−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS
−Removed: OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: The following discussion and analysis
−Removed: should be read in conjunction with our financial statements and related notes included elsewhere in this Annual Report.
−Removed: This discussion
−Removed: and other parts of this Annual Report contain forward-looking statements based upon current expectations that involve risks and uncertainties.
−Removed: Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements
−Removed: as a result of several factors, including those set forth under “ Risk Factors ” and elsewhere in this Annual Report.
−Removed: The preparation of financial statements
−Removed: in conformity with these accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets
−Removed: and liabilities, disclosure of contingent liabilities at the financial statement date and reported amounts of revenue and expenses during
−Removed: the reporting period.
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in
+Added: this Annual Report.
+Added: This discussion and other parts of this Annual Report contain forward-looking statements based upon current expectations
+Added: that involve risks and uncertainties.
+Added: Our actual results and the timing of selected events could differ materially from those anticipated
+Added: in these forward-looking statements as a result of several factors, including those set forth under “ Risk Factors ”
+Added: and elsewhere in this Annual Report.
+Added: preparation of financial statements in conformity with these accounting principles requires us to make estimates and assumptions that
+Added: affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the financial statement date and reported
+Added: amounts of revenue and expenses during the reporting period.
On an on-going basis, we review our estimates and assumptions.
−Removed: The estimates were based on historical experience
−Removed: and other assumptions that we believe to be reasonable under the circumstances.
−Removed: Actual results are likely to differ from those estimates
−Removed: or other forward-looking statements under different assumptions or conditions, but we do not believe such differences will materially
−Removed: affect our financial position or results of operations.
−Removed: Our actual results may differ materially as a result of many factors, including
−Removed: those set forth under the headings entitled “ Special Note Regarding Forward-Looking Statements ” and “ Risk
−Removed: Recent Developments
−Removed: (the “ Company ”) is an immuno-oncology biotechnology company with a strong focus on cancer immunotherapy.
−Removed: Immunotherapies
−Removed: have come to the forefront in the fight against cancer since they harness the body’s own immune system to recognize and destroy
−Removed: cancer cells.
−Removed: BriaCell owns the U.S.
−Removed: patent to SV-BR-1-GM (“ Bria-IMT™ ”), a whole-cell targeted immunotherapy
−Removed: for cancer (U.S.
−Removed: 7,674,456), as well as patents related to PKCδ inhibitors (U.S.
−Removed: 9,364,460 and 9,572,793).
−Removed: The Company is currently advancing our targeted immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™
−Removed: in combination with an immune checkpoint inhibitor and a companion diagnostic test, BriaDx™, to identify patients most likely to
−Removed: benefit from Bria-IMT™.
−Removed: The Bria-IMT™ regimen was evaluated in four patients in a prior study in 2004-2006 by Dr.
−Removed: Wiseman, the scientific founder, former member of the board of directors of the Company (the “ Board ”) and principal
−Removed: scientific advisor.
−Removed: Encouraging results were obtained, especially in a patient who matched Bria-IMT™ at HLA-DR alleles and had
−Removed: a grade II tumor.
−Removed: In 2017-2018 BriaCell evaluated 23 patients with advanced breast cancer with the Bria-IMT™ regimen and obtained
−Removed: confirmation of the ability of the Bria-IMT™ regimen to induce regression of metastatic breast cancer in patients who match Bria-IMT™
−Removed: at least at one HLA allele and/or if they had grade I or grade II tumors.
−Removed: A combination study with the immune checkpoint inhibitor pembrolizumab
−Removed: (KEYTRUDA®) was initiated and the first patient dosing in the “combination therapy” clinical trial occurred in September
−Removed: BriaCell purchased the KEYTRUDA® for this study as BriaCell does not have an agreement with Merck & Co., Inc.
−Removed: for the supply
−Removed: of KEYTRUDA®.
−Removed: Eleven patients were dosed in the combination therapy trial with Bria-IMT™ and the immune checkpoint inhibitor
−Removed: KEYTRUDA® and subsequently dosing with this combination was discontinued.
−Removed: The study was modified under an amended protocol which
−Removed: evaluates the combination of the Bria-IMT™ regimen with Incyte Corporation experimental drugs retifanlimab (anti-PD-1 antibody
−Removed: similar to pembrolizumab).
−Removed: The study is ongoing.
−Removed: is estimated by the National Cancer Institute that in 2022, approximately 287,500 women will be diagnosed with breast cancer in the United
−Removed: That means that every two minutes an American woman is diagnosed with breast cancer and more than 43,000 are projected to die
−Removed: Although about 100 times less common than in women, breast cancer also affects men.
−Removed: It is estimated that the lifetime risk of
−Removed: men getting breast cancer is about 1 in 1,000, and the American Cancer Society estimates that approximately 2,710 new cases of invasive
−Removed: male breast cancer will be diagnosed and approximately 530 men will die from breast cancer in 2022.
−Removed: to the May 2019 “Global Oncology Trends 2021” report by the IQVIA Institute, the global market for cancer drugs (including
−Removed: immunotherapy drugs) is expected to reach nearly $269 billion by the end of 2025, growing at a compound annual growth rate (“ CAGR ”)
−Removed: of 10% between 2021 and 2025, of which about 20% is expected to be immuno-oncology drugs.
−Removed: 12.9% percent of women will be diagnosed with breast cancer at some point during their lifetime.
−Removed: In 2018, there were an estimated 3,676,262
−Removed: women living with female breast cancer in the United States.
−Removed: Approximately 81% of cases present as invasive breast cancer.
−Removed: Approximately
−Removed: 6% of new breast cancer diagnoses are Stage IV (metastatic breast cancer (“ MBC ”), which has already spread to other
−Removed: Twenty to thirty percent of all women diagnosed with breast cancer will develop MBC.
−Removed: Breast cancer can be subdivided based on
−Removed: receptor status – the hormone receptors for estrogen (ER) and progesterone (PR), collectively referred to as hormone receptors
−Removed: (HR), and the Her2/neu growth factor receptor (HER2).
−Removed: Based on the latest SEER statistics, 74.6% were found to be HR+/HER2−, 10.8%
−Removed: were triple-negative (HR−/HER2−), 10.5% were HR+/HER2+, and 4.0% were HR−/HER2+.
−Removed: is estimated that over 150,000 women in the US are living with MBC.
−Removed: For those with metastatic disease at diagnosis, their 5-year survival
−Removed: For patients who develop MBC after initially having localized disease, if they had a good response to treatment (i.e.
−Removed: disease-free interval of more than 24 months), their survival rate is similar to that of patients with MBC at initial diagnosis, but
−Removed: if their disease-free interval is less than 24 months, their prognosis is worse.
−Removed: 4 We currently propose that Bria-IMT’s™
−Removed: indication will be for the treatment of patients with MBC who have failed at least two lines of therapy.
−Removed: Similarly, another study showed
−Removed: that the median overall survival among patients with de novo stage IV MBC was 39.2 months, while for patients with relapsed disease it
−Removed: was 27.2 months.
−Removed: Median progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent
−Removed: lines of therapy.
−Removed: One study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line
−Removed: therapy, 175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.
−Removed: September 14, 2022, the Company signed an agreement with Caris Life Sciences ® (Caris), a leading molecular science a nd technology
−Removed: company actively developing and delivering innovative solutions to revolutionize healthcare.
−Removed: Under the terms of the agreement, Caris will help
−Removed: BriaCell with efficient patient identification, accelerating enrollment for its current Phase I/II clinical trial in advanced metastatic
−Removed: breast cancer of certain genetically defined subgroups.
−Removed: The partnership between BriaCell and Caris leverages Caris’ Right-In-Time
−Removed: (RIT) Clinical Trial Network, a group of over 495 oncology sites that are able to quickly identify and enroll eligible patients in biomarker-directed
−Removed: clinical trials.
−Removed: This service offers patients and physicians access to the most cutting-edge precision medicine in development.
−Removed: Additionally,
−Removed: through Caris’ comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing), Caris will perform tumor profiling
−Removed: for the patients enrolled in the clinical trial.
−Removed: On August 2, 2022, the Company
−Removed: secured an exclusive license from University of Maryland, Baltimore County (“ UMBC ”) to develop and commercialize Soluble
−Removed: CD80 (“ sCD80 ”) as a biologic agent for the treatment of cancer.
−Removed: The novel technology, originally developed by Suzanne
−Removed: Ostrand-Rosenberg, PhD, Faculty at UMBC, and BriaCell’s scientific advisory board member, is entitled “Soluble CD80 as a Therapeutic
−Removed: to Reverse Immune Suppression in Cancer Patients” (Patent No.
−Removed: US 9,650,429 B2).
−Removed: In animal models, sCD80 has been shown to be safe
−Removed: and effective in stopping the tumor growth in animal models by potentially restoring natural anti-tumor immunity.
−Removed: Importantly, sCD80’s
−Removed: unique actions may involve both awakening and boosting the immune system to recognize and destroy tumor cells.
−Removed: Under the terms of the agreement, BriaCell gains the
−Removed: worldwide rights to develop and commercialize sCD80 as a therapeutic agent for the treatment of cancer, while UMBC holds all rights, title
−Removed: and interest in the inventions and the patent, except for certain rights retained by the United States Government.
−Removed: BriaCell will pay 2%
−Removed: royalties to UMBC upon the commercialization of the product plus other development costs.
−Removed: The licensing agreement was coordinated by UMBC.
−Removed: On October 12, 2022, the Company
−Removed: announced it has added Mayo Clinic, Jacksonville, Florida as a clinical site in the Phase I/II study of BriaCell’s lead candidate,
−Removed: Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab, in advanced breast cancer.
−Removed: On October 21, 2022, the Company
−Removed: announced the completion of the Phase I part of the clinical trial of its lead candidate, Bria-IMT™, in combination with Incyte’s
−Removed: PD-1 inhibitor, retifanlimab, in advanced breast cancer.
−Removed: The efficacy and survival data of the treated patients is being evaluated in
−Removed: the Phase II part of the study which was recently awarded the FDA’s fast track designation.
−Removed: Under an FDA approved protocol, another
−Removed: arm has recently been added to the Phase II study to evaluate the effects of dosing schedules for patients in the study.
−Removed: The Phase I portion of the trial,
−Removed: with the primary goal of assessing safety and tolerability of the combination, enrolled 12 subjects who had previously failed at least
−Removed: two prior lines of therapy, characterized as a difficult-to-treat patient population.
−Removed: The combination treatment had a favorable safety
−Removed: profile and appeared well-tolerated with no dose-limiting toxicities.
−Removed: Progressing through the Phase
−Removed: II part of the clinical trial, a randomized controlled design will be used to allow comparison of the effectiveness of the treatment regimens
−Removed: between the two arms of the study with different dosing schedules.
−Removed: BriaCell noted it is on schedule to meet with the
−Removed: FDA later this year to discuss the design of a key registration study.
−Removed: of Omnibus Incentive Plan
−Removed: August 2, 2022, the Company approved an omnibus equity incentive plan (“Omnibus Plan), which will permit the Company to grant incentive
−Removed: stock options, preferred share units, restricted share units (“RSU’s”), and deferred share units (collectively, the
−Removed: “Awards”) for the benefit of any employee, officer, director, or consultant of the Company or any subsidiary of the Company.
−Removed: The maximum number of Shares available for issuance under the Omnibus Plan shall not exceed 15% of the issued and outstanding Shares,
−Removed: from time to time, less the number of Shares reserved for issuance under all other security-based compensation arrangements of the Company,
−Removed: including the existing Stock Option Plan.
−Removed: The Omnibus Plan remains subject to approval by the shareholders of the Company (the “Shareholders”)
−Removed: and final approval of the Toronto Stock Exchange (“Exchange”) and will replace the Company’s existing Stock Option
−Removed: Plan upon receipt of such approvals (“Approvals”).
−Removed: Company may make grants under the Omnibus Plan, however, the grants cannot be settled until the Approvals have been received.
−Removed: Stock Option and RSU Grants
−Removed: September 1, 2021, the Company issued 100,000 options to a consultant with an exercise price of $5.74, which vest immediately and expire
−Removed: on September 1, 2026.
−Removed: November 1, 2021, the Company issued 12,600 options with an exercise price of $7.94, and expire on November 1, 2026.
−Removed: 10,000 of the options
−Removed: were issued to a director and vest immediately, and 2,600 options were issued to members of the Company’s scientific advisory board and
−Removed: vest in five equal instalments every six months, with the first instalment vesting immediately.
−Removed: January 13, 2022, the Company issued 524,700 options to directors, officers, and employees with an exercise price of $8.47 and expire
−Removed: on January 13, 2027.
−Removed: 482,300 of the options were granted to Insiders, as such term is defined in the Securities Act (British Columbia)
−Removed: and vest in four equal instalments every 90 days, with the first instalment vesting immediately.
−Removed: The remaining 42,400 options vest in
−Removed: eight equal instalments every 90 days, with the first installment vesting immediately.
−Removed: February 16, 2022, the Company issued 150,000 options to an officer with an exercise price of $7.51 and expire on February 16, 2027.
−Removed: The options vest in eight equal instalments every 90 days, with the first instalment vesting immediately.
−Removed: May 20, 2022, the Company issued 31,000 options with an exercise price of $4.71 and expire on May 20, 2027.
−Removed: The options vest in eight
−Removed: equal instalments every 90 days, with the first instalment vesting immediately.
−Removed: 20,000 options were issued to the Company’s CFO.
−Removed: August 2, 2022, the Company issued 180,100 options with an exercise price of C$8.38 and expire on August 2, 2027.
−Removed: The options vest in
−Removed: eight equal instalments every 90 days, with the first instalment vesting immediately.
−Removed: 142,100 of the options were issued to the Company’s
−Removed: In addition, the Company issued RSU
−Removed: August 2, 2022, the Company also granted, under the Omnibus Plan, 19,200 RSU’s to the CEO.
−Removed: The RSU’s vested immediately.
−Removed: Exercise of warrants
−Removed: During the year ended July 2022,
−Removed: 1,615,645 warrants with an weighted aggregate exercise price of $5.98 were exercised for gross proceeds of $6,509,767.
−Removed: Securities Repurchase Program
−Removed: As noted in a press release
−Removed: dated September 9, 2021, BriaCell announced that the Board has authorized the Company’s securities repurchase program whereby the
−Removed: Company may purchase through the facilities of the TSX Venture Exchange (“TSXV”) or The NASDAQ Capital Market (“NASDAQ”)
−Removed: (i) up to 1,341,515 common shares (the “Common Shares”) and (ii) up to 411,962 publicly traded BCTXW warrants (the “Listed
−Removed: Warrants”) in total, representing 10% of the 13,415,154 Common Shares and 10% of the 4,119,622 Listed Warrants comprising the “public
−Removed: float” as of September 8, 2021, over the next 12 months (the “Buyback”).
−Removed: Independent Trading Group (ITG), Inc.
−Removed: act as the Company’s advisor and dealer manager in respect of the Buyback.
−Removed: The Company received final regulatory approval on September
−Removed: The repurchase program will in no way interfere with BriaCell’s ambitious growth plans to expand into previously-announced
−Removed: areas of cancer immunotherapy and/or advance its current breast cancer clinical trials.
−Removed: BriaCell’s proposed repurchases may be conducted
−Removed: through open market transactions at prevailing market prices, in privately negotiated transactions, in block trades, and/or through other
−Removed: legally permissible means, subject to the market conditions and in compliance with applicable rules and regulations.
−Removed: The timing and dollar
−Removed: amount of repurchase transactions will be subject to the SEC’s Rule 10b-18 and/or Rule 10b5-1 requirements.
−Removed: Purchases of Common Shares
−Removed: or Listed Warrants through the NASDAQ will not, during the 12-month period, exceed 5% of the outstanding Common Shares or Listed Warrants
−Removed: in the aggregate, as at the commencement of the Buyback.
−Removed: Board of Directors will be reviewing the program periodically and may revise the terms and/or size or suspend or discontinue the program.
−Removed: As of October 27, 2022, the
−Removed: company has repurchased 1,031,672 common shares and 259,059 publicly traded warrants.
−Removed: All of the warrants and shares repurchased
−Removed: have been cancelled.
−Removed: Changes in the Board of Directors
−Removed: On September 1, 2021, Mr.
−Removed: Lustig was appointed to the Company’s Board of Directors.
−Removed: Lustig is a highly regarded investor, entrepreneur, and corporate
−Removed: finance veteran with a deep understanding of the life sciences industry, including biotechnology and pharmaceuticals, as well as the legal
−Removed: cannabis industry.
−Removed: Marc holds MSc and MBA degrees from McGill University.
−Removed: His professional experience includes working at Merck &
−Removed: Co., and his capital markets career includes roles in biotechnology equity research and corporate finance.
−Removed: Lustig was the founder
−Removed: and CEO of Origin House, which was sold to Cresco Labs Inc.
−Removed: CRLBF) in 2020, where he currently serves as a director and
−Removed: as Head of Capital Markets.
−Removed: In addition to being a director of a number of public companies, Marc founded the Lustig Family Medical Cannabis
−Removed: Research & Care Fund of the Cedars Cancer Foundation that provides cannabis to palliative cancer patients.
−Removed: Shareholder Meeting
−Removed: On May 19, 2021, BriaCell
−Removed: announced the results of its annual general and special meeting of shareholders of the Company (the “Shareholders”) for the
−Removed: years ended July 31, 2019 and July 31, 2020, held on May 18, 2021 (the “Meeting”).
−Removed: A total of 1,685,180 common shares of
−Removed: the Company (the “Common Shares”) were voted, representing 22.36% of the Company’s issued and outstanding Common Shares.
−Removed: At the Meeting, the Shareholders overwhelmingly voted in favor of all proposed resolutions that consisted of the following:
−Removed: The number of directors set at six;
−Removed: Election of Dr.
−Removed: Williams, Mr.
−Removed: Jamieson Bondarenko, Dr.
−Removed: Charles Wiseman, Dr.
−Removed: Rebecca Taub, Mr.
−Removed: Embro-Pantalony, and Mr.
−Removed: Martin Schmieg as directors of the Company;
−Removed: Appointment of MNP LLP as auditors of the Company for the ensuing year and authorizing the directors to fix their remuneration;
−Removed: Renewal of the Company’s stock option plan;
−Removed: Ratification of the number of directors set at six for the prior year ended July 31, 2019;
−Removed: Ratification of the election of Dr.
−Removed: Williams, Mr.
−Removed: Jamieson Bondarenko, Mr.
−Removed: Richard Berman, Mr.
−Removed: Embro-Pantalony, Dr.
−Removed: Rebecca Taub, and Dr.
−Removed: Charles Wiseman as directors of the Company for the prior year ended July 31, 2019;
−Removed: Ratification of the appointment of MNP LLP as the auditors of the Company for the prior year ended July 31, 2019 and ratifying the directors authorization to fix their remuneration;
−Removed: Ratification of the Company’s stock option plan for the prior year ended July 31, 2019;
−Removed: Ratification of holding the Company’s annual general and special meeting for the year ended July 31, 2019 on May 18, 2021.
−Removed: Having received shareholder approval,
−Removed: the Company’s stock option plan remains subject to approval from the TSX Venture Exchange.
−Removed: The formal report on voting results with
−Removed: respect to all matters voted upon during the Meeting will be filed on the Company’s SEDAR profile at www.sedar.com and will
−Removed: be filed with the SEC at www.sec.gov.
−Removed: Critical Accounting Policies and Estimates
+Added: The estimates
+Added: were based on historical experience and other assumptions that we believe to be reasonable under the circumstances.
+Added: Actual results are
+Added: likely to differ from those estimates or other forward-looking statements under different assumptions or conditions, but we do not believe
+Added: such differences will materially affect our financial position or results of operations.
+Added: Our actual results may differ materially as
+Added: a result of many factors, including those set forth under the headings entitled “ Special Note Regarding Forward-Looking Statements ”
+Added: and “ Risk Factors ”.
+Added: BriaCell Therapeutics Corp.
+Added: (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies
+Added: to transform cancer care.
+Added: Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own
+Added: immune system to recognize and destroy cancer cells.
+Added: The Company is currently advancing its Bria-IMT™ targeted immunotherapy in
+Added: combination with an immune check point inhibitor in a pivotal1 Phase 3 study in advanced metastatic breast cancer.
+Added: BriaCell recently reported
+Added: benchmark-beating patient survival and clinical benefit in advanced metastatic breast with median overall survival of 13.5 months in BriaCell’s
+Added: advanced metastatic breast cancer patients vs.
+Added: 6.7-9.8 months for similar patients reported in the literature2.
+Added: A completed Bria-IMT™
+Added: Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy.
+Added: BriaCell is also developing a personalized off-the-shelf immunotherapy, Bria-OTS™, which provides a platform technology to develop
+Added: personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator
+Added: of the immune system as well as an immune checkpoint inhibitor.
+Added: Accounting Policies and Estimates
Critical Estimates and Judgements
−Removed: The preparation of these consolidated
−Removed: financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
−Removed: at the date of the financial statements and reported amounts of expenses during the reporting period.
−Removed: Actual outcomes could differ from
−Removed: these estimates.
+Added: preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported
+Added: amounts of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period.
+Added: Actual outcomes could differ from these estimates.
The financial statements include estimates which, by their nature, are uncertain.
−Removed: The impacts of such estimates are pervasive
−Removed: throughout the financial statements, and may require accounting adjustments based on future occurrences.
−Removed: Revisions to accounting estimates
−Removed: are recognized in the period in which the estimate is revised and also in future periods when the revision affects both current and future
−Removed: The critical judgments and significant
−Removed: estimates in applying accounting policies that have the most significant effect on the amounts recognized in the consolidated financial
−Removed: statements are:
−Removed: Intangible assets are tested for impairment annually or more frequently if there is an indication of impairment.
−Removed: The carrying value of intangibles with definite lives is reviewed each reporting period to determine whether there is any indication of impairment.
−Removed: 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.
−Removed: The Company uses the Black-Scholes option-pricing model to estimate fair value of options and the warrant liability at each reporting date.
−Removed: The key assumptions used in the model are the expected future volatility in the price of the Company’s shares and the expected life of the warrants.
−Removed: The financial statements of each company within the consolidated group are measured using their functional currency which is the currency of the primary economic environment in which an entity operates.
−Removed: The Company changed its functional currency from the Canadian dollar (C$) to the United States dollar (US$) as of May 1, 2021.
−Removed: The change in presentation currency is a voluntary change which is accounted for retrospectively.
−Removed: For comparative reporting purposes, historical financial information has been translated to United States dollars using the exchange rate as of May 1, 2021, which is the date of the change in the functional and presentation currency.
+Added: The impacts of such estimates are pervasive throughout the financial statements, and may require accounting adjustments based on future
+Added: Revisions to accounting estimates are recognized in the period in which the estimate is revised and also in future periods
+Added: when the revision affects both current and future periods.
+Added: critical judgments and significant estimates in applying accounting policies that have the most significant effect on the amounts recognized
+Added: in the consolidated financial statements are:
+Added: assets are tested for impairment annually or more frequently if there is an indication of impairment.
+Added: The carrying value of intangibles
+Added: with definite lives is reviewed each reporting period to determine whether there is any indication of impairment.
+Added: If there are indications
+Added: of impairment the impairment analysis is completed and if the carrying amount of an asset exceeds its recoverable amount, the asset
+Added: is impaired and impairment loss is recognized.
+Added: Company uses the Black-Scholes option-pricing model to estimate fair value of options and the warrant liability at each reporting
+Added: The key assumptions used in the model are the expected future volatility in the price of the Company’s shares and the
+Added: expected life of the warrants.
+Added: Preparation of the consolidated
+Added: financial statement on a going concern basis, which contemplates the realization of assets and payments of liabilities in the ordinary
+Added: course of business.
+Added: Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of
+Added: its assets, including its intangible assets and to meet its liabilities as they become due
+Added: for taxes are made using the best estimate of the amount expected to be paid based on a qualitative assessment of all relevant factors.
+Added: The Company reviews the adequacy of these provisions at the end of the reporting period.
+Added: However, it is possible that at some future
+Added: date an additional liability could result from audits by taxing authorities.
+Added: Where the final outcome of these tax-related matters
+Added: is different from the amounts that were initially recorded, such differences will affect the tax provisions in the period in which
+Added: such determination is made.
New Accounting Policies Adopted
−Removed: No new accounting policies were
−Removed: adopted during the year ended July 31, 2022.
−Removed: Results of Operations
−Removed: Comparison of the year ended July 31, 2022,
−Removed: compared to the year ended July 31, 2021
−Removed: Research Costs
−Removed: Research costs are comprised primarily
−Removed: of (i) Salaries and wages to Company employees at our laboratory;
−Removed: and (ii) Clinical trials and investigational drug costs, which include
−Removed: the testing and manufacture of our investigational drugs and costs of our clinical trials.
−Removed: For the year ended July 31, 2022,
−Removed: research costs amounted to $8,021,489 as compared to $2,020,899 for the year ended July 31, 2021.
−Removed: The increase is attributed to the recommencing
−Removed: of the Company’s clinical trials and the increased activity in the lab, including the hiring of additional lab employees .
−Removed: General and Administrative Expenses
−Removed: For the year ended July 31, 2022,
−Removed: general and administrative expenses amounted to $7,267,452 as compared to $ 4,955,136 for the year ended July 31, 2021.
+Added: new accounting policies were adopted during the year ended July 31, 2023.
+Added: of Operations
+Added: of the year ended July 31, 2023, compared to the year ended July 31, 2022
+Added: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory;
+Added: and (ii) clinical trials and investigational
+Added: drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
+Added: following is a breakdown of our research and development costs by project:
+Added: Year ended July 31,
+Added: Clinical trials
+Added: Pre-clinical projects
+Added: Chemical, Manufacturing and Control Costs (“CMC Costs”)
+Added: clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase I/IIa clinical trial.
+Added: Clinical trial expenses
+Added: increased in 2023 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.
+Added: projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
+Added: Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an additional
+Added: pre-clinical program (sCD80).
+Added: costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational
+Added: CMC costs increased in 2023 to support the additional patients in our trials.
+Added: costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
+Added: board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
+Added: Other costs increased in 2023 as we investigated additional potential pre-clinical projects.
+Added: following is a breakdown of our research and development costs by nature of expenses:
+Added: Year ended July 31,
+Added: Clinical trial sites and investigational drug costs
+Added: Wages and salaries
+Added: Laboratory Rent
+Added: Share-based compensation
+Added: the year ended July 31, 2023, research costs totaled $15,336,638, compared to $8,021,489 for the same period in 2022.
+Added: The increase primarily
+Added: resulted from the expansion of the Company’s Bria-IMT™ trial and higher clinical trials and investigational drug costs, which
+Added: rose from $4,912,530 in 2022 to $9,611,630 in 2023.
+Added: Laboratory costs also increased due to the hiring of additional employees and higher
+Added: supplies, growing from $138,354 to $194,880 and $309,992 to $579,169, respectively.
+Added: Additionally, non-cash share-based compensation expenses
+Added: rose from $435,563 in 2022 to $1,072,592 in 2023, contributing to the overall increase in research and development expenses.
+Added: and Administrative Expenses
+Added: For the year ended July 31, 2023, general and administrative expenses amounted
+Added: to $7,935,626 as compared to $7,267,452 for the year ended July 31, 2022 The increase in general and administrative expenses primarily
+Added: stems from higher insurance premiums, professional fees, and salaries, offset by a decrease in share-based compensation expenses.
+Added: income (expenses), net
+Added: For the year ended July 31, 2023, financial income, net amounted to $2,969,870
+Added: as compared to financial loss $11,549,962 for the year ended July 31, 2022.
+Added: Financial income (expenses) comprises, primarily, changes in
+Added: the fair value of the warrant liability and interest earned on our treasury.
+Added: For the year ended July 31, 2023, the value of the warrant
+Added: liability decreased by $2,119,530.
+Added: The decrease was primarily due to the decrease in the share price at period end.
+Added: For the year ended
+Added: July 31, 2022, there was an increase in the value of the liability of $11,658,372 due to the increased share price at the period end.
+Added: Interest income for the year ended July 31, 2023 was $891,213 as compared to $136,731 for the year ended July 31, 2022.
The increase in
−Removed: 2022 is mainly due to a significant ramp up of activity in the Company, following the financings completed in 2021.
−Removed: These increases relate
−Removed: primarily to share based compensation (i.e.
−Removed: non-cash), increase in salaries due to hiring more personnel, and consulting and professional
−Removed: fees incurred by the Company.
−Removed: Financial expenses, net
−Removed: For the year ended July 31, 2022,
−Removed: financial expense, net amounted to $11,549,962 as compared to $6,840,165 for the year ended July 31, 2021.
−Removed: Financial expense, net in 2022
−Removed: is the result of the revaluation of warrant liability at period end offset slightly by interest income earned during the period on funds
−Removed: held in interest bearing accounts.
−Removed: The higher expense in 2021 can be attributed to a larger adjustment to the warrant liability from the
−Removed: issuance of warrants and the revaluation of warrants at period end.
−Removed: Loss for the period
−Removed: The Company reported a loss for
−Removed: the year ended July 31, 2022, of $26,838,903 as compared to $13,816,200 for the year ended July 31, 2021.
−Removed: The primary reason for reduced
−Removed: losses in 2022 is due to the decrease in fair value of the warrant liability.
−Removed: Going Concern Uncertainty
−Removed: The financial statements have
−Removed: been prepared on a going concern basis, which assumes that the Company will be able to realize its assets and discharge its liabilities
−Removed: in the normal course of business for the foreseeable future.
−Removed: The continuing operations of the Company are dependent upon its ability to
−Removed: continue to raise adequate financing and to commence profitable operations in the future.
−Removed: As of July 31, 2022, the Company
−Removed: has total assets of $42,577,041 (July 31, 2021 - $58,043,762) and a positive working capital balance of $41,405,614 (July 31, 2021 –$57,241,355).
−Removed: The Company is planning to finance
−Removed: its research and developmental activities from its existing and future working capital resources and to continue to evaluate additional
−Removed: sources of capital and financing.
−Removed: The Company believes that its existing capital resources will be adequate to satisfy its expected liquidity
−Removed: requirements for at least twelve months from the issuance of the consolidated financial statements.
−Removed: Liquidity and Capital Resources
−Removed: As of July 31, 2022, the
−Removed: Company has a working capital of $41,405,614 (July 31, 2021 – $57,241,355) and an accumulated deficit of $60,349,837 (July 31,
+Added: 2023 is attributable to higher interest rates in North America.
+Added: for the period
+Added: The Company reported a loss for the year ended July 31, 2023, of $20,302,394
+Added: as compared to $26,838,903 for the year ended July 31, 2022.
+Added: The loss in 2023 primarily stems from a substantial increase in operational
+Added: spending, offset by a gain in from a decrease in the fair value of the warrant liability.
+Added: Conversely, the higher loss in the prior period
+Added: can be attributed to a larger increase in the fair value of the warrant liability.
+Added: These factors account for the variance in the reported
+Added: losses between the two periods, highlighting the impact of changes in warrant valuation and operational spending on the Company’s
+Added: financial performance.
+Added: and Capital Resources
+Added: of July 31, 2023, the Company has a working capital of 25,147,050 (July 31, 2022 – $41,405,613) and an accumulated deficit of $80,652,231 (July
31, 2022 - $60,349,837).
−Removed: In June 2021, the Company completed a private placement of gross proceeds of $27.2 million.
−Removed: As of July 31, 2022, the Company’s
−Removed: capital resources consist primarily of cash and cash equivalents, comprising mostly of cash on deposit
−Removed: with banks, investments in money market funds, investments in U.S.
+Added: of July 31, 2023, the Company’s capital resources consist primarily of cash and cash equivalents, comprised mostly of cash on
+Added: deposit with banks, investments in money market funds, investments in U.S.
government securities, U.S.
−Removed: government agency securities, and investment
−Removed: grade corporate debt securities .
−Removed: Our investment policy and strategy are focused on preservation
−Removed: of capital and supporting our liquidity requirements.
−Removed: Historically, the Company
−Removed: has financed its operation through private and public placement of equity securities, as well as debt financing.
−Removed: The Company’s
−Removed: ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control.
−Removed: The Company intends
−Removed: to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives.
−Removed: Management believes
−Removed: that it can be successful in obtaining additional capital;
−Removed: however, no assurance can be provided that the Company will be able to do
−Removed: There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue
−Removed: as a going concern.
−Removed: To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement
−Removed: a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations.
−Removed: no assurance that such a plan will be successful
−Removed: During the year ended
−Removed: July 31, 2022, the Company’s overall position of cash and cash equivalents decreased by $16,227,033 from the year ended July 31,
−Removed: 2021 (including effects of foreign exchange).
+Added: government agency securities,
+Added: and investment grade corporate debt securities.
+Added: Our investment policy and strategy are focused on preservation of capital and supporting
+Added: our liquidity requirements.
+Added: Historically,
+Added: the Company has financed its operation through private and public placement of equity securities, as well as debt financing.
+Added: Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its
+Added: The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business
+Added: plan objectives.
+Added: Management believes that it can be successful in obtaining additional capital;
+Added: however, there can be no assurance that the Company will be able to do so.
+Added: There is no assurance that any funds raised will be sufficient to enable the
+Added: Company to attain profitable operations or continue as a going concern.
+Added: To the extent that the Company is unsuccessful, the Company
+Added: may need to curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional
+Added: capital is raised to support further operations.
+Added: There can be no assurance that such a plan will be successful.
+Added: the year ended July 31, 2023, the Company’s overall position of cash and cash equivalents decreased by $19,790,560 from the year ended
+Added: July 31, 2022 (including effects of foreign exchange).
This decrease in cash can be attributed to the following:
−Removed: The Company’s net cash used
−Removed: in operating activities during the year ended July 31, 2022 was $12,484,376 as compared to $7,750,188 for year ended July 31, 2021.
−Removed: This increase is mostly due to company growth and increased expenditures
−Removed: during the period.
−Removed: financing activities for the year ended July 31, 2022 was $3,742,657 as compared to $64,997,624 for the year ended July 31, 2021.
−Removed: used in 2022 is attributed to the money spent on the buyback program offset by warrant exercise proceeds.
−Removed: Cash provided in 2021
−Removed: was mainly from the Nasdaq Financing in February 2021, the private placement proceeds in June 2021, and the exercise of warrants
−Removed: offset by the repayment of these loans.
−Removed: Off-balance Sheet Arrangements
−Removed: Tabular Disclosure of Contractual Obligations
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES
−Removed: ABOUT MARKET RISK
−Removed: We are a smaller reporting company, as defined by
−Removed: Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required under this Item
+Added: Company’s net cash used in operating activities during the year ended July 31, 2023, was $23,744,860 as compared to
+Added: $12,484,376 for the year ended July 31, 2022.
+Added: gained in financing activities for the year ended July 31, 2023, was $3,954,300, as compared to a loss of $3,742,657 for the year
+Added: ended July 31, 2022.
+Added: Sheet Arrangements
+Added: Disclosure of Contractual Obligations
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
+Added: are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to
+Added: provide the information required under this Item 7A.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.