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bioAffinity Technologies Announces Pricing of $4.8 Million Public Offering

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.

FDA Approves Guardant360® CDx as Companion Diagnostic for Eli Lilly and Company’s Inluriyo™ (imlunestrant) for Treatment of ESR1-mutated Advanced Breast Cancer

On September 29, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved its Guardant360 CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and Company’s Inluriyo (imlunestrant) (Press release, Guardant Health, SEP 29, 2025, View Source [SID1234656334]). Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy (ET).

"This FDA approval provides another treatment for breast cancer patients with ESR1 mutations for their specific type of cancer along with expanded access to comprehensive genomic profiling with a simple blood draw," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "Precision testing plays a critical role in helping physicians identify the correct treatment, providing patients and their doctors with the comprehensive genomic profiling needed to see if they are eligible to receive the right treatment and improving outcomes."

Breast cancer remains the second leading cause of cancer death among women in the United States.1 Guardant360 CDx was used to identify patients who had ESR1 mutations in the Phase 3 EMBER-3 trial, in which Inluriyo was found to reduce the risk of progression or death by 38% versus ET.2 Patients with ESR1 E380, V422del, S463, L469, L536, Y537, and D538 mutations detected by Guardant360 CDx are eligible for treatment with Inluriyo.

The Inluriyo approval as a companion diagnostic marks the sixth CDx claim approved by the FDA for Guardant360 CDx, and the second FDA-approved indication in breast cancer treatment, following a similar approval for ORSERDU (elacestrant) granted by the FDA in 2023.

For more information about Inluriyo, please visit View Source

Aarvik Therapeutics Announces Successful Series Seed 2 Financing Round

On September 29, 2025 Aarvik Therapeutics, an innovative, ADC-focused biotechnology company dedicated to engineering precision medicines for cancer therapy, reported that it has successfully closed a Series Seed 2 financing round (Press release, Aarvik Therapeutics, SEP 29, 2025, View Source [SID1234656332]).

Following its launch in 2021, Aarvik closed an initial Series Seed financing round and signed a research collaboration agreement. Aarvik established laboratories in Hayward and developed its proprietary MUTTA (MUlti-epitope Targeting Tetravalent Antibody; pronounced MOO-TA) platform with a focus on developing next generation antibody drug conjugates (ADCs) that can expand the success of ADCs beyond a limited number of targets. Aarvik’s comprehensive approach facilitates the lowering of the minimum effective dose (MED) while maintaining or improving the maximum tolerated dose (MTD), thereby significantly improving the therapeutic window. In August 2024, the option was exercised to exclusively license the research collaboration program.

Aarvik’s new round of funding further validates the substantial progress made by Aarvik on the MUTTA platform. The funding comes from a diverse set of investors that includes original Series Seed investors as well as a new group of pharma and tech professionals, and contract research and contract development and manufacturing organizations. This funding will allow Aarvik to reach targeted research milestones and further advance its pipeline of ADC assets.

"We are delighted to see Aarvik reach this new milestone," said Ram K. Reddy, serial entrepreneur, venture partner and Independent Board Member of Aarvik Therapeutics. "The support from new as well as existing investors is a reflection of the progress achieved by Aarvik and the potential of Aarvik’s pipeline."

"Aarvik continues to demonstrate that it can combine its deep ADC drug development expertise with its next-generation MUTTA platform to enable powerful oncology therapies," said Jagath Reddy Junutula, PhD, Co-founder, President and CEO of Aarvik Therapeutics. "Aarvik relentlessly pursues novel therapies for hard-to-treat cancer indications through research and innovation."

TAE Life Sciences Novel Boronated Drugs for BNCT in Combination with Immune Checkpoint Inhibitors Demonstrate Superior Tumor Growth Inhibition in Preclinical in vivo Models

On September 29, 2025 TAE Life Sciences (TLS) reported preclinical results from its collaboration with Kyoto University, demonstrating that its next-generation boron drugs, when combined with immune checkpoint inhibitors, significantly inhibited tumor growth in certain conditions compared with either immunotherapy alone or BNCT alone (Press release, TAE Life Sciences, SEP 29, 2025, View Source [SID1234656331]). Based on the ongoing success of this collaboration and the exciting data being generated, TLS and Kyoto University have extended their BNCT research partnership through December 2026.

TLS’s findings are consistent with recent third-party publications highlighting the unique synergy between BNCT and checkpoint inhibitors. Both independent 2024 studies from Japan reported that combining BNCT with PD-1/PD-L1 blockade enhanced tumor control and survival, reinforcing TLS’s own observations of synergistic immune activation. This alignment underscores the translational potential of TLS’s BNCT-immunotherapy strategy.

"These preclinical results with TLS proprietary boronated compounds confirm the potential to not only deliver targeted BNCT but also amplify the effects of immunotherapy," said Rob Hill, CEO of TAE Life Sciences. "This in turn expands our clinical opportunity and strengthens our position in both oncology and the fast-growing immunotherapy markets."

"Our partnership with Kyoto University has been critical in driving novel drug development for BNCT," added Kendall Morrison, Chief Scientific Officer at TLS. "By extending this partnership through 2026, we ensure continuity in preclinical testing, combination optimization, and translational research that supports our IND-enabling path."

Strategic outlook

These results reinforce the potential for TLS’s novel boronated drugs to transform BNCT from a targeted radiation therapy into a powerful immuno-oncology strategy. By combining the precision of BNCT with the systemic effects of checkpoint inhibition, these drugs may help overcome resistance, broaden patient benefit, and establish a new standard for difficult-to-treat cancers. The extension of TLS’s partnership with Kyoto University provides a strong foundation to advance this program toward IND-enabling studies, first-in-human trials and upcoming scientific milestones.

Novocure to Present Final Results from the Pivotal Phase 3 METIS Trial of its Tumor Treating Fields (TTFields) Therapy for Brain Metastases from Non-Small Cell Lung Cancer at 2025 ASTRO Annual Meeting

On September 29, 2025 Novocure (NASDAQ: NVCR) reported that final results from the Phase 3 METIS trial of Tumor Treating Fields (TTFields) therapy for brain metastases from non-small cell lung cancer (NSCLC) will be presented today at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting taking place September 27 – October 1 in San Francisco and simultaneously published in the International Journal of Radiation Oncology Biology and Physics (Red Journal) (Press release, NovoCure, SEP 29, 2025, View Source [SID1234656330]).

"Lung cancer patients with brain metastases are living longer due to improved systemic therapies, bringing to the forefront an unmet need for well-tolerated treatment options that provide more durable control of brain metastases," said Vinai Gondi, MD, Director of Radiation Oncology in the Northwestern Medicine West Region and Proton Center, Clinical Associate Professor of Radiation Oncology at Northwestern University Feinberg School of Medicine. "The METIS trial, demonstrating that the addition of Tumor Treating Fields following stereotactic radiosurgery delays brain metastasis progression with no negative impact on quality of life or neurocognition, is a pivotal and practice-impacting step forward in providing patients with a new treatment option."

The METIS trial evaluated the use of TTFields therapy and best supportive care (BSC) to treat adult patients with 1-10 newly diagnosed brain metastases from NSCLC following stereotactic radiosurgery (SRS) compared to BSC alone. The trial met its primary endpoint, showing a statistically significant delay in time to first intracranial progression for patients who received TTFields therapy and BSC compared to patients receiving BSC alone.

"One of the challenges in treating patients with primary lung cancer is the high incidence of brain metastases in this population. When Tumor Treating Fields therapy was used to treat patients in the METIS trial, we saw a significant delay in the progression of intracranial metastases without adding systemic toxicity or causing neurocognitive side effects associated with other current treatments," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "We plan to submit our premarket approval application to the FDA for the treatment of adult patients with brain metastases from non-small cell lung cancer in the coming weeks."

Results from Pivotal Phase 3 METIS Trial

The pivotal Phase 3 METIS trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC, who were randomized to receive either TTFields therapy and BSC (n=149) or BSC alone (n=149) following SRS of their brain metastases. Systemic anti-cancer therapy was allowed to treat the primary disease.

The primary endpoint of the METIS trial was defined as the time to intracranial progression (TTIP), as measured from the date of first SRS treatment to intracranial progression or neurological death, whichever occurred first.

When accounting for competing risks using the Fine–Gray method, patients treated with TTFields therapy and BSC experienced a 28% lower risk of intracranial progression compared to those receiving BSC alone (HR 0.72, p=0.044). The median time to intracranial progression was 15.0 months in patients treated with TTFields therapy and BSC compared to 7.5 months in patients treated with BSC alone.

Intracranial progression rates in both groups were measured at specific time points up to 24 months. At 2 months, those patients treated with TTFields therapy and BSC had a 13.6% progression rate compared to 22.1% (p=0.034) in those treated with BSC alone. At 6 months a 33.7% progression rate compared to 46.4% (p=0.018) was observed; at 12 months a 46.9% progression rate compared to 59.4% (p=0.023) was observed and at 24 months the rate was 53.6% compared to 65.2% (p=0.031; post hoc), in those patients treated with TTFields therapy and BSC compared to those treated with BSC alone, respectively.

There was no significant difference observed in the secondary endpoint measures of neurocognitive failure, overall survival or radiological response of brain lesions (measured with MRI).

Time to distant intracranial progression (TTDP) trended in favor of TTFields therapy with a median time to distant progression of 18.6 months for patients treated with TTFields therapy and BSC, and 11.3 months in the BSC alone arm, HR 0.76, p=0.165.

In the 118 patients in the TTFields group who received immune checkpoint inhibitors (ICI) for their primary disease during their participation in the METIS study, the beneficial effects observed on TTIP and TTDP were more pronounced, HR=0.63 and HR=0.41, post hoc, respectively.

TTFields therapy did not cause quality of life deterioration overall in the measured outcomes. Improvements in deterioration-free survival and time to deterioration of the global health status, physical functioning and fatigue domains were observed in patients treated with TTFields therapy.

Median duration of TTFields therapy was 16 weeks and median usage was 67%. Baseline patient demographics and characteristics were well balanced across the arms of the study.

The safety profile of TTFields therapy was consistent with that seen in other clinical trials. Grade 1/2 skin issues were the most common device-related adverse events and subcutaneous tissue events.

Data Presentation & Publication Details

The Phase 3 METIS data, (LBA 03) Tumor Treating Fields (TTFields) After Stereotactic Radiosurgery (SRS) for Brain Metastases from Non-Small Cell Lung Cancer (NSCLC BM): Final Results of The Phase 3 METIS Trial, will be presented by Dr. Gondi September 29 during the 1:30 – 3:00 PM PT Plenary session in the San Francisco Ballroom at the Moscone Center.

The Phase 3 METIS publication in the International Journal of Radiation Oncology Biology and Physics (Red Journal), "Tumor Treating Fields (TTFields) therapy after stereotactic radiosurgery for brain metastases from non-small cell lung cancer: final results of the phase 3 METIS study", will be available online at www.redjournal.org.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.