Form 8-K - Current report

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): December 20, 2023

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 December 20, 2023, BriaCell Therapeutics Corp. (the “Company”) issued a press release announcing unprecedented preliminary survival and clinical benefit data in a new subset of advanced breast cancer patients treated with the Company’s Bria-IMT™ regimen.

A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

EXHIBIT INDEX

Exhibit		Description

99.1		Press Release.
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
December 20, 2023	William V. Williams
	President and Chief Executive Officer

Exhibit 99.1

BriaCell Reports Unprecedented Preliminary Survival and Clinical Benefit in

Antibody-Drug Conjugate (ADC) Refractory Patient Subset

●	In the subset of Antibody-Drug Conjugate (ADC) refractory patients, Overall Survival (OS) data of BriaCell’s combination regimen exceeded that of similar studies*
●	*Progression Free Survival (PFS) was similar or better than last regimen in 40% of the patients highlighting clinical efficacy*
●	*Disease control rate of 40% was observed in evaluable patients further indicating clinical benefit*

PHILADELPHIA, PA and VANCOUVER, British Columbia, December 20, 2023— 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 report unprecedented preliminary survival and clinical benefit data in a new subset of advanced breast cancer patients treated with BriaCell’s Bria-IMT™ regimen: patients that have developed resistance to (and failed to respond to) Antibody-Drug Conjugates (“ADC”, “ADCs”).

ADCs have significantly advanced cancer therapy in the past few years; however many patients experience serious side effects and others develop resistance to ADCs; therefore, their medical needs remain unmet.

“We are excited with our findings of unprecedented survival and clinical benefit in very difficult-to-treat patients who failed ADCs and view our findings as a significant clinical breakthrough in the field of cancer therapy. This is highly encouraging given our ongoing pivotal study is investigating the effects of Bria-IMT™ regimen in advanced breast cancer with overall survival as its primary endpoint,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Armed with our novel immunotherapy, we are hoping to make a meaningful contribution to the lives of patients who have failed ADCs across all breast cancer types.”

BriaCell Clinical Data in ADC Refractory Patients

Bria-IMT™ Combined with an Immune Check Point Inhibitor

●	In a subset of BriaCell’s ongoing Phase 2 study, clinical data of 23 advanced metastatic breast cancer patients who failed prior treatments with ADCs were analyzed. Four patients had prior treatments with KADCYLA®; 13 had prior treatments with ENHERTU®, 13 with TRODELVY®, of which 7 of these patients were treated with multiple agents (totaling 23 patients). In addition, 7 of these 23 patients had also failed prior treatment with immune checkpoint inhibitors.
●	Heavily pre-treated metastatic breast cancer patients had a median number of 6 prior treatments.
●	Kaplan-Meier analysis showed median overall survival (OS) that was up to twice that reported in the literature, with some patients recording survival of over a year.
●	Disease control rate of 40% was observed in evaluable patients further indicating clinical benefit.

●	Progression free survival (PFS) was similar or better than that of the patients’ prior therapy in 40% of patients, highlighting clinical benefit and tolerability of the Bria-IMT™ regimen.
●	17 of 23 patients remain alive as of today, suggesting efficacy, tolerability, and survival benefit of BriaCell’s Bria-IMT™ regimen. The data will continue to mature as patients remain on the study.
●	All patients received BriaCell’s therapy with no toxicity related discontinuations.
●	Importantly, there were no cases of Interstitial Lung Disease (ILD) with Bria-IMT™ – a well-documented serious side effect of ADCs.

* Laura Huppert et al., Multicenter retrospective cohort study of the sequential use of the antibody-drug conjugates (ADCs) trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in patients with HER2-low metastatic breast cancer (MBC) (PS08-04) - SABCS 2023

* François Poumeaud et al., Efficacy of Sacituzumab-Govitecan (SG) post Trastuzumab-deruxtecan (T-DXd) and vice versa for HER2low advanced or metastatic breast cancer (MBC): a French multicentre retrospective study. (PS08-02) - SABCS 2023

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 presented in today’s press release, 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.sedar.com 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

Director of Public Relations

CORE IR

917-885-7378

julesa@coreir.com

Investor Relations Contact:

CORE IR

investors@briacell.com

Cover	Dec. 20, 2023
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 20, 2023
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