Biotech Archives - Channelchek

Release – Eledon Pharmaceuticals Presents Long-Term Phase 1b Data for Tegoprubart in Kidney Transplant Patients at the American Society of Transplant Surgeons Winter Symposium

Posted on January 23, 2026January 23, 2026 by slightbourne@noblecapitalmarkets.com

January 23, 2026

Data from eight participants continue to support safety and tolerability profile of tegoprubart

Mean eGFR increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months

IRVINE, Calif., Jan. 23, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that it will present 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium, taking place January 23–25, 2026, in Scottsdale, Arizona.

There were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months.

Details on the poster presentation 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
Poster: #62
Session Title: Poster Session B
Date: Friday, January 23, 2026, from 5:45 – 7:15 p.m. PT

Following the presentation, a copy of the poster will be available in the Investors section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

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, 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
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

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

Posted on January 22, 2026January 22, 2026 by aweinsoff@channelchek.com

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 1^st 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: flamingo-01@greenwichlifesciences.com

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: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

Released January 22, 2026

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

Posted on January 20, 2026January 20, 2026 by slightbourne@noblecapitalmarkets.com

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 January 16, 2026January 16, 2026 by slightbourne@noblecapitalmarkets.com

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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Gyre Therapeutics, Inc (GYRE) – Hydronidone NDA Planned For 1H26, Meeting Expected Milestone

Posted on January 6, 2026January 6, 2026 by slightbourne@noblecapitalmarkets.com

Tuesday, January 06, 2026

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 Guidance Received From CDE. Gyre announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Ltd, has completed pre-NDA discussions with the Chinese Center for Drug Evaluation (CDE). The CDE indicated that the Phase 3 data meets the requirements for approval in chronic hepatitis B-associated liver fibrosis, as expected. An NDA submission is planned for 1H26, meeting our expected milestones for the product and the company.

Approval Would Allow Full Commercialization. Under the CDE regulations, the Phase 3 supports Conditional Approval for Hydronidone, allowing full commercialization. As part of the approval, company agrees to conduct a Phase 3c study after commercialization to confirm the effects seen in Phase 3. This is similar to a Phase 4 study in the US. The study design has not be finalized, although we expect similar endpoints for confirmation of the Phase 3 data.

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Cardiff Oncology (CRDF) – Onvansertib Could Treat Colorectal Cancers That Escape Other Treatments

Posted on January 5, 2026January 5, 2026 by slightbourne@noblecapitalmarkets.com

Monday, January 05, 2026

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.

Initiating Coverage With A $12 Price Target. Cardiff Oncology is developing onvansertib for the treatment of multiple cancer indications. Its lead program is in metastatic colorectal cancer for patients with a mutation that makes the cancer more aggressive and difficult to treat. This mutation, KRAS, is found in about 45% of the colorectal cancer patients. As a result of the mutation, several standard therapies are ineffective. We believe onvansertib’s unique mechanisms of action could be a breakthrough in cancer treatment.

Onvansertib Has Two Main Mechanisms of Action. Onvansertib inhibits PLK1, an intracellular protein needed for regulatory functions that control cell growth and division. This protein can be overexpressed in many cancers, including colorectal cancer, overriding the normal controls. A second mechanism stops a pathway that allows tumors to survive in low oxygen environments and resist treatment with bevacizumab (Avastin).

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Fulgent Genetics Expands Pathology Footprint With $55.5 Million Acquisition of Bako Diagnostics and StrataDx

Posted on December 23, 2025December 23, 2025 by slightbourne@noblecapitalmarkets.com

Fulgent Genetics is accelerating its transformation into a comprehensive precision diagnostics platform with the announced acquisition of selected assets of Bako Diagnostics and the full acquisition of StrataDx in a combined transaction valued at approximately $55.5 million. The deal, which will be funded entirely with cash on hand, is expected to close in the first half of 2026, subject to customary regulatory approvals.

The acquisition marks a strategic expansion of Fulgent’s laboratory services business, adding anatomic pathology services, proprietary PCR-based molecular tests, and a significantly broader national client base. Together, Bako Diagnostics and StrataDx bring deep expertise in specialty pathology and dermatopathology, positioning Fulgent to meaningfully strengthen its diagnostic offerings across multiple clinical touchpoints.

Bako Diagnostics, headquartered in Alpharetta, Georgia, is a premier national provider of specialty laboratory testing with a comprehensive menu that includes anatomic pathology, molecular genetic testing, and peripheral neuropathy immunohistochemical analysis. StrataDx, based in Lexington, Massachusetts, is a leading dermatopathology laboratory serving providers nationwide with advanced diagnostics for skin diseases, including melanocytic lesions, lymphomas, and complex dermatoses. Both laboratories are CLIA-certified, CAP-accredited, and licensed in their respective states.

Strategically, the transaction aligns closely with Fulgent’s long-term vision of becoming a one-stop diagnostic partner across the healthcare continuum. One of the most compelling aspects of the deal is the opportunity to apply Fulgent’s existing investments in digital pathology and artificial intelligence to Bako’s and StrataDx’s operations. Fulgent has already developed proprietary tools such as Eziopath, an image management system designed to enhance workflow efficiency, turnaround time, and diagnostic quality. Integrating these technologies is expected to increase capacity while maintaining high clinical standards.

The acquisition also significantly expands Fulgent’s test menu. Bako’s proprietary PCR assays offer faster turnaround times and cost efficiencies, strengthening Fulgent’s competitive position in molecular diagnostics. Combined with StrataDx’s dermatopathology expertise, the expanded portfolio allows Fulgent to serve a wider range of clinicians and patients with more comprehensive diagnostic solutions.

Commercial synergies represent another major driver of the transaction. Bako’s nationwide sales organization will nearly double the size of Fulgent’s pathology-focused sales team, immediately extending its commercial reach. The expanded client base creates additional opportunities to cross-sell existing Fulgent services, deepen payer relationships, and increase access to covered lives through managed care contracts.

Geographically, the acquisition enhances Fulgent’s laboratory footprint with additional certified facilities in Georgia and Massachusetts, including New York State–approved labs. This broader presence improves logistical efficiency and positions the company for future growth in regulated markets.

Ming Hsieh, Chairman and CEO of Fulgent Genetics, emphasized the strategic fit of the deal, highlighting the company’s ability to layer new pathology services onto a rapidly growing laboratory platform while leveraging AI to drive efficiency and quality. Bako and StrataDx leadership echoed that sentiment, pointing to the benefits of combining specialized diagnostic expertise with Fulgent’s technology-driven infrastructure.

As healthcare increasingly shifts toward precision medicine, Fulgent’s acquisition of Bako Diagnostics and StrataDx represents a calculated step toward scale, integration, and long-term growth in advanced diagnostics.

Release – NeuroSense Confirms Favorable Safety and Tolerability of PrimeC in an Alzheimer’s Phase 2 Study

Posted on December 22, 2025December 22, 2025 by slightbourne@noblecapitalmarkets.com

CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer’s disease.

The safety analysis indicated a favorable tolerability profile for PrimeC. No serious adverse events were reported, and no new or unexpected safety signals were identified.

As an exploratory proof-of-concept study, clinical outcome measures are descriptive by design. NeuroSense will analyze clinical observations alongside biomarker data to enable a more comprehensive interpretation of the clinical observations, with results 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

Greenwich LifeSciences, Inc. (GLSI) – FLAMINGO-01 Open-Label Arm Reports Preliminary Results and Reaches An Important Milestone

Posted on December 19, 2025December 19, 2025 by slightbourne@noblecapitalmarkets.com

Friday, December 19, 2025

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.

Data Reported From the Open-Label Arm Of The FLAMINGO Trial Greenwich LifeSciences announced preliminary Phase 3 results from the open-label, non-HLA-A*02 arm of its FLAMINGO-01 trial. The data showed a reduction in breast cancer recurrence rates of about 80% for patients that completed the primary vaccination series (PIS) ofGLSI-100. In addition, the first patient has completed the full 3-year treatment.

FLAMINGO0-01 Divides Patients By Immune Classification. The FLAMINGO-01 trial divides patients by their HLA types, a system of classifying a patient’s immune response. Patients with the most common HLA type, HLA-A*02, have enter one of the double-blind placebo-controlled arms of the trial. About 250 patients with other HLA types have been entered into an open-label portion, referred to as non-HLA-A*02.

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Cadrenal Therapeutics (CVKD) – New Anticoagulant Acquired For Heparin-Induced Thrombocytopenia.

Posted on December 12, 2025December 12, 2025 by slightbourne@noblecapitalmarkets.com

Friday, December 12, 2025

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.

Cadrenal Continues Build Its Anticoagulation Pipeline. Cadrenal has acquired VLX-1005, a platelet inhibitor from Veralox Therapeutics, adding another novel small-molecule anti-coagulant to its pipeline. VLX-1005 is a selective inhibitor of 12-LOX, an enzyme that initiates a signaling pathway for platelet-mediated inflammation and leads to heparin induced thrombocytopenia (HIT). VLX-1005 has Orphan Drug Designation from the FDA and EMA.

VLX-1005 Has Completed A Phase 2 Clinical Trial. Two Phase 1 studies showed safety and tolerability, followed by a Phase 2 trial in patients with suspected heparin induced thrombocytopenia (HIT). Interim results to date showed reductions in thromboembolic events.

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Greenwich LifeSciences, Inc. (GLSI) – Phase 3 FLAMINGO-01 Trial Reaches Enrollment Milestones

Posted on December 10, 2025December 10, 2025 by slightbourne@noblecapitalmarkets.com

Wednesday, December 10, 2025

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

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Phase 3 FLAMINGO-01 Trial Reaches Enrollment Milestone. Greenwich Pharmaceuticals has completed enrollment in the open-label arm (non HLA-A*2 patients) in the Phase 3 FLAMINGO-01 trial, its trial testing GLSI-100 for prevention of breast cancer recurrence in high-risk patients. The patients are stratified according to their HLA (human leukocyte antigen) types, immune system characteristics that classify an individual’s potential response to antigens. Over 1,000 patients have been screened for the trial at over 140 clinical sites in the US and Europe.

Greenwich Pharmaceuticals Presented At the NobleCon21 Conference. CEO Snehal Patel spoke at the annual NobleCon21 conference. He presented a brief summary of GLSI-100 and the clinical trial, followed by a fireside chat discussion, and questions from the audience. To listen to the presentation, click here.

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GeoVax Labs (GOVX) – 3Q25 Reported With Clinical Trial Updates and Plans To Move Products Forward

Posted on November 14, 2025November 14, 2025 by slightbourne@noblecapitalmarkets.com

Friday, November 14, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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

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Plans For MVA Vaccine and Gedeptin Trial Expectations Confirmed. GeoVax reported a 3Q25 loss of $6.3 million or $(0.31) per share, a smaller loss than the $8.0 million loss we had projected. The company reviewed several developments related to the Geo-MVA vaccine for smallpox/Mpox, Gedeptin, and CM04S1. Discussions for possible marketing collaborations continue. The cash balance on September 30, 2025 was $5.0 million.

Moving Forward With Geo-MVA. As discussed in our Research Note on June 17, the Geo-MVA vaccine for smallpox/Mpox is moving forward toward a Phase 3 trial. This follows receipt of Scientific Advice EMA (European Medicines Agency) stating that a marketing approval application can be submitted after a single, Phase 3 immuno-bridging study against the approved MVA vaccine. Phase 1 and Phase 2 would not be required. This saves several years and many millions dollars, allowing the company to sell the vaccine sooner.

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Eledon Pharmaceuticals (ELDN) – BESTOW Trial Leads To Misunderstanding of Tegoprubart Data

Posted on November 10, 2025November 10, 2025 by slightbourne@noblecapitalmarkets.com

Monday, November 10, 2025

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

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Phase 2 BESTOW Trial Data Reported. On Thursday evening, November 6, the results of the Phase 2 BESTOW trial in kidney transplant patients were presented. The trial did not meet its primary endpoint of tegoprubart superiority to the control arm but showed improvements in several important endpoints. We believe tegoprubart performed well and that the sharp decline in stock price is unwarranted.

Design Of The Phase 2 BESTOW Trial. The trial enrolled 126 patients into and randomized them into two arms. The first received tegoprubart and the second received tacrolimus, the standard of care, as a control arm. The primary endpoint was a difference in eGFR, a measure of kidney filtration and function. Additional endpoints reported were for the iBOX composite and measures of adverse events.

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