On February 3rd, 2025 Valerio Therapeutics S.A. (Euronext Growth Paris: ALVIO) reported a strategic decision to discontinue all clinical trials and associated activities, including the ongoing VIO-01 trial (Press release, Valerio Therapeutics, FEB 3, 2025, View Source [SID1234654355]). This shift was decided by the board of directors in the context of the financing challenges of the Company. The Company’s cash position should enable it to finance its refocused business other the next three months. In the meantime, in addition to the reduction of its expenses, it is negotiating with its stakeholders and is seeking to reach the agreement needed to secure its financial and cash trajectory in the next twelve months.

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The end of clinical trials will enable the company to focus exclusively on early-stage drug development, ensuring efficient use of available capital while maintaining a strong focus on innovation.

As part of this transition, Valerio will cease clinical-stage operations in oncology and close its U.S. office in Lexington, MA. The company is conducting a strategic review to redefine its pipeline and long-term vision, ensuring sustainable growth and value creation for stakeholders. The Company will focus on its early-stage activities, namely the development of its single chain antibody platform, which, coupled with chemistry capabilities and oligonucleotides expertise, can open new avenues for the company.

The company will update the market as soon as the ongoing discussions with its stakeholders lead to securing a long-term financing solution to achieve its strategic development milestones.

Julien Miara, Chairperson and CEO of Valerio Therapeutics, commented:
"This decision, which will help consolidate the financial position of the company together with other actions, allows us to focus on our core strengths in early-stage research while preserving financial flexibility to drive transformative innovation. We extend our gratitude to the patients, investigators, and partners who have supported our clinical efforts and remain steadfast in our mission to develop novel therapies addressing critical unmet needs."
Valerio is committed to providing updates on its revised strategy and future plans in due course.

For more information, visit www.valeriotx.com.

On February 3, 2025 Ono reported consolidated Financial Results for the Third Quarter of the Fiscal Year Ending March 31, 2025 (Filing, 3 mnth, DEC 31, Ono, 2024, FEB 3, 2025, View Source [SID1234654088]).

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On February 3, 2025 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 that it intends to offer to sell common shares in a best-efforts public offering (Press release, BriaCell Therapeutics, FEB 3, 2025, View Source [SID1234650079]). The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the size or terms of the offering. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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ThinkEquity is acting as sole placement agent for the offering.

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

The securities will be offered and sold pursuant to a 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 will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41 st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

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

On February 3, 2025 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 an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere (Press release, BriaCell Therapeutics, FEB 3, 2025, View Source [SID1234650078]). This patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS.

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Bria-OTS is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic recurrent breast cancer. Bria-OTS represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT which is currently in a pivotal Phase 3 study for metastatic breast cancer.

This 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative) had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS study. At enrollment on Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere.

"Despite recent advancements in cancer treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), metastatic breast cancer remains an unmet medical need as many patients do not respond to these treatments," stated Dr. Neal Chawla, Associate Director of Clinical Research at the Sarcoma Oncology Center, and Principal Investigator for the Bria-OTS study. "We are very impressed by the clinical response observed showing rapid and robust clinical activity in addition to excellent tolerability in the first patient treated with Bria-OTS and look forward to reproducing these results in other cancer patients in the study."

"This data supports our hypothesis of personalized immunotherapy with Bria-OTS, potentially leading to new and effective treatment of metastatic breast cancer," stated Dr. William V. Williams, BriaCell’s President and CEO. "We hope to transform the way we treat cancer patients with our novel personalized off-the-shelf immunotherapy approach."

"Resolution of metastatic lung disease in this breast cancer patient highlights the clinical effectiveness of Bria-OTS, and its therapeutic potential in MBC," commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "This result represents a major step towards advancing our innovative technology platform and our goal of offering safe and effective treatment to MBC patients and our plans to extend into prostate cancer, melanoma, and lung cancer."

The Phase 1/2a clinical trial is initially evaluating the safety and efficacy of Bria-OTS as monotherapy and, later, in combination with an immune checkpoint inhibitor in metastatic breast cancer. Key inclusion criteria include recurrent metastatic breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design includes a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with an immune check point inhibitor.

On February 3, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative cancer therapeutics, reported the successful completion of an oversubscribed US$112 million Series C financing (Press release, Advancell, FEB 3, 2025, View Source [SID1234650011]). This milestone funding round was co-led by SV Health Investors, Sanofi Ventures, Abingworth, and SymBiosis. Additional support came from existing investor Morningside, alongside new investors Tenmile, Brandon Capital, and others.

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Since its founding in June 2019, AdvanCell has grown from a belief in the potential of Targeted Alpha Therapy into a global organisation with 60 passionate team members, a 40,000-square-foot manufacturing facility, world-class pre-clinical infrastructure, a potentially best-in-class drug for prostate cancer that is in trials, and a deep and developing pipeline of assets.

This investment will fuel AdvanCell’s ongoing efforts to expand its manufacturing capacity, accelerate the clinical development of its pipeline of radionuclide therapies, and advance its mission of delivering life-changing treatments to cancer patients worldwide.

AdvanCell is currently enrolling patients for the highest dose cohort of its multi-center TheraPb Ph I/II dose escalation clinical trial of ADVC001 for metastatic prostate cancer, a potentially best-in-class Targeted Alpha Therapy. The trial aims to demonstrate the safety and efficacy of Pb-212-based radionuclide treatment.

As part of the financing, Jamil M. Beg from SV Health Investors, Christopher Gagliardi from Sanofi Ventures, and Bali Muralidhar from Abingworth have joined the AdvanCell Board of Directors. They bring extensive industry expertise to support the company’s growth and join existing directors Bill Ferris AC, Anthony Aiudi, Kevin Cameron, and Andrew Adamovich.

Jamil M. Beg, Partner at SV Health Investors, commented:

"We are delighted to support AdvanCell’s growth and play a role in its remarkable journey through leading this oversubscribed Series C. We have looked long and deep at the field of radionuclide therapies and are confident that AdvanCell stands out with a first-in-class Pb-212-PSMA program and a best-in-class manufacturing platform. The company’s exceptional team, technologies, robust infrastructure, collaborations with some of the world’s largest pharma companies and ability to consistently execute, position it to truly change outcomes for patients. We are excited to help AdvanCell realize its potential in transforming cancer care globally."

AdvanCell was founded on the belief that Targeted Alpha Therapies could change the course of cancer treatment and that the scalable supply of isotopes would enable the development of multiple practice-changing drugs. Radionuclide therapies for prostate cancer and gastroenteropancreatic neuroendocrine tumours have transformed patient care. Pb-212 Targeted Alpha Therapy has the potential to further advance this progress by leveraging the radiobiological and physical attributes of Pb-212 to make life-changing treatments for patients.

"This successful Series C round demonstrates strong confidence in our vision and capabilities," said Andrew Adamovich, CEO of AdvanCell. "We are grateful for the continued support from our existing investors, particularly the long-term support from Morningside and are excited to welcome new partners who share our commitment to transforming cancer care. With this funding, AdvanCell is well-positioned to scale our manufacturing operations and progress our cutting-edge therapies towards commercialization."

The Series C funding represents a significant step in AdvanCell’s journey to become a global leader in radionuclide-based cancer therapeutics.