8-K
BriaCell Therapeutics Corp. (BCTX)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 9, 2024
BRIACELL
THERAPEUTICS CORP.
(Exact name of registrant as specified in its charter)
| British Columbia | 47-1099599 |
|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation or organization) | (I.R.S.<br> Employer<br><br> <br>Identification<br> No.) |
| Suite 300 - 235 15th Street<br><br> <br>West Vancouver, BC V7T 2X1 | V7T 2X1 |
| (Address<br> of principal executive offices) | (Zip<br> Code) |
(604) 921-1810
(Registrant’s telephone number, including area code)
Commission
File No. 001-40101
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered under Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common<br> Shares, no par value | BCTX | The<br> Nasdaq Stock Market LLC |
| Warrants<br> to purchase common shares, no par value | BCTXW | The<br> Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On September 9, 2024, BriaCell Therapeutics Corp. (the “Company”) issued a press release announcing a poster presentation at the Society for Immunotherapy of Cancer 39th Annual Meeting, held November 6-10, 2024, in Houston, TX. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
On September 10, 2024, the Company issued a press release announcing positive outcomes from its pre-investigational new drug meeting with the U.S. Food and Drug Administration. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated by reference herein.
On September 11, 2024, the Company issued a press release announcing positive overall survival data in a six-month update of its Phase 2 clinical study of Bria-IMT™ in combination with an immune check point inhibitor in late stage metastatic breast cancer. A copy of the press release is attached hereto as Exhibit 99.3 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated September 9, 2024. |
| 99.2 | Press Release, dated September 10, 2024. |
| 99.3 | Press Release, dated September 11, 2024. |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BRIACELL<br> THERAPEUTICS CORP. | |
|---|---|
| /s/ William V. Williams | |
| September<br> 11, 2024 | William<br> V. Williams |
| President<br> and Chief Executive Officer |
Exhibit99.1
BriaCell Announces Presentation at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 09, 2024 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces a poster presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, held November 6-10, 2024, in Houston, TX.
“We are thrilled to be invited to present our data at this prestigious conference,” stated Miguel Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. “We look forward to continuing our investigations of novel targeted immunotherapy candidates in clinical studies with the goal of making a positive contribution to the lives of breast cancer and prostate cancer patients.”
The details about the presentation and session Information are as follows:
**Location:**Exhibit Halls A B George R. Brown Convention Center, Houston, TX
Date and Time: Friday, Nov. 8, 2024, 9:00 am -7:00 pm CST
Following the presentation, a copy of the poster will be posted on https://briacell.com/scientific-publications/.
AboutBriaCell 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/.
SafeHarbor
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 about BriaCell continuing its clinical study investigations of its novel targeted immunotherapy candidates, 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, such as those 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.sedarplus.ca 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.
ContactInformation
CompanyContact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
MediaRelations:
Jules Abraham
CORE IR
julesa@coreir.com
InvestorRelations Contact:
CORE IR
investors@briacell.com
Exhibit99.2
BriaCellAnnounces Positive Pre-IND Meeting with FDA for Bria-PROS+™ for Prostate Cancer
| ● | BriaCell has received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+™ in prostate cancer |
|---|---|
| ● | The meeting provides a clear path towards filing an IND and conducting a Phase 1/2 study of Bria-PROS+™ |
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 10, 2024 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce that it has received positive feedback from its Pre-IND meeting with the U.S. Food and Drug Administration (FDA), which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+™, in advanced prostate cancer.
“We were truly impressed by the FDA team of experts’ keen interest in Bria-PROS+™ as a potential novel personalized approach for advanced prostate cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Despite numerous approved drugs, prostate cancer remains the second-leading cause of cancer death in American men. We view the FDA’s positive feedback as a major step forward in the clinical development of our Bria-PROS+™ and in our efforts to bring hope to patients and families suffering from this deadly disease.”
As a result of the Pre-IND meeting, FDA waived the animal toxicology and animal pharmacokinetic (PK) studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+™. Other areas of discussion included BriaCell’s plan to initiate the Phase 1/2 study pending completion of standard manufacturing and testing requirements. These interactions also inform the further development of the proprietary Bria-OTS+™ platform as the company pursues the development of Bria-BRES+™, Bria-LUNG+™ and Bria-MEL+™, for breast cancer, lung cancer and melanoma, respectively.
BriaCell is currently evaluating its personalized immunotherapy Bria-BRES™ in a phase 1/2a study in metastatic breast cancer (ClinicalTrials.gov NCT06471673).
AboutBriaCell 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/.
SafeHarbor
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 statements about the Company’s belief of the therapeutic potential of Bria-PROS+™’s as a safe and effective treatment for prostate cancer patients, 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.sedarplus.caand 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.
ContactInformation
CompanyContact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
MediaRelations:
Jules Abraham
CORE IR
julesa@coreir.com
InvestorRelations Contact:
CORE IR
investors@briacell.com
Exhibit99.3
BriaCellReports Positive Overall Survival (OS) in Metastatic Breast Cancer
| ● | Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitor |
|---|---|
| ● | OS of 15.6 months compares favorably with 6.7-9.3 months reported for similar patients in the literature |
| ● | Ongoing Phase 3 study investigating Bria-IMT™ in similar metastatic breast cancer population |
| ● | No drug related discontinuations to date |
PHILADELPHIA, PA and VANCOUVER, BC, September 11, 2024— BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce positive overall survival data of its Phase 2 clinical study of Bria-IMT™ in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer.
Median overall survival of 15.6 months is reported in BriaCell’s most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). These patients are being treated with the same Bria-IMT™ formulation currently being used in BriaCell’s ongoing Phase 3 pivotal study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612) and represent patients enrolled post-COVID when full study activities resumed.
This represents a substantial improvement over BriaCell’s 13.4 months median overall survival previously reported in December 2023.
“Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor,” stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutch Cancer Center and University of Washington and BriaCell medical advisory board member. “The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints.”
“We wanted to look at the Phase 2 data of those patients who most closely resemble the patients being treated in our ongoing phase 3 study and compare them to similar patients in the literature,” stated Dr. William V. Williams, BriaCell’s President and CEO. “The nearly two-fold overall survival benefit we are seeing with the Bria-IMT™ regimen, together with the similar previously reported approximate doubling of progression free survival, compared with literature controls, strongly support our belief that Bria-IMT™ could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients. We look forward to further clinical development of Bria-IMT™ with the goal of establishing it as a new standard of care for patients with metastatic breast cancer.”
“The Bria-IMT™ regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments including immune check point inhibitors and antibody drug conjugates,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “These survival and clinical benefit data support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and drive the ongoing pivotal study of our combination regimen in the treatment of metastatic breast cancer.”
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6) who were treated with the Bria-IMT™ regimen and an immune checkpoint inhibitor. Of these 54 patients, 37 were treated with the Phase 3 formulation and 25 of these were treated post-COVID when full study activities resumed. This data represents an additional six months of follow-up of the survival data presented at the San Antonio Breast Cancer Symposium in December 2023.
Table1. Comparative Median Overall Survival (OS) and Progression-Free Survival (PFS) in Similar Patients (Interim Analysis Using Kaplan-MeierEstimate)
| Study | Prior Lines of Therapy (median, range) | Number of Patients | OS (months) | PFS (months) |
|---|---|---|---|---|
| BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (since 2022) | 5.5 (2-13) | 25 | 15.6 | 4.1 |
| BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (total) | 6 (2-13) | 37 | 13.4 | 3.9 |
| Bardia, A. et. al. ^1^(TNBC) | 4 (2-14) | 262 | 6.9 | 1.7 |
| Tripathy D. et. al. ^2^(Brain metastases) | ≥4 in 91% | 178 | 7.5-7.8 | 1.9-2.8 |
| O’Shaughnessy J. et. al. ^3^<br><br> <br>non-TNBC at initial diagnosis | 5 (2-14) | 76 | 6.7 | 2.3 |
| O’Shaughnessy J. et. al. ^3^<br><br> <br>TNBC at initial diagnosis | 4 (2-10) | 157 | 6.9 | 1.6 |
| Cortes et. al. ^4^ | 4 (0-13) | 594 | 9.1-9.3 | 1.9-2.5 |
References
| 1. | Bardia<br> A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic<br> Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor<br> Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744.<br> doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. PMID: 38422473. |
|---|---|
| 2. | Tripathy<br> D, et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and<br> brain metastases: final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol.<br> 2022;8(7):1047-1052. doi:10.1001/jamaoncol.2022.0514. |
| 3. | O’Shaughnessy<br> J et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis<br> in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative<br> breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7.<br> Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646. |
| 4. | Cortes<br> J, Perez-Garcia J, Levy C, Gómez Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez<br> N, Chao TC, Espié M, Nabholtz JM, Gonzàlez Farré X, Beliakouski V, Román<br> García J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine<br> versus an alkylating agent in patients with heavily pretreated metastatic breast cancer.<br> Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051. PMID: 29481630. |
| --- | --- |
AboutBriaCell 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/.
SafeHarbor
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 statements about: the impact of Bria-IMT™ on patients with metastatic breast cancer; BriaCell’s further clinical development of Bria-IMT™; and the efficacy of immune check point inhibitors, 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.sedarplus.ca 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.
ContactInformation
CompanyContact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
MediaRelations:
Jules Abraham
CORE IR
julesa@coreir.com
InvestorRelations Contact:
CORE IR
investors@briacell.com