BCTXW BriaCell Therapeutics Corporation

 

 

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 or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
Suite 300 - 235 15th Street West Vancouver, BC V7T 2X1		V7T 2X1
(Address of principal executive offices)		(Zip 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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement 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 Shares, no par value		BCTX		The Nasdaq Stock Market LLC
Warrants to purchase common shares, no par value		BCTXW		The 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 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 THERAPEUTICS CORP.
	/s/ William V. Williams
September 11, 2024	William V. Williams
	President and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

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/.

 

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 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.

 

Contact Information

 

Company Contact:

 

William V. Williams, MD

President & CEO

1-888-485-6340

info@briacell.com

 

Media Relations:

 

Jules Abraham

CORE IR

julesa@coreir.com

 

Investor Relations Contact:

 

CORE IR

investors@briacell.com

 

 

 

 

Exhibit 99.2

 

 

BriaCell Announces 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).

 

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 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.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.

 

Contact Information

 

Company Contact:

 

William V. Williams, MD

President & CEO

1-888-485-6340

info@briacell.com

 

Media Relations:

 

Jules Abraham

CORE IR

julesa@coreir.com

 

Investor Relations Contact:

 

CORE IR

investors@briacell.com

 

 

 

Exhibit 99.3

 

 

BriaCell Reports 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.

 

Table 1. Comparative Median Overall Survival (OS) and Progression-Free Survival (PFS) in Similar Patients (Interim Analysis Using Kaplan-Meier Estimate)

 

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 non-TNBC at initial diagnosis		5 (2-14)		76		6.7		2.3
O’Shaughnessy J. et. al. 3 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 A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. PMID: 38422473.
2.	Tripathy D, et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022;8(7):1047-1052. doi:10.1001/jamaoncol.2022.0514.
3.	O’Shaughnessy J et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646.

 

 

4.

Cortes J, Perez-Garcia J, Levy C, Gómez Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez N, Chao TC, Espié M, Nabholtz JM, Gonzàlez Farré X, Beliakouski V, Román García J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051. PMID: 29481630.

 

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 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.

 

Contact Information

 

Company Contact:

 

William V. Williams, MD

President & CEO

1-888-485-6340

info@briacell.com

 

Media Relations:

 

Jules Abraham

CORE IR

julesa@coreir.com

 

Investor Relations Contact:

 

CORE IR

investors@briacell.com

 

 

v3.24.2.u1

Cover	Sep. 09, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 09, 2024
Entity File Number	001-40101
Entity Registrant Name	BRIACELL THERAPEUTICS CORP.
Entity Central Index Key	0001610820
Entity Tax Identification Number	47-1099599
Entity Incorporation, State or Country Code	A1
Entity Address, Address Line One	Suite 300 - 235 15th Street
Entity Address, City or Town	West Vancouver
Entity Address, State or Province	BC
Entity Address, Postal Zip Code	V7T 2X1
City Area Code	(604)
Local Phone Number	921-1810
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Common Shares, no par value
Title of 12(b) Security	Common Shares, no par value
Trading Symbol	BCTX
Security Exchange Name	NASDAQ
Warrants to purchase common shares, no par value
Title of 12(b) Security	Warrants to purchase common shares, no par value
Trading Symbol	BCTXW
Security Exchange Name	NASDAQ

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