BCTX - BriaCell Therapeutics: One Step Closer To Fighting Breast And Prostate Cancers

Summary

• BriaCell Therapeutics Corp. is a clinical-stage biotechnology company specializing in targeted novel immuno-therapies to fight breast and prostate cancer.
• The FDA has agreed on the registration study design which will enroll advanced metastatic breast cancer patients for whom no approved treatment exists.
• In addition to metastatic breast cancer, BriaCell has been developing Bria-Pros™, an off-the-shelf personalized immunotherapy for advanced prostate cancer.
• I believe BriaCell is doing everything right and would make a great buy and hold investment. Where else can one find an investment with the potential of treating such a huge number of gravely ill cancer patients?

BriaCell Therapeutics Corp. (BCTX) (BCT:CA) is a clinical-stage biotechnology company specializing in targeted novel immuno-therapies to fight breast and prostate cancer and also is in the early stages of researching similar therapies for non-small cell lung cancer and melanoma.

Immunotherapies have become the forefront of the cancer treatments because they use the body’s immune system to destroy cancerous tumors by boosting the body’s own cancer fighting cells, offer the potential for higher levels of safety and efficacy than chemotherapy, and may also prevent cancer recurrence.

Metastatic Breast Cancer

Advanced metastatic breast cancer ((MBC)) remains one of the most difficult cancers to treat and there is an urgent, unmet medical need to find well-tolerated and effective treatments for these gravely ill cancer patients who have only months to live and cannot tolerate the harsh side effects of other cancer treatments.

Bria-IMT™

That being said, BriaCell's clinical trial collaboration with Incyte Corporation (NASDAQ: INCY ) to evaluate the effects of various combinations of novel clinical candidates has shown, according to Mayo Clinic Professor and Principal Clinical Investigator Saranya Chumsri, M.D., that a Bria-IMT™ in combination with retifanlimab (INCMGA00012), an anti-PD-1 antibody provided by Incyte, did not have any theoretical cross-resistance or overlapping toxicity with other MBC treatments allowing many patients to stay in the trial longer than their last therapy, suggesting the Bria-IMT™ is both well tolerated and clinically effective.

In a recent meeting with the FDA they has agreed on the registration study design and the primary end point. This pivotal registration study will enroll advanced metastatic breast cancer patients for whom no approved treatment options exists and its success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer. The company reports that source links for the FDA meeting and both ACS fact sheets (breast and prostate) are not available yet but will be shared with the public as soon as they are available.

Dr. William V. Williams, BriaCell’s President and CEO, reports that, “The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies. Jumping directly into a pivotal study has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options.”

In addition, BriaCell is developing:

Bria-OTS™

• Bria-OTS™, the first “off-the-shelf” personalized immunotherapy for the treatment of advanced stage breast cancer has recently been awarded Fast Track status by the U.S. Food and Drug Administration.
• In addition, a small molecule program consisting of novel selective protein kinase C delta inhibitors have shown activity in pre-clinical models of several cancers and fibrotic diseases.

How Bria-IMT™ and Bria-OTS™ Destroy Cancer Cells - A Video

About Breast Cancer

• The American Cancer Society's 2022 fact sheet estimated that:
  • 3.1 million women in the U.S. had a history of invasive breast cancer in 2022 and that it would reach 4 million by 2024,
  • 287,850 women and 2,710 men (representing just 0.9% of the total of which the author of this article is one) are expected to be diagnosed with invasive breast cancer in 2022 in the U.S. alone and
  • 43,780 (43,250 women, 530 men) are estimated to have died from breast cancer in 2022 making it the second leading cause of cancer death in women (after lung cancer).
• Approximately 62% of breast cancer cases are detected at the early stages (i.e., the cancer is found in the breast tissue, and has not spread to lymph nodes or other regions of the body), for which the 5-year survival rate is estimated to be 99%. As soon as the cancer spreads to lymph nodes under the arm or nearby tissues (regional stage), the 5-year survival rate drops to 85%.
• Once the cancer spreads to other lymph nodes or body parts (distant stage or metastatic cancer), the 5-year survival rate falls to as low as 27% (i.e. 73% of the patients die within 5 years). This shows the significant need for effective treatments for this deadly cancer.

About Prostate Cancer

Other than skin cancer, prostate cancer is the most common cancer in American men and the second leading cause of cancer death in American men, behind only lung cancer. The American Cancer Society’s estimates that there will be:

• about 268,490 new cases of prostate cancer in the U.S. in 2022;
• about 34,500 deaths from prostate cancer will occur during the year;
• about 1 man in 8 will be diagnosed with prostate cancer during his lifetime of which about 1 man in 41 will die of prostate cancer but, while prostate cancer is a serious disease, most men diagnosed with prostate cancer do not die from it. In fact, more than 3.1 million men in the United States who have been diagnosed with prostate cancer at some point are still alive today;
• about 6 cases in 10 are diagnosed in men who are 65 or older (with an average age of 66 and more likely to develop in non-Hispanic black men), and it is rare in men under 40.

Bria-Pros™

In addition to metastatic breast cancer, BriaCell has been developing Bria-Pros™, an off-the-shelf personalized immunotherapy for advanced prostate cancer, and has entered into a manufacturing service agreement with Waisman Biomanufacturing at the University of Wisconsin–Madison to manufacture Bria-Pros™ for anticipated use in clinical studies.

BriaCell’s Phase I/II trial in prostate cancer is expected to follow upon the completion of the manufacturing, testing, and the related regulatory filings.

4Q 2022 Financial Results

BriaCell Therapeutics is a clinical-stage startup with a market capitalization of only $117M. It is still in the product research and development of novel compounds and has no products and no revenue and requires a great deal of money to fund their R&D expenses. For a detailed look at all the financial metrics related to BriaCell in its last quarter (Q4 ending October 31st, 2022) and for every year going back to 2018, go here .

Summary highlights for Q4 showed:

• a SG&A expense of $7.18M attributed to the resumption of clinical trials and increased laboratory activity, including the hiring of additional employees;
• a net operating cash flow of $(4.1)M;
• growth in net operating cash flow of 22.6%;
• EBITDA of $(7.18)M;
• EBITDA growth of -17.1%;
• a net loss of $ (26.8)M or $(1.73) per share and
• cash and equivalents on hand of $51.1M.

As disappointing as the above financial metrics are BriaCell's stock price declined "only" 49% in 2022 which is much less than the 6 major clinical-stage psychedelic stocks I follow in the munKNEE Psychedelic Drug Stocks Index which, on average, went down 70% in 2022 (see details here ).

Investment Risks

The only downside I see in BriaCell's future is that it runs out of money to continue its research. That being said, the company reports that their cash position of US$37 million is sufficient to advance the company through its key value-creating clinical milestones without the need to raise additional financing over the next 2 years.

That being said, if another clinical-stage company were successful in developing a treatment for advanced breast cancer before BriaCell that would most likely cause negative investor sentiment towards BriaCell's stock price and, even more so, if such a competitor were able to take the treatment to market, i.e. commercialize it, and generate some revenue to offset its research and development costs.

Conclusion

From my analysis of BriaCell Therapeutics, I believe it is doing everything right and would make a great buy and hold investment. Where else can one find an investment with the potential of treating such a huge number of gravely ill cancer patients? If, and when, it is bought out by a major pharmaceutical company, or brings a product directly to market itself, its stock price should go up dramatically.

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