BriaCell Therapeutics Files 2024 10-K

Ticker: BCTXZ · Form: 10-K · Filed: Oct 29, 2024 · CIK: 1610820

Sentiment: neutral

Topics: 10-K, annual-report, biotech

Related Tickers: BCTX

TL;DR

BriaCell's 2024 10-K is in, check financials for FY ending 7/31/24.

AI Summary

BriaCell Therapeutics Corp. filed its 10-K for the fiscal year ending July 31, 2024, reporting on its financial condition and business operations. The company, formerly known as Ansell Capital Corp. until June 13, 2014, is engaged in the pharmaceutical preparations industry. Key financial data and operational details for the fiscal years 2022, 2023, and 2024 are presented within the filing.

Why It Matters

This filing provides investors and stakeholders with a comprehensive overview of BriaCell Therapeutics' financial health and strategic direction for the past fiscal year, crucial for investment decisions.

Risk Assessment

Risk Level: medium — As a clinical-stage biotechnology company, BriaCell Therapeutics faces inherent risks related to drug development, regulatory approvals, and market adoption.

Key Numbers

Key Players & Entities

FAQ

What was BriaCell Therapeutics Corp.'s former name and when did the name change occur?

BriaCell Therapeutics Corp. was formerly known as Ansell Capital Corp. The name change occurred on June 13, 2014.

What is the fiscal year end for BriaCell Therapeutics Corp. as reported in this 10-K?

The fiscal year end for BriaCell Therapeutics Corp. is July 31, 2024.

When was this 10-K filing submitted to the SEC?

This 10-K filing was submitted to the SEC on October 29, 2024.

What industry does BriaCell Therapeutics Corp. operate in?

BriaCell Therapeutics Corp. operates in the Pharmaceutical Preparations industry, with the Standard Industrial Classification code 2834.

What are the key dates for the fiscal periods covered by this filing?

The filing covers the fiscal year ending July 31, 2024, and includes comparative data for the fiscal years ending July 31, 2023, and July 31, 2022.

Filing Stats: 4,410 words · 18 min read · ~15 pages · Grade level 9.7 · Accepted 2024-10-28 18:22:28

Key Financial Figures

Filing Documents

Business

Business 5 Item 1A

Risk Factors

Risk Factors 30 Item 1B Unresolved Staff Comments 51 Item 1C Cybersecurity 51 Item 2

Properties

Properties 52 Item 3

Legal Proceedings

Legal Proceedings 52 Item 4 Mine Safety Disclosures 52 PART II Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 53 Item 6 [Reserved] 53 Item 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 53 Item 7A

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 57 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 57 Item 9 Changes In and Disagreements with Accountants on Accounting and Financial Disclosure 57 Item 9A

Controls and Procedures

Controls and Procedures 57 Item 9B Other Information 57 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 57 PART III Item 10 Directors, Executive Officers, and Corporate Governance 58 Item 11

Executive Compensation

Executive Compensation 67 Item 12

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 70 Item 13 Certain Relationship and Related Transactions, and Director Independence 73 Item 14 Principal Accountant Fees and Services 73 PART IV Item 15 Exhibits 74 Item 16 Form 10-K Summary 77

SIGNATURES

SIGNATURES 78 2 Forward-Looking This Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements may be identified by such forward-looking terminology as "may," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue" or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks in the section titled " Risk Factors ", that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In addition, you are directed to factors discussed in the " Business " section and the " Management's Discussion and Analysis of Financial Condition and Results of Operations " section, as well as those discussed elsewhere in this Annual Report on Form 10-K. All of our forward-looking statements are as of the date of this Annual Report on Form 10-K only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such ex

BUSINESS

BUSINESS Overview of the Company BriaCell Therapeutics Corp. ("Briacell" or the "Company") is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body's own immune system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab) in a pivotal 1 Phase 3 study in metastatic breast cancer. Bria-IMT is currently under Fast Track Designation by the U.S. Food and Drug Administration (the "FDA") intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT immune checkpoint inhibitor combination in metastatic breast cancer. BriaCell reported benchmark-beating patient survival and clinical benefit in metastatic breast cancer with median overall survival of 13.4 months in BriaCell's metastatic breast cancer patients vs. 6.7-9.8 months 2 for similar patients reported in the literature in its Phase 2 study of Bria-IMT combination study with retifanlimab at the 2023 San Antonio Breast Cancer Symposium. Additionally, BriaCell reported median overall survival of 15.6 months in Phase 2 Bria-IMT study patients treated in combination with immune checkpoint inhibitor in patients treated with the Phase 3 formulation since 2022 (post-COVID). A completed Bria-IMT Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy. BriaCell is also developing personalized off-the-shelf immunotherapies, Bria-OTS and Bria-OTS+, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer. In September 2024, the Company announced BriaCell has received positive

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