PROVISIONS FOR EMPLOYEES OUTSIDE THE U.S.
Terms and Conditions
This Appendix includes additional terms and conditions that govern the RSUs granted to Participant under the Plan if
Participant resides and/or works in one of the countries below. This Appendix forms part of the Agreement. Any capitalized
term used in this Appendix without definition will have the meaning ascribed to it in the Notice, the Agreement or the Plan,
as applicable.
If Participant is a citizen or resident of a country, or is considered resident of a country, other than the one in which
Participant is currently working, or Participant transfers employment and/or residency between countries after the Date of
Grant, the Company will, in its sole discretion, determine to what extent the additional terms and conditions included herein
will apply to Participant under these circumstances.
Notifications
This Appendix also includes information relating to exchange control and other issues of which Participant should
be aware with respect to Participant’s participation in the Plan. The information is based on the securities, exchange control
and other laws in effect in the respective countries as of July 2021, if applicable. Such laws are often complex and change
frequently. As a result, the Company strongly recommends that Participant not rely on the information herein as the only
source of information relating to the consequences of Participant’s participation in the Plan because the information may
be out of date at the time that Participant vests in the RSUs or sells Shares acquired under the Plan.
In addition, the information is general in nature and may not apply to Participant’s particular situation, and the
Company is not in a position to assure Participant of any particular result. Accordingly, Participant is advised to seek
appropriate professional advice as to how the relevant laws in Participant’s country may apply to Participant’s situation.
Finally, if Participant is a citizen or resident of a country, or is considered resident of a country, other than the one
in which Participant is currently working, or Participant transfers employment and/or residency after the Date of Grant, the
information contained herein may not apply to Participant in the same manner.
A-1
There are no country-specific provisions.
UNITED STATES
A-2
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN UK
SUB-PLAN
NOTICE OF STOCK OPTION GRANT
Unless otherwise defined herein, the terms defined in the KalVista Pharmaceuticals, Inc. (the “Company”) 2021 Equity Inducement Plan (the
“Plan”) and the UK Sub-Plan to the Plan (the “UK Sub-Plan”) will have the same meanings in this Notice of Stock Option Grant and the
electronic representation of this Notice of Stock Option Grant established and maintained by the Company or a third party designated by the
Company (this “Notice”).
Name:
Address:
You (the “Participant”) have been granted an option to purchase shares of Common Stock of the Company under the UK Sub-Plan subject
to the terms and conditions of the Plan and the UK Sub-Plan, this Notice and the Stock Option Award Agreement (the “Option Agreement”).
Grant Number:
Date of Grant:
Vesting Commencement Date:
Exercise Price per Share:
Total Number of Shares:
Type of Option:
Expiration Date:
, 20 ; This Option expires earlier if Participant’s Service terminates earlier, as
described in the Option Agreement.
Non-Qualified Stock Option
Vesting Schedule:
Subject to the limitations set forth in this Notice, the Planand the Agreement, the
Options will vest in accordance with the following schedule: [insert applicable vesting
schedule, which may be time- and/or performance-based]
By accepting (whether in writing, electronically or otherwise) the Option, Participant acknowledges and agrees to the following:
Participant acknowledges that the vesting of the Options pursuant to this Notice is earned only by continuing Service as an Employee or
Director. Furthermore, the period during which Participant may exercise the Option after such termination of Service will commence on the
date Participant ceases to actively provide Service and will not be extended by any notice period mandated under employment laws in the
jurisdiction where Participant is employed or terms of Participant’s employment agreement.
Participant agrees and acknowledges that the Vesting Schedule may change prospectively in the event that Participant’s service status
changes between full- and part-time status in accordance with Company policies relating to work schedules and vesting of awards.
Participant also understands that this Notice is subject to the terms and conditions of the Option Agreement, the Plan and the UK Sub-Plan,
all of which are incorporated herein by reference.
Participant has read the Company’s Insider Trading Policy, and agrees to comply with such policy, as it may be amended from time to time,
whenever Participant acquires or disposes of the Company’s securities.
Participant has read the Option Agreement, the Plan and the UK Sub-Plan. By accepting this Option, Participant consents to electronic
delivery as set forth in the Option Agreement.
PARTICIPANT
KALVISTA PHARMACEUTICALS, INC.
2533020 v3
30268/00600/FW/12237143.2
Signature:
Print Name:
By:
Its:
2
30268/00600/FW/12237143.2
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN UK
SUB-PLAN
STOCK OPTION AWARD AGREEMENT
Unless otherwise defined in this Stock Option Award Agreement (this “Option Agreement”), any capitalized terms
used herein will have the meaning ascribed to them in the KalVista Pharmaceuticals, Inc. 2021 Equity Inducement Plan (the
“Plan”) and the UK Sub-Plan to the Plan (the “UK Sub-Plan”).
Participant has been granted an option to purchase Shares (the “Option”) of KalVista Pharmaceuticals, Inc. (the
“Company”), subject to the terms and conditions of the Plan and the UK Sub- Plan (referred for the purposes of this Option
Agreement together as the “Plan”) the Notice of Stock Option Grant (the “Notice”) and this Option Agreement.
1.
Vesting Rights. Subject to the applicable provisions of the Plan and this Option
Agreement, this Option may be exercised, in whole or in part, in accordance with the schedule set forth in the Notice.
Participant acknowledges and agrees that the Vesting Schedule may change prospectively in the event Participant’s service
status changes between full and part-time status and/or in the event Participant is on an approved leave of absence in
accordance with Company policies relating to work schedules and vesting of awards or as determined by the Committee.
Participant acknowledges that the vesting of the Shares pursuant to this Notice and Agreement is earned only by continued
Service.
2.
Grant of Option. Participant has been granted an Option for the number of Shares set
forth in the Notice at the exercise price per Share in U.S. Dollars set forth in the Notice (the “Exercise Price”). In the
event of a conflict between the terms and conditions of the Plan and the terms and conditions of this Option Agreement, the
terms and conditions of the Plan shall prevail.
3.
Termination Period.
(a)
General Rule. If Participant’s Service terminates for any reason
except death or Disability, and other than for Cause, then this Option will expire at the close of business at Company
headquarters on the date three (3) months after Participant’s Termination Date (or such shorter time period not less than
thirty (30) days or longer time period as may be determined by the Committee, with any exercise beyond three (3) months
after the date Participant’s Service terminates deemed to be the exercise of an NSO). If Participant’s Service is terminated
for Cause, this Option will expire upon the date of such termination. The Company determines when Participant’s Service
terminates for all purposes under this Option Agreement.
(b)
Death; Disability. If Participant dies before Participant’s Service
terminates (or Participant dies within three months of Participant’s termination of Service other than for Cause (as defined in
the Plan)), then this Option will expire at the close of business at Company headquarters on the date 12 months after the
date of death (or such shorter time period not less than six (6) months or longer time period as may be determined by the
Committee, subject to the expiration details in Section 6). If Participant’s Service terminates because of Participant’s
Disability, then this Option will expire at the close of business at Company headquarters on the date 12 months after
Participant’s Termination Date (or such shorter time period not less than six (6) months or longer time period as may be
determined by the Committee, subject to the expiration details in Section 6).
(c)
No Notice. Participant is responsible for keeping track of these
exercise periods following Participant’s termination of Service for any reason. The Company will not provide further notice
of such periods. In no event shall this Option be exercised later than the Expiration Date set forth in the Notice.
2533020 v3
3
30268/00600/FW/12237143.2
(d)
Termination. For purposes of this Option, Participant’s Service will be
considered terminated as of the date Participant is no longer providing Services to the Company, its Parent or one of its
Subsidiaries or Affiliates (regardless of the reason for such termination and whether or not later found to be invalid or in
breach of employment laws in the jurisdiction where Participant is employed or the terms of Participant’s employment
agreement, if any) (the “Termination Date”). The Committee shall have the exclusive discretion to determine when
Participant is no longer actively providing services for purposes of Participant’s Option (including whether Participant may
still be considered to be providing services while on an approved leave of absence). Unless otherwise provided in this
Option Agreement or determined by the Company, Participant’s right to vest in this Option under the Plan, if any, will
terminate as of the Termination Date and will not be extended by any notice period (e.g., Participant’s period of services
would not include any contractual notice period or any period of “garden leave” or similar period mandated under
employment laws in the jurisdiction where Participant is employed or the terms of Participant’s employment agreement, if
any). Following the Termination Date, Participant may exercise the Option only as set forth in the Notice and this Section,
provided that the period (if any) during which Participant may exercise the Option after the Termination Date, if any, will
commence on the date Participant ceases to provide services and will not be extended by any notice period mandated
under employment laws in the jurisdiction where Participant is employed or terms of Participant’s employment
agreement, if any. If Participant does not exercise this Option within the termination period set forth in the Notice or the
termination periods set forth above, the Option shall terminate in its entirety. In no event, may any Option be exercised
after the Expiration Date of the Option as set forth in the Notice.
4.
Exercise of Option.
(a)
Right to Exercise. This Option is exercisable during its term in
accordance with the Vesting Schedule set forth in the Notice and the applicable provisions of the Plan and this Option
Agreement. In the event of Participant’s death, Disability, termination for Cause or other cessation of Service, the
exercisability of the Option is governed by the applicable provisions of the Plan, the Notice and this Option Agreement.
This Option may not be exercised for a fraction of a Share.
(b)
Method of Exercise. This Option is exercisable by delivery of an
exercise notice in a form specified by the Company (the “Exercise Notice”), which will state the election to exercise the
Option, the number of Shares in respect of which the Option is being exercised (the “Exercised Shares”), and such other
representations and agreements as may be required by the Company pursuant to the provisions of the Plan. The Exercise
Notice will be delivered in person, by mail, via electronic mail or facsimile or by other authorized method to the Secretary
of the Company or other person designated by the Company. The Exercise Notice will be accompanied by payment of the
aggregate Exercise Price as to all Exercised Shares together with any Tax-Related Items (as defined in Section 8 below).
This Option will be deemed to be exercised upon receipt by the Company of such fully executed Exercise Notice
accompanied by such aggregate Exercise Price and payment of any Tax-Related Items. No Shares will be issued pursuant
to the exercise of this Option unless such issuance and exercise complies with all relevant provisions of law and the
requirements of any stock exchange or quotation service upon which the Shares are then listed. Assuming such
compliance, for income tax purposes the Exercised Shares will be considered transferred to Participant on the date the
Option is exercised with respect to such Exercised Shares.
(c)
Exercise by Another. If another person wants to exercise this Option
after it has been transferred to him or her in compliance with this Agreement, that person must prove to the Company’s
satisfaction that he or she is entitled to exercise this Option. That person must also complete the proper Exercise Notice
form (as described above) and pay the Exercise Price (as described below) and any applicable tax withholding due upon
exercise of the Option (as described below).
4
30268/00600/FW/12237143.2
5.
Method of Payment. Payment of the aggregate Exercise Price will be by any of
the following, or a combination thereof, at the election of Participant:
cashier’s check;
(a)
Participant’s personal check (or readily available funds), wire transfer, or a
(b)
other method authorized by the Company.
6.
Non-Transferability of Option. This Option may not be sold, assigned, transferred,
pledged, hypothecated, or otherwise disposed of other than on death to Participant’s personal representative and may be
exercised during the lifetime of Participant only by Participant.
7.
Term of Option. This Option will in any event expire on the expiration date set forth
in the Notice, which date is 10 years after the Date of Grant.
8.
Tax Consequences.
(a)
Exercising the Option. Participant acknowledges that, regardless of
any action taken by the Company or a Parent or Subsidiary or Affiliate employing or retaining Participant (the
“Employer”), the ultimate liability for all income tax, social insurance, payroll tax, fringe benefits tax, payment on
account or other tax related items related to Participant’s participation in the Plan and legally applicable to Participant
(“Tax-Related Items”) is and remains Participant’s responsibility and may exceed the amount actually withheld by the
Company or the Employer. Participant further acknowledges that the Company and/or the Employer (i) make no
representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of this
Option, including, but not limited to, the grant, vesting or exercise of this Option, the subsequent sale of Shares acquired
pursuant to such exercise and the receipt of any dividends; and (ii) do not commit to and are under no obligation to
structure the terms of the grant or any aspect of this Option to reduce or eliminate Participant’s liability for Tax-Related
Items or achieve any particular tax result. Further, if Participant is subject to Tax-Related Items in more than one
jurisdiction between the Date of Grant and the date of any relevant taxable or tax withholding event, as applicable,
Participant acknowledges that the Company and/or the Employer (or former employer, as applicable) may be required to
withhold or account for Tax-Related Items in more than one jurisdiction. PARTICIPANT SHOULD CONSULT A TAX
ADVISER APPROPRIATELY QUALIFIED IN THE COUNTRY OR COUNTRIES IN WHICH PARTICIPANT RESIDES
OR IS SUBJECT TO TAXATION BEFORE EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
Prior to the relevant taxable or tax withholding event, as applicable, Participant agrees to make adequate
arrangements satisfactory to the Company and/or the Employer to satisfy all Tax-Related Items. In this regard, Participant
authorizes the Company and/or the Employer, or their respective agents, at their discretion, to satisfy the obligations with
regard to all Tax-Related Items by one or a combination of the following:
(i)
withholding from Participant’s wages or other cash compensation paid to Participant by
the Company and/or the Employer; or
(ii) withholding from proceeds of the sale of Shares acquired at exercise of this Option
either through a voluntary sale or through a mandatory sale arranged by the Company
(on Participant’s behalf pursuant to this authorization) without further consent; or
(iii) withholding in Shares to be issued upon exercise of the Option, provided the Company
only withholds from the amount of Shares necessary to satisfy the applicable statutory
withholding amount;
5
30268/00600/FW/12237143.2
(iv)
Participant’s payment of a cash amount (including by check representing readily
available funds or a wire transfer); or
(v)
any other arrangement approved by the Committee;
all under such rules as may be established by the Committee and in compliance with the Company’s
Insider Trading Policy and 10b5-1 Trading Plan Policy, if applicable; provided however, that if Participant is a Section 16
officer of the Company under the Exchange Act, then the Committee (as constituted in accordance with Rule 16b-3 under
the Exchange Act) shall establish the method of withholding from alternatives (i)-(v) above, and the Committee shall
establish the method prior to the Tax- Related Items withholding event.
Depending on the withholding method, the Company may withhold or account for Tax- Related Items by
considering applicable statutory withholding amounts or other applicable withholding rates, including maximum
applicable rates, in which case Participant will receive a refund of any over- withheld amount in cash and will have no
entitlement to the Common Stock equivalent. If the obligation for Tax-Related Items is satisfied by withholding in Shares,
for tax purposes, Participant is deemed to have been issued the full member of Shares issued upon exercise of the Options;
notwithstanding that a member of the Shares are held back solely for the purpose of paying the Tax-Related Items. The Fair
Market Value of these Shares, determined as of the effective date of the Option exercise, will be applied as a credit against
the Tax-Related Items withholding.
Finally, Participant agrees to pay to the Company or the Employer any amount of Tax- Related Items that
the Company or the Employer may be required to withhold or account for as a result of Participant’s participation in the
Plan that cannot be satisfied by the means previously described. The Company may refuse to issue or deliver the Shares or
the proceeds of the sale of Shares, if Participant fails to comply with his or her obligations in connection with the Tax-
Related Items.
(b)
UK Tax Liabilities. As a condition of the exercise of the Option,
Participant unconditionally and irrevocably agrees:
(i)
to place the Company in funds and indemnify the Company in respect of (1) all liability
to UK income tax which the Company is liable to account for on Participant’s behalf
directly to HM Revenue & Customs; (2) all liability to national insurance contributions
which the Company is liable to account for on Participant’s behalf to HM Revenue &
Customs (including secondary class 1 (employer’s) national insurance contributions for
which Participant is liable); and (3) to the extent legally permitted, all liability to
national insurance contributions for which the Company is liable, which in all cases
arise as a consequence of or in connection with the vesting or exercise of the Option,
Participant entering into of any tax election as detailed below or Participant’s
ownership of Shares by virtue of such exercise including, without limitation, in respect
of any liability arising under or in connection with Part 7 or Part 7A of the Income Tax
(Earnings and Pensions) Act 2003 (“ITEPA”) (the “UK Tax Liability”); or
(ii)
to permit the Company to sell at the best price which it can reasonably obtain such
number of Shares allocated or allotted to Participant following exercise as will provide
the Company with an amount equal to the UK Tax Liability; and to permit the Company
to withhold an amount not exceeding the UK Tax Liability from any payment made to
Participant (including, but not limited to, salary); and
(iii)
if so required by the Company, and to the extent permitted by law, to enter into a joint
election or other arrangements under which the liability for all or
6
30268/00600/FW/12237143.2
part of employer’s national insurance contributions liability is transferred to Participant;
and
(iv)
(v)
if so required by the Company, to enter into a joint election within Section 431 of
ITEPA in respect of computing any tax charge on the acquisition of Restricted
Securities; and
to sign, promptly, all documents, required by the Company to effect the terms of this
provision, and references in this provision to “the Company” shall, if applicable, be
construed as also referring to any Affiliate.
Nature of Grant. By accepting the Option, Participant acknowledges, understands
9.
and agrees that:
the Plan is established voluntarily by the Company, it is discretionary
in nature, and may be amended, suspended or terminated by the Company at any time, to the extent permitted by the Plan;
(a)
(b)
the grant of the Option is voluntary and occasional and does not
create any contractual or other right to receive future grants of options, or benefits in lieu of options, even if options have
been granted in the past;
(c)
all decisions with respect to future Option or other grants, if any, will
be at the sole discretion of the Company;
(d)
the Option grant and Participant’s participation in the Plan will not
create a right to employment or be interpreted as forming an employment or service contract with the Company, the
Employer or any Parent or Subsidiary or Affiliate;
(e)
Participant is voluntarily participating in the Plan;
(f)
the Option and any Shares acquired under the Plan are not intended to
replace any pension rights or compensation;
(g)
the Option and any Shares acquired under the Plan and the income
and value of same, are not part of normal or expected compensation for purposes of calculating any severance,
resignation, termination, redundancy, dismissal, end-of-service payments, bonuses, long-service awards, pension or
retirement or welfare benefits or similar payments;
(h)
the future value of the Shares underlying the Option is unknown,
indeterminable, and cannot be predicted with certainty;
(i)
if the underlying Shares do not increase in value, the Option will have no value;
(j)
if Participant exercises the Option and acquires Shares, the value of
such Shares may increase or decrease in value, even below the Exercise Price;
(k)
no claim or entitlement to compensation or damages will arise from
forfeiture of the Option resulting from Participant ceasing to provide employment or other services to the Company or the
Employer (for any reason whatsoever, whether or not later found to be invalid or in breach of employment laws in the
jurisdiction where Participant is employed or the terms of Participant’s employment agreement, if any), and in
consideration of the grant of the Option to which Participant is otherwise not entitled, Participant irrevocably agrees never
to institute any claim against the Company, any Parent or Subsidiary or Affiliate or the Employer, waives his or her ability,
if any, to bring any such claim, and releases the Company, any Parent or Subsidiary or Affiliate and the Employer from any
such claim; if,
7
30268/00600/FW/12237143.2
notwithstanding the foregoing, any such claim is allowed by a court of competent jurisdiction, then, by participating in the
Plan, Participant will be deemed irrevocably to have agreed not to pursue such claim and agrees to execute any and all
documents necessary to request dismissal or withdrawal of such claim;
(l)
unless otherwise provided in the Plan or by the Company in its
discretion, the Option and the benefits evidenced by this Option Agreement do not create any entitlement to have the
Option or any such benefits transferred to, or assumed by, another company nor to be exchanged, cashed out or substituted
for, in connection with any corporate transaction affecting the Shares; and
United States:
(m)
the following provisions apply only if Participant is providing services outside the
(i)
(ii)
the Option and the Shares subject to the Option are not part of normal or expected
compensation or salary for any purpose;
Participant acknowledges and agrees that neither the Company, the Employer nor any
Parent or Subsidiary or Affiliate will be liable for any foreign exchange rate fluctuation
between Participant’s local currency and the United States Dollar that may affect the
value of the Option or of any amounts due to Participant pursuant to the exercise of the
Option or the subsequent sale of any Shares acquired upon exercise.
(n)
Participant hereby waives all and any rights to compensation or
damages in consequence of Participant’s termination of employment for any reason whatsoever (whether lawful or
unlawful and including, without prejudice to the generality of the foregoing, in circumstances giving rise to a claim for
wrongful dismissal) insofar as those rights arise or may arise from Participant ceasing to have rights under or being entitled
to exercise the Option as a result of such termination, or from the loss or diminution in value of such rights or
entitlements.
10.
No Advice Regarding Grant. The Company is not providing any tax, legal or
financial advice, nor is the Company making any recommendations regarding Participant’s participation in the Plan, or
Participant’s acquisition or sale of the underlying Shares. Participant is hereby advised to consult with his or her own
personal tax, legal and financial advisors regarding his or her participation in the Plan before taking any action related to the
Plan.
11.
Data Privacy. Participant understands that the Company and the Employer may hold
certain personal information about Participant including, but not limited to, Participant’s name, home address and
telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any
shares of stock or directorships held in the Company, details of all Options or any other entitlement to shares of stock
awarded, canceled, exercised, vested, unvested or outstanding in Participant’s favor (the “Personal Data”). Certain
Personal Data may also constitute “Sensitive Personal Data” or similar classification under applicable local law and be
subject to additional restrictions on collection, processing and use of the same under such laws. The Company and the
Employer may collect, hold, and process any such Personal Data for the purpose of performing this Option Agreement
and such collection, holding and processing is necessary for such performance. The Company and the Employer may
retain such Personal Data for as long as necessary to perform this Option Agreement. The Company and the Employer
may transfer any such Personal Data outside the country in which Participant is employed or retained, including the United
States which does not provide for an adequate level of data protection based on an EU Commission decision. As an
appropriate safeguard for such Personal Data, and also as the legal basis for such transfer, the Company will collect and
process the information in accordance with the privacy notice provided to Participant. The legal persons with whom such
Personal Data may be shared are the Company and any broker company providing services to the Company in connection
with the administration of the Plan. Participant has the right, in certain circumstances, to access, correct, restrict the
processing of, erase and port his Personal Data and also to object to the processing of his Personal Data and/or automated
decision-making using his Personal Data. Participant also has the right to complain to
8
30268/00600/FW/12237143.2
his local data protection supervisory authority. For details as to how Participant can exercise his rights please contact the
Company representative identified on the Grant Notice.
12.
Language. If Participant has received this Option Agreement, or any other document
related to the Option and/or the Plan translated into a language other than English and if the meaning of the translated
version is different than the English version, the English version will control.
13.
Imposition of Other Requirements. The Company reserves the right to impose
other requirements on Participant’s participation in the Plan, on the Option and on any Shares purchased upon exercise of
the Option, to the extent the Company determines it is necessary or advisable for legal or administrative reasons, and to
require Participant to sign any additional agreements or undertakings that may be necessary to accomplish the foregoing.
14.
Acknowledgement. The Company and Participant agree that the Option is granted
under and governed by the Notice, this Option Agreement and by the provisions of the Plan (incorporated herein by
reference). Participant: (a) acknowledges receipt of a copy of the Plan and the Plan prospectus,
(b) represents that Participant has carefully read and is familiar with their provisions, and (c) hereby accepts the Option
subject to all of the terms and conditions set forth herein and those set forth in the Plan and the Notice.
15.
Entire Agreement; Enforcement of Rights. This Option Agreement, the Plan and
the Notice constitute the entire agreement and understanding of the parties relating to the subject matter herein and
supersede all prior discussions between them. Any prior agreements, commitments or negotiations concerning the
purchase of the Shares hereunder are superseded. No modification of or amendment to this Option Agreement, nor any
waiver of any rights under this Option Agreement, will be effective unless in writing and signed by the parties to this
Option Agreement. The failure by either party to enforce any rights under this Option Agreement will not be construed as a
waiver of any rights of such party.
16.
Compliance with Laws and Regulations. The issuance of Shares and any restriction
on the sale of Shares will be subject to and conditioned upon compliance by the Company and Participant with all applicable
state, federal and local laws and regulations and with all applicable requirements of any stock exchange or automated
quotation system on which the Company’s Shares may be listed or quoted at the time of such issuance or transfer.
Participant understands that the Company is under no obligation to register or qualify the Common Stock with any state,
federal or foreign securities commission or to seek approval or clearance from any governmental authority for the
issuance or sale of the Shares. Further, Participant agrees that the Company shall have unilateral authority to amend the
Plan and this Option Agreement without Participant’s consent to the extent necessary to comply with securities or other
laws applicable to issuance of Shares. Finally, the Shares issued pursuant to this Option Agreement shall be endorsed with
appropriate legends, if any, determined by the Company.
17.
Severability. If one or more provisions of this Option Agreement are held to be
unenforceable, the parties agree to renegotiate such provision in good faith. In the event that the parties cannot reach a
mutually agreeable and enforceable replacement for such provision, then (a) such provision will be excluded from this
Option Agreement, (b) the balance of this Option Agreement will be interpreted as if such provision were so excluded and
(c) the balance of this Option Agreement will be enforceable in accordance with its terms.
18.
Governing Law and Venue. This Option Agreement and all acts and transactions
pursuant hereto and the rights and obligations of the parties hereto will be governed, construed and interpreted in
accordance with the laws of the State of Delaware, without giving effect to principles of conflicts of law.
Any and all disputes relating to, concerning or arising from this Option Agreement, or relating to, concerning or
arising from the relationship between the parties evidenced by the Plan or this Option Agreement, will be brought and
heard exclusively in the United States District Court for the District of New
9
30268/00600/FW/12237143.2
Delaware or the Delaware Superior Court, New Castle County. Each of the parties hereby represents and agrees that such
party is subject to the personal jurisdiction of said courts; hereby irrevocably consents to the jurisdiction of such courts in
any legal or equitable proceedings related to, concerning or arising from such dispute, and waives, to the fullest extent
permitted by law, any objection which such party may now or hereafter have that the laying of the venue of any legal or
equitable proceedings related to, concerning or arising from such dispute which is brought in such courts is improper or that
such proceedings have been brought in an inconvenient forum.
19.
No Rights as Employee or Director. Nothing in this Option Agreement will affect in
any manner whatsoever the right or power of the Company, or a Parent or Subsidiary or Affiliate, to terminate Participant’s
Service, for any reason, with or without Cause.
20.
Consent to Electronic Delivery of all Plan Documents and Disclosures. By
Participant’s signature and the signature of the Company’s representative on the Notice, Participant and the Company agree
that this Option is granted under and governed by the terms and conditions of the Plan, the Notice and this Option
Agreement. Participant has reviewed the Plan, the Notice and this Option Agreement in their entirety, has had an
opportunity to obtain the advice of counsel prior to executing the Notice, and fully understands all provisions of the Plan,
the Notice and this Option Agreement. Participant hereby agrees to accept as binding, conclusive and final all decisions or
interpretations of the Committee upon any questions relating to the Plan, the Notice and the Option Agreement.
Participant further agrees to notify the Company upon any change in the residence address indicated on the Notice. By
acceptance of this Option, Participant agrees to participate in the Plan through an on-line or electronic system established
and maintained by the Company or a third party designated by the Company and consents to the electronic delivery of the
Notice, this Option Agreement, the Plan, account statements, Plan prospectuses required by the U.S. Securities and
Exchange Commission, U.S. financial reports of the Company, and all other documents that the Company is required to
deliver to its security holders (including, without limitation, annual reports and proxy statements) or other communications
or information related to the Option and current or future participation in the Plan. Electronic delivery may include the
delivery of a link to the Company intranet or the internet site of a third party involved in administering the Plan, the
delivery of the document via e-mail or such other delivery determined at the Company’s discretion. Participant
acknowledges that Participant may receive from the Company a paper copy of any documents delivered electronically at
no cost if Participant contacts the Company by telephone, through a postal service or electronic mail to Stock
Administration. Participant further acknowledges that Participant will be provided with a paper copy of any documents
delivered electronically if electronic delivery fails; similarly, Participant understands that Participant must provide on
request to the Company or any designated third party a paper copy of any documents delivered electronically if electronic
delivery fails. Also, Participant understands that Participant’s consent may be revoked or changed, including any change in
the electronic mail address to which documents are delivered (if Participant has provided an electronic mail address), at
any time by notifying the Company of such revised or revoked consent by telephone, postal service or electronic mail
through Stock Administration. Finally, Participant understands that Participant is not required to consent to electronic
delivery if local laws prohibit such consent.
21.
Insider Trading Restrictions/Market Abuse Laws. Participant acknowledges that,
depending on Participant’s country, Participant may be subject to insider trading restrictions and/or market abuse laws,
which may affect Participant’s ability to acquire or sell the Shares or rights to Shares under the Plan during such times as
Participant is considered to have “inside information” regarding the Company (as defined by the laws in Participant’s
country). Any restrictions under these laws or regulations are separate from and in addition to any restrictions that may be
imposed under any applicable Company insider trading policy. Participant acknowledges that it is Participant’s
responsibility to comply with any applicable restrictions, and Participant is advised to speak to Participant’s personal
advisor on this matter.
22.
Award Subject to Company Clawback or Recoupment. To the extent permitted by
applicable law, the Option shall be subject to clawback or recoupment pursuant to any compensation clawback or
recoupment policy adopted by the Board or required by law during the term of Participant’s employment or other Service
that is applicable to Participant. In addition to any other remedies available
10
30268/00600/FW/12237143.2
under such policy, applicable law may require the cancellation of Participant’s Option (whether vested or unvested) and the
recoupment of any gains realized with respect to Participant’s Option.
BY ACCEPTING THIS OPTION, PARTICIPANT AGREES TO ALL OF THE TERMS AND
CONDITIONS DESCRIBED ABOVE AND IN THE PLAN (INCLUDING THE UK SUB- PLAN).
11
30268/00600/FW/12237143.2
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN UK
SUB-PLAN
NOTICE OF RESTRICTED STOCK UNIT AWARD GRANT
NUMBER:
Unless otherwise defined herein, the terms defined in the KalVista Pharmaceuticals, Inc. 2021 Equity Inducement
Plan (the “Plan”) and the UK Sub-Plan to the Plan (the “UK Sub-Plan”) will have the same meanings in this Notice of
Restricted Stock Unit Award and the electronic representation of this Notice of Restricted Stock Unit Award established
and maintained by the Company or a third party designated by the Company (this “Notice”).
Name:
Address:
You (“Participant”) have been granted an award of Restricted Stock Units (“RSUs”) under the UK Sub-Plan subject
to the terms and conditions of the Plan and the UK Sub-Plan, this Notice and the attached Restricted Stock Unit Award
Agreement (hereinafter the “Agreement”).
Number of RSUs:
Date of Grant:
Vesting Commencement Date:
Expiration Date:
Vesting Schedule:
Notice, the Plan
The earlier to occur of: (a) the date on which settlement of all RSUs
granted hereunder occurs and (b) the tenth anniversary of the Date
of Grant. This RSU expires earlier if Participant’s Service
terminates earlier, as described in the Agreement.
Subject to the limitations set forth in this
and the Agreement, the RSUs will vest in accordance with the
following schedule: [insert applicable vesting schedule, which
may be time- and/or performance- based]
By accepting (whether in writing, electronically or otherwise) the RSUs, Participant acknowledges and agrees to
the following:
Participant acknowledges that the vesting of the RSUs pursuant to this Notice is earned only by continuing
Service (as defined in the Plan) as an Employee or Director. Participant agrees and acknowledges that the Vesting
Schedule may change prospectively in the event that Participant’s service status changes between full- and part-time status
and/or in the event Participant is on a leave of absence, in accordance with Company policies relating to work schedules
and vesting of awards or as determined by the Committee to the extent permitted by applicable law. Participant also
understands that this Notice is subject to the terms and conditions of the Agreement, the Plan and the UK Sub-Plan,
all of which are
[Signature Page Follows]
incorporated herein by reference. Participant has read the Agreement the Plan and the UK Sub-Plan. By accepting the
RSUs, Participant consents to electronic delivery as set forth in the Agreement.
Participant has read the Company’s Insider Trading Policy, and agrees to comply with such policy, as it may be
amended from time to time, whenever Participant acquires or disposes of the Company’s securities.
PARTICIPANT
Signature:
Print
Name:
KALVISTA PHARMACEUTICALS, INC.
By:
Its:
[Signature Page to 2021 Equity Inducement Plan Notice of Restricted Stock Unit Award]
KALVISTA PHARMACEUTICALS, INC.
2021 EQUITY INDUCEMENT PLAN RESTRICTED
STOCK UNIT AWARD AGREEMENT
Unless otherwise defined herein, the terms defined in the KalVista Pharmaceuticals, Inc. 2021 Equity Inducement
Plan (the “Plan”) and the UK Sub-Plan to the Plan (the “UK Sub-Plan”) will have the same defined meanings in this
Restricted Stock Unit Award Agreement (this “Agreement”).
Participant has been granted Restricted Stock Units (“RSUs”) subject to the terms, restrictions and conditions of the
Plan and the UK Sub-Plan (referred for purposes of this Agreement together as the “Plan”), the Notice of Restricted Stock
Unit Award (the “Notice”) and this Agreement.
1.
Settlement. Settlement of RSUs will be made within 30 days following the applicable
date of vesting under the vesting schedule set forth in the Notice. Notwithstanding Section 6.2 of the Plan, settlement of
RSUs awarded to United Kingdom Employees will be in Shares only. No fractional RSUs or rights for fractional Shares
shall be created pursuant to this Agreement.
2.
No Stockholder Rights. Unless and until such time as Shares are issued in settlement
of vested RSUs, Participant will have no ownership of the Shares allocated to the RSUs and will have no rights to dividends
or to vote such Shares.
3.
credited to Participant.
Dividend Equivalents. Dividends, if any (whether in cash or Shares), will not be
4.
Non-Transferability of RSUs. The RSUs and any interest therein will not be sold,
assigned, transferred, pledged, hypothecated, or otherwise disposed of in any manner other than on death to Participant’s
personal representative.
5.
Termination. If Participant’s Service terminates for any reason, all unvested RSUs
will be forfeited to the Company forthwith, and all rights of Participant to such RSUs will immediately terminate without
payment of any consideration to Participant. Participant’s Service will be considered terminated as of the date Participant
is no longer providing services (regardless of the reason for such termination and whether or not later found to be invalid
or in breach of employment laws in the jurisdiction where Participant is employed or the terms of Participant’s
employment agreement, if any) and will not, subject to the laws applicable to Participant’s Award, be extended by any
notice period mandated under local laws (e.g., Service would not include a period of “garden leave” or similar period).
Participant acknowledges and agrees that the Vesting Schedule may change prospectively in the event Participant’s service
status changes between full- and part-time status and/or in the event Participant is on an approved leave of absence in
accordance with Company policies relating to work schedules and vesting of awards or as determined by the Committee.
Participant acknowledges that the vesting of the Shares pursuant to this Notice and Agreement is earned only by continued
Service. In case of any dispute as to whether termination of Service has occurred, the Committee will have sole discretion to
determine whether such termination of Service has occurred and the effective date of such termination (including whether
Participant may still be considered to be providing services while on an approved leave of absence).
6.
Withholding Taxes.
(a)
Participant acknowledges that, regardless of any action taken by the
Company or, if different, Participant’s employer (the “Employer”) the ultimate liability for all income tax, social
insurance, payroll tax, fringe benefits tax, payment on account or other tax-related items related to
A-1
Participant’s participation in the Plan and legally applicable to Participant (“Tax-Related Items”), is and remains
Participant’s responsibility and may exceed the amount actually withheld by the Company or the Employer. Participant
further acknowledges that the Company and/or the Employer (1) make no representations or undertakings regarding the
treatment of any Tax-Related Items in connection with any aspect of the RSUs, including, but not limited to, the grant,
vesting or settlement of the RSUs and the subsequent sale of Shares acquired pursuant to such settlement and the receipt of
any dividends; and (2) do not commit to and are under no obligation to structure the terms of the grant or any aspect of the
RSUs to reduce or eliminate Participant’s liability for Tax-Related Items or achieve any particular tax result. Further, if
Participant is subject to Tax-Related Items in more than one jurisdiction between the date of grant and the date of any
relevant taxable or tax withholding event, as applicable, Participant acknowledges that the Company and/or the Employer
(or former employer, as applicable) may be required to withhold or account for Tax-Related Items in more than one
jurisdiction.
Prior to any relevant taxable or tax withholding event, as applicable, Participant agrees to make adequate
arrangements satisfactory to the Company and/or the Employer to satisfy all Tax-Related Items. In this regard, Participant
authorizes the Company and/or the Employer, or their respective agents, at their discretion, to satisfy the obligations with
regard to all Tax-Related Items by one or a combination of the following:
(i)
(ii)
(iii)
(iv)
withholding from Participant’s wages or other cash compensation paid to Participant
by the Company and/or the Employer; or
withholding from proceeds of the sale of Shares acquired upon settlement of the
RSUs either through a voluntary sale or through a mandatory sale arranged by the
Company (on Participant’s behalf pursuant to this authorization); or
withholding in Shares to be issued upon settlement of the RSUs, provided the
Company only withholds the amount of Shares necessary to satisfy the applicable
statutory withholding amounts;
Participant’s payment of a cash amount (including by check representing readily
available funds or a wire transfer); or
(v)
any other arrangement approved by the Committee;
all under such rules as may be established by the Committee and in compliance with the Company’s Insider Trading Policy
and 10b5-1 Trading Plan Policy, if applicable; provided however, that if Participant is a Section 16 officer of the Company
under the Exchange Act, then the Committee (as constituted in accordance with Rule 16b-3 under the Exchange Act) shall
establish the method of withholding from alternatives (i)-(v) above, and the Committee shall establish the method prior to
the Tax-Related Items withholding event.
Depending on the withholding method, the Company may withhold or account for Tax-Related Items by considering
applicable statutory withholding amounts, including maximum applicable rates, in which case Participant will receive a
refund of any over-withheld amount in cash and will have no entitlement to the Common Stock equivalent. If the
obligation for Tax- Related Items is satisfied by withholding in Shares, for tax purposes, Participant is deemed to have
been issued the full number of Shares subject to the vested RSUs, notwithstanding that a number of the Shares are held
back solely for the purpose of paying the Tax- Related Items. The Fair Market Value of these Shares, determined as of
the effective date when taxes
A-2
otherwise would have been withheld in cash, will be applied as a credit against the Tax-Related Items withholding.
Finally, Participant agrees to pay to the Company or the Employer any amount of Tax-Related Items that the
Company or the Employer may be required to withhold or account for as a result of Participant’s participation in the Plan
that cannot be satisfied by the means previously described. The Company may refuse to issue or deliver the Shares or the
proceeds of the sale of Shares, if Participant fails to comply with Participant’s obligations in connection with the Tax-
Related Items.
(b)
UK Tax Liabilities. As a condition of the settlement of the RSU,
Participant unconditionally and irrevocably agrees:
(i)
(ii)
(iii)
(iv)
to place the Company in funds and indemnify the Company in respect of
(1)
all liability to UK income tax which
the Company is liable to account for on Participant’s behalf directly to HM Revenue
& Customs; (2) all liability to national insurance contributions which the Company
is liable to account for on Participant’s behalf to HM Revenue & Customs (including
secondary class 1 (employer’s) national insurance contributions for which Participant
is liable); and (3) to the extent legally permitted, all liability to national insurance
contributions for which the Company is liable, which in all cases arise as a
consequence of or in connection with the vesting or settlement of the RSU,
Participant entering into of any tax election as detailed below or Participant’s
ownership of Shares by virtue of such exercise including, without limitation, in
respect of any liability arising under or in connection with Part 7 or Part 7A of the
Income Tax (Earnings and Pensions) Act 2003 (“ITEPA”) (the “UK Tax Liability”);
or
to permit the Company to sell at the best price which it can reasonably obtain such
number of Shares allocated or allotted to Participant following exercise as will provide
the Company with an amount equal to the UK Tax Liability; and to permit the
Company to withhold an amount not exceeding the UK Tax Liability from any
payment made to Participant (including, but not limited to, salary); and
if so required by the Company, and to the extent permitted by law, to enter into a joint
election or other arrangements under which the liability for all or part of employer’s
national insurance contributions liability is transferred to Participant; and
if so required by the Company, to enter into a joint election within Section 431 of
ITEPA in respect of computing any tax charge on the acquisition of Restricted
Securities; and
to sign, promptly, all documents, required by the Company to effect the terms of this provision, and references in
this provision to “the Company” shall, if applicable, be construed as also referring to any Affiliate.
A-3
7.
and agrees that:
Nature of Grant. By accepting the RSUs, Participant acknowledges, understands
(a)
the Plan is established voluntarily by the Company, it is discretionary
in nature and it may be modified, amended, suspended or terminated by the Company at any time, to the extent permitted by
the Plan;
(b)
the grant of the RSUs is voluntary and occasional and does not create
any contractual or other right to receive future grants of RSUs, or benefits in lieu of RSUs, even if RSUs have been
granted in the past;
(c)
all decisions with respect to future RSU or other grants, if any, will
be at the sole discretion of the Company;
(d)
the RSU grant and Participant’s participation in the Plan will not
create a right to employment or be interpreted as forming an employment or services contract with the Company, the
Employer or any Parent or Subsidiary or Affiliate;
(e)
Participant is voluntarily participating in the Plan;
(f)
the RSUs and the Shares subject to the RSUs are not intended to
replace any pension rights or compensation;
(g)
the RSUs and the Shares subject to the RSUs, and the income and
value of same, are not part of normal or expected compensation for purposes of calculating any severance, resignation,
termination, redundancy, dismissal, end-of- service payments, bonuses, long-service awards, pension or retirement or
welfare benefits or similar payments;
(h)
the future value of the underlying Shares is unknown, indeterminable
and cannot be predicted with certainty;
(i)
no claim or entitlement to compensation or damages will arise from
forfeiture of the RSUs resulting from Participant’s termination of Service, and in consideration of the grant of the RSUs to
which Participant is otherwise not entitled, Participant irrevocably agrees never to institute any claim against the
Company, or any Parent or Subsidiary or Affiliate or the Employer, waives his or her ability, if any, to bring any such
claim, and releases the Company, any Parent or Subsidiary or Affiliate and the Employer from any such claim; if,
notwithstanding the foregoing, any such claim is allowed by a court of competent jurisdiction, then, by participating in the
Plan, Participant will be deemed irrevocably to have agreed not to pursue such claim and agrees to execute any and all
documents necessary to request dismissal or withdrawal of such claim;
(j)
unless otherwise provided in the Plan or by the Company in its
discretion, the RSUs and the benefits evidenced by this Agreement do not create any entitlement to have the RSUs or any
such benefits transferred to, or assumed by, another company nor to be exchanged, cashed out or substituted for, in
connection with any Corporate Transaction affecting the Shares; and
United States:
(k)
the following provisions apply only if Participant is providing services outside the
(i)
the RSUs and the Shares subject to the RSUs are not part of normal or expected
compensation or salary for any purpose;
A-4
(ii)
Participant acknowledges and agrees that neither the Company, the Employer nor
any Parent or Subsidiary or Affiliate will be liable for any foreign exchange rate
fluctuation between Participant’s local currency and the United States Dollar that may
affect the value of the RSUs or of any amounts due to Participant pursuant to the
settlement of the RSUs or the subsequent sale of any Shares acquired upon
settlement.
(l)
Participant hereby waives all and any rights to compensation or
damages in consequence of Participant’s termination of employment for any reason whatsoever (whether lawful or
unlawful and including, without prejudice to the generality of the foregoing, in circumstances giving rise to a claim for
wrongful dismissal) insofar as those rights arise or may arise from Participant ceasing to have rights under or being entitled
to vest in the RSU as a result of such termination, or from the loss or diminution in value of such rights or entitlements.
8.
No Advice Regarding Grant. The Company is not providing any tax, legal or
financial advice, nor is the Company making any recommendations regarding Participant’s participation in the Plan, or
Participant’s acquisition or sale of the underlying Shares. Participant is hereby advised to consult with his or her own
personal tax, legal and financial advisors regarding his or her participation in the Plan before taking any action related to the
Plan.
9.
Data Privacy. Participant understands that the Company and the Employer may hold
certain personal information about Participant including, but not limited to, Participant’s name, home address and
telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any
shares of stock or directorships held in the Company, details of all RSUs or any other entitlement to shares of stock
awarded, canceled, exercised, vested, unvested or outstanding in Participant’s favor (the “Personal Data”). Certain
Personal Data may also constitute “Sensitive Personal Data” or similar classification under applicable local law and be
subject to additional restrictions on collection, processing and use of the same under such laws. The Company and the
Employer may collect, hold, and process any such Personal Data for the purpose of performing this RSU Agreement and
such collection, holding and processing is necessary for such performance. The Company and the Employer may retain
such Personal Data for as long as necessary to perform this RSU Agreement. The Company and the Employer may transfer
any such Personal Data outside the country in which Participant is employed or retained, including the United States which
does not provide for an adequate level of data protection based on an EU Commission decision. As an appropriate
safeguard for such Personal Data, and also as the legal basis for such transfer, the Company will collect and process the
information in accordance with the privacy notice provided to Participant. The legal persons with whom such Personal
Data may be shared are the Company and any broker company providing services to the Company in connection with the
administration of the Plan. Participant has the right, in certain circumstances, to access, correct, restrict the processing of,
erase and port his Personal Data and also to object to the processing of his Personal Data and/or automated decision-
making using his Personal Data. Participant also has the right to complain to his local data protection supervisory
authority. For details as to how Participant can exercise his rights please contact the Company representative identified on
the Grant Noticed
10.
Language. If Participant has received this Agreement or any other document related
to the Plan translated into a language other than English and if the meaning of the translated version is different than the
English version, the English version will control.
11.
Imposition of Other Requirements. The Company reserves the right to impose
other requirements on Participant’s participation in the Plan, on the RSUs and on any Shares acquired under the
A-5
Plan, to the extent the Company determines it is necessary or advisable for legal or administrative reasons, and to require
Participant to sign any additional agreements or undertakings that may be necessary to accomplish the foregoing.
12.
Acknowledgement. The Company and Participant agree that the RSUs are granted
under and governed by the Notice, this Agreement and the provisions of the Plan. Participant: (a) acknowledges receipt of
a copy of the Plan and the Plan prospectus, (b) represents that Participant has carefully read and is familiar with their
provisions, and (c) hereby accepts the RSUs subject to all of the terms and conditions set forth herein and those set forth in
the Plan and the Notice.
13.
Entire Agreement; Enforcement of Rights. This Agreement, the Plan and the
Notice constitute the entire agreement and understanding of the parties relating to the subject matter herein and supersede
all prior discussions between them. Any prior agreements, commitments or negotiations concerning the purchase of the
Shares hereunder are superseded. No modification of or amendment to this Agreement, nor any waiver of any rights under
this Agreement, will be effective unless in writing and signed by the parties to this Agreement. The failure by either party
to enforce any rights under this Agreement will not be construed as a waiver of any rights of such party.
14.
Compliance with Laws and Regulations. The issuance of Shares will be subject to
and conditioned upon compliance by the Company and Participant with all applicable state and federal laws and
regulations and with all applicable requirements of any stock exchange or automated quotation system on which the
Company’s Common Stock may be listed or quoted at the time of such issuance or transfer. Participant understands that
the Company is under no obligation to register or qualify the Common Stock with any state, federal or foreign securities
commission or to seek approval or clearance from any governmental authority for the issuance or sale of the Shares.
Further, Participant agrees that the Company shall have unilateral authority to amend the Plan and this RSU Agreement
without Participant’s consent to the extent necessary to comply with securities or other laws applicable to issuance of
Shares. Finally, the Shares issued pursuant to this RSU Agreement shall be endorsed with appropriate legends, if any,
determined by the Company.
15.
Severability. If one or more provisions of this Agreement are held to be
unenforceable under applicable law, the parties agree to renegotiate such provision in good faith. In the event that the
parties cannot reach a mutually agreeable and enforceable replacement for such provision, then (a) such provision will be
excluded from this Agreement, (b) the balance of this Agreement will be interpreted as if such provision were so excluded
and (c) the balance of this Agreement will be enforceable in accordance with its terms.
16.
Governing Law and Venue. This Agreement and all acts and transactions pursuant
hereto and the rights and obligations of the parties hereto will be governed, construed and interpreted in accordance with the
laws of the State of Delaware, without giving effect to principles of conflicts of law.
Any and all disputes relating to, concerning or arising from this Agreement, or relating to, concerning or
arising from the relationship between the parties evidenced by the Plan or this Agreement, will be brought and heard
exclusively in the United States District Court for the District of New Delaware or the Delaware Superior Court, New
Castle County. Each of the parties hereby represents and agrees that such party is subject to the personal jurisdiction of
said courts; hereby irrevocably consents to the jurisdiction of such courts in any legal or equitable proceedings related to,
concerning or arising from such dispute, and waives, to the fullest extent permitted by law, any objection which such party
may now or hereafter have that the laying of the venue of any legal or equitable proceedings related to, concerning or
arising from such dispute which is brought in such courts is improper or that such proceedings have been brought in an
inconvenient forum.
A-6
17.
No Rights as Employee or Director. Nothing in this Agreement will affect in any
manner whatsoever the right or power of the Company, or a Parent or Subsidiary or Affiliate of the Company, to terminate
Participant’s Service, for any reason, with or without Cause.
18.
Consent to Electronic Delivery of All Plan Documents and Disclosures. By
Participant’s acceptance (whether in writing, electronically or otherwise) of the Notice, Participant and the Company agree
that the RSUs are granted under and governed by the terms and conditions of the Plan, the Notice and this Agreement.
Participant has reviewed the Plan, the Notice and this Agreement in their entirety, has had an opportunity to obtain the
advice of counsel prior to executing this Agreement, and fully understands all provisions of the Plan, the Notice and this
Agreement. Participant hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the
Committee upon any questions relating to the Plan, the Notice and this Agreement. Participant further agrees to notify the
Company upon any change in Participant’s residence address. By acceptance of the RSUs, Participant agrees to participate
in the Plan through an on-line or electronic system established and maintained by the Company or a third party designated
by the Company and consents to the electronic delivery of the Notice, this Agreement, the Plan, account statements, Plan
prospectuses required by the U.S. Securities and Exchange Commission,
U.S. financial reports of the Company, and all other documents that the Company is required to deliver to its security
holders (including, without limitation, annual reports and proxy statements) or other communications or information
related to the RSUs and current or future participation in the Plan. Electronic delivery may include the delivery of a link to
a Company intranet or the internet site of a third party involved in administering the Plan, the delivery of the document
via e- mail or such other delivery determined at the Company’s discretion. Participant acknowledges that Participant may
receive from the Company a paper copy of any documents delivered electronically at no cost if Participant contacts the
Company by telephone, through a postal service or electronic mail to Stock Administration. Participant further
acknowledges that Participant will be provided with a paper copy of any documents delivered electronically if electronic
delivery fails; similarly, Participant understands that Participant must provide on request to the Company or any
designated third party a paper copy of any documents delivered electronically if electronic delivery fails. Also, Participant
understands that Participant’s consent may be revoked or changed, including any change in the electronic mail address to
which documents are delivered (if Participant has provided an electronic mail address), at any time by notifying the
Company of such revised or revoked consent by telephone, postal service or electronic mail through Stock
Administration. Finally, Participant understands that Participant is not required to consent to electronic delivery if local laws
prohibit such consent.
19.
Insider Trading Restrictions/Market Abuse Laws. Participant acknowledges that,
depending on Participant’s country, Participant may be subject to insider trading restrictions and/or market abuse laws,
which may affect Participant’s ability to acquire or sell the Shares or rights to Shares under the Plan during such times as
Participant is considered to have “inside information” regarding the Company (as defined by the laws in Participant’s
country). Any restrictions under these laws or regulations are separate from and in addition to any restrictions that may be
imposed under any applicable Company insider trading policy. Participant acknowledges that it is Participant’s
responsibility to comply with any applicable restrictions, and Participant is advised to speak to Participant’s personal
advisor on this matter.
20.
Code Section 409A. For purposes of this Agreement, a termination of employment
will be determined consistent with the rules relating to a “separation from service” as defined in Section 409A of the
Internal Revenue Code and the regulations thereunder (“Section 409A”). Notwithstanding anything else provided herein,
to the extent any payments provided under this RSU Agreement in connection with Participant’s termination of
employment constitute deferred compensation subject to Section 409A, and Participant is deemed at the time of such
termination of employment to be a “specified employee” under Section 409A, then such payment shall not be made or
commence until the earlier of (i) the expiration of the six-month period measured from Participant’s separation from
service from the Company or (ii) the
A-7
date of Participant’s death following such a separation from service; provided, however, that such deferral shall only be
effected to the extent required to avoid adverse tax treatment to Participant including, without limitation, the additional tax
for which Participant would otherwise be liable under Section 409A(a)(1)(B) in the absence of such a deferral. To the
extent any payment under this RSU Agreement may be classified as a “short- term deferral” within the meaning of Section
409A, such payment shall be deemed a short-term deferral, even if it may also qualify for an exemption from Section 409A
under another provision of Section 409A. Payments pursuant to this section are intended to constitute separate payments
for purposes of Section 1.409A-2(b)(2) of the Treasury Regulations.
21.
Award Subject to Company Clawback or Recoupment. The RSUs shall be subject
to clawback or recoupment pursuant to any compensation clawback or recoupment policy adopted by the Board or
required by law during the term of Participant’s employment or other Service that is applicable to executive officers,
Employees, directors or other service providers of the Company, and in addition to any other remedies available under
such policy and applicable law may require the cancellation of Participant’s RSUs (whether vested or unvested) and the
recoupment of any gains realized with respect to Participant’s RSUs.
BY ACCEPTING THIS AWARD OF RSUS, PARTICIPANT AGREES TO ALL OF THE TERMS AND
CONDITIONS DESCRIBED ABOVE AND IN THE PLAN (INCLUDING THE UK SUB- PLAN).
A-8
APPENDIX UK
SUB-PLAN
TO THE KALVISTA PHARMACEUTICALS, INC. 2021
EQUITY INDUCEMENT PLAN
This sub-plan (the “UK Sub-Plan”) to the Kalvista Pharmaceuticals, Inc., 2021 Equity Inducement Plan (the
“Inducement Plan”) governs the grant of Awards to induce the employment of newly hired United Kingdom
Employees, and has been adopted in accordance with Section 4.5of the Inducement Plan. The UK Sub-Plan
incorporates all the provisions of the Plan except as modified in accordance with the provisions of this UK Sub-
Plan.
EMI Options may only be granted for the purpose as set out in paragraph 4 of Schedule 5 (that is, for
commercial reasons in order to recruit or retain Eligible Employees and not as part of a scheme or arrangement
the main purpose, or one of the main purposes of which, is the avoidance of tax).
For the purposes of the UK Sub-Plan, the provisions of the Plan shall operate subject to the following
modifications:
1.
DEFINITIONS IN THE PLAN
Any capitalized terms not already defined in the Plan shall be as defined in the UK Sub-Plan.
For the purposes of the UK Sub-Plan, the following definitions in the Plan shall be replaced as set out below:
“Fair Market Value” means the market value of a Share as defined in paragraph 55 of Schedule 5 and
determined in accordance with paragraph 56 of Schedule 5 and paragraph 5(7) of Schedule 5 (in respect of the
Individual EMI Limit).
“Nonqualified Stock Option” means a right granted or to be granted to an Employee pursuant to the UK
Sub-Plan that does not qualify as an EMI Option satisfying the provisions of Schedule 5.
“Option” means a Nonqualified Stock Option or an EMI Option to purchase shares of Common Stock granted
pursuant to the UK Sub-Plan.
2.
ELIGIBILITY
Only newly hired Employees (including Directors who are also newly hired Employees) may be granted
Awards (other than EMI Options) under the UK Sub-Plan, and only newly hired Eligible Employees may be
granted EMI Options under the UK Sub-Plan and Sections 3 and 5 of the Plan shall be read and construed to
take effect accordingly. Consultants and Non-Employee Directors may not be granted Awards under the UK
Sub-Plan.
30268/00600/FW/12236835.2
3.
EMI OPTION REQUIREMENTS
An Option granted under the UK Sub-Plan shall only be an EMI Option if the Shares which may be acquired
satisfy the conditions specified in paragraph 35 (1) of Schedule 5 (ordinary shares, fully paid up and not
redeemable).
EMI Options may only be granted if at the date of grant of the EMI Option:
(a)
the Company is independent in accordance with paragraph 9 of Schedule 5, that is, it is not:
(i)
(ii)
a 51% Subsidiary of another company; or
under the Control of another company; or another company and any other person Connected
with that company,
and there are no arrangements in existence (except for arrangements with a view to a Qualifying
Exchange of Shares) by virtue of which the Company could become within (i) or (ii) above;
the Company, or the Group as the case may be, meets the trading activities requirements as set out in
paragraphs 13 and 14 and read with paragraphs 15 to 23 of Schedule 5;
the Company’s subsidiaries are Qualifying Subsidiaries and, where appropriate, qualifying property
managing subsidiaries as set out in paragraph 11A of Schedule 5;
the Group meets the requirement as to the number of employees set out in paragraph 12A of Schedule 5
(currently 250 full-time equivalents); and
the Gross Assets Limit is not exceeded (currently £30 million).
COMMITTEE DISCRETION
(b)
(c)
(d)
(e)
4.
The following additional wording shall be included at the end of Section 4.2 of the Plan:
“Where the Committee is aware that the exercise of any of its powers under the Plan would constitute a
Disqualifying Event or would otherwise impact on the tax treatment of an EMI Option or the Shares subject
thereto, the Committee shall notify the Participant as such prior to the exercise of its powers.”
5.
EMI OPTION AWARD AGREEMENT
For the purposes of Section 5 of the Plan, EMI Options granted under the UK Sub-Plan shall be made by EMI
Option Award Agreement being a written agreement between the Participant and the Company in a form
determined by the Committee for the time being, and shall be evidence of the Participant’s agreement to the
terms of this UK Sub-Plan and shall include all details required pursuant to paragraph 37 of Schedule 5,
including:
(a)
the Date of Grant;
2
30268/00600/FW/12236835.2
(b)
(c)
(d)
(e)
(f)
(g)
6.
that the EMI Option is granted under the provisions of Schedule 5;
any conditions that must be met before an EMI Option may be exercised;
the number, or maximum number, of Shares that may be acquired;
the Exercise Price payable or the method by which the Exercise Price is to be determined;
when and how it may be exercised; and
any restrictions that cause the Shares to be Restricted Securities.
EXERCISE PRICE FOR EMI OPTIONS
In relation to EMI Options, Sections 7(a) to (e) of the Plan shall not apply.
7.
HMRC NOTICE OF GRANT
The Company shall give notice to HMRC of the grant of an EMI Option in such form as may be required by
HMRC from time to time within 92 days thereof.
Failure of the Company to give notice to HMRC of the grant in a proper and timely manner for whatever reason
shall result in the Option subsisting as a Nonqualified Stock Option.
The Company does not warrant that any Option qualifies as an EMI Option and the Company does not have any
obligation whatsoever to a Participant in the event that an Option is or becomes a Nonqualified Stock Option
for any reason whatsoever including any deliberate action on the part of the Company.
8.
NONQUALIFIED STOCK OPTIONS
If an Option intended to be an EMI Option does not qualify under Schedule 5, the Option shall subsist as a
Nonqualified Stock Option.
9.
(a)
(b)
LIMITATIONS ON GRANTS OF EMI OPTIONS
Subject to paragraphs (b) and (c) below, the grant of an EMI Option shall be limited and shall take effect
so that the Individual EMI Limit and the Individual Three Year EMI Limit are not exceeded;
Where the Committee grants an option intended to be an EMI Option to an Eligible Employee which
causes the aggregate Fair Market Value of his unexercised EMI Options and CSOP Options granted by
reason of his employment within the Group to exceed the Individual EMI Limit, the Option so far as it
relates to the excess number of Shares that cause the Individual EMI Limit to be exceeded shall continue
to subsist as a Nonqualified Stock Option.
3
30268/00600/FW/12236835.2
(c)
(d)
(e)
(f)
(g)
Where the Committee grants an Option intended to be an EMI Option to an Eligible Employee which by
virtue of the Individual Three Year EMI Limit is a Nonqualified Stock Option, the Option shall continue
to subsist as a Nonqualified Stock Option.
An EMI Option cannot be granted if the Company EMI Limit is already exceeded.
Notwithstanding paragraph (d) above, where the Committee grants one or more options intended to be
EMI Options to one or more Eligible Employees when the Company EMI Limit is already exceeded, the
Options shall subsist as Nonqualified Stock Options.
Where the Committee grants one or more options intended to be EMI Options to one or more Eligible
Employees which either individually or taken together would cause the Company EMI Limit to be
exceeded, each option shall, so far as it relates to the excess number of Shares that cause the Company
EMI Limit to be exceeded as determined in accordance with paragraph 7(5) of Schedule 5, continue to
subsist as a Nonqualified Stock Option.
No option may be exercised as an EMI Option by a person who is excluded from participation in the
Plan by virtue of paragraph 29 of Schedule 5 to the Act (interest in more than 30% of ordinary share
capital of the Company).
10.
RESTRICTIONS ON TRANSFER ABILITY
Notwithstanding Section 9 of the Plan, an Award granted under the UK Sub-Plan shall be personal to the
Participant to whom it is granted and shall not be capable of being transferred, assigned or charged except that a
Participant's Award may be transmitted to the Participant's personal representatives on his death. Participants
may not designate a third party to be a beneficiary of his Award after his death.
11.
NO OBLIGATION TO EMPLOY
The following additional wording shall be included at the end of Section 14 of the Plan:
"A Participant waives all and any rights to compensation or damages under the Plan and the UK Sub-Plan in
consequence of the termination of the Participant’s employment with the Company or an Affiliate for any
reason whatsoever (whether lawful or unlawful and including, without prejudice to the generality of the
foregoing, in circumstances giving rise to a claim for wrongful dismissal)."
12.
WITHHOLDING TAXES
4
30268/00600/FW/12236835.2
The following additional wording shall be included at the end of Section 8 of the Plan:
“13.3 UK Tax Liability A Participant shall, unconditionally and irrevocably agree as a condition of the
vesting or exercise of his Award (as appropriate):
(a)
(b)
(c)
(d)
(e)
to place the Company in funds and indemnify the Company in respect of (i) all liability to UK
income tax which the Company is liable to account for on behalf of the Participant directly to HM
Revenue & Customs; (ii) all liability to national insurance contributions which the Company is
liable to account for on behalf of the Participant to HM Revenue & Customs (including secondary
class 1 (employer's) national insurance contributions for which the Participant is liable); and (iii) to
the extent legally permitted, all liability to national insurance contributions for which the Company
is liable, which in all cases arise as a consequence of or in connection with the vesting or exercise
of the Award, the entering into of any tax election as detailed below or the ownership of Shares by
virtue of such exercise including, without limitation, in respect of any liability arising under or in
connection with Part 7 or Part 7A of the Income Tax (Earnings and Pensions) Act 2003 (”ITEPA”)
(the "UK Tax Liability"); or
to permit the Company to sell at the best price which it can reasonably obtain such number of
Shares allocated or allotted to the Participant following exercise or vesting (as the case may be) of
his Award as will provide the Company with an amount equal to the UK Tax Liability; and to permit
the Company to withhold an amount not exceeding the UK Tax Liability from any payment made
to the Participant (including, but not limited to salary); and
if so required by the Company, and, to the extent permitted by law, to enter into a joint election or
other arrangements under which the liability for all or part of such employer's national insurance
contributions liability is transferred to the Participant; and
if so required by the Company, to enter into a joint election within Section 431 of ITEPA in respect
of computing any tax charge on the acquisition of Restricted Securities; and
to sign, promptly, all documents required by the Company to effect the terms of this Section and
references in this Section to "the Company" shall, if applicable, be construed as also referring to
any Affiliate."
13.
DEFINITIONS IN THE UK SUB-PLAN
“Committed Time” means the time an Eligible Employee is required to spend on the business of the
Company or any Qualifying Subsidiary (including any time which the Employee would have been so required
to spend but for Permitted Absence) as defined in paragraph 26(2) of Schedule 5;
5
30268/00600/FW/12236835.2
“Company EMI Limit” means the total value of Shares in respect of which unexercised EMI Options exist
being not more than £3 million or such other amount as may from time to time be specified in paragraph 7 of
Schedule 5;
“Connected” has the meaning given by Section 718 of ITEPA;
“Control” has the meaning given by Section 719 of ITEPA;
“CSOP Options” means an option granted pursuant to Schedule 4 of ITEPA; “Disqualifying Event”
means an event specified in Sections 534 to 536 inclusive of ITEPA; “Eligible Employee” means an
individual who at the Date of Grant of an EMI Option is:
(i)
a newly hired Employee of the Company or a Qualifying Subsidiary whose
Committed Time is at least 25 hours per week, or, if less, 75% of his “working time” as defined in
paragraph 27 of Schedule 5; and
(ii)
material interest);
not precluded from such participation by paragraph 28 of Schedule 5 (no
“EMI Option” means an option granted under this UK Sub-Plan which is a qualifying option for the
purposes of the EMI Code as defined in section 527(4) of ITEPA;
“EMI Option Award Agreement” means the written agreement evidencing the grant of an EMI Option
containing the terms set out in paragraph 5 of this UK Sub-Plan;
Gross Assets Limit” means £30 million or such other amount as may from time to time be specified in
paragraph 12 of Schedule 5;
“Group” means the Company and its Qualifying Subsidiaries and the phrase “Group Company” shall be
construed accordingly;
“HMRC” means Her Majesty’s Revenue and Customs;
“Individual EMI Limit” means £250,000 less £1 or such other amount as may from time to time be specified
in paragraph 5 of Schedule 5 less £1;
“Individual Three Year EMI Limit” means £250,000 or such other amount as may from time to time be
specified in paragraph 6 of ITEPA;
“ITEPA” means the Income Tax (Earnings & Pensions) Act 2003;
“Permitted Absence” means the time spent as set out in paragraph 26(3) of Schedule 5 (summarised as
absence from work for injury, ill-health or disability, pregnancy, childbirth, maternity or paternity leave or
parental leave, reasonable holiday entitlement or not being required to work during a period of notice of
termination of employment);
6
30268/00600/FW/12236835.2
“Qualifying Exchange of Shares” means arrangements which meet the conditions of paragraph 40 of
Schedule 5;
“Qualifying Subsidiary” has the meaning given in paragraph 11 of Schedule 5; “Restricted
Securities” has the meaning given in section 423 of ITEPA; and “Schedule 5” means
Schedule 5 to ITEPA as amended from time to time.
7
30268/00600/FW/12236835.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Exhibit 23.1
We consent to the incorporation by reference in Registration Statement Nos. 333-215185, 333-217009, 333-228831, and 333-256378 on Form S-3 and Registration
Statement Nos. 333-203721, 333-215184, 333-216032, 333-217008, 333-226442, 333-230279, 333-237059, and 333-254178 on Form S-8 of our report dated July 13, 2021,
relating to the financial statements of KalVista Pharmaceuticals, Inc. appearing in this Annual Report on Form 10-K of KalVista Pharmaceuticals, Inc. for the year ended April
30, 2021.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
July 13, 2021
CERTIFICATION PURSUANT TO
RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 31.1
I, T. Andrew Crockett, certify that:
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of KalVista Pharmaceuticals, 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;
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;
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.
b.
c.
d.
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;
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;
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
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.
b.
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
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: July 13, 2021
By:
/s/ T. Andrew Crockett
T. Andrew Crockett
Chief Executive Officer
(Principal Executive Officer)
RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
CERTIFICATION PURSUANT TO
Exhibit 31.2
1.
2.
3.
4.
I, Benjamin L. Palleiko, certify that:
I have reviewed this Annual Report on Form 10-K of KalVista Pharmaceuticals, 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;
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;
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.
b.
c.
d.
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;
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;
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
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.
b.
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
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: July 13, 2021
By: /s/ Benjamin L. Palleiko
Benjamin L. Palleiko
Chief Business Officer & 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
I, T. Andrew Crockett, Chief Executive Officer of KalVista Pharmaceuticals, Inc. (the “Company”), do hereby certify, 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 my knowledge:
•
•
this Annual Report on Form 10-K of the Company for the year ended April 30, 2021 (the “Report”), as filed with the Securities and
Exchange Commission, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as
amended; and
the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the
Company for the periods presented therein.
Date: July 13, 2021
By: /s/ T. Andrew Crockett
T. Andrew Crockett
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
I, Benjamin L. Palleiko, Chief Financial Officer of KalVista Pharmaceuticals, Inc. (the “Company”), do hereby certify, 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 my knowledge:
•
•
this Annual Report on Form 10-K of the Company for the year ended April 30, 2021 (the “Report”), as filed with the Securities and
Exchange Commission, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as
amended; and
the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the
Company for the periods presented therein.
Date: July 13, 2021
By:
/s/ Benjamin L. Palleiko
Benjamin L. Palleiko
Chief Business Officer & Chief Financial Officer
(Principal Financial Officer)