On September 28, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that new data from the prospective, randomized integral biomarker BALANCE trial (NCT03371719) finds that the PAM50 molecular signature predicts which patients with recurrent prostate cancer benefit from hormone therapy with apalutamide in addition to salvage radiation therapy (Press release, Veracyte, SEP 28, 2025, View Source [SID1234656299]). The prostate PAM50 biomarker is currently available for Research Use Only on the Decipher GRID (Genomic Resource for Intelligent Discovery) research tool.

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The new findings were shared today by Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University, in a podium presentation at ASTRO 2025, the annual meeting of the American Society for Radiation Oncology, being held in San Francisco.

"Our findings mark the first time, to my knowledge, that a predictive biomarker has been validated in a prospective, biomarker-driven, randomized trial in non-metastatic prostate cancer," said Dr. Spratt. "Thus, this is an unprecedented advancement for patients who can be more-precisely selected to receive hormone therapy or forego the treatment and the potential side effects."

For the study, 295 men with recurrent, non-metastatic prostate cancer following prostate-removal surgery were randomly assigned to salvage radiation therapy with a placebo or apalutamide for 6 months. The PAM50 biomarker was a key stratification variable to ensure each arm had a similar proportion of luminal B and non-luminal B subtypes. They were followed for a median of 5 years during which they were evaluated for biochemical failure, which is a rise in levels of prostate-specific antigen (PSA) post treatment—an early sign of salvage therapy failure. Among the 127 men with luminal B molecular subtype tumors (as determined by the PAM50 signature), 72% of those taking apalutamide did not experience biochemical failure, as compared to the 54% rate in the placebo group [HR 0.45 (80% CI 0.29-0.68), p=0.0062]. In the non-luminal B subset, there was no difference between those taking apalutamide versus placebo (70% vs 71%) [HR 0.95 (80% CI 0.65-1.41), p=0.44].

"These results from NRG GU006 represent the highest level of evidence to support routine biomarker testing in recurrent prostate cancer patients planned to receive secondary radiotherapy," Dr. Spratt added. "With such a strong difference in the metastasis-free survival response to hormone therapy between luminal B and non-luminal-B tumors, the use of the predictive PAM50 biomarker is a game changer to help personalize treatment for men with recurrent prostate cancer beyond merely prognostic tools."

The PAM50 signature is the third biomarker—assessed through the whole-transcriptome-based Decipher platform—that a major study has shown predicts benefit from hormone therapy, radiation therapy or chemotherapy. Another trial—PREDICT-RT—recently completed enrollment two years early and is evaluating the Decipher Prostate test’s ability to predict benefit of combined hormone therapy (ADT and apalutamide) concurrent with radiation in patients with high-risk prostate cancer at initial diagnosis.

"Prostate cancer, like all cancers, is a disease of the genome," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Our Decipher GRID tool uniquely enables researchers to better pinpoint adverse molecular features that are associated with poor outcomes. This can ultimately lead to more-personalized care for each patient based on their tumor’s unique molecular make-up. We are proud to partner with the world’s leading prostate cancer researchers to help uncover insights that can change the trajectory of care for each individual patient and also help deliver the next generation of prostate cancer diagnostics."

The BALANCE trial results are among 9 Decipher-focused abstracts being presented at the ASTRO 2025 conference. More information can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found.

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.

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.

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.

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.