Exhibit
99.2
Management’s
Discussion and Analysis
For
the Three Month Period Ended October 31, 2021
(in
US Dollars)
 |
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
| 1. | Management’s
Discussion and Analysis |
The
following discussion and analysis are management’s assessment of the results and financial condition of BriaCell Therapeutics Corp.
(collectively, “BriaCell”, “we” or the “Company”).
The
following information should be read in conjunction with the audited financial statements for the year ended July 31, 2021 and the unaudited
condensed interim financial statements for the three months ended October 31, 2021 and the notes to those financial statements, all of
which are available on BriaCell’s issuer profile on SEDAR at www.sedar.com and on the Company’s website at www.briacell.com.
The
date of this management’s discussion and analysis (“MD&A”) is December 14, 2021. The Company’s comparative
amounts in this MD&A have been prepared in accordance with International Financial Reporting Standards (“IFRS”). All
dollar amounts are stated in US dollars unless otherwise indicated.
Statements
in this report that are not historical facts are forward-looking statements involving known and unknown risks and uncertainties, which
could cause actual results to vary considerably from these statements. Readers are cautioned not to put undue reliance on forward-looking
statements.
Cautionary
Statement Regarding Forward-Looking Information
This
MD&A contains “forward-looking information” within the meaning of applicable Canadian securities legislation (“forward-looking
information”). Such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause
the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking information. Readers are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date the statements were made, and readers are advised to consider such forward-looking statements in light
of the risks set forth below and as detailed under RISKS AND UNCERTAINTIES in this MD&A.
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 information, there may be other factors that cause actions, events or results to differ from those
anticipated, estimated or intended. Forward-looking information contained herein is given as of the date of this MD&A and the Company
disclaims any obligation to update any forward-looking information, whether as a result of new information, future events or results,
except as may be required by applicable securities laws. There can be no assurance that forward-looking information will prove to be
accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers
should not place undue reliance on forward-looking information.
Risk
factors affecting the Company include risks associated with the undertaking of a new business model; share dilution; a history of operating
losses; early stages of development; ability to manage growth; unproven market; manufacturing, pharmaceutical development and marketing
capability; pre-clinical studies and initial clinical trials are not necessarily predictive of future results; raw materials and product
supply; the need for additional capital and access to capital markets; competition; intellectual property; litigation to protect the
intellectual property; dependence upon management; governmental regulation and litigation risk the Company’s ability to attract
and retain skilled employees and contractors, and changes in foreign currency exchange rates.
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
| 2. | Description
of Business |
BriaCell
was incorporated under the Business Corporations Act (British Columbia) on July 26, 2006 and is listed on the TSX Venture Exchange (“TSXV”),
and as of February 24, 2021, on the Nasdaq Capital Market under the symbols “BCTX” and “BCTXW”. The Company is
developing a new therapy for advanced breast cancer. The Company’s head office in Canada is located at Suite 300 – 235 West
15th Street, West Vancouver, British Columbia, V7T 2X1 and in the United States, the Company has an office located at 180 Varick Street,
6th Floor New York, NY 10014.
Overview
BriaCell
is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer. Immunotherapies
have come to the forefront in the fight against cancer. They harness the body’s own immune system to recognize and destroy cancer
cells. BriaCell owns the US patent to SV-BR-1-GM (Bria-IMT™), a whole-cell targeted immunotherapy for cancer (U.S. Patent No. 7,674,456),
as well as patents related to PKCδ inhibitors (U.S. Patent Nos. 9,364,460 and 9,572,793). The Company is currently advancing its
targeted immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™ in combination with immune checkpoint
inhibitors and a companion diagnostic test, BriaDX™, to identify patients likely benefitting from Bria-IMT™. BriaCell currently
has a non-exclusive clinical trial collaboration with Incyte Corporation (“Incyte”) to evaluate the effects of combinations
of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte’s
development portfolio with BriaCell’s drug candidates in advanced breast cancer patients. BriaCell is conducting a Phase I/IIa
clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a combination study with immune checkpoint inhibitors such as
the Incyte drugs retifanlimab (an anti-PD-1 antibody similar to pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE:
MRK)]) and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1). The combination study
is listed in ClinicalTrials.gov as NCT03328026.
The
Company has demonstrated an early proof of principle with the Bria-IMT™ regimen (Bria-IMT™ given in combination with low-dose
pre-dose cyclophosphamide to reduce immune suppression and post-dose low-dose local interferon alpha to boost the response with cycles
every 2 weeks x 3 then monthly) without an immune checkpoint inhibitor and is intent on building upon these results to further develop
Bria-IMT™ through additional clinical testing. The results of two previous Phase I clinical trials (one with a precursor of the
Bria-IMT™ targeted immunotherapy and the other with Bria-IMT™) were encouraging in terms of both safety and efficacy in patients
with stage IV breast cancer who had failed other available therapies including various kinds of chemotherapy. Most notably, a patient
with recurrent metastases developed a remarkable response after receiving the Bria-IMT™ regimen. A lesion in the lung regressed
totally and near-complete responses were seen in other lesions. Injections were stopped as the patient completed the clinical protocol.
About three months after the last Bria-IMT™ injection, the patient was found to have relapsed, both locally and in distant areas
including the brain.
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Within
2 months after restarting Bria-IMT™ (after having obtained FDA permission), all areas of involvement showed significant regressions,
including regression of multiple lesions in the brain.
This
patient was found to allele-match1 with Bria-IMT™ at HLA-DRB1 and HLA-DRB3, human leukocyte antigen
(HLA) genes implicated in helper T cell activation and as such potentially involved in the generation of tumor-directed cellular and/or
humoral (antibodies) immune responses.
Additional
breast cancer patients have been dosed with the Bria-IMT™ regimen in 2017-2018, of which some have experienced mixed responses
(tumor regression at some sites but not at others) and clinical benefit (stable disease). Again, these responses were seen especially
in patients who matched Bria-IMT™ at certain HLA alleles who were able to develop an immune response.
These
are very preliminary results but suffice to clearly demonstrate biological activity for inducing tumor regression, an excellent safety
profile, and validate the preliminary findings. Furthermore, the data adds importantly to a proposed mechanism of action in that most
patients with tumor regressions in the initial two clinical trials (without immune checkpoint inhibitor) have had at least 1 HLA allele
match with Bria-IMT™. This is an important confirmation that Bria-IMT™ can be effective in shrinking metastatic breast cancer,
especially in patients who match at certain HLA alleles.
Subsequently
Bria-IMT™ was evaluated in combination with KEYTRUDA® in 11 patients with advanced breast cancer. The combined treatment was
generally safe and well tolerated without dose limiting toxicities. Of the eleven patients, 2 had regression of multiple tumors and another
had stable disease with clinical benefit. This study is proceeding now evaluating the combination of Bria-IMT™ with the Incyte
assets.
Bria-IMT™
was developed from a patient diagnosed with grade 2 breast cancer. As for other cancers, breast cancer can be subdivided based on its
histologic appearance (how it looks under the microscope) into grade 1 or well-differentiated (where the microscopic appearance looks
a lot like normal breast tissue); grade 2 or moderately differentiated (where the microscopic appearance looks somewhat like normal breast
tissue) and grade 3 or poorly differentiated (where the microscopic appearance looks nothing like normal breast tissue). Since Bria-IMT™
is derived from a tumor specimen from a patient with grade 2 breast cancer, it may have retained some of the characteristics of grade
2 disease. Consistently, a high proportion of patients with grade 1 or grade 2 breast cancer who had been involved in our clinical studies
had disease control, regardless of HLA-matching, suggesting that this subset may also derive more benefit from the Bria-IMT™ therapy.
1
HLA alleles correspond to HLA types and are typically used to match patients with organs when they are receiving an organ transplant
(like a kidney transplant)
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Significant
financial and corporate developments during the period
Stock
Option Grants
On
November 1, 2021, the Company issued 12,600 options with an exercise price of CAD$9.92, and expire on November 1, 2026. 10,000 of the
options were issued to a director and vest immediately, and 2,600 options were issued to members of the Company’s scientific advisory
board and vest in five equal instalments every six months, with the first instalment vesting immediately.
Exercise
of warrants
From
August 1, 2021 and through to the date of this report, 33,065 warrants with an exercise price of $5.31 were exercised for gross proceeds
of $175,575 and 800,000 warrants with an exercise price of $6.19 were exercised for gross proceeds of $4,952,000. In total, the Company
issued 833,065 shares in respect of the exercise of these warrants.
In
addition, from August 1, 2021 and through to the date of this report 190,742 warrants with an exercise price of $5.31 per warrant were
exercised into 73,649 common shares by way of a cashless exercise.
Share
Buy-Back Program
As
noted in a press release dated September 9, 2021, BriaCell announced that its board of directors (the “Board”) has authorized
the Company’s repurchase program whereby the Company may purchase through the facilities of the TSX Venture Exchange (“TSXV”)
or The NASDAQ Capital Market (“NASDAQ”) (i) up to 1,341,515 common shares (the “Common Shares”) and (ii) up to
411,962 publicly traded BCTXW warrants (the “Listed Warrants”) in total, representing 10% of the 13,415,154 Common Shares
and 10% of the 4,119,622 Listed Warrants comprising the “public float” as of September 8, 2021, over the next 12 months (the
“Buyback”). Independent Trading Group (ITG) Inc. will act as the Company’s advisor and dealer manager in respect of
the Buyback.
As
of September 8, 2021, the Company had 15,269,583 Common Shares and 4,219,622 Listed Warrants issued and outstanding. BriaCell’s
cash balance as of July 31, 2021 was US$57 million. The repurchase program will in no way interfere with BriaCell’s ambitious growth
plans to expand into previously-announced areas of cancer immunotherapy and/or advance its current breast cancer clinical trials. BriaCell’s
proposed repurchases may be conducted through open market transactions at prevailing market prices, in privately negotiated transactions,
in block trades, and/or through other legally permissible means, subject to the market conditions and in compliance with applicable rules
and regulations. The timing and dollar amount of repurchase transactions will be subject to the Securities and Exchange Commission (the
“SEC”) Rule 10b-18 and/or Rule 10b5-1 requirements. Purchases of Common Shares or Listed Warrants through the NASDAQ will
not, during the 12-month period, exceed 5% of the outstanding Common Shares or Listed Warrants in the aggregate, as at the commencement
of the Buyback. Additionally, the program is subject to the approval by TSXV. BriaCell’s Board of Directors will be reviewing the
program periodically and may revise the terms and/or size or suspend or discontinue the program.
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
From
August 1, 2021 and through to the date of this report, the Company repurchased a total of 452,182 shares and 141,411 publicly traded
warrants with a total value of $4,934,733, of which 364,306 shares and all the warrants have been cancelled.
Repayment
of CEBA Loan
On
December 13, 2021, the Company repaid the CEBA loan in the amount of $23,454.
Changes
in the Board of Directors and Scientific Advisory Board
In
a press release dated September 1, 2021— BriaCell announced the appointment of Mr. Marc Lustig to the Company’s Board of
Directors, effective September 1, 2021. At that time Marc, through his investment company L5 Capital Inc., owned 1,530,000 common shares
of BriaCell, representing 10.0% of BriaCell’s issued and outstanding common shares.
Mr.
Lustig is a highly regarded investor, entrepreneur, and corporate finance veteran with a deep understanding of the life sciences industry,
including biotechnology and pharmaceuticals, as well as the legal cannabis industry. Marc holds MSc and MBA degrees from McGill University
and his professional experience includes working at Merck & Co., and his capital markets career includes roles in biotech equity
research, corporate finance and as Head of Capital Markets. Mr. Lustig was the founder and CEO of Origin House which was sold to Cresco
Labs Inc. (CSE: CL; OTCQX: CRLBF) in 2020 where he currently serves as a director. In addition to being a director of a number of public
companies, Marc founded the Lustig Family Medical Cannabis Research & Care Fund of the Cedars Cancer Foundation that provides cannabis
to palliative cancer patients.
In
a press release dated November 2, 2021, BriaCell announced the appointment of Jane Gross, Ph.D. to its Board of Directors. Dr. Jane Gross
is a highly experienced biotech executive with over 30 years in leading research and development teams from discovery through preclinical
evaluation and clinical development of therapeutics for the treatment of cancer and autoimmune and inflammatory diseases. Dr. Gross currently
serves as an Independent Director for aTyr Pharmaceuticals (Nasdaq: LIFE), a biotechnology company developing novel therapeutics for
respiratory diseases and multiple cancer indications.
Dr.
Gross’s experience includes roles as Chief Scientific Officer and SVP, Research and Non-Clinical Development at Aptevo Therapeutics
(Nasdaq: APVO), during which she led the discovery of novel antibody-based, bispecific protein therapeutics as immunotherapies to treat
diseases like cancer. Previously, Dr. Gross served as VP, Applied Research and Non-Clinical Development at Emergent BioSolutions (NYSE:
EBS), during which she successfully introduced a drug to patients from design stage into clinic. This drug was partnered with Morphosys
in a co-development transaction for treatment of metastatic castration resistant prostate cancer. Formerly, as VP, Immunology Research
at ZymoGenetics, Dr. Gross discovered and developed 30+ new product candidates, completed partnerships and out-licensing of assets, and
helped position ZymoGenetics for a successful acquisition by Bristol Myers Squibb (NYSE: BMY) in 2010.
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Dr.
Gross earned her Ph.D. in Immunology from the University of California, Berkeley under James P. Allison, Ph.D., who gained fame as the
co-recipient of the 2018 Nobel Prize in Physiology or Medicine for being a pioneer in cancer immunotherapy, and her Post-Doctoral Fellowship
from the University of Washington in Immunology under Dr. Roger M. Perlmutter, M.D., Ph.D., formerly of Merck Research Laboratories and
Amgen (Nasdaq: AMGN).
The
Board of Directors consists of:
| ● | Dr.
William V. Williams, Director and Chief Executive Officer; |
| | | |
| ● | Mr.
Jamieson Bondarenko, Director and Chairman of the Board; |
| | | |
| ● | Mr.
Marc Lustig, Director; |
| | | |
| ● | Dr.
Rebecca Taub, Director; |
| | | |
| ● | Mr.
Vaughn C. Embro-Pantalony, Director; |
| | | |
| ● | Mr.
Martin Schmieg, director |
| | | |
| ● | Dr.
Jane Gross |
In
a press release dated November 5, 2021, BriaCell announced the addition of Suzanne Ostrand-Rosenberg, Ph.D. to its Scientific Advisory
Board.
Dr.
Ostrand-Rosenberg has more than 40 years of experience leading investigations focused on the immune system’s response to cancer.
She is currently the Robert & Jane Meyerhoff Professor of Biochemistry, Emeritus, and Professor of Biological Sciences, Emeritus,
University of Maryland Baltimore County, Baltimore, MD, and has been working with the University since 1977. She was also appointed as
the Adjunct Professor of Pathology, Huntsman Cancer Institute (HCI), University of Utah, Salt Lake City, UT, in 2018.
In
the 1980s and 1990s, Dr. Ostrand-Rosenberg and her team were instrumental in demonstrating the importance of CD4+ T-helper lymphocytes.
Since 1990, her team has pioneered studies on myeloid-derived suppressor cells (MDSCs) in fighting cancer and has led the development
of novel cell-based immuno-therapeutics. Additionally, Dr. Ostrand-Rosenberg’s research on the Programmed Death Ligand 1 pathway
(PD-L1) resulted in the discovery of two novel anti-PD-L1 therapeutics.
Dr.
Ostrand-Rosenberg has served as an editor of multiple immunology and cancer journals, has regularly reviewed grants for national and
international scientific organizations, and has served on the NCI Board of Scientific Counselors. One of her team’s publications
was recognized as the most cited publication in the Journal of Immunology in 2021. She has been the recipient of numerous scientific
awards, including Distinguished Lecturer, German Cancer Research Center (DKFZ), Heidelberg in 2012 and Distinguished Fellow of the American
Association of Immunologists in 2020. She was appointed by Maryland’s governor to the State of Maryland Human Stem Cell Commission
from 2007-2013.
Dr.
Ostrand-Rosenberg obtained her BA in Biology from Barnard College of Columbia University and her Ph.D. in Immunology from California
Institute of Technology and completed her postdoctoral studies in Immunology at Johns Hopkins University.
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
The
Scientific Advisory Board consists of:
| ● | Charles
L. Wiseman, MD, FACP |
| | | |
| ● | Doug
Faller, MD, PhD |
| | | |
| ● | Cara
L. Haymaker, PhD |
| | | |
| ● | Thomas
Kieber-Emmons, PhD |
| | | |
| ● | Brian
Metcalf, PhD |
| | | |
| ● | Maria
Trojanowska, PhD |
| | | |
| ● | Suzanne
Ostrand-Rosenberg, PhD |
Clinical
Operations
Bria-IMT™
PHASE I//IIa “monotherapy”
clinical trial (Expanded Clinical Trial; ClinicalTrials.gov Identifier: NCT03066947)
Clinical
Operations – Safety and Efficacy Data
As
outlined in press releases dated April 23, 2019 and May 28, 2019, BriaCell has obtained evidence of efficacy and safety of Bria-IMT™
(Bria-IMT™) in the Clinical Trial (ClinicalTrials.gov Identifier: NCT03066947): Twenty-three patients received inoculations during
the trial in 2017 and 2018. The patients were all very heavily pre-treated with an average of 4 prior systemic therapy regimens (chemotherapy,
biological therapy and/or “targeted” therapies). The regimen was well tolerated, had few side effects, and appears safe.
Imaging studies have demonstrated regression of metastatic tumors in some patients especially those who match Bria-IMT™ at HLA
alleles. Interim results were presented at the ASCO-SITC meeting on March 1, 2019, the Precision Breast Cancer Summit on April 25, 2019,
and the 2nd Annual Next Gen Immuno-Oncology Congress on September 19, 2019, a total of 27 patients were treated with the Bria-IMT™
regimen: 4 in Dr. Wiseman’s original series in 2004-2006 and 23 in the monotherapy study (ClinicalTrials.gov Identifier: NCT03066947).
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
At
completion of the clinical trial (ClinicalTrials.gov identifier: NCT03066947), a total of 23 subjects had been dosed (press release dated
January 2, 2019). Patients were evaluated for clinical and immune responses. Clinical responses could include progressive disease (PD),
stable disease (SD), partial response (PR) or complete response (CR). Patients with SD, PR or CR were considered to have disease control.
The clinical responses were influenced by the ability of the patients to develop a cellular immune response against Bria-IMT™.
Those unable to develop a cellular immune response (as measured by delayed-type hypersensitivity - DTH) did not respond, while of those
who did respond all had evidence of a DTH response. These results for Dr. Wiseman’s original series in 2004-2006 (4 patients) and
the monotherapy study (ClinicalTrials.gov Identifier: NCT03066947) (23 patients) are noted here.
| Patients | |
HLA Match | | |
Disease Control* | | |
Disease Control
in Immune
Responders** | |
| N=6 | |
| ≥2 | | |
| 50 | % | |
| 75 | % |
| N=20 | |
| ≥1 | | |
| 25 | % | |
| 33 | % |
| N=7 | |
| 0 | | |
| 29 | % | |
| 29 | % |
Clinical
responses for patients treated with Bria-IMT regimen monotherapy in the Phase I/IIa studies. These data support the hypothesis
that both the ability to mount an immune response to Bria-IMT™ and at least one HLA match may be predictive of patients more likely
to derive clinical benefit.
Bria-IMT™
PHASE I//IIa “combination
therapy” clinical trial (ClinicalTrials.gov Identifier: NCT03328026)
Clinical
Operations - Combination study of Bria-IMT™ with Immune Checkpoint Inhibitors
Immune
checkpoint inhibitors such as pembrolizumab (KEYTRUDA®; anti-PD-1), designed to overcome immune suppression in cancer patients, have
come to the forefront in the fight against cancer with substantial benefits for some patients. Bria-IMT™, in essence a breast cancer
cell line with features of immune cells (the cells that start immune responses) and engineered to produce an immune-activating factor
(GM-CSF), has been shown to stimulate T cells, i.e., important cells of the immune system. BriaCell has published these findings in a
leading immunology journal in the first half of 2018. Based on the published, proposed mechanism of action of Bria-IMT™, the Company
envisions that Bria-IMT™ and immune checkpoint inhibitors can exert additive or synergistic tumor-directed effects. It is important
to note that pembrolizumab (KEYTRUDA®) and related checkpoint inhibitors have not been shown to work well on their own
in breast cancer but are approved for other indications.
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Summary
of Early Data of Bria-IMT™ with KEYTRUDA® Combination Study
| ● | All
11 patients were very heavily pre-treated with a median of 5 prior systemic therapy regimens
(such as chemotherapy) prior to enrollment in BriaCell’s Combination Study. |
| | | |
| ● | These
patients previously did not respond to a number of currently available therapies, and many
had very weak immune systems, further emphasizing the importance of the positive results
observed in BriaCell’s Combination Study. |
Efficacy
Data
Four
patients rolled-over from BriaCell’s Bria-IMT™ monotherapy study:
| ● | One
woman with stable disease on monotherapy had been on 8 prior chemotherapy or biological therapy
regimens and had extensive tumor growth in her liver. She experienced a 25% reduction in
the sum of diameters of her liver metastases within 2 months. |
| ● | She
had a tumor type that typically does not respond to KEYTRUDA® alone, suggesting
distinct benefits by the Combination Study. |
| | | |
| ● | Of
note, she is not an HLA match with Bria-IMT™ suggesting that the combination with immune
checkpoint inhibitors such as KEYTRUDA® may not require a ‘match with Bria-IMT™’
to result in tumor reduction. Consequently, the Combination Study regimen may work for patients
regardless of HLA matching. |
| | | |
| ● | She
was able to develop a very strong immune response to Bria-IMT™ (as measured by skin
testing (DTH)). |
| ● | Three
women on the monotherapy study had progressive disease prior to entry into the Combination
Study – they were only dosed for a short time, and either discontinued the treatment
or showed progressive disease. They had very weak immune systems and very advanced cancer
prior to BriaCell’s Combination Study. |
|
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Seven
patients entered the Combination Study directly without previous Bria-IMT™ treatment:
| ● | One
woman who had been on 12 prior regimens with 16 different agents, including 13 chemotherapy
agents, had breast cancer metastatic to the adrenal gland and to the dura mater (the outside
lining of the brain) and behind the left eye (orbital tumor). |
| ● | After
less than 2 months on treatment, she had a marked reduction in the size of her adrenal and
dural metastases and decrease in the size of the orbital tumor. |
| | | |
| ● | She
matched Bria-IMT™ at two HLA alleles (“type”). |
| | | |
| ● | She
was able to develop and very strong immune response to Bria-IMT™ (as measured by skin
testing (DTH)). |
| | | |
| ● | There
is more on this patient below (see January 13, 2020, press release information). |
| ● | One
woman achieved stable disease, in spite of 9 prior anti-cancer regimens (including 6 chemotherapy
regimens and 3 biological therapy regimens) and therefore appears to have derived clinical
benefit from the combination treatment. She matched Bria-IMT™ at one HLA allele (“type”). |
Safety
Data
The
combination was very safe and well-tolerated in all 11 patients of the study.
On
January 9, 2020, BriaCell announced it had identified a new group of patients with high levels of clinical benefit in response to its
novel immunotherapy, and its combinations.
Breast
cancer is subdivided into 3 categories based on its appearance under the microscope: Grade 1 (well differentiated), Grade II (moderately
differentiated) and Grade III (poorly differentiated). The Bria-IMT™ cell line was derived from a Grade II tumor biopsy. Upon reanalysis
of some of its clinical data, BriaCell learned of correlative patterns of tumor response in Grade I/II breast cancer patient populations.
In the Company’s view, this seems logical because Bria-IMT™ is derived from a Grade II (moderately differentiated) breast
cancer tumor. Importantly, approximately 40% of recurrent breast cancers are Grade I/II.
Monotherapy:
The clinical benefit rate in BriaCell’s monotherapy studies for Grade I/II patients with immune responses was 5/7 (71%) despite
the fact that these patients were very heavily pre-treated with a median of 7 prior regimens (such as chemotherapy).
Combination
study of Bria-IMT™ with KEYTRUDA®: All 3 patients with Grade I/II tumors had clinical benefit (100%). All of these patients
had been very heavily pre-treated with 14-15 prior regimens.
Further
analysis of the patients with Grade I/II tumors shows that patients with the greatest tumor reductions within the Grade I/II subset also
had double HLA matches with Bria-IMT™ in both monotherapy and combination study groups. Based on the Company’s new findings,
it believes it is able to identify a sizeable patient population who will derive significant clinical benefit from treatment with Bria-IMT™,
adding further biomarker capability incremental to the Company’s HLA-matching hypothesis.
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BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Combination
Therapy with Incyte Drugs
On
October 7, 2019, BriaCell announced dosing of the first patient in its Phase I/IIa Study evaluating Bria-IMT™ in combination with
INCMGA00012 (retifanlimab) and epacadostat in patients with advanced breast cancer. The study design includes an initial group of patients
to be treated with the Bria-IMT™ regimen in combination with INCMGA00012, Incyte’s PD-1 inhibitor (similar to KEYTRUDA®)
to establish safety. A subsequent group of patients will be treated with the triple combination of the Bria-IMT™ with INCMGA00012
and epacadostat, Incyte’s IDO inhibitor. The dose of epacadostat to be used has been established to be safe when given in combination
with INCMGA00012 in patients with cancer. The goal is to remove cancer-induced suppression of the immune system (i.e., taking the foot
off the brakes that the cancer puts on the immune system) thereby awakening the immune response. This should permit the potent immune
responses induced by the Bria-IMT™ regimen (i.e., putting the foot on the gas pedal) to attack the cancer.
On
January 13, 2020, the Company provided an update on the previously-announced top responder (“Remarkable Responder”) in the
combination study of its lead candidate, Bria-IMT™, with Incyte’s INCMGA00012 (retifanlimab), a PD-1 inhibitor. The patient,
who had experienced notable tumor shrinkage while on treatment with Bria-IMT™ in combination with the PD-1 inhibitor pembrolizumab
[KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)], had since transitioned to treatment in combination with INCMGA00012.
On this combination treatment, the patient had had a subsequent further remarkable reduction in a breast cancer tumor behind the left
eye in the left orbital region. This tumor, which had pushed the eye forward from the skull (known as proptosis), had resolved following
3 months of treatment. The tumor had shrunk by 19% during treatment with the Bria-IMT™ regimen in combination with KEYTRUDA®,
and had completely disappeared during treatment in combination with INCMGA00012. While not all of the patient’s tumors resolved,
the proptosis and associated eye problem were resolved. This patient had an overall 70% reduction in the sum of diameters of her measurable
tumors, qualifying as a partial response (PR).
BriaCell’s
“matching hypothesis” has been further strengthened: The Remarkable Responder matched Bria-IMT™ at 2 HLA loci (HLA-C
and HLA-DRB3). BriaCell’s immunotherapy treatment appears most effective when the patient’s HLA-type matches the Bria-IMT™
HLA-type as concluded in prior Phase IIa proof-of-concept work.
This
patient remained on study for over 9 months before there was disease progression.
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Clinical
Update – Survival Data
In
a press release dated June 2, 2021, BriaCell provided an update on the overall survival (OS) data on its previously disclosed advanced
breast cancer patients. These women were treated with BriaCell’s lead candidate Bria-IMT™ as monotherapy and also in combination
with checkpoint inhibitors, including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.) and Incyte’s retifanlimab
(manufactured and provided under a corporate collaboration with Incyte Corporation).
HLA-Typing:
Cells with HLA (human leukocyte antigen) molecules on their surface determine and trigger the body’s immune response. BriaCell’s
immunotherapy treatment appears most effective when the patient’s HLA-type matches with Bria-IMT™, allowing BriaCell to potentially
identify patients most likely to respond. HLA-typing is a simple and widely available test.
Tumor
Grade: BriaCell has noted clinical benefit in its patients with grade I and grade II tumors, suggesting another subgroup of patients
for whom BriaCell’s treatment would be most effective.
| BriaCell Treatment 1 |
|
|
|
Leading Treatment Comparison 2 |
| N
= |
|
Filter |
|
Prior
Regimens |
|
Overall
Survival |
|
vs. |
|
Prior
Regimens |
|
Overall
Survival |
| 7 |
|
Combination
Therapy |
|
9 |
|
12.0
months |
|
|
|
2 |
|
7.2
- 9.8 months |
| 9 |
|
1+
HLA |
|
8 |
|
12.1
months |
|
|
|
|
|
|
| 5 |
|
2+
HLA |
|
5 |
|
13.4
months |
|
|
|
|
|
|
| 6 |
|
Tumor
Grade I/II |
|
12 |
|
12.5
months |
|
|
|
|
|
|
| Patient
06-005 3 |
|
2
HLA; Grade II |
|
13 |
|
21.4
months |
|
|
|
|
|
|
1)
BriaCell treats severely sick patients, as indicated by the “Prior Regimens” column. To more accurately present survival
data, BriaCell has included only those women able to mount an immune response. Patients from both the monotherapy and combination therapy
are included unless otherwise indicated.
2)
Overall survival of 7.2-9.8 months in similar patients with metastatic breast cancer who have failed 2 prior therapy attempts (third
line setting); Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17.
3)
Remarkable Responder highlighted; included within subsets “Tumor Grade I/II” and “2+ HLA”.
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Highlighting
BriaCell’s Top Responder:
Initially
announced on September 19, 2019 and subsequently on January 13, 2020, BriaCell has continued to emphasize this patient’s
positive response to BriaCell’s treatment. Prior to BriaCell’s treatment, the patient had received 12 regimens with 16 agents
(incl. 13 chemotherapies), yet her condition worsened and included a gruesome orbital tumor that metastasized behind her left eye and
caused the eye to bulge from its socket (proptosis). After just six months of BriaCell’s treatment, the orbital tumor had
been completely eliminated, and she survived for over 21 months, a significant clinical benefit.
Figure
1: The figure shows MRI scans of the top responder patient. The arrows on the images (baseline scans) show the location of the orbital
tumors. As shown on the images on the right hand side, the tumors were eliminated following 6 months of treatment with the Bria-IMT combination
regimen.
In
the figure above, and with tumors indicated by white arrows, complete resolution of the orbital tumor was observed after six months on
BriaCell’s treatment. Of note, she had two HLA matches with Bria-IMT™ and a grade II tumor, supporting BriaCell’s hypotheses
outlined above.
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Clinical
Operations – Clinical Sites
Enrollment
in the Phase I/IIa “monotherapy” study with Bria-IMT™ (ClinicalTrials.gov Identifier: NCT03066947) was completed in
November 2018. All patients have either ceased treatment or “rolled over” to the “combination therapy” trial
(Combination Study of SV-BR-1-GM in Combination With Pembrolizumab, ClinicalTrials.gov Identifier: NCT03328026). As of November 20, 2020,
12 patients have been dosed in the latter “combination therapy” trial as noted above. The following clinical sites are listed
in the combination therapy trial (ClinicalTrials.gov Identifier: NCT03328026):
| ● | St.
Joseph Heritage Healthcare, Santa Rosa, CA; Principle Investigator: Dr. Jarrod P Holmes,
M.D. |
| | | |
| ● | Sylvester
Comprehensive Cancer Center, University of Miami, FL: Principal Investigator: Dr. Carmen
J Calfa, MD |
| | | |
| ● | Cancer
Center of Kansas (CCK): Principle Investigator: Dr. Shaker R. Dakhil, MD. Under the direction
of Dr. Dakhil, the Cancer Center of Kansas lists 16 offices, and 13 Sub Investigators. |
| | | |
| ● | In
a press release dated November 18, 2021 BriaCell announced that Mary Crowley Cancer Research
center in Dallas, Texas is now actively screening and enrolling advanced breast cancer patients
in the Phase I/IIa combination study of BriaCell’s lead candidate, Bria-IMT™,
with Incyte’s checkpoint inhibitors, retifanlimab and epacadostat. |
| | | |
| ● | Dr.
Minal Barve, the Executive Medical Director and Chief Medical Officer for Mary Crowley Cancer
Research center and Board-Certified in medical oncology and internal medicine, will act as
the clinical site’s Principal Investigator. Dr. Barve will work closely with Cancer
Insight, LLC to manage the clinical and regulatory aspects of the Phase I/IIa clinical trial
in advanced breast cancer on behalf of BriaCell. |
| | | |
| ● | BriaCell
anticipates the addition of the Mary Crowley Cancer Research center clinical sites may accelerate
patient enrolment to build on our existing patient data. BriaCell had previously reported
12.0 months average overall survival in advanced breast cancer patients in its Phase I/IIa
combination study including 13.4 months in patients with 2+ HLA matches and 12.5 months in
patients with Grade I/II tumors, compared with 7.2-9.8 months survival in historical comparison
treatment studies. The top responder patient showed 21.4 months survival plus 100% resolution
of ‘eye-bulging’ orbital tumor. |
| | | |
| ● | Founded
by Dallas entrepreneur Mary C. Crowley and her fundamental belief that cancer patients needed
access to better cancer treatments, Mary Crowley Cancer Research center was established in
1997 to provide potentially curative treatments for adult cancer patients. Mary Crowley Cancer
Research center’s mission is to bring hope to cancer patients through innovative clinical
trials, while advancing treatment for patients in the future. |
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Presentations
and public updates
Conference
and Symposia Presentations
Keystone
Symposium®
As
noted in a press release dated January 26, 2021, BriaCell presented clinical data at the Keystone Symposium, “Emerging Cell Therapies:
Realizing the Vision of NextGen Cell Therapeutics”.
Presentation
Title: Personalized off-the-shelf whole cell immunotherapy for cancer.
Highlights
of the Clinical Data:
Monotherapy
Study – 27 patients: The patients were heavily pre-treated (median of 5 prior therapy regimens). Disease control including
stable disease (SD), partial responses (PR) or complete responses (CR) was seen in 8 patients (30%) suggesting clinical benefit. Importantly,
disease control was more frequent in patients who had 2 or more HLA matches with Bria-IMT™ (67%) or had moderately or well differentiated
tumors (63%) suggesting the potential importance of these factors in designing the next generation of personalized immunotherapies.
Combination
Study – 12 patients (Bria-IMT™ regimen with checkpoint inhibitors): The patients were heavily pre-treated (median of
6 prior therapy regimens). Disease control was seen in 4 patients (33%). Importantly, patients with moderately or well differentiated
tumors were more likely to achieve disease control (3/4, 75%) suggesting clinical benefit in this subset of patients. Furthermore, the
data suggests the potential additive or synergistic effects of check point inhibitors when combined with the Bria-IMT™ regimen.
Patients
with moderately or well differentiated tumors: The patients with moderately or well differentiated tumors (monotherapy and combination
therapy studies combined) were heavily pre-treated (median of 8 prior therapy regimens). Disease control was seen in 7 of 11 patients
(64%) suggesting clinical benefit in this subset of patients. This included 2 of 5 patients with objective responses, both of whom had
2 or more HLA matches with Bria-IMT™. Overall survival (OS), collected in 6 patients, was 12.5 months suggesting clinical benefit.
In comparison, an OS of 7.2-9.8 months was reported in similar patients in the third line setting (Kazmi S, et al., Breast Cancer Res
Treat. 2020).
Capitalizing
on these findings, BriaCell has engineered cell lines to express specific HLA alleles allowing a single HLA match with ~99% and a double
HLA match with ~90% of the population. These cell lines will provide a personalized approach to cancer immunotherapy that is pre-manufactured
rather than prepared individually per patient, eliminating the time and complex manufacturing logistics of other personalized immunotherapies.
American
Association for Cancer Research Annual Meeting 2021
As
noted in a press release dated March 30, 2021, BriaCell announced that that it was selected to present at the American Association for
Cancer Research (AACR) Annual Meeting 2021, a virtual meeting, held over two weeks (Week 1: April 10-15; Week 2: May 17-21).
As
noted in a press release dated April 12, 2021, BriaCell announced the presentation of results from clinical studies with its lead product
candidate, Bria-IMT™, summarized in a poster session held at the American Association for Cancer Research (AACR) Annual Meeting
2021, a virtual meeting, held over two weeks (Week 1: April 10-15; Week 2: May 17-21).
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
The
findings indicate disease control in advanced breast cancer patients, including stable disease (SD), partial responses (PR) or complete
responses (CR). Disease control was especially noted in patients with Grade I/II (i.e. well or moderately differentiated) tumors or those
that matched Bria-IMT™ at 2 or more HLA alleles. Patients with low or undetectable levels of circulating cancer cells were more
likely to benefit from therapy.
Patients
were treated with the Bria-IMT™ regimen alone (i.e. monotherapy study) or the Bria-IMT™ regimen in combination with immune
checkpoint inhibitors, including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and, more recently, Incyte’s
retifanlimab (INCMGA00012, under a corporate collaboration with Incyte Corporation). Dr. Bill Williams, BriaCell’s President &
CEO, presented the results of the clinical and pathological analysis. The patient data summarized and discussed belong to previously
disclosed patients (i.e., no incremental numbers enrolled).
Details
and results on the poster presentation are summarized below:
Poster
Title: Predictors of response to a modified whole tumor cell immunotherapy in patients with advanced breast cancer from two phase I/IIa
trials
Analysis
and Discussion:
The
Bria-IMT™ regimen with or without checkpoint inhibitors is able to induce an effective immune response and disease control in heavily
pre-treated advanced breast cancer patients. The patients were all heavily pretreated and failed multiple prior regimens.
Delayed
Type Hypersensitivity (DTH) to Bria-IMT™ analysis identified a group with significantly higher rates of disease control and progression-free
survival (8 months) in both monotherapy and combination therapy studies suggesting a robust immune response is predictive of clinical
benefit in these patients.
Highest
levels of disease control and PFS was observed in patients who matched Bria-IMT™ at 2 or more HLA alleles in the monotherapy study
but not in the combination therapy study supporting our strategy to develop Bria-OTS™, an off-the-shelf personalized immunotherapy
for advanced breast cancer.
Patients
with Grade I/II tumors (median of 8 prior therapy regimens) were more likely to respond with disease control (67%) and longer progression
free survival. The response was more pronounced in the patients in the combination therapy study suggesting additive or synergistic effects
of checkpoint inhibitors when combined with the Bria-IMT™ regimen. Bria-IMT™, with a molecular signature most closely related
to Grade I/II tumors, may result in disease control and clinical benefit especially in this subset of patients.
A
copy of the poster is posted at the following: https://briacell.com/novel-technology/scientific-publications/.
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
Media
Outreach
In
a press release dated April 15, 2021, BriaCell announced that it had recently expanded its investor and media outreach platform in order
to enhance communication with investors and increase investor awareness of and interest in the Company, its product candidates, and its
clinical programs. The comprehensive program is expected to enhance BriaCell’s dialogue with institutional and retail investors,
industry analysts, and the investing public. The following IR and PR groups are currently engaged by the Company. It is important to
disclose that BriaCell is unrelated and unaffiliated with each of the following entities, but the following firms and their clients may
have an interest, directly or indirectly, in the securities of BriaCell.
CorProminence,
LLC d/b/a CORE IR (“Core IR”): Based in Garden City, NY, Core IR is a leading investor relations firm that provides investor
relations services pursuant to a marketing and consulting agreement dated March 15, 2021 and amended on April 9, 2021 (the “Agreement”).
Services will include the initiation of strategic market and investor awareness programs by providing comprehensive corporate and shareholder
communications development services that will promote the Company’s brand. All such services and goals are subject to the prior
approval of the Company. The Agreement has a six-month term (“Initial Term”) and thereafter automatically renews for consecutive
six-month terms (“Renewal Term”), unless BriaCell or Core IR provide written notice of its intention not to renew the Agreement
five (5) days prior to the end of the Initial Term or any Renewal Term. Core IR will be compensated out of working capital in monthly
instalments of USD$13,500 (“Monthly Retainer”). In addition to the Monthly Retainer, BriaCell has granted Core IR an option
to purchase up to 60,000 common shares of BriaCell (“Options”) under BriaCell’s stock option plan dated November 24,
2014. The Options are exercisable at US$4.24 per common share of BriaCell (“Shares”). The right to exercise the Options vests
in four quarterly instalments of 15,000 Shares while the contract is in effect, with the first installment to vest on July 12, 2021.
BriaCell has no interest in Core IR or its securities. Core IR has no interest in BriaCell or its securities, except as set out in this
news release. Core IR is not a Non-Arm’s Length Party of BriaCell, as that term is defined in TSX Venture Exchange (“TSXV”)
policies. The engagement of CORE IR remains subject to the approval of the TSXV.
Dig
Media Inc. d/b/a Investing News Network (“INN”): INN is a private company headquartered in Vancouver, Canada, dedicated to
providing independent news and education to investors since 2007. BriaCell entered into a campaign allocation agreement with INN on March
29, 2021 for a term of 12-months (the “INN Agreement”). Pursuant to the INN Agreement, INN will provide advertising to increase
awareness of the Company. INN does not provide Investor Relations or Market Making services. The INN Agreement is a non-cancellable binding
contract. INN will be compensated out of working capital semi-annually in the amount of US$68,000. INN currently holds 1,163 shares of
BriaCell. INN is not a Non-Arm’s Length Party of BriaCell, as that term is defined in TSX Venture Exchange policies. The engagement
of INN remains subject to the approval of the TSXV.
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
SmallCapVoice.com,
Inc.: Based in Cedar Park, TX, SmallCapVoice.com, Inc. (“SmallCapVoice”), is a leading online marketing and investor relations
firm that specializes in providing investor communication services to small cap companies using online tools like Search engine optimization
(SEO), social media, email campaigns, audio interviews, etc. It is known for its ability to help emerging growth companies build a following
among retail and institutional investors in the United States and Canada. On March 24, 2021, BriaCell entered into a financial public
relations agreement with SmallCapVoice for a term of one month (“SmallCapVoice Agreement”). Services provided to the Company
under the SmallCapVoice Agreement include social media, email campaigns, and audio interviews. SmallCapVoice shall be compensated out
of working capital at the end of each month in the amount of US$3,250. Either party to the SmallCapVoice Agreement may terminate the
SmallCapVoice Agreement upon one month notice to the other party. The engagement of SmallCapVoice remains subject to the approval of
the TSXV.
Pursuant
to the option issuance disclosed on March 30, 2021, the options will have an amended effective date of April 13, 2021. All other terms
and quantities remain the same.
In
a press release dated April 21, 2021, SmallCapVoice.com Inc. (“SCV”) announces the availability of a new interview with Bill
Williams, M.D., President and CEO of BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX-V: BCT) (“the Company”), to discuss
the Company’s targeted immunotherapies for breast cancer and its unique position as a clinical-stage biotech company.
BriaCell
develops novel targeted therapies for the management of cancer. Speaking with SCV’s Stuart Smith, Dr. Williams discusses BriaCell’s
drug pipeline, highlighting lead candidate, Bria-IMT™, for advanced breast cancer.
As
the second-leading cause of cancer in women, breast cancer kills 43,000 women in the U.S. each year. With Bria-IMT™, BriaCell sees
the potential to change these statistics; Bria-IMT™ has achieved positive proof-of-concept (POC) in one of our clinical programs,
where it improved the survival rate of women with advanced-stage breast cancer.
While
the positive data was an obvious win for BriaCell in 2020, the year also delivered challenges. Dr. Williams describes how he and the
Company’s board of directors and advisors were able to lead BriaCell through the hardships of the COVID 19 pandemic.
The
full interview can be heard at: https://www.smallcapvoice.com/interview-briacell-therapeutics-corp-btcx/
As
part of a press release dated November 2, 2021, BiraCell announced it has entered into a 6-month marketing and investor engagement
contract with Toronto-based marketing firm North Equities Corp. (the “Contract”). North Equities Corp. specializes in various
social media platforms and will be able to facilitate greater awareness and widespread dissemination of the Company’s news. In
connection with the Contract, the Company will pay North Equities CAD$105,000. North Equities Corp. does not have an equity stake in
the Company currently.
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
In
a press release dated May 11, 2021, announced that Dr. William V. Williams, President & CEO of BriaCell, is scheduled to participate
in the following virtual conferences:
| ● | Benzinga
Global Small Cap Investor Conference: May 13-14, 2021 |
| ○ | Dr.
Williams will deliver his corporate presentation at 12:20pm ET on May 13, 2021. |
| | | |
| ○ | Dr.
Williams will also participate in a panel discussion titled “Investing Post COVID –
Back to the Fundamentals” at 11:50am ET on May 13, 2021. The panel will discuss healthcare
investing in the post COVID world. |
| | | |
| ○ | Investors
may request one-on-one meetings with Dr. Williams. |
| | | |
| ○ | Investors
may register for the conference here: https://www.benzinga.com/events/small-cap/global/. |
| ● | Q2
Investor Summit: May 17-18, 2021 |
| ○ | Dr.
Williams will deliver his corporate presentation at 2:00pm ET on May 17, 2021. |
| | | |
| ○ | Investors
may request one-on-one meetings with Dr. Williams. |
| | | |
| ○ | Investors
may register for the conference here: https://investorsummitgroup.com/. |
| ● | 2021
LD Micro Invitational Investor Conference: June 8-10, 2021 |
| ○ | Dr.
Williams will deliver his corporate presentation at 12:00pm ET on June 9, 2021. |
| | | |
| ○ | Investors
may request one-on-one meetings with Dr. Williams. |
| | | |
| ○ | Investors
may register for the conference here: https://ldmicrojune2021.mysequire.com/. |
| ● | MarketsandMarkets
4th Annual Next Gen Immuno-Oncology Virtual Congress-US Edition: June 28-30, 2021 |
| ○ | Dr.
Williams will be speaking at the scientific conference at 11:30am ET on June 29, 2021. |
| | | |
| ○ | The
topic is “Personalized, off-the-shelf cellular immunotherapy for cancer”. |
| | | |
| ○ | A
copy of the presentation will be posted here: https://briacell.com/novel-technology/scientific-publications/. |
| | | |
| ○ | For
additional information on the conference and the speaker, please visit: |
https://events.marketsandmarkets.com/4th-annual-next-gen-immuno-oncology-virtual-congress-us-edition/speakers
As
part of a press release dated November 12, 2021, announced it will be participating in these upcoming conferences:
| ● | Q4
Investor Summit: November 16 – 17, 2021 |
| ○ | Dr.
Williams will deliver his corporate presentation at 10:15 a.m. ET on November 16, 2021 |
| | | |
| ○ | Investors
may register for the conference at: https://investorsummitgroup.com/ o Investors may request
one-on-one meetings with management |
| | | |
| ○ | A
public webcast can be accessed via the following link: https://us06web.zoom.us/webinar/register/WN_qK33aeh9TOmLiCnC-GM91w |
|
|
BriaCell
Therapeutics Corp
Management’s Discussion and Analysis
For
the three month period ended October 31, 2021
(In
US Dollars) |
| ● | The
2021 San Antonio Breast Cancer Symposium®: December 7 – 10, 2021 |
| ○ | BriaCell’s
lead product candidate, Bria-IMT™, will be featured during the following: |
| | | |
| ○ | Poster
Session 2: 5:00 - 6:30 p.m. CT on Wednesday, December 8, 2021 |
| | | |
| ○ | Presentation
Title: Overall Survival Following Treatment with a Modified Whole Tumor Cell Targeted Immunotherapy
in Patients with Advanced Breast Cancer |
| | | |
| ○ | The
poster presentation will be accessible at a later date at: https://briacell.com/novel-technology/scientific-publications/ |
| ● | MedInvest
Oncology Conference: December 7 – 10, 2021 |
| ○ | Dr.
Williams will be speaking at the conference at 2:30 p.m. ET on December 7, 2021 |
| | | |
| ○ | Investors
may register for the conference at: https://www.medinvestconferences.com/ |
| | | |
| ○ | Investors
may request on-on-one meetings with management |
| ● | Benzinga
Global Small Cap Virtual Investor Conference: December 8 – 9, 2021 |
| ○ | Dr.
Williams will be speaking at the conference at 1:35 p.m. ET on December 9, 2021 |
| | | |
| ○ | Investors
may register for the conference at: https://www.benzinga.com/events/small-cap/december-2021-global/ |
In
a press release dated September 16, 2021, BriaCell announced that the Company will be presenting at the Benzinga Healthcare Small Cap
Conference, which was held virtually on September 29-30, 2021.
Dr.
Bill Williams, BriaCell’s President and CEO, delivered his corporate presentation at 1:15pm ET on September 29. Management was
available for one-on-one meetings held throughout the conference.
Research
Grant, Personnel Change
As
part of a press release dated May 11, 2021, BriaCell announced the appointment of Miguel A. Lopez-Lago, Ph.D. as Senior Director, Research
and Development. Since 2000, Dr. Lopez-Lago has been working as a cancer scientist at Memorial Sloan-Kettering Cancer Center, New York
(MSKCC). Specifically, he has investigated various aspects of tumor biology, including the development of targeted therapies for Mesothelioma
and the characterization of the biological mechanisms underlying cancer metastasis. More recently, Dr. Lopez-Lago has been interested
in the study of the tumor immune-microenvironment and in the development of immunotherapies for thoracic cancers using chimeric antigen
receptor (CAR) T cell technologies. Since 2013, Dr. Lopez-Lago has been working as Senior Research Scientist at MSKCC. Dr. Lopez-Lago
received his Bachelor of Science in Bio-Sciences and his doctorate in Molecular Biology from Santiago of Compostela University, Spain.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Collaboration
with the National Cancer Institute
As
noted in a press release dated November 10, 2020, BriaCell announced a Cooperative Research and Development Agreement with the National
Cancer Institute (NCI, Center for Cancer Research), part of the National Institutes of Health, to develop novel off-the-shelf personalized
therapeutics for cancer.
Specifically,
BriaCell and the National Cancer Institute will work together to conduct pre-clinical studies to develop and test Bria-OTS™, BriaCell’s
off-the-shelf personalized immunotherapy, as a treatment for cancer to improve upon and broaden applicability of this therapeutic approach.
BriaCell and NCI will use their combined expertise in tumor immunology, molecular biology and development of cellular therapies to design
preclinical studies which are intended to trigger the immunologic pathways necessary to create potent immune responses against cancer
in mouse models. The goal of the collaboration is to develop novel therapeutics for future clinical collaborations, allowing cancer patients
to potentially benefit from potent and personalized cancer immunotherapy in the future.
The
NCI research will be led by Jay A. Berzofsky, M.D., Ph.D., Chief of the Vaccine Branch, Center for Cancer Research. As Chief, Dr. Berzofsky
oversees the NCI Vaccine Branch’s basic, translational, and clinical research in cancer and retroviral vaccines and immunotherapy.
Bria-OTS™
involves a simple saliva test to determine the HLA-type of individual patients with breast cancer who are being evaluated for possible
treatment with this novel therapy. BriaCell foresees engineering only 15 unique HLA-types (molecules), collectively referred to as Bria-OTS™,
to allow sufficient HLA coverage to be able to treat >99% of the population. BriaCell then anticipates treating each patient with
the appropriate pre-manufactured Bria-OTS™ formulation based on the particular patient’s HLA-type, depending on the outcome
of the proposed preclinical studies.
Due
to COVID-19, the cooperative agreement has not yet initiated.
Pipeline
Expansion
In
a press release dated June 16, 2021, BriaCell announced the advancement of its targeted oncology therapeutics into several novel immunotherapy
cell lines: Bria-Pros™ for prostate cancer, Bria-Mel™ for melanoma, and Bria-Lung™ for lung cancer.
BriaCell’s
immunotherapy treatment appeared most effective in breast cancer when the patient human leukocyte antigen molecules (HLA-type) matched
with the targeted immunotherapy, allowing BriaCell to potentially identify patients most likely to respond to the treatment. The novel
approach uses an HLA-typing test - a simple and widely available test. Using its proprietary cell engineering technology, BriaCell is
now developing off-the-shelf personalized immunotherapy, utilizing this “HLA-matching” platform technology, for multiple
cancer indications:
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Bria-Pros™:
Bria-Pros™ is an off-the-shelf personalized immunotherapy for prostate cancer. Prostate cancer, aside from non-melanoma skin cancer,
is the most common cancer among men in the United States. It is also one of the leading causes of cancer death in men. With over 200,000
new cases diagnosed each year, over 30,000 men died of prostate cancer in 2017. Current treatments for metastatic prostate cancer include
immunotherapy, hormone therapy, chemotherapy and targeted treatments. However, none of these treatments are curative. Newer therapies
are needed for advanced prostate cancer.
Bria-Mel™:
Bria-Mel™ is an off-the-shelf personalized immunotherapy for melanoma. There are over 80,000 cases of melanoma diagnosed each year
in the United States and over 8,000 deaths annually. Treatment for advanced melanoma includes immunotherapy, targeted therapy and chemotherapy.
There remains a significant opportunity for safe and effective new therapies for melanoma.
Bria-Lung™:
Bria-Lung™ is an off-the-shelf personalized immunotherapy for lung cancer. Lung cancer is the third most common cancer in the United
States. Over 230,000 cases are diagnosed each year in the United States and over 130,000 people die each year from lung cancer. The most
common type of lung cancer is called non-small cell lung cancer (NSCLC) and when it has spread (metastatic), current treatments include
targeted therapies, immunotherapy and chemotherapy but treatment is unlikely to cure these cancers. The high number of deaths each year
highlights the need for new, effective and safe therapies.
BriaCell
anticipates commencing clinical trials for these novel therapies in 2022. Bria-OTS™ in advanced breast cancer (essentially matching
the Bria-IMT™ immunotherapy to each patient) remains on track to commence patient dosing in 2021.
ImaginAb
Collaboration
In
a press release dated August 19, 2021, BriaCell jointly announces a multi-year, non-exclusive license agreement with ImaginAb Inc (“ImaginAb”),
a market leading global biotechnology company focused on developing next-generation immuno oncology imaging agents and radiopharmaceutical
therapies. Under the terms of the agreement, ImaginAb will supply clinical doses of its market leading CD8 ImmunoPET technology (89Zr-Df-Crefmirlimab)
to BriaCell for use in a study implemented as part of BriaCell’s ongoing Phase I/IIa study with Incyte in metastatic or locally
recurrent breast cancer patients. Specifically, ImaginAb will receive license fees and payments for providing ongoing technical, clinical,
and regulatory support to enable the successful implementation of its CD8 ImmunoPET technology. No other terms are disclosed.
The
CD8 ImmunoPET technology allows whole body visualization of increased CD8 T cells, especially those infiltrating and attacking tumors.
BriaCell will use the technology to provide a readout of both safety and efficacy of its novel cancer immunotherapy.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
| 4. | Selected
Financial Information |
The
following financial data prepared in accordance with IFRS in US dollars is presented for the three-month periods ended October 31,2021
and 2020.
| | |
Three month period ended October
31, | |
| | |
2021 | | |
2020 Restated(*) | |
| Expenses: | |
| | | |
| | |
| Research and development costs | |
$ | 875,636 | | |
$ | 149,062 | |
| General and administration costs | |
| 891,039 | | |
| 231,309 | |
| Share-based compensation | |
| 518,134 | | |
| - | |
| Total expenses | |
| 2,284,809 | | |
| 380,371 | |
| | |
| | | |
| | |
| Operating loss | |
| (2,284,809 | ) | |
| (380,371 | ) |
| Interest income | |
| 6,305 | | |
| | |
| Interest expense | |
| (979 | ) | |
| (15,722 | ) |
| Change in fair value of warrant liability | |
| (106,766 | ) | |
| - | |
| Loss on extinguishment of debt | |
| - | | |
| (25,234 | ) |
| Foreign exchange loss | |
| 34 | | |
| - | |
| | |
| (101,406 | ) | |
| (40,956 | ) |
| | |
| | | |
| | |
| Loss for the period | |
| (2,386,215 | ) | |
| (421,327 | ) |
| Foreign currency translation adjustment | |
| - | | |
| 35,340 | |
| Comprehensive loss for the period | |
$ | (2,386,215 | ) | |
$ | (385,987 | ) |
| Loss per share | |
$ | (0.16 | ) | |
$ | (0.54 | ) |
| Weighted average number of shares outstanding | |
| 15,238,646 | | |
| 774,401 | |
(*)
The Company changed its functional currency from the Canadian dollar (C$) to the United States dollar (US$) as of May 1, 2021. The change
in presentation currency is a voluntary change which is accounted for retrospectively. For comparative reporting purposes, historical
financial information has been translated to United States dollars which is disclosed in the tables below using the exchange rate as
of May 1, 2021, which is the date of the change in the functional and presentation currency.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Three-month
period ended October 31, 2021, compared to the three-month period ended October 31, 2020
Research
Costs
Research
costs are comprised primarily of (i) Salaries and wages to Company employees at our laboratory; and (ii) Clinical trials and investigational
drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
For
the three-month period ended October 31, 2021, research costs amounted to $875,636 as compared to $149,062 for the three-month period
ended October 31, 2020. The increase is attributed to the hiring of lab employees and increased spending on research activities.
General
and Administrative Expenses
For
the three-month period ended October 31, 2021, general and administrative expenses amounted to $891,039 as compared to $231,309 for the
three-month period ended October 31, 2020. The increase is due mainly to salaries, consulting and professional fees incurred by the Company
during the period.
Share-based
Compensation
For
the three-month period ended October 31, 2021, share based compensation of $518,134 as compared to $ nil for the three-month period ended
October 31, 2020. The increase relates to stock options that were issued during the period with immediate vesting.
Interest
Income
For
the three-month period ended October 31, 2021, interest income amounted to $6,305 as compared to $ nil for the three-month period ended
October 31, 2020. Interest income earned during the period is a function of the amount of funds held in interest bearing accounts.
Interest
expense
For
the three-month period ended October 31, 2021, interest expense amounted to $979 as compared to $15,722 for the three-month period ended
October 31, 2020. Interest expense is incurred as a result of the receipt of interest-bearing convertible loan, short-term loans, interest
incurred on late payments to vendors, interest on government grants and accretion expenses. The decrease is due to all of the short-term
loans being repaid.
Change
in fair value of a warrant liability
For
the three-month period ended October 31, 2021, the increase in fair value of warrant liability amounted to $106,766 as compared to $
nil for the three-month period ended October 31, 2020. Certain warrants with an exercise price denominated in Canadian dollars are treated
as a warrant liability, since the exercise price is denominated in a currency different than the functional currency of the Company (US
Dollars). The fair value of these warrants, based on the Black-Scholes and is therefore valued at the end of each reporting period with
the change in valuation being recorded in the Statement of Operations and Comprehensive Loss.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Loss
on extinguishment of debt
For
the three-month period ended October 31, 2021, the Loss on extinguishment of debt amounted to $ nil as compared to $25,234 for the three-month
period ended October 31, 2020. The loss in 2020 is a result of the issuance of shares at $8.10 per share to extinguish debts valued at
$7.48.
Foreign
Exchange Loss
For
the three-month period ended October 31, 2021, the foreign exchange gain of $34 as compared to $ nil for the three-month period ended
October 31, 2020. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates
in the United States and Canada, most of its monetary assets are held in US dollars and most of the Company’s expenditures in the
United States are made in US dollars. The Company has not hedged its exposure to currency fluctuations.
Loss
for the year
The
Company reported a loss for the three-month period ended October 31, 2021 of $2,386,215 as compared to a loss of $421,327 for the three-month
period ended October 31, 2020. The primary reason for increased losses in 2021 is due to company growth and increased spending.
Comprehensive
loss for the period
The
Company reported a comprehensive loss for the three-month period ended October 31, 2021 of $2,386,215 as compared to a comprehensive
loss of $385,987 for the three-month period ended October 31, 2020. The difference between net loss and comprehensive loss results from
the foreign currency translation adjustment that was caused by the difference between functional currency and financial statement presentation.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
| 5. | Summary
of Quarterly Results |
The
following is a summary of the Company’s quarterly results for the last eight quarters ended October 31, 2021:
| | |
QUARTER ENDED | |
| | |
October 31 | | |
July 31 | | |
April 30 | | |
January 31 | |
| | |
2021 | | |
2021 | | |
2021 | | |
2021 | |
| Total revenue | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| Net profit (loss) before income taxes | |
$ | (2,386,215 | ) | |
$ | (2,720,715 | ) | |
$ | 2,949,645 | | |
$ | (235,936 | ) |
| Net profit (loss) for the period | |
$ | (2,386,215 | ) | |
$ | (2,720,715 | ) | |
$ | 2,949,645 | | |
$ | (235,936 | ) |
| Basic profit (loss) per share | |
$ | (0.16 | ) | |
$ | 0.13 | | |
$ | 0.63 | | |
$ | (0.30 | ) |
| | |
QUARTER ENDED | |
| | |
October 31 | | |
July 31 | | |
April 30 | | |
January 31 | |
| | |
2020 | | |
2020 | | |
2020 | | |
2020 | |
| Total revenue | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| Net profit (loss) before income taxes | |
$ | (421,327 | ) | |
$ | (618,423 | ) | |
$ | (570,328 | ) | |
$ | (1,532,718 | ) |
| Net profit (loss) for the period | |
$ | (421,327 | ) | |
$ | (618,423 | ) | |
$ | (570,328 | ) | |
$ | (1,532,718 | ) |
| Basic profit (loss) per share | |
$ | (0.54 | ) | |
$ | (0.63 | ) | |
$ | (0.94 | ) | |
$ | (2.14 | ) |
Net
profit (loss) per quarter is primarily a function of the research and operational activity during that quarter. There is no seasonal
trend. From the quarter ended April 2020 through to the quarter ended January 2021, the Company’s quarterly loss decreased due
to lack of funds and a slow down in trials due to the effects of COVID-19. The primary reason for change from loss to profit in quarter
ending April 2021, is due to the decrease in fair value of the warrant liability, offset partially by the significant costs incurred
in the completion of our Nasdaq Listing and a one-time charge related to stock options issued to directors and officers following the
successful listing and public offering. The Company recorded a significant loss in quarter ending July 2021, largely due to the foreign
exchange loss generated by our functional currency change to the US dollar. The large loss in quarter ending October 2021 is a result
of Company’s growth and increased spending.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
As
of October 31, 2021, the Company has a working capital of $55,484,835 (July 31, 2021 – $57,241,355) and an accumulated deficit
of $18,140,246 (July 31, 2021 - $15,754,031). As of December 13, 2021, the Company has approximately $52 million in cash.
Three-month
period ended October 31, 2021, compared to three months period ended October 31, 2020
During
the three-month period ended October 31, 2021, the Company’s overall position of cash and cash equivalents decreased by $1,778,599
from the year ended July 31, 2021 (including effects of foreign exchange). This decrease in cash can be attributed to the following:
The
Company’s net cash used in operating activities during the three-month period ended October 31, 2021, was $1,778,599 as compared
to $58,096 for three-month period ended October 31, 2020. This increase is mostly due to company growth and the increased expenditure
during the quarter.
Cash
provided by financing activities for the three-month period ended October 31, 2021 was $ nil as compared to $27,102 for the three-month
period ended October 31, 2020. Cash provided in 2020 was from the receipt of short terms loans.
At
October 31, 2021, the Company’s capital resources consist primarily of cash.
| 8. | Off
Balance Sheet Arrangements |
The
Company has not entered into any off-Balance Sheet arrangements.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
| 9. | Transactions
Between Related Parties |
Parties
are considered to be related if one party has the ability, directly or indirectly, to control the other party or exercise significant
influence over the other party in making operating and financial decisions. This would include the Company’s senior management,
who are considered to be key management personnel by the Company.
Parties
are also related if they are subject to common control or significant influence. Related parties may be individuals or corporate entities.
A transaction is considered to be a related party transaction when there is a transfer of resources or obligations between related parties.
As
of October 31, 2021, included in accounts payable and accrued liabilities and short-term loans are amounts owing to a company controlled
by an officer in the amount of $6,462 (July 31, 2021 - $6,283) for consulting fees and a short-term loan; and amounts owing to directors
of $49,228 (July 31, 2021 - $42,247) for directors’ fees and short term loans.
During
the three months period ended October 31, 2021 and 2020, the Company incurred the following expenses charged by directors and key management
personnel or companies controlled by these individuals:
| | |
Three month period ended October
31, | |
| | |
2021 | | |
2020 | |
| | |
| | |
| |
| a) Paid or accrued professional fees to a company controlled by an officer of the Company | |
$ | 19,173 | | |
$ | 8,547 | |
| b) Paid or accrued consulting fees to companies controlled by individual directors. | |
$ | 21,211 | | |
$ | 8,140 | |
| c) Paid or accrued wages and consulting fees to directors | |
$ | 212,108 | | |
$ | 109,447 | |
| a. | Paid
or accrued consulting to Ninety Six Capital Ltd, a company controlled by Gadi Levin, the
Company’s CFO. |
| | | |
| b. | Paid
or accrued consulting to Stratpath Management Inc, a Company controlled by Mr. Vaughn C.
Embro-Pantalony. |
| | | |
| c. | Paid
or accrued wages and directors’ fees to directors: Mr. Jamieson Bondarenko, Mr. Marc
Lustig, Dr. William V. Williams, and Dr. Rebecca Taub. |
These
transactions were in the normal course of operations and were measured at the exchange value which represented the amount of consideration
established and agreed to by the related parties
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
| 10. | Financial
Instruments and Financial Risk Exposures |
The
Company’s financial instruments consist of cash, short term investments, amounts receivable, investments and accounts payable and
accrued liabilities and short term loans. Unless otherwise noted, it is management’s opinion that the Company is not exposed to
significant interest or credit risks arising from these financial instruments. The fair value of these financial instruments approximates
their carrying values, unless otherwise noted.
Management
understands that the Company is exposed to financial risk arising from fluctuations in foreign exchange rates and the degree of volatility
of these rates as a portion of the Company’s transactions occur in Canadian Dollars (mainly costs relating to being a public company
in Canada), and the Company’s functional and presentation currency is the US dollar. The Company does not use derivative instruments
to reduce its exposure to foreign currency risk.
The
Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors
the risk management process. The overall objectives of the Board are to set policies that seek to reduce risk as far as possible without
unduly affecting the Company’s competitiveness and flexibility.
The
type of risk exposure and the way in which such exposure is managed is as follows:
The
Company has no significant concentration of credit risk arising from operations. Management believes that the credit risk concentration
with respect to financial instruments is remote.
The
Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come
due. As of October 31, 2021, the Company has working capital balance of $55,484,835 (July 31, 2021 – working capital of $57,241,355).
The table below presents the maturity profile of the Company’s financial liabilities based on contractual undiscounted payments:
| | |
Carrying amount | | |
Contractual cash flows | | |
Within 1 year | | |
1-2 years | | |
2-5 years | | |
5+ years | |
| Accounts payable and accrued liabilities | |
$ | 431,366 | | |
$ | 431,366 | | |
$ | 431,366 | | |
$ | - | | |
$ | - | | |
$ | - | |
| Government grant | |
| 26,964 | | |
| 32,098 | | |
| - | | |
| 32,098 | | |
| - | | |
| - | |
| | |
$ | 458,330 | | |
$ | 463,464 | | |
$ | 431,366 | | |
$ | 32,098 | | |
$ | - | | |
$ | - | |
Interest
Rate risk is the risk that the fair value of a financial instrument will fluctuate because of changes in market interest rates. Loans
payable include both fixed and variable interest rates; however, the Company does not believe it is exposed to material interest rate
risk.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
As
the Company has no revenues, price risk is remote.
The
Company is exposed to foreign exchange risk as a portion of the Company’s transactions occur in Canadian Dollars (mainly costs
relating to being a public company in Canada) and, therefore, the Company is exposed to foreign currency risk at the end of the reporting
period through its Canadian denominated accounts payable and cash. As of July 31, 2021, a 5% depreciation or appreciation of the Canadian
dollar against the US dollar would not have a material effect on the in total loss and comprehensive loss.
The
carrying values of short-term investments, amounts receivable, and accounts payable and accrued liabilities approximate their fair values
due to their short terms to maturity.
The
cash, short term investments and investments are valued using quoted market prices in active markets.
| 11. | Critical
Estimates and Judgements |
The
preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period.
Actual outcomes could differ from these estimates. The financial statements include estimates which, by their nature, are uncertain.
The impacts of such estimates are pervasive throughout the financial statements, and may require accounting adjustments based on future
occurrences. Revisions to accounting estimates are recognized in the period in which the estimate is revised and also in future periods
when the revision affects both current and future periods.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
The
critical judgments and significant estimates in applying accounting policies that have the most significant effect on the amounts recognized
in the consolidated financial statements are:
| ● | Intangible
assets are tested for impairment annually or more frequently if there is an indication of
impairment. The carrying value of intangibles with definite lives is reviewed each reporting
period to determine whether there is any indication of impairment. If there are indications
of impairment the impairment analysis is completed and if the carrying amount of an asset
exceeds its recoverable amount, the asset is impaired and impairment loss is recognized. |
| ● | The
Company uses the Black-Scholes option-pricing model to estimate fair value of options the
warrant liability at each reporting date. The key assumptions used in the model are the expected
future volatility in the price of the Company’s shares and the expected life of the
warrants. |
| ● | The
financial statements of each company within the consolidated group are measured using their
functional currency which is the currency of the primary economic environment in which an
entity operates. The Company changed its functional currency from the Canadian dollar (C$)
to the United States dollar (US$) as of May 1, 2021. The change in presentation currency
is a voluntary change which is accounted for retrospectively. For comparative reporting purposes,
historical financial information has been translated to United States dollars using the exchange
rate as of May 1, 2021, which is the date of the change in the functional and presentation
currency. |
| | | |
| 12. | New
Accounting Policies Adopted |
No
new accounting polices were adopted during the three months period ended October 31, 2021.
13. Commitments
The
Company is currently on a month-to-month lease arrangement for office and lab space in New York, New York in the amount of approximately
$8,600 per month.
14. Other
Information
The
following details the common shares, warrants, compensation warrants, and stock options, warrants outstanding as of the date of this
MD&A.
Common
Shares
Authorized:
Unlimited common shares, without par value issued and outstanding shares as at December 14, 2021: 15,912,820
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Share
Purchase Warrants (as of December 14, 2021)
| Number of Warrants | | |
Exercise Price | | |
Exercisable At December 14, 2021 | | |
Expiry Date |
| | 9,780 | | |
$ | 28.35 | | |
| 9,780 | | |
November 2021 to June 2022 |
| | 51,698 | | |
$ | 4.41 | | |
| 51,698 | | |
November 16, 2025 |
| | 4,045,146 | | |
$ | 5.31 | | |
| 4,045,146 | | |
February 26, 2026 - April 26, 2026 |
| | 4,370,343 | | |
$ | 6.19 | | |
| 4,370,343 | | |
December 7, 2026 |
| | 8,476,967 | | |
| | | |
| 8,476,967 | | |
|
Compensation
Warrants (as of December 14, 2021)
| Number of Warrants | | |
Exercise Price | | |
Exercisable At December 14, 2021 | | |
Expiry Date |
| | 4,890 | | |
$ | 4.41 | | |
| 4,890 | | |
November 16, 2025 |
| | 17,074 | | |
$ | 5.31 | | |
| 17,074 | | |
February 26, 2026 |
| | 142,525 | | |
$ | 6.19 | | |
| 142,525 | | |
June 7, 2026 |
| | 164,489 | | |
| | | |
| 164,489 | | |
|
Stock
Options (as of December 14, 2021)
| Number of Options | | |
Exercise Price | | |
Exercisable At December 14, 2021 | | |
Expiry Date |
| | 1,667 | | |
$ | 47.24 | | |
| 1,667 | | |
March 10, 2022 |
| | 833 | | |
$ | 33.07 | | |
| 833 | | |
July 1, 2023 |
| | 166 | | |
$ | 16.54 | | |
| 166 | | |
September 9, 2024 |
| | 612,000 | | |
$ | 4.24 | | |
| 612,000 | | |
March 29, 2026 |
| | 60,000 | | |
$ | 4.24 | | |
| 60,000 | | |
April 19, 2026 |
| | 100,000 | | |
$ | 5.74 | | |
| 100,000 | | |
September 1, 2026 |
| | 12,600 | | |
$ | 7.74 | | |
| 12,600 | | |
November 1, 2026 |
| | 787,266 | | |
| | | |
| 787,266 | | |
|
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
| 15. | Risks
and Uncertainties |
History
of Operating Losses
BriaCell
is a development stage corporation that to date has not recorded any revenues from the sale of diagnostic or therapeutic products. Since
incorporation, BriaCell has accumulated net losses and expects such losses to continue as it commences product and pre-clinical development
and eventually enters into license agreements for its technology. Management expects to continue to incur substantial operating losses
unless and until such time as product sales and/or licensing generates sufficient revenues to fund continuing operations. BriaCell has
neither a history of earnings nor has it paid any dividends and it is unlikely to pay dividends or enjoy earnings in the immediate or
foreseeable future.
Early
Stage Development
The
Company expects to spend a significant amount of capital to fund research and development. As a result, the Company expects that its
operating expenses will increase significantly and, consequently, it will need to generate significant revenues to become profitable.
Even if the Company does become profitable, it may not be able to sustain or increase profitability on a quarterly or annual basis. The
Company cannot predict when, if ever, it will be profitable. There can be no assurances that the Intellectual Property of BriaCell, or
other technologies it may acquire, will meet applicable regulatory standards, obtain required regulatory approvals, be capable of being
produced in commercial quantities at reasonable costs, or be successfully marketed. The Company will be undertaking additional laboratory
studies or trials with respect to the Intellectual Property of BriaCell, and there can be no assurance that the results from such studies
or trials will result in a commercially viable product or will not identify unwanted side effects.
Pre-Clinical
Studies and Initial Clinical Trials are not Necessarily Predictive of Future Results
Pre-clinical
tests and Phase I/II clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand
the side effects of product candidates at various doses and schedules. Success in pre-clinical and early clinical trials does not ensure
that later large-scale efficacy trials will be successful nor does it predict final results. Favorable results in early trials may not
be repeated in later trials.
A
number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive
results in earlier trials. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory
approvals. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed,
repeated or terminated. Any pre-clinical data and the clinical results obtained for BriaCell’s technology may not predict results
from studies in larger numbers of subjects drawn from more diverse populations or in the commercial setting, and also may not predict
the ability of our products to achieve their intended goals, or to do so safely.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Dependence
upon Management
Although
the Company is expected to have experienced senior management and personnel, the Company will be substantially dependent upon the services
of a few key personnel, particularly Dr. William V. Williams and the professionals for the successful operation of its business. Phase
I of the Company’s research and development is planned to be completed by qualified professionals and is expected to concentrate
on engaging the pharmaceutical companies for the licensing of the new vaccine candidates. The loss of the services of any of these personnel
could have a material adverse effect on the business of the Company. The Company may not be able to attract and retain personnel on acceptable
terms given the intense competition for such personnel among high technology enterprises, including biotechnology, and healthcare companies,
universities and non-profit research institutions. If it loses any of these persons, or is unable to attract and retain qualified personnel,
its business, financial condition and results of operations may be materially and adversely affected.
Dependence
on Third Parties
Due
to the complexity of the process of developing pharmaceutical products which includes immunotherapeutic products and therapeutic
vaccines, the Company’s business may depend on arrangements with pharmaceutical and biotechnology companies, corporate and
academic collaborators, licensors, licensees and others for the research, development, clinical testing, technology rights,
manufacturing, marketing and commercialization of its products. Such agreements could obligate the Company to diligently bring
potential products to market, make milestone payments and royalties that, in some instances, could be substantial, and incur the
costs of filing and prosecuting patent applications. There can be no assurance that the Company will be able to establish or
maintain collaborations that are important to its business on favorable terms, or at all.
A
number of risks arise from the Company’s potential dependence on collaborative agreements with third parties. Product development
and commercialization efforts could be adversely affected if any collaborative partner terminates or suspends its agreement with the
Company, causes delays, fails to on a timely basis develop or manufacture in adequate quantities a substance needed in order to conduct
clinical trials, fails to adequately perform clinical trials, determines not to develop, manufacture or commercialize a product to which
it has rights, or otherwise fails to meet its contractual obligations. The Company’s collaborative partners could pursue other
technologies or develop alternative products that could compete with the products the Company is developing.
The
Company has signed Non-Disclosure Agreements (“NDA”) with many different third parties as is customary in the industry. There
is no guarantee that, despite the terms of the NDA which bind third parties, the Company will ultimately be able to prevent from such
third parties from breaching their obligations under the NDA. Use of the Company’s confidential information in an unauthorized
manner is likely to negatively affect the Company.
|
BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Intellectual
Property
BriaCell’s
success depends to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies. BriaCell
files patent applications in the United States and in foreign jurisdictions as part of its strategy to protect its Intellectual Property.
However, patents provide only limited protection of BriaCell’s Intellectual Property. The assertion of patent protection involves
complex legal and factual determinations and is therefore uncertain and expensive. BriaCell cannot provide assurances that patents will
be granted with respect to any of its pending patent applications, that the scope of any of its patents will be sufficiently broad to
offer meaningful protection, or that it will develop additional proprietary technologies that are patentable. BriaCell’s current
patents could be successfully challenged, invalidated or circumvented. This could result in BriaCell’s patent rights failing to
create an effective competitive barrier. Losing a significant patent or failing to get a patent to issue from a pending patent application
that BriaCell considers significant could have a material adverse effect on the Company’s business. The laws governing the scope
of patent coverage in various countries continue to evolve. The laws of some foreign countries may not protect BriaCell’s intellectual
property rights to the same extent as the laws of United States. BriaCell holds patents only in selected countries. Therefore, third
parties may be able to replicate BriaCell technologies covered by BriaCell’s patents in countries in which it does not have patent
protection.
Litigation
to Protect the Company’s Intellectual Property
The
Company’s future success and competitive position depends in part upon its ability to maintain 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 to be infringing its
rights. In addition, enforcement of the Company’s 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 distribute any products that are the subject of such litigation. In addition, the Company’s
involvement in intellectual property litigation could result in significant expense, which could materially adversely affect the use
responsibilities, whether or not such litigation is resolved in the Company’s favor.
Legal
Proceedings
In
the course of the Company’s business, the Company may from time to time have access to confidential or proprietary information
of third parties, and these parties could bring a claim against the Company asserting that it has misappropriated their technologies
and had improperly incorporated such technologies into the Company’s products.
Due
to these factors, there remains a constant risk of intellectual property litigation affecting the Company’s business. In the future,
the Company may be made a party to litigation involving intellectual property matters and such actions, if determined adversely, could
have a material adverse effect on the Company.
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BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Ability
to Manage Growth
Anticipated
growth in all areas of BriaCell’s business is expected to continue. The Company expects operating expenses and staffing levels
to increase in the future. To manage such growth, the Company must expand its operational and technical capabilities and manage its employee
base while effectively administering multiple relationships with various third parties. Any failure to implement cohesive management
and operating systems, to add resources on a cost-effective basis or to properly manage the Company’s expansion could have a material
adverse effect on its business and results of operations.
Liquidity
and Need for Additional Capital and Access to Capital Markets
The
Company anticipates that additional capital will be required in the future. It is anticipated that future research, additional pre-clinical
and toxicology studies and manufacturing initiatives, including that to prepare for market approval and successful product market launch
will require additional funds. Further financing may dilute the current holdings of Shareholders and may thereby result in an investment
loss for the shareholders. There can be no assurance that the Company will be able to obtain adequate financing, or financing on terms
that are reasonable or acceptable for these or other purposes, or to fulfill the Company’s obligations under various license agreements.
Failure to obtain such additional financing could result in delay or indefinite postponement of further research and development of the
Company’s technologies with the possible loss of license rights to these technologies.
Although
the Company’s common shares are listed for trading on the TSXV and NASDAQ, there can be no assurance that a liquid market will
exist which may have an adverse effect on the market price of the Company’s common shares.
Competition
The
market for cancer therapeutics is highly competitive. The Company will compete with other research teams who are also examining potential
therapeutics with regards to autoimmune diseases and disorders. Many of its competitors have greater financial and operational resources
and more experience in research and development than the Company. These and other companies may have developed or could in the future
develop new technologies that compete with the BriaCell’s technologies or even render its technologies obsolete. Competition in
cancer therapeutics markets is primarily driven by timing of technological introductions; ability to develop, maintain and protect proprietary
products and technologies; and expertise of research and development team.
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BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
Other
legislation or regulatory proposals may affect the Company’s revenues and profitability
Existing
and proposed changes in the laws and regulations affecting public companies may cause the Company to incur increased costs as the Company
evaluates the implications of new rules and responds to new requirements. Failure to comply with new rules and regulations could result
in enforcement actions or the assessment of other penalties. New laws and regulations could make it more difficult to obtain certain
types of insurance, including director’s and officer’s liability insurance, and the Company may be forced to accept reduced
policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage, to the extent that such coverage
remains available.
The
impact of these events could also make it more difficult for the Company to attract and retain qualified persons to serve on the Company’s
board of directors, or as executive officers. The Company may be required to hire additional personnel and utilize additional outside
legal, accounting and advisory services, all of which could cause the Company’s general and administrative costs to increase beyond
what the Company currently has planned. Although the Company evaluates and monitors developments with respect to new rules and laws,
the Company cannot predict or estimate the amount of the additional costs the Company may incur or the timing of such costs with respect
to such evaluations and/or compliance and cannot provide assurances that such additional costs will render the Company compliant with
such new rules and laws.
If
the Company experiences a data security breach and confidential information is disclosed, the Company may be subject to penalties and
experience negative publicity
The
Company and its customers could suffer harm if personal and health information were accessed by third parties due to a system security
failure. The collection of data requires the Company to receive and store a large amount of personally identifiable data. Recently, data
security breaches suffered by well-known companies and institutions have attracted a substantial amount of media attention, prompting
legislative proposals addressing data privacy and security. The Company may become exposed to potential liabilities with respect to the
data that it collects, manages and processes, and may incur legal costs if information security policies and procedures are not effective
or if the Company is required to defend its methods of collection, processing and storage of personal data. Future investigations, lawsuits
or adverse publicity relating to its methods of handling such information could have a material adverse effect on the Company’s
business, financial condition and results of operations due to the costs and negative market reaction relating to such developments.
Effects
of COVID-19
Since
January 2020, the Coronavirus outbreak has dramatically expanded into a worldwide pandemic creating macro-economic uncertainty and disruption
in the business and financial markets. Many countries around the world, including Canada and the United States have been taking measures
designated to limit the continued spread of the Coronavirus, including the closure of workplaces, restricting travel, prohibiting assembling,
closing international borders and quarantining populated areas. Such measures present concerns that may dramatically affect the Company’s
ability to conduct its business effectively, including, but not limited to, adverse effect relating to employees’ welfare, slowdown
and stoppage of manufacturing, commerce, shipping, delivery, work, travel and other activities which are essential and critical for maintaining
on-going business activities. Given the uncertainty around the extent and timing of the future spread or mitigation of COVID-19 and around
the imposition or relaxation of protective measures, the Company cannot reasonably estimate the impact to its future results of operations,
cash flows or financial condition; infections may become more widespread and the limitation on the ability to work, travel and timely
sell and distribute products, as well as any closures or supply disruptions, may be extended for longer periods of time and to other
locations, all of which would have a negative impact on the Company’s business, financial condition and operating results. In addition,
the unknown scale and duration of these developments have macro and micro negative effects on the financial markets and global economy
which could result in an economic downturn that could affect demand for the Company’s products and have a material adverse effect
on its operations and financial results, earnings, cash flow and financial condition.
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BriaCell Therapeutics Corp
Management’s Discussion and Analysis
For the three month period ended October 31, 2021
(In US Dollars) |
This
MD&A was prepared as of December 14, 2021. This MD&A should be read in conjunction with the consolidated financial statements
three-month period ended October 31, 2021. This MD&A is intended to assist the reader’s understanding of BriaCell Therapeutics
Corp. and its operations, business, strategies, performance and future outlook from the perspective of management. The documents
mentioned above, as well as news releases and other important information may be viewed through the SEDAR website at www.sedar.com.
Managements
Responsibility for Financial Statements
Evaluation
of disclosure controls and procedures
Our
CEO, and CFO are responsible for establishing and maintaining disclosure controls and procedures for the Company. As such, we maintain
a set of disclosure controls and procedures designed to ensure that information required to be disclosed in filings is recorded, processed,
summarized and reported within the time periods specified by the Canadian Securities Administrators rules and forms. In designing and
evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required
to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our
CEO and CFO have evaluated our disclosure controls and procedures as at October 31, 2021 and have concluded that disclosure controls
and procedures are effective.
Management’s
report on internal controls over financial reporting
Our
CEO and CFO are responsible for establishing and maintaining effective internal controls over financial reporting. Our internal controls
over financial reporting are designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with IFRS. Because of their inherent limitations, internal controls over
financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only
reasonable assurance with respect to financial statement preparation and presentation.
Our
CEO and CFO evaluated the effectiveness of our internal controls over financial reporting as at October 31, 2021 and identified the material
weakness outlined below.
Material
weakness
The
material weaknesses we identified in our internal controls over financial reporting at October 31, 2021 were as follows: We did not have
sufficient accounting resources with relevant technical accounting skills to address issues related to the financial statement close
process because of the size of the Company and its staff complement, we were not able to sufficiently design internal controls to provide
the appropriate level of oversight regarding the financial recordkeeping and review of the Company’s financial reporting. This
weakness will continue to be addressed the 2021 and 2022. See “Changes in Internal Controls Over Financial Reporting” below.
In
making this assessment, management used the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission
(“COSO”) in Internal Control – Integrated Framework (2013).
Consistent
with our stage of development, we continue to rely on risk-mitigating procedures during our financial closing process in order to provide
comfort that the financial statements are presented fairly in accordance with IFRS.
