Form 8-K
8-K — BriaCell Therapeutics Corp.
Accession: 0001493152-26-014156
Filed: 2026-03-31
Period: 2026-03-31
CIK: 0001610820
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — form8-k.htm (Primary)
EX-99.1 (ex99-1.htm)
EX-99.2 (ex99-2.htm)
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): March 31, 2026
BRIACELL
THERAPEUTICS CORP.
(Exact
name of registrant as specified in its charter)
British
Columbia A1
47-1099599
(State
or other jurisdiction
of
incorporation or organization)
(I.R.S.
Employer
Identification
No.)
Suite
300 - 235 15th Street
West
Vancouver, BC V7T 2X1
V7T
2X1
(Address
of principal executive offices)
(Zip
Code)
(604)
921-1810
(Registrant’s
telephone number, including area code)
Commission
File No. 001-40101
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered under Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common Shares, no par value
BCTX
The Nasdaq Stock Market
LLC
Warrants to purchase common
shares, no par value
BCTXW
The Nasdaq Stock Market
LLC
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
March 31, 2026, BriaPro Therapeutics Corp., a subsidiary of BriaCell Therapeutics Corp. (the “Company”),
filed its unaudited condensed interim consolidated financial statements and management’s discussion and analysis for the three
and six month period ended January 31, 2026, with the British Columbia Securities Commission and Alberta Securities Commission. A copy
of the condensed interim consolidated financial statements and management’s discussion and analysis for the three and six
month period ended January 31, 2026 are included as Exhibit 99.1 and Exhibit 99.2 to this Current Report on Form 8-K and are incorporated
herein by reference.
The
information furnished pursuant to this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the
liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities
Act of 1933 (the “Securities Act”) or the Exchange Act, regardless of any general incorporation language in such filings.
Item
9.01 Condensed interim financial statements and Exhibits
EXHIBIT
INDEX
Exhibit
No.
99.1
BriaPro Therapeutics Corp. Unaudited Condensed interim consolidated financial statements for the three and six month period ended January 31, 2026.
99.2
BriaPro Therapeutics Corp. Management’s Discussion and Analysis for the three and six month period ended January 31, 2026.
104
Cover Page Interactive
Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
BRIACELL THERAPEUTICS CORP.
/s/ William
V. Williams
March
31, 2026
William V. Williams
President and Chief Executive Officer
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
Exhibit
99.1
BRIAPRO
THERAPEUTICS CORP.
CONDENSED
INTERIM CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE AND SIX MONTH PERIOD ENDED JANUARY 31, 2026
(Unaudited)
(Expressed
in United States Dollars)
NOTICE
TO SHAREHOLDERS
The
accompanying Unaudited Condensed Interim Consolidated Financial Statements of BriaPro Therapeutics Corp. for the three and six month
periods ended January 31, 2026 and 2025 have been prepared by management in accordance with International Financial Reporting Standards
applicable to Condensed Interim Consolidated Financial Statements. Recognizing that the Company is responsible for both the integrity
and objectivity of the Unaudited Condensed Interim Consolidated Financial Statements, management is satisfied that these Unaudited Condensed
Interim Consolidated Financial Statements have been fairly presented.
Under
National Instrument 51-102, part 4, sub-section 4.3(3)(a), if an auditor has not performed a review of the Condensed Interim Consolidated
Financial Statements, they must be accompanied by a notice indicating that the financial statements have not been reviewed by an auditor.
The
Company’s independent auditor has not performed a review of these Unaudited Condensed Interim Consolidated Financial Statements
in accordance with standards established by the Institute of Chartered Professional Accountants of Canada for a review of interim financial
statements by an entity’s auditor.
F-1
BriaPro
Therapeutics Corp.
Unaudited
Condensed Interim Consolidated Statements of Financial Position
As
at January 31, 2026
(Expressed
in US Dollars)
January 31, 2026
July 31, 2025
(Audited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 1
$ 1
Total current assets
1
1
NON-CURRENT ASSETS:
Intangible assets, net (Note 4)
176,889
184,525
Total non-current assets
176,889
184,525
Total assets
$ 176,890
$ 184,526
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Due to related parties (Note 7)
$ 1,606,112
$ 1,121,053
Accrued expenses and other payables
32,688
27,440
Total current liabilities
1,638,800
1,148,493
NON-CURRENT LIABILITIES:
Warrant liability (Note 5d)
156,231
181,943
Total non-current liabilities
156,231
181,943
SHAREHOLDERS’ DEFICIT:
Share capital (Note 5)
1
1
Share-based payment reserve (Note 5)
34,514
34,514
Accumulated deficit
(1,652,656 )
(1,180,425 )
Total shareholders’ deficit
(1,618,141 )
(1,145,910 )
Total liabilities and shareholders’ deficit
$ 176,890
$ 184,526
Nature of Operations and Going Concern (Note
1)
Events After the Reporting Period (Note 11)
These
Condensed interim consolidated financial statements were approved and authorized for issue on behalf of the Board of Directors on March
31, 2026 by:
On behalf
of the Board:
“Martin
Schmieg”
“William
Williams”
Director
Director
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
F-2
BriaPro
Therapeutics Corp.
Condensed
Interim Consolidated Statement of Operations and Comprehensive Loss
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
Three months ended
January 31,
Six months ended
January 31,
2026
2025
2026
2025
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 195,806
$ 81,523
$ 433,307
130,023
General and administrative expenses
43,692
57,509
64,636
80,012
Operating loss
(239,498 )
(139,032 )
(497,943 )
(210,035 )
Change in fair value of warrant liability (Note 5d)
12,005
(12,030 )
25,712
(23,150 )
Total operating loss and comprehensive loss
(227,493 )
(151,062 )
(472,231 )
(233,185 )
Basic and diluted weighted average loss per share
$ (0.005 )
$ (0.003 )
$ (0.011 )
$ (0.005 )
Basic and diluted weighted average number of shares
43,884,247
43,884,247
43,884,247
43,884,247
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
F-3
BriaPro
Therapeutics Corp.
Condensed
Interim Statement of Changes in Shareholder’s Equity (Deficit)
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
Shares
Amount
Share
based payment reserve
Accumulated
deficit
Total
shareholder’s
deficit
Balance October 31, 2024
47,945,178
$ 1
34,514
$ (522,332 )
$ (487,817 )
Loss for the period
-
-
(151,062 )
(151,062 )
Balance, January 31, 2025
47,945,178
$ 1
34,514
$ (673,394 )
$ (638,879 )
Shares
Amount
Share
based payment reserve
Accumulated
deficit
Total
shareholder’s
equity (deficit)
Balance July 31, 2024
47,945,178
$ 1
34,514
$ (440,209 )
$ (405,694 )
Loss for the period
-
-
-
(233,185 )
(233,185 )
Balance, January 31, 2025
47,945,178
$ 1
34,514
$ (673,394 )
$ (638,879 )
Shares
Amount
Share
based payment reserve
Accumulated
deficit
Total
shareholder’s
deficit
Balance October 31, 2025
47,945,178
$ 1
34,514
$ (1,425,163 )
$ (1,390,648 )
Loss for the period
-
-
-
(227,493 )
(227,493 )
Balance, January 31, 2026
47,945,178
$ 1
34,514
$ (1,652,656 )
$ (1,618,141 )
Shares
Amount
Share
based payment reserve
Accumulated
deficit
Total
shareholder’s
deficit
Balance July 31, 2025
47,945,178
$ 1
34,514
$ (1,180,425 )
$ (1,145,910 )
Loss for the period
-
-
-
(472,231 )
(472,231 )
Balance, January 31, 2026
47,945,178
$ 1
34,514
$ (1,652,656 )
$ (1,618,141 )
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
F-4
BriaPro
Therapeutics Corp.
Condensed
Interim Statement of Cash Flows
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
For the Six
Months Ended
January 31, 2026
For the Six
Months Ended
January 31, 2025
Cash flow from operating activities
Net loss
$ (472,231 )
$ (233,185 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
7,636
7,636
Change in fair value of warrants
(25,712 )
23,150
Changes in assets and liabilities:
Increase in due to related parties
485,059
233,395
Increase (decrease) in accrued expenses and other payables
5,248
(30,996 )
Total cash flow from operating activities
-
-
Change in cash and cash equivalents
-
-
Cash and cash equivalents at beginning of the period
1
1
Cash and cash equivalents at end of the period
$ 1
$ 1
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
F-5
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
1: NATURE OF OPERATIONS AND GOING CONCERN
a.
BriaPro Therapeutics Corp.
(“BriaPro” or the “Company”) was incorporated under the Business Corporations Act (British Columbia) on May
15, 2023. Following the completion of the Arrangement (as defined below), BriaPro is a pre-clinical immuno-oncology biotechnology
company with multiple assets, specifically Bria-TILsRx™, and PKCδ inhibitors for multiple indications including cancer.
The Company’s head office is located at 235 15th Street, Suite 300, West Vancouver B.C, V7T 2X1, Canada. The Company
is an unlisted reporting issuer in Canada.
b.
On
August 31, 2023 (the “Effective Date”), the Company and BriaCell Therapeutics Corp, the Company’s holding company,
and immune-oncology biotechnology company listed on the Toronto Stock Exchange and NASDAQ (“BriaCell”), closed a plan
of arrangement spinout transaction (the “Arrangement”) pursuant to which certain assets of the BriaCell, including Bria-TILsRx™
and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the “BriaPro Assets”),
were spun-out to the Company (see note 5c and note 7 for further details).
On February 18, 2026, the Company entered into a definitive
purchase agreement with BriaCell, pursuant to which the Company agreed to acquire BriaCell’s exclusive license to develop and
commercialize Soluble CD80 (“sCD80”) as a biologic agent for the treatment of cancer and certain related assets (see
note 11 for further details).
c.
The accompanying Consolidated
Financial Statements have been prepared on the basis of a going concern which contemplates the realization of assets and liquidation
of liabilities in the normal course of business for the foreseeable future. The Company has incurred losses of $1,652,656 since incorporation,
is currently in the pre-clinical research stage and has not commenced commercial operations. The Company’s ability to continue
as a going concern is dependent upon its ability to attain future profitable operations and to obtain the necessary financing to
meet its obligations and repay its liabilities arising from normal business operations when they come due. Until the Company raises
additional financing, it is entirely dependent on BriaCell to finance the Company’s operations. The Company expects to incur
further losses through to the completion of the research and development of any therapy; the nature of a development stage immune-oncology
company requires the raising of financial capital to support its clinical development programs and administrative costs. The Company
is planning to finance its operations by exploring additional sources of capital and financing, while managing its existing working
capital resources. The material uncertainty of the Company’s ability to raise such financial capital casts significant doubt
on the Company’s ability to continue as a going concern. These Consolidated Financial Statements do not include any adjustments
to the amounts and classification of assets and liabilities that might be necessary should the Company not be able to continue as
a going concern.
F-6
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
2: BASIS OF PRESENTATION
a.
Statement of Compliance:
The
Company prepares its unaudited condensed interim consolidated financial statements in accordance with International Financial Reporting
Standards (“IFRS”) using the accounting policies described herein as issued by International Accounting Standards Board (“IASB”)
and International Financial Reporting Interpretations Committee (“IFRIC”) interpretations. These unaudited condensed interim
consolidated financial statements have been prepared in accordance with International Accounting Standards (“IAS”) 34 Interim
Financial Reporting.
The
policies applied in these condensed interim consolidated financial statements are based on IFRS effective as of January 31, 2026.
The
preparation of financial data is based on accounting principles and practices consistent with those used in the preparation of the audited
financial statements as of July 31, 2025. The accompanying condensed interim consolidated financial statements should be read in conjunction
with the Company’s audited financial statements for the period ended July 31, 2025.
b.
Basis of presentation
The
condensed interim consolidated financial statements are prepared on a going concern basis and have been presented in United States dollars
which is the Company’s reporting currency.
c.
Basis of Measurement:
These
condensed interim consolidated financial statements have been prepared on a going concern basis, under the historical cost basis, except
for financial instruments which have been measured at fair value.
d.
Functional Currency and Presentation Currency:
The
functional currency is the currency that best reflects the economic environment in which the Company operates and conducts its transactions.
The Company’s management believes that the functional currency of the Company is the U.S. dollar.
Accordingly,
monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars at each reporting period end.
All transaction gains and losses of the remeasured monetary financial position items are reflected in the statement of operations and
comprehensive loss as financing income or expenses as appropriate.
F-7
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
3: SIGNIFICANT ACCOUNTING JUDGEMENTS AND ESTIMATES
The
accounting policies and use of estimates and judgments described below have been applied consistently in these condensed interim consolidated
financial statements.
The
preparation of condensed interim consolidated financial statements in conformity with IFRS requires management to make estimates, judgments
and assumptions that affect the amounts reported in the condensed
interim consolidated financial statements and accompanying notes. The Company’s management
believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made.
These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the condensed
interim consolidated financial statements, and the reported amount of expenses during the reporting
periods. Actual results could differ from those estimates.
Going
Concern
Preparation
of the condensed interim consolidated financial statements is on a going concern basis, which contemplates the realization of assets
and payments of liabilities in the ordinary course of business. Should the Company be unable to continue as a going concern, it may be
unable to realize the carrying value of its assets, including its intangible assets, and to meet its liabilities as they become due.
Intangible
assets
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.
Warrant
liability and equity incentive grants
The
Company uses the Black-Scholes option-pricing model to estimate fair value of the warrant liability at each reporting date and options
granted under the Company’s equity inceptive plan. The key assumptions used in the model are the share price of the Company and
the expected future volatility in the price of the Company’s shares and the expected life of the instrument.
F-8
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
4: INTANGIBLE ASSETS, NET
Acquired
intangible assets with finite lives consisted of the following as of January 31, 2026 and July 31, 2025:
January 31, 2026
July 31, 2025
Patents
$ 213,800
$ 213,800
Less – accumulated amortization
(36,911 )
(29,274 )
Intangible assets, net
$ 176,889
$ 184,526
The
attributable intellectual property relates to the BriaPro Assets acquired in the Arrangement, which the Company is amortizing over 14
years, consistent with its accounting policy.
NOTE
5: SHARE CAPITAL
a)
Authorized share capital
The
authorized share capital consists of an unlimited number of common shares with no par value (“Share”).
b)
Issued share capital
There
were no issuances of Shares during the six month period ended January 31, 2026.
c)
Share Purchase Warrants
Pursuant
to the Arrangement, each BriaCell warrant (“BriaCell Warrant”) shall, in accordance with its terms, entitle the holder thereof
to receive, upon the exercise thereof, one BriaCell Share and one BriaPro Share for the original exercise price.
Upon
the exercise of BriaCell Warrants, BriaCell shall, as agent for BriaPro, collect and pay to BriaPro an amount for each one (1) BriaPro
Share so issued that is equal to the exercise price under the BriaCell Warrant multiplied by the fair market value of one (1) BriaPro
Share at the Effective Date divided by the total fair market value of one (1) BriaCell Share and one (1) BriaPro Share at the Effective
Date (“BriaPro Pro-rata Warrant Proceeds”).
As
of January 31, 2026, there are issued and outstanding an aggregate of 8,111,714 BriaCell Warrants as follows:
Number of
BriaCell
Warrants (*)
BriaPro Pro-rata
Warrant Proceeds(*)
Expiry Date
3,896,809
106,216
February 26, 2026 – April 26, 2026
4,173,143
132,536
June 7, 2026 - December 7, 2026
17,074
465
February 26, 2026
24,688
784
June 7, 2026
8,111,714
$ 240,001
(*)
The number of Shares issuable and proceeds, should the BriaCell Warrants be exercised.
F-9
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
5: SHARE CAPITAL (CONTINUED)
d)
Warrant liability continuity
(i)
The following table presents
the summary of the changes in the fair value of the warrants recorded as a liability on the Balance Sheet (*):
Warrants liability
Balance as of July 31, 2025
$ 181,943
Change in fair value during the period (*)
(25,712 )
Balance as of January 31, 2026
$ 156,231
(*)
The
warrants issued by BriaCell contain terms that require the warrants to be recorded as a liability at fair value under IFRS.
As a result, these warrants are valued at the end of each reporting period. For the six months ended January 31, 2026, the Company
recorded a gain on the revaluation of the total warrant liability of $25,712 in the condensed interim consolidated statements
of operations and comprehensive loss.
The
key inputs used in the valuation of the warrants as of July 31, 2025 and January 31, 2026 were as follows:
July 31, 2025
January 31, 2026
Share price (*)
$ 0.0365
$ 0.0365
Exercise price
$ 0.0206-0.0318
$ 0.0273-0.0318
Expected life (years)
0.30-1.35
0.07-0.85
Volatility
157-209 %
177-355 %
Dividend yield
0 %
0 %
Risk free rate
2.68-2.74 %
2.14-2.33 %
(*)
The share price was determined using the discounted cash flow method. Key assumptions included a discount rate of 15.5% and a growth
rate of 5%, a royalty rate of 3%, clinical trials taking approximately 8 years. A 1% increase or decrease in enterprise value would result
in an approximate +/- $0.00036 change in the share price, which would correspond to an estimated impact of approximately +/- $2,341 on
the warrant value.
NOTE
6: SHARE-BASED COMPENSATION
The
BriaPro Board adopted the BriaPro incentive plan, The purpose of the BriaPro incentive plan is to allow BriaPro to issue stock options,
performance share units (“PSUs”), restricted share units (“RSUs”), and deferred share units (“DSUs”
and together with the PSUs and RSUs, “Share Units”) to directors, officers, employees and consultants, as additional compensation,
and as an opportunity to participate in the success of BriaPro. The granting of such Awards is intended to align the interests of such
persons with that of the shareholders (the “Omnibus Plan”).
F-10
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
6: SHARE-BASED COMPENSATION (CONTINUED)
a.
The following table summarizes the number of options granted under the Omnibus Plan for the six month period ended January 31,
2026 and related information:
Number of
options
Weighted
average
exercise price
Weighted average
remaining contractual
term (in years)
Aggregate
intrinsic value
Balance as of July 31, 2025
2,131,400
0.0957
1.55
-
Balance as of January 31, 2026
2,131,400
0.0957
1.05
-
Exercisable as of January 31, 2026
2,131,400
$ 0.0957
1.05
-
As
the date of this report, the Company has 2,131,400 stock options outstanding as follows:
BriaPro Option
Exercise Price
Options
outstanding
Expiry Date
$ 0.0933
440,000
June 20, 2028
$ 0.1108
21,000
February 27, 2028
$ 0.0984
180,100
August 2, 2027
$ 0.0729
31,000
May 20, 2027
$ 0.1162
150,000
February 16, 2027
$ 0.1310
524,700
January 13, 2027
$ 0.1165
12,600
November 1, 2026
$ 0.0888
100,000
September 1, 2026
$ 0.0656
60,000
April 19, 2026
$ 0.0656
612,000
March 29, 2026
2,131,400
b.
Restricted Share Units
The
following table summarizes the number of RSU’s granted to directors under the Omnibus Plan for the six month period ended January
31, 2026:
Number of RSU’s
outstanding
Aggregate
intrinsic value
Balance, July 31, 2025
19,200
$ 700
Balance, January 31, 2026
19,200
$ 700
F-11
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
7: RELATED PARTY TRANSACTIONS AND BALANCES
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.
On
August 31, 2023, the Company and BriaPro executed a transition services agreement (the “Transition Agreement”), pursuant
to which BriaCell will provide certain research and development and head office services (the “Services”) to BriaPro for
a fixed monthly fee of $20,000.
BriaCell
and BriaPro acknowledged the transitional nature of the Services and accordingly, as promptly as practicable, BriaPro agreed to use commercially
reasonable efforts to transition each Service to its own internal organization or to obtain alternate third party providers to provide
the Services.
As
of January 31, 2026, pursuant to the Transition Agreement, the total balance owing to BriaCell group companies is $1,606,112. For the
six month period ending January 31, 2026 the fixed monthly services expense totaled $120,000 and direct expenses incurred by BriaCell
on behalf of BriaPro totaled $365,059.
During
the six month period ended January 31, 2026, the Company incurred Services and direct expense paid for by BriaCell in the amount
of $485,059.
See also note for a transaction with a related
party subsequent to the balance sheet date.
F-12
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
NOTE
10: FINANCIAL INSTRUMENTS AND RISK MANAGEMENT
Financial
Instruments and Financial Risk Exposures
The
Company’s financial instruments consist of cash, accounts payable and accrued liabilities, loans from a related party, and the
warrant liability. 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, 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:
a.
Credit Risk
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.
b.
Liquidity Risk
The
Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come
due. Until the Company raises additional financing, it is entirely dependent on BriaCell to finance the Company’s operations. As
of January 31, 2026, the Company has a negative working capital balance of $1,638,799 (July 31, 2025 – negative working capital
of $1,148,492). 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
Accrued expenses and other payables
$ 32,688
$ 32,688
$ 32,688
$ -
$ -
$ -
Amounts owing to holding company
1,606,112
1,606,112
1,606,112
$ 1,638,800
$ 1,638,800
$ 1,638,800
$ -
$ -
$ -
F-13
BriaPro
Therapeutics Corp.
Notes
to the Condensed Interim Consolidated financial statements
For
the three and six months ended January 31, 2026
(Unaudited)
(Expressed
in US Dollars)
c.
Market Risk
i.
Interest Rate Risk
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.
ii.
Price Risk
As
the Company has no revenues, price risk is remote.
iii.
Exchange Risk
The
Company is exposed to foreign exchange risk as a portion of the Company’s transactions occur in Canadian Dollars 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, 2025, 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.
d.
Fair Values
The
carrying values of accounts payable and accrued liabilities approximate their fair values due to their short terms to maturity.
Cash,
is valued using quoted market prices in active markets. The warrant liability is measured using the Black-Scholes Option Pricing Model.
Capital
management
The
Company considers its capital to be comprised of shareholders’ equity. The Company’s objectives in managing its capital are
to maintain its ability to continue as a going concern and to further develop its business. To effectively manage the Company’s
capital requirements, the Company has a planning and budgeting process in place to meet its strategic goals. In order to facilitate the
management of its capital requirements, the Company prepares expenditure budgets that are updated as necessary depending on various factors,
including successful capital deployment and general industry conditions. Management reviews the capital structure on a regular basis
to ensure the above objectives are met. There have been no changes to the Company’s approach to capital management during the six
months ended January 31, 2026. There are no externally imposed restrictions on the Company’s capital.
NOTE
11: EVENTS AFTER THE REPORTING PERIOD
On
February 18, 2026, the Company entered into a definitive purchase agreement (the “Purchase Agreement”) with BriaCell, pursuant to which the Company agreed to acquire BriaCell’s exclusive license to develop and commercialize
Soluble CD80 (“sCD80”) as a biologic agent for the treatment of cancer and certain related assets (the “Transaction”).
Under
the terms of the Purchase Agreement, the Company will obtain worldwide rights to develop and commercialize sCD80 as a therapeutic agent
for the treatment of cancer. The underlying intellectual property is owned by the University of Maryland, Baltimore County (“UMBC”),
which retains all rights, title, and interest in the inventions and patents, subject to certain rights retained by the United States
Government. Upon commercialization of the product, the Company will be required to pay royalties of 2% to UMBC, together with certain
additional development-related payments.
In
connection with the Transaction, BriaCell has agreed to make available to the Company a credit facility of up to $3,000,000 to fund research
and development activities related to sCD80. Each drawdown under the credit facility will be subject to BriaCell’s approval regarding
the use of funds.
As
consideration for the transfer of the exclusive license and the availability of the credit facility, the Company will issue 23,972,589
common shares to BriaCell with an aggregate value of approximately C$1.18 million, which is expected to increase BriaCell’s ownership
interest in the Company to approximately 78% following completion of the Transaction.
Completion
of the Transaction is subject to customary closing conditions, including approval by the disinterested shareholders of the Company and
receipt of an independent third-party valuation confirming that the Transaction is occurring at fair market value. In accordance with
Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions, BriaCell’s shareholdings
were excluded from voting on the resolution approving the Transaction.
On March 5, 2026, the disinterested shareholders of the Company approved
the Transaction and the Transaction closed on March 30, 2026.
F-14
EX-99.2
EX-99.2
Filename: ex99-2.htm · Sequence: 3
Exhibit
99.2
BRIAPRO
THERAPEUTICS CORP.
MANAGEMENT’S
DISCUSSION AND ANALYSIS
For
the three and six months ended January 31, 2026
(Expressed
in U.S. Dollars)
The
following Management’s Discussion and Analysis (“MD&A”) for BRIAPRO THERAPEUTICS CORP. (“BriaPro”
or the “Company”) is prepared as of March 31, 2026 and relates to the unaudited condensed interim financial
condition and results of operations of the Company for the three and six month period ended January 31, 2026. Past performance may
not be indicative of future performance. This MD&A should be read in conjunction with the Company’s audited annual
condensed interim consolidated financial statements for the year ended July 31, 2025, which have been prepared using accounting
policies consistent with International Financial Reporting Standards as issued by the International Accounting Standards Board
(“IFRS”).
All
amounts are presented in United States dollars (“USD” or “$”), the Company’s presentation currency, unless
otherwise stated.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
of the statements made and information contained herein is “forward-looking information” within the meaning of the Ontario
Securities Act. These statements relate to future events or the Company’s future performance. All statements, other than statements
of historical fact, may be forward-looking statements. Generally, these forward-looking statements can be identified by the use of forward
looking terminology such as “anticipates”, “plans”, “budget”, “scheduled”, “continue”,
“estimates”, “forecasts”, “expect”, “is expected”, “project”, “propose”,
“potential”, “targeting”, “intends”, “believes” or variations of such words and phrases
or statements that certain actions, events or results “may”, “could”, “would”, “might”,
or “will be taken”, “occur” or “be achieved” or the negative connotation thereof. These statements
involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those
anticipated in such forward-looking statements. The Company believes that the expectations reflected in those forward-looking statements
are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking statements included
in this MD&A should not be unduly relied upon by readers, as actual results may vary. These statements speak only as of the date
of this MD&A and are expressly qualified, in their entirety, by this cautionary statement.
The
Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of the
risk factors set forth above. Although the Company has attempted to identify important factors that could cause results to differ materially
from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated
or intended. There can be no assurance that such statements 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 statements.
Readers are cautioned that the foregoing lists of factors are not exhaustive. Forward looking statements are made as of the date hereof
and accordingly are subject to change after such date. The forward-looking statements contained in this MD&A are expressly qualified
by this cautionary statement. The Company does not undertake to update or revise any forward-looking statements, whether as a result
of new information, future events or otherwise, except in accordance with applicable securities laws.
Name,
Address and Incorporation
BriaPro
was incorporated under the laws of Business Corporations Act (British Columbia) on May 15, 2023. BriaPro has not conducted any business
to date and is currently a private company and is a subsidiary of BriaCell Therapeutics Corp (“BriaCell”). No material amendments
have been made to BriaPro’s articles or other constating documents since its incorporation. The Company is an unlisted reporting
issuer in Canada.
BriaPro’s
head and principal business address are all located at 235 15th Street, Suite 300, West Vancouver B.C., V7T 2X1. BriaPro’s
registered office address is located at Suite 2500 Park Place, 666 Burrard Street, Vancouver B.C., V6C 2X8.
1
About
the Company
BriaPro
is a wholly owned subsidiary of BriaCell Therapeutics Corp., a clinical stage biotechnology company focused on the development of Bria-TILsRx™,
and PKCδ inhibitors for multiple indications including cancer, and anti-B7-H3 antibodies for cancer.
BriaPro’s
novel Bria-TILsRx™ (“TILsRx”) multi-specific (multivalent) binding reagents are designed to act as potent immune cell
activators and/or immune checkpoint inhibitors. They are expected to selectively target and destroy cancer cells with minimal effect
on normal (non-cancerous) cells. This may mean less severe side effects for the treated cancer patients compared with those of alternative
therapies. BriaPro’s novel and highly selective PKCδ inhibitors may be developed as candidates for multiple disease indications
including several cancer types. BriaPro’s novel anti-B7-H3 antibodies are expected to destroy cancer cells on two levels –
by delivering a toxic payload to cancer cells by directly binding to B7-H3 on the cancer cell surface and by reducing the immune suppression
commonly present in patients’ tumors by blocking the checkpoint activity of B7-H3 on immune cells
BriaPro’s
operations are conducted in compliance with local laws where such activities are permissible and either (a) do not require any specific
legal or regulatory approvals, or (b) BriaPro has all necessary legal and/or regulatory approvals. See “Risk Factors.”
Significant
developments during the period
Over
the last few months, using an in silico modeling approach, BriaPro has designed a battery of antibodies (antibody fragments) to an important
molecular target in the oncology space. This target is both an immune checkpoint and a tumor-associated antigen. A subset of the antibodies
were designed as humanized constructs to shorten the development timeline.
BriaPro
has also continued its work on protein kinase C delta (PKC-delta) inhibitors previously carried out by BriaCell. Recent work was dedicated
to the development of a new platform and in silico approaches to model potential drug-target interactions. Initial assays have shown
positive results for inhibition. BriaPro intends to continue to improve the design of these inhibitors.
On February 18, 2026, the Company entered into
a definitive purchase agreement (the “Purchase Agreement”) with BriaCell, pursuant to which the Company agreed to acquire
BriaCell’s exclusive license to develop and commercialize Soluble CD80 (“sCD80”) as a biologic agent for the treatment
of cancer and certain related assets (the “Transaction”).
Under the terms of the Purchase Agreement, the
Company will obtain worldwide rights to develop and commercialize sCD80 as a therapeutic agent for the treatment of cancer. The underlying
intellectual property is owned by the University of Maryland, Baltimore County (“UMBC”), which retains all rights, title,
and interest in the inventions and patents, subject to certain rights retained by the United States Government. Upon commercialization
of the product, the Company will be required to pay royalties of 2% to UMBC, together with certain additional development-related payments.
In connection with the Transaction, BriaCell has
agreed to make available to the Company a credit facility of up to $3,000,000 to fund research and development activities related to
sCD80. Each drawdown under the credit facility will be subject to BriaCell’s approval regarding the use of funds.
As consideration for the transfer of the exclusive
license and the availability of the credit facility, the Company will issue 23,972,589 common shares to BriaCell with an aggregate value
of approximately C$1.18 million, which is expected to increase BriaCell’s ownership interest in the Company to approximately 78%
following completion of the Transaction.
Completion of the Transaction is subject to customary
closing conditions, including approval by the disinterested shareholders of the Company and receipt of an independent third-party valuation
confirming that the Transaction is occurring at fair market value. In accordance with Multilateral Instrument 61-101 – Protection
of Minority Security Holders in Special Transactions, BriaCell’s shareholdings were excluded from voting on the resolution approving
the Transaction.
On March 5, 2026, the disinterested shareholders of the Company approved the Transaction and the Transaction closed
on March 30, 2026. Upon closing of the Transaction, Mr. Jamieson Bondarenko was appointed to the BriaPro board as Chairman. Mr. Bondarenko
has served as Chairman of BriaCell since 2019. He provides strategic capital markets & corporate development advice to early-stage
life sciences companies through his merchant capital company, JGRNT Capital Corp. Previously, he held a number of senior investment banking
roles, including as Managing Director at Eight Capital and at Dundee Securities. Mr. Bondarenko is expected to play a significant role
in BriaPro's pursuit of capital markets and other strategic opportunities as the company advances its expanding IP portfolio.
2
Overview of BriaPro’s business
BriaPro is a pre-clinical stage immunotherapy company
developing proteins and binding agents with the intention to boost the ability of the body’s own cancer-fighting cells to destroy
cancerous tumors. Additionally, using artificial intelligence (“AI”) [with Receptor.AI], BriaPro will identify small-molecule
drug candidates.
The
lead drug discovery candidates for BriaPro include (“BriaPro Assets”):
●
Bria-TILsRx™: Multi-Specific
Binding Reagents - Immunotherapy for Cancer: being developed in house (with a contract research organization). As outlined in a press
release dated July 29, 2025, BriaPro filed a provisional patent application for its TILsRx platform. Compared to its original design,
the platform now includes a more detailed design supported by additional in vitro experiments.
●
Small Molecule Program:
Protein Kinase C delta (PKCδ) Inhibitors being developed in a research collaboration with Receptor.AI (outlined in a press
release dated November 20, 2025).
●
B7-H3: Antibodies to B7-H3
for cancer: being developed in house (with a contract research organization). As announced in a press release dated April 10, 2025,
BriaPro filed provisional patent applications for novel antibodies to B7-H3. In May 2025, a corresponding PCT international patent
was filed. Antibodies described may also be used as domains in TILsRx.
Following the completion of the Transaction, BriaPro
has an exclusive license to develop and commercialize sCD80 as a biologic agent for the treatment of cancer and certain related assets.
The
power of AI in drug candidate selection has been hailed by experts and investments in AI-driven drug discovery companies have tripled
over the past four years, reaching $24.6 billion in 2022.2 Using AI technology to identify the next blockbuster therapies
can help eliminate some of the guesswork that typically requires hundreds of lab experiments—often spread over many years—to
identify promising molecules.
Instead
of coming up with tens of thousands of compounds to figure out, computers suggest testing ten compounds in a lab, then getting feedback
from the lab results. The machines learn from those results to make a better prediction to provide the next hundred candidates for testing
and ultimately filter to one molecule.
Over
the course of the next year, BriaPro expects to screen several different TILsRx multi-specific binding reagents for activity in vitro
as well as in mouse models of cancer, including TILsRx reagents carrying anti-B7-H3 antibody domains. BriaPro also expects to select
at least one candidate to advance into IND enabling studies. Human clinical studies are expected to be initiated in the first half of
2027, pending funding. In parallel, BriaPro will select novel protein kinase C delta inhibitors, optimize structure(s), and advance to
the candidates selection stage. Human clinical studies are expected to be initiated in the second half of 2026. In addition to their
use in the TILsRx program, anti-B7-H3 antibodies are planned to be developed as antibody drug conjugates (ADC), with IND enabling studies
expected to begin when funding is available.
BriaPro’s
Business Strategy
BriaPro’s
business strategy incorporates using AI (as well as alternative computational methods such as molecular modeling) to guide the design
of novel multi-specific binding reagents known as Bria-TILsRx™. BriaPro will use AI to further enhance the selectivity and potency
of novel protein kinase C delta inhibitors. These agents will be tested in vitro and in animal models to optimize their characteristics.
They will then enter preclinical IND enabling studies which are expected to take up to one year in duration. They will then be introduced
into the clinic in phase 1 clinical studies in patients with cancer. When the activity and safety of these assets is confirmed, BriaPro
will advance their clinical programs, culminating in applying for biologics license applications (BLAs) or new drug applications (NDAs)
to the US FDA and other regulatory authorities around the world. Bria-TILsRx™, protein kinase C delta inhibitors, and B7-H3 antibodies
will then be marketed for the treatment of patients with cancer.
BriaPro’s
Research and Development Programs
Bria-TILsRx™:
BriaPro Lead Assets
T
cells typically recognize and attack cancer cells. But cancer can suppress the immune response. Bria-TILsRx™ work in one of two
ways:
●
Directly linking killer
T cells to cancer cells and activating them to kill the cancer cells; or
●
Blocking the molecules
on the cancer cells that suppress the immune response.
2
“AI Drug Discovery Is a $50 Billion Opportunity for Big Pharma,” (https://www.bloomberg.com/news/articles/2023-05-09/pharmaceutical-companies-embrace-ai-to-develop-new-drugs).
3
Bria-TILsRx™
Rationale:
The
global cancer immunotherapy market was estimated at $115 billion in 2022. Current immunotherapies only work in some cancers, and then
not in all patients. Recent entrees into the cancer immunotherapy field are bi-specific T cell engagers (BiTEs). These work by linking
killer T cells to cancer cells and activating the killer T cells to kill the cancer cells. Hailed as a potentially major advance in cancer
therapy, they still suffer from side effects and don’t work in all patients. BriaPro’s Bria-TILsRx™ platform is quadrivalent,
enhancing the ability to specifically target tumor cells and potently activate T cells, and to block the ability of the cancer cells
to shut down the immune system. Bria-TILsRx™: Multivalent Binding Reagents are designed to activate the immune system against cancer
more specifically and more potently than current approaches.
Bria-TILsRx™
Advantages:
Multi-specific
Binding Reagents have the potential to (i) bind more selectively to cancer cells and link them with T cells to kill the cancer cells;
and (ii) block the ability of cancer cells to shut down the T cells more potently that current agents.
There
are two approved BiTEs to date, with many others in development: BLINCYTO® for leukemia and IMDELLTRA™ for lung cancer. These
are limited by the cancer cell targets available. By using artificial AI, BriaPro can rapidly develop novel binding agents that can target
more and different types of cancer than other BiTEs. The BriaPro molecules are also able to engage more than one target, as shown below.
4
Current
immunotherapies (Keytruda®, Opdivo®, Tecentriq®, etc) block the ability of selected molecules on cancer cells to shut down
the immune response (so-called immune checkpoints). Their mechanism of action is shown here.
However,
cancer cells express multiple different immune checkpoints. Bria-TILsRx™ can block multiple immune checkpoints with a single molecule
making them potentially more effective, as shown below.
Protein
Kinase C delta (PKCδ) Inhibitors: BriaPro Small Molecule Program
Rationale:
30%
of all human malignancies display activating RAS mutations. As well, another 60% show over-activity of Ras-signaling pathways. BriaPro’s
novel, proprietary PKCδ inhibitors have shown activity against multiple RAS transformed tumors. Lung cancer, Melanoma, Breast cancer,
Neuroendocrine cancer, Pancreatic cancer, Colorectal cancer. This target has an attractive safety profile based on in vivo studies and
knock out mouse studies. PKCδ inhibitors should qualify for an accelerated clinical development plan and regulatory pathway. PKCδ
inhibitors potentially offer a safe treatment for up to 90% of all human cancers.
5
Protein
Kinase C delta (PKCδ) Inhibitors: Advantages:
BriaPro
will have access to novel structures with extended patent life and large number of chemical moieties covered. Fourth generation inhibitors
are under development using AI in collaboration with Receptor. AI to optimize drug-like characteristics.
Studies
have also shown that PKCδ inhibitors lack endothelial cell cytotoxicity & PKCδ deficient mice develop normally and are
fertile. This portends an excellent safety profile.
The
below graphic shows three generations of PKCδ inhibitors. The first generation is the natural compound rottlerin, which corresponds
to Generation 1 in the table below. The low potency and selectivity of rottlerin for PKCδ was enhanced by making a hybrid structure,
combining part of the staurosporine molecular structure (shown in red) with part of the rottlerin structure (shown in blue) to produce
KAM1. Note that staurosporine is a highly potent but non-selective PKC inhibitor. The improvement in selectivity of KAM1 over rottlerin
is shown in the table (Generation 2). KAM1 was further modified for produce BP-106 with enhances potency and selectivity (Generation
3).
Generation
PKC-δ
IC50
PKC-α
IC50
PKC-δ/
PKC-α Selectivity Ratio
1
3 μM
75 μM
28-fold
2
2 μM
157 μM
56-fold
3
0.05 μM
50 μM
1000-fold
High
selectivity of the currently available inhibitors suggests an excellent safety profile with potent anti-cancer activity. Novel PKCδ
inhibitors with excellent safety in vitro and in animal models have been developed and are being optimized. New generation molecules
taking advantage of additional scaffolds based on known PKCδ inhibitors are being designed using AI.
6
Several
in vitro and animal model studies have shown efficacy against various human cancers as depicted by the charts below.
PKCδ
inhibitor reduces tumor burden in a human lung cancer model (left; the red line shows increasing tumor size in the control animals while
the blue line shows the tumor size shrinking in the animals treated with a PKCδ inhibitor) and a human pancreatic cancer model
(right) with decreases in tumor amounts (right top; the blue line shows increasing tumor size in the control animals while the purple
line shows the tumor size shrinking in the animals treated with a PKCδ inhibitor) and increased survival (right bottom; survival
is shown, which quickly goes to 0 in the control animals (purple line), but survival of the treated animals (green line) stabilizes at
50% and is maintained for up to 300 days).
Soluble
CD80 (sCD80)
sCD80
has several mechanisms whereby it can augment anti-tumor immunity. In the absence of sCD80, tumor cell or antigen-presenting cell expression
of PD-L1 and CD80 sends inhibitory signals to T cells via PD-1 and CTLA4 reducing T cell activation, as shown here:
In
the presence of sCD80-Fc, sCD80 binds to Fc receptors on the tumor cell or antigen-presenting cell blocking CTLA4 and PD-1 inhibitory
activity permitting T cell activation via the T cell receptor and CD28 and enhancing CD28-mediated T cell activation as shown here:
7
To
evaluate the activity of sCD80 in a mouse model of cancer, mice were injected with colon cancer (CT26) or melanoma (B16F10) tumor cells
and the tumors allowed to grow. When tumors were 4.5mm in diameter mice were treated intratumorally (IT) 2x weekly with sCD80 or control
IgG. sCD80 slowed tumor growth in both models as shown in these graphs below.
Other
forms of sCD80 have previously been introduced into the clinic (Davoceticept (ALPN-202) from Alpine therapeutics, and FPT155 from Five
Prime Therapeutics. Both of these showed some evidence of early efficacy in patients with cancer. While these molecules are no longer
in development, BP-80 has been engineered to avoid the pitfalls encountered by these molecules.
BriaCell
originally secured the exclusive license from the University of Maryland, Baltimore County (“UMBC”) on August 2, 2022.
The novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell’s
scientific advisory board, is titled “Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients” and
is covered under USPN 8,956,619 B2, USPN 9,650,429 B2, and USPN 10,377,810 B2. In animal models, sCD80 was well-tolerated and stopped
tumor growth by potentially restoring natural anti-tumor immunity. Additionally, strong anti-tumor activity of sCD80 has been reported
in multiple tumor types. Importantly, as demonstrated in the same studies, sCD80’s unique actions may involve both awakening and
boosting the immune system to recognize and destroy tumor cells
Following
the completion of the Transaction, the Company as an exclusive license from University of UMBC to develop and commercialize sCD80 as
a biologic agent for the treatment of cancer. Under the terms of the agreement, the Company has the worldwide rights to develop and commercialize
sCD80, while UMBC maintains ownership of the patents (the “UMBC Licensing Agreement”). the Company will pay royalties to
UMBC upon the commercialization of the product plus patent management costs. The licensing agreement was coordinated by UMBC’s
Office of Technology Development.
The
patents held under UMBC Licensing Agreement are as follows:
USPN
8,956,619 B2
USPN
9,650,429 B2
USPN
10,377,810 B2
BriaCell
had previously performed pre-clinical toxicology evaluation of sCD80, hereinafter referred to as BP-80. The key IND enabling study was
a 1 month study in cynomolgus macaques. Intravenous doses of 0.5, 5 and 50 mg/kg were evaluated and there were only minimal findings,
establishing 50 mg/kg, the highest dose evaluated, was established as a safe dose. This equates to a human dose of over 650 mg, while
the mouse cancer studies indicated an effective dose in humans would be just over 50 mg. So there is a wide potential safety margin for
BP-80.
BriaCell
also had previously worked with a contract manufacturer to develop BP-80 drug substance and this is available to complete manufacturing
into drug product. It is anticipated that this can be completed within a few months and the information will then be available to open
the Investigational New Drug Application (INDA) following which clinical studies with BP-80 can commence.
Production
and Services
BriaPro
contains the expertise to both discover and develop novel drug candidates, take them through clinical testing and have them approved
for use and marketing in humans. BriaPro will predominantly operate as a virtual company using contract research organizations for the
bulk of the research that will be performed. This includes the molecular biology aspect of developing novel protein therapeutics, having
them tested in vitro and tested in animal models, and performing IND enabling toxicology pharmacology and pharmacokinetics studies. BriaPro
may develop a small laboratory presence to perform some of these activities in house.
Specialized
Skill and Knowledge
BriaPro
possesses individuals with expertise in multiple scientific areas relevant to drug discovery and development. This includes molecular
biology, immunology, immune-oncology, clinical pharmacology, preclinical evaluation, basic pharmacology, interpretation of toxicological
studies, regulatory interactions, design and implementation of phase one, phase two, and phase three clinical studies. In addition, BriaPro
works with consultants who are experts in medicinal chemistry, artificial intelligence, structural biology, and other relevant disciplines.
8
Competitive
Conditions
The
market for cancer therapeutics is highly competitive. BriaPro will compete with other research teams who are also examining potential
therapeutics with regards to cancer, both immunotherapies and targeted approaches. Many of its competitors have greater financial and
operational resources and more experience in research and development than BriaPro. Other companies may have developed, or could in the
future develop, new technologies that compete with BriaPro’s technologies or render its technologies obsolete. Competition in cancer
therapeutics markets is primarily driven by (i) timing of technological introductions; (ii) the ability to develop, maintain and protect
proprietary products and technologies; and (iii) expertise of research and development team. BriaPro possesses particular unique expertise
and approaches that differentiate BriaPro from its competition. Very few competitors are using a quadrivalent platform (TILsRx) to develop
immunotherapies, and even fewer are targeting the specific receptors that BriaPro is targeting. As well, small molecules that combat
RAS transformed tumors are not common and even less so protein kinase C delta inhibitors.
Management’s
Expectations
Multiple
independent programs at various developmental stages leverage risk. An anti-B7-H3 antibody was designed at BriaPro and shown to have
a superior target-binding potential compared to an anti-B7-H3 antibody developed and tested in the clinic by others. The PKCδ inhibitor
field appears stalled as isoform-selectivity is challenging to obtain. BriaPro believes that by partnering with experts in the field
it has a competitive advantage to develop selective and potent PKCδ inhibitors. The TILsRx program embodies a new concept to selectively
target cancer cells. It bears risks such as that true cancer-selectivity may not be achievable, but has high potential as a new, potentially
first-in-class drug platform.
BriaPro
has expanded its technology with budgetary constraints in mind, limiting activity predominantly to computational methods and in vitro
experiments. To further develop these assets, BriaPro anticipates raising additional funds for animal studies including efficacy experiments
in mice and toxicology/pharmacokinetics studies needed for Investigational New Drug applications.
New
Products
Bria-TILsRx™:
Multi-Specific Binding Reagents - Immunotherapies for Cancer
Developed
as potential immunotherapies for cancer, BriaPro’s novel Bria-TILsRx™ multi-specific binding reagents are designed to act
as potent immune cell activators and/or immune checkpoint inhibitors. They are expected to selectively target and destroy cancer cells
with minimal effect on normal (non-cancerous) cells. This may mean less severe side effects for the treated cancer patients compared
with those of alternative therapies.
PKCδ
Inhibitors: Therapeutics for multiple disease indications including cancer
PKCδ,
also called novel PKC, has been associated with a number of diseases including cancer. Selective inhibitors of PKCδ, have been
shown to be effective treatments for several animal models of cancer and other diseases. BriaPro’s novel and highly selective PKCδ
inhibitors may be developed as candidates for multiple disease indications, including several tumor types.
B7-H3:
Antibodies to B7-H3 for Cancer:
As
both an immune checkpoint molecule that regulates T cell activity and a molecule expressed on the cell surface of many types of cancer
cells, B7-H3 is a promising drug target. BriaPro plans on developing anti-B7-H3 antibodies for multiple cancer indications and on including
them in its Bria-TILsRx™ platform.
Components
BriaPro
depends on third party suppliers to obtain BriaPro’s raw ingredients, intermediate drug substances and specialized equipment, which
are necessary for the production of BriaPro’s products.
BriaPro
currently obtains ingredients and API for the manufacturing of BriaPro’s pipeline products from specialized suppliers. For some
components, including raw ingredients, BriaPro has so far identified only one supplier which is qualified for outsourcing and/or current
good manufacturing practice (“cGMP”) process. If that supplier were to stop supplying the required ingredient(s),
BriaPro would need to identify an alternative source of such components, if possible, and may need to wait until it is qualified for
BriaPro’s outsourcing and/or cGMP process before procuring the components. This could cause substantial delays and a significant
increase in costs to one or all of BriaPro’s development programs. If no alternate suppliers were identified, such supply issues
could terminate the program.
Intellectual
Property Rights
Protection
of intellectual property is integral to BriaPro’s success. As such, BriaPro has and will continue to pursue patent protection,
register trademarks, and protect other intellectual property through trade secrets, copyright, confidential disclosure agreements, and
other mechanisms as appropriate. This includes the use of confidential disclosure agreements with all prospective vendors and partners,
reviewed by legal counsel under the direction of BriaPro.
In
order to maximize the duration of patent protection during the commercial life of a potential product and/or allow the generation of
data to strengthen a potential patent, BriaPro may on occasion delay patent filing. However, BriaPro will ensure it does not risk the
product protection during such delay.
To
ensure protection of all trade secrets, BriaPro will put in place strict confidentiality agreements with its directors, executive officers
and staff and stores research and development materials and data in secure facilities.
9
Patents
and Proprietary Information
Licensing
Agreement between Faller & Williams Technology LLC (“FWT”) and Sapientia Pharmaceuticals, Inc. (“Sapientia”)
This
Licensing Agreement (the “Agreement”) was entered into on March 16, 2017 between FWT and Sapientia, a subsidiary of BriaCell
(The assets that were transferred to BriaPro as part of the Arrangement were owned by Sapientia.) FWT is the owner of certain patents
set forth in Exhibit A, which were assigned to them from the inventors recorded at Reel/Frame 041014/0095 on January 19, 2017, and FWT,
pursuant to this Agreement, licensed the patents to Sapientia. Within 30 days of the date of this Agreement, Sapientia must pay to FWT
$75,000 to be paid half in cash ($37,500) and the other half in Sapientia common shares, fully vested, valued at $37,500, representing
Sapientia’s reimbursement of FWT’s prior expenses associated with the Patents and execution of the Agreement, in addition
to certain milestone payments.
Royalties
are also payable pursuant to this Agreement. Following the first Commercial Sale of a first Product in the United States, Sapientia shall
pay to FWT 5% of Net Sales of Products encompassed by one or more valid claims of the Patents and/or the Improvement within the Territory,
and 2.5% of Net Sales of Products not encompassed within one or more valid claims of the Patents within the Territory. Payment must be
made on or before January 1st and on or before July 1st of every year. If sales of Product require the payment of a royalty to a Third
Party for a prior art patent, Royalties payable to FWT shall be reduced by the amount of the Third Party royalty actually paid, but in
no event shall the Royalty payments payable to FWT be reduced by more than one half of the amounts set forth in this Section. Three years
after receiving marketing approval from the regulatory bodies listed in Section 3.5, Sapientia must make minimum royalty payments to
FWT of US$250,000 per year. Within 30 days of sublicensing to a Third Party, Sapientia must pay to FWT 25% of all consideration received
by Sapientia for the sublicense.
FWT
retains all rights to use and practice the Patents and any Improvement for research, education, and other non-commercial purposes, and
may exercise those rights with or without Notice or compensation to Sapientia.
Patents
licensed to Sapientia pursuant to this Agreement include:
●
U.S. Provisional Application
No. 61/703,081 entitle “PKC Delta Inhibitors for use as Therapeutics” filed 19 September 2012.
●
International Application
No. PCT/US2013/60638 entitled “PKC Delta Inhibitors for use as Therapeutics” filed 19 September 2013.
●
U.S. Patent No. 9,364,460
entitled “PKC Delta Inhibitors for use as Therapeutics” issued 14 June 2016.
●
U.S. Patent Application
No. 15/148,420 entitled “PKC Delta Inhibitors for use as Therapeutics” filed 06 May 2016.
●
U.S. Patent Application
No. 15/425,381 entitled “PKC Delta Inhibitors for use as Therapeutics” filed 06 February 2017.
●
EP Patent Application No.
13839158.6 “PKC Delta Inhibitors for use as Therapeutics” filed 25 March 2015.
Pursuant
to the Agreement, Sapientia agrees that the Patents are the property of FWT and agrees to not challenge their validity or ownership.
Sapientia has no rights to the Patents except as expressly contained in the Agreement. Improvements made by Sapientia during the term
of this Agreement shall be assigned to FWT and included as a part of the Agreement. The license granted to Sapientia from FWT is exclusive,
and Sapientia has an exclusive license to make, use, sell, offer to sell, import, and export the rights afforded under the Patents in
the Field and in the Territory, subject to rights reserved by FWT pursuant to the Agreement.
Patent
applications to protect the TILsRx platform and anti-B7-H3 antibodies
TILsRx
As
outlined in a press release dated July 29, 2025, BriaPro filed a provisional patent application for its TILsRx platform. Compared to
its original design, the platform now includes a more detailed design supported by additional in vitro experiments.
B7-H3
As
announced in a press release dated April 10, 2025, BriaPro filed provisional patent applications for novel antibodies to B7-H3. In May
2025, a corresponding PCT international patent was filed. Antibodies described may also be used as domains in TILsRx.
10
Cycles
The
nature of BriaPro’s business is not seasonal or cyclical.
Economic
Dependence
BriaPro
does not have a contract upon which its business is substantially dependent.
Changes
to Contracts
BriaPro
does not anticipate any aspect of its business in the current financial year that would be affected by renegotiation or termination of
contracts or sub-contracts.
Environmental
Protection
BriaPro
does not anticipate any financial or operational effects of environmental protection requirements on the capital expenditures, profit
or loss and competitive position in the current financial year or in future years.
Management
and Employees
BriaPro
currently has one full time employee and will expand this number as operations progress.
Foreign
Operations
BriaPro
does not have any foreign operations. Several of BriaPro’s contractors are located in other countries and this could present a
risk to ongoing operations.
Lending
BriaPro
does not have any lending operations.
Market
Opportunity
BriaPro
is dedicated to the development of novel immunotherapies to fight cancer and improve the lives of patients whose medical needs are currently
unmet. The global cancer immunotherapy market is estimated at $115 billion in 2022.1 However, current immunotherapies only
work in some cancers, and even then, not in all patients. Recent entries into the cancer immunotherapy field are bi-specific T cell engagers
(BiTEs). To date, there are two approved BiTEs, with many others in development: BLINCYTO® for leukemia and KIMMTRAK® for melanoma.
These existing options are limited by the cancer cell targets available. By using AI and other computational methods, BriaPro can rapidly
develop novel binding agents that can target more and different types of cancer. Currently, one of BriaPro’s lead drug discovery
candidates, Protein Kinase C Delta (PKCδ) Inhibitors, is being developed with AI with the intention of boosting the ability of
the body’s own cancer-fighting cells to destroy various types of cancerous tumors. Technology and discovery like this allows BriaPro
to also exist and be an early competitor in a market subset of AI-driven drug discovery, a sector that was estimated at USD 1.5 billion
in 2023 and is projected to reach USD 20.30 billion by 2030, growing at a CAGR of 29.7% from 2024 to 2030.2
BriaPro
expects any products that it develops and commercializes to compete on the basis of, among other things, efficacy, safety, price and
the availability of reimbursement from government and other third-party payors. BriaPro’s commercial opportunity is significantly
influenced by its ability to obtain regulatory approval for current product candidates or any future product candidate more rapidly than
BriaPro’s competitors.
1
“Cancer Immunotherapy Market Size, Share & Trends Analysis Report by Product (Monoclonal Antibodies, Immunomodulators),
By Application, By Distribution Channel, By End-use, By Region, And Segment Forecasts, 2023-2030),” https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy
market#:~:text=Report%20Overview,8.7%25%20from%202023%20to%202030.
2
“Artificial Intelligence In Drug Discovery Market (2024 - 2030)” https://www.grandviewresearch.com/industry-analysis/artificial-intelligence-drug-discovery-market.
11
Regulatory
Environment
Drug
products must be approved by the appropriate governing body before they can be sold in that country or area. The FDA approves products
for the United States market and Health Canada approves products for the Canadian market. The European Medicines Agency (“EMA”)
approves products for the European Union. While the process by which products are approved by the FDA and Health Canada is very similar,
each regulatory body has its own unique requirements for a product. In both cases, the development of a product through to approval can
be a lengthy process and, in some cases, can take over ten years. While early studies conducted in one jurisdiction will usually be accepted
in the other, further and somewhat modified studies may be required to have a product approved in another jurisdiction.
The
process required by the FDA before drug products may be marketed in the United States generally involves the following:
●
completion of extensive
preclinical laboratory tests and preclinical animal studies, some performed in
●
accordance with the GLP
regulations;
●
submission to the FDA of
a pre-investigational new drug (“IND”), which must be reviewed by the FDA and become active before human clinical
trials may begin and must be updated annually;
●
approval by an independent
review board (“IRB”) or ethics committee representing each clinical site before each clinical trial may be initiated;
●
performance
of adequate and well-controlled human clinical trials conducted under Good Clinical Practices (“GCP”) to establish
the safety and efficacy of the product candidate for each proposed indication;
●
preparation of and
submission to the FDA of an NDA or BLA after completion of all pivotal clinical trials;
●
a determination by the
FDA within 60 days of its receipt of an NDA or BLA to file the application for review;
●
potential review of the
product application by an FDA advisory committee, where appropriate and if applicable;
●
satisfactory completion
of an FDA pre-approval inspection of the manufacturing facilities where the proposed product is produced to assess compliance with
cGMP.
●
a potential FDA audit of
the preclinical research and clinical trial sites that generated the data in support of the NDA or a Biologics License Application
(“BLA”); and
●
FDA review and approval
of an NDA or BLA prior to any commercial marketing or sale of the product in the United States.
The
preclinical research, clinical testing and approval process require substantial time, effort, and financial resources, and BriaPro cannot
be certain that any approvals for BriaPro’s product candidates will be granted on a timely basis, if at all. An IND is a request
for authorization from the FDA to administer an investigational new drug product to humans in clinical trials. The central focus of an
IND submission is on the general investigational plan and the protocol(s) for human clinical trials. The IND also includes results of
animal studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry,
manufacturing, and controls information; and any available human data or literature to support the use of the investigational new drug.
An IND must become effective before human clinical trials may begin. An IND will automatically become effective 30 days after receipt
by the FDA, unless before that time the FDA raises concerns or questions related to the proposed clinical trials. In such a case, the
IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before clinical
trials can begin. Accordingly, submission of an IND may or may not result in the FDA allowing clinical trials to commence. As drug product
programs continue in development, clinical trial protocols, additional preclinical testing results, and manufacturing information is
submitted with the IND to facilitate discussions with the FDA and approval of additional clinical trials. See “Risk Factors.”
12
Options
and Other Rights to Purchase Shares
The
BriaPro Board adopted the BriaPro Incentive Plan, and the BriaCell Shareholders subsequently approved same. The purpose of the BriaPro
Incentive Plan is to allow BriaPro to issue performance share units (“PSUs”), restricted share units (“RSUs”),
and deferred share units (“DSUs” and together with the PSUs and RSUs, “Share Units”) and BriaPro Options
(together with the Share Units, “Awards”) to directors, officers, employees and consultants, as additional compensation,
and as an opportunity to participate in the success of BriaPro. The granting of such options is intended to align the interests of such
persons with that of the shareholders.
Following
the closing of the Arrangement and the exchange of BriaCell Options for BriaCell Replacement Options and BriaPro Options under the Plan
of Arrangement, BriaCell Replacement Options (and, any new options of BriaCell granted thereafter) will continue to be governed by the
BriaCell Omnibus Plan or BriaCell Stock Option Plan, as applicable, based on the original issuance of such BriaCell Options, and BriaPro
Options shall be governed by the BriaPro Incentive Plan. The exercise price of the BriaCell Options exchanged will be apportioned between
the BriaCell Replacement Options and the BriaPro Options, subject to adjustments as provided for therein.
There
are no other immediate plans to grant BriaPro Options under the BriaPro Incentive Plan. As the date hereof, there is no current market
for the BriaPro Shares.
Resale
Restrictions
There
is currently no market through which the BriaPro Shares may be sold and, unless the BriaPro Shares are listed on a stock exchange, BriaCell
Shareholders may not be able to resell the BriaPro Shares. There can be no assurances that BriaPro will be obtain such a listing on the
TSX, NASDAQ or any other recognized North American stock exchange.
13
DISCUSSION
OF OPERATIONS
The
following financial data prepared in accordance with IFRS in US dollars is presented for the three month period ended January 31, 2026.
Three months ended January 31
2026
2025
Research and development expenses
$ 195,806
$ 81,523
General and administrative expenses
43,692
57,509
Operating Loss
(239,498 )
(139,032 )
Change in fair value of warrant liability
12,005
(12,030 )
Total operating loss and comprehensive loss
$ (227,493 )
$ (151,062 )
Basic and diluted weighted average loss per share
$ (0.005 )
$ (0.003 )
Basic and diluted weighted average number of shares
43,884,247
43,884,247
Three-month
period ended January 31, 2026
Research
and development expenses
For
the three-month period ended January 31, 2026, research and development expenses were $195,806, compared to $81,523 for the same period
in 2025. The increase was primarily driven by an increase in consulting fees and supplies, which increased from $77,500 and 4,023
in 2025, to $134,313 and $19,339 respectively in 2026.
General
and administrative expenses
General
and administrative expenses for the three-month period ended January 31, 2026, amounted to $43,692, a slight decrease from $57,509 for
the same period in 2025. The decrease was mainly due to a reduction in professional fees, which declined from $25,674 in 2025 to $12,992
in 2026. This reduction reflects a scaling back of external services.
Change
in fair value of warrant liability
The
change in fair value of the warrant liability for the three-month period ended January 31, 2026, was a decrease of $12,005, compared
to an increase of $12,030 in the same period in 2025. The variance was driven by adjustments based on underlying assumptions, such as
changes in market conditions and volatility.
The
following financial data prepared in accordance with IFRS in US dollars is presented for the six month period ended January 31, 2026.
Six months ended January 31
2026
2025
Research and development expenses
$ 433,307
$ 130,023
General and administrative expenses
64,636
80,012
Operating Loss
(497,943 )
(210,035 )
Change in fair value of warrant liability
25,712
(23,150 )
Total operating loss and comprehensive loss
$ (472,231 )
$ (233,185 )
Basic and diluted weighted average loss per share
$ (0.011 )
$ (0.005 )
Basic and diluted weighted average number of shares
43,884,247
43,884,247
Six-month
period ended January 31, 2026
Research
and development expenses
For
the six-month period ended January 31, 2026, research and development expenses were $433,307, compared to $130,023 for the same period
in 2025. The increase was primarily driven by an increase in consulting fees and supplies, which increased from $126,000 and 4,023
in 2025, to $296,188 and $94,965 respectively in 2026.
General
and administrative expenses
General
and administrative expenses for the six-month period ended January 31, 2026, totaled $64,636, remaining relatively consistent compared
to $80,012 in the same period of 2025. The slight decrease was primarily driven by lower professional fees, which declined from $ 29,359
in 2025 to $14,826 in 2026 due to reduced reliance on external services and consulting costs.
Change
in fair value of warrant liability
The
change in fair value of the warrant liability for the six-month period ended January 31, 2026, was a decrease of $25,712, compared to
an increase of $23,150 in the same period in 2025. The variance was driven by adjustments to underlying assumptions such as market conditions
and volatility.
SUMMARY
OF QUARTERLY RESULTS
QUARTER ENDED
January 31,
October 31,
July 31,
April 30,
2026
2025
2025
2025
Total revenue
$ -
$ -
$ -
-
Net loss before income taxes
$ (227,493 )
$ (244,738 )
$ (220,412 )
(286,619 )
Net loss for the period
$ (227,493 )
$ (244,738 )
$ (220,412 )
(286,619 )
Basic loss per share
$ (0.005 )
$ (0.006 )
$ (0.003 )
(0.007 )
QUARTER ENDED
January 31,
October 31,
July 31,
April 30,
2025
2024
2024
2024
Total revenue
$ -
$ -
$ -
-
Net loss before income taxes
$ (151,062 )
$ (82,123 )
$ (103,770 )
(70,557 )
Net loss for the period
$ (151,062 )
$ (82,123 )
$ (103,770 )
(70,557 )
Basic loss per share
$ (0.003 )
$ (0.002 )
$ (0.002 )
(0.002 )
Net
loss per quarter is primarily a function of the research and operational activity during the quarter in addition to the adjustment to
the warrant liability. There is no seasonal trend.
14
LIQUIDITY
AND CAPITAL RESOURCES
Liquidity
is a measure of a company’s ability to meet potential cash requirements.
The
Company is an early-stage biotech company focused on research and development of its products, and currently does not generate any revenues
from its operations.
The
Company’s current financial resources are not sufficient to meet its short-term liquidity requirements and to fund its operations
for at least the coming 12 months, and will require additional proceeds to be raised through an offering of securities.
As
of January 31, 2026, the Company has a negative working capital of $1,638,799 (July 31, 2025 – $1,148,492) and an accumulated deficit
of $1,652,656, (July 31, 2025 - $1,180,425).
During
the six month period ended January 31, 2026, the Company’s overall position of cash and cash equivalents remained unchanged. This
can be attributed to the following:
The
Company’s net cash used in operating activities during the six month period ended January 31, 2026, was nil. as the Company continues
to be financed by its holding company – BriaCell.
Capital
Management
The
Company manages its capital to maintain its ability to continue as a going concern and to provide returns to shareholders and benefits
to other stakeholders. The capital structure of the Company consists of cash and equity comprised of issued capital.
The
Company manages its capital structure and makes adjustments to it in light of economic conditions. The Company, upon approval from its
Board of Directors, will balance its overall capital structure through new share issuances or by undertaking other activities as deemed
appropriate under the specific circumstances.
The
Company is not subject to externally imposed capital requirements and the Company’s overall strategy with respect to capital risk
management remains unchanged.
Off
Balance Sheet Arrangements and commitment
There
are no off-balance sheet arrangements to which the Company is committed.
Transactions
With 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 January 31, 2026, pursuant to the Transition Agreement, the total balance owing to BriaCell group companies is $1,606,112. For the
six month period ending January 31, 2026 the fixed monthly services expense totaled $120,000 and direct expenses incurred by BriaCell
on behalf of BriaPro totaled $365,059.
During
the six month period ended January 31, 2026, the Company incurred Services and direct expense paid for by BriaCell in the amount
of $485,059.
As noted above, On February 18, 2026, the Company
entered into a Purchase Agreement with BriaCell, pursuant to which the Company agreed to acquire BriaCell’s exclusive license to
develop and commercialize Soluble CD80 (“sCD80”) as a biologic agent for the treatment of cancer and certain related assets.
On March 5, 2026, the disinterested shareholders of the Company approved the Transaction and the Transaction closed
on March 30, 2026.
15
Financial
Instruments and Financial Risk Exposures
The
Company’s financial instruments consist of cash, accounts payable and accrued liabilities, and the warrant liability. 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, 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:
a.
Credit Risk
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.
b.
Liquidity Risk
The
Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come
due. Until the Company raises additional financing, it is entirely dependent on BriaCell to finance the Company’s operations.
As of January 31, 2026 , the Company has a negative working capital balance of $1,638,799 (July 31, 2025 – working capital of $1,148,492).
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
Accrued expenses and other payables
$ 32,688
$ 32,688
$ 32,688
$ -
$ -
$ -
Amounts owing to holding company
1,606,112
1,606,112
1,606,112
$ 1,638,800
$ 1,638,800
$ 1,638,800
$ -
$ -
$ -
c.
Market Risk
i.
Interest Rate Risk
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.
ii.
Price Risk
As
the Company has no revenues, price risk is remote.
16
iii.
Exchange Risk
The
Company is exposed to foreign exchange risk as a portion of the Company’s transactions occur in Canadian Dollars 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 January 31, 2026, 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.
d.
Fair Values
The
carrying values of accounts payable and accrued liabilities approximate their fair values due to their short terms to maturity.
Cash,
is valued using quoted market prices in active markets. The warrant liability is measured using the Black-Scholes Option Pricing Model.
11.
Critical Estimates and Judgements
The
preparation of the unaudited condensed interim 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 condensed interim consolidated 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.
New
Accounting Policies Adopted
No
new accounting policies were adopted during the six months period ended January 31, 2026.
Additional
Disclosure for Companies Without Significant Revenue
An
analysis of material components of the Company’s general and administrative expenses is disclosed in the condensed interim consolidated
financial statements for the six month period ended January 31, 2026, to which this MD&A relates.
Disclosure
of Outstanding Share Data
Authorized
share capital consists of unlimited number of common shares without par value.
As
of July 31, 2025, January 31, 2026 and March 31, 2026, the Company had 47,945,178 and 71,917,767 and common shares issued
and outstanding, respectively.
As
of July 31, 2025, January 31, 2026 and March 31, 2026, the Company had 2,131,400 and 1,519,400 stock options outstanding,
respectively.
As
of July 31, 2025, January 31, 2026 and March 31, 2026, the Company had no share purchase warrants outstanding. However, BriaCell
has 8,111,714 and 5,080,183 warrants outstanding, and these warrants entitle holders thereof to receive, upon the exercise
thereof, one BriaCell Share and one BriaPro Share for the original exercise price.
As
of July 31, 2025, January 31, 2026 and March 31, 2026, the Company had 19,200 RSU’s outstanding, respectively.
17
Risk
Factors
The
Company business, and investing in the Company’s securities, are subject to numerous risks. If any of these risks actually occur,
the Company’s business, financial condition or results of operations would likely be materially adversely affected. In each case,
the trading price of the Company’s securities would likely decline, and investors may lose all or part of their investment. The
following is a summary of some of the principal risks the Company faces:
Risks
Associated with the Business
Nature
of the Securities and No Assurance of any Listing
BriaPro
Shares are not currently, and will not as a result of the Arrangement, be listed on any stock exchange and there is no assurance that
the BriaPro Shares will ever be listed on any stock exchange. Even if a listing is obtained in the future, the holding of BriaPro Shares
will involve a high degree of risk and should be undertaken only by investors whose financial resources are sufficient to enable them
to assume such risks and who have no need for immediate liquidity in their investment. BriaPro Shares should not be held by persons who
cannot afford the possibility of the loss of their entire investment. Furthermore, an investment in securities of BriaPro should not
constitute a major portion of an investor’s portfolio.
Future
Sales or Issuances of Securities
BriaPro
may issue additional securities to finance future activities. BriaPro cannot predict the size of future issuances of securities or the
effect, if any, that future issuances and sales of securities will have on the market price of the BriaPro Shares. Sales or issuances
of substantial numbers of BriaPro Shares, or the perception that such sales could occur, may adversely affect prevailing market prices
of the BriaPro Shares. With any additional sale or issuance of BriaPro Shares, investors will suffer dilution to their voting power and
BriaPro may experience dilution in its earnings per share.
Limited
Operating History
BriaPro
was incorporated on May 15, 2023 and has a limited operating history and no operating revenues.
Lack
of Supporting Clinical Data
The
clinical effectiveness and safety of any of BriaPro’s developmental products is not yet supported by extensive clinical data and
the medical community has not yet developed a large body of peer reviewed literature that supports the safety and efficacy of BriaPro’s
products. If future studies call into question the safety or efficacy of BriaPro’s products, BriaPro’s business, financial
condition, and results of operations could be adversely affected.
Unproven
Market for Product Candidates
BriaPro
believes that the anticipated market for its potential products and technologies if successfully developed will continue to exist and
expand. These assumptions may prove to be incorrect for a variety of reasons, including competition from other products and the degree
of commercial viability of the potential product.
Growth
of Business
Anticipated
growth in all areas of BriaPro’s business is expected to continue to place a significant strain on its managerial, operational
and technical resources. BriaPro expects operating expenses and staffing levels to increase in the future. To manage such growth, BriaPro
must expand its operational and technical capabilities and manage its employee base while effectively administering multiple relationships
with various third parties. There can be no assurance that BriaPro will be able to manage its expanding operations effectively. Any failure
to implement cohesive management and operating systems, to add resources on a cost-effective basis or to properly manage BriaPro’s
expansion could have a material adverse effect on its business and results of operations.
Reliance
on Third Parties
BriaPro
does not expect to have any in-house manufacturing, pharmaceutical development or marketing capability. To be successful, a product must
be manufactured and packaged in commercial quantities in compliance with regulatory requirements and in reasonable time frames and at
accepted costs. BriaPro intends to contract with third parties to develop its products. No assurance can be given that BriaPro or its
suppliers will be able to meet the supply requirements in respect of the product development or commercial sales. Production of therapeutic
products may require raw materials for which the sources and amount of supply are limited, or may be hindered by quality or scheduling
issues in respect of the third party suppliers over which BriaPro has limited control. An inability to obtain adequate supplies of raw
materials could significantly delay the development, regulatory approval and marketing of a product. BriaPro has limited in-house personnel
to internally manage all aspects of product development, including the management of multi-center clinical trials. BriaPro is significantly
reliant on third-party consultants and contractors to provide the requisite advice and management. There can be no assurance that the
clinical trials and product development will not encounter delays which could adversely affect prospects for BriaPro’s success.
To be successful, an approved product must also be successfully marketed. The market for BriaPro’s product being developed by BriaPro
may be large and will require substantial sales and marketing capability. At the present time, BriaPro does not have any internal capability
to market pharmaceutical products. BriaPro intends to enter into one or more strategic partnerships or collaborative arrangements with
pharmaceutical companies or other companies with marketing and distribution expertise to address this need. If necessary, BriaPro will
establish arrangements with various partners for geographical areas. There can be no assurance that BriaPro can market, or can enter
into a satisfactory arrangement with a third party to market a product in a manner that would assure its acceptance in the marketplace.
18
However,
if a satisfactory arrangement with a third party to market and/or distribute a product is obtained; BriaPro will be dependent on the
corporate collaborator(s) who may not devote sufficient time, resources and attention to BriaPro’s programs, which may hinder efforts
to market the products. Should BriaPro not establish marketing and distribution strategic partnerships and collaborative arrangements
on acceptable terms, and undertake some or all of those functions, BriaPro will require significant additional human and financial resources
and expertise to undertake these activities, the availability of which is not guaranteed. BriaPro will rely on third parties for the
timely supply of raw materials, equipment, contract manufacturing, and formulation or packaging services. Although BriaPro intends to
manage these third-party relationships to ensure continuity and quality, some events beyond BriaPro’s control could result in complete
or partial failure of these goods and services. Any such failure could have a material adverse effect on the financial conditions and
results of operations of BriaPro. Due to the complexity of the process of developing pharmaceutical products, BriaPro’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 BriaPro 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 BriaPro 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 BriaPro’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 BriaPro,
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. BriaPro’s collaborative partners could pursue other technologies
or develop alternative products that could compete with the products BriaPro is developing.
BriaPro
is expected to sign Non-Disclosure Agreements (“NDA”) with third parties with which it engages in research and development
activities. There is no guarantee that, despite the terms of the NDA which bind third parties, BriaPro will ultimately be able to prevent
such third parties from breaching their obligations under the NDA. Use of BriaPro’s confidential information in an unauthorized
manner is likely to negatively affect BriaPro.
Pre-Clinical
Studies and Initial Clinical Trials 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 BriaPro’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 BriaPro’s products to achieve their intended goals, or to do so safely.
19
Results
of Early Clinical Trials May Not be Predictive of Future Trial Results
BriaPro
has limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including the United
States Food and Drug Administration (“FDA”) approval. Clinical trials are expensive and complex, can take many years and
have uncertain outcomes. BriaPro cannot predict whether it or its licensees will encounter problems with any of the completed, ongoing
or planned clinical trials that will cause it or its licensees or regulatory authorities to delay or suspend clinical trials, or delay
the analysis of data from completed or ongoing clinical trials. BriaPro estimates that clinical trials of their most advanced therapeutic
candidates will continue for several years, but they may take significantly longer to complete. Failure can occur at any stage of the
testing and BriaPro may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay
or prevent commercialization of their current or future therapeutic candidates, including but not limited to: delays in securing clinical
investigators or trial sites for the clinical trials; delays in obtaining institutional review board and other regulatory approvals to
commence a clinical trial; slower than anticipated patient recruitment and enrollment; negative or inconclusive results from clinical
trials; unforeseen safety issues; uncertain dosing issues; an inability to monitor patients adequately during or after treatment; and
problems with investigator or patient compliance with the trial protocols. A number of companies in the pharmaceutical and biotechnology
industries, including those with greater resources and experience than BriaPro, have suffered significant setbacks in advanced clinical
trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier clinical trials for BriaPro’s
therapeutic candidates, BriaPro does not know whether any phase 3 or other clinical trials that BriaPro or its licensees may conduct
will demonstrate adequate efficacy and safety to result in regulatory approval to market BriaPro’s therapeutic candidates. If later-stage
clinical trials of any therapeutic candidate do not produce favorable results, BriaPro’s ability to obtain regulatory approval
for the therapeutic candidate may be adversely impacted, which will have a material adverse effect on BriaPro’s business, financial
condition and results of operations.
Inability
to Obtain Raw Materials
Raw
materials and supplies are generally available in quantities to meet the needs of BriaPro’s business. BriaPro will be dependent
on third-party manufacturers for the pharmaceutical products that it markets. An inability to obtain raw materials or product supply
could have a material adverse impact on BriaPro’s business, financial condition and results of operations.
Must
Obtain Additional Capital to Continue Operations
BriaPro
anticipates that additional capital will be required to complete its current research and development programs. It is anticipated that
future research, additional pre-clinical and toxicology studies and manufacturing initiatives, including 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 a loss for the shareholders. There can be no assurance that BriaPro will be able to obtain adequate financing,
or financing on terms that are reasonable or acceptable for these or other purposes, or to fulfill BriaPro’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 BriaPro’s technologies with the possible loss of license rights to these technologies.
Highly
Dependent on Key Personnel.
Although
BriaPro is expected to have experienced senior management and personnel, BriaPro will be substantially dependent upon the services of
a few key personnel, particularly Dr. William V. Williams and other professionals for
the successful operation of its business. The loss of the services of any of these personnel could have a material adverse effect on
the business of BriaPro. BriaPro 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 BriaPro loses any of these persons, or is unable to attract and retain qualified personnel, BriaPro’s business,
financial condition and results of operations may be materially and adversely affected. BriaPro’s directors and officers and other
BriaCell personnel support made available pursuant to the Transition Services Agreement may be subject to competing commitments to BriaCell
and its research and development programs.
20
Conflicts
of Interest
Certain
directors and officers of BriaPro are, and may continue to be, involved in the health and biotechnology industries through their direct
and indirect participation in corporations, partnerships or joint ventures which are potential competitors of BriaPro, including BriaCell.
Situations may arise in connection with potential acquisitions in investments where the other interests of these directors and officers
may conflict with the interests of BriaPro. Directors and officers of BriaPro with conflicts of interest will be subject to the procedures
set out in applicable corporate and Securities Legislation, regulation, rules and policies.
No
History of Earnings
BriaPro
has no history of earnings or of a return on investment, and there is no assurance that BriaPro Assets or any other asset or business
that BriaPro may acquire or undertake will generate earnings, operate profitably or provide a return on investment in the future. BriaPro
has no plans to pay dividends for some time in the future, if ever. The future dividend policy of BriaPro will be determined by the BriaPro
Board.
Risks
Related to Regulatory Changes
Existing
and proposed changes in the laws and regulations affecting public companies may cause BriaPro to incur increased costs as BriaPro 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 BriaPro 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 BriaPro to attract and retain qualified persons to serve on the Board, or
as executive officers. BriaPro may be required to hire additional personnel and utilize additional outside legal, accounting and advisory
services, all of which could cause the BriaPro’s general and administrative costs to increase beyond what BriaPro currently has
planned. Although BriaPro will evaluate and monitor developments with respect to new rules and laws, BriaPro cannot predict or estimate
the amount of the additional costs BriaPro 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 BriaPro compliant with such new rules and laws.
Dilution
Issuances
of additional securities including, but not limited to, BriaPro shares, BriaPro options or BriaPro warrants, will
result in a substantial dilution of the equity interests of any persons who may become BriaPro Shareholders as a result of or subsequent
to the Arrangement.
No
Independent Operating History
The
BriaPro Assets have no operating history independent from BriaCell, and estimates of future cash flows have been based upon the combined
operations of BriaPro and BriaCell. There can be no assurance that the estimates of future cash flows will prove to be accurate once
BriaPro begins operating independently.
Early
Stage Development Company
Market
perception of early stage companies may change, potentially affecting the value of investors’ holdings and the ability of BriaPro
to raise further funds through the issue of further BriaPro Shares or otherwise. BriaPro is developing novel technologies that may not
be efficacious or safe. BriaPro expects to spend a significant amount of capital to fund research and development. As a result, BriaPro
expects that its operating expenses will increase significantly and, consequently, it will need to generate significant revenues to become
profitable. Even if BriaPro does become profitable, it may not be able to sustain or increase profitability on a quarterly or annual
basis. BriaPro cannot predict when, if ever, it will be profitable. There can be no assurances that the intellectual property of BriaPro,
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. BriaPro will be undertaking additional laboratory
studies or trials with respect to the intellectual property of BriaPro, 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.
21
Dividend
Policy
No
dividends on BriaPro Shares have been paid by BriaPro to date. BriaPro anticipates that it will retain all earnings and other cash resources
for the foreseeable future for the operation and development of its business. Payment of any future dividends will be at the discretion
of the BriaPro Board after taking into account many factors, including BriaPro’s operating results, financial condition and current
and anticipated cash needs.
Government
Regulations, Permits and Licenses
BriaPro’s
operations may be subject to governmental laws or regulations promulgated by various legislatures or governmental agencies from time
to time. A breach of such legislation may result in the imposition of fines and penalties. The cost of compliance with changes in governmental
regulations has the potential to reduce the profitability of operations. BriaPro intends to fully comply with all governmental laws and
regulations. While there are currently no indications that BriaPro will require approval by a governmental or regulatory authority in
Canada or the U.S., such approvals may ultimately be required. If any permits are required for BriaPro’s operations and activities
in the future, there can be no assurance that such permits will be obtainable on reasonable terms or on a timely basis, or that applicable
laws and regulations will not have an adverse effect on BriaPro’s business.
The
current and future operations of BriaPro are and will be governed by laws and regulations governing the healthcare industry, labour standards,
occupational health and safety, land use, environmental protection, and other matters. Amendments to current laws, regulations and permits
governing operations, or more stringent implementation thereof, could have a material adverse impact on BriaPro and cause increases in
capital expenditure or costs, or reduction in levels of its medical services.
Privacy
and Data Regulation
BriaPro
may be subject to federal, state and provincial data protection laws and regulations in the jurisdictions in which it operates, such
as laws and regulations that address privacy and data security. BriaPro may obtain health information from third parties, which are subject
to privacy and security requirements under applicable laws. Depending on the facts and circumstances, BriaPro could be subject to significant
civil, criminal, and administrative penalties if it obtains, uses, or discloses individually identifiable health information maintained
by entities covered by applicable health and data protection laws in a manner that is not authorized or permitted by such laws.
Compliance
with privacy and data protection laws and regulations could require BriaPro to contractually restrict its ability to collect, use and
disclose data, or in some cases, impact its ability to operate in certain jurisdictions. Failure to comply with these laws and regulations
could result in civil, criminal and administrative penalties, private litigation, or adverse publicity and could negatively affect BriaPro’s
operating results and business. Moreover, clinical trial subjects, employees and other individuals may limit our ability to collect,
use and disclose information collected. Claims that BriaPro has violated privacy rights, failed to comply with data protection laws,
or otherwise breached obligations, could be expensive and time-consuming to defend and could result in adverse publicity that could harm
BriaPro’s business.
Data
Security
BriaPro
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 BriaPro 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. BriaPro 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 BriaPro
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 BriaPro’s business, financial
condition and results of operations due to the costs and negative market reaction relating to such developments.
22
Product
Liability
As
BriaPro’s drug candidates enter clinical trials, BriaPro will face an inherent risk of product liability suits and will face an
even greater risk if BriaPro obtains approval to commercialize any drugs. For example, BriaPro may be sued if its drug candidates cause
or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any
such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent
in the drug, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts.
If BriaPro cannot successfully defend itself against product liability claims, BriaPro may incur substantial liabilities or be required
to limit commercialization of BriaPro’s drug candidates. Even successful defense would require significant financial and management
resources. Regardless of the merits or eventual outcome, liability claims may result in: decreased demand for BriaPro’s drugs;
injury to BriaPro’s reputation; withdrawal of clinical trial participants and inability to continue clinical trials; initiation
of investigations by regulators; costs to defend the related litigation; diversion of management’s time and BriaPro’s resources;
substantial monetary awards to trial participants or patients; product recalls, withdrawals or labeling, marketing or promotional restrictions;
loss of revenue; exhaustion of any available insurance and BriaPro’s capital resources; the inability to commercialize any drug
candidate; and a decline in the price of BriaPro Shares.
BriaPro
shall seek to obtain the appropriate insurance once its candidates are ready for clinical trial. However, BriaPro’s inability to
obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent
or inhibit the commercialization of drugs BriaPro develops, alone or with collaborators. BriaPro does not currently have in place product
liability insurance and although BriaPro plans to have in place such insurance as when the products are ready for commercialization,
as well as insurance covering clinical trials, the amount of such insurance coverage may not be adequate, BriaPro may be unable to maintain
such insurance, or may not be able to obtain additional or replacement insurance at a reasonable cost, if at all. BriaPro’s insurance
policies may also have various exclusions, and may be subject to a product liability claim for which BriaPro has no coverage. BriaPro
may have to pay any amounts awarded by a court or negotiated in a settlement that exceeds BriaPro’s coverage limitations or that
are not covered by BriaPro’s insurance, and may not have, or be able to obtain, sufficient capital to pay such amounts. Even if
BriaPro’s agreements with any future corporate collaborators entitle BriaPro to indemnification against losses, such indemnification
may not be available or adequate should any claim arise.
Additionally,
BriaPro may be sued if the products that BriaPro commercialize, market or sell cause or are perceived to cause injury or are found to
be otherwise unsuitable, and may result in: decreased demand for those products; damage to BriaPro’s reputation; costs incurred
related to product recalls; limiting BriaPro’s opportunities to enter into future commercial partnerships; and a decline in the
price of BriaPro’s common shares.
Third
Party License Risk
BriaPro’s
intellectual property is currently under third-party licenses and may require additional third-party licenses to effectively develop
and manufacture its key products or future technologies. BriaPro is currently unable to predict the availability or cost of such licenses.
A substantial number of patents have already been issued to other biotechnology and pharmaceutical companies. To the extent that valid
third-party patent rights cover BriaPro’s products or services, BriaPro or its strategic collaborators would be required to seek
licenses from the holders of these patents in order to manufacture, use or sell these products and services, and payments under them
would reduce BriaPro’s profits from these products and services. BriaPro is currently unable to predict the extent to which it
may wish or be required to acquire rights under such patents, the availability and cost of acquiring such rights, and whether a license
to such patents will be available on acceptable terms or at all. There may be patents in the U.S. or in foreign countries or patents
issued in the future that are unavailable to license on acceptable terms. BriaPro’s inability to obtain such licenses may hinder
or eliminate an ability to manufacture and market products.
23
Failure
to Comply with Intellectual Property or License Agreements
BriaPro
is or may become a party to third-party agreements under which BriaPro grants or is granted rights to intellectual property that are
potentially important to BriaPro’s business and BriaPro expect that BriaPro may need to enter into additional license or collaboration
agreements in the future. BriaPro’s existing third party agreements impose, and BriaPro expect that future license agreements will
impose, various obligations related to, among other things, therapeutic development and payment of royalties and fees based on achieving
certain milestones. In addition, under several of BriaPro’s collaboration agreements, BriaPro are prohibited from developing and
commercializing therapies that would compete with the therapies licensed under such agreements.
If
BriaPro fails to comply with BriaPro’s obligations under these agreements, BriaPro’s licensor or collaboration partner may
have the right to terminate the agreement, including any licenses included in such agreement. The termination of any license or collaboration
agreements or failure to adequately protect such license agreements or collaboration could prevent BriaPro from commercializing BriaPro’s
therapeutic candidates or any future therapeutic candidates covered by the agreement or licensed intellectual property. For example,
BriaPro may rely on license agreements which grant failure BriaPro rights to certain intellectual property and proprietary materials
that BriaPro use in connection with the development of BriaPro’s therapies. If this agreement were to terminate, BriaPro would
be unable to timely license similar intellectual property and proprietary materials from an alternate source, on commercially reasonable
terms or at all, and may be required to conduct additional bridging studies on BriaPro’s therapeutic candidates or any future therapeutic
candidates, which could delay or otherwise have a material adverse effect on the development and commercialization of BriaPro’s
therapeutic candidates or any future therapeutic candidates.
Reliance
on the Transition Services Agreement
BriaPro
entered into a Transition Services Agreement with BriaCell, whereby certain BriaCell employees will assist with the day to day
operation of BriaPro. In the short term, BriaPro will continue to rely on BriaCell to assist with operations. If such agreement is found
to be invalid or unenforceable or is terminated by the counterparty, this could have a material adverse effect on the business, prospects,
financial condition and operating results of BriaPro.
Significant
Majority Shareholder
BriaCell
owns a substantial number of the outstanding BriaPro Shares (on a non-diluted and partially-diluted basis). As such, BriaCell is able
to exercise influence over matters requiring shareholder approval, including the election of directors and the determination of corporate
actions. As well, BriaCell could delay or prevent a change in control of the BriaPro that could otherwise be beneficial to the BriaPro
Shareholders.
Inflation
Inflation
has the potential to adversely affect BriaPro’s business, results of operations, financial position and liquidity by increasing
BriaPro’s overall cost structure, particularly if BriaPro is unable to achieve commensurate increases in the prices it charges
customers. The existence of inflation in the economy has the potential to result in higher interest rates and capital costs, supply shortages,
increased costs of labor and other similar effects. As a result of inflation, BriaPro may experience increases in the costs of labor,
materials, and other inputs, such as engineering consultants. Although BriaPro may take measures to mitigate the impact of this inflation,
if these measures are not effective BriaPro’s business, results of operations, financial position and liquidity could be materially
adversely affected. Even if such measures are effective, there could be a difference between the timing of when these beneficial actions
impact BriaPro’s results of operations and when the cost of inflation is incurred.
24
Failure
to Remediate Material Weaknesses in Internal Accounting Controls
Management
may identify material weaknesses in BriaPro’s internal control over financial reporting related to lack of segregation of duties
within account processes, and systems, inadequate documentation to evidence the operation of controls, inconsistent procedures and approvals,
lack of periodic user access reviews, lack of assessment of controls of financially significant vendors and insufficient written policies
and procedures for accounting, IT and financial reporting and record keeping. Disclosure controls and procedures will need to be implemented
going forward. Management is implementing processes to document and retain evidence to support reviews and reconciliations. Such changes
may not, however, be effective in establishing the adequacy of BriaPro’s internal control over financial reporting. If the material
weaknesses are not adequately remedied, or if BriaPro identifies further material weaknesses in its internal controls, BriaPro’s
failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting could result
in material misstatements in its condensed interim consolidated financial statements and a failure to meet reporting and financial obligations,
each of which could have a material adverse effect on BriaPro’s financial condition. In addition, investors’ perceptions
that BriaPro’s internal control over financial reporting is inadequate or that BriaPro is unable to produce accurate condensed
interim consolidated financial statements may materially adversely affect the price of BriaPro’s securities.
Government
Price Controls and Other Restrictions on Pricing, Reimbursement and Access to Drugs
To
the extent BriaPro’s products are developed, commercialized, and successfully introduced to market, they may not be considered
cost-effective and third-party or government reimbursement might not be available or sufficient. Globally, governmental and other third-party
payors are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly,
pricing and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and
BriaPro expects pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue.
In the U.S., BriaPro may in the future be subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs,
private insurance programs and pharmacy benefit managers, and implementation of U.S. health care reform legislation is increasing these
pricing pressures. The Affordable Care Act instituted comprehensive health care reform, and includes provisions that, among other things,
reduce and/or limit Medicare reimbursement, require all individuals to have health insurance (with limited exceptions), and impose new
and/or increased taxes. The future of the Affordable Care Act and its constituent parts are uncertain at this time. In almost all markets,
pricing and choice of prescription pharmaceuticals are subject to governmental control. Therefore, the price of BriaPro’s products
and their reimbursement in Europe and in other countries is and will be determined by national regulatory authorities. Reimbursement
decisions from one or more of the European markets may impact reimbursement decisions in other European markets. A variety of factors
are considered in making reimbursement decisions, including whether there is sufficient evidence to show that treatment with the product
is more effective than current treatments, that the product represents good value for money for the health service it provides, and that
treatment with the product works at least as well as currently available treatments. The continuing efforts of government and insurance
companies, health maintenance organizations, and other payors of health care costs to contain or reduce costs of health care may affect
BriaPro’s future revenues and profitability or those of BriaPro’s potential customers, suppliers, and collaborative partners,
as well as the availability of capital.
U.S.
Federal and State Privacy Laws May Increase Costs of Operation and Expose BriaPro to Civil and Criminal Sanctions
Pursuant
to the Health Insurance Portability and Accountability Act (“HIPPA”), and the regulations that have been issued under it,
and similar laws outside the United States, contains substantial restrictions and requirements with respect to the use and disclosure
of individuals’ protected health information. The HIPAA privacy rules prohibit “covered entities,” such as healthcare
providers and health plans, from using or disclosing an individual’s protected health information, unless the use or disclosure
is authorized by the individual or is specifically required or permitted under the privacy rules. Under the HIPAA security rules, covered
entities must establish administrative, physical and technical safeguards to protect the confidentiality, integrity and availability
of electronic protected health information maintained or transmitted by them or by others on their behalf. While BriaPro does not believe
that it will be a covered entity under HIPAA, BriaPro believes many of its potential future customers will be covered entities subject
to HIPAA. Such customers may require BriaPro to enter into business associate agreements, which will obligate BriaPro to safeguard certain
health information obtained in the course of BriaPro’s relationship with them, restrict the manner in which BriaPro may use and
disclose such information and impose liability on BriaPro for failure to meet contractual obligations.
25
In
addition, under the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which was signed into
law as part of the U.S. stimulus package in February 2009, certain of HIPAA’s privacy and security requirements are now also directly
applicable to “business associates” of covered entities and subject them to direct governmental enforcement for failure to
comply with these requirements. BriaPro may be deemed as a “business associate” of some of its customers. As a result, BriaPro
may be subject as a “business associate” to civil and criminal penalties for failure to comply with applicable privacy and
security rule requirements. Moreover, HITECH created a new requirement obligating “business associates” to report any breach
of unsecured, individually identifiable health information to their covered entity customers and imposes penalties for failing to do
so.
In
addition to HIPAA, most U.S. states have enacted patient confidentiality laws that protect against the disclosure of confidential medical
information, and many U.S. states have adopted or are considering adopting further legislation in this area, including privacy safeguards,
security standards, and data security breach notification requirements. These U.S. state laws, which may be even more stringent than
the HIPAA requirements, are not supplanted by the federal requirements, and BriaPro is therefore required to comply with them to the
extent they are applicable to its operations. These and other possible changes to HIPAA or other U.S. federal or state laws or regulations,
or comparable laws and regulations in countries where BriaPro conducts business, could affect BriaPro’s business and the costs
of compliance could be significant. Failure by BriaPro to comply with any of the standards regarding patient privacy, identity theft
prevention and detection, and data security may subject BriaPro to penalties, including civil monetary penalties and in some circumstances,
criminal penalties. In addition, such failure may damage BriaPro’s reputation and adversely affect BriaPro’s ability to retain
customers and attract new customers. The protection of personal data, particularly patient data, is subject to strict laws and regulations
in many countries. The collection and use of personal health data in the E.U. is governed by the provisions of Directive 95/46/EC of
the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal
data and on the free movement of such data (the “Data Protection Directive”). The Data Protection Directive imposes a number
of requirements, including an obligation to seek the consent of individuals to whom the personal data relates, the information that must
be provided to the individuals, notification of data processing obligations to the competent national data protection authorities of
individual E.U. member states and the security and confidentiality of the personal data. The Data Protection Directive also imposes strict
rules on the transfer of personal data out of the E.U. to the U.S. Failure to comply with the requirements of the Data Protection Directive
and the related national data protection laws of the E.U. member states may result in fines and other administrative penalties and harm
BriaPro’s business. BriaPro may incur extensive costs in ensuring compliance with these laws and regulations, particularly if it
is considered to be a data controller within the meaning of the Data Protection Directive.
Development,
Formulation, Manufacturing, Packaging, Labeling, Handling, Distribution, Import, Export, Licensing, Sale and Storage of Pharmaceuticals
and Medical Devices
Such
laws, regulations and other constraints can exist at the federal, provincial or local levels in Canada and at all levels of government
in foreign jurisdictions. There can be no assurance that BriaPro and BriaPro’s partners are in compliance with all of these laws,
regulations and other constraints. BriaPro and its partners may be required to incur significant costs to comply with such laws and regulations
in the future, and such laws and regulations may have an adverse effect on the business. The failure of BriaPro or its partners to comply
with current or future regulatory requirements could lead to the imposition of significant penalties or claims and may have a material
adverse effect on the business. In addition, the adoption of new laws, regulations or other constraints or changes in the interpretations
of such requirements might result in significant compliance costs or lead BriaPro and its partners to discontinue product development
and could have an adverse effect on the business.
26
Risks
Associated with BriaPro’s Intellectual Property
Intellectual
Property Litigation
There
is a substantial amount of litigation over patent and other intellectual property rights in the biotechnology industry. Whether or not
a product infringes a patent involves complex legal and factual considerations, the determination of which is often uncertain. BriaPro’s
management is presently unaware of any other parties’ patents and proprietary rights which BriaPro’s products under development
would infringe. Searches typically performed to identify potentially infringed patents of third parties are often not conclusive and,
because patent applications can take many years to issue, there may be applications now pending, which may later result in issued patents
which BriaPro’s current or future products may infringe or be alleged to infringe. In addition, BriaPro’s competitors or
other parties may assert that BriaPro’s product candidates and the methods employed may be covered by patents held by them. If
any of BriaPro’s products infringes a valid patent, BriaPro could be prevented from manufacturing or selling such product unless
it is able to obtain a license or able to redesign the product in such a manner as to avoid infringement. A license may not always be
available or may require BriaPro to pay substantial royalties. BriaPro also may not be successful in any attempt to redesign its product
to avoid infringement, nor does a later redesign protect BriaPro from prior infringement. Infringement and other intellectual property
claims, with or without merit, can be expensive and time-consuming to litigate and can divert BriaPro’s management’s attention
from operating BriaPro business.
Steps
Taken to Protect Intellectual Property May be Inadequate
BriaPro’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 BriaPro’s patents in foreign jurisdictions will depend on the legal procedures
in those jurisdictions. In addition to filing patent applications, BriaPro relies on confidentiality, non-compete, non-disclosure and
assignment of inventions provisions, as appropriate, in BriaPro’s agreements with employees, consultants, and service providers,
to protect and otherwise seek to control access to, and distribution of, BriaPro’s proprietary information. These measures may
not be adequate to protect BriaPro’s intellectual property from unauthorized disclosure, third-party infringement or misappropriation,
for the following reasons: the agreements may be breached, may not provide the scope of protection BriaPro believes it provides or may
be determined to be unenforceable; BriaPro may have inadequate remedies for any breach; proprietary information could be disclosed to
BriaPro competitors; or others may independently develop substantially equivalent or superior proprietary information and techniques
or otherwise gain access to BriaPro’s trade secrets or disclose such technologies.
Specifically,
with respect to non-compete agreements, both state law and precedent varies greatly from state to state and BriaPro may be unable to
enforce these agreements, in whole or in part, and it may be difficult for BriaPro to restrict its competitors from gaining the expertise
that its former employees gained while working for BriaPro. If BriaPro’s intellectual property is disclosed or misappropriated,
it could harm BriaPro’s ability to protect its rights and could have a material adverse effect on its business, financial condition
and results of operations.
27
Need
to Initiate Lawsuits to Protect or Enforce Patents and Other Intellectual Property Rights
BriaPro
relied on patents, confidentiality and trade secrets to protect a portion of its intellectual property and competitive position. Patent
law relating to the scope of claims in the technology fields in which BriaPro operates is still evolving and, consequently, patent positions
in the biotechnology/pharmaceutical industry can be uncertain. In order to protect or enforce BriaPro’s patent rights, BriaPro
may initiate patent and related litigation against third parties, such as infringement suits or requests for injunctive relief. BriaPro’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 BriaPro’s patents in foreign jurisdictions will depend on the legal procedures
in those jurisdictions. Any lawsuits that BriaPro initiates could be expensive, take significant time and divert BriaPro’s management’s
attention from other business concerns and the outcome of litigation to enforce BriaPro’s intellectual property rights in patents,
copyrights, trade secrets or trademarks is highly unpredictable. Litigation also puts BriaPro’s patents at risk of being invalidated
or interpreted narrowly and BriaPro’s patent applications at risk of not issuing, or adversely affect its ability to distribute
any products that are subject to such litigation. In addition, BriaPro may provoke third parties to assert claims against BriaPro. BriaPro
may not prevail in any lawsuits that it initiates, and the damages or other remedies awarded, including attorney fees, if any, may not
be commercially valuable. The occurrence of any of these events could have a material adverse effect on BriaPro’s business, financial
condition and results of operations.
Damage
Resulting from Claims
Many
of BriaPro’s employees and contractors were previously employed at universities or other biotechnology or pharmaceutical companies,
including BriaPro’s competitors or potential competitors. Although no claims against BriaPro are currently pending, BriaPro may
be subject to claims that BriaPro or any employee or contractor have inadvertently or otherwise used or disclosed trade secrets or other
proprietary information of his or her former employers. Litigation may be necessary to defend against these claims. If BriaPro fails
in defending such claims, in addition to paying monetary damages, BriaPro may lose valuable intellectual property rights or personnel.
A loss of key research personnel or their work product could hamper or prevent BriaPro’s ability to commercialize certain therapeutic
candidates, which could severely harm BriaPro’s business, financial condition and results of operations. Even if BriaPro is successful
in defending against these claims, litigation could result in substantial costs and be a distraction to management.
Regulatory
Approval of a New Drug
Once
a new drug application is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication,
“Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Manufacturers may seek
approval of generic versions of reference listed drugs through submission of abbreviated new drug applications in the United States.
In support of an abbreviated new drug applications, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally
must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or
labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed
in the body at the same rate and to the same extent. Generic products may be significantly less costly to bring to market than the reference
listed drug and companies that produce generic products are generally able to offer them at lower prices. Thus, following the introduction
of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic
product. The FDA may not approve abbreviated new drug applications for a generic product until any applicable period of non-patent exclusivity
for the reference listed drug has expired. The United States Federal Food, Drug, and Cosmetic Act provides a period of five years of
non-patent exclusivity for a new drug containing a new chemical entity (“NCE”). Specifically, in cases where such exclusivity
has been granted, abbreviated new drug applications may not be submitted to the FDA until the expiration of five years, unless the submission
is accompanied by a Paragraph IV certification that a patent covering the reference listed drug is either invalid or will not be infringed
by the generic product, in which case the applicant may submit its application four years following approval of the reference listed
drug. While BriaPro believes that its products contain active ingredients that would be treated as NCEs by the FDA and, therefore, if
approved, should be afforded five years of data exclusivity, the FDA may disagree with that conclusion and may approve generic products
after a period that is less than five years. If the FDA were to award NCE exclusivity to someone other than BriaPro, BriaPro believes
that it would still be awarded three year “Other” exclusivity protection from generic competition, which is awarded when
an application or supplement contains reports of new clinical investigations (not bioavailability studies) conducted or sponsored by
an applicant and essential for approval. Manufacturers may seek to launch these generic products following the expiration of the applicable
marketing exclusivity period, even if BriaPro still has patent protection for its product. If BriaPro does not maintain patent protection
and data exclusivity for its product candidates, BriaPro’s business may be materially harmed. Competition that BriaPro’s
products may face from generic versions of BriaPro’s products could materially and adversely impact BriaPro’s future revenue,
profitability and cash flows and substantially limit BriaPro’s ability to obtain a return on the investments BriaPro has made in
those product candidates.
28
Patent
Terms may be Inadequate to protect Competitive Position on Product Candidates for an Adequate Amount of Time
Patents
have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent,
and the protection it affords, is limited. Even if patents covering BriaPro’s product candidates are obtained, once the patent
life has expired, BriaPro may be open to competition from competitive products, including generics or biosimilars. Given the amount of
time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might
expire before or shortly after such candidates are commercialized. As a result, BriaPro’s owned and licensed patent portfolio may
not provide BriaPro with sufficient rights to exclude others from commercializing products similar or identical to BriaPro’s.
General
Risk Factors for BriaPro
BriaPro’s
Operations are Subject to Human Error
Despite
efforts to attract and retain qualified personnel, as well as the retention of qualified consultants, to manage BriaPro’s interests,
and even when those efforts are successful, people are fallible and human error could result in significant uninsured losses to BriaPro.
These could include loss or forfeiture of assets for non-payment of fees or taxes, significant tax liabilities in connection with any
tax planning effort BriaPro might undertake and legal claims for errors or mistakes by BriaPro personnel.
Difficulty
in Enforcing Judgments and Effecting Service of Process on Directors and Officers
Certain
directors and officers of BriaPro reside outside of Canada. Some or all of the assets of such persons may be located outside of Canada.
Therefore, it may not be possible for investors to collect or to enforce judgments obtained in Canadian courts predicated upon the civil
liability provisions of applicable Canadian securities laws against such persons. Moreover, it may not be possible for investors to effect
service of process within Canada upon such persons.
Litigation
BriaPro
may become party to litigation from time to time in the ordinary course of business, or a claim based in related legal theories of negligence
or vicarious liability among others, which could adversely affect BriaPro’s business. Should any litigation in which BriaPro becomes
involved be determined against BriaPro, such a decision could adversely affect BriaPro’s ability to continue operating and the
market price if ever listed, of BriaPro Shares. Even if BriaPro is involved in litigation and wins, litigation can redirect significant
resources. Litigation may also create a negative perception of BriaPro’s business.
Insurance
BriaPro
believes the Company’s insurance coverage addresses material risks to which it is exposed and that a company of its size and nature
would insure for in the context of underwriting conditions, and is adequate and customary in its current state of operations, however
such insurance is subject to coverage limits and exclusions and may not be available for the risks and hazards to which BriaPro is exposed.
Moreover, there can be no guarantee that BriaPro will be able to obtain adequate insurance coverage in the future or obtain or maintain
liability insurance on acceptable terms or with adequate coverage against all potential liabilities.
Social
Media
There
has been a recent marked increase in the use of social media platforms and similar channels that provide individuals with access to a
broad audience of consumers and other interested persons. The availability and impact of information on social media platforms is virtually
immediate and many social media platforms publish user-generated content without filters or independent verification as to the accuracy
of the content posted. Information posted about BriaPro may be averse to BriaPro’s interests or may be inaccurate, each of which
may harm BriaPro’s business, financial condition and results of operations.
29
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