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 29, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that the first patient has been dosed under the KOMET-017 clinical trial protocol (NCT07007312), comprising two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib, Kura Oncology’s investigational menin inhibitor, in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) (Press release, Kura Oncology, SEP 29, 2025, View Source [SID1234656319]).

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"The dosing of the first patient under the KOMET-017 protocol is a major milestone in the pursuit of improved treatments for patients with newly diagnosed AML," said Amer Zeidan, M.B.B.S., M.H.S., Chief of the Division of Hematologic Malignancies, Director of Hematology Early Therapeutics Research at Yale Cancer Center and lead investigator of KOMET-017. "AML remains one of the most aggressive and difficult-to-treat blood cancers, with many patients relapsing despite currently available therapies. Ziftomenib, which in my opinion has the potential to be the best-in-class menin inhibitor, has demonstrated promising safety and activity in early phase clinical trials of NPM1-m and KMT2A-r AML both as monotherapy and in combination with multiple standards of care. These two randomized Phase 3 trials offer the potential to confirm benefit across frontline populations that account for nearly half of newly diagnosed AML patients and where safe, tolerable and effective options are urgently needed."

"This is a pivotal moment for Kura, Kyowa Kirin, and patients with AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "To our knowledge, KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings, underscoring the potential to address a broad spectrum of patients with AML. The opportunity to advance to the frontline AML setting offers the potential to reach patients earlier in their disease course, when the possibility to meaningfully change the trajectory of the disease is greatest. The willingness of the FDA to allow the trials to use MRD negative CR and CR as primary endpoints for accelerated approval is groundbreaking and could potentially enable us to deliver ziftomenib more quickly to patients in need. We are committed to driving the KOMET-017 program forward with the goal of transforming care for patients who continue to face a devastating prognosis."

"The initiation of the KOMET-017 trial represents a significant step forward in expanding treatment options for newly diagnosed AML patients with NPM1-m and KMT2A-r," said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. "AML remains a disease with poor prognosis, and developing safe and effective therapies is an urgent need. Ziftomenib’s innovative mechanism of action, combined with its potential efficacy alongside both intensive and non-intensive therapies, holds promise to improve patients’ quality of life and extend survival. Kyowa Kirin is committed to collaborating closely with Kura Oncology to bring life-changing value to patients living with AML."

Each frontline trial design includes dual-primary endpoints to support potential U.S. accelerated approval and full approval. The intensive chemotherapy Phase 3 trial of ziftomenib in combination with standard induction cytarabine / daunorubicin (7+3) will assess minimal residual disease (MRD) negative complete response (CR) and event-free survival (EFS) as dual-primary endpoints. The non-intensive chemotherapy Phase 3 trial of ziftomenib in combination with venetoclax / azacitidine will assess CR and overall survival (OS) as dual-primary endpoints. The trial is intended to serve as a registrational study and builds on encouraging clinical data previously reported with ziftomenib in genetically defined subsets of AML. The trial is expected to enroll patients at up to 200 sites worldwide, reflecting strong global interest in advancing ziftomenib for patients in need. More information regarding the KOMET-017 trial is available at www.clinicaltrials.gov (identifier: NCT07007312).

On September 29, 2025 Accendatech Co., Ltd, a clinical-stage biotech company developing natural compound-based small molecule drugs with unique pharmacological properties reported the enrollment of first small cell lung cancer patient with brain metastasis this month for the pivotal phase 3 study in China (CTR20253399) (Press release, Accendatech, SEP 29, 2025, View Source [SID1234656336]). The initiation of phase 3 trial is based on encouraging intracranial tumor response and overall survival signal from a phase 2b ACT001-CN-051 study which were released during 2025 SNO/ASCO conference held in Baltimore, MD in August, 2025. The topline data is expected to be published in a peer-reviewed journal.

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ACT001 is the first study drug with the potential to enhance both chemoradiotherapy and immune therapy simultaneously that enters a phase 3 stage. It is also the first pivotal-stage study drug targeting NF-κB and STAT3 pathways since the cloning of gene involved in these two pathways approximately 39 and 33 years ago respectively. There have been numerous pre-clinical publications that proposed the pathways as therapeutic targets.

The kick-off of phase 3 ACT001 study is another evidence to reflect the increasingly dynamic nature of drug study in SCLC space since the approval of immune checkpoint inhibitors in 2019 and more recent approval of tarlatamab in 2024 as the first T cell engager ever approved in any solid tumor. The phase 3 ACT001 trial further diversify the drug development landscape in SCLC space that has now become a hot battle ground due to interesting efficacy data from studies on multiple novel modalities such as ADC and bi-specific antibodies.

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 28, 2025 Santo Therapeutics reported the company successfully completed a tens of millions of RMB angel+ round of financing. This round of financing was exclusively invested by Fir Creek Capital, and the funds raised will be focused on advancing the company’s globally leading lentiviral gene therapy pipeline.

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Syntop Biotech stated: "The Fir Creek team’s expertise and long-term commitment to the biotechnology field give us great confidence in our collaboration. This investment not only highly recognizes Syntop Biotech’s leading advantages in the lentiviral vector field, but also reflects the deep synergy between the two companies in the gene therapy industry. We are also very grateful to our existing shareholders for their long-term support, and to our medical partners and patients for their continued support. This financing will help Syntop achieve key milestones and accelerate our dual US and Chinese drug registrations and further research on innovative projects."

Fir Creek Capital stated: "We have always been committed to investing in innovative biotechnologies and therapies such as cell and gene therapy. We are excited about Syntop Biotech’s technological accumulation and breakthroughs in the field of lentiviral vector design. We hope to work with the company to usher in a new era of gene therapy."

(Press release, Santo Therapeutics, SEP 28, 2025, View Source;scene=1&srcid=0225XxejoQWkgy8ZZdODAgrJ&sharer_shareinfo=8d75cf4435709cdf87dcc4e9179111ea&sharer_shareinfo_first=8d75cf4435709cdf87dcc4e9179111ea&from=industrynews&color_scheme=light#rd [SID1234663849])