Management’s Discussion and Analysis
For the Year Ended March 31, 2019
DATE OF REPORT: June 24, 2019
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MANAGEMENT’S DISCUSSION AND ANALYSIS
The following management’s discussion and analysis (“MD&A”) has been prepared as of June 24, 2019 and
should be read in conjunction with the consolidated audited financial statements of Medicenna Therapeutics
Corp. (“Medicenna”, the “Company”, “we”, “our”, “us” and similar expressions). The unaudited condensed
consolidated interim financial statements and related notes of Medicenna, were prepared in accordance with
International Financial Reporting Standards (“IFRS”) and all dollar amounts are expressed in Canadian dollars
unless otherwise noted.
FORWARD-LOOKING STATEMENTS
This MD&A contains forward-looking statements within the meaning of applicable securities laws. These
statements involve known and unknown risks, uncertainties and other factors which may cause the actual results,
performance or achievements of the Company, or industry results, to be materially different from any future
results, performance or achievements expressed or implied by such forward-looking statements. All statements
contained herein that are not clearly historical in nature are forward-looking, and the words such as “plan”,
“expect”, “is expected”, “budget”, “scheduled”, “estimate”, “forecast”, “contemplate”, “intend”, “anticipate”, or
“believe” or variations (including negative variations) of such words and phrases, or statements that certain
actions, events or results “may”, “could”, “would”, “might”, “shall” or “will” be taken, occur or be achieved and
similar expressions are generally intended to identify forward-looking statements. Forward-looking statements
in this MD&A include, but are not limited to, statements with respect to the Company’s:
requirements for, and the ability to obtain, future funding on favorable terms or at all;
•
• business strategy;
• expected future loss and accumulated deficit levels;
• projected financial position and estimated cash burn rate;
• expectations about the timing of achieving milestones and the cost of the Company’s development
programs;
• observations and expectations regarding the effectiveness of MDNA55 and the potential benefits to
patients;
• expectations of securing Breakthrough Therapy Designation, accelerated approval or expedited
approvals in major markets;
regarding the completion of enrolment of the Company’s Phase 2b clinical trial;
•
• expectations about the timing with respect to commencement of additional clinical trials;
• expectations about the Company’s products safety and efficacy;
•
the Company’s ability to maintain compliance with its agreement with the Cancer Prevention Research
Institute of Texas (“CPRIT”) and collect any remaining funding;
• expectations regarding the Company’s ability to arrange for the manufacturing of the Company’s
products and technologies;
• expectations regarding the progress and successful and timely completion of the various stages of the
regulatory approval process;
• ability to secure strategic partnerships with larger pharmaceutical and biotechnology companies;
• strategy to acquire and develop new products and technologies and to enhance the safety and efficacy
of existing products and technologies;
• plans to market, sell and distribute the Company’s products and technologies;
• expectations regarding the acceptance of the Company’s products and technologies by the market;
• ability to retain and access appropriate staff, management, and expert advisers;
• expectations with respect to existing and future corporate alliances and licensing transactions with third
parties, and the receipt and timing of any payments to be made by the Company or to the Company in
respect of such arrangements; and
• strategy and ability with respect to the protection of the Company’s intellectual property.
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all as further and more fully described under the section of this MD&A titled “Risk Factors”. Although the
Company has attempted to identify important factors that could cause actual actions, events or results to differ
materially from those described in forward-looking statements, there may be other factors that cause actions,
events or results to differ from those anticipated, estimated or intended.
Although the forward-looking statements contained in this MD&A are based upon what the Company’s
management believes to be reasonable assumptions, the Company cannot assure readers that actual results
will be consistent with these forward-looking statements.
Any forward-looking statements represent the Company’s estimates only as of the date of this MD&A and should
not be relied upon as representing the Company’s estimates as of any subsequent date. The Company
undertakes no obligation to update any forward-looking statement or statements to reflect events or
circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated
events, except as may be required by securities laws.
All references in this MD&A to “the Company”, “Medicenna”, “we”, “us”, or “our” refer to Medicenna Therapeutics
Corp. and the subsidiaries through which it conducts its business, unless otherwise indicated.
COMPANY OVERVIEW
Medicenna Therapeutics Corp. is the company resulting from a “three-cornered” amalgamation involving A2
Acquisition Corp (“A2”), 1102209 B.C. Ltd., a wholly-owned subsidiary of A2 and Medicenna Therapeutics Inc.
(“MTI”), a privately held clinical stage biotechnology company. A2 was formed by articles of incorporation under
the Business Corporations Act (Alberta) (“ABCA”) on February 2, 2015, and following its initial public offering,
was a “capital pool company” listed on the Toronto Stock Exchange Venture (“TSXV”). As a capital pool
company, A2 had no assets other than cash and did not carry on any operations other than identifying and
evaluating opportunities for the acquisition of an interest in assets or businesses for the completion of a qualifying
transaction.
In February 2015, the Company received notice that it had been awarded a grant by CPRIT whereby the
Company is eligible to receive up to US$14,100,000 on eligible expenditures over a three year period related to
the development of the Company’s phase 2b clinical program for MDNA55.
On March 1, 2017, A2 completed its qualifying transaction in accordance with the policies of the TSXV by way
of a reverse takeover of A2 by the shareholders of MTI (the “Qualifying Transaction”). In connection with the
Qualifying Transaction, A2 changed its name to Medicenna Therapeutics Corp. and completed a consolidation
of its share capital on the basis of one post-consolidation common share for every 14 pre-consolidation common
shares (the “Consolidation”).
On August 2, 2017, Medicenna graduated from the TSXV to the Toronto Stock Exchange (“TSX”). On November
13, 2017, Medicenna continued under the Canada Business Corporations Act.
Medicenna has three wholly owned subsidiaries: MTI, Medicenna Biopharma Inc. (Delaware) and Medicenna
Biopharma Inc. (British Columbia).
Medicenna is a clinical stage immuno-oncology company developing novel, highly selective versions of IL-2, IL-
4 and IL-13 tunable cytokines, called “Superkines”. These Superkines can be developed either on their own as
short or long-acting therapeutics or fused with cell killing proteins in order to generate Empowered Cytokines™
(“ECs”) that precisely deliver potent toxins to the cancer cells without harming healthy cells. Medicenna’s mission
is to become the leader in the development and commercialization of targeted ECs and Superkines for the
treatment of a broad range of cancers. The Company seeks to achieve its goals by drawing on its expertise, and
that of world-class collaborators, in order to develop a unique set of druggable Superkines. Compared to naturally
occurring cytokines - that bind to multiple receptor types on many cell types - Superkines are engineered with
unique specificity toward defined target cell subsets to enable precise activation or inhibition of relevant immune
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cells in order to improve therapeutic efficacy and safety. Superkines can also be fused with other types of proteins
such as antibodies to generate novel “immunocytokines” or combined with other treatment modalities such as
checkpoint inhibitors, CAR-T cells or oncolytic viruses to stimulate tumor-killing immune cells or overcome the
immunosuppressive tumor micro-environment.
MDNA55, Medicenna’s lead EC has recently completed enrollment in a Phase 2b clinical trial for the treatment
of recurrent glioblastoma (“rGBM”), the most common and uniformly fatal form of brain cancer. It is a fusion of a
circularly permuted version of interleukin 4 (“IL-4”), fused to a potent fragment of the bacterial toxin,
Pseudomonas exotoxin and is designed to preferentially target tumor cells that over-express the interleukin-4
receptor (“IL-4R”). MDNA55 has now been studied in 5 clinical trials in 132 patients, including 112 patients with
rGBM, in which it has shown indications of superior efficacy when compared to the current standard of care.
MDNA55 has secured Orphan Drug Status from the United States Food and Drug Administration (“FDA”) and
the European Medicines Agency (“EMA”) as well as Fast Track Designation from the FDA for the treatment of
rGBM and other types of high grade glioma.
Medicenna announced on April 30, 2019 that patient enrollment was complete in the Phase 2b clinical trial of
MDNA55 after treating 46 patients with rGBM. Medicenna announced preliminary top-line data from the study
on June 18, 2019 as described below. The Company plans to have an End of Phase 2 (“EOP2”) meeting with
the FDA in the second half of 2019 and will have 12 month survival data on all patients in the study in early 2020.
In addition, Medicenna plans to initiate a Phase 2 clinical trial with MDNA55 for the treatment of newly diagnosed
GBM in the second half of 2019.
Complementing Medicenna’s lead clinical asset (MDNA55), the Company has built a deep pipeline of promising
pre-clinical candidates. These include a library of Superkines such as IL-2 agonists (“MDNA109”), IL-2
antagonists (“MDNA209”), dual IL-4/IL-13 antagonists (“MDNA413”) and IL-13 Superkine (“MDNA132”) in-
licensed from Leland Stanford Junior University (“Stanford”). The most advanced of these programs is
MDNA109, which is in pre-clinical development and is the only engineered IL-2 Superkine designed to
specifically target CD122 (IL-2Rβ) with high affinity without CD25 dependency. Unlike native IL-2, MDNA109
potently stimulates effector T cells, reverses Natural Killer (NK) cell anergy and acts with exceptional synergy
when combined with checkpoint inhibitors. Data was presented on MDNA109 and the lead candidate selected
in June 2019 as described below.
ACHIEVEMENTS & HIGHLIGHTS
The following are the achievements and highlights for the year ending March 31, 2019 through to the date hereof:
• On June 18, 2019, Dr. Fahar Merchant presented results from the Phase 2b MDNA55 clinical trial which
recently completed enrollment (N=46) at the Inaugural Immuno-Oncology Pharma Congress in Boston, MA.
The presentation highlighted disease control in up to 83% of the patients according to iRANO criteria
(immunotherapy Response Assessment in Neuro-Oncology) which measures tumor response relative to the
largest tumor size post-treatment (nadir). In addition, safety data from the Phase 2b clinical trial show a
similar safety profile to previous MDNA55 trials, with no systemic toxicities, no clinically significant laboratory
abnormalities and no drug-related deaths.
• On June 20, 2019, Medicenna presented a poster entitled “Engineering a long-acting CD122 biased IL-2
superkine displaying potent anti-tumoral responses”. The presentation by Dr. Moutih Rafei, Associate
Professor, Department of Pharmacology and Physiology, Université de Montreal highlighted that
MDNA109-LA when combined with checkpoint inhibitors (a) demonstrated durable tumor control with strong
memory response; (b) blunted Treg activity by abolishing CD25 binding while enhancing activation of naïve
CD8 T cells and NK cells (responsible for attacking tumor cells) and (c) attained long term tumor control with
fewer treatment cycles and a less frequent dosing regimen.
• On June 3, 2019 we announced a poster entitled “MDNA55: A Locally Administered IL4 Guided Toxin as a
Targeted Treatment for Recurrent Glioblastoma” presented at the 55th Annual Meeting of the American
Society of Clinical Oncology (ASCO) being held in Chicago, IL. The presentation by Dr. Dina Randazzo of
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Duke University School of Medicine and a Principal Investigator, focused on the development of a new
biomarker test for the interleukin-4 receptor (IL4R) that may enable better selection and superior treatment
outcomes for patients with rGBM.
• On May 1, 2019, December 5, 2018 and August 10, 2018, Medicenna received amounts of US$757,940,
US$1.2 million and US$1.2 million, respectively, from CPRIT for reimbursement of past expenses.
• On April 30, 2019, we announced completion of enrolment in the MDNA55 Phase 2b clinical study for the
treatment of rGBM.
• On February 7, 2019, Dr. John H. Sampson, MD, PhD, (Robert H. and Gloria Wilkins Distinguished
Professor and Chair of Neurosurgery at Duke University in Durham, NC) presented new clinical study results
on MDNA55. Dr. Sampson outlined that following a single treatment with MDNA55 at the low dose, (a) the
IL4R positive (high) group showed a meaningful increase in median overall survival (“mOS”) of 15.2 months
when compared to 8.5 months in the IL4R negative (low) group, (b) survival rates at 6, 9, and 12 months
were 100%, 67% and 55% in the IL4R positive group versus 73%, 40%, and 30%, in the IL4R negative
group, (c) irrespective of IL4R expression, mOS was 11.8 months in all patients with an overall survival rate
of 89% at 6 months, 59% at 9 months and 46% at 12 months, substantially exceeding landmark mOS and
survival rates reported for approved drugs for rGBM.
• On February 6, 2019, Dr. Moutih Rafei, PhD, (Associate Professor, Department of Pharmacology and
Physiology, Université de Montreal) presented new results on MDNA109 and its long acting variants. The
presentation outlined that MDNA109 (a) is an engineered IL-2 Superkine exhibiting 1000-fold enhanced
affinity toward the CD122 receptor, (b) has best-in-class potency toward cancer killing effector T cells, (c)
was not immunogenic in-vivo and (d) potently synergized with anti-PD-1 or anti-CTLA-4 checkpoint inhibitors
to eliminate tumors in the majority of tumor-bearing mice.
• On December 21, 2018, the Company completed a public offering and issued 4,000,000 units for gross
proceeds of $4,000,000.
• On November 16, 2018, Medicenna presented an update on intratumoral delivery of MDNA55 using MRI-
guided convective delivery at the 23rd Annual Meeting of the Society for Neuro-Oncology.
• On November 9, 2018, Medicenna presented an update on preliminary pre-clinical results on MDNA109 at
the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (“SITC”) held in Washington, DC.
• On October 22, 2018, the Company presented results and participated in a poster discussion session at the
European Society for Medical Oncology (“ESMO”) congress held in Munich. Based on interim data from
patients treated at low doses implemented during the first half of the Phase 2b study of MDNA55, the
presentation highlighted the benefits of using of advanced imaging modalities in order to help tumor response
evaluation and identify pseudo-progression in some patients which ultimately translates into tumor shrinkage,
and potential treatment benefit.
• On August 28, 2018, Medicenna presented preliminary pre-clinical results on MDNA109 at the Sixth Annual
Immuno-Oncology Summit held in Boston, MA. The poster presentation highlighted data comparing efficacy
and pharmacokinetics of MDNA109 and long-acting variants of MDNA109 in mouse models.
FINANCING UPDATE
Year ended March 31, 2019
On December 21, 2018, the Company closed a short-form prospectus offering of 4,000,000 units for gross
proceeds of $4,000,000 (the “Offering”). Each unit consisted of one common share of the Company (each,
a “Common Share”) and one-half common share purchase warrant of the Company (each full common share
purchase warrant, a “Unit Warrant”). Each Unit Warrant entitles the holder to purchase one Common Share, at
an exercise price of $1.20 per Common Share until December 21, 2023. In the context of the Offering, Medicenna
issued 4,000,000 Common Shares, 2,000,000 Unit Warrants and 280,000 broker warrants as partial
consideration for the services provided by the agents in connection with the Offering (the “Broker Warrants”).
The total costs associated with the transaction were $643,686, including an amount of $91,000 which represents
the estimated fair value of the Broker Warrants. Each Broker Warrant is exercisable for one Common Share at
a price of $1.20 per Common Share until December 21, 2020.
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Year ended March 31, 2018
During the year ended March 31, 2018, 164,447 common share purchase warrants and 100,356 options were
exercised for total cash proceeds of $469,393. In addition to the cash proceeds received, the original fair value
related to these common share purchase warrants and options of $369,068 was transferred from contributed
surplus to share capital. This resulted in a total amount of $838,461 credited to share capital.
Escrowed Securities
In connection with the initial public offering of A2 and pursuant to an escrow agreement dated June 8, 2015, an
aggregate of 714,285 Common Shares were placed in escrow.
In connection with the Qualifying Transaction and pursuant to an escrow agreement dated March 1, 2017, an
additional 15,600,000 Common Shares were placed into escrow.
Pursuant to the policies of the TSX, all shares held in escrow were released during the year ended March 31,
2019.
RESEARCH & DEVELOPMENT UPDATE
MDNA55
Excluding the recently completed Phase 2b clinical study, MDNA55 has been studied in previous clinical trials
under two Investigational New Drug Applications (“IND”) for the treatment of rGBM, high grade glioma and non-
CNS solid tumors. In these earlier studies, MDNA55 showed promising clinical results from 72 patients including
66 adult patients with rGBM following a single intra-tumoral infusion. It has secured Orphan Drug Status from
the FDA and the EMA as well as Fast Track Designation from the FDA.
Since the above mentioned clinical trials, there have been many improvements to the convection enhanced
delivery (“CED”) technology, a drug delivery technique for localized administration of MDNA55 into brain tumors.
This includes use of newly developed techniques for high precision placement of catheters into the tumor bed
as well as novel stepped design catheters that prevent backflow and leakage of MDNA55 during treatment.
Furthermore, by co-infusion of a magnetic resonance imaging (“MRI”) contrast agent with MDNA55, drug
distribution can be monitored in real-time in order to achieve maximum coverage of the tumor bed and the tumor
margins. Unlike previous clinical trials, early data from the MDNA55 Phase 2b clinical trial presented in October
and November 2017, show that each of these improvements facilitates more accurate targeting and superior
distribution of MDNA55 to regions of active tumor growth as well as the margins around the tumor. Medicenna
has obtained an exclusive license from the National Institute of Health (“NIH”) to patents covering CED and the
use of a surrogate tracer for real-time monitoring of MDNA55 delivery and distribution.
Phase 2b Study Outline for Glioblastoma at First or Second Recurrence or Progression
The Phase 2b trial with MDNA55 using enhanced CED delivery is a multi-center, open-label, single-arm study
in up to 52 subject and at least 46 intent to treat (ITT) patients, with first or second recurrence or progression of
GBM after surgery or radiotherapy ± adjuvant therapy or other experimental therapies.
The primary endpoint of the study is median Overall Survival (mOS) comparing a null survival rate of 8.0 months
(based on historical control) with an alternative pursue rate of 11.5 months (1-sided alpha = 0.10 and 80% power
for 46 ITT subjects). The secondary endpoint is objective response rate (ORR) assessed by the modified
Response Assessment in Neuro-Oncology (mRANO)-based criteria incorporating advanced imaging modalities
according to a null response rate of 6% with alternative pursue rate of 18% (1-sided alpha = 0.10 and 80% power
for at least 35 subjects evaluable for response). IL4R expression levels in tumor biopsies and their potential
impact on patient outcomes following treatment with MDNA55, were and are being retrospectively evaluated.
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Phase 2b Study Update
In April 2017, we treated the first rGBM patient in the Phase 2b clinical trial of MDNA55 and enrolled patients at
eight clinical sites across the United States with enrolment in the study (46 ITT patients) completed in April 2019.
While the Company previously targeted completion of the Phase 2b by not later than Q4 2018, the protocol
amendments announced in September 2017 and May 2018, and described below, resulted in slower than
anticipated patient recruitment.
On September 28, 2017 we announced that based on encouraging drug distribution and safety data observed
we implemented an amended protocol incorporating enhanced drug delivery procedure which was used for the
treatment of the remaining patients. The amended protocol allowed higher doses and volumes of MDNA55 as
well as an increase in the total expected study size – from 43 patients under the original protocol to up to 52 total
planned patients. This protocol amendment was based on a planned safety analysis following a unanimous
recommendation from MDNA55’s Safety Review Committee. Of the up to 52 patients to be treated in the study
we required at least 46 of those patients to be evaluable for survival and at least 35 subjects evaluable for
response. We met our threshold enrolment requirements in April 2019 with 46 patients treated.
On October 10, 2017, clinical data was presented by Principal investigator John H. Sampson MD, PhD, (Robert
H. and Gloria Wilkins Distinguished Professor and Chair of Neurosurgery at Duke University in Durham, NC) at
the 2017 Congress of Neurological Surgeons (Boston, MA), demonstrating successful delivery in rGBM patients
and a reassuring safety profile for MDNA55. Furthermore, the data showed that a substantially higher proportion
of the target tissue was being covered then in previous similar trials. In some cases, close to 100% of the tumor
and the 1cm margin around it (at risk for tumor spread) had been successfully covered.
Additional clinical data from the Phase 2b rGBM clinical trial of MDNA55 were presented at the 22nd Annual
Meeting of the Society of Neuro-Oncology (“SNO”) held in San Francisco in November 2017. Dr. Krystof
Bankiewicz, MD, PhD, Professor in Residence of Neurological Surgery at the University of California San
Francisco, provided an update on drug distribution and safety data from the first 15 patients treated in the study.
The oral and poster presentations at the SNO conference outlined that through a process of real-time image
guided delivery together with the ability to monitor and adjust infusion parameters, drug delivery was dramatically
improved with significant enhancement in target coverage. A previous CED study in rGBM, without the advances
implemented by Medicenna, [ref: J Neurosurg. 2010 Aug;113(2):301-9], was able to achieve, on average,
coverage of only 20% of the target volume. In contrast, in the current study, a comparable estimate for coverage
of the tumor and a 1cm high-risk margin around it showed approximately 65% coverage with the figure rising to
75% for the tumor area alone, with some patients achieving near 100% coverage of the target volume.
It was reported on May 2, 2018 that half the patients in the study had been recruited and the data to date
demonstrated solid safety results and early signals of efficacy based on the findings of the Safety Review and
Clinical Advisory Committees, comprised of key opinion leaders and study investigators. Following the Safety
Review, Medicenna amended the protocol at the recommendation of clinical advisors to further improve the
chances for demonstrating increased therapeutic benefit for patients. The amendment allowed the
implementation of optimal methodologies including more personalized dosing based on the tumor load,
incorporation of advanced imaging modalities to measure treatment responses more reliably, use of sub-
therapeutics dose of Avastin in patients that could not tolerate steroid use to control edema and inflammation
and allowing investigators to administer a second dose of MDNA55 where appropriate.
Review of some patients who had been withdrawn from the study, believing that their disease had progressed,
found that the apparent increases in tumor volumes, seen on brain scans, were, in fact, due to tissue necrosis,
inflammation and edema. This is a known effect of immunotherapeutic agents such as MDNA55, called pseudo-
progression, which poses a challenge to patient retention, management and data interpretation. When evaluating
images from such patients, using multi-modal imaging, Medicenna found evidence of biological activity of
MDNA55 suggesting that these patients were benefiting from the treatment, and in multiple cases following
withdrawal from the study, surgical resection showed significant tumor necrosis. This amendment allowed a
biopsy and/or advanced multi-modal imaging to more accurately discriminate between necrosis/inflammation
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and true disease progression. It is believed these tools could encourage subjects to remain in the study, where
appropriate, giving time for the pseudo-progression to resolve and increase the likelihood of clinical responses.
Following the amended protocol as announced on May 2, 2018 and after receiving the necessary regulatory and
site approvals patient enrolment was resumed at the established maximum tolerated dose (“MTD”) which was
not to exceed 240µg.
The protocol amendments announced September 28, 2017 and May 2, 2018 resulted in increased timelines for
completion of the MDNA55 Phase 2b clinical trial due to an increase in the original number of patients as well
as delays in patient recruitment while the necessary regulatory reviews and approvals were completed.
On October 22, 2018, the Company presented results and participated in a poster discussion session at the
ESMO Congress held in Munich. Based on interim data from patients treated at low doses implemented during
the first half of the Phase 2b study of MDNA55, the presentation highlighted the benefits of using of advanced
imaging modalities in order to help tumor response evaluation and identify pseudo-progression in some patients
which ultimately translates into tumor shrinkage, and potential treatment benefit.
On October 31, 2018, Medicenna provided an interim update from the ongoing Phase 2b clinical trial of MDNA55
for the treatment of rGBM. These results were superseded by data reported on February 7, 2019 as described
below.
On February 7, 2019 Medicenna presented new clinical study results in a podium presentation entitled, “The IL4
Receptor as a Biomarker and Immunotherapeutic Target for Glioblastoma: Preliminary Evidence with MDNA55,
a Locally Administered IL-4 Guided Toxin” by John H. Sampson, MD, PhD, Robert H. and Gloria Wilkins
Distinguished Professor and Chair of Neurosurgery at Duke University during the 5th Annual Immuno-Oncology
360o Conference held in New York, NY. Following treatment with MDNA55 at the low dose, the IL4R positive
group showed a remarkable increase in mOS of 15.2 months when compared to 8.5 months in the IL4R negative
group. Survival rates at 6, 9, and 12 months were 100%, 67% and 55% versus 73%, 40%, and 30%, in the IL4R
positive and negative groups, respectively. In addition, Dr. Sampson presented that irrespective of IL4R
expression, mOS was 11.8 months in all patients following a single treatment with MDNA55 at the low dose with
an overall survival rate of 89% at 6 months, 59% at 9 months and 46% at 12 months, substantially exceeding
landmark mOS and survival rates reported for approved drugs for rGBM (mOS is 8 months for Avastin and
Lomustine and survival rates at 6, 9 and 12 months are 62%, 38%, 26% and 65%, 43%, 30%, respectively). In
these participants, patients with IL4R positive tumors showed a faster time to relapse (10.3 months) following
initial diagnosis of GBM when compared to patients with low to no expression of IL4R (16.7 months) supporting
published research showing that the Type 2 IL4R is a key biomarker for more aggressive forms of GBM.
On April 30, 2019 we announced that enrolment in the study was complete with 46 evaluable patients.
On June 3, 2019 we announced a poster entitled “MDNA55: A Locally Administered IL4 Guided Toxin as a
Targeted Treatment for Recurrent Glioblastoma” presented at the 55th Annual Meeting of the American Society
of Clinical Oncology (ASCO) being held in Chicago, IL. The presentation by Dr. Dina Randazzo of Duke
University School of Medicine and a Principal Investigator, focused on the development of a new biomarker test
for the interleukin-4 receptor (IL4R) that may enable better selection and superior treatment outcomes for
patients with rGBM. This data was subsequently updated at the World Pharma Conference described below.
On June 18, 2019, Dr. Fahar Merchant presented results from the Phase 2b MDNA55 clinical trial which recently
completed enrollment (N=46) at the Inaugural Immuno-Oncology Pharma Congress in Boston, MA. The
presentation highlighted disease control in up to 83% of the patients according to iRANO criteria (immunotherapy
Response Assessment in Neuro-Oncology) which measures tumor response relative to the largest tumor size
post-treatment (nadir). Use of advanced imaging techniques (such as perfusion and diffusion MRI) was able to
show underlying tissue response amidst inflammation and edema in some subjects. In addition, safety data
from the Phase 2b clinical trial show a similar safety profile to previous MDNA55 trials, with no systemic toxicities,
no clinically significant laboratory abnormalities and no drug-related deaths.
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Medicenna plans to have an End of Phase 2 (“EOP2”) meeting with the FDA in the second half of 2019 to discuss
the results of the MDNA55 Phase 2b clinical study and the development pathway forward, including the possibility
of seeking accelerated approval in patients with IL4R positivity which is considered to display a more aggressive
form of rGBM. Medicenna expects to have twelve month survival data on all patients in the study by Q1 2020.
As at March 31, 2019, direct costs related to the research and development of MDNA55 represented
approximately $3.8 million. The Company expects the completion of clinical development of MDNA55 (Phase 3
clinical trial), if undertaken, to last until at least 2021, with a projected aggregate cost of approximately $75
million, incremental to the current cash on hand. It is anticipated that following the successful completion of the
Phase 2b clinical trial and a successful EOP2 meeting with the FDA the Company will license the program to
one or more partners who would continue the Phase 3 clinical development of MDNA55 as well as prepare the
program for commercialization. Additional time and capital will also be required to obtain pre-market approval for
MDNA55 in the United States and Canada and to complete business development, marketing and other pre-
commercialization activities related to the commercial launch of MDNA55. In addition to development and
regulatory approval of MDNA55, the Company and/or its partner may also have to develop and commercialize
a companion diagnostic to measure IL4R expression prior to treatment with MDNA55. See “Risk Factors” below.
Superkine and Empowered Cytokine Platforms
IL-2 Superkines
IL-2 was one of the first effective immunotherapies developed to treat cancer due to its proficiency at expanding
T cells, the central players in cell-mediated immunity. Originally discovered as a growth factor for T cells, IL-2
can also drive the generation of activated immune cells, immune memory cells, and immune tolerance.
In contrast, IL-2 induced overstimulation of immune cells can lead to an imbalance in the ratio of effector and
regulatory T cells, resulting in autoimmune diseases.
Part of the reason for this is due to the nature of the IL-2 receptor.
The IL-2 receptor is composed of three different subunits, IL-2Rα (also known as CD25), IL-2Rβ (CD122) and
IL-2Rγ (CD132). The arrangement of these different proteins determines the response to IL-2 signaling.
The IL-2β and IL-2γ components together make a receptor capable of binding IL-2, but only moderately so.
When all three components are together, including IL-2Rα, the receptor binds IL-2 with a much higher affinity.
This complete receptor is usually found on regulatory T cells, which dampen an ongoing immune response. The
lower affinity receptor, composed of just the IL-2β and IL-2γ components, is more often found on “naive” immune
cells, which are awaiting instructions before seeking out cancer cells.
Altering IL-2’s propensity for binding these receptors could encourage greater immune cell activation or block
the function of regulatory cells.
Medicenna’s MDNA109 and MDNA209 take advantage of this dynamic by binding to specific receptors and
either activating or blocking them.
MDNA109 is an enhanced version of IL-2 that binds up to 1000 times more effectively to IL-2Rβ, thus greatly
increasing its ability to activate and proliferate the immune cells needed to fight cancer. Because it preferentially
binds IL-2Rβ and not the receptor containing IL-2Rα, MDNA109 drives effector T cell responses over regulatory
T cells. Additionally, MDNA109 reverses Natural Killer (NK) cell anergy and acts with exceptional synergy when
combined with checkpoint inhibitors.
On August 2, 2018, we announced preliminary pre-clinical data on MDNA109, the only IL-2 in development with
high affinity to CD122 to boost cancer fighting T cells, showing that fusions of MDNA109 with inactive protein
scaffolds are long-acting and provide the convenience of easier dosing without sacrificing its safety and efficacy.
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On February 6, 2019 the Company presented new results on MDNA109 and its long acting variants in a podium
presentation entitled, “Putting Pedal to the Metal: Combining IL-2 Superkine (MDNA109) with Checkpoint
Inhibitors” by Moutih Rafei, PhD, Associate Professor, Department of Pharmacology and Physiology,
Université de Montreal at the 5th Annual Immuno-Oncology 360° Meeting in New York, NY.
The results presented demonstrated that MDNA109 exhibited 1000-fold enhanced affinity toward the CD122
receptor and best-in-class potency toward cancer killing effector T cells. When tested in vivo, MDNA109 was not
immunogenic and led to potent delay in the growth of pre-established B16F10 melanoma tumors compared to
IL-2. Likewise, significant delay in the growth of pre-established MC38 and CT-26 colon cancer was observed
in syngeneic mice receiving MDNA109, whereas its co-administration with anti-PD1 checkpoint inhibitor
eliminated tumors in 90% of MC38 tumor-bearing mice. Furthermore, MDNA109 in combination with anti-CTLA-
4 antibody, complete responses were observed in a majority of mice in the CT26 model. When cured animals
were re-challenged on the counter-lateral flank with CT26 tumor cells, tumor growth was blocked at the
secondary site clearly suggesting the generation of potent memory responses. Additional results on long-acting
MDNA109 variants with impaired CD25 binding demonstrated abrogation of regulatory T cell activation at
therapeutic doses in order to mitigate peripheral side effects, which are dependent on CD25 binding.
Medicenna presented a poster entitled “Engineering a long-acting CD122 biased IL-2 superkine displaying potent
anti-tumoral responses” at the Inaugural Immuno-Oncology Pharma Congress, held from June 18-20, 2019
during World Pharma Week in Boston, MA. Highlights from the presentation by Dr. Moutih Rafei included the
following: A) When MDNA109-LA was co-administered with the immune-checkpoint blocker anti-cytotoxic T-
Lymphocyte-Associated Protein (CTLA)4 in a colon cancer mouse model, 67% of animals with pre-established
tumors remained tumor-free for over 100 days. When these animals received a second and third re-challenge of
the tumor without further treatment, 100% and 75% remained tumor free, respectively, demonstrating a strong
memory response. B) A long-acting variant, MDNA109-LA1, engineered to mitigate Treg activation by abolishing
binding to the CD25 had 50-fold decreased Treg activity and 6-fold higher activity towards naïve CD8 T cells for
an overall 300-fold preferential activation of cancer killing T cells than recombinant IL-2. C) In addition, binding
affinity studies using surface plasmon resonance confirmed absence of CD25 binding by MDNA109-LA1. D) To
further validate the potency of MDNA109-LA1 mice with pre-established aggressive B16F10 melanoma tumors
showed potent tumor control with a weekly dosing schedule.
MDNA209 can be used to induce the opposite effect. This Superkine mimics the shape of IL-2 and also binds
500 to 1,000 times effectively to IL-2Rβ. But rather than triggering IL-2 signaling, MDNA209 acts as an
antagonist, blocking the receptor and preventing it from transmitting the signal. This could be used for diseases
such as autoimmune disorders where it is essential to prevent T cells from becoming activated and attacking
healthy tissue. Development timelines for MDNA209 have yet to be established.
As preparing, submitting, and advancing applications for regulatory approval, developing products and
processes and clinical trials are sometimes complex, costly, and time consuming processes, an estimate of the
future costs related to the development of MDNA109 and MDNA209 is not reasonable at this time.
IL-4 and IL-13 Superkines
Medicenna’s IL-4 and IL-13 Superkines are engineered versions of wild type cytokines which possess enhanced
affinity and selectivity for either the Type 1 or Type 2 IL4R. This selectivity is achieved through mutations of the
IL-4 or IL-13 proteins to enhance affinity for binding to specific IL4R subunits. Additional mutations have also
been engineered to modulate their bioactivity, resulting in Superkines with enhanced signaling (super-agonists)
or the ability to block signaling (super-antagonists).
One promising IL-13 Superkine antagonist is MDNA413. Compared to wild type IL-13, MDNA413 has been
engineered to have 2,000-fold higher selectivity for the Type 2 IL4R and which potently blocks IL-4 and IL-13
signaling (Moraga et al, 2015). Blocking of Type 2 IL4R by MDNA413 may be relevant not only for targeting
solid tumors that overexpress this receptor, but also for Th2-mediated diseases such as atopic dermatitis,
asthma and idiopathic pulmonary fibrosis. With commercial validation of the IL-4/IL-13 axis as an effective
10
therapeutic target for atopic dermatitis and asthma, Medicenna believes a topical or aerosol formulation of
MDNA413 may be an important differentiated product compared to a blocking antibody (DupixentÒ: Regeneron
Pharmaceuticals and Sanofi) recently approved by the FDA for the treatment of moderate to severe atopic
dermatitis. DupixentÒ is administered by subcutaneous injection every other week. Development timelines for
MDNA413 have yet to be established.
Another promising IL-13 Superkine is MDNA132. Unlike MDNA413, MDNA132 is an IL-13 ligand that has been
engineered to increase affinity for IL13R alpha2 overexpressed on certain solid tumors while exhibiting sharply
decreased affinity for IL13R alpha1. Medicenna believes MDNA132 has superior targeting compared to other
IL-13 variants in development, and is an attractively differentiated targeting domain for inclusion in new and
exciting field of immuno-oncology based on the CAR-T platform. Development timelines for MDNA132 have yet
to be established.
As preparing, submitting, and advancing applications for regulatory approval, developing products and
processes and clinical trials are sometimes complex, costly, and time consuming processes, an estimate of
the future costs related to the development of MDNA413 and MDNA132 is not reasonable at this time.
IL-4 and IL-13 Empowered Cytokines
As part of the CPRIT funded project, Medicenna had initially been pursuing development of MDNA57 (a fully
human version of MDNA55) designed to specifically target solid tumors that express the Type 2 IL4R. Being fully
human, we expect MDNA57 to be less or non-immunogenic allowing multi-cycle systemic administration. Use of
IL-4 or IL-13 Superkines, licensed from Stanford, as targeting domains may provide a higher degree of selectivity
and therefore much better safety and efficacy profile. Development timelines for MDNA57 have yet to be
established with priority allocated to MDNA55 and MDNA109. After review of the competitive activity within our
industry, it became apparent that we should focus our non-CPRIT funds for our early stage assets to the
development of MDNA109 rather than MDNA57 (as originally intended). As such, limited work has been done
on MDNA57 to date.
As preparing, submitting, and advancing applications for regulatory approval, developing products and
processes and clinical trials are sometimes complex, costly, and time consuming processes, an estimate of the
future costs related to the development of MDNA57 is not reasonable at this time.
SELECTED FINANCIAL INFORMATION
General and Administration
Research and Development
Net Loss
Basic and Diluted Loss per Share
Total Assets
Non-current Financial Liabilities
Total Liabilities
2019
$
1,709,286
3,017,997
(4,708,031)
(0.18)
5,187,428
174,432
2,570,871
2018
$
2,334,684
5,090,146
(7,465,452)
(0.31)
4,374,582
336,971
2,212,757
2017
$
1,684,671
4,229,110
(7,631,265)
(0.45)
14,483,227
477,000
7,826,486
We have not earned revenue in any of the previous fiscal years, other than income from interest earned on our cash
balances.
For the year ended March 31, 2019, we reported a net loss of $4,727,283 or $0.18 per share compared to a loss of
$7,465,452 or $0.30 per share for the year ended March 31, 2018. The decrease in net loss in the year ended
March 31, 2019 compared with the year ended March 31, 2018 was primarily a result of lower general and
administrative expenses due to reduced stock based compensation expenses, lower professional fees and listing
11
costs associated with the TSX graduation and OTC listing in the prior year as well as lower travel, and salary costs
resulting from overall cost containment. In addition, research and development expenses were reduced in the
current year due to lower consulting and CRO costs related to the ongoing MDNA55 clinical trial for which
recruitment completed shortly after year end as well as lower discovery costs associated with work completed in the
prior year and reduced salary and travel costs resulting from cost containment measures.
RESULTS OF OPERATIONS FOR THE YEAR ENDING MARCH 31, 2019
Research and Development Expenses
Chemistry, manufacturing and controls
Regulatory
Discovery and pre-clinical
Research & Development Warrant
Clinical
Salaries and benefits
Licensing, patent legal fees and royalties
Stock based compensation
CPRIT grant claimed on eligible expenses
Other research and development expenses
Year ended March 31,
2019
$
399,994
48,105
805,477
710,574
3,710,789
1,190,142
783,458
435,439
(5,140,039)
74,058
3,017,997
2018
$
197,646
192,448
1,136,582
947,432
4,787,093
1,353,527
437,642
658,655
(5,016,479)
395,600
5,090,146
Research and development (“R&D”) expenses of $3,017,997 were incurred during the year ended March 31, 2019,
compared with $5,090,146 incurred in the year ended March 31, 2018. The decrease in the expenses in the year
ended March 31, 2019 can be primarily attributed to:
• Deceased regulatory costs due to the timing of expenditures and the protocol amendments incurred in
the prior year.
• Reduced discovery and pre-clinical expenses due to work ongoing and completed in the prior year related
to the development of MDNA57.
• Lower clinical trial costs due to reduced consulting costs, clinical supplies and CRO fees due to nearing
the end of the clinical study and general cost containment.
• Reduced salaries and benefits due to lower headcount and overall cost containment measures.
• Lower stock based compensation expense due to the timing of option grants in the current year.
• A reduction in other R&D expenses due to reduced travel and employee recruitment expenses.
The above reductions were offset by the following increases:
• Chemistry, manufacturing and controls costs related to MDNA109 program development.
• Higher licensing fees, patent costs, royalties and consulting expenses associated with pipeline review
and program prioritization.
Expenses incurred that were eligible for reimbursement from the CPRIT grant totaled $5,140,039 in the year
ended March 31, 2019 compared with $5,016,479 in the year ended March 31, 2018.
12
General and Administrative Expenses
Depreciation expense
Stock based compensation
Facilities and operations
Legal, professional and finance
Salaries and benefits
Other expenses
CPRIT grant claimed on eligible expenses
Year ended March 31,
2019
$
6,818
563,180
162,995
166,277
676,952
639,252
(506,188)
1,709,286
2018
$
9,704
958,377
225,840
332,706
761,995
717,702
(671,640)
2,334,684
General and administrative (“G&A”) expenses of $1,709,286 were incurred during the year ended March 31, 2019,
compared with $2,334,684 during the year ended March 31, 2018. The decrease in G&A expenses year over year
is attributed primarily to the following factors:
• Lower stock based compensation costs due to timing of grants as well as a lower value of option grants
in the current year.
• Reduced legal, professional and finance expenses in the current year periods due to expenses related
to the graduation from the TSXV to TSX as well as the OTC listing incurred in the prior year periods.
• Lower salary and benefit costs due to headcount reductions.
• Lower ‘other’ expenses due to reduced travel costs, and listing fees incurred on the TSX graduation in
the prior year.
Expenses incurred that were eligible for reimbursement from the CPRIT grant totaled $506,188 in the year ended
March 31, 2019 compared with $671,640 in the year ended March 31, 2018.
SUMMARY OF QUARTERLY FINANCIAL RESULTS
Mar. 31
2019
$
Dec. 31
2018
$
Sept. 30
2018
$
June 30
2018
$
March 31
2018
$
Dec. 31
2017
$
Sept. 30
2017
$
June 30
2017
$
Revenue
-
-
-
-
-
-
-
-
General and administration
414,154
437,218
443,363
414,551
440,454
824,007
632,132
438,091
Research and development
661,314
1,275,896
445,814
634,973
864,005
1,351,703
1,069,648
1,804,790
Net loss
(1,049,074)
(1,723,081)
(897,659)
(1,038,217)
(1,310,506)
(2,181,022)
(1,718,252)
(2,255,672)
Basic and diluted loss per
share
Total assets
Total liabilities
(0.04)
(0.07)
(0.04)
(0.04)
(0.05)
(0.09)
(0.07)
(0.09)
5,187,428
6,017,780
3,408,806
3.644,480
4,374,582
6,838,585
9,904,455
12,465,849
2,570,871
2,512,414
2,173,528
2,000,746
2,212,757
4,534,080
6,323,242
7,593,559
R&D expenses fluctuate quarter over quarter based on the amount of expenditures eligible for CPRIT
reimbursement in the period as well as the pace of the clinical trial enrollment during the period. Research and
development costs in the quarter ended December 31, 2018 were higher than prior periods due to patient
treatment costs and a lower CPRIT reimbursement in the quarter. During the three months ended June 30, 2017
and December 31, 2017 the CPRIT expenses eligible for offset were smaller than comparable quarter and
therefore expenses were higher than comparable periods.
13
G&A expenses are lower in the current four quarters compared with the prior year quarters due to a reduction in
salaries and legal fees as well as lower stock based compensation costs. The increase in the quarter ended
December 31, 2017 related to costs associated with stock option grants issued to general and administrative
employees and directors during that quarter.
Results for the Three Months ended March 31, 2019
Research and Development Expenses
Chemistry, manufacturing and controls
Regulatory
Discovery and pre-clinical
Research & Development Warrant
Clinical
Salaries and benefits
Licensing, patent legal fees and royalties
Stock based compensation
CPRIT grant claimed on eligible expenses
Other research and development expenses
Three months ended
March 31
2019
$
97,866
21,968
170,452
-
1,029,379
268,932
213,381
139,503
(1,315,746)
35,579
661,314
2018
$
-
68,903
303,774
236,858
1,229,054
201,660
190,325
215,785
(1,682,055)
99,701
864,005
R&D expenses of $661,314 were incurred during the three months ended March 31, 2019, compared with $864,005
incurred in the three months ended March 31, 2018. The decrease in expenses in the three months ended March
31, 2019 can be attributed to:
• Reduced discovery and pre-clinical expenses due to work completed in the prior year, relating to the
development of MDNA57.
• Lower clinical trial costs due to reduced consulting costs, clinical supplies and CRO fees due to nearing
the end of the clinical study and general cost containment.
• Lower stock based compensation expense due to reduced option grants in the current year.
• Fully expensed research and development warrant, resulting in no related cost in the current period.
These reductions were offset by a lower reimbursement of expenses from CPRIT of $1,315,746 in the current
year period compared with $1,682,055 in the same period in the prior year due to overall spending reductions
as well as the timing of claims. Salaries and benefits were higher in the current year period resulting from a
bonus accrual reversed in the prior period and increased chemistry, manufacturing and controls costs are
associated with the MDNA109 program development.
14
General and Administrative Expenses
Depreciation expense
Stock based compensation
Facilities and operations
Legal, professional and finance
Salaries and benefits
Other expenses
CPRIT grant claimed on eligible expenses
Three months ended
March 31
2019
$
1,704
96,966
49,161
30,455
168,204
184,581
(116,917)
414,154
2018
$
1,705
258,589
60,697
49,025
87,244
129,746
(146,552)
440,454
In the three months ended March 31, 2019, G&A expenses of $414,154 were incurred compared with $440,454
during the three months ended March 31, 2018. The decrease in G&A expenses period over period is attributed
primarily due to lower stock based compensation costs due to timing of grants as well as a lower value of option
grants in the current year periods. This reduction was offset by higher salaries and benefits resulting from a
bonus accrual reversed in the prior period and increased other expenses pertaining to investor relations
expenses in the current year period. In addition, reimbursement of expenses from CPRIT were lower in the
current year period compared with the same period in the prior year.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, the Company has devoted its resources to funding R&D programs, including securing
intellectual property rights and licenses, conducting discovery research, manufacturing drug supplies, initiating
preclinical and clinical studies, submitting regulatory dossiers and providing administrative support to R&D
activities, which has resulted in an accumulated deficit of $22,789,651 as of March 31, 2019. With current
revenues only consisting of interest earned on excess cash, losses are expected to continue while the
Company’s R&D programs are advanced.
We currently do not earn any revenues from our drug candidates and are therefore considered to be in the
development stage. As required, the Company will continue to finance its operations through the sale of equity
or pursue non-dilutive funding sources available to the Company in the future. The continuation of our research
and development activities and the commercialization of MDNA55 is dependent upon our ability to successfully
finance and complete our research and development programs through a combination of equity financing and
revenues from strategic partners. We have no current sources of revenues from strategic partners.
Management has forecasted that the Company’s current level of cash will not be sufficient to execute its current
planned expenditures for the next 12 months without further financing being obtained. Management believes
that it will complete one or more of these arrangements in sufficient time to continue to execute its planned
expenditures. However, there can be no assurance that the capital will be available as necessary to meet these
continuing expenditures, or if the capital is available, that it will be on terms acceptable to the Company. The
issuance of Common Shares by the Company could result in significant dilution in the equity interest of existing
shareholders. There can be no assurance that the Company will be able to obtain sufficient financing to meet
future operational needs which may result in the delay, reduction or discontinuation of ongoing development
programs. As a result, there is a substantial doubt as to whether the Company will be able to continue as a going
concern and realize its assets and pay its liabilities as they fall due.
15
CASH POSITION
At March 31, 2019, we had a cash balance of $2,370,976 compared to $3,938,734 at March 31, 2018. We invest
cash in excess of current operational requirements in highly rated and liquid instruments. Working capital at
March 31, 2019 was $2,709,784 (March 31, 2018: $2,410,772). In addition, we have US$2.3 million remaining
available under the CPRIT grant to be used towards the development of MDNA55.
We do not expect to generate positive cash flow from operations for the foreseeable future due to additional R&D
expenses, including expenses related to drug discovery, preclinical testing, clinical trials, chemistry,
manufacturing and controls (“CMC”) and operating expenses associated with supporting these activities. It is
expected that negative cash flow from operations will continue until such time, if ever, that we receive regulatory
approval to commercialize any of our products under development and/or royalty or milestone revenue from any
such products should they exceed our expenses.
CONTRACTUAL OBLIGATIONS
As of March 31, 2019, we have the following obligations to make future payments, representing contracts and
other commitments that are known and committed:
Contractual obligations
Payments Due by Period
Less than
1 year
1-3 years
3-5 years
Total
Patent licensing costs, minimum annual royalties per
license agreements
$ 66,500 $ 172,900 $ 532,000 $ 771,400
Liquidity event payment
$ 174,432 $ 174,432
$ 0 $ 348,864
The Company utilizes temporary office space with terms of less than one year.
The Company cannot reasonably estimate future royalties which may be due upon the regulatory approval of
MDNA55.
CPRIT assistance
In February 2015, the Company received notice that it had been awarded a grant by CPRIT whereby the
Company is eligible to receive up to US$14,100,000 on eligible expenditures over a three year period related to
the development of the Company’s phase 2b clinical program for MDNA55. On an ongoing basis, we must
demonstrate that the expenditures are eligible using CPRIT’s criteria, show proof that we have 50% matching
funds available, that development milestones have been achieved and that best efforts have been made to
establish substantial project related expenses within the state of Texas. In October 2017 the Company was
granted a one-year extension to the grant allowing expenses to be claimed over a four year period ending
February 28, 2019 and on February 4, 2019 the Company was granted an additional six month extension
allowing expense to be claimed until August 31, 2019.
Of the US$14.1 million grant approved by CPRIT, Medicenna has received US$10.8 million from CPRIT as of
June 24, 2019. The Company is eligible to receive the remaining US$3.3 million upon the achievement of certain
criteria as determined by CPRIT, from time to time. There can be no assurances that the balance of such grants
will be received from CPRIT.
The amount receivable at March 31, 2019 represents funds spent on grant expenditures, but not yet reimbursed,
of this amount US$757,940 was received subsequent to the year end.
16
Ongoing program funding from CPRIT is subject to a number of conditions including the satisfactory achievement
of milestones that must be met to release additional CPRIT funding, proof the Company has raised 50% matching
funds and that best efforts have been made to establish substantial project related expenses within the state of
Texas. If the Company is found to have used any grant proceeds for purposes other than intended, is in violation
of the terms of the grant, or relocates the majority of its project related operations outside of the state of Texas,
then the Company may be required to repay any grant proceeds received. There can be no assurances that the
Company will continue to meet the necessary CPRIT criteria or that CPRIT will continue to advance additional
funds to the Company.
Intellectual Property
The Company has entered into various license agreements with respect to accessing intellectual property in the
form of filed and issued patents. In order to maintain these agreements, the Company is obligated to pay certain
costs based on timing or certain milestones within the agreements, the timing of which is uncertain. These costs
include ongoing license fees, patent prosecution and maintenance costs, royalty and other milestone payments.
As at March 31, 2019, the Company is obligated to pay the following:
• Patent licensing costs due within 12 months totaling $66,500.
• Patent licensing costs, including the above, due within the next five years totaling $705,000.
• Project milestone payments, assuming continued success in the development programs, of uncertain
timing totaling US$2,800,000 and an additional US$2,000,000 in sales milestones.
• A liquidity payment of $174,432 due in 2019 and $174,432 due in 2020 to the NIH which represents the
remaining payments resulting from the Company’s liquidity event in March 2017.
As part of these license agreements, the Company has committed to make certain royalty payments based on
net sales to the NIH and Stanford.
OFF-BALANCE SHEET ARRANGEMENTS
The Company has no material undisclosed off-balance sheet arrangements that have, or are reasonably likely
to have, a current or future effect on our results of operations, financial condition, revenues or expenses, liquidity,
capital expenditures or capital resources that is material to investors.
TRANSACTIONS WITH RELATED PARTIES
Key management personnel, which consists of the Company’s officers (Dr. Fahar Merchant, President and Chief
Executive Officer, Ms. Elizabeth Williams, Chief Financial Officer, and Ms. Rosemina Merchant, Chief
Development Officer) and directors, received the following compensation for the following periods:
Salaries and Wages
Board Fees
Stock Option Expense
Related Party Rent
Three months ended
March 31
Year ended
March 31
2019
$
222,937
35,278
180,247
2,093
440,555
2018
$
249,607
35,780
355,830
6,134
647,351
2019
$
891,748
141,466
786,121
21,515
1,840,850
2018
$
1,101,891
121,472
1,282,374
21,332
2,527,069
17
As at March 31, 2019, the Company had trade and other payables in the normal course of business, owing to
directors and officers of $380,328 (2018: $222,228) related to deferred salaries, board fees and accrued vacation
($107,249 in deferred salaries, included in amounts earned).
The Company paid $21,515 (2018: $21,332) in office rent to Aries Biologics Corp, a company controlled by the
Chief Executive Officer (Dr. Fahar Merchant) and Chief Development Officer (Ms. Rosemina Merchant) of the
Company. This transaction was in the normal course of business and has been measured at the exchange
amount, which is the amount of consideration established and agreed to by the related parties.
NEW STANDARDS, AMENDMENTS AND INTERPRETATIONS ADOPTED DURING FISCAL 2019
The following IFRS pronouncement has been adopted during 2019:
The Company has adopted new accounting standard IFRS 9 - Financial Instruments, effective for the
Company’s annual period beginning April 1, 2018. The adoption of IFRS 9 did not result in any changes to the
classification, measurement or carrying amounts of the Company’s existing financial instruments on transition
date.
The new standard brings together the classification and measurement, impairment and hedge accounting
phases of the IASB’s project to replace IAS 39 - Financial instruments: recognition and measurement. The
standard retains but simplifies the mixed measurement model and establishes two primary measurement
categories for financial assets: amortized cost and fair value.
The Company continues to classify and measure its cash at fair value through profit or loss with changes in fair
value recognized in profit or loss as they arise (“FVTPL”). Other receivables and government grant receivables
are classified initially at FVTPL, and subsequently at amortized cost using the effective interest rate method.
Accounts payable and accrued liabilities and license fee payable are classified and measured as financial
liabilities, initially at FVTPL, and subsequently at amortized cost using the effective interest rate method.
ACCOUNTING PRONOUNCEMENTS FOR FUTURE ADOPTION
IFRS 16, Leases IFRS 16 is a new standard that sets out the principles for recognition, measurement,
presentation, and disclosure of leases including guidance for both parties to a contract, the lessee and the lessor.
The new standard eliminates the classification of leases as either operating or finance leases as is required by
IAS 17 and instead introduces a single lessee accounting model. IFRS 16 is effective for annual periods
beginning on or after January 1, 2019. The Company does not have any leases and has therefore determined
that this standard will not have an impact on its unaudited interim condensed consolidated financial statements.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Accounting policies are described in note 2 of the audited consolidated financial statements.
The Company makes estimates and assumptions about the future that affect the reported amounts of assets
and liabilities. Estimates and judgments are continually evaluated based on historical experience and other
factors, including expectations of future events that are believed to be reasonable under the circumstances. In
the future, actual experience may differ from these estimates and assumptions. The effect of a change in an
accounting estimate is recognized prospectively by including it in comprehensive income in the period of the
change, if the change affects that period only, or in the period of the change and future periods, if the change
affects both. Significant assumptions about the future and other sources of estimation uncertainty that
management has made at the statement of financial position date, that could result in a material adjustment to
the carrying amounts of assets and liabilities include:
18
Fair value of financial instruments
Where the fair value of financial assets and financial liabilities recorded in the consolidated statements of financial
position cannot be derived from active markets, they are determined using valuation techniques including
discounted cash flow models. The inputs to these models are taken from observable markets where possible,
but where this is not feasible, a degree of judgment is required in establishing fair values.
The judgments include considerations of inputs such as liquidity risk, credit risk and volatility. Significant
management judgment is necessary. Changes in assumptions about these factors could affect the reported fair
value of financial instruments
Deferred taxes
The determination of deferred income tax assets or liabilities requires subjective assumptions regarding future
income tax rates and the likelihood of utilizing tax carry-forwards. Changes in these assumptions could materially
affect the recorded amounts, and therefore do not necessarily provide certainty as to their recorded values.
Share-based payments and compensation
The Company applies estimates with respect to the valuation of shares issued for non-cash consideration.
Common Shares are valued at the fair value of the equity instruments granted at the date the Company receives
the goods or services.
The Company measures the cost of equity-settled transactions with employees by reference to the fair value of
the equity instruments at the date at which they are granted. Estimating fair value for share-based payment
transactions requires determining the most appropriate valuation model, which is dependent on the terms and
conditions of the grant. This estimate also requires determining the most appropriate inputs to the valuation
model including the fair value of the underlying Common Shares, the expected life of the share option, volatility
and dividend yield and making assumptions about them. The fair value of the underlying Common Shares are
assessed as the most recent issuance price per Common Share for cash proceeds.
USE OF PROCEEDS
The following table provides an update on the anticipated use of proceeds raised in the December 2018 equity
offering along with amounts actually expended. As of March 31, 2019, the following expenditures have been
incurred:
Item
Amount to
Spend
Spent to Date
Adjustments
Remaining to Spend
Patient treatment costs
$ 1,500,000
$ 656,966
(900,000)1
Clinical trial overhead costs
750,000
372,424
-
500,000
377,381
450,000
-
377,576
572,619
Salaries and intellectual
property costs
General corporate and
working capital purposes
950,000
315,484
450,000
1,084,516
Total
$ 3,700,000
$ 1,722,255
$ -
$2,034,711
1. Original use of proceeds assumed treatment of 52 patients in the study to reach an evaluable patient population of 46 patients.
Only 46 patients were required to be treated in order to achieve 46 evaluable patients and as such a portion of the costs have
been relocated to ‘salaries and intellectual property costs’ and ‘general corporate and working capital’
19
FINANCIAL INSTRUMENTS
(a) Fair value
The Company’s financial instruments recognized on the consolidated statements of financial position consist of
cash, other receivables, accounts payable and accrued liabilities, deferred government grants and license fee
payable. The fair value of these instruments, approximate their carry values due to their short-term maturity.
Classification of financial instruments
Financial instruments measured at fair value on the statement of financial position are summarized into the
following fair value hierarchy levels:
Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2: inputs other than quoted prices included within Level 1 that are observable for the asset or
liability
Level 3: inputs for the asset or liability that are not based on observable market data (unobservable
inputs).
The Company classifies its financial assets and liabilities depending on the purpose for which the financial
instruments were acquired, their characteristics, and management intent as outlined below:
Cash is measured using Level 1 inputs and changes in fair value are recognized through profit or loss, with
changes in fair value being recorded in net earnings at each period end.
Government grant receivables and other receivables have been classified as loans and receivables and are
measured at amortized cost less impairments.
Accounts payable and accrued liabilities have been classified as financial liabilities.
The Company has exposure to the following risks from its use of financial instruments: credit, interest rate,
currency and liquidity risk. The Company reviews its risk management framework on a quarterly basis and makes
adjustments as necessary.
(b) Financial risk management
We have exposure to credit risk, liquidity risk and market risk. Our Board of Directors has the overall responsibility
for the oversight of these risks and reviews our policies on an ongoing basis to ensure that these risks are
appropriately managed.
i.
Credit risk
Credit risk arises from the potential that a counterparty will fail to perform its obligations. The financial
instruments that are exposed to concentrations of credit risk consist of cash and cash equivalents.
The Company attempts to mitigate the risk associated with cash and cash equivalents by dealing only
with major Canadian financial institutions with good credit ratings.
ii.
Interest rate risk
Interest rate risk is the risk that the fair values and future cash flows of the Company will fluctuate because
of changes in market interest rates. The Company believes that its exposure to interest rate risk is not
significant.
iii.
Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due.
The Company currently settles all of its financial obligations out of cash. The ability to do so relies on the
Company maintaining sufficient cash in excess of anticipated needs. As at March 31, 2019, the
Company’s liabilities consist of trade and other payables that have contracted maturities of less than one
year.
20
iv.
Currency risk
Currency risk is the risk that future cash flows of a financial instrument will fluctuate because of changes
in foreign exchange rates. The Company is exposed to currency risk from employee costs as well as the
purchase of goods and services primarily in the United States and the cash balances held in foreign
currencies. Fluctuations in the US dollar exchange rate could have a significant impact on the Company’s
results. Assuming all other variables remain constant, a 10% depreciation or appreciation of the Canadian
dollar against the US dollar would result in an increase or decrease in loss and comprehensive loss for
the year ended March 31, 2019 of $69,000 (March 31, 2018 - $88,000).
Balances in foreign currencies are as follows:
Cash
Accounts payable and accrued liabilities
Deferred government grant receivable
March 31, 2019
$
118,440
(1,430,518)
1,831,337
March 31, 2018
$
2,115,262
(1,429,909)
-
519,259
685,353
(c) Managing Capital
The Company’s objectives, when managing capital, are to safeguard cash as well as maintain financial liquidity
and flexibility in order to preserve its ability to meet financial obligations and deploy capital to grow its businesses.
The Company’s financial strategy is designed to maintain a flexible capital structure consistent with the objectives
stated above and to respond to business growth opportunities and changes in economic conditions. In order to
maintain or adjust its capital structure, the Company may issue shares or issue debt (secured, unsecured,
convertible and/or other types of available debt instruments).
There were no changes to the Company’s capital management policy during the year. The Company is not
subject to any externally imposed capital requirements.
RISKS AND UNCERTAINTIES
An investment in the Common Shares involves a high degree of risk and should be considered speculative. An
investment in the Common Shares should only be undertaken by those persons who can afford the total loss of
their investment. Investors should carefully consider the risks and uncertainties set forth below, as well as other
information described elsewhere in this MD&A. The risks and uncertainties below are not the only ones the
Company faces. Additional risks and uncertainties not presently known to Medicenna or that Medicenna believes
to be immaterial may also adversely affect Medicenna’s business. If any of the following risks occur, Medicenna’s
business, financial condition and results of operations could be seriously harmed and you could lose all or part
of your investment. Further, if Medicenna fails to meet the expectations of the public market in any given period,
the market price of the Common Shares could decline. Medicenna operates in a highly competitive environment
that involves significant risks and uncertainties, some of which are outside of Medicenna’s control.
Risks Related to the Company’s Business and the Company’s Industry
The Company has no sources of product revenue and will not be able to maintain operations and research and
development without sufficient funding.
The Company has no sources of product revenue and cannot predict when or if it will generate product revenue.
The Company’s ability to generate product revenue and ultimately become profitable depends upon its ability,
alone or with partners, to successfully develop the product candidates, obtain regulatory approval, and
commercialize products, including any of the current product candidates, or other product candidates that may
be developed, in-licensed or acquired in the future. The Company does not anticipate generating revenue from
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the sale of products for the foreseeable future. The Company expects research and development expenses to
increase in connection with ongoing activities, particularly as MDNA55 is advanced through clinical trials and
MDNA109 is advanced towards the clinic.
The Company will require significant additional capital resources to expand its business, in particular the further
development of its proposed products. Advancing its product candidates or acquisition and development of any
new products or product candidates will require considerable resources and additional access to capital markets.
In addition, the Company’s future cash requirements may vary materially from those now expected.
The Company can potentially seek additional funding through corporate collaborations and licensing
arrangements, through public or private equity or debt financing, or through other transactions. However, if
clinical trial results are neutral or unfavourable, or if capital market conditions in general, or with respect to life
sciences companies such as Medicenna, are unfavourable, the Company’s ability to obtain significant additional
funding on acceptable terms, if at all, will be negatively affected. Additional financing that it may pursue may
involve the sale of the Common Shares or financial instruments that are exchangeable for, or convertible into,
the Common Shares, which could result in significant dilution to its shareholders. If sufficient capital is not
available, the Company may be required to delay the implementation of its business strategy, which could have
a material adverse effect on its business, financial condition, prospects or results of operations.
The Company is highly dependent upon certain key personnel and their loss could adversely affect the its ability
to achieve its business objective.
The loss of Dr. Fahar Merchant, the President and Chief Executive Officer, Rosemina Merchant, the Chief
Development Officer or other key members of the scientific and operating staff could harm the Company.
Employment agreements exist with Dr. Merchant and Ms. Merchant, although such employment agreements do
not guarantee their retention. The Company also depends on scientific and clinical collaborators and advisors,
all of whom have outside commitments that may limit their availability. In addition, the Company believes that
future success will depend in large part upon its ability to attract and retain highly skilled scientific, managerial,
medical, clinical and regulatory personnel. Agreements have been entered into with scientific and clinical
collaborators and advisors, key opinion leaders and academic partners in the ordinary course of business as
well as with physicians and institutions who will recruit patients into the MDNA55 clinical trial. Notwithstanding
these arrangements, there is significant competition for these types of personnel from other companies, research
and academic institutions, government entities and other organizations. The loss of the services of any of the
executive officers or other key personnel could potentially harm the Company’s business, operating results or
financial condition.
If the Company breaches any of the agreements under which it licenses rights to product candidates or
technology from third parties, it can lose license rights that are important to its business. The Company’s current
license agreements may not provide an adequate remedy for breach by the licensor.
The Company is developing MDNA55, MDNA109 and other earlier stage pre-clinical and discovery drug
candidates pursuant to license agreements with NIH and Stanford (collectively, the “Licensors”). The Company
is subject to a number of risks associated with its collaboration with the Licensors, including the risk that the
Licensors may terminate the license agreement upon the occurrence of certain specified events. The license
agreement requires, among other things, that the Company makes certain payments and use reasonable
commercial efforts to meet certain clinical and regulatory milestones. If the Company fails to comply with any of
these obligations or otherwise breach this or similar agreements, the Licensors or any future licensors may have
the right to terminate the license in whole. The Company can also suffer the consequences of non-compliance
or breaches by Licensors in connection with the license agreements. Such non-compliance or breaches by such
third parties can in turn result in breaches or defaults under the Company’s agreements with other collaboration
partners, and the Company can be found liable for damages or lose certain rights, including rights to develop
and/or commercialize a product or product candidate. Loss of the Company’s rights to the licensed intellectual
property or any similar license granted to it in the future, or the exclusivity rights provided therein, can harm the
Company’s financial condition and operating results.
22
Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of
earlier studies and trials may not be predictive of future trial results and the Company’s product candidates may
not have favourable results in later trials or in the commercial setting.
Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain.
Failure can occur at any time during the clinical trial process. The results of pre-clinical studies and early clinical
trials may not be predictive of the results of later-stage clinical trials. Success in pre-clinical or animal studies
and early clinical trials does not ensure that later large-scale efficacy trials will be successful nor does it predict
final results. Favourable results in early trials may not be repeated in later trials. There is no assurance the FDA,
EMA or other similar government bodies will view the results as the Company does or that any future trials of its
proposed products for other indications will achieve positive results. Product candidates in later stages of clinical
trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical studies
and initial clinical trials.
The Company will be required to demonstrate through larger-scale clinical trials that any potential future product
is safe and effective for use in a diverse population before it can seek regulatory approvals for commercial sale
of its product. There is typically an extremely high rate of attrition from the failure of product candidates
proceeding through clinical and post-approval trials. If MDNA55 fails to demonstrate sufficient safety and efficacy
in the recently completed or future clinical trials, the Company’s operations and financial condition will be
adversely impacted.
The Company is subject to the restrictions and conditions of the CPRIT agreement. Failure to comply with the
CPRIT agreement may adversely affect the Company’s financial condition and results of operations.
The Company has obtained a grant from CPRIT to fund a portion of its operations to date. The CPRIT grant is
subject to the Company’s compliance with the scope of work outlined in the CPRIT agreement and demonstration
of its progress towards achievement of the milestones set forth in the CPRIT agreement. If the Company fails to
comply with the terms of the CPRIT agreement, it may not receive the remaining tranches of the CPRIT grant or
it may be required to reimburse some or the entire CPRIT grant. Further, the CPRIT grant may only be applied
to a limited number of allowable expenses. Failure to obtain the remaining tranches of the CPRIT grant or being
required to reimburse all or a portion of the CPRIT grant may cause a halt or delay in ongoing operations, which
may adversely affect the Company’s financial condition and operating results.
If the Company’s competitors develop and market products that are more effective than its existing product
candidates or any products that it may develop, or obtain marketing approval before the it does, its products may
be rendered obsolete or uncompetitive.
Technological competition from pharmaceutical companies, biotechnology companies and universities is intense
and is expected to increase. Many of the Company’s competitors and potential competitors have substantially
greater product development capabilities and financial, scientific, marketing and human resources than the
Company does. Our future success depends in part on our ability to maintain a competitive position, including
our ability to further progress MDNA55 and MDNA109 through the necessary pre-clinical and clinical trials
towards regulatory approval for sale and commercialization. Other companies may succeed in commercializing
products earlier than we are able to commercialize our products or they may succeed in developing products
that are more effective than our products. While the Company will seek to expand its technological capabilities
in order to remain competitive, there can be no assurance that developments by others will not render its products
non-competitive or that the Company or its licensors will be able to keep pace with technological developments.
Competitors have developed technologies that could be the basis for competitive products. Some of those
products may have an entirely different approach or means of accomplishing the desired therapeutic effect than
the Company’s products and may be more effective or less costly than its products. In addition, other forms of
medical treatment may offer competition to the products. The success of the Company’s competitors and their
products and technologies relative to its technological capabilities and competitiveness could have a material
adverse effect on the future pre-clinical and clinical trials of its products, including its ability to obtain the
necessary regulatory approvals for the conduct of such trials.
23
The Company relies and will continue to rely on third parties to plan, conduct and monitor preclinical studies and
clinical trials, and their failure to perform as required could cause substantial harm to the Company’s business.
The Company relies and will continue to rely on third parties to conduct a significant portion of clinical
development and planned preclinical activities. Preclinical activities include in vivo studies providing access to
specific disease models, pharmacology and toxicology studies, and assay development. Clinical development
activities include trial design, regulatory submissions, clinical patient recruitment, clinical trial monitoring, clinical
data management and analysis, safety monitoring and project management. If there is any dispute or disruption
in the Company’s relationship with third parties, or if the Company is unable to provide quality services in a timely
manner and at a feasible cost, any active development programs could face delays. Further, if any of these third
parties fails to perform as expected or if their work fails to meet regulatory requirements, testing could be delayed,
cancelled or rendered ineffective.
The Company relies on contract manufacturers over whom the Company has limited control. If the Company is
subject to quality, cost or delivery issues with the preclinical and clinical grade materials supplied by contract
manufacturers, business operations could suffer significant harm.
The Company has limited manufacturing experience and relies on contract development and manufacturing
organizations (“CDMOs”), to manufacture MDNA55 for clinical trials and MDNA109 for pre-clinical development.
The Company relies on CDMOs for manufacturing, filling, packaging, storing and shipping of drug product in
compliance with current good manufacturing practices (“cGMP”), regulations applicable to its products. The FDA
ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with cGMP
regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities and
controls used in manufacturing, processing and packing of a drug product. The Company currently has sufficient
quantity of MDNA55 to complete the planned clinical studies. The Company plans to utilize CDMO’s which are
licensed by both the FDA and EMA.
There can be no assurances that the CDMOs selected will be able to meet future timetables and requirements.
If the Company is unable to arrange for alternative third-party manufacturing sources on commercially
reasonable terms or in a timely manner, it may delay the development of the product candidates. Further,
contract manufacturers must operate in compliance with cGMP and failure to do so could result in, among other
things, the disruption of product supplies. The Company’s dependence upon third parties for the manufacture of
its products may adversely affect profit margins and ability to develop and deliver products on a timely and
competitive basis.
The Company’s future success is dependent primarily on the regulatory approval of a single product.
The Company does not have any products that have gained regulatory approval. Currently, its only clinical
product candidate is MDNA55. As a result, the Company’s near-term prospects, including its ability to finance
its operations and generate revenue, are substantially dependent on its ability to obtain regulatory approval
for, and, if approved, to successfully commercialize MDNA55 in a timely manner. The Company cannot
commercialize MDNA55 or other future product candidates in the United States without first obtaining regulatory
approval for the product from the FDA; similarly, it cannot commercialize MDNA55 or other future product
candidates outside of the United States without obtaining regulatory approval from comparable foreign
regulatory authorities. Although MDNA55 has received Orphan Drug (FDA, EMA) and Fast Track (FDA)
designations, there can be no assurance regulatory approval will be granted. Before obtaining regulatory
approvals for the commercial sale of MDNA55 or other future product candidates for a target indication, the
Company must demonstrate with substantial evidence gathered in pre-clinical and clinical studies to the
satisfaction of the relevant regulatory authorities, that the product candidate is safe and effective for use
for that target indication and that the manufacturing facilities, processes and controls are adequate. Many of
these factors are beyond the Company’s control. If the Company, or its potential commercialization
collaborators, are unable to successfully commercialize MDNA55, the Company may not be able to earn
sufficient revenues to continue its business.
24
MDNA55 is in the mid stages of clinical development and MDNA109 in pre-clinical development and, as a result,
the Company will be unable to predict whether it will be able to profitably commercialize its product.
The Company has not received regulatory approval for the sale of MDNA55 in any market. Accordingly, the
Company has not generated any revenues from product sales. A substantial commitment of resources to conduct
clinical trials and for additional product development will be required to commercialize all of our product
candidates. There can be no assurance that MDNA55, MDNA109 or any of our other product candidates will
meet applicable regulatory standards, be capable of being produced in commercial quantities at reasonable cost
or be successfully marketed, or that the investment made by the Company in the commercialization of the
products will be recovered through sales, license fees or related royalties.
The Company will be subject to extensive government regulation that will increase the cost and uncertainty
associated with gaining final regulatory approval of its product candidates.
Securing final regulatory approval for the manufacture and sale of human therapeutic products in the United
States, Canada and other markets is a long and costly process that is controlled by that particular country’s
national regulatory agency. Approval in the United States, Canada, or Europe does not assure approval by other
national regulatory agencies, although often test results from one country may be used in applications for
regulatory approval in another country. Other national regulatory agencies have similar regulatory approval
processes, but each is different.
Prior to obtaining final regulatory approval to market a drug product, every national regulatory agency has a
variety of statutes and regulations which govern the principal development activities. These laws require
controlled research and testing of products, government review and approval of a submission containing pre-
clinical and clinical data establishing the safety and efficacy of the product for each use sought, approval of
manufacturing facilities including adherence to cGMP during production and storage and control of marketing
activities, including advertising and labelling. There can be no assurance that MDNA55 or MDNA109 will be
successfully commercialized in any given country. There can be no assurance that the Company’s licensed
products will prove to be safe and effective in clinical trials under the standards of the regulations in the various
jurisdictions or receive applicable regulatory approvals from applicable regulatory bodies.
Negative results from clinical trials or studies of third parties and adverse safety events involving the targets of
the Company’s products may have an adverse impact on future commercialization efforts.
From time to time, studies or clinical trials on various aspects of biopharmaceutical products are conducted by
academic researchers, competitors or others. The results of these studies or trials, when published, may have a
significant effect on the market for the biopharmaceutical product that is the subject of the study. The publication
of negative results of studies or clinical trials or adverse safety events related to the Company’s product
candidates, or the therapeutic areas in which the Company’s product candidates compete, could adversely affect
the share price and ability to finance future development of the Company’s product candidates, and the business
and financial results could be materially and adversely affected.
If the Company is unable to enroll subjects in clinical trials, it will be unable to complete these trials on a timely
basis.
Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size
and nature of the patient population, the proximity of subjects to clinical sites, the eligibility criteria for the
trial, the design of the clinical trial, ability to obtain and maintain patient consents, risk that enrolled subjects
will drop out before completion, competing clinical trials and clinicians’ and patients’ perceptions as to the
potential advantages of the drug being studied in relation to other available therapies, including any new drugs
that may be approved for the indications the Company is investigating. Furthermore, the Company relies on
Contract Research Organizations (“CROs”) and clinical trial sites to ensure the proper and timely conduct of
its clinical trials, and while it has agreements governing their committed activities, the Company has limited
influence over their actual performance.
25
If the Company experiences delays in the completion or termination of any clinical trial of its proposed products
or any future product candidates, the commercial prospects of its product candidates will be harmed and its
ability to generate product revenues from any of these product candidates will be delayed. In addition, any
delays in completing clinical trials will increase costs, slow down product candidate development and
approval process and can shorten any periods during which the Company may have the exclusive right to
commercialize its product candidates or allow its competitors to bring products to market before it does.
Delays can further jeopardize the Company’s ability to commence product sales, which will impair its ability
to generate revenues and may harm the business, results of operations, financial condition and cash flows
and future prospects. In addition, many of the factors that can cause a delay in the commencement or
completion of clinical trials may also ultimately lead to the denial of regulatory approval of its proposed
products or its future product candidates.
The Company faces the risk of product liability claims, which could exceed its insurance coverage and produce
recalls, each of which could deplete cash resources.
The Company is exposed to the risk of product liability claims alleging that use of its product candidate MDNA55
caused an injury or harm. These claims can arise at any point in the development, testing, manufacture,
marketing or sale of product candidates and may be made directly by patients involved in clinical trials of product
candidates, by consumers or healthcare providers or by individuals, organizations or companies selling the
products. Product liability claims can be expensive to defend, even if the product or product candidate did not
actually cause the alleged injury or harm.
Insurance covering product liability claims becomes increasingly expensive as a product candidate moves
through the development pipeline to commercialization. Currently the Company maintains clinical trial liability
insurance coverage of $5 million. However, there can be no assurance that such insurance coverage is or will
continue to be adequate or available at a cost acceptable to the Company or at all. The Company may choose
or find it necessary under its collaborative agreements to increase the insurance coverage in the future but may
not be able to secure greater or broader product liability insurance coverage on acceptable terms or at
reasonable costs when needed. Any liability for damages resulting from a product liability claim could exceed
the amount of the coverage, require payment of a substantial monetary award from the Company’s cash
resources and have a material adverse effect on the business, financial condition and results of operations.
Moreover, a product recall, if required, could generate substantial negative publicity about the products and
business, inhibit or prevent commercialization of other products and product candidates or negatively impact
existing or future collaborations.
The Company may not achieve its publicly announced milestones according to schedule, or at all.
From time to time, the Company may announce the timing of certain events expected to occur, such as the
anticipated timing of results from clinical trials. These statements are forward-looking and are based on the best
estimates of management at the time relating to the occurrence of such events. However, the actual timing of
such events may differ from what has been publicly disclosed. The timing of events such as initiation or
completion of a clinical trial, filing of an application to obtain regulatory approval, or announcement of additional
clinical trials for a product candidate may ultimately vary from what is publicly disclosed. These variations in
timing may occur as a result of different events, including the ability to recruit patients in a clinical trial in a timely
manner, the nature of results obtained during a clinical trial or during a research phase, problems with a CDMO
or a CRO, or any other event having the effect of delaying the publicly announced timeline. The Company
undertakes no obligation to update or revise any forward-looking information, whether as a result of new
information, future events or otherwise, except as otherwise required by law. Any variation in the timing of
previously announced milestones could have a material adverse effect on the business plan, financial condition
or operating results and the trading price of the Common Shares.
26
Changes in government regulations, although beyond the Company’s control, could have an adverse effect on
the Company’s business.
The Company depends upon the validity of its licenses and access to the data for the timely completion of clinical
research. Any changes in the drug development regulatory environment or shifts in political attitudes of a
government are beyond the Company’s control and may adversely affect its business. The Company’s business
may also be affected in varying degrees by such factors as government regulations with respect to intellectual
property, regulation or export controls. Such changes remain beyond the Company’s control and the effect of
any such changes cannot be predicted. These factors could have a material adverse effect on the Company’s
ability to further develop its licensed products.
The Company’s significant shareholders may have material influence over its governance and operations.
Dr. Fahar Merchant and Ms. Rosemina Merchant (collectively, the “Merchants”), hold a controlling interest in the
Company’s outstanding Common Shares on a fully diluted basis. For as long as the Merchants maintain a
significant interest in the Company, they may be in a position to affect the Company’s governance and
operations. In addition, the Merchants may have significant influence over the passage of any resolution of the
Company’s shareholders (such as those that would be required to amend the constating documents or take
certain other corporate actions) and may, for all practical purposes, be able to ensure the passage of any such
resolution by voting for it or prevent the passage of any such resolution by voting against it. The effect of this
influence may be to limit the price that investors are willing to pay for the Common Shares. In addition, the
potential that The Merchants may sell their Common Shares in the public market (commonly referred to as
“market overhang”), as well as any actual sales of such Common Shares in the public market, could adversely
affect the market price of the Common Shares.
The Company’s discovery and development processes involve use of hazardous and radioactive materials which
may result in potential environmental exposure.
The Company’s discovery and development processes involve the controlled use of hazardous and radioactive
materials. The Company is subject to federal, provincial, state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of such materials and certain waste products. Although the
Company believes that the current safety procedures for handling and disposing of such materials comply with
the standards prescribed by such laws and regulations, the risk of accidental contamination or injury from these
materials cannot be completely eliminated. In the event of such an accident, the Company could be held liable
for any damages that result and any such liability could exceed the Company’s resources. The Company is not
specifically insured with respect to this liability. Although the Company believes that the Company is in
compliance in all material respects with applicable environmental laws and regulations and currently does not
expect to make material capital expenditures for environmental control facilities in the near-term, there can be
no assurance that the Company will not be required to incur significant costs to comply with environmental laws
and regulations in the future, or that the operations, business or assets will not be materially adversely affected
by current or future environmental laws or regulations.
If the Company is unable to successfully develop companion diagnostics for its therapeutic product candidates,
or experience significant delays in doing so, the Company may not achieve marketing approval or realize the full
commercial potential of its therapeutic product candidates.
The Company plans to develop companion diagnostics for its therapeutic product candidates. It is expected that,
at least in some cases, regulatory authorities may require the development and regulatory approval of a
companion diagnostic as a condition to approving a therapeutic product candidate. The Company has limited
experience and capabilities in developing or commercializing diagnostics and plans to rely in large part on third
parties to perform these functions. The Company does not currently have any agreement in place with any third
party to develop or commercialize companion diagnostics for any of its therapeutic product candidates.
27
Companion diagnostics are subject to regulation by the FDA, Health Canada and comparable foreign regulatory
authorities as medical devices and may require separate regulatory approval or clearance prior to
commercialization. If the Company, or any third parties that the Company engages to assist, are unable to
successfully develop companion diagnostics for the Company’s therapeutic product candidates, or experience
delays in doing so, the Company’s business may be substantially harmed.
Significant disruption in availability of key components for ongoing clinical studies could considerably delay
completion of potential clinical trials, product testing and regulatory approval of potential product candidates.
The Company relies on third parties to supply ingredients and excipients for the manufacture and formulation of
its drugs, catheters required to deliver the drug to the brain as well as imaging software to accurately place
catheters in the tumour (each, a “Component” and collectively the “Components”). Each of the suppliers of these
Components in turn need to comply with regulatory requirements. Any significant disruption in supplier
relationships could harm the Company’s business. Any significant delay in the supply of a Component, for a
potential ongoing clinical study could considerably delay completion of potential clinical trials, product testing
and regulatory approval of potential product candidates. If the Company or its suppliers are unable to purchase
these Components after regulatory approval has been obtained for the product candidates, or the suppliers
decide not to manufacture these Components or provide support for any of the Components, clinical trials or the
commercial launch of that product candidate would be delayed or there would be a shortage in supply, which
would impair the ability to generate revenues from the sale of the product candidates. It may take several years
to establish an alternative source of supply for such Components and to have any such new source approved
by the FDA and other regulatory agencies.
Risks Related To Intellectual Property And Litigation
The Company’s success depends upon its ability to protect its intellectual property and its proprietary technology.
The Company’s success depends, in part, on its ability and its licensors’ ability to obtain patents, maintain trade
secrets protection and operate without infringing on the proprietary rights of third parties or having third parties
circumvent its rights. Certain licensors and the institutions that they represent, and in certain cases, have filed
and are actively pursuing certain applications for Canadian and foreign patents. The patent position of
pharmaceutical and biotechnology firms is uncertain and involves complex legal and financial questions for
which, in some cases, certain important legal principles remain unresolved. There can be no assurance that the
patent applications made in respect of the owned or licensed products will result in the issuance of patents, that
the term of a patent will be extendable after it expires in due course, that the licensors or the institutions that they
represent will develop additional proprietary products that are patentable, that any patent issued to the licensors
or the Company will provide it with any competitive advantages, that the patents of others will not impede its
ability to do business or that third parties will not be able to circumvent or successfully challenge the patents
obtained in respect of the licensed products. The cost of obtaining and maintaining patents is high. Furthermore,
there can be no assurance that others will not independently develop similar products which duplicate any of the
licensed products or, if patents are issued, design around the patent for the product. There can be no assurance
that the Company’s processes or products or those of its licensors do not or will not infringe upon the patents of
third parties or that the scope of its patents or those of its licensors will successfully prevent third parties from
developing similar and competitive products.
Much of the Company’s know-how and technology may not be patentable, though it may constitute trade secrets.
There can be no assurance, however, that the Company will be able to meaningfully protect its trade secrets. To
help protect its intellectual property rights and proprietary technology, the Company requires employees,
consultants, advisors and collaborators to enter into confidentiality agreements. There can be no assurance that
these agreements will provide meaningful protection for its intellectual property rights or other proprietary
information in the event of any unauthorized use or disclosure.
The Company’s potential involvement in intellectual property litigation could negatively affect its business.
28
Its future success and competitive position depends in part upon its ability to maintain the its intellectual property
portfolio. There can be no assurance that any patents will be issued on any existing or future patent applications.
Even if such patents are issued, there can be no assurance that any patents issued or licensed to the Company
will not be challenged. The Company’s ability to establish and maintain a competitive position may be achieved
in part by prosecuting claims against others who it believes are infringing its rights and by defending claims
brought by others who believe that the Company is infringing their rights. In addition, enforcement of its patents
in foreign jurisdictions will depend on the legal procedures in those jurisdictions. Even if such claims are found
to be invalid, the Company’s involvement in intellectual property litigation could have a material adverse effect
on its ability to out-license any products that are the subject of such litigation. In addition, its involvement in
intellectual property litigation could result in significant expense, which could materially adversely affect the use
or licensing of related intellectual property and divert the efforts of its valuable technical and management
personnel from their principal responsibilities, whether or not such litigation is resolved in its favour.
The Company’s reliance on third parties requires it to share its trade secrets, which increases the possibility
that a competitor will discover them.
Because the Company relies on third parties to develop its products, it must share trade secrets with them. The
Company seeks to protect its proprietary technology in part by entering into confidentiality agreements and, if
applicable, material transfer agreements, collaborative research agreements, consulting agreements or other
similar agreements with its collaborators, advisors, employees and consultants prior to beginning research or
disclosing proprietary information. These agreements typically restrict the ability of the Company’s collaborators,
advisors, employees and consultants to publish data potentially relating to the Company’s trade secrets. The
Company’s academic collaborators typically have rights to publish data, provided that the Company is notified
in advance and may delay publication for a specified time in order to secure its intellectual property rights arising
from the collaboration. In other cases, publication rights are controlled exclusively by the Company, although in
some cases it may share these rights with other parties. The Company also conducts joint research and
development programs which may require it to share trade secrets under the terms of research and development
collaboration or similar agreements. Despite the Company’s efforts to protect its trade secrets, its competitors
may discover its trade secrets, either through breach of these agreements, independent development or
publication of information including its trade secrets in cases where the Company does not have proprietary or
otherwise protected rights at the time of publication. A competitor’s discovery of the Company’s trade secrets
may impair its competitive position and could have a material adverse effect on its business and financial
condition.
Product liability claims are an inherent risk of the Company’s business, and if the Company’s clinical trial and
product liability insurance prove inadequate, product liability claims may harm its business.
Human therapeutic products involve an inherent risk of product liability claims and associated adverse publicity.
There can be no assurance that the Company will be able to obtain or maintain product liability insurance on
acceptable terms or with adequate coverage against potential liabilities. Such insurance is expensive, difficult to
obtain and may not be available in the future on acceptable terms, or at all. An inability to obtain sufficient
insurance coverage on reasonable terms or to otherwise protect against potential product liability claims could
have a material adverse effect on the Company’s business by preventing or inhibiting the commercialization of
its products, licensed and owned, if a product is withdrawn or a product liability claim is brought against the
Company.
Other Risks
Our common share price has been volatile in recent years, and may continue to be volatile.
The market prices for securities of biotechnology companies, including ours, have historically been volatile. In
the year ended March 31, 2019, our common shares traded on the TSX at a high of $2.30 and a low of $0.68
per share. A number of factors could influence the volatility in the trading price of our Common Shares, including
changes in the economy or in the financial markets, industry related developments, the results of product
development and commercialization, changes in government regulations, and developments concerning
29
proprietary rights, litigation and cash flow. Our quarterly losses may vary because of the timing of costs for clinical
trials, manufacturing and preclinical studies. Also, the reporting of clinical data or the lack thereof, adverse safety
events involving our products and public rumors about such events could cause our share price to decline or
experience periods of volatility. Each of these factors could lead to increased volatility in the market price of our
Common Shares. In addition, changes in the market prices of the securities of our competitors may also lead to
fluctuations in the trading price of our Common Shares.
Future sales or issuances of equity securities or the conversion of securities into Common Shares could
decrease the value of the Common Shares, dilute investors’ voting power, and reduce earnings per share.
The Company may sell additional equity securities in future offerings, including through the sale of securities
convertible into equity securities, to finance operations, acquisitions or projects, and issue additional Common
Shares if outstanding securities are converted into Common Shares, which may result in dilution.
The Company’s board of directors will have the authority to authorize certain offers and sales of additional
securities without the vote of, or prior notice to, shareholders. Based on the need for additional capital to fund
expected expenditures and growth, it is likely that the Company will issue additional securities to provide such
capital.
Sales of substantial amounts of securities, or the availability of such securities for sale, as well as the issuance
of substantial amounts of Common Shares upon conversion or exchange of outstanding convertible or
exchangeable securities, could adversely affect the prevailing market prices for securities and dilute investors’
earnings per share. A decline in the future market prices of the Company’s securities could impair its ability to
raise additional capital through the sale of securities should it desire to do so.
In the past, following periods of volatility in the market price of a company’s securities, shareholders have
instituted class action securities litigation against those companies. Such litigation, if instituted, could result in
substantial costs and diversion of management attention and resources, which could significantly harm the
Company’s profitability and reputation.
The market price for the Common Shares may also be affected by the Company’s ability to meet or exceed
expectations of analysts or investors. Any failure to meet these expectations, even if minor, may have a material
adverse effect on the market price of the Common Shares.
The Company is subject to foreign exchange risk relating to the relative value of the United States dollar.
A material portion of the Company’s expenses are denominated in United States dollars. As a result, the
Company is subject to foreign exchange risks relating to the relative value of the Canadian dollar as compared
to the United States dollar. A decline in the Canadian dollar would result in an increase in the actual amount of
its expenses and adversely impact financial performance.
Any failure to maintain an effective system of internal controls may result in material misstatements of the
Company’s consolidated financial statements or cause the Company to fail to meet the reporting obligations or
fail to prevent fraud; and in that case, shareholders could lose confidence in the Company’s financial reporting,
which would harm the business and could negatively impact the price of the Common Shares.
Effective internal controls are necessary to provide reliable financial reports and prevent fraud. If there is a failure
to maintain an effective system of internal controls, the Company might not be able to report financial results
accurately or prevent fraud; and in that case, shareholders could lose confidence in the Company’s financial
reporting, which would harm the business and could negatively impact the price of the common shares. While
the Company believes that it will have sufficient personnel and review procedures to maintain an effective system
of internal controls, no assurance can be provided that potential material weaknesses in internal control could
arise. Even if it is concluded that the internal control over financial reporting provides reasonable assurance
regarding the reliability of financial reporting and the preparation of consolidated financial statements for external
purposes in accordance with IFRS, as issued by the International Accounting Standards Board (“IASB”), because
30
of its inherent limitations, internal control over financial reporting may not prevent or detect fraud or
misstatements. Failure to implement required new or improved controls, or difficulties encountered in their
implementation, could harm results of operations or cause a failure to meet future reporting obligations.
Any future profits will likely be used for the continued growth of the business and products and will not be used
to pay dividends on the issued and outstanding shares.
The Company will not pay dividends on the issued and outstanding Common Shares in the foreseeable future.
If the Company generates any future earnings, such cash resources will be retained to finance further growth
and current operations. The board of directors will determine if and when dividends should be declared and paid
in the future based on the Company’s financial position and other factors relevant at the particular time. Until the
Company pays dividends, which it may never do, a shareholder will not be able to receive a return on his or her
investment in the Common Shares unless such Common Shares are sold. In such event, a shareholder may
only be able to sell his, her or its Common Shares at a price less than the price such shareholder originally paid
for them, which could result in a significant loss of such shareholder’s investment.
The Company may pursue other business opportunities in order to develop its business and/or products.
From time to time, the Company may pursue opportunities for further research and development of other
products. The Company’s success in these activities will depend on its ability to identify suitable technical
experts, market needs, and effectively execute any such research and development opportunities. Any research
and development would be accompanied by risks as a result of the use of business efforts and funds. In the
event that the Company chooses to raise debt capital to finance any such research or development opportunities,
its leverage will be increased. There can be no assurance that the Company would be successful in overcoming
these risks or any other problems encountered in connection with any research or development opportunities.
Generally, a litigation risk exists for any company that may compromise its ability to conduct the Company’s
business.
All industries are subject to legal claims, with and without merit. Defense and settlement costs can be substantial,
even with respect to claims that have no merit. Due to the inherent uncertainty of the litigation process, the
resolution of any particular legal proceeding could have a material adverse effect on the Company’s business,
prospects, financial condition and results of operations.
The Company’s success depends on its ability to effectively manage its growth.
The Company may be subject to growth-related risks including pressure on its internal systems and controls.
The Company’s ability to manage its growth effectively will require the Company to continue to implement and
improve its operational and financial systems and to expand, train and manage its employee base. Inability to
deal with this growth could have a material adverse impact on its business, operations and prospects. The
Company may experience growth in the number of its employees and the scope of its operating and financial
systems, resulting in increased responsibilities for its personnel, the hiring of additional personnel and, in general,
higher levels of operating expenses. In order to manage its current operations and any future growth effectively,
the Company will also need to continue to implement and improve its operational, financial and management
information systems and to hire, train, motivate, manage and retain its employees. There can be no assurance
that the Company will be able to manage such growth effectively, that its management, personnel or systems
will be adequate to support its operations or that the Company will be able to achieve the increased levels of
revenue commensurate with the increased levels of operating expenses associated with this growth.
The Company is likely a “passive foreign investment company,” which may have adverse United States federal
income tax consequences for United States shareholders.
United States investors should be aware that the Company believes it was classified as a passive foreign
investment company (“PFIC”), during the tax years ended March 31, 2019 and 2018, and based on current
business plans and financial expectations, the Company expects that it will be a PFIC for the current tax year
and may be a PFIC in future tax years. If the Company is a PFIC for any year during a United States shareholder’s
31
holding period of the Common Shares, then such United States shareholder generally will be required to treat
any gain realized upon a disposition of the Common Shares, or any so-called “excess distribution” received on
the Common Shares, as ordinary income, and to pay an interest charge on a portion of such gain or distributions,
unless the shareholder makes a timely and effective “qualified electing fund” election (“QEF Election”), or a
“mark-to-market” election with respect to the Common Shares. A United States shareholder who makes a QEF
Election generally must report on a current basis its share of the Company’s net capital gain and ordinary
earnings for any year in which the Company is a PFIC, whether or not the Company distribute any amounts to
its shareholders. A United States shareholder who makes the mark-to-market election generally must include as
ordinary income each year the excess of the fair market value of the Common Shares over the shareholder’s
adjusted tax basis therein. Each United States shareholder should consult its own tax advisors regarding the
PFIC rules and the United States federal income tax consequences of the acquisition, ownership and disposition
of the Common Shares.
It may be difficult for non-Canadian investors to obtain and enforce judgments against the Company because
of the Company’s Canadian incorporation and presence.
The Company is a corporation existing under the laws of Canada. Several of the Company’s directors and
officers, and several of the experts are residents of Canada, and all or a substantial portion of their assets, and
a substantial portion of the Company’s assets, are located outside the United States. Consequently, although
the Company has appointed an agent for service of process in the United States, it may be difficult for holders
of the Company’s securities who reside in the United States to effect service within the United States upon those
directors and officers, and the experts who are not residents of the United States. It may also be difficult for
holders of the Company’s securities who reside in the United States to realize in the United States upon
judgments of courts of the United States predicated upon the Company’s civil liability and the civil liability of the
Company’s directors, officers and experts under the United States federal securities laws. Investors should not
assume that Canadian courts (i) would enforce judgments of United States courts obtained in actions against
the Company or such directors, officers or experts predicated upon the civil liability provisions of the United
States federal securities laws or the securities or “blue sky” laws of any state or jurisdiction of the United States
or (ii) would enforce, in original actions, liabilities against the Company or such directors, officers or experts
predicated upon the United States federal securities laws or any securities or “blue sky” laws of any state or
jurisdiction of the United States. In addition, the protections afforded by Canadian securities laws may not be
available to investors in the United States.
DISCLOSURE CONTROLS AND INTERNAL CONTROL OVER FINANCIAL REPORTING
The Company has implemented a system of internal controls that it believes adequately protects the assets of
the Company and is appropriate for the nature of its business and the size of its operations. The internal control
system was designed to provide reasonable assurance that all transactions are accurately recorded, that
transactions are recorded as necessary to permit preparation of financial statements in accordance with IFRS,
and that our assets are safeguarded.
These internal controls include disclosure controls and procedures designed to ensure that information required
to be disclosed by the Company is accumulated and communicated as appropriate to allow timely decisions
regarding required disclosure.
Internal control over financial reporting means a process designed by or under the supervision of the Chief
Executive Officer and the Chief Financial Officer, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with IFRS as
issued by the IASB.
The internal controls are not expected to prevent and detect all misstatements due to error or fraud. There were
no changes in our internal control over financial reporting that occurred during the year ended March 31, 2019
that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
32
As of March 31, 2019, the Company’s management has assessed the effectiveness of our internal control over
financial reporting and disclosure controls and procedures using the Committee of Sponsoring Organizations of
the Treadway Commission’s 2013 framework. Based on their evaluation, the Chief Executive Officer and the
Chief Financial Officer have concluded that these controls and procedures are effective.
OTHER MD&A REQUIREMENTS
Outstanding Share Data
As at the date of this report, the Company has the following securities outstanding:
Common Shares
Warrants
Stock Options
Total
Number
28,802,792
4,920,428
3,325,000
37,048,220
For a detailed summary of the outstanding securities convertible into, exercisable or exchangeable for voting or
equity securities of Medicenna as at March 31, 2019, refer to Notes, 8, 9 & 10 in the audited 2019 annual financial
statements of the Company.
Additional information relating to the Company, including the Company’s annual information form in respect of
fiscal year 2019, is available under the Company’s profile on SEDAR at www.sedar.com.
33
Consolidated financial statements of
Medicenna Therapeutics Corp.
(Expressed in Canadian Dollars)
For the years ended March 31, 2019 and 2018
INDEPENDENT AUDITOR’S REPORT
To the Shareholders of
Medicenna Therapeutics Corp.
Opinion
We have audited the accompanying consolidated financial statements of Medicenna Therapeutics Corp. (the “Company”),
which comprise the consolidated statements of financial position as at March 31, 2019 and 2018, and the consolidated
statements of operations, cash flows and changes in shareholders’ equity for the years then ended, and notes to the consolidated
financial statements, including a summary of significant accounting policies.
In our opinion, these consolidated financial statements present fairly, in all material respects, the financial position of the
Company as at March 31, 2019 and 2018, and its financial performance and its cash flows for the years then ended in accordance
with International Financial Reporting Standards (“IFRS”).
Basis for Opinion
We conducted our audits in accordance with Canadian generally accepted auditing standards. Our responsibilities under those
standards are further described in the Auditor's Responsibilities for the Audit of the Consolidated Financial Statements section
of our report. We are independent of the Company in accordance with the ethical requirements that are relevant to our audit of
the consolidated financial statements in Canada, and we have fulfilled our other ethical responsibilities in accordance with
these requirements. We believe that the audit evidence we have obtained in our audits is sufficient and appropriate to provide
a basis for our opinion.
Material Uncertainty Related to Going Concern
We draw attention to Note 2 of the consolidated financial statements, which describes matters and conditions that indicate the
existence of a material uncertainty that may cast significant doubt on the Company’s ability to continue as a going concern.
Our opinion is not modified in respect of this matter.
Other Information
Management is responsible for the other information. The other information obtained at the date of this auditor's report includes
Management’s Discussion and Analysis and Annual Information Form.
Our opinion on the consolidated financial statements does not cover the other information and we do not express any form of
assurance conclusion thereon.
In connection with our audit of the consolidated financial statements, our responsibility is to read the other information and, in
doing so, consider whether the other information is materially inconsistent with the consolidated financial statements or our
knowledge obtained in the audit, or otherwise appears to be materially misstated.
We obtained Management’s Discussion and Analysis and Annual Information Form prior to the date of this auditor’s report.
If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are
required to report that fact. We have nothing to report in this regard.
Responsibilities of Management and Those Charged with Governance for the Consolidated Financial Statements
Management is responsible for the preparation and fair presentation of the consolidated financial statements in accordance with
IFRS, and for such internal control as management determines is necessary to enable the preparation of consolidated financial
statements that are free from material misstatement, whether due to fraud or error.
In preparing the consolidated financial statements, management is responsible for assessing the Company's ability to continue
as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting
unless management either intends to liquidate the Company or to cease operations, or has no realistic alternative but to do so.
Those charged with governance are responsible for overseeing the Company's financial reporting process.
Auditor's Responsibilities for the Audit of the Consolidated Financial Statements
Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from
material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinion. Reasonable
assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Canadian generally
accepted auditing standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or
error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the
economic decisions of users taken on the basis of these consolidated financial statements.
As part of an audit in accordance with Canadian generally accepted auditing standards, we exercise professional judgment and
maintain professional skepticism throughout the audit. We also:
Identify and assess the risks of material misstatement of the consolidated financial statements, whether due to fraud
or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and
appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud
is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions,
misrepresentations, or the override of internal control.
Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate
in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control.
Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related
disclosures made by management.
Conclude on the appropriateness of management's use of the going concern basis of accounting and, based on the
audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant
doubt on the Company's ability to continue as a going concern. If we conclude that a material uncertainty exists, we
are required to draw attention in our auditor's report to the related disclosures in the consolidated financial statements
or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained
up to the date of our auditor's report. However, future events or conditions may cause the Company to cease to continue
as a going concern.
Evaluate the overall presentation, structure and content of the consolidated financial statements, including the
disclosures, and whether the consolidated financial statements represent the underlying transactions and events in a
manner that achieves fair presentation.
Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities
within the Company to express an opinion on the consolidated financial statements. We are responsible for the
direction, supervision and performance of the group audit. We remain solely responsible for our audit opinion.
We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the
audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.
We also provide those charged with governance with a statement that we have complied with relevant ethical requirements
regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to
bear on our independence, and where applicable, related safeguards.
The engagement partner on the audit resulting in this independent auditor’s report is Grant P. Block.
Vancouver, Canada
June 24, 2019
“DAVIDSON & COMPANY LLP”
Chartered Professional Accountants
Medicenna Therapeutics Corp.
Consolidated Statements of Financial Position
(Expressed in Canadian Dollars)
March 31, 2019
March 31, 2018
$
$
2,370,976
258,423
2,444,285
32,539
5,106,223
81,205
-
3,938,734
187,108
-
160,716
4,286,558
86,152
1,872
5,187,428
4,374,582
2,396,439
2,396,439
174,432
2,570,871
1,875,786
1,875,786
336,971
2,212,757
16,615,648
8,633,395
157,165
14,302,195
5,790,341
150,909
(22,789,651)
(18,081,620)
2,616,557
5,187,428
2,161,825
4,374,582
as at
Assets
Current assets
Cash
Prepaids and deposits
Government grant receivable (Note 11)
Other receivables
Intangible assets (Note 12)
Fixed assets
Liabilities
Current liabilities
Accounts payable and accrued liabilities (Note 7)
License fee payable (Note 12)
Shareholders' Equity
Common shares (Note 8)
Contributed surplus (Notes 9 and 10)
Accumulated other comprehensive income
Deficit
Nature of business (Note 1)
Subsequent events (Note 16)
Approved by the Board
/s/ Albert Beraldo
Director
/s/ Chandra Panchal
Director
The accompanying notes are an integral part of these consolidated financial statements.
1
Medicenna Therapeutics Corp.
Consolidated Statements of Operations
(Expressed in Canadian Dollars)
Operating expenses
General and administration (Note 15)
Research and development (Note 15)
Year ended
Year ended
March 31,
2019
$
1,709,286
3,017,997
March 31,
2018
$
2,334,684
5,090,146
Total operating expenses
4,727,283
7,424,830
Interest income
Foreign exchange (gain) loss
Net loss for the year
Cummulative translation adjustment
Comprehensive loss for the year
(102)
(19,150)
(19,252)
(4,708,031)
6,256
(4,701,775)
(3,291)
43,913
40,622
(7,465,452)
(63,321)
(7,528,773)
Basic and diluted loss per share for the year
(0.18)
(0.31)
Weighted average number of common shares
outstanding (Note 8(c))
25,674,027
24,367,789
The accompanying notes are an integral part of these consolidated financial statements.
2
Year ended
March 31,
2019
$
Year ended
March 31,
2018
$
(4,708,031)
(7,465,452)
Medicenna Therapeutics Corp.
Consolidated Statements of Cash Flows
(Expressed in Canadian Dollars)
Operating activities
Net loss for the year
Items not involving cash
Depreciation
Stock based compensation
R&D warrant expense
Government grant expense recoveries
Unrealized foreign exchange
Changes in non-cash working capital
Other receivables and deposits
Accounts payable and accrued liabilities
Investing activities
Long term license fee payable
Financing activities
Government grant received (Note 11)
Units issued for cash
Warrant and option exercises
Effect of foreign exchange on cash
Net increase (decrease) in cash
Cash, beginning of year
Cash, end of year
Other non-cash transactions
Broker warrants issued
Warrants issued
Share issuance costs accrued through
accounts payable and accrued liabilities
The accompanying notes are an integral part of these consolidated financial statements.
6,818
998,619
710,574
(5,646,227)
(82,419)
56,862
626,799
(8,037,005)
(354,458)
(354,458)
3,242,073
3,579,910
-
6,821,983
31,722
(1,567,758)
3,938,734
2,370,976
$
$
91,000
1,042,861
$
102,596
9,704
1,617,032
947,432
(5,688,119)
3,612
(439)
451,878
(10,124,352)
(140,029)
(140,029)
-
-
469,393
469,393
(304,393)
(10,099,381)
14,038,115
3,938,734
-
-
-
3
Medicenna Therapeutics Corp.
Consolidated Statements of Changes in Shareholders' Equity
(Expressed in Canadian Dollars)
Balance, March 31, 2017
Stock based compensation
Research and development w arrant amortization
Warrant and option exercises
Net loss and comprehensive loss
Balance, March 31, 2018
Stock based compensation
Research and development w arrant amortization
Issued on financing (Note 8(b))
Net loss and comprehensive loss
Balance, March 31, 2019
Common shares issued and
outstanding
Contributed
Surplus
Number
Amount
$
24,313,334
13,463,734
-
-
264,803
-
-
-
838,461
-
$
3,594,945
1,617,032
947,432
(369,068)
-
24,578,137
14,302,195
5,790,341
-
-
-
-
998,619
710,574
4,000,000
2,313,453
1,133,861
-
-
-
28,578,137
16,615,648
8,633,395
Accumulated
other
comprehensive
income
Deficit
Total
shareholders'
equity
$
214,230
$
$
(10,616,168)
6,656,741
-
-
-
-
-
-
1,617,032
947,432
469,393
(63,321)
150,909
(7,465,452)
(7,528,773)
(18,081,620)
2,161,825
-
-
-
-
-
-
998,619
710,574
3,447,314
6,256
157,165
(4,708,031)
(4,701,775)
(22,789,651)
2,616,557
The accompanying notes are an integral part of these consolidated financial statements.
4
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
1.
Nature of business
Medicenna Therapeutics Corp. (“Medicenna” or the "Company") was incorporated as A2 Acquisition Corp.
(“A2”) under the Alberta Business Corporations Act on February 2, 2015 and was classified as a Capital
Pool Corporation ("CPC") as defined in Policy 2.4 of the TSX Venture Exchange Inc. (the "Exchange")
Corporate Finance Manual. On March 1, 2017, the Company completed a qualifying transaction with
Medicenna Therapeutics Inc. (“MTI.”) and the name of the Company was changed to Medicenna
Therapeutics Corp. (the “Transaction”). MTI has been identified for accounting purposes as the acquirer,
and accordingly the entity is considered to be a continuation of MTI and the net assets of A2 at the date
of the Transaction are deemed to have been acquired by MTI. These consolidated financial statements
include the results of operations of Medicenna from March 1, 2017. On August 2, 2017 Medicenna
graduated to the main board of the Toronto Stock Exchange. On November 13, 2017, Medicenna
continued under the Canadian Business Corporations Act.
Medicenna has three wholly owned subsidiaries, Medicenna Therapeutics Inc. (“MTI”) (British Columbia),
Medicenna Biopharma Inc. (“MBI”) (Delaware) and Medicenna Biopharma Inc. (“MBIBC”). (British
Columbia).
The Company's principal business activity is the development and commercialization of Empowered
Cytokines and Superkines for the treatment of cancer.
As at March 31, 2019, the head office is located at 2 Bloor St W, 7th Floor, Toronto, Ontario, Canada, and
the registered office is located at 181 Bay Street, Suite 2100, Toronto, Ontario, Canada.
2.
Significant accounting policies
a) Basis of Measurement and statement of compliance
These consolidated financial statements have been prepared in accordance with International
Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board
(“IASB”) and the Interpretations of the International Financial Reporting and Interpretations Committee
(“IFRIC”).
The consolidated financial statements have been prepared on a historical cost basis except for certain
financial assets measured at fair value. In addition, these consolidated financial statements have been
prepared using the accrual basis of accounting, except for cash flow information.
The functional currency of an entity and its subsidiary is the currency of the primary economic
environment in which the entity operates. The functional currency of the parent company, MTI and
MBIMC is the Canadian dollar and the functional currency of MBI is the US dollar and the presentation
currency of the Company is the Canadian dollar.
The consolidated financial statements were approved by the Company’s Board of Directors and
authorized for issue on June 24, 2019.
b) Going Concern
These consolidated financial statements have been prepared in accordance with IFRS accounting
principles applicable to a going concern using the historical cost basis.
Management has forecasted that the Company’s current level of cash will not be sufficient to execute
its current planned expenditures for the next 12 months without further financing being obtained. The
Company is currently in discussion with several potential investors and partners to provide additional
funding. Management believes that it will complete one or more of these arrangements in sufficient
time to continue to execute its planned expenditures. However, there can be no assurance that the
capital will be available as necessary to meet these continuing expenditures, or if the capital is
available, that it will be on terms acceptable to the Company. The issuance of common shares by the
Company could result in significant dilution in the equity interest of existing shareholders. There can
be no assurance that the Company will be able to obtain sufficient financing to meet future operational
needs which may result in the delay, reduction or discontinuation of ongoing development programs.
5
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
2.
Significant accounting policies cont’d
As a result, there is a substantial doubt as to whether the Company will be able to continue as a going
concern and realize its assets and pay its liabilities as they fall due.
These consolidated financial statements do not reflect the adjustments that would be necessary
should the Company be unable to continue as a going concern and therefore be required to realize
its assets and settle its liabilities and commitments in other than the normal course of business and
at amounts different from those in the accompanying consolidated financial statements. Such
amounts could be material.
c) Principles of Consolidation
These consolidated financial statements include the accounts of the Company and its wholly-owned
Subsidiaries MTI, MBI and MBIBC (British Columbia, Inactive). Subsidiaries are fully consolidated
from the date at which control is determined to have occurred and are deconsolidated from the date
that the Company no longer controls the entity. The financial statements of the subsidiaries are
prepared for the same reporting period as the Company using consistent accounting policies.
Intercompany transactions, balances, and gains and losses on transactions between subsidiaries are
eliminated.
d) Foreign currency
Transactions in foreign currencies are translated to the functional currency at the rate on the date of
the transactions. Monetary assets and liabilities denominated in foreign currencies are retranslated at
the spot rate of exchange as at the reporting date. All differences are taken to profit or loss. Non-
monetary items that are measured in terms of historical cost in a foreign currency are translated using
the exchange rate as at the date of the initial transaction. Non-monetary items measured at fair value
in a foreign currency are translated using the exchange rate at the date when the fair value was
determined.
On translation of the entities whose functional currency is other than the Canadian dollar, revenues
and expense are translated at the exchange rates approximately those in effect on the date of the
transactions. Assets and liabilities are translated at the spot rate of exchange as at the reporting date.
Exchange gains and losses, including results of retranslation, are recorded in other comprehensive
income.
e) Cash
Cash consists of amounts held in banks with maturities less than three months at inception. Interest
from cash is recorded on an accrual basis. The Company does not have any cash equivalents.
f) Research and development costs
Expenditures on research and development activities, undertaken with the prospect of gaining new
scientific or technical knowledge and understanding, are recognized in profit or loss as incurred.
Investment tax credits related to current expenditures are included in the determination of net income
as the expenditures are incurred when there is reasonable assurance they will be realized.
Development activities involve a plan or design for the production of new or substantially improved
products and processes. Development expenditures are capitalized only if development costs can be
measured reliably, the product or process is technically and commercially feasible, future economic
benefits are probable, and the Company intends to and has sufficient resources to complete
development and to use or sell the asset. These criteria will be deemed by the Company to have been
met when revenue is received by the Company and a determination that it has sufficient resources to
market and sell its product offerings. Upon a determination that the criteria to capitalize development
expenditures have been met, the expenditures capitalized will include the cost of materials, direct
6
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
2.
Significant accounting policies cont’d
labour and overhead costs that are directly attributable to preparing the asset for its intended use.
Other development expenditures will be expensed as incurred.
Capitalized development expenditures will be measured at cost less accumulated amortization and
accumulated impairment losses. No development costs have been capitalized to date.
g) Government assistance
Government grants, including grants from similar bodies, consisting of investment tax credits are
recorded as a reduction of the related expense or cost of the asset acquired. Government grants are
recognized when there is reasonable assurance that the Company has met the requirements of the
approved grant program and there is reasonable assurance that the grant will be received.
Research grants that compensate the Company for expenses incurred are recognized in profit, or loss
in reduction thereof on a systematic basis in the same years in which the expenses are recognized.
Grants that compensate the Company for the cost of an asset are recognized in profit or loss on a
systematic basis over the useful life of the asset.
h)
Intangible assets
The Company owns certain patents, intellectual property licenses and options to acquire intellectual
property. The Company expenses patent costs, including license fees and other maintenance costs,
until such time as the Company has certainty over the future recoverability of the intellectual property
at which time it capitalizes the costs incurred. The Company capitalizes costs directly related to the
acquisition of existing license patents.
The Company does not hold any intangible asset with an indefinite life.
Intangible assets with finite lives are amortized over the useful economic life and assessed for
impairment whenever there is an indication that the intangible asset may be impaired. The
amortization method and amortization period of an intangible asset with a finite life is reviewed at least
annually. Changes in the expected useful life or the expected pattern of consumption of future
economic benefits embodied in the asset is accounted for by changing the amortization period or
method, as appropriate, and are treated as changes in accounting estimates. The amortization
expense on intangible assets with finite lives is recognized in general and administrative expenses.
Amortization is recognized in profit or loss on a straight-line basis over the estimated useful lives of
intangible assets from the date they are available for use to August 31, 2035.
i)
Income taxes
Current tax and deferred tax are recognized in the Company’s profit and loss, except to the extent
that it relates to a business combination or items recognized directly in equity or in net loss and
comprehensive loss.
Current income taxes are recognized for the estimated taxes payable or receivable on taxable income
or loss for the current year and any adjustment to income taxes payable in respect of previous years.
Current income taxes are determined using tax rates and tax laws that have been enacted or
substantively enacted by the period end date.
Deferred tax assets and liabilities are recognized where the carrying amount of an asset or liability
differs from its tax base, except for taxable temporary differences arising on the initial recognition of
goodwill and temporary differences arising on the initial recognition of an asset or liability in a
7
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
2.
Significant accounting policies cont’d
transaction which is not a business combination and at the time of the transaction affects neither
accounting nor taxable profit or loss.
Recognition of deferred tax assets for unused tax losses, tax credits and deductible temporary
differences is restricted to those instances where it is probable that future taxable profit will be
available against which the deferred tax assets can be utilized. At the end of each reporting period,
the Company reassesses unrecognized deferred tax assets. The Company recognizes a previously
unrecognized deferred tax asset to the extent that it has been probable that future taxable profit will
allow the deferred tax asset to be recovered.
j) Basic and diluted loss per common share
Basic loss per share is computed by dividing the loss available to common shareholders by the
weighted average number of common shares outstanding during the year. The computation of diluted
earnings per share assumes the conversion, exercise or contingent issuance of securities only when
such conversion, exercise or issuance would have a dilutive effect on earnings per share. The dilutive
effect of convertible securities is reflected in diluted earnings per share by application of the “if
converted” method. The dilutive effect of outstanding options and warrants and their equivalents is
reflected in diluted earnings per share. Since the Company has losses, the exercise of outstanding
options has not been included in this calculation as it would be anti-dilutive.
k) Equipment
The Company’s fixed assets comprise of computer equipment for use in general and administrative
and research activities.
Depreciation is recognized using the straight-line method based on an expected life of the assets
Computer equipment
2 years
Impairment of long-lived assets:
The Company’s long-lived assets are reviewed for indications of impairment at the date of preparing
each statement of financial position. If indication of impairment exists, the asset’s recoverable amount
is estimated.
An impairment loss is recognized when the carrying value of an asset, or its cash-generating unit,
exceeds its recoverable amount. A cash-generating unit is the smallest identifiable group of assets
that generates cash inflows that are largely independent of cash inflows from other assets or groups
of assets. For the purpose of impairment testing, the Company determined it has one cash-generating
unit. The recoverable amount is the greater of the asset’s fair value less cost to sell and value in use.
l) Stock-based compensation
The Company has a stock-based compensation plan (the "Plan") available to officers, directors,
employees and consultants with grants under the Plan approved by the Company's Board of
Directors. Under the Plan, the exercise price of each option equals the closing trading price of the
Company's stock on the day prior to the grant or a higher price as determined by the Board of
Directors. Vesting is provided for at the discretion of the Board of Directors and the expiration of
options is to be not greater than 10 years from the date of grant. The Company uses the fair value-
based method of accounting for employee awards granted under the Plan. The Company calculates
the fair value of each stock option grant using the Black Scholes option pricing model at the grant
date. The stock-based compensation cost of the options is recognized as stock-based compensation
8
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
2.
Significant accounting policies cont’d
expense over the relevant vesting period of the stock options using an estimate of the number of
options that will eventually vest.
Stock options awarded to non-employees are accounted for at the fair value of the goods received or
the services rendered. The fair value is measured at the date the Company obtains the goods or the
date the counterparty renders the service. If the fair value of the goods or services cannot be reliably
measured, the fair value of the options granted will be used.
m) Share Capital
Common shares are classified as equity. Incremental costs directly attributable to the issue of
common shares are recognized as a reduction of equity.
The Corporation has adopted a relative fair value method with respect to the measurement of shares
and warrants issued as private placement units. The relative fair value method allocates value to each
component on a pro-rata basis, based on the fair value of the components calculated independently
of one another. The Company measures the fair value of the warrant component of the unit using the
Black-Scholes option pricing model. The unit value is then allocated, pro-rata, between the two
components, with the fair value attributed to the warrants being recorded to contributed surplus.
n) Financial Instruments
Financial assets and liabilities are recognized when the Company becomes a party to the contractual
provisions of the instrument. Financial assets are derecognized when the rights to receive cash flows
from the assets have expired or have been transferred and the Company has transferred substantially
all risks and rewards of ownership.
Financial assets and liabilities are offset and the net amount is reported in the consolidated statement
of financial position when there is a legally enforceable right to offset the recognized amounts and
there is an intention to settle on a net basis, or realize the asset and settle the liability simultaneously.
The Company recognizes financial instruments based on their classification. Depending on the
financial instruments’ classification, changes in subsequent measurements are recognized in net loss
and comprehensive loss.
The Company has implemented the following classifications:
• Cash and cash equivalents, government grant receivable and amounts receivable are
classified as amortized cost (previously loans and receivables). After their initial fair value
measurement, they are measured at amortized cost using the effective interest method; and
• Accounts payable and accrued liabilities are classified as other amortized cost (previously
financial liabilities). After their initial fair value measurement, they are measured at amortized
cost using the effective interest method.
Impairment of financial assets
The Company applies the simplified method of the expected credit loss model required under IFRS
9. Under this method, the Company estimates a lifetime expected loss allowance for all receivables.
Receivables are written off when there is no reasonable expectation of recovery.
If there is objective evidence that an impairment loss has been incurred, the amount of the loss is
measured as the difference between the asset’s carrying amount and the present value of estimated
future cash flows. The present value of the estimated future cash flows is discounted at the financial
asset’s original effective interest rate.
9
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
2.
Significant accounting policies cont’d
o) Employee benefits
Short-term employee benefit obligations are measured on an undiscounted basis and are expensed
as the related service is provided. A liability is recognized for the amount expected to be paid in short-
term cash bonuses if the Company expects to pay these amounts as approved by the Board of
Directors as a result of past services provided by the employee and the obligation can be estimated
reliably.
p) Provisions
A provision is recognized if, as a result of a past event, the Company has a present legal or
constructive obligation that can be estimated reliably, and it is probable that an outflow of economic
benefits will be required to settle the obligation. Provisions are assessed by discounting the expected
future cash flows at a pre-tax rate that reflects current market assessments of the time value of money
and the risks specific to the liability. The unwinding of the discount on provisions is recognized in
finance costs. A provision for onerous contracts is recognized when the unavoidable costs of meeting
the obligations under the contract exceed the economic benefits expected to be received under it. The
provision is measured at the present value of the lower of the expected cost of terminating the contract
and the expected net cost of continuing with the contract.
3.
Key sources of estimation uncertainty
The preparation of consolidated financial statements 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 revenue
and expenses during the reporting period. Actual results could differ from those estimates. Estimates and
underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are
accounted for prospectively.
The key sources of estimation uncertainty that have a significant risk of causing material adjustment to
the carrying amounts of assets and liabilities are discussed below:
Deferred taxes
The determination of deferred income tax assets or liabilities requires subjective assumptions regarding
future income tax rates and the likelihood of utilizing tax carry-forwards. Changes in these assumptions
could materially affect the recorded amounts, and therefore do not necessarily provide certainty as to their
recorded values.
Valuation of stock-based compensation and warrants
Management measures the costs for stock-based compensation and warrants using market-based option
valuation techniques. Assumptions are made and estimates are used in applying the valuation techniques.
These include estimating the future volatility of the share price, expected dividend yield, expected risk-
free interest rate, future employee turnover rates, future exercise behaviours and corporate performance.
Such estimates and assumptions are inherently uncertain. Changes in these assumptions affect the fair
value estimates of stock-based compensation and warrants.
Intangible assets
The Company estimates the useful lives of intangible assets from the date they are available for use in
the manner intended by management and periodically reviews the useful lives to reflect management’s
intent about developing and commercializing the assets.
Functional currency
Management considers the determination of the functional currency of the Company a significant
judgment. Management has used its judgment to determine the functional currency that most faithfully
represents the economic effects of the underlying transactions, events and conditions and considered
10
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
3.
Key sources of estimation uncertainty cont’d
various factors including the currency of historical and future expenditures and the currency in which funds
from financing activities are generated. A Company’s functional currency is only changed when there is a
material change in the underlying transactions, events and conditions.
4.
Accounting standards
The following IFRS pronouncement has been adopted during 2019:
The Company has adopted new accounting standard IFRS 9 - Financial Instruments, effective for the
Company’s annual period beginning April 1, 2018. The adoption of IFRS 9 did not result in any changes
to the classification, measurement or carrying amounts of the Company’s existing financial instruments
on transition date.
The new standard brings together the classification and measurement, impairment and hedge accounting
phases of the IASB’s project to replace IAS 39 - Financial instruments: recognition and measurement. The
standard retains but simplifies the mixed measurement model and establishes two primary measurement
categories for financial assets: amortized cost and fair value.
The Company continues to classify and measure its cash at fair value through profit or loss with changes
in fair value recognized in profit or loss as they arise (“FVTPL”). Other receivables and government grant
receivables are classified initially at FVTPL, and subsequently at amortized cost using the effective interest
rate method. Accounts payable and accrued liabilities are classified and measured as financial liabilities,
initially at FVTPL, and subsequently at amortized cost using the effective interest rate method.
The following IFRS pronouncements have been issued but are not yet effective:
IFRS 16, Leases. In January 2016 the IASB issued IFRS 16 Leases (“IFRS 16”) which requires lessees
to recognize assets and liabilities for most leases on their statements of financial position. Lessees
applying IFRS 16 will have a single accounting model for all leases, with certain exemptions. The new
standard will be effective for annual periods beginning on or after January 1, 2019 with limited early
application permitted. The Company has does not have any leases with a term greater than one year and
has determined that the adoption of IFRS16 will not impact the financial statements on April 1, 2019.
5. Capital disclosures
The Company’s objectives, when managing capital, are to safeguard cash as well as maintain financial
liquidity and flexibility in order to preserve its ability to meet financial obligations and deploy capital to grow
its businesses.
The Company’s financial strategy is designed to maintain a flexible capital structure consistent with the
objectives stated above and to respond to business growth opportunities and changes in economic
conditions. In order to maintain or adjust its capital structure, the Company may issue shares or issue debt
(secured, unsecured, convertible and/or other types of available debt instruments).
There were no changes to the Company’s capital management policy during the year. The Company is
not subject to any externally imposed capital requirements.
6. Financial risk management
(a) Fair value
The Company’s financial instruments recognized on the consolidated statements of financial position
consist of cash, government grant receivable, other receivables, and accounts payable and accrued
liabilities. The fair value of these instruments, approximate their carrying values due to their short-
term maturity.
Classification of financial instruments
Financial instruments measured at fair value on the statement of financial position are summarized
into the following fair value hierarchy levels:
11
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
6.
Financial risk management cont’d
Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2: inputs other than quoted prices included within Level 1 that are observable for the asset
or liability
Level 3: inputs for the asset or liability that are not based on observable market data
(unobservable inputs).
The Company classifies its financial assets and liabilities depending on the purpose for which the
financial instruments were acquired, their characteristics, and management intent as outlined below:
Cash is measured using Level 1 inputs and changes in fair value are recognized through profit or loss,
with changes in fair value being recorded in net earnings at each period end.
Other receivables are measured at amortized cost less impairments.
Accounts payable and accrued liabilities, deferred government grants and license fee payable are
measured at amortized cost.
The Company has exposure to the following risks from its use of financial instruments: credit, interest
rate, currency and liquidity risk. The Company reviews its risk management framework on a quarterly
basis and makes adjustments as necessary.
(b) Credit risk
Credit risk arises from the potential that a counterparty will fail to perform its obligations. The financial
instruments that are exposed to concentrations of credit risk consist of cash and cash equivalents.
The Company manages credit risk associated with its cash by maintaining minimum standards of R1-
med or A-high investments and the Company invests only in highly rated Canadian corporations which
are capable of prompt liquidation.
(c) Interest rate risk
Interest rate risk is the risk that the fair values and future cash flows of the Company will fluctuate
because of changes in market interest rates. The Company believes that its exposure to interest rate
risk is not significant.
(d) Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall
due. The Company currently settles all of its financial obligations out of cash. The ability to do so relies
on the Company maintaining sufficient cash in excess of anticipated needs (refer to Note 2 (b)). As at
March 31, 2019, the Company’s liabilities consist of accounts payable and accrued liabilities that have
contracted maturities of less than one year.
(e) Currency risk
Currency risk is the risk that future cash flows of a financial instrument will fluctuate because of
changes in foreign exchange rates. The Company is exposed to currency risk from employee costs
as well as the purchase of goods and services primarily in the United States and cash balances held
in foreign currencies. Fluctuations in the US dollar exchange rate could have a significant impact on
the Company’s results. Assuming all other variables remain constant, a 10% depreciation or
appreciation of the Canadian dollar against the US dollar would result in an increase or decrease in
loss and comprehensive loss for the year ended March 31, 2019 of $69,305 (March 31, 2018 -
$88,000).
12
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
6.
Financial risk management cont’d
Balances in US dollars are as follows:
Cash
Accounts payable and accrued liabilities
Deferred government grant receivable (note 11)
7.
Accounts payable and accrued liabilities
Trade payables
Accrued liabilities
8.
Share capital
Authorized
Unlimited common shares
a) MTI Shareholders
March 31, 2019
$
118,440
(1,430,518)
1,831,337
519,259
March 31, 2018
$
2,115,262
(1,429,909)
-
685,353
March 31, 2019
March 31, 2018
$
802,025
1,594,414
2,396,439
$
877,300
998,486
1,875,786
On March 1, 2017, the company completed the Transaction resulting in the issuance of 16,249,999
common shares to the former shareholders of MTI.
b) Equity Issuances
Year ended March 31, 2018
During the year ended March 31, 2018, 164,447 warrants and 100,356 options were exercised for
cash proceeds of $469,393. In addition to the cash proceeds received, the original fair value related
to these warrants and options of $369,068 was transferred from contributed surplus to share capital.
This resulted in a total amount of $838,461 credited to share capital.
Year ended March 31, 2019
On December 21, 2018, the Company closed a short-form prospectus offering of 4,000,000 units for
gross proceeds of $4,000,000. Each unit consisted of one common share of the Company and one-
half common share purchase warrant of the Company. Each full warrant entitles the holder to
purchase one common share, for five years after the closing of the offering, at an exercise price of
$1.20 per common share. The Company issued 4,000,000 common shares, 2,000,000 warrants and
280,000 broker warrants in connection with this transaction.
The total costs associated with the transaction were approximately $643,686, including the $91,000
which represented the fair value of the brokers' services provided as part of the offering and
compensated by warrants. Each such broker warrant is exercisable for one common share at a price
of $1.20 per share for a period of 24 months following the closing of the Offering. The Company has
allocated the net proceeds of the offering to the common shares and the common share purchase
13
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
8.
Share capital cont’d
warrants based on their estimated relative fair values. Based on relative fair values, $2,404,453 of the
net proceeds were allocated to the common shares and $1,042,861 to the common share purchase
warrants.
c) Calculation of loss per share
Loss per common share is calculated using the weighted average number of common shares
outstanding. For years ended March 31, 2019 and 2018 the calculation was as follows:
Common shares issued and outstanding, beginning of year
24,578,137
24,313,334
Effect of warrants and options exercised
Common shares issued during the year (Note 8(b))
Weighted average shares outstanding, end of year
Common shares issued and outstanding, end of year
-
54,455
1,095,890
-
25,674,027
24,367,789
28,578,137
24,578,137
2019
2018
The effect of any potential exercise of the Company's stock options and warrants outstanding during
the period has been excluded from the calculation of diluted loss per common share as it would be anti-
dilutive.
9. Warrants
Year ended March 31, 2018
There were no warrants issued in the year ending March 31, 2018.
Year ended March 31, 2019
As part of the short-form prospectus offering closed on December 21, 2018, 2,000,000 warrants and
280,000 broker warrants were issued, exercisable at $1.20 per share at any time up to December 21, 2023
and with a fair value of $746,000 and $91,000 respectively.
Warrant continuity:
Balance outstanding at March 31, 2017
Warrants exercised during the year
Warrants expired during the year
Balance outstanding at March 31, 2018
Warrants expired during the period
Common share purchase warrants issued in the financing (Note 8(b))
Broker warrants issued in the financing (Note 8(b))
Balance outstanding and exercisable at March 31, 2019
Number of
Warrants
3,294,105
(164,447)
(55,616)
3,074,042
(208,959)
2,000,000
280,000
5,145,083
Weighted average
exercise price
$ 2.00
2.00
2.00
$ 2.00
2.00
1.20
1.20
$ 1.65
As at March 31, 2019, the incentive warrants issued on January 1, 2017 have been fully amortized and a
total of $1,894,860 has been recognized in contributed surplus representing the fair value of these
warrants. During the year ended March 31, 2019, the Company recognized $710,574 to research and
development warrant expense (2018 - $947,430).
14
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
9. Warrants cont’d
At March 31, 2019, warrants were outstanding and exercisable, enabling holders to acquire common
shares as follows:
Number of
Warrants
Exercise
Price
Expiry Date
1,379,083
1,288,000
198,000
280,000
2,000,000
5,145,083
$
2.00
2.00
2.00
1.20
1.20
January 1, 2021
March 1, 2021
April 5, 2021
December 21, 2020
December 21, 2023
10. Stock options
Year ended March 31, 2018
On September 21, 2017 the shareholders of the Company voted in favour of a new stock option plan
compliant with the policies of the Toronto Stock Exchange governing options which may be granted to
directors, officers, employees and consultants of the Company to purchase up to a maximum of 15% of
the total number of outstanding common shares, estimated at 4,286,000 options as at March 31, 2019.
Options are granted at the fair market value of the common shares on the closing trading price of the
Company’s stock on the day prior to the grant if the grant is made during the trading day or the closing
trading price on the day of grant if the grant is issued after markets have closed or at a higher price at the
discretion of the Board of Directors. Options vest at various rates (immediate to three years) and have a
maximum term of 10 years.
During the year ended March 31, 2018 the Company granted 700,000 stock options exercisable at $2.01
per share, 200,000 stock options exercisable at $2.88 per share, 125,000 stock options exercisable at
$2.00 per share and 125,000 options exercisable at $2.40 per share. 950,000 stock options vest 50%
after one year, 25% after two years and 25% after three years and have a ten-year life. 200,000 stock
options vest 50% on issuance and 50% after one year, and have a five year life.
Year ended March 31, 2019
During the year ended March 31, 2019 the Company granted 200,000 stock options exercisable at $1.09
per share, with a 5-year life. The options vested 25% on issue on September 1, 2018, 25% on December
1, 2018, 25% on March 1, 2019 and 25% on June 1, 2019. The Company granted an additional 1,175,000
options on February 14, 2019 at an exercise price of $1.00. 200,000 of these options vested 50%
immediately and 50% will vest on February 14, 2020. These options have a 5-year life. The remaining
975,000 options vest 50% after one year, 25% after two years and 25% after three years and have a ten-
year life.
15
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
10. Stock options cont’d
Stock option transactions for the years ended March 31, 2018 and 2019 are set forth below:
Balance outstanding at March 31, 2017
Granted
Exercised
Expired
Forfeited
Balance outstanding at March 31, 2018
Granted
Exercised
Expired
Forfeited
Balance outstanding at March 31, 2019
Number of
options
Weighted
average
exercise
price
1,291,657 $ 1.97
1,150,000 $ 2.20
1.40
(100,356)
1.40
(41,301)
(125,000)
2.40
2,175,000 $ 2.11
1,375,000 $ 1.01
-
-
-
-
(275,000)
1.85
3,275,000 $ 1.67
The following table summarizes information about stock options outstanding at March 31, 2019:
Exercise
Prices
Options Outstanding
Weighted
average
remaining
contractual
life
Weighted
average
exercise
price
Options
$
Years
$
Options Exercisable
Options
Weighted
average
exercise
price
$
1.00
1,175,000
1.09
100,000
2.00
1,100,000
2.01
700,000
2.88
200,000
3,275,000
9.03
0.17
7.88
8.48
3.62
7.93
1.00
- -
1.09
100,000
1.09
2.00
825,000
2.00
2.01
350,000
2.01
2.88
200,000
2.88
1.67
1,475,000
2.06
The following assumptions were used in the Black-Scholes option-pricing model to determine the fair value
of stock options granted during the year:
Exercise price
Grant date share price
Risk free interest rate
Expected life of options
Expected volatility
Expected dividend yield
Forfeiture rate
Weighted average fair value of
March 31, 2019
March 31, 2018
$1.00-1.09
$0.80- 1.09
1.5 - 3.0%
2.5-5 years
100-116%
-
0-15%
$2.00-2.88
$2.00-2.88
0.65-1.75%
5 years
80-100%
-
0-15%
options granted during the year
$0.61
$1.61
16
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
11. Government assistance
CPRIT assistance
In February 2015, the Company received notice that it had been awarded a grant by the Cancer Prevention
Research Institute of Texas (“CPRIT”) whereby the Company is eligible to receive up to US$14,100,000
on eligible expenditures over a three year period related to the development of the Company’s phase 2b
clinical program for MDNA55. In October 2017 the Company was granted a one year extension to the
grant allowing expenses to be claimed over a four year period ending February 28, 2019. On February 4,
2019 the Company was approved for a further six month extension ending August 31, 2019.
Ongoing program funding from CPRIT is subject to a number of conditions including the satisfactory
achievement of milestones that must be met to release additional CPRIT funding, proof the Company has
raised 50% matching funds and maintaining substantial functions of the Company related to the project
grant in Texas as well as using Texas-based subcontractor and collaborators wherever possible. There
can be no assurances that the Company will continue to meet the necessary CPRIT criteria, satisfactorily
achieve milestones, or that CPRIT will continue to advance additional funds to the Company.
If the Company is found to have used any grant proceeds for purposes other than intended, is in violation
of the terms of the grant, or relocates its operations outside of the state of Texas, then the Company is
required to repay any grant proceeds received.
Under the terms of the grant, the Company is also required to pay a royalty to CPRIT, comprised of 3-5%
of revenues until aggregate royalty payments equal 400% of the grant funds received at which time the
ongoing royalty will be 0.5%.
During the year ended March 31, 2019, the Company received $3,242,073 (2018 - $Nil). The amount
receivable at March 31, 2019 of $2,444,285 (US $1,831,337), represents funds spent on grant
expenditures, but not yet reimbursed.
12. Commitments
Intellectual Property
On August 21, 2015, the Company exercised its right to enter into two license agreements (the “Stanford
License Agreements”) with the Board of Trustees of the Leland Stanford Junior University (“Stanford”). In
connection with this licensing agreement the Company issued 649,999 common shares with a value of
$98,930 to Stanford and affiliated inventors. The value of these shares has been recorded as an intangible
asset that is being amortized over the life of the underlying patents. As at March 31, 2019, the Company’s
intangible assets have a remaining capitalized netbook value of $81,205 (March 31, 2018 - $86,152).
The Company has entered into various license agreements with respect to accessing patented technology.
In order to maintain these agreements, the Company is obligated to pay certain costs based on timing or
certain milestones within the agreements, the timing of which is uncertain. These costs include ongoing
license fees, patent prosecution and maintenance costs, royalty and other milestone payments. As at
March 31, 2019, the Company is obligated to pay the following:
• Patent licensing costs due within 12 months totaling $66,500.
• Patent licensing costs, including the above, due within the next five years totaling $705,000.
• Project milestone payments, assuming continued success in the development programs, of uncertain
timing totaling US$2,800,000 and an additional US$2,000,000 in sales milestones.
• A liquidity payment of $174,432 due in 2019 and $174,432 due in 2020 to the National Institute of
Health (“NIH”) which represents the remaining payments resulting from the Company’s liquidity event
in March 2017.
17
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
12. Commitments cont’d
Contractual obligations
Less than
1 year
1-3 years
3-5 years
Total
Patent licensing costs, minimum annual royalties
per license agreements
$ 66,500
$ 172,900
$ 532,000
$ 771,400
Liquidity event payment (1)
$ 174,432
$ 174,432
$ 0
$ 348,864
(1) During the year ended March 31, 2019, the Company adjusted $174,432 from license fee payables
to accounts payable and accrued liabilities. This amount remains in accrued liabilities at March 31,
2019.
13. Related party disclosures
(a) Key management personnel
Key management personnel, which consists of the Company’s officers (President and Chief Executive
Officer, Chief Financial Officer, and Chief Development Officer) and directors, earned the following
compensation for the following periods:
Salaries and wages
Board fees
Stock option expense
Related party rent
2019
$
891,748
141,466
786,121
21,515
2018
$
1,101,891
121,472
1,282,374
21,332
1,840,850
2,527,069
During the year ended March 31, 2019, the Company paid $21,515 (2018: $21,332) in office rent to
Aries Biologics Corp, a company controlled by the CEO and CDO of the Company.
This transaction was in the normal course of business and has been measured at the exchange
amount, which is the amount of consideration established and agreed to by the related parties.
(b) Amounts payable to related parties
As at March 31, 2019, the Company had trade and other payables in the normal course of business,
owing to directors and officers of $380,328 (2018: $222,228) related to deferred salary, board fees
and accrued vacation ($107,249 in deferred salaries, included in amounts earned).
18
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
14.
Income taxes
a) Provision for Income Tax
A reconciliation of income taxes at statutory rates with the reported taxes is as follows:
Loss before income taxes
Tax rate
Expected tax recovery
Change in statutory rates and foreign exchange rates
Permanent differences
Share issuance costs
Change in unrecognized deductible temporary difference
Total income tax expense (recovery)
2019
$
2018
$
(4,708,031)
(7,465,452)
27.0%
26.5%
(1,271,000)
(1,978,000)
(9,000)
270,000
(149,000)
1,159,000
-
200,000
673,000
-
1,105,000
-
b) Deferred Income Tax
The significant components of the Company’s deferred tax assets that have not been included on the
consolidated statement of financial position are as follows:
Non-capital losses carry-forward
Property and equipment
Share issuance costs
Unrecognized deferred tax asset
Net deferred tax assets
2019
$
2018
$
4,299,000
3,040,000
50,000
49,000
249,000
200,000
4,393,000
3,289,000
(4,393,000)
(3,289,000)
-
-
The significant components of the Company’s temporary differences, unused tax credits and unused tax
losses that have not been included in the consolidated statements of financial position are as follows:
Type
Non-capital losses carry-forward
Property and equipment
Share issuance costs
Amount
Expiry
$ 15,755,000
2034-2039
186,000
922,000
N/A
2040-2043
19
Medicenna Therapeutics Corp.
Notes to the consolidated financial statements
For the Years Ended March 31, 2019 and 2018
(Expressed in Canadian Dollars)
15. Components of Expenses
General and Administration Expenses
Depreciation expense
Stock based compensation
Facilities and operations
Legal, professional and finance
Salaries and benefits
Other expenses
CPRIT grant claimed in eligible expenses (Note 11)
Research and Development Expenses
Chemistry, manufacturing and controls
Regulatory
Discovery and pre-clinical
Research and development warrant
Clinical
Salaries and benefits
Licensing, patent, legal fees and royalties
Stock based compensation
CPRIT grant claimed on eligible expenses (Note 11)
Other research and development expenses
2019
$
6,818
563,180
162,995
166,277
676,952
639,252
2018
$
9,704
958,377
225,840
332,706
761,995
717,702
(506,188)
1,709,286
(671,640)
2,334,684
2019
2018
399,994
48,105
805,477
710,574
3,710,789
1,190,142
783,458
435,439
197,646
192,448
1,136,582
947,432
4,787,093
1,353,527
437,642
658,655
(5,140,039)
(5,016,479)
74,058
395,600
3,017,997
5,090,146
16.
Subsequent Events
Subsequent to the year end, on May 1, 2019, Medicenna received a US$757,940 (CD$1.02 million)
reimbursement of past expenses from CPRIT. This amount was shown as receivable as of March 31,
2019.
In June 2019, 224,655 common share purchase warrants were exercised for an equivalent number of
common shares for total proceeds to the Company of $269,586.
20