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Medicenna Therapeutics

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FY2020 Annual Report · Medicenna Therapeutics
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Management’s Discussion and Analysis 

For the Year Ended March 31, 2020 

DATE OF REPORT: May 14, 2020 

 
 
 
 
 
 
 
 
 
 
 
 
 
MANAGEMENT’S DISCUSSION AND ANALYSIS 

The following management’s discussion and analysis (“MD&A”) has been prepared as of May 14, 2020 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 audited consolidated 
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 favourable 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 about the Company’s products’ safety and efficacy; 
•  expectations regarding the Company’s ability to arrange for the manufacturing of the Company’s 

products and technologies; 

•  expectations  regarding  the  progress,  and  the  successful  and  timely  completion,  of  the  various 

stages of the regulatory approval process; 

•  expectations  regarding  the  filing  and  approval  of  various  submissions  by  regulatory  agencies 

regarding the conduct of new clinical trials;  

•  ability  to  initiate,  progress,  and  successful  and  timely  completion,  of  various  preclinical  and 

manufacturing activities associated with future clinical trials; 

•  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 with respect to the protection of the Company’s intellectual property. 

• 

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. 

2 

 
The  forward-looking  information  in  this  MD&A  does  not  include  a  full  assessment  or  reflection  of  the 
unprecedented impacts of the COVID-19 pandemic occurring in the first quarter of 2020 and the ongoing 
and  developing  resulting  indirect  global  and  regional  economic  impacts.  The  Company  is  currently 
experiencing  uncertainty  related  to  the  rapidly  developing  COVID-19  situation.  It  is  anticipated  that  the 
spread of COVID-19 and global measures to contain it, will have an impact on the Company, however it is 
challenging  to  quantify  the  potential  magnitude  of  such  impact  at  this  time.  The  Company  is  regularly 
assessing  the  situation  and  remains  in  contact  with  its  partners,  clinical  sites  investigators,  contract 
research  organizations,  contract  development  and  manufacturing  organizations  and  suppliers  to  assess 
any impacts and risks. 

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 was 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  (later  extended  to  a  five-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. 

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 
tunable  cytokines,  called 
interleukin-2  (“IL-2”), 
“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 

interleukin-4  (“IL-4”)  and 

interleukin-13  (“IL-13”) 

3 

 
potent toxins to the cancer cells without harming adjacent 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 therapeutic 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 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, chimeric antigen receptor T cells (“CAR-Ts”) or oncolytic viruses 
to  stimulate  tumor-killing  immune  cells  or  overcome  the  immunosuppressive  tumor  microenvironment 
(“TME”).  

Medicenna has completed enrolment in a Phase 2b clinical trial of MDNA55, Medicenna’s lead EC, for the 
treatment of recurrent glioblastoma (“rGBM”), the most common and uniformly fatal form of brain cancer. 
MDNA55  is  a  fusion  of  a  circularly  permuted  version of  IL-4, fused to  a  potent fragment  of  the  bacterial 
toxin, Pseudomonas exotoxin (“PE”), that is designed to preferentially target tumor cells that over-express 
the  interleukin-4  receptor  (“IL4R”).  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 and additional survival data in December 2019 and January 2020. Medicenna plans to have 
an End of Phase 2 (“EOP2”) meeting with the FDA in 2020. 

Complementing  Medicenna’s  lead  clinical  asset  (MDNA55),  the  Company  has  built  a  deep  pipeline  of 
promising  preclinical  Superkine  candidates  such  as  IL-2  agonists  (MDNA109),  IL-2  antagonists 
(MDNA209), dual IL-4/IL-13 antagonists (MDNA413) and IL-13 Superkine (MDNA132) all in-licensed from 
Leland  Stanford  Junior  University  (“Stanford”).  The  most  advanced  of  these  programs  is  the  MDNA109 
platform  (comprising  of  MDNA11  and  MDNA19),  which  is  in  preclinical  development  and  is  the  only 
engineered IL-2 Superkine designed to specifically target CD122 (IL-2Rβ) with high affinity without CD25 
dependency.  Both  MDNA11  and  MDNA19,  which  unlike  native  IL-2  (Proleukin),  have  superior 
pharmacokinetic properties, lack CD25 binding in order to improve safety, potently stimulate effector T cells, 
reverse natural killer (“NK”) cell anergy and act with exceptional synergy when combined with checkpoint 
inhibitors. Medicenna is working towards initiating a Phase 1 clinical study with the MDNA109 platform in 
mid-2021. 

ACHIEVEMENTS & HIGHLIGHTS  

The following are the achievements and highlights for the year ending March 31, 2020 through to the date 
hereof: 

•  On April 30, 2019, we announced completion of enrolment in the MDNA55 Phase 2b clinical study for 

the treatment of rGBM. 

•  On May 1, 2019, Medicenna received US$757,940 from CPRIT for reimbursement of past expenses. 

•  On June 3, 2019 a poster entitled “MDNA55: A Locally Administered IL4 Guided Toxin as a Targeted 
Treatment  for  Recurrent  Glioblastoma”  was  presented  at  the  55th  Annual  Meeting  of the  American 
Society of Clinical Oncology (“ASCO”) 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  IL4R  that  may  enable  better  selection  and  superior  treatment  outcomes  for 
patients with rGBM.  

4 

 
•  On June 18, 2019, Dr. Fahar Merchant presented results from the Phase 2b MDNA55 clinical trial for 
rGBM  at  the  Inaugural  Immuno-Oncology  Pharma  Congress  in  Boston,  MA.  The  presentation 
highlighted  disease  control  in  up  to  83%  of  the  patients  according  to  Immunotherapy  Response 
Assessment  in  Neuro-Oncology  (“iRANO”)  criteria  which  measure  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  Montréal, 
highlighted that MDNA109-LA (a precursor of MDNA19) when combined with checkpoint inhibitors (a) 
demonstrated durable tumor control with strong memory response; (b) enhancing activation of naive 
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 26, 2019, we reported preclinical data on MDNA55 which showed promising results in ovarian 

cancer models. 

•  On July 9, 2019 Medicenna announced that it had received US$1,915,372 in non-dilutive funding from 

CPRIT. 

•  On July 31, 2019, we announced the selection of MDNA19 as our second immuno-oncology clinical 
candidate  for  the  treatment  of  cancer.  MDNA19  is  a  best-in-class  long-acting  IL-2  developed  from 
Medicenna's Superkine platform that has shown unique ability to selectively stimulate cancer killing 
immune cells without the limitations seen with other long-acting IL-2 programs.  

•  On  September  24,  2019,  we  announced  the  appointment  of  Ms.  Karen  Dawes  to  our  Board  of 
Directors. Ms. Dawes is an experienced and highly regarded leader in the life sciences industry with 
extensive strategic expertise and considerable commercial background. 

•  On  September  25,  2019,  we  presented  updated  efficacy  results  from  the  Phase 2b clinical  trial 
(MDNA55-05) in the first 33 rGBM patients enrolled in the study. MDNA55 is a potent immunotherapy 
agent as it potently targets the IL4R which is overexpressed in glioblastoma (“GBM”) as well as non-
cancerous  cells  that  make  up  the  brain  tumour  microenvironment  (“TME”).  The  data  imply  that 
targeting the TME, particularly in GBM, is critical where almost half of the tumor mass is made up of 
the TME, a cancer swamp that hides the tumor from the immune system. The TME is emerging as 
one of the key reasons why glioblastoma is extremely aggressive, and continues to be one of the most 
difficult cancers to treat. Since MDNA55 can simultaneously kill both the tumor cells and the TME by 
targeting the IL4R, the results to date indicate that MDNA55 could emerge as a new treatment for this 
deadly disease. 

•  On September 26, 2019 Medicenna announced the publication of a peer-reviewed article in the August 
2019 edition of Nature Communications providing independent third-party validation of Medicenna’s 
IL-2 Superkine platform, MDNA109. 

•  On  September 30,  2019,  we  announced  the  presentation  of  new  preclinical  data  from  our  IL-2 
Superkine program to support the differentiating characteristics of long-acting MDNA109 variants and 
their potency in vitro and in vivo from other long-acting IL-2 programs.  

•  On  October  17,  2019,  Medicenna  completed  a  public  offering  raising  total  gross  proceeds  of 
$6,900,000. The Company issued 5,307,693 units at a price of $1.30, each such unit consisting of one 
common share and one-half common share purchase warrant. Each such whole warrant is exercisable 
at a price of $1.75 until October 17, 2022. 

5 

 
•  On  November  21,  2019,  we  announced  new  positive  results  on  drug  distribution  from  the  recently 
completed Phase 2b clinical trial of MDNA55. Implementing new advances in convection enhanced 
delivery (“CED”), that were previously not available allows us to bypass the blood-brain barrier and 
deliver  high  concentrations  of  MDNA55  directly  to  the  tumor  and  the  at-risk  area  immediately 
surrounding it, without exposure to the rest of the body. 

•  On November 25, 2019, Medicenna announced the presentation of updated clinical results from the 
Phase 2b trial  of  MDNA55,  by  Dr.  John  Sampson  at  the  24th Society  for  Neuro-Oncology  (“SNO”) 
annual  meeting.  Dr.  Sampson  discussed  updated  efficacy  results  from  the  Phase 2b clinical  trial  of 
MDNA55 in rGBM patients using the IL4R as an immunotherapy target.  

•  On  December  12,  2019,  we  announced  a  presentation  by  Dr. Fahar  Merchant  at  the  Inaugural 
Glioblastoma Drug Development Annual Summit. The presentation reported subgroup analysis from 
the first 40 patients treated with MDNA55 in a Phase 2b clinical trial for patients with rGBM.  

•  On January 8, 2020 we announced receipt of $1.3 million in proceeds from the exercise of previously 

issued warrants. 

•  On January 13, 2020, Medicenna announced results from a retrospective study of subjects with rGBM 
who  matched  eligibility  requirements  of  subjects  enrolled  in  the  MDNA55-05  clinical  trial  (Synthetic 
Control Arm, “SCA”) receiving standard therapies and compared their survival versus subjects treated 
with  MDNA55,  in  the  Phase 2b rGBM  clinical. The  SCA  comprised  81  rGBM  patients  receiving 
standard  therapies  including  Avastin®,  lomustine  and  temozolomide  (“TMZ”)  with  similar  baseline 
features as patients treated in the MDNA55 trial such as age, tumor size, ineligibility for surgery, lack 
of isocitrate dehydrogenase (“IDH”) mutations, IL4R expression and other parameters known to affect 
survival. When comparing IL4R High groups across the two populations, a 150% survival advantage 
is seen in patients who received MDNA55. 

•  On March 17, 2020, the Company closed a public offering of 11,290,323 common shares at a price 
of $3.10 per share for gross proceeds of approximately $35 million (the “2020 Public Offering”). 

•  On March 25, 2020, Medicenna presented preclinical data, including non-human primate (“NHP”) data 
from its IL-2 Superkine program, highlighting data from the long-acting variant MDNA19, engineered 
to  have  enhanced  binding  to  CD122  without  binding  to  CD25.  This  allows  MDNA19  to  specifically 
activate naive CD8 T cells and NK cells with minimal stimulation of regulatory T cells (“Tregs”), thereby 
circumventing toxicity and demonstrating potential for best-in-class features which was supported by 
the NHP data. 

• 

In March 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic. 
We continue to monitor the COVID-19 situation, which is rapidly developing. The Company operates 
in a virtual manner and current operations have not been impacted in any material way by the health 
crisis. However, the pandemic does have an impact on our third party vendors which could result in 
the interruption of operations and result in development delays including the timing of the EOP2 clinical 
study meeting for MDNA55 with the FDA, the ongoing preclinical and future clinical activities related 
to MDNA19 or MDNA11. We have required all of our employees to work from home and are asking 
business partners to engage us by telephone or video conference where possible, eliminating business 
travel and requiring self-isolation for employees travelling outside of Canada. As the COVID-19 health 
crisis further develops, we will continue to rely on guidance and recommendations from local health 
authorities, Health Canada and the Centers for Disease Control and Prevention to update our policies. 

• 

Subsequent  to the  year  end, On  April  15,  2020, Medicenna  announced  the  closing  of  the full  over-
allotment  option  to  purchase  an  additional  1,693,548  common  shares  of  Medicenna  at  a  price 
of $3.10 per share, in connection with the 2020 Public Offering. 

6 

 
•  Subsequent to the year end, on May 4, 2020, we announced that Medicenna will be presenting two 
abstracts  at  the  American  Society  of  Clinical  Oncology  Virtual  Scientific  Program  to  be  held 
from May 29 to May 31, 2020. The first abstract on our MDNA55 rGBM program has been selected 
for a poster discussion and will provide new data on tumor response as well as survival outcomes 
compared  to  a  matched  SCA.  The  second  abstract  will  present  preclinical  data  including  non-
human primate data for MDNA11, one of Medicenna's MDNA109 platform candidates.  

FINANCING UPDATE 

Year ended March 31, 2020 

On October 17, 2019, Medicenna completed a public offering raising total gross proceeds of $6,900,000. 
The  Company  issued  5,307,693  units  at  $1.30,  consisting  of  one  common  share  and  one-half  common 
share purchase warrant. Each whole warrant is exercisable at $1.75 until October 17, 2022. The Company 
paid commission to the agents totaling $455,175 and issued 350,134 warrants to the agents exercisable 
into one common share of the Company at an exercise price of $1.30 for a period of twenty-four months.  

On  March  17,  2020,  Medicenna  completed  the  2020  Public  Offering  of  11,290,323  shares  for  gross 
proceeds  of  $35,000,001.  In  the  context  of  the  2020 Public  Offering,  Medicenna  issued  790,323  broker 
warrants as partial consideration for the services provided by the agents in connection with the 2020 Public 
Offering. Each broker warrant is exercisable for one common share at a price of $3.10 per common share 
until March 17, 2022. The total costs associated with the 2020 Public Offering were $3,365,487, including 
an amount of $456,016 which represents the estimated fair value of the broker warrants.  

During the year ended March 31, 2020, 1,623,675 warrants were exercised for proceeds of $2,372,822, 
the details of which are described below: 

Number of 
Warrants 

Exercise 
Price 

Proceeds 

Expiry Date 

695,544 
138,631 
35,000 
222,500 
532,000 
1,623,675 

$ 
1.75 
1.30 
2.00 
1.20 
1.20 

$ 
1,217,202 
180,220 
70,000 
267,000 
638,400 
2,372,822 

October 17, 2022 
October 17, 2021 
April 5, 2021 
December 21, 2020 
December 21, 2023 

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  such  whole  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 this offering, Medicenna issued 4,000,000 common shares and 2,000,000 warrants, as well as 280,000 
broker  warrants  as  partial  consideration  for  the  services  provided  by  the  agents  in  connection  with  this 
offering. Each such broker warrant is exercisable for one common share at a price of $1.20 per common 
share until December 21, 2020. 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 issued.  

There were no warrants exercised in the year ended March 31, 2019. 

Subsequent Events 

Subsequent to the year end, on April 15, 2020, Medicenna announced the closing of the full over-allotment 
option to purchase an additional 1,693,548 common shares of Medicenna at a price of $3.10 per share, in 

7 

 
 
 
 
 
 
connection  with  the  2020  Public  Offering.  As  a  result  of  the  exercise  of  this  over-allotment  option, 
Medicenna  received  additional  gross  proceeds  of  $5,249,999,  which  will  be  used  to  fund  further 
development  of  Medicenna’s  MDNA109  platform  candidate  (MDNA19  or  MDNA11)  including  preclinical 
activities,  manufacturing  and  Phase  1/2a  clinical  trials  as  well  as  for  general  corporate  purposes  and 
working capital. 

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 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,  data  from  the  MDNA55  Phase  2b  clinical  trial  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 Institutes 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 patients (at least 46 intent-to-treat (“ITT”) patients evaluable for survival and 35 patients 
evaluable for response), 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 an expected 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 approximately 46 ITT or per protocol 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 an 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 retrospectively evaluated. 

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  and  1  site  in  Europe  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. 

8 

 
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  (ITT  population)  of  which  44  patients  met  all  the  protocol  eligibility 
requirements (per protocol population). 

On October 10, 2017, clinical data were 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 of MDNA55 in rGBM patients and a reassuring safety profile. 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  1 cm  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 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 and true disease progression. These tools would encourage 
subjects to remain in the study, where appropriate, giving time for the pseudo-progression to resolve and 
increase the likelihood of clinical responses.  

9 

 
Following the amended protocol as announced on May 2, 2018 and after receiving the necessary regulatory 
and  site  approvals  patient  enrolment  was  resumed  at  higher  doses  provided  that  the  pre-established 
maximum tolerated dose (“MTD”) of 240µg was not to be exceeded.  

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 a slowdown of 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.  These  results  have  subsequently  be 
superseded by more complete data presented in late 2019 and January 2020. 

On  April  30,  2019,  Medicenna  announced  that  enrolment  in  the  study  was  complete  with  46  evaluable 
patients (ITT population) of which 44 patients were subsequently identified as meeting protocol eligibility 
requirements without major deviations (per protocol population). 

On  June  3,  2019,  a  poster  entitled  “MDNA55:  A  Locally  Administered  IL4  Guided  Toxin  as  a  Targeted 
Treatment for  Recurrent Glioblastoma”  was  presented  at  the  55th  Annual  Meeting  of  the  ASCO  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  IL4R  that  may  enable  better 
selection and superior treatment outcomes for patients with rGBM. These data were subsequently updated 
as 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, which 
measure 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.  

On September 25, 2019, the Company presented updated efficacy results from the Phase 2b clinical trial 
MDNA55-05  in  rGBM  patients  using  the  IL4R  as  an  immunotherapy  target,  as  it  is  overexpressed  in 
glioblastoma as well as in cells that make up the brain tumor microenvironment (“TME”). The data imply 
that targeting the TME, particularly in GBM, is critical where almost half of the tumor mass consists of non-
cancerous cells that make up the TME, a cancer swamp that hides the tumor from the immune system. The 
TME is emerging as one of the key reasons why glioblastoma is extremely aggressive, and continues to be 
one of the most difficult cancers to treat. Since MDNA55 can simultaneously kill both the tumor cells and 
the TME by targeting the IL4R, the results to date continue to show that MDNA55 is likely to emerge as a 

10 

 
new treatment for this deadly disease. These data were subsequently updated in November and December 
2019 and January 2020. 

On November 25, 2019, Medicenna announced the presentation of updated clinical results presented by 
Dr. John Sampson from our Phase 2b trial of MDNA55 at the 24th SNO annual meeting. The presentation 
highlighted that with a single treatment with MDNA55, the mOS in IL4R High subjects (n=21) was 15 months 
showing a survival advantage of up to nine months when compared to approved therapies (mOS of 5.4 to 
9.2 months with temozolomide, Avastin® and lomustine), among the 38 evaluable subjects, irrespective of 
IL4R expression, 82% of the subjects experienced tumor shrinkage or stabilization from nadir. The mOS of 
patients showing tumor control (n=31) was significantly longer when compared to patients with progressive 
disease (mOS of 15 months vs 8.4 months, respectively; p-value of 0.0112) and updated analysis included 
the first 40 subjects treated with MDNA55 continuing to show an overall survival rate at 12 months (OS-12) 
of  45%,  irrespective  of  IL4R  expression,  and  OS-12  of  58%  in  patients  showing  a  treatment  response 
(n=32). This is an improvement of up to 150% when compared to approved therapies for rGBM (OS-12 is 
18-34%). 

On December 12, 2019, the Company announced a presentation by Dr. Fahar Merchant at the Inaugural 
Glioblastoma  Drug  Development  Annual  Summit.  The  presentation reported  subgroup  analysis  from the 
first 40 patients treated with MDNA55 in the Phase 2b clinical trial. The presentation highlighted that the 
patient  characteristics  in  the  clinical  study  excluded  patients  that  are  known  to  have  a  much  better 
prognosis, such as patients that were, (a) eligible for surgery to remove the tumor, (b) had a lower grade of 
brain cancer at initial diagnosis (only de novo GBM patients were enrolled), and (c) had a known mutation 
associated with better prognosis (IDH mutation). Furthermore, the presentation emphasized that despite 
enrolling only patients known to have a very poor prognosis, patients actually did much better and were 
surviving significantly longer following only one treatment with MDNA55, particularly in patients with high 
expression of the IL4R target. Of particular interest, subjects receiving lower doses of steroids (≤ 4mg of 
concurrent steroid per day) showed a trend towards improved survival, particularly in the IL4R High group, 
with  a  mOS  of  16.5  months  with  88%  of  patients  being  still  alive  at  12  months.  In  patients  resistant  to 
approved chemotherapy temozolomide (rGBM with unmethylated MGMT promoter), MDNA55 treatment in 
IL4R High patients had a median overall survival of 15.2 months and a 12 month survival rate of 69% versus 
22% for lomustine and less than 19% for Avastin®. 

On January 13, 2020, Medicenna announced that it had completed a retrospective study on subjects with 
rGBM who matched eligibility requirements of subjects enrolled in the MDNA55-05 clinical trial. The study 
was conducted to compare the survival of subjects treated with MDNA55 in the Phase 2b rGBM clinical trial 

11 

 
 
versus matched patients (Synthetic Control Arm or SCA) recently treated using other standard therapies. 
The SCA comprised of 81 rGBM patients receiving standard therapies including Avastin®, lomustine and 
temozolomide with similar baseline features as patients treated in the MDNA55 trial such as age, tumor 
size, ineligibility for surgery, IL4R expression and other parameters known to affect survival. 

Key data from the study are summarized below and have been computed from the date of relapse rather 
than from the date of treatment in results previously reported by the Company: 

•  When comparing IL4R High groups across the two populations, a 150% survival advantage is 

seen in patients who received MDNA55. 

o 

IL4R High subjects treated with MDNA55 (n=21) had a mOS of 15.8 months versus 6.2 
months in the SCA (n=17), a survival advantage of an impressive 9.6 months. 

o  The 12 month overall survival (“OS-12”) was 62% in the MDNA55 arm versus 24% in the 

SCA. 

•  Regardless of IL4R status, subjects treated with MDNA55 (n=44 subjects comprising the 

complete per protocol analysis population) demonstrated 112% increase in OS-12 over subjects 
in the SCA (n=81). 

o  OS-12 for the MDNA55 arm was 53% versus 25% in the SCA. 

o  mOS in the MDNA55 arm was 12.4 months versus 7.7 in the SCA. 

Medicenna plans to have an EOP2 meeting with the FDA in 2020 to discuss the results of the MDNA55 
Phase 2b clinical study and the development pathway forward. This date is later than previously anticipated 
due  to  additional  information  being  prepared  in  order  to  strengthen  the  submission  to  the  FDA  as 
recommended by regulatory consultants. 

The  Company  expects  the  completion  of  clinical  development  of  MDNA55  to  full  approval  (including  a 
pivotal  Phase  3  clinical  trial),  if  undertaken  by  Medicenna,  to  last  until  at  least  2022,  with  a  projected 
aggregate cost of up to 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 work to out-license the program to one or more partners who would fund or co-

12 

 
 
fund Phase 3 clinical development of MDNA55 as well as prepare the program for commercialization and 
its subsequent launch in various countries where approval has been granted. 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 test for IL4R expression prior to treatment with MDNA55. See 
“Risk Factors” below.  

Superkine Platform 

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 dampens 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 and/or 
block the function of regulatory cells. Medicenna’s MDNA109 and MDNA209 platforms take advantage of 
this  dynamic  by  binding  to  specific  receptors  and  either  activating  (MDNA109)  or  blocking  them 
(MDNA209). The majority of development has been focused on the MDNA109 platform candidates where 
promising results have been demonstrated in various animal tumour models, as described below. 

MDNA109 (a precursor to MDNA19 and MDNA11) is an enhanced version of IL-2 that binds up to 200 to 
1,000  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 
NK cell anergy and acts with exceptional synergy when combined with checkpoint inhibitors.  

One of the development challenges with MDNA109 was its short half-life, similar to native IL-2, which would 
require frequent dosing in a commercial setting. In order to extend the half-life of MDNA109, Medicenna 
fused inactive protein scaffolds to MDNA109 including Fc-fusions (Fc) and Albumin fusions (Alb) and, on 
August 2, 2018, we announced preliminary preclinical data on long acting variants of MDNA109, showing 
that these fusions have better pharmacokinetic properties enabling less frequent dosing without sacrificing 
its efficacy or safety.  

Further  modifications  were  made 
to  enhance 
pharmacodynamics and further enhance selectivity in order to reduce binding to CD25 which is associated 
with the toxic side effect profile of Proleukin. These modifications have provided us with two lead candidates 
in development, MDNA19 and MDNA11. 

its  extended  half-life 

to  MDNA109 

forms 

in 

On February 6, 2019, the Company presented 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 

13 

 
Inhibitors”  by  Moutih  Rafei,  PhD,  Associate  Professor,  Department  of  Pharmacology  and  Physiology, 
Université de Montréal, 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, MDNA19, 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 MDNA19. (d) To further validate the potency of MDNA19 mice with 
pre-established aggressive B16F10 melanoma tumors showed potent tumor control with a weekly dosing 
schedule.  

On  July  31,  2019,  we  announced  the  selection  of  MDNA19  as  our  second  immuno-oncology  clinical 
candidate  for  the  treatment  of  cancer.  MDNA19  is  a  best-in-class  long-acting  IL-2  developed  from 
Medicenna's MDNA109 Superkine platform that has shown unique ability to selectively stimulate cancer 
killing immune cells without the limitations seen with other long-acting IL-2 programs.  

On September 26, 2019, Medicenna announced the publication of a peer-reviewed  article in the August 
2019  edition  of Nature  Communications providing  independent  third-party  validation  of  Medicenna’s 
MDNA109 Superkine platform. 

The publication titled “A next-generation tumor-targeting IL-2 preferentially promotes tumor infiltrating CD8+ 
T-cell  response  and  effective 
the  safety,  efficacy,  pharmacokinetics, 
immunogenicity as well  as efficacy profile in different tumor models of long-acting variants of MDNA109 
including  fusions  to  antibodies  to  create  tumor  targeted  immunocytokines.  The  work  reported  in  the 
publication is covered by Medicenna’s patents and patents in-licensed by the Company. 

tumor  control” describes 

On  September 30,  2019,  Medicenna  announced  the  presentation  by  Dr. Minh  To,  Director  of  Preclinical 
Development at Medicenna, of preclinical data to support the differentiating characteristics of long-acting 
MDNA109 variants and their potency in vitro and in vivo from other long-acting IL-2 programs.  

Highlights from the presentation included:  

•  High potency towards naive effector T cells but diminished potency on unwanted regulatory T cells 
(Tregs). Of the long-acting MDNA109 variants, MDNA19 is superior in having decreased binding 
to CD25 and increased affinity to CD122, therefore selectively activating cancer killing CD8 T cells 
instead of tumor protecting Tregs. 

14 

 
•  Potent effects as monotherapy with improved PK characteristics. In CT26 (mouse colon cancer) 
and B16F10 (mouse melanoma) models, treatment with long acting variants of MDNA109 (biweekly 
for 2 weeks or once weekly for 2 or 3 weeks) potently inhibited tumor growth. These data suggest 
that long-acting MDNA109 variants could lead to potent therapeutic effects with a dosing schedule 
similar  to  that  used  for  immune  checkpoint  inhibitors.  In  addition,  the  results  also  confirm  that 
different protein scaffolds may be used to extend the half-life of MDNA109 and can provide similar 
tumor control as MDNA19. 

•  Compelling  preclinical  synergism  with  immune  checkpoint  inhibition.  In  a  pre-established  colon 
cancer CT26 model, long-acting MDNA109 variants co-administered with the immune-checkpoint 
blocker anti-cytotoxic T-Lymphocyte-Associated Protein (CTLA) 4, showed significant tumor growth 
inhibition with as many as 89% of animals remaining tumor-free for over 175 days. 

•  Strong  Memory  Response.  Furthermore,  tumor  free  animals  receiving  a  second  and  third  re-
challenge  of  the  tumor  without  further  treatment  remained  tumor  free  in  up  to  100%  of  mice, 
demonstrating development of a strong memory response with the ability to prevent tumor relapses.  

On  March  25,  2020,  Medicenna  announced  preclinical  data  including  NHP  data  from  its IL-2  Superkine 
program during a conference call and webcast. 

The  presentation  highlighted  data  from  the  long-acting  variant  MDNA19,  engineered  to  have  enhanced 
binding to CD122 without binding to CD25 and included: 

•  Kinetic studies in NHP showed a dose-dependent upregulation of Ki67 in CD8 T-cells lasting for 

almost two weeks post-MDNA19 administration, with no apparent side effects. 

•  When administered to NHP, MDNA19 increases the absolute number of circulating CD8 T-cells in 
the absence of Treg and eosinophil stimulation (the latter being a major source of IL-5 production 
which is responsible for triggering vascular leak syndrome and associated toxicity). 

•  MDNA19  administration  as  a  monotherapy  in  syngeneic  mice  with  pre-established  CT26  colon 
cancer led to 60% survival and induction of strong and long-lasting memory responses correlating 
with resistance to subsequent re-challenges. 

•  Furthermore, MDNA19 treatment of B16F10 tumors favoured activation of CD8 T cells over Tregs 

in the tumor microenvironment driving a strong therapeutic effect. 

Medicenna has commenced GLP and GMP related manufacturing activities with the intention of starting 
IND  enabling  studies  in  the  second  half  of  calendar  2020  and  initiating  a Phase  1/2a  clinical  trial  in  mid 
2021.  These  timelines  are  later  than  what  was  previously  disclosed  as  additional  optimization  to  the 
molecules  in  development  was  necessary  to  to  further  enhance  Medicenna's  long  acting  MDNA109 
program as potentially best in class. 

Like the MDNA109 platform, MDNA209 therapeutics bind with exceptional affinity to IL-2Rβ, but are unable 
to bind to the common IL-2γ receptor which in turn blocks signaling and activation of NK cells and memory 
CD8  T  cells.  MDNA209  platform  offers  a  variety  of  candidates  that  are  either  partial  agonists,  partial 
antagonists  or  complete  antagonists,  enabling  us  to  dampen  the  signaling  properties  of  an  over-active 
immune system to an amplitude that elicits desired therapeutic function without causing undesired toxicity. 
MDNA209 variants can therefore be used to treat a host of autoimmune diseases such as multiple sclerosis 
and preliminary studies (Mitra et al, 2015) have shown that MDNA209 variants can also mitigate graft versus 
host  disease  (GvHD)  following  transplantation.  Limited  work  on  MDNA209  has  been  initiated  but 
development timelines have not been established 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 IL4 receptors or dedicated IL13 receptors 
such as IL13Ra2. This selectivity is achieved through mutations of the IL-4 or IL-13 proteins to enhance 

15 

 
affinity for binding to specific IL4R or IL13R 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 the Th2 biased tumour microenvironment, 
which shields the cancer from the immune system. 

Another promising IL-13 Superkine is MDNA132. Unlike MDNA413, MDNA132 is an IL-13 ligand that has 
been  engineered  to  increase  affinity  for IL13Ra2  overexpressed  on  certain  solid  tumors  while  exhibiting 
sharply decreased affinity for IL13Ra1. 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 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. 

SELECTED FINANCIAL INFORMATION  

General and administration 

Research and development 

Net loss 

Basic and diluted loss per share 

Total assets 

Total liabilities 

2020 
$ 

2,375,211 

5,869,588 

2019 
$ 

1,709,286 

3,017,997 

2018 
$ 

2,334,684 

5,090,146 

(8,277,069) 

(4,708,031) 

(7,465,452) 

(0.26) 

37,996,268 

1,847,196 

(0.18) 

5,187,428 

2,570,871 

(0.31) 

4,374,582 

2,212,757 

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, 2020, we reported a net loss of $8,277,069, or $0.26 per share, compared to a 
loss of $4,708,031, or $0.18 per share, for the year ended March 31, 2019. The increase in net loss for the 
year ended March 31,  2020 compared with the year  ended March 31, 2019 was primarily a result of  lower 
amount of costs reimbursed under the CPRIT grant in the current year compared with the prior year and an 
increase in spending on discovery and preclinical expenses associated with the development of the MDNA109 
platform (MDNA11 and MDNA19).  

Cash utilized in operating activities for the year ended March 31, 2020 of $8,799,856, compared to cash utilized 
in operating activities for the year ended March 31, 2019 of $8,037,005. The increase in cash utilized in the 
current year was primarily a result of reduced accounts payable and accrued liabilities balances. 

16 

 
 
 
RESULTS OF OPERATIONS FOR THE YEAR ENDING MARCH 31, 2020 

Research and Development Expenses 

Chemistry, manufacturing and controls  

Regulatory 
Discovery and preclinical 
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, 2020 
$ 

Year ended 
March 31, 2019 
$ 

342,578 

432,948 
1,898,191 
- 
1,528,299 
1,095,118 
810,987 
486,421 

(951,166) 

226,282 

5,869,588 

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 

Research and development (“R&D”) expenses of $5,869,588 were incurred during the year ended March 31, 
2020, compared with $3,017,997 incurred in the year ended March 31, 2019.  

The increase in R&D expenses in the current year is primarily attributable to: 

Increased regulatory costs associated with preparation for the EOP2 meeting.  

• 
•  Higher  discovery  and  preclinical  expenses  associated  with  the  development  of  the  MDNA109 

platform (MDNA11 and MDNA19) as we advance it towards the clinic. 

•  Other  research  and  development  expenses  increased  due  to  travel  and  administrative  costs 

associated with closing clinical sites, program symposium and the EOP2 meeting. 

•  A lower reimbursement of expenses with respect to the CPRIT grant of $951,166 in the year ended 

March 31, 2020, compared with $5,140,039 in the year ended March 31, 2019. 

The above increases were partially offset by the following reductions: 

•  No amortization related to the research & development warrant which was fully amortized in the 

prior year. 

•  Lower clinical trial costs due to completion of enrolment in the Phase 2b rGBM clinical study and 

the wind down of the study.  

The clinical trial costs incurred in the current year consist of: 

•  Clinical trial site close out costs and associated data collection from sites and central labs. 
•  Completion of all laboratory analysis of samples obtained from clinical trials. 
•  Costs  associated  with  the  initiation  and  completion  of  the  Synthetic  Control  Arm  study  in  81 

patients. 

17 

 
 
 
 
 
 
 
 
General and Administrative Expenses 

Depreciation expense 
Stock based compensation 
Facilities and operations 
Legal, professional and finance 
Salaries and benefits 
Corporate communications 
Other expenses 
CPRIT grant claimed on eligible expenses 

Year ended 
March 31, 2020 
$ 

Year ended 
March 31, 2019 
$ 

7,893 
638,556 
252,716 
186,026 
595,588 
559,089 
260,715 
(125,372) 

6,818 
563,180 
162,995 
166,277 
676,952 
368,199 
271,054 
(506,188) 

2,375,211 

1,709,286 

General and administrative (“G&A”) expenses of $2,375,211 were incurred during the year ended March 31, 
2020, compared with $1,709,286 during the year ended March 31, 2019.  

The increase in G&A expenditures year over year is primarily attributed to lower amounts of expenses eligible 
for  reimbursement  from  CPRIT  in  the  current  year  as  well  as  higher  facilities  and  operations  expenses 
associated with office rent and relocation costs and higher corporate communications expenses in the current 
year due to  increased  activity. Stock  based compensation  expense  increased in the year  ended March  31, 
2020 compared with the prior year due to the timing of grants as well as higher Black Scholes values of current 
year grants.  

SUMMARY OF QUARTERLY FINANCIAL RESULTS 

Mar. 31 
2020 

$ 

Dec. 31 
2019 

$ 

Sept. 30 
2019 

$ 

June 30 
2019 

$ 

Mar. 31 
2019 

$ 

Dec. 31 
2018 

$ 

Sept. 30 
2018 

$ 

June 30 
2018 

$ 

Revenue 

- 

- 

- 

- 

- 

- 

- 

- 

General and administration 

529,338 

741,786 

642,548 

461,539 

414,154 

437,218 

443,363 

414,551 

Research and development 

2,135,410 

1,659,444 

1,246,292 

828,442 

661,314 

1,275,896 

445,814 

634,973 

Net loss 

(2,688,713) 

(2,389,463) 

(1,904,259) 

(1,294,634) 

(1,049,074) 

(1,723,081) 

(897,659) 

(1,038,217) 

Basic and diluted loss per 
share 

Total assets 

Total liabilities 

(0.07) 

(0.07) 

(0.07) 

(0.05) 

(0.04) 

(0.07) 

(0.04) 

(0.04) 

37,996,268 

7,315,780 

2,243,789 

3,674,228 

5,187,428 

6,017,780 

3,408,806 

3.644,480 

1,847,196 

1,993,314 

2,050,249 

1,897,899 

2,570,871 

2,512,414 

2,173,528 

2,000,746 

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 
March 31, 2020, December 31, 2019 and September 30, 2019, the CPRIT expenses eligible for offset were 
smaller than comparable quarters and therefore expenses were higher than comparable periods. 

G&A expenses are higher in the quarters ended December 31, 2019 and September 30, 2019 due to no 
expenditures  claimed  for  CPRIT  reimbursement  as  well  as  higher  stock-based  compensation  costs  and 
expenses associated with investor relations activities.  

18 

 
 
 
 
 
 
 
 
RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDING MARCH 31, 2020 

Research and Development Expenses 

Chemistry, manufacturing and controls  

Regulatory 
Discovery and preclinical 
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, 2020 
$ 

Three months 
ended 
March 31, 2019 
$ 

164,010 

168,521 
632,222 
273,732 
278,472 
413,260 
169,131 

97,866 

21,968 
170,452 
1,029,379 
268,932 
213,381 
139,503 

- 

(1,315,746) 

36,062 

2,135,410 

35,579 

661,314 

R&D expenses of $2,135,410 were incurred during the three months ended March 31, 2020, compared with 
$661,314 incurred in the three months ended March 31, 2019.  

The increase in R&D expenses in the current year is primarily attributable to: 

•  No reimbursement of expenses with respect to the CPRIT grant in the three months ended March 
31, 2020, compared with a reimbursement of $1,315,746 in the same period in the prior year. 
Increased regulatory costs associated with preparation for the EOP2 meeting.  

• 
•  Higher discovery, preclinical and manufacturing expenses associated with the development of the 

MDNA109 platform (MDNA11 and MDNA19) as we advance it towards the clinic. 

•  Higher patent and licensing fees associated with a license amendment fee. 

The above increases were partially offset by lower clinical trial costs due to completion of enrolment in the 
Phase 2b rGBM clinical study and the wind down of the study.  

General and Administrative Expenses 

Depreciation expense 

Stock based compensation 
Facilities and operations 

Legal, professional and finance 
Salaries and benefits 
Corporate communications 

Other expenses 

CPRIT grant claimed on eligible expenses 

Three months 
ended 
March 31, 2020 
$ 

Three months 
ended 
March 31, 2019 
$ 

4,183 
122,902 

65,048 
32,717 

148,760 
82,243 

73,485 
- 

529,338 

1,704 
96,966 

49,161 
30,455 

168,204 
114,395 

70,186 
(116,917) 

414,154 

19 

 
 
 
 
 
 
 
 
G&A expenses of  $529,338  were  incurred  during the three months ended  March  31,  2020, compared  with 
$414,154 during the three months ended March 31, 2019.  

The increase in G&A expenditures in the current period is primarily attributed to lower amounts of expenses 
eligible for reimbursement from CPRIT in the current year period. 

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 $31,066,720 as of March 31, 2020. With 
current  revenues  only  consisting  of  interest  earned  on  excess  cash,  cash  equivalents  and  marketable 
securities, 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  for  both  MDNA55  and  the  MDNA109  platform  (MDNA19  or 
MDNA11) 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 be sufficient to execute its current 
planned expenditures for more than the next 24 months without further financing being obtained.  

CASH POSITION 

At March 31, 2020, we had a cash, cash equivalents and marketable securities balance of $37,700,202, 
compared to $2,370,976 at March 31, 2019. We invest cash in excess of current operational requirements 
in highly rated and liquid instruments. Working capital at March 31, 2020 was $36,037,022 (March 31, 2019: 
$2,709,784). 

Subsequent  to  March  31,  2020,  we  received  gross  proceeds  of  $5,249,999  from  fulfillment  of  the  over-
allotment  in  connection  with  the  2020  Public  Offering.  We  also  have  up  to  US$1.4  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  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 

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. 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,  on  July  25,  2019  an  additional  six-month  extension  was  granted  to 

20 

 
February 28, 2020 and on January 6, 2020 an additional six-month extension was granted to August 28, 
2020. 

Of the US$14.1 million grant approved by CPRIT, Medicenna has received US$12.7 million from CPRIT as 
of March 31, 2020. The Company is eligible to receive the remaining US$1.4 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. 

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 MDNA55 related 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  on  net  sales  of  MDNA55  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, 2020, the Company received $3,539,465 from CPRIT (2019: $3,242,073). 

Intellectual Property  

On August 21, 2015, the Company exercised its right to enter into two license agreements with Stanford 
(the “Stanford  License  Agreements”).  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,  2020,  the  Company’s  intangible  assets  have  a  remaining  capitalized  net  book 
value of $76,259 (March 31, 2019: $81,205). 

The development milestones under the Stanford License Agreements were updated during the year ended 
March 31, 2020 to reflect the current stage of development of the Company’s programs. In connection with 
the amendment of the Stanford License Agreements, Medicenna paid a US$150,000 fee to Stanford. 

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, 2020, the Company is obligated to pay the following: 

•  Patent licensing costs due within 12 months totaling $70,500. 
•  Patent licensing costs, including the above, due within the next five years totaling $1,283,100. 
•  Given the current development plans and expected timelines of the Company it is assumed that 

project milestones of US$50,000 and US$100,000 will be due in the next five years. 

•  Project  milestone  payments,  assuming  continued  success  in  the  development  programs,  of 
uncertain timing totaling US$2,650,000 and an additional US$2,000,000 in sales milestones. 
•  A  liquidity  payment  of  $370,375  is  due  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. 

21 

 
As of March 31, 2020, we have the following obligations to make future payments, representing contracts 
and other commitments that are known and committed: 

 Contractual obligations 

Patent licensing costs, minimum annual 
royalties per license agreements 
Lease payments 

Liquidity event payment 

Payments Due by Period 

Less than 1 
year 

1-3 years 

3-5 years 

Total 

$ 70,500 

$ 465,300 

$ 747,300  $ 1,283,100 

$ 41,460 

$ 38,005 

$ 370,375 

$ 0 

$ 0 

$ 0 

$ 79,465 

$ 370,375 

The Company cannot reasonably estimate future royalties which may be due upon the regulatory approval 
of MDNA55 or MDNA109 assets (MDNA11 or MDNA19). 

As  at  March  31,  2020,  the  Company  had  obligations  to  make  future  payments,  representing  significant 
research  and  development  and  manufacturing  contracts  and  other  commitments  that  are  known  and 
committed, in the amount of approximately $5,740,000. Most of these agreements are cancellable by the 
Company with notice. These commitments include agreements for manufacturing and preclinical studies.  

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 and moving expenses 

$ 

891,747 
142,264 

872,585 
64,561 

Year ended 
March 31, 
2020 

2019 

$ 

891,748 
141,466 

786,121 
21,515 

Three months ended 
March 31, 
2020 

2019 

$ 

222,937 
35,512 

279,853 
7,000 

545,302 

$ 

222,937 
35,278 

180,247 
2,093 

440,555 

1,977,157 

1,840,850 

During the year ended March 31, 2020, the Company paid $64,561 (2019: $21,515) in moving, storage and 
rent  expenses  to  the  CEO  and  CDO  of  the  Company.  These transactions  were  in the  normal  course  of 
business  and  have  been  measured  at  the  exchange  amount,  which  is  the  amount  of  consideration 
established and agreed to by the related parties. 

As at March 31, 2020, the Company had trade and other payables in the normal course of business, owing 
to directors and officers of $247,696 (2019: $380,328) related to board fees and accrued vacation. 

22 

 
 
 
 
 
 
 
 
ACCOUNTING PRONOUNCEMENTS ADOPTED IN FISCAL YEAR 2020  

The  Company  has  adopted  new  accounting  standard  IFRS  16  –  Leases  (“IFRS  16),  effective  for  the 
Company’s annual period beginning April 1, 2019.  

IFRS 16 sets out the principles for the recognition, measurement, presentation and disclosure of leases 
and  requires  lessees  to  account  for  all  leases  under  a  single  on-balance  sheet  model,  with  certain 
exemptions. The standard includes two recognition exemptions for lessees: leases of “low-value” assets 
and short-term leases with a lease term of 12 months or less. At the commencement date of a lease, a 
lessee  will  recognize  a  liability  to  make  lease  payments  and  an  asset  representing  the  right  to  use  the 
underlying  asset  during  the  lease  term.  Lessees  will  be  required  to  separately  recognize  the  interest 
expense  on  the  lease  liability  and  the  depreciation  expense  on  the  right-of-use  asset.  Lessees  are  also 
required to remeasure the lease liability upon the occurrence of certain events such as a change in lease 
term.  The  lessee  will  generally  recognize  the  amount  of  the  remeasurement  of  the  lease  liability  as  an 
adjustment to the right-of-use asset. 

At the time of adoption, the Company did not have any leases which fell under IFRS 16, as all leases had 
a term of 12 months or less. 

In March 2020, the Company entered into a lease with a term of two years for which it has applied IFRS 
16. 

The Company recognized a right-of-use asset based on the amount equal to the lease liability, adjusted for 
any related prepaid and accrued lease payments previously recognized. The lease liability was recognized 
based on the present value of remaining lease payments, discounted using the incremental borrowing rate 
at  the  date  of  initial  application.  The  lease  payments  include  fixed  payments  less  any  lease  incentives 
receivable,  variable  lease  payments  that  depend  on  an  index  or  rate,  and  amounts  expected to  be  paid 
under residual value guarantees. The variable lease payments that do not depend on an index or a rate 
are recognized as expense in the period as incurred.  

The  carrying  amounts  of  the  Company’s  right-of-use  assets  and  lease  liabilities  and  movements  during 
2020 were as follows:  

 Balance as of April 1, 2019 
 Additions 
 Depreciation 
 Accreted interest expense 
 Payments 

Classification: 
Current portion of lease liabilities 
Long-term portion of lease liabilities 

Right of Use 
Asset 
$ 
- 
70,706 
(2,946) 
-  
- 
67,760  

 Lease Liability  
$ 
-  
70,706 
- 
62  
(3,455) 
67,313  

- 
- 
- 

35,344 
31,969 
67,313 

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 

23 

 
  
 
  
 
 
 
 
 
 
 
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: 

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. 

FINANCIAL INSTRUMENTS 

(a)  Fair value  

The  Company’s  financial  instruments  recognized  on  the  consolidated  statements  of  financial  position 
consist of cash, cash equivalents, marketable securities, government grant receivable, other receivables, 
accounts  payable  and  accrued  liabilities,  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. 

24 

 
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, cash equivalents and marketable securities are 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 and government grant receivable are measured at amortized cost less impairments. 

Accounts payable, 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) 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 and marketable securities. 

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,  2020,  the  Company’s  liabilities  consist  of  trade  and  other  payables  that  have  contracted 
maturities of less than one year.  

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 

25 

 
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, 2020 of $108,423 (March 31, 2019: 
$69,305). 

Balances in US dollars are as follows: 

Cash  
Accounts payable and accrued liabilities 

Deferred government grant receivable 

March 31, 2020 

March 31, 2019  

$ 

134,835  
 (899,992)   

- 

(765,157)  

$ 

118,440  
 (1,430,518)   

1,831,337 

519,259  

(c) Managing Capital 

The  Company’s  objectives,  when  managing  capital,  are  to  safeguard  cash,  cash  equivalents  and 
marketable securities 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. 

USE OF PROCEEDS 

The following table provides an update on the anticipated use of proceeds raised in the October 2019 equity 
offering  along  with  amounts  actually  expended.  As  of  March  31,  2020,  the  following  expenditures  have 
been incurred: 

Item 

Amount to 
Spend 

Spent to Date 

Adjustments 

Remaining to 
Spend 

Continued clinical 
development of 
MDNA55 
Preclinical development 
of lead IL2 Superkine 
MDNA19 or MDNA11 
General corporate and 
working capital 
purposes 
Total 

$1,400,000 

$1,239,007 

$2,375,000 

$1,565,321 

$2,392,002 

$644,332 

- 

- 

- 

$160,994 

$809,680 

$1,747,670 

$6,167,002 

$3,448,659 

$ - 

$2,718,343 

26 

 
  
 
  
The following table provides an update on the anticipated use of proceeds raised in the 2020 Public Offering 
along  with  amounts  actually  expended.  As  of  March  31,  2020,  the  following  expenditures  have  been 
incurred: 

Item 

Preclinical development 
of MDNA19 or MDNA11 
Manufacturing of 
MDNA11 or MDNA19 
clinical batch 
Clinical development of 
MDNA19 or MDNA11 
General corporate and 
working capital 
purposes 
Total 

Amount to 
Spend 

$3,300,000 

$4,400,000 

$13,150,000 

$11,350,000 

Spent to Date 

Adjustments 

Remaining to 
Spend 

- 

- 

- 

- 

- 

- 

- 

- 

$3,300,000 

$4,400,000 

$13,150,000 

$11,350,000 

$32,200,000 

$ - 

$ - 

$32,200,000 

RISKS AND UNCERTAINTIES  

An investment in the Company’s common shares (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 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 the MDNA109 platform (MDNA19 or MDNA11) 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 

27 

 
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 recruited patients 
into  the  MDNA55  clinical  trial  and  will  recruit  patients  into  future  clinical  trials.  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, the MDNA109 platform (MDNA19 and MDNA11) and other earlier 
stage  preclinical  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. 

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, 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 preclinical studies and early 
clinical trials may not be predictive of the results of later-stage clinical trials. In the case of MDNA55, the 
promising  results  seen  in  the  Phase  2b  clinical  study may  not  be  replicated  in  a  randomized,  controlled 
Phase 3 clinical study. Success in preclinical or animal studies and early clinical trials does not ensure that 

28 

 
later large-scale efficacy trials will be successful nor does it predict final results. This is applicable to the 
MDNA109 platform (MDNA19 and MDNA11) as the promising preclinical data may not be replicated in a 
clinical setting. Favourable results in early trials may not be repeated in later trials. There is no assurance 
the FDA, the 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 preclinical 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 future clinical trials, the Company’s operations and financial condition will be adversely 
impacted. 

If the  Company’s competitors  develop  and  market  products  that  are  more  effective  than the  Company’s 
existing product candidates or any products it may develop, or if they obtain marketing approval before it 
does, the Company’s 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 the MDNA109 platform (MDNA19 
and MDNA11) through the necessary preclinical 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 
its  technological  capabilities  and 
technologies  relative 
competitiveness  could  have  a  material  adverse  effect  on  the  future  preclinical  and  clinical  trials  of  its 
products, including its ability to obtain the necessary regulatory approvals for the conduct of such trials.  

their  products  and 

to 

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 
US$1.4 million tranche 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 tranche 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. 

29 

 
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 the MDNA109 platform (MDNA19 
and  MDNA11)  for  preclinical  development.  The  Company  relies  on  CDMOs  for  manufacturing,  filling, 
packaging,  storing  and  shipping  of  drug  product  in  compliance  with  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 plans to utilize CDMOs that are licensed by both the FDA and the 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  preclinical 
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. 

30 

 
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 contract research organization (“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. 

MDNA55 is in the mid stages of clinical development and the MDNA109 platform (MDNA19 and MDNA11) 
in preclinical development and, as a result, the Company will be unable to predict whether it will be able to 
profitably commercialize its product candidates. 

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,  the  MDNA109  platform  (MDNA19  and 
MDNA11) 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 
preclinical 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 the 
MDNA109  platform  (MDNA19  and  MDNA11)  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 

31 

 
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. 

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, and in the future, the MDNA109 platform (MDNA19 and MDNA11), 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. 

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 significant 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. 

32 

 
If the Company is unable to enroll subjects in clinical trials, it will be unable to complete these trials on a 
timely basis. 

It is anticipated that the COVID-19 pandemic crisis will impact ongoing trial activities across the industry 
due to the pressure placed on the healthcare system as well as governmental and institutional restrictions. 
The  Company  is  not  currently  enrolling  patients  in  a  clinical  study  and  does  not  plan  to  enroll  additional 
patients  until  2021.  Should  the  COVID-19  pandemic  continue  into  2021  the  Company’s  will  need  to 
determine at that time if initiating a clinical trial is feasible and if so the clinical team will need to work closely 
with  each  clinical  site  and  a  CRO  on  a  plan  to  ensure  that  patient  safety  and  the  integrity  of  data  is 
maintained. It is noted that some clinical sites have paused or slowed enrollment in clinical trials, while other 
sites, less impacted, are continuing activities as planned.  

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 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. 

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’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. 

33 

 
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. 

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 tumor (“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, including the potential impact of COVID-19. 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 

34 

 
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. 

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 

35 

 
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. 

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.  

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, 2020, our Common Shares traded on the TSX at a high of $4.86 and a low of 
$0.64  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 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.  

36 

 
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.  

The Company’s disclosure controls and procedures may not prevent or detect all errors or acts of fraud. 

The  Company’s  disclosure  controls  and  procedures  are  designed  to  reasonably  assure  that  information 
required to be disclosed by the Company in reports it files or submits under applicable securities laws is 
accumulated and communicated to management, recorded, processed, summarized and reported within 
the  time  periods  specified  under  applicable  securities  laws.  The  Company  believes  that  any  disclosure 
controls and procedures or internal controls and procedures, no matter how well conceived and operated, 
can  provide  only  reasonable,  not  absolute,  assurance  that  the  objectives  of the  control  system  are  met. 
These inherent limitations include the realities that judgments in decision-making can be faulty, and that 
breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by 
the individual acts of some persons, by collusion of two or more people or by an unauthorized override of 
the  controls.  Accordingly,  because  of  the  inherent  limitations  in  the  Company’s  control  system, 
misstatements or insufficient disclosures due to error or fraud may occur and not be detected. 

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  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. 

Failure to comply with the U.S. Foreign Corrupt Practices Act (“FCPA”), the Canadian Corruption of Foreign 
Public  Officials  Act  (“CFPOA”),  and  other  global  anti-corruption  and  anti-bribery  laws  could  subject  the 
Company to penalties and other adverse consequences. 

The  FCPA  and  the  CFPOA,  as  well  as  any  other  applicable  domestic  or  foreign  anti-corruption  or  anti-
bribery laws to which the Company is or may become subject generally prohibit corporations and individuals 
from engaging in certain activities to obtain or retain business or to influence a person working in an official 
capacity and requires companies to maintain accurate books and records and internal controls, including 
at foreign-controlled subsidiaries. 

Compliance with these anti-corruption laws and anti-bribery laws may be expensive and difficult, particularly 
in  countries  in  which  corruption  is  a  recognized  problem.  In  addition,  these  laws  present  particular 
challenges  in  the  pharmaceutical  industry,  because,  in  many  countries,  hospitals  are  operated  by  the 
government, and physicians and other hospital employees are considered to be foreign officials. Certain 
payments  by  other  companies  to  hospitals  in  connection  with  clinical  trials  and  other  work  have  been 
deemed to be improper payments to governmental officials and have led to FCPA enforcement actions. 

37 

 
 
The Company’s internal control policies and procedures may not protect it from reckless or negligent acts 
committed by the Company’s employees, future distributors, licensees or agents. The Company can make 
no assurance that they will not engage in prohibited conduct, and the Company may be held liable for their 
acts under applicable anti-corruption and anti-bribery laws. Noncompliance with these laws could subject 
the  Company  to  investigations,  sanctions,  settlements,  prosecution,  other  enforcement  actions, 
disgorgement  of  profits,  significant  fines,  damages,  other  civil  and  criminal  penalties  or  injunctions, 
suspension or debarment from contracting with certain persons, the loss of export privileges, whistleblower 
complaints,  reputational  harm,  adverse  media  coverage,  and  other  collateral  consequences.  Any 
investigations,  actions  or  sanctions  or  other  previously  mentioned  harm  could  have  a  material  negative 
effect on the Company’s business, operating results and financial condition. 

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.  

The  Company  may  acquire  businesses  or  products,  or  form  strategic  alliances,  in  the  future,  and  the 
Company may not realize the benefits of such acquisitions.  

The  Company  may  acquire  additional  businesses  or  products,  form  strategic  alliances  or  create  joint 
ventures with third parties that the Company believes will complement or augment its existing business. If 
the Company acquires businesses with promising products or technologies, the Company may not be able 
to realize the benefit of acquiring such businesses if the Company is unable to successfully integrate them 
with  its  existing  operations  and  company  culture.  The  Company  may  encounter  numerous  difficulties  in 
developing, manufacturing and marketing any new products resulting from a strategic alliance or acquisition 
that delay or prevent it from realizing their expected benefits or enhancing the Company’s business. The 
Company  cannot  assure  investors  that,  following  any  such  acquisition,  it  will  achieve  the  expected 
synergies to justify the transaction. 

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 

38 

 
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. 

If the Company is treated as a passive foreign investment company, United States shareholders may be 
subject to adverse U.S. federal income tax consequences 

Under the U.S. Internal Revenue Code of 1986, as amended (the “Code”), the Company will be classified 
as a passive foreign investment company (“PFIC”) in respect of any taxable year in which either (i) 75% or 
more of its gross income consists of certain types of “passive income” or (ii) 50% or more of the average 
quarterly  value  of  its  assets  is  attributable  to  “passive  assets”  (assets  that  produce  or  are  held  for  the 
production of passive income). For purposes of these tests, passive income includes dividends, interest, 
gains  from  the  sale  or  exchange  of  investment  property  and  certain  rents  and  royalties.  In  addition,  for 
purposes of the above calculations, if the Company directly or indirectly owns at least 25% by value of the 
shares  of  another  corporation,  the  Corporation  will  be  treated  as  if  it  held  its  proportionate  share  of  the 
assets and received directly its proportionate share of the income of such other corporation. PFIC status is 
a factual determination that needs to be made annually after the close of each taxable year, on the basis 
of the  composition  of  the  Company’s  income, the  relative  value  of  its  active  and  passive  assets,  and  its 
market capitalization. For this purpose, the Company’s PFIC status depends in part on the application of 
complex  rules,  which  may  be  subject  to  differing  interpretations,  relating  to  the  classification  of  the 
Company’s  income  and  assets.  Based  on  our  interpretation  of  the  law,  the  Company’s  recent  financial 
statements,  and  considering  expectations  about  the  Company’s  income,  assets  and  activities,  the 
Company believes that it was a PFIC for the taxable year ended March 31, 2020 and expects that it will be 
a PFIC for the current taxable year.  

If the Company is a PFIC for any taxable year during which a United States shareholder holds the Common 
Shares, the Company will continue to be treated as a PFIC with respect to such United States shareholder 
in all succeeding years during which the United States shareholder owns the Common Shares, regardless 
of  whether  the  Company  continues  to  meet  the  PFIC  test  described  above,  unless  the  United  States 
shareholder  makes  a  specified  election  once  the  Company  ceases  to  be  a  PFIC.  If  the  Company  is 
classified  as  a  PFIC  for  any taxable  year  during  which  a  United  States  shareholder  holds  the  Common 
Shares, the United States shareholder may be subject to adverse tax consequences regardless of whether 
the  Company  continues  to  qualify  as  a  PFIC,  including  ineligibility  for  any  preferred  tax  rates  on  capital 
gains  or  on  actual  or  deemed  dividends,  interest  charges  on  certain  taxes  treated  as  deferred,  and 
additional  reporting  requirements.  In  certain  circumstances,  a  United  States  shareholder  may  alleviate 
some of the adverse tax consequences attributable to PFIC status by making either a “qualified electing 
fund,”  (“QEF”)  election  or  a  mark-to-market  election  (if  the  Common  Shares  constitute  “marketable” 
securities under the Code). If the Company determines that it is a PFIC for this year or any future taxable 
year,  the  Company  currently  expects  that  it  would  provide  the  information  necessary  for  United  States 
shareholders to make a QEF election. 

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.  

The  Company’s  operations could  be  adversely  affected  by  events  outside  of  its  control,  such  as  natural 
disasters, wars or health epidemics 

The  Company  may  be  impacted  by  business  interruptions  resulting  from  pandemics  and  public  health 
emergencies,  including  those  related  to  COVID-19  coronavirus,  geopolitical  actions,  including  war  and 
terrorism or natural disasters including earthquakes, typhoons, floods and fires. An outbreak of infectious 
disease, a pandemic or a similar public health threat, such as the recent outbreak of the novel coronavirus 

39 

 
known as COVID-19, or a fear of any of the foregoing, could adversely impact the Company by causing 
operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour 
shortages, travel and shipping disruption  and shutdowns (including as a result of government regulation 
and  prevention  measures).  It  is  unknown  whether  and  how  the  Company  may  be  affected  if  such  an 
epidemic persists for an extended period of time. The Company may incur expenses or delays relating to 
such events outside of its control, which could have a material adverse impact on its business, operating 
results and financial condition. 

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 federal laws of Canada. Most 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, it may be difficult for holders of the Company’s securities who reside in the United States to 
effect service of process within the United States upon those directors, officers and 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. 

The Company may lose foreign private issuer status in the future, which could result in significant additional 
costs and expenses. 

The Company may in the future lose foreign private issuer status if a majority of the Common Shares are 
held in the United States and the Company fails to meet the additional requirements necessary to avoid 
loss of foreign private issuer status, such as if: (i) a majority of the Company’s directors or executive officers 
are U.S. citizens or residents; (ii) a majority of the Company’s assets are located in the United States; or 
(iii) the Company’s business is administered principally in the United States. The regulatory and compliance 
costs to the Company under U.S. securities laws as a U.S. domestic issuer may be significantly more than 
the costs incurred as a foreign private issuer.   

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.  

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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, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over 
financial reporting.  

As of March 31, 2020, 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 
48,500,376 
7,363,764 
4,130,000 
59,994,140 

For  a  detailed  summary  of  the  outstanding  securities  convertible  into,  exercisable  or  exchangeable  for 
voting or equity securities of Medicenna as at March 31, 2020, refer to notes 8, 9, and 10 in the audited 
2020 annual financial statements of the Company.  

Additional information relating to the Company, including the Company’s annual information form in respect 
of fiscal year 2020, is available under the Company’s profile on SEDAR at www.sedar.com. 

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