BCTX: Pivotal Study Protocol Cleared
NASDAQ:BCTX
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Third Quarter Fiscal Year 2023 Operational and Financial Results
On June 14th 2023, BriaCell Therapeutics Corp. (NASDAQ:BCTX) reported third quarter fiscal year 2023 financial and operational results. The results for the quarter ending April 30, 2023 were reported in its Form 10-Q filing with the SEC. Since our previous update, BriaCell has announced a strategic investment with Prevail Partners and a clinical alliance with Prevail InfoWorks, which are separate but related entities. The former provided a $4 million investment, signaling optimism over the potential for the upcoming Bria-IMT trial and the latter will serve as the CRO for the upcoming pivotal trial in advanced metastatic breast cancer, whose design was recently cleared by the FDA. Other news includes the anticipated spinout of BriaPro Therapeutics which will shift several preclinical assets into a separate entity.
Highlights for fiscal year 2023 to-date include:
➢ License secured to commercialize CD80 from UMBC – August 2022
➢ Trial enrollment assistance with Caris – September 2022
➢ Presentation of multiple posters at San Antonio Breast Cancer Symposium – December 2022
➢ Bria-OTS patent issued for Whole-cell Cancer Vaccines and Methods for Selection – January 2023
➢ End of Phase II meeting with FDA for Bria-IMT – January 2023
➢ Bria-OTS trial launch – 2Q:23
➢ Presentation of multiple posters at AACR – April 2023
➢ Strategic Investment and Clinical Alliance with Prevail – May 2023
➢ Announced arrangement to spin out Bria Pro Therapeutics – May 2023
➢ FDA clearance of Bria-IMT study design for pivotal trial in advanced metastatic breast cancer – June 2023
BriaCell produced no revenues in its fiscal third quarter and incurred operating expense of ($5.7) million, yielding a net loss of ($4.9) million, or ($0.32) per share. For the second quarter ending April 30, 2023 versus the same ending April 30, 2022:1
➢ Research & development expense was $3.9 million, up 52% from $2.5 million, attributed to increased clinical activity for the 46-subject Bria-IMT trial, increased wages and salaries, greater laboratory activity, including the hiring of additional employees, and higher supply usage. Spending on preclinical projects and Chemistry, Manufacturing and Control (CMC) was also significantly higher;
➢ General & administrative expenses totaled $1.8 million, down 21% from $2.3 million, due to a reduction in share-based compensation;
➢ Financial income totaled $782,000 with a positive change in warrant liability related to a decrease in the stock price over the measurement period;
➢ Net loss totaled ($4.9) million vs. ($4.8) million, which was a loss per share of ($0.32) in both periods.
As of April 30, 2023, cash and equivalents totaled $28.2 million compared to $41.0 million at the end of the fiscal year last July. Cash burn year to date totaled ($12.8) million. Financing cash flows were minimal and related to a small share and warrant buyback minimally offset by proceeds from warrant exercise.
BriaCell Gains Clearance for Bria-IMT Study Protocol
On June 27th 2023, BriaCell Therapeutics Corp. (NASDAQ:BCTX) announced that the protocol for its pivotal registrational trial for Bria-IMT in advanced metastatic breast cancer had been cleared by the FDA. Bria-IMT will be administered in combination with a checkpoint inhibitor in the active arm and compared against the control arm which will include treatment of the physician’s choice. The checkpoint inhibitor that will be used has not yet been determined. However, we expect to see that one of the previous checkpoints that have been evaluated with Bria-IMT will be used, as there is safety data related to each in combination with BriaCell’s drug. Both Incyte’s retifanlimab (Zynyz)2 and Merck’s Keytruda have been tested with Bria-IMT in clinical trials.
Final details for the pivotal trial have not yet been announced and include the number of subjects that will be enrolled and the checkpoint inhibitor that will be used. BriaCell is undertaking a statistical analysis that will identify the optimal study enrollment number. There are expected to be 100 sites in the US, Canada and potentially in Western Europe to accommodate the anticipated enrollees. Fast track status was granted by the FDA in April 2022. The status should increase the frequency of meetings between BriaCell and the FDA and open the door for other benefits including Accelerated Approval, Priority Review and Rolling Review if appropriate.
Based on management commentary, we expect the trial to begin enrollment this summer. Both enrollment and patient evaluation are expected to take approximately twelve months apiece suggesting that topline from the trial could be available by autumn 2025.
Prevail Partners Strategic Investment
BriaCell announced a strategic investment and clinical alliance with Prevail Partners and Prevail InfoWorks in May and followed up shortly after with a press release confirming receipt of a $4 million strategic investment from Prevail Partners. The relationship involves both a strategic investment fund (Prevail Partners) and a contract research organization (CRO) (Prevail InfoWorks).
Prevail Partners will purchase 463,408 BriaCell common shares at a price of $8.63, generating $4.0 million in process. The price is a 20% premium to the trailing 30-day volume-weighted average price (VWAP) prior to the transaction. Prevail InfoWorks will manage the upcoming pivotal trial for Bria-IMT in metastatic breast cancer. The Philadelphia, Pennsylvania-based CRO uses its Single Interface integrated real-time data analytics platform to provide clinical support and provide real-time data analysis.
Spinout of BriaPro Therapeutics Corp.
In a May 25th press release, BriaCell announced that it will spin out a new entity to be called BriaPro Therapeutics Corp. The new company will hold the intellectual property and development obligations for BriaCell’s preclinical assets: Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer.
Bria-TILsRx
Bria-TILsRx are being developed as potential immunotherapies for cancer. Bria-Pro features two TILsRx novel candidates which are multi-specific binding reagents designed to act as potent immune cell activators and/or immune checkpoint inhibitors. The assets are expected to selectively target and destroy cancer cells without harming normal (non-cancerous) cells. This mechanism may be associated with less severe side effects for the treated cancer patients compared with those of alternative therapies.
PKCδ
Protein kinase C delta (PKCδ), also called novel PKC, is associated with a number of diseases including cancer, cardiovascular diseases, neurodegenerative disorders and inflammation. PKCδ inhibitors have been shown to be effective treatments for several animal models of cancer and other diseases. The cytoplasmic enzyme plays a crucial role in cellular signaling pathways, particularly in regulating cell growth, differentiation, proliferation, and apoptosis. BriaPro’s highly selective PKCδ inhibitors may be developed as candidates for multiple disease indications including several tumor types.
In a March 30 press release, BriaCell first indicated its intention to spin out BriaPro’s preclinical assets. The new entity is expected to be majority-owned, controlled, and governed by BriaCell and owned by its shareholders of record who will receive equity shares. Management has identified “significant independent value” from these assets and will allow their development to proceed under a separate balance sheet and with its own focus.
Each BriaCell share will receive one BriaPro share, and BriaCell shareholders will initially comprise one-third of BriaPro ownership. BriaCell warrant and option holders will receive one BriaCell share and one BriaPro share upon exercise. The new company will become an unlisted reporting issuer in Canada after shareholder approval is granted in a vote that is expected to take place later in July.
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1. We provide comparative year over year analysis using information as originally reported. 2Q:22 was reported in a 6-K as a foreign issuer and fell under different accounting standards.
2. Zynyz (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. The Biologics License Application (BLA) for Zynyz was approved under accelerated approval by the U.S. FDA in March 2023.
3. Source: BriaCell Spring 2023 Corporate Presentation
