Category: Health

Release – Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01

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Research News and Market Data on GLSI

 Download as PDFJanuary 22, 2026 6:00am EST

STAFFORD, Texas, Jan. 22, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01.

FDA Reviews and Approves Use of 1st GP2 Commercial Lot in FLAMINGO-01

The first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials is now approved for use in FLAMINGO-01 in the US.

CEO Snehal Patel commented, “With our manufacturing investments in 2023 and 2024, and now the FDA’s review and approval to use the first commercial lot of finished GP2 vials in FLAMINGO-01, we have taken major steps to further de-risk the filing of a BLA in the US. We plan to start using these new GP2 vials in the coming weeks at all 40 US sites. We have 3 years of stability data to support the GP2 vial expiration date which may translate to the commercial expiration date of GP2 vials.”

Preparation for Filing of BLA in the US under Fast Track Designation

In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data for three lots will be critical to the filing of a Biological License Application (BLA) for GLSI-100 in the US and for regulatory filings in other countries. These GP2 vials can be stored in preparation for commercial launch or used in clinical trials. At least two more lots of finished GP2 product will be manufactured so that both clinical and manufacturing data are available for review by the biologics division of the FDA prior to potentially being granted a marketing license with up to 12 years of market exclusivity based on current law.

Mr. Patel further added, “We look forward to submitting the same manufacturing data to regulatory agencies in Europe, the United Kingdom, and Canada. The objective is to manufacture GP2 and to conduct FLAMINGO-01 at the 150 leading clinical sites in the US and Europe in a manner that provides for an efficient transition to product launch and commercial sales if GLSI-100 is approved.”

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

  • In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
  • This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
  • The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

  • 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
  • The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

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Source: Greenwich LifeSciences, Inc.

Released January 22, 2026

Release – Ocugen, Inc. Announces Pricing of $22.5 Million Offering of Common Stock

Posted on by [email protected]

Research News and Market Data on OCGN

January 21, 2026

PDF Version

MALVERN, Pa., Jan. 21, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the pricing of its underwritten offering of 15,000,000 shares of its common stock at an offering price of $1.50 per share of common stock for gross proceeds of $22.5 million, before deducting commissions and other estimated offering expenses payable by Ocugen. The offering is expected to close on or about January 22, 2026, subject to the satisfaction of customary closing conditions. All of the securities to be sold in the offering are being offered by Ocugen. The financing is being led by RTW Investments, with additional participation from new and existing investors.

Ocugen intends to use the net proceeds from the offering for general corporate purposes, capital expenditures, working capital, and general and administrative expenses.

Oppenheimer & Co. is acting as the sole book-running manager for the offering.

The offering is being made by Ocugen pursuant to a shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the Securities and Exchange Commission (the “SEC”) on April 18, 2024, which became effective on May 1, 2024. The securities may be offered only by means of a prospectus and prospectus supplement that form a part of the registration statement. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. When available, copies of the prospectus supplement and the accompanying base prospectus relating to the offering, may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Oppenheimer & Co. Inc. Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at [email protected].

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 registration or qualification under the securities laws of such state or jurisdiction.

About Ocugen, Inc.

Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding Ocugen’s expectations regarding the timing of the completion of the offering and the anticipated use of proceeds. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the SEC, including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by applicable law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, changed circumstances or otherwise, after the date of this press release.

Ocugen Contact:

Tiffany Hamilton
AVP, Head of Communications
[email protected]

Release – NeuroSense Granted U.S. Patent for Treatment of Alzheimer’s Disease

Posted on by [email protected]

Research News and Market Data on NRSN

  • Patent protection extended through 2043
  • Alzheimer’s proof-of-concept study completed
  • Clinical and Biomarker Outcomes Expected in Q1 2026

CAMBRIDGE, Mass., Jan. 21, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the United States Patent and Trademark Office has granted U.S. Patent No. 12,527,768, entitled “Compositions Comprising an Anti-Inflammatory Drug and a Dicer Activator for use in the Treatment of Neuronal Diseases.”

The granted patent provides protection for the use of PrimeC combination in Alzheimer’s disease, strengthening NeuroSense’s intellectual property estate and supporting the program’s long-term development and potential commercialization, with protection extending through 2043.

“This patent meaningfully expands and reinforces our intellectual property position around the PrimeC combination,” said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. “It reflects both the breadth of the underlying biology and our strategy to build durable protection as we advance PrimeC combination clinically in Alzheimer’s disease and other neurodegenerative conditions.”

NeuroSense recently concluded its proof-of-concept Alzheimer’s disease study (RoAD), with top-line results demonstrating a favorable safety and tolerability profile. Clinical and biomarker outcomes from the study are expected in the first quarter of 2026.

About Alzheimer’s Disease
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.

About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the timing of the reporting of additional data from the study of PrimeC in Alzheimer’s disease, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

For further information: For further information: Email: [email protected], Tel: +972-(0)9-799-6183

Release – GeoVax Highlights 2026 as a Pivotal Year for Progress

Posted on by [email protected]

Research News and Market Data on GOVX

Management Highlights 2026 as a Portfolio-Wide Inflection Year Driven by Regulatory De-Risking, Clinical Readouts, and Scalable Manufacturing

ATLANTA, GA – January 20, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today provided a post-conference update following the J.P. Morgan Healthcare Conference Week in San Francisco, where, during investor, banker and partner engagements, the Company outlined 2026 as a pivotal inflection year driven by multiple late-stage clinical, regulatory, and manufacturing milestones across its diversified portfolio.

“GeoVax enters 2026 with increasing clarity on execution, prioritization, and value creation,” said David Dodd, Chairman & CEO of GeoVax. “With GEO-MVA representing an expedited path to potential commercialization, alongside multiple clinical data readouts relative to GEO-CM04S1, our multi-antigen COVID-19 vaccine and, the anticipated initiation of the Phase 2 Gedeptin® trial, we believe that this year will provide a meaningful convergence of regulatory, clinical, and manufacturing catalysts for the Company.”

Dodd added, “We were particularly encouraged by the level of interest and the quality of discussions we had during JP Morgan/Biotech Showcase with investors, potential strategic partners, and global health stakeholders. The feedback we received around GeoVax’s progress, our differentiated platforms, and our regulatory momentum, especially for GEO-MVA, reinforces our confidence that 2026 has the potential to be a pivotal breakout year for the Company.”

GEO-MVA (Mpox & Smallpox): Expedited Path to Commercialization in a Currently Constrained Market

GEO-MVA is GeoVax’s most advanced program and represents the Company’s near-term opportunity for potential commercialization. The global Mpox and smallpox vaccine market remains constrained by reliance on a single foreign manufacturer whose production capacity has proven insufficient to meet sustained worldwide demand, particularly during periods of expanding or recurring outbreaks. This structural supply imbalance underscores both the commercial opportunity and the public health imperative for an additional, scalable MVA vaccine source.

Following receipt of supportive Scientific Advice from the European Medicines Agency (EMA), GeoVax has regulatory alignment on a single, pivotal Phase 3 immunobridging study versus the approved MVA vaccine. This guidance supports an expedited development pathway and meaningfully de-risks the regulatory route toward potential approval and revenue generation.

Key 2026 milestones for GEO-MVA include:

  • Initiation of the pivotal Phase 3 immunobridging trial, expected in the second half of 2026
  • Continued engagement with European and global health authorities seeking to diversify Mpox and smallpox vaccine supply in light of ongoing global demand pressures
  • Advancement toward a U.S.-sourced vaccine supply model addressing both civilian public health needs and biodefense preparedness

With GEO-MVA clinical material manufactured and fill-finish completed, the program is positioned to transition from development into Phase 3 execution in 2026, reinforcing its role as GeoVax’s lead value driver and shortest path to potential commercialization.

Gedeptin® (Oncology): Advancing Toward Combination-Driven Value Inflection

In oncology, GeoVax continues to advance Gedeptin®, its gene-directed enzyme prodrug therapy, following encouraging safety and tumor-response signals from prior clinical studies.

Key 2026 inflection points include:

  • Publication of results from the recently completed Gedeptin trial
  • Initiation of a Phase 2 study evaluating Gedeptin in combination with an immune checkpoint inhibitor as a potential first-line therapy for head and neck cancer by year-end
  • Updates on preclinical evaluations of Gedeptin in combination with immune checkpoint inhibitors, informing potential expansion into additional solid tumor indications.

GeoVax continues to pursue a partnership-oriented development strategy for Gedeptin, designed to advance the program efficiently while preserving long-term upside.

GEO-CM04S1 (COVID-19): Multiple Clinical Data Readouts

GeoVax’s next-generation COVID-19 vaccine, GEO-CM04S1, continues to advance as a differentiated, multi-antigen (Spike + Nucleocapsid) candidate designed to address unmet needs in immunocompromised and high-risk populations inadequately served by current single-antigen vaccines.

During 2026, the Company expects:

  • Clinical data readouts from ongoing Phase 2 trials
  • Continued evaluation of GEO-CM04S1 as both a primary and booster vaccine in immunocompromised populations
  • Additional translational insights supporting future regulatory and partnering discussions

AGE1 Continuous Cell-Line Manufacturing: Advancing MVA Scalability and Supply

The AGE1 continuous avian cell-line manufacturing process has the potential to significantly improve how MVA-based vaccines are produced by addressing historical scalability and supply constraints. By enabling continuous, cell-line–based production, AGE1 provides a more reliable and scalable alternative to traditional chicken embryo fibroblast–dependent methods.

AGE1 is directly integrated into the GEO-MVA program, strengthening GeoVax’s ability to support sustained commercial supply, rapid scale-up, and domestic manufacturing – capabilities increasingly critical as global demand for Mpox and smallpox vaccines exceeds available supply.

Manufacturing progress anticipated during 2026 includes:

  • Continued optimization of the AGE1 process to support commercial-scale GEO-MVA production
  • Advancement of AGE1 as a scalable, U.S.-based manufacturing solution aligned with pandemic preparedness and supply-chain resilience priorities

Positioned for Execution

Collectively, these milestones reflect GeoVax’s transition into a catalyst-rich period where multiple programs are advancing in parallel toward late-stage development, regulatory decision points, and potential commercialization pathways.

“As we emphasized during JP Morgan/Biotech Showcase Week, GeoVax has moved beyond platform validation,” Dodd added. “We are now executing against clearly defined milestones, with GEO-MVA leading the portfolio and multiple additional programs advancing toward value-inflection events in 2026 and beyond.”

Dodd concluded, “As we move through 2026, GeoVax is entering a phase where years of platform development, regulatory engagement, and manufacturing investment begin to translate into tangible outcomes. With GEO-MVA advancing along a clearly defined path toward commercialization, multiple clinical data readouts expected across our COVID-19 and oncology programs, and a scalable manufacturing foundation in place, we believe GeoVax is well positioned for a pivotal year of execution and value creation.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Release – MAIA Biotechnology Advances Ateganosine Cancer Treatment Program, Outlines Targeted 2026 Clinical Milestones and Growth Momentum

Posted on by [email protected]

Research News and Market Data on MAIA

January 20, 2026 10:15am EST Download as PDF

High probability of technical success in pivotal Phase 3 trial based on unmatched efficacy data for third-line non-small cell lung cancer (NSCLC) treatment

FDA’s Fast Track designation for ateganosine in NSCLC advances concurrent Phase 2 expansion and Phase 3 trials along strategic regulatory pathways

Strong momentum toward goal of early commercial approval

Potential breakthrough therapeutic for estimated $50+ billion global immunotherapy market;
first and only telomere-targeting anticancer agent in clinical development anywhere

CHICAGO, Jan. 20, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today provided a corporate update on 2025 achievements and highlighted key targeted milestones and growth catalysts for 2026.

“MAIA’s strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks,” said MAIA founder and CEO Vlad Vitoc, M.D. “The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA’s Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways.

“Our statistical assessments of ateganosine imply a high probability of technical success in our concurrent Phase 3 and Phase 2 trials. As our first-in-class small molecule advances toward potential early commercial approval—possibly within 18 to 24 months—we believe our strong execution is driving a clear value-creation inflection point, with meaningful long-term benefits for stockholders.”

2025 Achievements

  • Secured FDA Fast Track designation for ateganosine as a treatment for NSCLC. Fast Track expedites the review of investigational drugs that treat serious conditions and fill an unmet medical need.
  • Marked a major clinical milestone by initiating a full approval THIO-104 Phase 3 trial in third-line (3L) NSCLC patients resistant to immunotherapy and chemotherapy.
  • Advanced the THIO-101 Phase 2 clinical trial to the Part C expansion phase, substantially increasing the patient pool to include countries in Asia and Europe. The expansion trial positions the ateganosine program for broader regulatory and commercial relevance.
  • Awarded $2.3 million grant from the National Institutes of Health (NIH) for the expansion of Phase 2 trial. The grant is intended to support expenses related to the enrollment of U.S. patients who are resistant to chemo and immunotherapy.
  • Validated telomere-targeting as a differentiated therapeutic approach with applicability to multiple high mortality cancers. To our knowledge, ateganosine remains the only direct telomere-targeting anticancer agent in clinical development anywhere.
  • Established checkpoint inhibitor combination partnerships through a master agreement with Roche for atezolizumab and a clinical supply agreement with BeOne Medicines for tislelizumab, enabling multiple future combination trials.
  • Raised approximately $17.6 million from capital raises throughout 2025, with participation by members of the Board in nearly all transactions. This signals strong conviction and confidence in the long-term value creation potential of the ateganosine platform. As of December 31,2025, MAIA’s directors and officers hold more than 5 million shares or approximately 13% of the Company.

Targeted 2026 Milestones

  • Initial measures of efficacy from Phase 3 study. Interim disease control rates (DCR), overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will support regulatory discussions. Strong interim data could lead to early full commercial approval.
  • Conclusion of Part C of Phase 2 study. Expansion of the trial provides additional clinical efficacy data to support regulatory review for commercial approval.
  • Engage in regulatory interactions with the FDA. Expand ongoing FDA dialogue under the Fast Track designation, including discussions around trial enhancements and prospects for Accelerated Approval and Priority Review.
  • Clinical development of second-generation molecules to start in Phase 1 trials. Additional small molecules fully developed in-house with better expected efficacy compared to ateganosine.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

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Source: MAIA Biotechnology, Inc.

Released January 20, 2026

GSK’s $2.2 Billion Acquisition of RAPT Therapeutics Highlights Big Pharma’s Appetite for Small-Cap Innovation

Posted on by [email protected]

GSK’s agreement to acquire RAPT Therapeutics for $58 per share in cash underscores a growing trend in biotech investing: large pharmaceutical companies are increasingly turning to small-cap innovators to fill critical gaps in their pipelines. For small-cap investors, the deal offers a clear example of how differentiated science, even at the clinical-stage level, can command a meaningful premium.

Under the terms of the agreement, GSK will acquire RAPT Therapeutics for an estimated equity value of $2.2 billion, or approximately $1.9 billion net of cash acquired. The transaction is expected to close in the first quarter of 2026, pending customary regulatory approvals and shareholder tender conditions. Shares of RAPT surged following the announcement, reflecting both the attractive takeover premium and validation of the company’s lead asset.

At the center of the deal is ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody currently in Phase IIb development for prophylactic protection against food allergens. IgE is a clinically validated target and is responsible for roughly 94% of severe food allergy reactions, making it one of the most established mechanisms in allergy treatment. However, existing anti-IgE therapies require injections every two to four weeks, creating a significant burden for patients—most of whom are children.

Ozureprubart’s potential differentiator lies in its dosing profile. The therapy is designed to be administered once every 12 weeks, which could dramatically improve patient compliance and expand treatment eligibility to an estimated 25% of patients who are currently unable to use standard therapies. If successful in late-stage trials, ozureprubart could represent a best-in-class option in a market with substantial unmet medical need.

From GSK’s perspective, the acquisition strengthens its Respiratory, Immunology, and Inflammation pipeline and leverages its existing commercial footprint in allergy and immunology. For a company of GSK’s scale, the upfront investment is manageable, while the long-term upside could be significant. In the U.S. alone, more than 17 million people are diagnosed with food allergies, with over 1.3 million experiencing severe reactions that often require emergency care.

For small-cap investors, the RAPT deal is instructive. RAPT was a clinical-stage company without an approved product, yet it attracted a multibillion-dollar buyout based on a single, well-positioned asset targeting a validated pathway. This reinforces the idea that big pharma is willing to pay for de-risked science, especially when it addresses large, underserved markets and fits cleanly into an existing commercial infrastructure.

The transaction also highlights the importance of platform credibility. RAPT’s focus on immunology and its ability to advance ozureprubart into mid-stage clinical development made it a credible acquisition target rather than a speculative bet.

While not every small-cap biotech will see a similar outcome, GSK’s acquisition of RAPT Therapeutics serves as a reminder that disciplined execution, clear differentiation, and alignment with big pharma priorities can create substantial shareholder value—even before commercialization.

Ocugen (OCGN) – Preliminary Phase 2 Data From OCU410 Shows Improvements in dAMD Geographic Atrophy

Posted on by [email protected]


Friday, January 16, 2026

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Positive Preliminary Data From The OCU410 Trial. Ocugen announced first data from its Phase 2 ArMaDa trial testing OCU410 in Geographic Atrophy associated with dry Age-related Macular Degeneration (GA-dAMD). The announcement included the patients who have reached 12 months after treatment, with 23 out of the total 51 patients enrolled. The data shows an overall 46% reduction in lesion growth compared with controls. We see this as a highly meaningful difference.

OCU410 Is A Single-Treatment Gene Therapy. OCU410 is being developed as gene therapy for patients with GA secondary to dry AMD. A single OCU410 intravitreal injection delivers RORA (retinoid-related orphan receptor alpha), a nuclear receptor that regulates key pathways involved in retinal homeostasis with four mechanisms of action.


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Release – Ocugen Announces Positive Preliminary Phase 2 Data from OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Posted on by [email protected]

Research News and Market Data on OCGN

January 15, 2026

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  • Phase 2 (~50% of patients evaluated to date at 12 months) shows 46% lesion growth reduction vs. control
  • There are no OCU410-related serious adverse events reported across the Phase 1 and Phase 2 clinical trials to date

MALVERN, Pa., Jan. 15, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced positive preliminary 12-month data (~50% of patients evaluated to date) from the Phase 2 ArMaDa clinical trial evaluating OCU410 (AAV5-RORA), its novel modifier gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The global prevalence of dAMD is 266 million worldwide, and GA – the late stage of dAMD – affects approximately 2-3 million people in the United States (U.S.) and Europe.

There are limited options for patients with dAMD in the U.S. and current therapies involve frequent (monthly or every other month) injections and have unwanted side effects that can affect vision. Outside of the U.S., there are no approved products available, leaving approximately 2 million patients in Europe without a treatment option.

Key findings from Phase 2 include:

  • 46% lesion growth reduction (medium + high dose vs. control; p=0.015; N=23) at 12 months
  • Medium dose achieved 54% lesion reduction (p=0.02; N=10) vs. high dose 36% (p=0.05; N=8) compared to control
  • 50% responder rate with patients achieving >50% lesion size reduction vs. control
  • Subgroup (N=14, subjects with ≥7.5 mm2 at baseline) showed 57% greater reduction in lesion size compared to control

New findings from Phase 1 (N=9) include:

  • In evaluable subjects (N=7) ellipsoid zone (EZ) loss was 60% slower in OCU410-treated eyes compared to untreated fellow eyes at 12 months
  • EZ-RPE complex loss reduced in treated eyes versus fellow eyes, demonstrating photoreceptor + RPE preservation

In both the Phase 1 and Phase 2 clinical trials no OCU410-related serious adverse events were observed and no cases of endophthalmitis, retinal detachment, vasculitis, choroidal neovascularization, or optic ischemic neuropathy have been reported to date.

GA is a multifactorial disease with a complex etiology that involves genetic and environmental factors. The current treatment options for GA in the U.S. are limited to those targeting a single mechanism—the complement pathway—requiring frequent intravitreal injections, either monthly or every other month. By contrast, OCU410 is a multifunctional modifier gene therapy, which targets multiple pathways associated with GA.

“The OCU410 Phase 1 and Phase 2 results mark a pivotal moment for Ocugen’s modifier gene therapy platform and GA patients worldwide,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Delivering 60% slower EZ loss in Phase 1 and 46% lesion growth reduction in the Phase 2 preliminary analysis demonstrates the capability of our multi-pathway RORA approach. We look forward to reporting full data from the OCU410 Phase 2 clinical trial later this quarter and initiating Phase 3 in 2026.”

“The clinical development journey of OCU410 has been remarkable,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “Our Phase 2 randomized trial delivered robust anatomic efficacy that was statistically significant across multiple analyses. Critically, our safety data across 60 patients has shown no drug-related serious adverse events, no inflammation signals, and no injection complications to date, supporting a favorable risk-benefit profile.”

“As a practicing retinal specialist, OCU410’s clinical profile is genuinely exciting for geographic atrophy patients—including a reduction in ellipsoid zone loss observed in Phase 1, which may serve as a potential marker of retinal health, and a reduction in lesion growth seen in Phase 2,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Professor of Ophthalmology with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Retina Scientific Advisory Board Chair of Ocugen. “With these promising results, I believe OCU410 has the potential to set a new standard of care with a single treatment for life.”

In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD are being assessed. Fifty-one (51) patients were randomized 1:1:1 into either of two treatment groups (medium or high dose) or a control group. In the treatment groups, subjects received a single subretinal 200-µL administration of 5 x 1010 vector genomes (vg)/mL (medium dose) or 1.5 x 1011 vg/mL (high dose), while the control group remained untreated. The Company remains on track for a Biologics License Application (BLA) filing for OCU410 in 2028, aligned with its strategy to advance three regulatory submissions for marketing authorization in three years.

About dAMD and Geographic Atrophy
Geographic atrophy is an advanced form of dAMD characterized by progressive degeneration of the macula, leading to irreversible central vision loss. Millions of patients worldwide are affected by GA, with a particularly high burden in aging populations in the United States and Europe. Despite recent approvals, treatment options remain limited and require chronic intravitreal injections, underscoring the need for innovative, durable therapies that address multiple disease mechanisms. dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 is an investigational, intravitreally administered, AAV5-based gene therapy that delivers RORA (retinoid-related orphan receptor alpha), a nuclear receptor that regulates key pathways involved in retinal homeostasis, including oxidative stress response, complement regulation, inflammation, and lipid metabolism. OCU410 is being developed as a one-time gene therapy for patients with GA secondary to dry AMD. OCU410 has received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]

Release – Ocugen to Host Webcast on Thursday, January 15 at 8:30 a.m. ET to Discuss OCU410 Phase 2 Clinical Trial Data

Posted on by [email protected]

Research News and Market Data on OCGN

January 13, 2026

PDF Version

MALVERN, Pa., January 13, 2026 (GLOBE NEWSWIRE) – Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast with KOLs and Ocugen executive leadership to discuss data from the first half of patients completing one year since treatment in the OCU410 Phase 2 ArMaDa clinical trial at 8:30 a.m. ET on Thursday, January 15, 2026. OCU410 is the Company’s novel modifier gene therapy candidate for geography atrophy secondary to dry age-related macular degeneration.

Study investigators leading the webcast include:

  • Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno School of Medicine
     
  • Jay Chhablani, MD, Vitreo-Retina Specialist at the University of Pittsburgh Eye Center
     
  • Lejla Vajzovic, MD, FASRS, Professor of Ophthalmology, Director of CME-Ophthalmology, Duke University School of Medicine
     

Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7783588
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]

Release – Cadrenal Therapeutics Highlights High Incidence of Thrombotic Complications in Heparin-Induced Thrombocytopenia (HIT) at the J.P. Morgan Healthcare Conference and VLX-1005 as a Potential Therapeutic Solution as the First and Only Selective 12-LOX Inhibitor

Posted on by [email protected]

Research News and Market Data on CVKD

Company to also participate in Fireside Chat at Lytham Partners 2026 Investor Healthcare Summit on Thursday, January 15, 2026

SAN FRANCISCO, Jan. 12, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today highlighted the significant and persistent unmet medical need in heparin-induced thrombocytopenia (HIT) and underscored the promise of its recently acquired investigational drug candidate, VLX-1005, the first and only potent, highly selective 12-LOX inhibitor in clinical testing as a potential new treatment option.

Cadrenal Therapeutics acquired VLX-1005 in December 2025, recognizing its potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders.

Emerging data from a recent Phase 2 clinical trial evaluating VLX-1005 in individuals with suspected HIT suggest that VLX-1005 may reduce thrombotic complications, supporting its further development as a novel, mechanism-based therapy. Early trial results suggest that selective 12-LOX inhibition may offer a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation.

HIT is a serious immune-mediated reaction to heparin that paradoxically increases the risk of thrombosis despite a drop in platelet count. It occurs when antibodies activate platelets, triggering widespread clot formation in veins and arteries. Thrombotic complications affect a large proportion of patients and are the primary cause of illness and death in HIT. Recent clinical and translational research continues to reinforce the urgent need for safer, more targeted therapies that address the immune-driven platelet activation underlying this disease.

Recent findings reported in a 2025 American Society of Hematology (ASH) abstract by Shatzel et al. and in a 2025 publication by Ramadan et al. highlight the high incidence and clinical burden of thrombotic complications in HIT, even with current standard-of-care anticoagulation. These data emphasize the limitations of existing therapies, which primarily inhibit coagulation pathways but do not directly modulate the platelet immune responses central to HIT pathophysiology.

Growing scientific evidence has identified 12-lipoxygenase (12-LOX) as a key mediator of platelet activation and immune thrombotic responses. Foundational work by McKenzie et al. (2022) significantly advanced the understanding of 12-LOX signaling in platelet-driven immune thrombosis, including in HIT, supporting the enzyme as a compelling therapeutic target.

Historically, however, drug development efforts targeting 12-LOX have been hindered by a lack of selectivity, raising concerns about off-target effects and safety. This challenge has limited the clinical translation of earlier 12-LOX inhibitors.

VLX-1005 represents a breakthrough in this area. Supported by preclinical and translational studies (Tourdot et al., 2017; Renna et al., 2023), VLX-1005 is the first and only highly selective 12-LOX inhibitor in clinical development. Its selectivity profile is designed to specifically modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways.

Cadrenal is moving forward rapidly to engage with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT.

“HIT remains a life-threatening condition with a strikingly high risk of thrombosis despite available therapies,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “By selectively targeting 12-LOX, VLX-1005 has the potential to address a core disease mechanism in HIT. We believe this program represents a meaningful opportunity to improve outcomes for patients who currently have limited options.”

VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation oral therapeutics targeting 12-LOX are also under development for type 1 diabetes and other chronic immune-mediated and inflammatory diseases.

Lytham Partners 2026 Investor Healthcare Summit

Cadrenal will participate in a webcast fireside chat at the Lytham Partners 2026 Investor Healthcare Summit, which will be held virtually at 4:30 p.m. ET on Thursday, January 15, 2026.

The webcast can be accessed via the conference home page at https://lythampartners.com/hc2026/ or at https://lythampartners.com/hc2026/cvkd. A replay will also be available through the same links.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products designed to bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding VLX-1005 as a potential therapeutic solution, the promise of VLX-1005 as a potential new treatment option for HIT, VLX-1005’s potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, VLX-1005 reducing thrombotic complications in patients with HIT, selective 12-LOX inhibition offering a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation, 12-LOX inhibitor in clinical development advancing into human clinical development, 12-LOX being able to modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways, Cadrenal moving forward to engage with the FDA to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT, the program representing a meaningful opportunity to improve outcomes for patients who currently have limited options. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT, including designing a pivotal Phase 3 registration study acceptable to the FDA; Cadrenal’s ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected including support for VLX-1005’s potential to be a treatment option for HIT and transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
[email protected]

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
[email protected]

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Release – Ocugen Announces Publication of Phase 1 GARDian1 Trial Results for OCU410ST Modifier Gene Therapy

Posted on by [email protected]

Research News and Market Data on OCGN

January 12, 2026

PDF Version

  • Study supports favorable safety and tolerability profile and clinically meaningful functional and structural benefits in Stargardt disease patients

MALVERN, Pa., Jan. 12, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the publication of positive Phase 1 GARDian1 trial results for OCU410ST, its novel modifier gene therapy for Stargardt disease, in the peer-reviewed journal Nature Eye—published by the Royal College of Ophthalmologists.

The publication, A novel modifier gene therapy to treat Stargardt disease: Phase 1 GARDian1 Trial Insights, was authored by Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno School of Medicine; Lejla Vajzovic, MD, FASRS, Professor of Ophthalmology, Director of CME-Ophthalmology, Duke University School of Medicine; Benjamin A. Bakall, MD, PhD. Associated Retina Consultants, President and Founder, Retina Research Foundation of America, Clinical Assistant Professor, University of Arizona College of Medicine; and Ocugen researchers Dr. Murthy Chavali and Dr. Huma Qamar. The publication reports comprehensive 12-month safety, tolerability, and exploratory efficacy data from the first-in-human Phase 1 trial evaluating OCU410ST in patients with early to advanced Stargardt disease.

The Phase 1 GARDian1 trial demonstrated robust efficacy and safety outcomes supporting the clinical development of OCU410ST:

Key Findings include:

  • Among six patients with gradable Fundus Auto Fluorescence images, atrophic lesion growth was reduced by 54% (0.55 ± 0.27 mm²) in treated eyes, compared to untreated fellow eyes (1.19 ± 0.31 mm²) over 12 months​
  • Lesion expansion was 50% slower (0.10 ± 0.039 mm/year) in treated eyes versus untreated eyes (0.19 ± 0.026 mm/year), below published natural history rates​ (0.14–0.18 mm/year)
  • Among six BCVA-evaluable patients without confounders, treated eyes gained +6 letters in BCVA (+4.5 letters) compared to a −1.5 letter decline in untreated fellow eyes at 12​ months
  • 100% of treated eyes either stabilized (±4 letters) or improved (≥5 letters) in visual acuity​
  • No drug-related serious adverse events or adverse events of special interest were observed​

Stargardt disease is the most common form of inherited macular degeneration, affecting more than 100,000 people in the United States and Europe combined. The disease is characterized by progressive central vision loss due to photoreceptor degeneration caused by toxic lipofuscin accumulation in the retinal pigment epithelium. Currently, no approved treatment exists for this devastating condition, representing a critical unmet medical need.

“This publication in Eye validates the scientific approach and clinical promise of OCU410ST as a modifier gene therapy for Stargardt disease,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “The Phase 1 GARDian1 trial demonstrated convergent functional and structural benefits. This represents a paradigm shift from any other approaches, including oral or mutation-constrained replacement approaches, to an agnostic modification strategy that can potentially benefit patients regardless of their underlying ABCA4 mutation with a potential single gene therapy for life. These results provide important support for our ongoing Phase 2/3 GARDian3 trial.”

“The consistent benefits observed across both structural and functional endpoints including slowing atrophic lesion progression and stabilization or improvement in visual acuity highlight the potential of this modifier gene therapy platform approach to transform treatment outcomes for patients with Stargardt disease, who currently have no disease-modifying options available,” said Dr. Arshad M. Khanani, lead author of the publication, Director of Clinical Research at Sierra Eye Associates, and Ocugen Scientific Advisory Board member. “I am looking forward to the data read out from the ongoing Phase 2/3 GARDian3 trial.”

The Phase 2/3 GARDian3 trial is progressing ahead of schedule with anticipated enrollment completion in the first quarter of 2026. The Company remains positioned for Biologics License Application (BLA) filing in the first half of 2027, aligned with its strategy to advance three regulatory submissions in three years.

About OCU410ST
OCU410ST utilizes an AAV5 delivery platform to deliver the RORA (RAR-Related Orphan Receptor A) gene to the retina. By restoring nuclear hormone receptor signaling, OCU410ST addresses pathophysiological pathways linked to Stargardt disease, including lipofuscin formation, oxidative stress, complement activation, inflammation, and photoreceptor survival networks independent of the underlying ABCA4 genotype.

About Stargardt Disease
Stargardt disease type 1 is a genetic eye disorder caused by biallelic mutations in the ABCA4 gene. The condition leads to progressive macular degeneration, with onset typically occurring during childhood or adolescence. Affected patients experience progressive central vision loss while peripheral vision is usually preserved. There are currently no FDA-approved treatments for this orphan indication.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]

Release – Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2026 Outlook

Posted on by [email protected]

Research News and Market Data on ELDN

January 8, 2026

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Phase 2 BESTOW trial data evaluating tegoprubart in kidney transplantation showed favorable efficacy, safety and tolerability, supporting advancement into Phase 3 development

Reported positive preliminary results from first six patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study

Tegoprubart continues to be used as key component of immunosuppression regimen in xenotransplants, including three transplants of a genetically modified pig kidney into a human at Massachusetts General Hospital

Completed $57.5 million financing, with funds expected to support operations into 2Q 2027

IRVINE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced a summary of 2025 accomplishments and provided guidance for anticipated upcoming 2026 business milestones.

“2025 was a significant year for Eledon as we achieved multiple key milestones across our tegoprubart clinical programs in kidney allotransplantation, islet transplantation and xenotransplantation. We were particularly encouraged by results from our Phase 2 BESTOW trial, presented at ASN Kidney Week in November, which further validated the favorable safety and tolerability profile of tegoprubart, reducing the metabolic, neurologic and cardiovascular toxicities commonly associated with tacrolimus,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We look forward to engaging with regulatory authorities, including the FDA, as we advance tegoprubart into Phase 3 development this year, with the goal of delivering a safer alternative to tacrolimus-based immunosuppression. We also remain focused on expanding the potential of tegoprubart to address broader challenges such as organ shortages and type 1 diabetes and look forward to providing additional updates throughout the year.”

2025 Key Highlights

  • Presented results from the Phase 2 BESTOW clinical trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX. Tegoprubart demonstrated a favorable safety and tolerability profile, reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus, the current standard of care in immunosuppression therapy. Kidney function, as measured by estimated glomerular filtration rate (eGFR), for study participants treated with tegoprubart was 69 mL/min/1.73 m² (n=51) at 12 months, delivering what the Company believes is the highest mean eGFR level reported to date in larger kidney transplant clinical trials evaluating rejection prevention. The efficacy failure composite endpoint including rejection rate was 22.2% in the tegoprubart group vs. 17.2% in the tacrolimus group demonstrating non-inferiority for tegoprubart vs. tacrolimus, using a 20% non-inferiority margin. The data support the advancement of tegoprubart into Phase 3 clinical development as a potential new standard immunosuppression approach for the prevention of organ rejection in patients undergoing kidney transplantation.
  • Reported positive preliminary results from the first six patients with type 1 diabetes (T1D) treated with tegoprubart as the core immunosuppressant following islet transplantation in an investigator-initiated trial conducted at the University of Chicago Medicine’s Transplant Institute. All six treated patients achieved insulin independence with marked improvements in glycemic control after one or two transplants, with the first three remaining insulin-free for more than one year after transplant. Results demonstrated prevention of islet rejection without calcineurin inhibitors (CNIs), such as tacrolimus, and sustained insulin-free HbA1c control. To date, a total of eight patients have undergone islet transplantation with tegoprubart as the core immunosuppressant, and one additional patient with CNI-associated nephrotoxicity was transitioned to tegoprubart from tacrolimus.
  • Announced the use of tegoprubart as a cornerstone component of the immunosuppression treatment regimen in a patient who received a xenotransplant of a genetically modified pig kidney, conducted at Massachusetts General Hospital (MGH) in collaboration with eGenesis. This procedure marked the fourth use of tegoprubart in a pig-to-human xenotransplant and the third use at MGH.
  • Completed a $57.5 million underwritten public offering of common stock and pre-funded warrants, which is anticipated to support company operations into the second quarter of 2027.

Anticipated 2026 Milestones

  • Present 24-month data from eight patients in Phase 1 extension study evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons (ASTS) Winter Symposium in Phoenix, AZ. Details are below:

    Title: Long-Term Outcomes of a Phase 1, Single Arm Cohort of De Novo Kidney Transplant Recipients Treated with Tegoprubart, an Anti-CD40L Antibody, as the Core Immunosuppression Regimen
    Abstract ID: #44
    Session Title: Poster Session B
    Date: Friday, January 23, 2026, from 5:45 – 7:15 p.m. PT
  • Receive U.S. Food & Drug Administration (“FDA”) guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.
  • Report long-term data from the Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
  • Report updated data from T1D patients in the investigator-led islet cell transplantation study evaluating tegoprubart at UChicago Medicine.
  • Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation.
  • Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.
  • Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
  • Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to establish and maintain proper and effective internal control over financial reporting and other risks disclosed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 14, 2025. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

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Source: Eledon Pharmaceuticals, Inc.

World-Renowned Alzheimer’s Expert Prof. Steven Arnold Joins NeuroSense SAB

Posted on by [email protected]

Research News and Market Data on NRSN

Alzheimer’s Clinical and Biomarker Outcomes Expected in Q1 2026

CAMBRIDGE, Mass., Jan. 8, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that Prof. Steven E. Arnold, a world-renowned Alzheimer’s disease expert and Professor of Neurology at Harvard Medical School, has joined the Company’s Scientific Advisory Board. Prof. Arnold brings decades of experience in neurodegenerative disease research, biomarker-driven clinical development, and translational neuroscience, further strengthening NeuroSense’s scientific leadership as it advances PrimeC in ALS and expands its Alzheimer’s disease program.

“Prof. Arnold’s depth of experience in biomarker-driven clinical development and translational neuroscience aligns closely with how we are advancing our programs,” said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. “His perspective will be valuable as we continue to execute across both Alzheimer’s disease and ALS.”

“PrimeC’s multi-target mechanism addresses biological pathways that are highly relevant to Alzheimer’s disease,” said Prof. Steven E. Arnold. “I look forward to reviewing the forthcoming clinical and biomarker data and to contributing to the program as it moves forward.”

NeuroSense recently concluded its proof-of-concept Alzheimer’s disease study (RoAD), with top-line results demonstrating a favorable safety and tolerability profile. Clinical and biomarker outcomes from the study are expected in the first quarter of 2026. 

About Alzheimer’s Disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the timing of the reporting of additional data from the study of PrimeC in Alzheimer’s disease, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

For further information: For further information: Email: [email protected], Tel: +972 (0)9 799 6183