• According to American Cancer Society Facts and Figures, breast cancer is the most common cancer in the United States with 300,590 expected new cases in 2023
• 43,700 women and men are expected to die of breast cancer in the U.S. in 2023, making breast cancer the 2nd leading cause of cancer death in women in the U.S.
• BriaCell’s pivotal Phase 3 study (under Fast Track Designation) investigating the Bria-IMT™ regimen in advanced metastatic breast cancer is enrolling patients
• BriaCell recently reported benchmark-beating patient survival and clinical benefit with median overall survival of 13.5 months vs literature reported 6.7-9.8 months in advanced metastatic breast cancer
• Key Opinion Leaders from the Mayo Clinic and University of Pittsburgh to discuss metastatic breast cancer treatment challenges and the Bria-IMT™ solution on October 26, 2023

PHILADELPHIA and VANCOUVER, British Columbia, Oct. 20, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, recognizes that October is Breast Cancer Awareness Month, an annual campaign to increase awareness of the disease. Despite the current advancements in breast cancer support, prevention, detection, diagnosis, treatment, and care – the fact that there are an estimated 43,700 breast cancer deaths per year in the U.S. highlights the need for more effective treatments.

Breast Cancer: Facts & Statistics (U.S.)

According to the American Cancer Society Facts and Figures 2023 report:

• Breast cancer is the most frequently diagnosed cancer in the United States with 297,790 women and 2,800 men expected to be diagnosed with invasive breast cancer in 2023. The overall risk of a woman in the United States developing breast cancer sometime in her life is about 13%. This means there is an approximately 1 in 8 chance she will develop breast cancer;
• Approximately 43,170 women and 530 men are expected to die of breast cancer in the U.S. in 2023, making breast cancer the 2nd leading cause of cancer death in women (after lung cancer) in the U.S.

Note from BriaCell CEO

Dear BriaCell Shareholders,

I am writing this letter during Breast Cancer Awareness month to alert all to the devastation of advanced breast cancer. While the focus of the month is on early detection, as it should be, I highlight our recent accomplishments in the fight against advanced breast cancer, an incurable disease. In advanced metastatic breast cancer patients who have failed other therapies, life expectancy can be weeks to months. We strongly believe our novel immunotherapy candidates have the potential to transform the way we treat breast cancer patients.

Our Lead Program and Value Driver: Bria-IMT™

This year has brought several positive clinical and developmental milestones that we are delighted to share with you.

We recently reported benchmark-beating patient survival and clinical benefit in advanced metastatic breast cancer with median overall survival of 13.5 months in BriaCell’s advanced metastatic breast cancer patients (vs. 6.7-9.8 months for similar patients reported in the literature).

In a partnership with experts at the multicenter New York Cancer & Blood Specialists (NYCBS), we are pleased to announce that our pivotal Phase 3 study of Bria-IMT™ in combination with an immune checkpoint inhibitor in advanced metastatic breast cancer (under FDA Fast Track designation) is enrolling patients. Positive results from the pivotal study (listed on ClinicalTrials.gov as NCT06072612) could allow commercialization of Bria-IMT™.

The FDA has agreed on our primary endpoint related to mortality improvement with Bria-IMT™ regimen in comparison to physician’s choice of treatment. Note that the average survival in this very sick patient population is under one year and as little as weeks or months in women who have progressed through multiple regimens. The importance of helping these patients is of critical concern. These women have significant unmet medical need for new and effective therapies.

We also accepted a letter of intent from Dr. Massimo Cristofanilli, Director of Breast Medical Oncology and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties’ plans and commitment, upon regulatory clearance, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell’s novel immunotherapy, Bria-IMT™, in combination with a check point inhibitor (CPI), in early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC) patients in the neoadjuvant setting.

Hosting a Discussion with World-Renowned Breast Cancer Expert Oncologists

BriaCell will be hosting a Key Opinion Leader roundtable to discuss the current treatment challenges and Bria-IMT™ regimen as a potential solution featuring world-renowned breast cancer oncologists, Adam M. Brufsky, MD, PhD, FACP from University of Pittsburgh School of Medicine and Saranya Chumsri, MD from the Mayo Clinic, on October 26, 2023.

As a member of BriaCell’s clinical team, involved in 19 previous drug approvals, I can attest that I am truly thrilled with our progress to date and very proud of our outstanding team of physicians and scientists – together we strive to find solutions for cancer patients whose medical needs are unmet.

I wanted to end this letter with thanking all our shareholders who have continued to support us throughout our journey, our employees, board members, scientific advisory board, collaborators, and clinical teams who have worked tirelessly to make these clinical advancements possible, and finally offer our sincerest thanks to our patients and their families for their patience and trust in our science and technology. I am looking forward to sharing more news with you as our journey continues.

Yours very truly,
William V. Williams, MD
President & CEO
BriaCell Therapeutics Corp.

About BriaCell Therapeutics Corp.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those relating to: BriaCell’s pivotal Phase 3 study of the Bria-IMT™ regimen, any potential outcomes related to the letter of intent from Dr. Massimo Cristofanilli, and the upcoming Key Opinion Leader roundtable, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company's most recent Management’s Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under “Risks and Uncertainties” in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
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Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
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Investor Relations Contact:
CORE IR
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