On September 29, 2025 bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW) a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported that it has priced a public offering of securities as described below for aggregate gross proceeds to the Company of $4.8 million, before deducting agent fees and other estimated expenses payable by the company (Press release, BioAffinity Technologies, SEP 29, 2025, View Source [SID1234656335]).

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The offering consists of 1,921,799 shares (the "Shares") of our Common Stock (or pre-funded warrants (the "Pre-Funded Warrants") in lieu thereof) at a purchase price of $2.50 per share (or $2.493 per Pre-Funded Warrant). Each Pre-Funded Warrant will be exercisable for one share of our Common Stock and will be immediately exercisable and will expire when exercised in full. The purchase price of each Pre-Funded Warrant will equal the price per share of Common Stock being sold to the public, minus $0.007, and the exercise price of each Pre-Funded Warrant will be $0.007 per share.

The closing of the offering is expected to occur on or about September 30, 2025, subject to the satisfaction of customary closing conditions.

WallachBeth Capital, LLC is acting as sole placement agent for the offering.

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

The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-290480), as amended, previously filed and declared effective by the Securities and Exchange Commission (SEC). 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 the registration or qualification under the securities laws of any such state or jurisdiction. The offering is being made only by means of a preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.

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 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 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 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.