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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
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
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