Third Quarter Fiscal Year 2022 Operational and Financial Results
On June 13th 2022, BriaCell Therapeutics Corp. (NASDAQ:BCTX) published third quarter fiscal year 2022 financial and operational results in its Form 6-K filing with the SEC.
Highlights for calendar year 2022 include:
➢ Results of 2022 Annual and Special Meeting of Shareholders – January 2022
➢ Buyback and insider buying update – February 2022
➢ Giuseppe Del Priore, M.D., MPH, appointed Chief Medical Officer – February 2022
➢ Alexander Kharazi, M.D., Ph.D., appointed to Scientific Advisory Board – February 2022
➢ Additional clinical trial sites added to accelerate patient enrollment – February/May 2022
➢ Establishment of Philadelphia Lab – 1H:22
➢ Bria-OTS presentation at AACR – April 2022
➢ Fast Track status granted to Bria-IMT – April 2022
BriaCell produced no revenues in the third quarter of fiscal year 2022 and incurred operating expense totaling ($4.8) million, yielding net loss of ($4.8) million, or ($0.32) per share.
For the third quarter ending April 30, 2022 versus the same ending April 30, 2021:
➢ Research & development expense was $2.5 million, up considerably from $1.1 million, attributed to the resumption of clinical trials and increased laboratory activity, including the hiring of additional employees;
➢ General & administrative expenses totaled $2.3 million, down from $3.7 million, due to expenses related to NASDAQ listing being recognized in the prior year period;
➢ Other income totaled $6,000 vs. $7.8 million, with prior year contributions attributable predominantly due to the change in fair value of a the warrant liability;
➢ Net loss totaled ($4.8) million vs. a $2.8 million gain, or ($0.32) and $0.63, respectively.
As of April 30, 2022, cash and equivalents totaled $44.5 million compared to $57.3 million at the end of the fiscal year last July. Cash used in operations was ($9.2) million for the first nine months of FY:22. Cash burn year to date totaled ($9.2) million. Financing cash flows consumed ($3.6) million and were dominated by share and warrant repurchase program outflows and repayment of a government grant partially offset by proceeds from exercise of warrants.
Phase I/IIa Bria-IMT + Retifanlimab + Epacadostat (NCT03328026)
BriaCell’s ongoing Phase I/IIa clinical trial is actively enrolling patients in advanced breast cancer which was discussed in our initiation. Updates on safety and efficacy are expected throughout 2022. The trial is investigating Bria-IMT in combination with Incyte’s checkpoint inhibitor retifanlimab and epacadostat. Fast track status was granted by the FDA in mid-April. The status should increase the frequency of meetings between BriaCell and the FDA and open the door for other programs including Accelerated Approval, Priority Review and Rolling Review if appropriate.
Four Clinical Trial Sites Added to Accelerate Patient Enrollment
On February 28th BriaCell announced that it had added two trial sites to support enrollment of its Phase I/IIa combination study and on May 18th two additional sites were added. Sites added included the Atlantic Health System, Tranquil Clinical Research, Hoag Memorial Hospital Presbyterian and Sylvester Comprehensive Cancer Center bringing the total number of sites to seven.1
Bria-IMT along with an anti-PD-1 antibody2 and IDO13 inhibitor epacadostat4 is being investigated using a combination approach in breast cancer patients that have failed two or more prior lines of therapy. The regimen includes a pre-dose of the chemotherapy cyclophosphamide and post-dose antiviral interferon-α2b. Late last year, 12 patients had been evaluated and additional patients have been added at the new sites announced. In a previous update, three of four patients with grade I/II tumors attained disease control. As highlighted in a December 2021 poster presentation at the San Antonio Breast Cancer Symposium, disease control was 33% in the combination study. Complete tumor reduction of selected tumors was observed in several patients, including those with two or more HLA matches with Bria-IMT and Grade I/II tumors. For the evaluable Grade I/II patients, disease control was seen in three of four patients in the combination study.
Manufacturing and release testing is underway and BriaCell expects to file the IND in the mid-summer timeframe. Bria-OTS is also working with the National Cancer Institute (NCI) on characterization of the product in the lab and is progressing as expected. The NCI project has a three year duration and expected to complete in October of 2023.
Giuseppe Del Priore, MD, MPH, Appointed Chief Medical Officer
On February 16, 2022, BriaCell announced that Giuseppe Del Priore, MD, MPH, had been appointed the company’s Chief Medical Officer. Dr. Del Priore will oversee the clinical and regulatory aspects of BriaCell’s active and upcoming clinical trials including the ongoing Phase I/IIa combination study. He is a seasoned healthcare executive with over 25 years of experience in research, drug development, and clinical trials management. Dr. Del Priore’s prior work experience includes serving as Chief Medical Officer, a National Director at the Cancer Treatment Centers of America (CTCA), as well as faculty at Indiana University School of Medicine, Weill Cornell Medicine, and New York University School of Medicine. He completed his MPH degree in Biostatistics and Epidemiology at the University of Illinois Chicago School of Public Health, his medical degree from The State University of New York and his BA in Philosophy at The City University of New York. Dr. Del Priore has undergone additional training at Memorial Sloan Kettering Cancer Center (MSKCC), The University of Chicago, Northwestern University, and the University of Rochester.
Alexander Kharazi, M.D., Ph.D., Appointed to Scientific Advisory Board
On February 23, 2022, BriaCell announced that Dr. Alexander Kharazi, co-inventor of Bria-IMT, was appointed to the company’s Scientific Advisory Board. Dr. Kharazi is Chief Technology Officer at Stemedica Cell Technologies, Inc. His experience includes roles as Chief Scientist of the Immunotherapy laboratory at St. Vincent Medical Center and Chief Pathologist of a large good laboratory practice (GLP) animal study at the UCLA, reporting results to the U.S. Congress. Additionally, he has worked as a Research Fellow in the department of Pathology at the Tokyo Metropolitan Institute of Gerontology. Dr. Kharazi earned his Ph.D. in immunology and his medical degree in internal medicine and pathology in Kiev, Ukraine.
➢ Bria-IMT End of Phase II meeting with FDA – 2H:22
➢ Presentation at AACR Bria-OTS NCI data – April 2023
➢ Completion of the Bria-OTS NCI project – October 2023
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1. Other sites include Mary Crowley Cancer Research Center, Dallas, Texas; Providence Medical Group, Santa Rosa, California; Cancer Center of Kansas, Wichita, Kansas
2. The trial has used Incyte/Macrogenics’ retifanlimab and Merck’s Keytruda in the role of PD-1 inhibitor.
3. IDO: indoleamine 2,3-dioxygenase
4. Epacadostat targets and binds to IDO1, an enzyme responsible for the oxidation of tryptophan into kynurenine. By inhibiting IDO1 and decreasing kynurenine in tumor cells, epacadostat increases and restores the proliferation and activation of various immune cells, including dendritic cells (DCs), NK cells, and T-lymphocytes, as well as interferon (IFN) production, and a reduction in tumor-associated regulatory T cells (Tregs). (Source: NIH Drug Dictionary)
5. BriaCell Investor Presentation Summer 2022
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8. BriaCell Investor Presentation Summer 2022