8-K
BriaCell Therapeutics Corp. (BCTX)
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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): January 10, 2023
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. ☐
Item7.01 Regulation FD Disclosure.
On January 10, 2023, BriaCell Therapeutics Corp. (the “Company”) issued a press release announcing that the United States Patent and Trademark Office has provided the Company with an Issue Notification for Patent Application no. 16/110,317, “Whole-cell cancer vaccines and methods for selection thereof,” covering the composition of matter and method of use of the Company’s personalized off-the-shell cell-based immunotherapy for cancer (the “Immunotherapy”). Once issued, the resulting patent, U.S. Patent No. 11,559,574, will provide intellectual property protection for the Immunotherapy from January 24, 2023, through May 25, 2040. The Company simultaneously revealed that it was awarded Australian Patent no. 2017224232, which provides intellectual property protection for the Immunotherapy through February 27, 2037.
The Company further disclosed that it has received guidance from the FDA regarding the development of cells and final cell-bank testing for the Company’s Bria-OTS™ clinical-grade cell lines. Once completed in accordance with FDA’s requirements, the Company expects to initiate the Bria-OTS™ study under an Investigational New Drug Application (IND) in the first half of 2023.
Finally, the Company announced that it had added the Carle Cancer Institute and the American Oncology Network, LLC, as additional sites for the screening and enrollment of advanced breast cancer patients in the randomized Phase II study of BriaCell’s lead candidate, Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab.
A copy of the press release is attached as Exhibit 99.1.
The information in this Item 7.01 disclosure, 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. 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 of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item9.01 Financial Statements and Exhibits
EXHIBIT
INDEX
| Exhibit | Description |
|---|---|
| 99.1 | Press Release dated January 10, 2023 |
| 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 | |
| January<br> 10, 2023 | William<br> V. Williams<br><br> <br>President<br> and Chief Executive Officer |
Exhibit99.1
BriaCellAnnounces New Patent Issuance, Bria-OTS™ IND Timing Guidance, and Additional Clinical Sites to Boost Enrolment
| ● | BriaCell’s new patent protects its novel personalized off-the-shelf cell-based technology for breast cancer and multiple other cancer indications until 2040. |
|---|---|
| ● | BriaCell expects to initiate its Bria-OTS™ clinical study under an Investigational New Drug Application (IND) in the first half of 2023, in accordance with FDA guidance. |
| ● | Two additional clinical sites are now active in Phase II Bria-IMT™ study to broaden patient access: Carle Cancer Institute in Urbana, Illinois and the American Oncology Network, LLC (AON) in Baltimore, Maryland. |
PHILADELPHIA, PA and VANCOUVER, British Columbia, January 10, 2023— BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is pleased to announce that it has received an Issue Notification from the United States Patent and Trademark Office for the composition of matter and method of use of its personalized off-the-shelf cell-based immunotherapy for cancer. The patent will issue on January 24, 2023 as US Patent No. 11,559,574 with the term extending to May 25, 2040. Additionally, BriaCell was awarded an Australian patent (Patent No. 2017224232, extends to February 27, 2037) covering composition of matter and method of use for its whole-cell cancer immunotherapy technology in Australia.
“We are extremely excited with the new patent for our novel personalized off-the-shelf cancer immunotherapy technology, which provides patent protection for the Bria-OTS™ immunotherapy cell lines under development and further validates and extends our whole-cell cancer immunotherapy technology. This is particularly important because the patent protection is not for one single type of cancer, but rather applies to multiple cancer indications,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Unlike other personalized treatments in the marketplace and under development, our pre-made personalized cancer immunotherapies would allow more rapid treatments and may significantly extend the lives of late-stage cancer patients. We are working diligently to efficiently develop our personalized off-the-shelf immunotherapies for multiple cancers to bring hope to many late-stage cancer patients with no other treatment options.”
IntellectualProperty: US Patent No. 11,559,574, titled “Whole-cell cancer vaccines and methods for selection thereof,” will issue on January 24, 2023, and covers the composition of matter and method of use of BriaCell’s personalized off-the-shelf whole-cell immunotherapies. The novel technology involves the development of several HLA specific whole-cell immunotherapies in advance, and selection of the appropriate off-the-shelf (i.e. pre-made) immunotherapies for each patient (i.e. personalized therapy) based on the patient’s HLA type using a fast and easy saliva test. Once issued, the patent will provide intellectual property protection through May 25, 2040, and a patent term extension under Hatch-Waxman potentially applies (which would extend such protection for an additional five years).
Additionally, BriaCell was awarded Australian Patent No. 2017224232, titled “Whole-cell cancer vaccines and methods for selection thereof,” for claims covering composition of matter and method of use for BriaCell’s whole-cell immunotherapy for cancer in Australia.
BriaCell currently holds multiple issued patents and pending patent applications to cover its whole-cell immunotherapy’s composition of matter and method of use worldwide. For a summary of BriaCell’s issued patents, please visit https://briacell.com/patents/.
Bria-OTS™Program Timelines: FDA has provided guidance regarding the development of cells and final cell-bank testing for BriaCell’s Bria-OTS™ clinical-grade cell lines. Once completed in accordance with FDA’s requirements, BriaCell expects to initiate the Bria-OTS™ study under an Investigational New Drug Application (IND) in the first half of 2023.
AdditionalClinical Sites: BriaCell is pleased to announce that it has added Carle Cancer Institute, Urbana, Illinois, and the American Oncology Network, LLC (AON), Baltimore, Maryland, as two additional clinical sites for the screening and enrollment of advanced breast cancer patients in the randomized Phase II study of BriaCell’s lead candidate, Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab.
The following clinical sites are actively enrolling patients for BriaCell’s ongoing Phase II combination study:
| ● | Carle<br> Cancer Institute, Urbana, Illinois |
|---|---|
| ● | American<br> Oncology Network, LLC (AON), Baltimore, Maryland |
| ● | Mayo<br> Clinic, Jacksonville, Florida |
| ● | Hoag,<br> Newport Beach, California |
| ● | Sylvester<br> Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, Miami, Florida |
| ● | Atlantic<br> Health System, Morristown and Overlook Hospitals, Morristown and Summit, New Jersey |
| ● | Tranquil<br> Clinical Research, Webster, Texas |
| ● | Mary<br> Crowley Cancer Research center, Dallas, Texas |
| ● | Providence<br> Medical Group, Santa Rosa, California |
| ● | Cancer<br> Center of Kansas, Wichita, Kansas |
AboutBriaCell Therapeutics Corp.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. 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. Examples of forward-looking statements in this news release include statements that the Company makes regarding the initiation of the Company’s Bria-OTS™ clinical study under an Investigational New Drug Application in the first half of 2023; the ability to treat patients more rapidly with pre-made personalized immunotherapies; the potential ability to significantly improve survival outcomes in late-stage cancer patients; and the potential patent term extension under Hatch-Waxman. Forward-looking statements 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.
ContactInformation
CompanyContact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
MediaRelations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
InvestorRelations Contact:
CORE IR
investors@briacell.com