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.

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

On September 25, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported that the U.S. Food and Drug Administration (FDA) approved PALSONIFY (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly.

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"With the FDA approval of our lead therapy Palsonify, today marks a new era for those living with acromegaly and also for Crinetics as a company," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "We are very pleased to be fulfilling our commitment to transforming patient lives. This approval is the first to come from our deep pipeline of first-in-class, small molecule drugs. This would not be possible without the help and partnership of people living with acromegaly, their caretakers, our employees, and the clinical researchers and health care professionals who contributed to Palsonify’s successful development program. Thank you to all involved."

The approval is based on data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials, which evaluated PALSONIFY’s safety and efficacy in previously treated and medically untreated adults with acromegaly. Across both trials, PALSONIFY consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy.

Participants also reported significant reductions in signs and symptoms associated with acromegaly as measured by the Acromegaly Symptom Diary (ASD) — an FDA-aligned patient-reported outcome tool developed to capture the symptoms that matter to people living with acromegaly. Symptoms include headaches, joint pain, sweating, fatigue, weakness, swelling, and/or numbness/tingling. PALSONIFY was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trial.

Long-term results from the open-label extension (OLE) phases of both trials were presented at this year’s Endocrine Society’s annual meeting, ENDO 2025, providing further evidence of PALSONIFY’s ability to deliver durable IGF-1 control, sustained improvements in patient symptom burden, and a consistent safety profile. Ninety-one percent of patients from PATHFNDR-1 and 97 percent of completers from PATHFNDR-2 enrolled in the OLE.

"The PATHFNDR clinical development program set a new standard for acromegaly treatment by demonstrating the ability of Palsonify to drive both biochemical and symptom control, regardless of the degree of underlying disease severity," said Dr. Shlomo Melmed, Executive Vice President of Medicine and Health Sciences and Dean of the Medical Faculty at Cedars-Sinai, "The approval of Palsonify is a significant advancement for our patients, as there is an unmet need for an easy-to-administer and safe therapeutic option with a rapid action and durable response that can consistently manage acromegaly."

"For people living with acromegaly, treatment once meant burdensome injections, breakthrough symptoms, and lifestyle sacrifices just to stay on track," said Jill Sisco, President of Acromegaly Community. "What matters most to our community – maintaining consistent control so the disease doesn’t control us – led us to partner with the FDA on Externally Led Patient-Focused Drug Development meetings. This new treatment reflects that our voices have been heard in shaping the next generation of acromegaly care."

PALSONIFY is expected to be available in the U.S. in early October. Crinetics is ensuring broad access to PALSONIFY by working closely with payers, healthcare providers, and patient advocacy organizations to support those who may benefit from this treatment.

As part of this commitment, Crinetics has launched CrinetiCARE, a comprehensive support program designed to assist people living with acromegaly throughout their treatment journey. CrinetiCARE provides disease and product education, benefit verification, financial assistance resources, and access to dedicated nurse educators who can offer support with treatment onboarding and ongoing adherence. For more information, visit www.CrinetiCARE.com or the PALSONIFY product website Palsonify.com.

A Marketing Authorization Application (MAA) for paltusotine in acromegaly is currently under review for use in the European Union, and the current timeline for the Committee for Medicinal Products and Human Use (CHMP) opinion is the first half of 2026. Crinetics is in partnership with Sanwa Kagaku Kenkyuso (SKK) to develop and commercialize paltusotine for acromegaly in Japan.

Paltusotine is also being evaluated for the treatment of carcinoid syndrome in the pivotal Phase 3 CAREFNDR trial. Global enrollment for CAREFNDR is expected throughout 2025.

(Press release, Crinetics Pharmaceuticals, SEP 25, 2025, View Source [SID1234669419])