# EDGAR Filing Document

**Accession Number:** 0001610820
**File Stem:** 0001493152-23-001731
**Filing Date:** 2023-1
**Character Count:** 10385
**Document Hash:** 59f88f5a8aa6fb321716157b36515bef
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-001731.hdr.sgml**: 20230118

**ACCESSION NUMBER**: 0001493152-23-001731

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230118

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230118

**DATE AS OF CHANGE**: 20230118

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** BriaCell Therapeutics Corp.
- **CENTRAL INDEX KEY:** 0001610820
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** A1
- **FISCAL YEAR END:** 0731

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40101
- **FILM NUMBER:** 23533031

**BUSINESS ADDRESS:**
- **STREET 1:** 3RD FLOOR, BELLEVUE CENTRE, 235-15TH STR
- **CITY:** WEST VANCOUVER
- **STATE:** A1
- **ZIP:** V7T 2X1
- **BUSINESS PHONE:** (604) 921-1810

**MAIL ADDRESS:**
- **STREET 1:** 3RD FLOOR, BELLEVUE CENTRE, 235-15TH STR
- **CITY:** WEST VANCOUVER
- **STATE:** A1
- **ZIP:** V7T 2X1

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Ansell Capital Corp.
- **DATE OF NAME CHANGE:** 20140613

?xml version="1.0" encoding="utf-8"?

**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 18, 2023

---

| |
|:---|
| **BRIACELL THERAPEUTICS CORP.** |
| (Exact name of registrant as specified in its charter) |

---

---

| | |
|:---|:---|
| **British Columbia** | **47-1099599** |
| (State or other jurisdiction<br> of incorporation or organization) | (I.R.S. Employer<br> Identification No.) |

---

---

| | |
|:---|:---|
| **Suite 300 - 235 15th Street**<br> **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 January 18, 2023, BriaCell Therapeutics Corp. (the "Company") issued a press release announcing that that it has received agreement and positive feedback from its End of Phase II meeting with the FDA regarding the Company's lead clinical candidate, Bria-IMT™, in combination with a checkpoint inhibitor in advanced metastatic breast cancer.

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.

**Item 9.01 Financial Statements and Exhibits**

**EXHIBIT INDEX**

<u>Exhibit</u> <u>Description</u> <br> 99.1 [Press Release dated January 18, 2023](ex99-1.htm) <br> 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* |
| January 18, 2023 | William V. Williams<br> President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**BriaCell Announces Positive End of Phase II Meeting with the FDA for Bria-IMT™ Combination in Advanced Metastatic Breast Cancer**

●  ***BriaCell has received agreement and positive feedback from its End of Phase II meeting with the FDA for lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor, in advanced metastatic breast cancer.*** 

●  ***After reviewing BriaCell's Fast Track designated Phase I* / *IIa data, the FDA has agreed on the primary end point, the essential elements of the pivotal registration study design, and type of patients to be included.*** 

●  ***Registration study success could lead to a Biologics License Application (BLA) submission and commercialization approvals for BriaCell's novel immunotherapy approach.*** 

 ****

PHILADELPHIA, PA and VANCOUVER, British Columbia, January 18, 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 agreement and positive feedback from its End of Phase II meeting with the FDA regarding BriaCell's lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer.

BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell's upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.

Registration study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.

"The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies," stated Dr. William V. Williams, BriaCell's President and CEO. "Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options."

**About BriaCell 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 <u>https://briacell.com/</u>.

**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. Examples of forward-looking statements in this news release include statements that the Company makes regarding to the Company upcoming pivotal clinical study and the potential for the Company to make a Biologics License Application for the approval of the combination regimen. 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 **<u>www.sedar.com</u>** and on EDGAR at **<u>www.sec.gov</u>**. 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

<u>info@briacell.com</u>

**Media Relations:**

Jules Abraham

Director of Public Relations

CORE IR

917-885-7378

<u>julesa@coreir.com</u>

**Investor Relations Contact:**

CORE IR

<u>investors@briacell.com</u>