BriaCell Announces Intention to Spin-Out Certain Pre-Clinical Assets into a Newly Created "SpinCo" Entity whereby Shareholders to Receive One New Share of "SpinCo" in Addition to Each Current Share of BriaCell Already Held

BriaCell Announces Intention to Spin-Out Certain Pre-Clinical Assets into a Newly Created "SpinCo" Entity whereby Shareholders to Receive One New Share of "SpinCo" in Addition to Each Current Share of BriaCell Already Held

  • SpinCo Assets (SpinCo) includes Bria-TILsRx™, and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer.
  • SpinCo's goal is to potentially accelerate the development of its assets, and to create value.

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces today that its Board of Directors has unanimously approved a potential reorganization (the "Transaction") that would result in the spin-out of certain pre-clinical pipeline assets of the Company, specifically Bria-TILsRx™, and PKCδ inhibitors for multiple indications including cancer (collectively, the "SpinCo Assets") to an unlisted corporation to own the SpinCo Assets ("SpinCo"). On closing of the Transaction, it is anticipated that the SpinCo Assets will be majority-owned, controlled, and governed by BriaCell and owned by BriaCell shareholders of record who will receive SpinCo Shares as defined herein.

Dr. William V. Williams, BriaCell's President and CEO stated, "Housing the SpinCo Assets in a new corporate structure would be beneficial to both BriaCell shareholders and SpinCo shareholders as we believe there is significant independent value to be had from these assets. Developing them under a separate entity allows us to unlock the development potential of the SpinCo Assets as novel treatments for multiple diseases under a separate balance sheet, allowing for maximizing both entities to maintain their focus, while providing our shareholders the opportunity to own shares in both companies."

On closing of the Transaction, it is expected that each share of BriaCell will be exchanged for one new share of the post-Transaction Company and one common share of SpinCo (a "SpinCo Share"). SpinCo Shares issued to BriaCell shareholders will comprise 33.33% ownership of SpinCo Shares upon closing of the Transaction. BriaCell shareholders who receive SpinCo Shares will ultimately own shares in both companies: BriaCell, which will continue with its mission to develop targeted immunotherapies for cancer, and SpinCo, which will focus on the development of the SpinCo Assets. SpinCo may seek funding subsequent to the closing of the Transaction and will intend to use the majority of the proceeds to advance the development of the SpinCo Assets.

It is anticipated that the SpinCo Shares will be issued to BriaCell shareholders by way of a plan of arrangement under the Business Corporations Act (British Columbia) (the "Act"). BriaCell will retain SpinCo Shares representing 66.67% ownership of SpinCo. It is intended that SpinCo will be managed by Dr. William V. Williams, as President and CEO, and Mr. Gadi Levin, as CFO. SpinCo's board of directors will consist of, BriaCell's current board of directors' members including Dr. William V. Williams, Mr. Martin E. Schmieg, and Dr. Jane A. Gross.

Following the Transaction, BriaCell will remain listed on both the NASDAQ Stock Market and Toronto Stock Exchange, and SpinCo will become an unlisted reporting issuer in Canada.

The Transaction will be implemented by way of a court approved plan of arrangement under the Act. The Transaction will require the approval of: (i) 66.67% of the votes cast by the holders of BriaCell's shares; and, if required, (ii) a simple majority of the votes cast by holders of BriaCell's shares after excluding votes from certain shareholders as required under Multinational Instrument 61-101 – Protection of Minority Security Holders in Special Transactions , at a special meeting of BriaCell's shareholders to be held to consider the Transaction (the "Meeting"). In addition to shareholder approval, the Transaction is also subject to the receipt of court approval and other customary closing conditions for transactions of this nature.

Additional details of the Transaction will be included in an information circular to be mailed to shareholders of BriaCell in connection with the Meeting. Bennett Jones LLP is acting as Canadian legal advisor to the Company. Sichenzia Ross Ference LLP is acting as US legal advisor to the Company.

Strategic Rationale for the Transaction

BriaCell believes that the Transaction will increase shareholder value by allowing capital markets to ascribe value to the SpinCo Assets independently of BriaCell's core immunotherapy assets. SpinCo will provide an opportunity for SpinCo Assets to be funded and developed on their own.

About the SpinCo Assets

PKCδ Inhibitor: Therapeutics for multiple disease indications including cancer

PKCδ, also called novel PKC, has been associated with a number of diseases including cancer.

Selective inhibitors of PKCδ, have been shown to be effective treatments for several animal models of cancer and other diseases. SpinCo's novel and highly selective PKCδ inhibitors may be developed as candidates for multiple disease indications including several tumor types.

Bria-TILsRx™: Multi-Specific Binding Reagents - Immunotherapies for Cancer

Developed as potential immunotherapies for cancer, SpinCo's two novel Bria-TILsRx™s are multi-specific binding reagents designed to act as potent immune cell activators and/or immune checkpoint inhibitors. They are expected to selectively target and destroy cancer cells without harming normal (non-cancerous) cells. This may mean less severe side effects for the treated cancer patients compared with those of alternative therapies.

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 https://briacell.com/ .

Safe Harbor

The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company and SpinCo, including, but not limited to, statements with respect to future events or future performance, the completion and structure of the Transaction, anticipated shareholder, court and regulatory approvals and the realization of the anticipated benefits by any entity from the Transaction. 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 are based on the Company'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.

None of the securities to be issued pursuant to the Transaction have been or will be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and any securities issuable in the Transaction are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act and applicable exemptions under state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.
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


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

BCT:CA
The Conversation (0)
BriaCell Partners with New York Cancer & Blood Specialists  for Pivotal Phase 3 Study of Bria-IMT in Advanced Breast Cancer

BriaCell Partners with New York Cancer & Blood Specialists for Pivotal Phase 3 Study of Bria-IMT in Advanced Breast Cancer

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 announce a partnership with New York Cancer & Blood Specialists (NYCBS), a group of leading community cancer centers in the United States, to evaluate the Bria-IMT™ combination with a checkpoint inhibitor in its pivotal Phase 3 registration study in advanced breast cancer patients in New York.

"Cancer is complex. It takes a village to care for a cancer patient. At NYCBS, our mission is to offer cancer patients access to state-of-the-art treatments close to their homes, families, and support networks at convenient locations across Long Island, New York City, and Upstate New York," stated Dr. Jeffrey Vacirca, CEO of NYCBS. "We were impressed with the survival data of the Bria-IMT™ regimen to date and look forward to working with the BriaCell team to make these novel therapeutics available to our patients."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
BriaCell Initiates Pivotal Phase 3 Study of Bria-IMT in Advanced Metastatic Breast Cancer

BriaCell Initiates Pivotal Phase 3 Study of Bria-IMT in Advanced Metastatic Breast Cancer

  • The randomized pivotal Phase 3 study is expected to enroll a total of 354 patients in either Bria-IMT™ combination or physician's choice therapy (1:1)
  • Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™
  • The study's primary endpoint is overall survival in patients treated with the Bria-IMT™ combination regimen versus those treated with physician's choice
  • The study initiation follows FDA Fast Track designation and earlier supportive Phase 2 safety and efficacy data in the same patient population

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, today announces that its registration-enabling pivotal Phase 3 study of its lead clinical candidate, Bria-IMT™, in combination with an immune check point inhibitor, is fully approved by the Institutional Review Board (IRB) and will soon enroll patients with advanced metastatic breast cancer.

"Timely initiation of our pivotal study is a key milestone for us further confirming our expedited timeline for FDA approval of our immunotherapy," stated Dr. William V. Williams, BriaCell's President and CEO. "Based on our recently announced benchmark beating survival data, we strongly believe that our novel immunotherapy may transform the way we treat advanced metastatic breast cancer patients, and we look forward to sharing additional development milestones in the coming months."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
BriaCell Reports Benchmark-Beating Patient Survival and Clinical Benefit in Advanced Metastatic Breast Cancer

BriaCell Reports Benchmark-Beating Patient Survival and Clinical Benefit in Advanced Metastatic Breast Cancer

  • Median overall survival of 13.5 months in BriaCell's advanced metastatic breast cancer patients (vs. 6.7-9.8 months for similar patients reported in the literature)
  • 21 out of 29 patients treated since 2022 are still alive suggesting a strong survival benefit for BriaCell's combination regimen
  • No dose limiting toxicities to date

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, today announces the completion of patient enrollment in its Phase 2 clinical study and reports clinical data showing strong patient survival benefit and clinical benefit in advanced metastatic breast cancer patients.

"The promising survival data of BriaCell's combination regimen suggests the potential for an industry-shaping leap in advanced metastatic breast cancer treatment," stated Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, and Principal Clinical Investigator of the Phase 2 Bria-IMT™ plus check point inhibitors study. "The overall safety profile and survival data in advanced metastatic breast cancer is extremely encouraging in this heavily pre-treated patient population."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
BriaCell Therapeutics Corp. Announces Closing of Plan of Arrangement Spinning Out BriaPro Therapeutics Corp. to Existing Shareholders

BriaCell Therapeutics Corp. Announces Closing of Plan of Arrangement Spinning Out BriaPro Therapeutics Corp. to Existing Shareholders

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, today announces that the Company has closed the previously announced plan of arrangement spinout transaction (the " Arrangement ") pursuant to which certain pipeline assets of the Company, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the " SpinCo Assets "), were spun-out to BriaPro Therapeutics Corp. (" SpinCo "), resulting in a 23 rd owned subsidiary of the Company with the remaining 13 rd held by BriaCell shareholders (" BriaCell Shareholders ").

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
BriaCell Accepts Letter of Intent from Weill Cornell Medicine Outlining Plans to Initiate a Clinical Trial of Bria-IMT in High-Risk Early-Stage Triple Negative Breast Cancer

BriaCell Accepts Letter of Intent from Weill Cornell Medicine Outlining Plans to Initiate a Clinical Trial of Bria-IMT in High-Risk Early-Stage Triple Negative Breast Cancer

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, announces that it has accepted a letter of intent from Dr. Massimo Cristofanilli, Director of Breast Medical Oncology and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties' plans and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell's novel immunotherapy, Bria-IMT™, in combination with a check point inhibitor (CPI), in early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC) patients in the neoadjuvant setting.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Top 5 Life Science ETFs in 2024

Top 5 Life Science ETFs in 2024

Taking a position in a life science exchange-traded fund (ETF) provides exposure to a basket of stocks focused on the healthcare sector, while mitigating the risks of holding shares in a single company.

While ETFs provide diversification by their nature, fund managers often narrow down their offerings to follow a specific aspect of the market — for example, biotech or pharma. They also typically adjust the weight of ETF holdings to match movements in the life science industry in an effort to give investors the best possible returns.

There are many choices when it comes to life science ETFs, and to help investors understand their options, the Investing News Network has listed the top life science ETFs by year-on-year performance.

Keep reading...Show less
Radiopharm Theranostics

Australian Ethics Committee Approval to Expand PD-L1 Nanobody (RAD204) Phase 1 Trial in Multiple Tumor Types

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce it has been granted Human Research Ethics Committee (HREC) approval to include participants with Programmed Death-Ligand 1 (PD-L1) positive Small Cell Lung Cancer (SCLC), Triple Negative Breast Cancer (TNBC), Melanoma, Head and Neck Cancer (HNSCC), and Endometrial Cancer, as part of its ongoing Phase 1 clinical trial of 177Lu-labelled RAD204 for the treatment of PD-L1 expressing cancers.
Keep reading...Show less
Cardiol Therapeutics' Phase II MAvERIC-Pilot Clinical Results in Recurrent Pericarditis Presented at the American Heart Association Scientific Sessions 2024

Cardiol Therapeutics' Phase II MAvERIC-Pilot Clinical Results in Recurrent Pericarditis Presented at the American Heart Association Scientific Sessions 2024

Marked and rapid reductions in both pericarditis pain and inflammation
maintained throughout the 26-week study

Episodes of pericarditis per year substantially reduced

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Radiopharm Theranostics (ASX:RAD)

Radiopharm Theranostics CEO Shares Company Milestones as NASDAQ Listing Nears

Description

During a fireside chat with analysts from Brookline Capital Markets, Radiopharm Theranostics’ (ASX:RAD) CEO Riccardo Canevari provided clinical and corporate updates highlighting the company’s achievements while waiting for the completion of its listing on the NASDAQ expected at the end of 2024.

Keep reading...Show less
Radiopharm Theranostics

68Ga-RAD 301 (68Ga-Trivehexin) Demonstrates Strong Potential for Imaging of αvβ6-Integrin Expression in Pancreatic Cancer Patients

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that a clinical study featuring 68Ga-Trivehexin (68Ga-RAD 301), conducted by Dr. Rehm and colleagues from the Technische Universität Dresden, has now been published in Frontiers in Nuclear Medicine.

Keep reading...Show less

AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024

MITIGATE Phase 3 Study Results Reinforce Promise of UPLIZNA ®   as the First Potential Treatment tor IgG4-RD

Phase 4 AGILE Data Support Shortening KRYSTEXXA ® Infusion Time

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×