BriaCell Therapeutics Announces Closing of $5.5 Million Public Offering

On December 13, 2024 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, reported the closing of its previously announced underwritten public offering of 7,400,000 common shares and warrants to purchase 7,400,000 common shares at a combined public offering price of $0.75 per share and associated warrant (Press release, BriaCell Therapeutics, DEC 13, 2024, View Source [SID1234649128]). The warrants have an exercise price of $0.9375 per share and are immediately exercisable upon issuance for a period of five years following the date of issuance. Total gross proceeds from the offering, before deducting the underwriter’s discounts and other offering expenses, is $5.55 million.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as the sole book-running manager for the offering.

The securities were offered and sold pursuant to the Company’s currently effective shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering was made by means of a prospectus supplement and prospectus which have been filed with the SEC and are available on the SEC’s website at www.sec.gov. You should read the prospectus supplement and prospectus for more complete information about the Company and the offering. You may obtain these documents free of charge by visiting the SEC website at www.sec.gov. Alternatively, you may obtain copies by contacting ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

BrightPath Bio and Cellistic Announces Process Development and Manufacturing Collaboration for Phase 1 Clinical Trial of iPSC-derived BCMA CAR-iNKT cell

On December 13, 2024 BrightPath Bio (Tokyo Stock Exchange Growth 4594, "BrightPath"), a pioneer in iPS cell-derived Natural Killer T ("NKT") cell therapy, and Cellistic, a leader in advanced iPS cell therapy manufacturing, reported a process development and manufacturing agreement to advance BrightPath’s novel allogeneic CAR-T cell therapy platform, utilizing iPSC-derived NKT cells for clinical trials (Press release, BrightPath Biotherapeutics, DEC 13, 2024, View Source [SID1234649112]).

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The strategic collaboration includes the use of Cellistic’s innovative 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale manufacturing of iPSC-derived BCMA-targeting CAR-NKT cells for Phase 1 multiple myeloma trial; establishing BrightPath as a first mover in this emerging field.

"The use of NKT cells as effectors in allogeneic CAR-T therapy represents a promising strategy, offering not only direct cytotoxicity but also indirect anti-tumor activity through the priming of host CD8+ T cells—a mechanism expected to evade host immune rejection and to enhance the durability of clinical responses. However, achieving clinical-scale manufacturing of such a rare subset of T cells while preserving their original functionality has conventionally been a significant challenge. Induced pluripotent stem (iPS) cell technology has overcome this barrier, making large-scale production feasible," stated Ken Nagai, CEO of BrightPath.

"While we have established a robust 2D culture-based manufacturing process, we have recognized the importance of anticipating the full scalability potential of the iPS cells from commercial perspective at an early stage. To address this need, we are committed to implement more scalable manufacturing solutions. Cellistic is well-positioned to meet this critical requirement with their unique 3D platform and extensive experiences in iPSC differentiation and scale-up of a variety of cell types," Ken Nagai further noted. "We are delighted to partner with Cellistic, which has the most experience in culturing iPS cells using 3D bioreactors. This collaboration with Cellistic allows us to leverage their state-of-the-art development and manufacturing capabilities to accelerate the development of our BCMA CAR-NKT product."

"We are excited to partner with BrightPath in the development of their revolutionary iPSC derived cell therapy," said Gustavo Mahler, CEO of Cellistic. "Our Echo manufacturing platform is designed to meet the unique challenges of cell therapy production, ensuring scalability, quality, and regulatory compliance. Together, we can advance the therapeutic potential of BCMA CAR-NKT cells and help BrightPath to bring innovative solutions to patients in need."

The agreement marks a significant step forward in the industry’s pursuit of innovative and effective cell therapies, with both companies committed to advancing healthcare solutions that improve patient outcomes.

BIOVAXYS ANNOUNCES CLOSING OF FIRST TRANCHE OF PRIVATE PLACEMENT AND ANNOUNCES DEBT SETTLEMENT AGREEMENT

On December 13, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported that it has closed the first tranche (the "First Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 2,200,000 units (the "Units") of the Company at a price of $0.05 per Unit for aggregate gross proceeds of $110,000 (Press release, BioVaxys Technology, DEC 13, 2024, View Source [SID1234649111]).

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Each Unit consist of one (1) common share in the capital of the Company (each, a "Share") and one (1) whole Share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until December 13, 2026, being the date that is 24 months from the date of issue.

The Company intends to use the net proceeds of the First Tranche for working capital. No finder’s fees were paid in connection with the First Tranche. All securities issued pursuant to the First Tranche are subject to a statutory hold period expiring April 14, 2025, being the date that is four months and one day from the date of issuance in accordance with applicable securities legislation

In addition, the Company announces that it has entered into a debt settlement agreement with an arm’s-length consultant of the Company to settle an aggregate of $500,000 in debt owed to the consultant by issuing 5,000,000 Shares at a deemed price of $0.10 per Share (the "Debt Settlement"). The board of directors of the Company has determined that it is in the best interests of the Company to settle the outstanding debt through the issuance of Shares in order to preserve the Company’s cash for working capital purposes.

All securities proposed to be issued pursuant to the Debt Settlement will be subject to a statutory hold period of four months from the date of issuance in accordance with applicable securities legislation. Closing of the Debt Settlement is conditional upon a number of conditions, including receipt of all applicable corporate and regulatory approvals, including the acceptance of the Canadian Securities Exchange.

This news release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States. The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom.

Marengo to Present Clinical Data Highlighting Invikafusp Alfa (STAR0602), a First-in-Class Selective, Dual T Cell Agonist at ESMO Immuno-Oncology Congress 2024

On December 13, 2024 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, reported that Chief Executive Officer, Zhen Su, M.D., MBA, presented a clinical update highlighting the STARt-001 trial at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2024 taking place in Geneva, Switzerland (Press release, Marengo Therapeutics, DEC 13, 2024, View Source [SID1234649110]).

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The oral presentation highlighted findings from the Phase 1 clinical study of invikafusp alfa (STAR0602), Marengo’s first-in-class Vβ6/10 selective dual T cell agonist as monotherapy in patients with PD-1-resistant cancers. The results, previously showcased during a late-breaking plenary session at the SITC (Free SITC Whitepaper) Annual Meeting, demonstrated initial anti-tumor activity and a favorable safety profile in heavily pre-treated, biomarker-enriched patients who are resistant to prior PD-1 therapy.

"We are honored to share this exciting clinical advancement with the global oncology community at ESMO (Free ESMO Whitepaper) IO," said Dr. Su. "The insights gained from the STARt-001 trial underscore the potential of invikafusp alfa to address the unmet needs of patients with PD-1-resistant tumors. They also validate the precision immunology approach underlying our STAR platform, which drives the design of Marengo’s selective dual T cell agonist antibodies. We look forward to advancing invikafusp alfa into a Phase 2 study in the near term."

Oral presentation details:

Title: Reinvigorating T cell repertoire in vivo: Igniting the TIL Compartment
Session Title: Special Session: Boosting cancer cell immunity
Presentation Date and Time: Friday, December 13, 2024, 10:45 AM – 11:00 PM CET
Presenter: Zhen Su, M.D., MBA, Chief Executive Officer at Marengo

AbbVie to Acquire Nimble Therapeutics, Further Strengthening Immunology Pipeline

On December 13, 2024 AbbVie (NYSE: ABBV) and Nimble Therapeutics reported a definitive agreement under which AbbVie will acquire Nimble, including its lead asset, an investigational oral peptide IL23R inhibitor in preclinical development for the treatment of psoriasis and a pipeline of other novel oral peptide candidates with potential across several autoimmune diseases (Press release, AbbVie, DEC 13, 2024, View Source [SID1234649109]). Additionally, AbbVie will acquire Nimble’s peptide synthesis, screening, and optimization platform, which uses proprietary technology to help drive rapid discovery and optimization of peptide candidates for a range of targets.

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"The addition of Nimble’s pipeline to AbbVie’s existing pipeline, combined with our deep clinical and translational expertise in immunology, represents an important growth opportunity," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "Together, AbbVie and Nimble have the potential to help address the significant unmet medical need for people living with autoimmune diseases."

"Nimble Therapeutics is committed to transforming the discovery of oral peptide-based medicines. With AbbVie’s world-class expertise in developing and commercializing medicines on a global scale, Nimble’s novel oral therapies will be well-positioned to reach more people living with autoimmune diseases," said Jigar Patel, Ph.D., founder and chief executive officer, Nimble Therapeutics. "The talented, passionate and dedicated team at Nimble has made great progress over the past few years and we are pleased that AbbVie has recognized the tremendous potential of our proprietary platform and emerging immunology pipeline."

Nimble’s preclinical-stage IL23R inhibitor is an investigational oral therapy for the treatment of psoriasis and inflammatory bowel disease (IBD). IL23R is a clinically validated therapeutic target in certain autoimmune diseases and a major contributing factor to psoriasis and IBD pathogenesis and progression through increased inflammation and amplified immune responses.

Under the terms of the agreement, AbbVie will make a cash payment of $200 million at closing to acquire Nimble, subject to certain customary adjustments, in addition to certain interim funding payments. Nimble’s shareholders remain eligible for a potential payment, subject to the achievement of a development milestone. The transaction is subject to the satisfaction of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Nimble is backed by founding investors Telegraph Hill Partners and Roche Ventures.