Soligenix Announces Pricing of $7.5 Million Public Offering

On September 26, 2025 Soligenix, Inc. (Nasdaq: SNGX) ("Soligenix" or the "Company"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported the pricing of its "reasonable best efforts" public offering with existing and certain healthcare focused institutional investors for the purchase and sale of 5,555,560 shares of common stock of the Company (or common stock equivalents in lieu thereof) and warrants to purchase up to 5,555,560 shares of common stock at a combined purchase price of $1.35 per share and accompanying warrant (the "Offering") (Press release, Soligenix, SEP 26, 2025, View Source [SID1234656278]). The warrants will have an exercise price of $1.35 per share, will be exercisable immediately and will expire five years from the issuance date.

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The Company also has agreed that certain existing May 2023, April 2024 and July 2024 warrants (together, the "Existing Warrants") to purchase an aggregate of 1,162,064 shares of common stock will be amended such that the Existing Warrants will have a reduced exercise price of $1.35 per share and shall expire commensurate with the warrants sold in the Offering.

The closing of the Offering is expected to occur on or about September 29, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $7.5 million, before deducting placement agent fees and other estimated Offering expenses. The Company intends to use the net proceeds of this Offering to fund research and development and commercialization activities, working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the Offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-290413), previously filed with the Securities and Exchange Commission ("SEC") on September 19, 2025, which became effective on September 25, 2025. The Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the Offering has been filed with the SEC. An electronic copy of the final prospectus will be filed with the SEC and may be obtained, when available, on the SEC’s website located at View Source and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

Onconetix Announces Financing Through a $12.9 Million Private Placement of Series D Preferred Stock and Warrants, Termination of Merger Agreement with Ocuvex, Inc. and Settlement of $8.8 Million Debt with Veru, Inc.

On September 26, 2025 Onconetix, Inc. (Nasdaq: ONCO) ("Onconetix" or the "Company") a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology, reported the September 22, 2025 signing and closing of a private placement of (i) shares of the Company’s Series D Convertible Preferred Stock, $0.00001 par value (the "Series D Preferred Stock"), and (ii) warrants (the "Warrants") to purchase up to an aggregate of 4,362,827 shares of the Company’s common stock, $0.00001 par value per share (the "Common Stock"), for an aggregate purchase price of approximately $12.9 million (the "Financing Transaction") (Press release, Onconetix, SEP 26, 2025, View Source [SID1234656277]). Approximately $9.3 million was paid in cash and the balance was used to offset certain amounts owed by the Company to certain investors. The Series D Preferred Stock are initially convertible into an aggregate of 4,362,827 shares of Common Stock, subject to certain anti-dilution adjustments. The Warrants will have an initial exercise price of $3.6896 per share, subject to certain anti-dilution adjustments, and are exercisable beginning on the issuance date (the "Initial Exercisability Date") and expiring on the third anniversary of the Initial Exercisability Date.

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The Company has filed a Current Report on Form 8-K with the Securities and Exchange Commission on September 26, 2025, with additional details of the transaction. The Company agreed to seek stockholder approval for the issuance of all of the shares of Common Stock issuable upon conversion of the Series D Preferred Stock and exercise of the Warrants in accordance with the rules and regulations of the Nasdaq Stock Market.

In full satisfaction of the Company’s approximately $8.8 million debt to Veru, Inc., approximately $6.3 million of the cash proceeds from the Financing Transaction was paid to Veru, Inc., and the remaining $2.5 million of debt was converted into 3,125 shares of Series D Preferred Stock and 846,975 warrants as part of the Financing Transaction. The Company intends to use the remaining net cash proceeds from the Financing Transaction to cover costs and expenses associated with the termination of a previously contemplated business combination with Ocuvex, Inc., and for working capital and general corporate purposes.

ME THERAPEUTICS SECURES U.S. PATENT FOR LEAD CANDIDATE AND ADVANCES BROADER THERAPEUTIC PROGRAMS

On September 26, 2025 ME Therapeutics Holdings Inc. ("ME Therapeutics" or the "Company") (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company working on novel cancer fighting drugs in the field of immuno-oncology, reported its subsidiary, ME Therapeutics Inc., has secured a U.S. patent for its lead G-CSF antibody candidate, as it continues to advance its broader drug development and discovery programs for cancer (Press release, ME Therapeutics, SEP 26, 2025, View Source [SID1234656276]).

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"We are pleased with the business and scientific progress we have made across our pipeline as we work towards bringing novel immuno-oncology drugs to patients worldwide who today have limited treatment options," said Salim Dhanji, CEO of ME Therapeutics. "This quarter we reached several key milestones for our lead G-CSF antibody candidate that keep us on our pathway to the clinic, including securing a U.S. patent and moving forward cell line development in preparation for Good Manufacturing Practices (GMP). We also continued to progress our therapeutic mRNA and in vivo CAR programs through preclinical testing and discovery research."

U.S. patent received

ME Therapeutics has received US Patent No. 12,421,308 from the United States Patent and Trademark Office (USPTO) for its G-CSF antibody candidate. The patent protects the amino acid sequence of the antibody candidate and its therapeutic use for cancer treatment in the United States. The antibody candidate, also known as H1B11-12, is a humanized biological drug formulated to target and block G-CSF, a glycoprotein cytokine known to drive immune suppression in the tumour microenvironment.

The U.S. patent marks the second international patent ME Therapeutics has received for the G-CSF antibody candidate. In 2023, ME Therapeutics also received a patent from the China National Intellectual Property Administration.

Other highlights:

Antibody candidate cell line development: To support clinical trial regulatory meetings, ME Therapeutics is progressing cell line development to meet Good Manufacturing Practices (GMP) standards. Work at the contract research organization has identified candidate cell lines demonstrating robust antibody production and stability. Next steps will involve continued testing of the antibody characteristics prior to choosing a lead clone for the development of a GMP master cell bank.
Therapeutic mRNA candidates preclinical testing: The Company’s therapeutic mRNA program is advancing through preclinical testing, with the lead therapeutic mRNA candidate tested in vivo. To date, results show the lead therapeutic mRNA candidate leads to immune cell recruitment into the tumour microenvironment (TME). ME Therapeutics now intends to initiate a study to test the lead candidate in a mouse colon cancer model, both alone and in combination with an immune checkpoint inhibitor. Meanwhile, their second therapeutic mRNA candidate has demonstrated strong T cell activation in vitro. This candidate will continue to be advanced through further in vitro testing.
In vivo CAR program discovery: ME Therapeutics is also progressing its in vivo CAR program through the discovery stage. This next-generation approach delivers genetic instructions directly into a patient’s body to reprogram cells within the TME. The Company has confirmed in vitro activity of its tumour-targeted CARs and plans to conduct further in vitro testing before exploring in vivo
Expanded research team: ME Therapeutics continues to grow its research and development capabilities with the addition of two new associate research scientists. This positions the company to move its lead antibody candidate towards clinical trials as well as accelerate progress for its broader drug development and discovery programs.

Immuneering to Discuss Recently Announced Overall Survival Data from Phase 2a Clinical Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer Patients on Monday, September 29, 2025

On September 26, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, reported that it will host a conference call and live webcast at 8:30 am ET on September 29, 2025, to discuss recently announced updated overall survival and safety data in first-line pancreatic cancer patients treated with atebimetinib + mGnP (N=34) with 9 months median follow up (Press release, Immuneering, SEP 26, 2025, View Source [SID1234656274]).

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"These exciting results were first announced in our press release on September 24, 2025, will be highlighted in a poster presentation at the Pancreatic Cancer Action Network (PanCAN) Scientific Summit 2025 on Sunday, and will be discussed during our conference call on Monday. We are committed to ensuring the community has multiple opportunities to engage with and understand these important results," said Ben Zeskind, Ph.D., CEO of Immuneering.

Individuals interested in listening to the live conference call may do so through this webcast link or by dialing (800) 715-9871 in the U.S. or (646) 307-1963 for other locations and reference conference ID 9502940. A webcast replay will be available from the "Investors" section of the Company’s website.

Novartis to showcase transformative data in advanced prostate and early breast cancer at ESMO 2025

On September 26, 2025 Novartis reported it will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin (October 17-21, 2025) (Press release, Novartis, SEP 26, 2025, View Source [SID1234656245]).

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"We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients," said Dushen Chetty, PhD, Global Head of Oncology Development, Novartis, Ad Interim. "Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy."

Key highlights of data accepted by ESMO (Free ESMO Whitepaper) include:

Medicine Abstract title Abstract Number/
Presentation Details
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Phase 3 trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition) #LBA6
Presidential Symposium 2 (Proffered Paper session)
October 19, 2025
16:30 – 18:15 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Associations between quantitative baseline 68Ga-PSMA-11 PET parameters and 177Lu-PSMA-617 efficacy in the PSMAfore Study #2390P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Final analysis of patients treated with [177Lu]Lu-PSMA-617 in early access program in metastatic castration-resistant prostate cancer (mCRPC) in France #2389P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
[225Ac]-PSMA-617 PSMAcTION trial-in-progress: a phase 2/3 randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy #2516TiP
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 5-year outcomes #LBA14
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST
Kisqali (ribociclib) Impact of neoadjuvant chemotherapy (NACT) response on clinical outcomes with ribociclib (RIB) in HR+/HER2− EBC: a subgroup analysis from the phase 3 NATALEE trial #366P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) A NATALEE data–based machine learning (ML) model to predict distant recurrence (DR) and treatment (tx) effect in real-world (RW) patients (pts) with HR+/HER2– early breast cancer (EBC) without CDK4/6 inhibitor (CDK4/6i) tx #372P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Real-world characteristics, treatments and outcomes of NATALEE and monarchE-eligible HR+/HER2- early breast cancer patients in the hospital district of Helsinki and Uusimaa (HUS), Finland #360P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Risk of Recurrence (ROR) After Neoadjuvant Ribociclib Plus ET in Clinically High-Risk ER+/HER2− BC: Preliminary Analysis of the SOLTI-RIBOLARIS Trial #296O
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST