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): November 30, 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 7.01 Regulation FD Disclosure

On November 30, 2023, BriaCell Therapeutics Corp. (the “Company”) issued a press release announcing a new remarkable responder in the Company’s Phase 2 study of the Bria-IMT™ combination regimen.

In the same press release, the Company also announced that additional survival updates and clinical data sets on the entire Phase 2 study cohort will be presented at the San Antonio Breast Cancer Symposium on December 6-December 7, 2023.

The press release is attached hereto as Exhibit 99.1.

The information in this Item 7.01 and Item 9.01 (including Exhibit 99.1), is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, amended (the “Securities Act”). In addition, the information in this Item 7.01 disclosure, including Exhibit 99.1, shall not be incorporated by reference into the filings of the Company under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits

EXHIBIT INDEX

Exhibit		Description
99.1		Press Release dated November 30, 2023
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
November 30, 2023	William V. Williams
	President and Chief Executive Officer

Exhibit 99.1

BriaCell Records New Responder with Remarkable Improvement of “Eye-Bulging” Metastatic Tumor

●	*After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye.*
●	*Significant ocular pain reduction recorded.*
●	*Heavily treated patient had 7 prior failed regimens*.
●	*The patient continues to receive treatment.*

PHILADELPHIA, PA and VANCOUVER, British Columbia, November 30, 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 thrilled to announce a new remarkable responder in our Phase 2 study of the Bria-IMT™ combination regimen. BriaCell’s clinical team reported a patient with extensive metastatic breast cancer who had failed all available therapies. The patient had cancer behind the eye, causing proptosis (eye-bulging) and significant pain that were both resolved with BriaCell’s treatment.

Additional survival updates and clinical data sets on the entire Phase 2 study cohort will be presented at the San Antonio Breast Cancer Symposium on December 6th and 7th, 2023.

“Responses like this are not often seen in heavily pretreated patients and are especially rare in metastatic disease to the eye,” stated Carmen Calfa, M.D., Clinical Research Lead for the breast site disease group at the University of Miami Miller School of Medicine, Co-Director of the Cancer Survivorship Program at Sylvester Comprehensive Cancer Center, and Principal Clinical Investigator of the Phase 2 Bria-IMT™ study. “We were excited to offer her the latest treatments and thrilled to share in her success and joy.”

The noted responder, a post-menopausal metastatic breast cancer patient (the “Remarkable Responder”), experienced a remarkable improvement of proptosis caused by breast cancer tumors behind the eye, resulting in significant pain reduction in the ocular region. Her disease is characterized as positive for hormone receptor and 3+ for HER2. The woman had extensive metastatic disease (i.e. breast cancer tumors that have migrated to other areas of the body) including the bones of the spine, pelvis, sternum, the skull, and face, which included proptosis of the right eye from which the patient was clinically blind in that eye.

The patient was heavily pre-treated (7 prior regimens) highlighting the remarkable nature of her response on BriaCell’s treatment despite her very advanced cancer stage. Her last disease progression was recorded in August 2023. The patient started on BriaCell’s Bria-IMT™ combination therapy on October 4, 2023 and has received only 3 cycles of therapy. The Bria-IMT™ combination regimen has been well tolerated and the patient remains on treatment.

BriaCell had previously reported a similar case of a remarkable response with 100% resolution of an eye-bulging orbital tumor (release here). This particular patient had received (and failed) 12 regimens with 16 agents (incl. 13 chemotherapies) prior to BriaCell’s treatment, again adding to the remarkable nature of her response.

“We are reporting remarkable clinical responses in patients who were previously thought untreatable, suggesting effectiveness in difficult-to-reach tumors such as those in the bones and the brain,” said Dr. William V. Williams, BriaCell’s President and CEO. “We hypothesize that our Bria-IMT™ regimen may cross the blood brain barrier to treat these difficult-to-reach areas, such as the brain, which continues to increase our excitement for our novel cancer immunotherapy. We have seen several patients with central nervous system metastases respond to our therapy and are looking forward to further investigating this unique observation in our pivotal Phase 3 study of Bria-IMT™ combination therapy in advanced metastatic breast cancer.”

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: the presentation of additional survival updates and clinical data sets on the entire Phase 2 study cohort at the San Antonio Breast Cancer Symposium on December 6th and 7th, 2023; whether the remarkable responder patient will remain on the treatment; the potential effectiveness of BriaCell’s treatment, including for difficult-to-reach tumors such as those in the bones and the brain; and whether the Bria-IMT™ regimen may cross the blood brain barrier to treat these difficult-to-reach areas, such as the brain; 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	Nov. 30, 2023
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 30, 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
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