Category: Health

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

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Wednesday, December 10, 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.

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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Release – GeoVax Announces Issuance of U.S. Patent Covering Enhanced Therapeutic Use of Gedeptin® Gene Therapy

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Research News and Market Data on GOVX

  • Last updated: 09 December 2025
  • Created: 09 December 2025
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Patent Protects Novel Application of Gedeptin Therapy Across Multiple Solid Tumor Types; Supports Expansion of Gedeptin Product Platform 

ATLANTA, GA – December 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against cancers and infectious diseases, today announced the issuance of U.S. Patent No. 12,453,760, titled “Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug”, by the United States Patent and Trademark Office (USPTO). The patent provides composition-of-matter and method-of-use protection for GeoVax’s Gedeptin® platform in combination with targeted delivery approaches for solid tumors, including head and neck cancer.

The newly issued patent, which extends through 2045, enhances the Company’s intellectual property estate for Gedeptin and its use across a range of solid tumor cancers — consolidating GeoVax’s leadership in the field of targeted gene therapies and supporting ongoing clinical development plans.

“The issuance of this patent marks an important milestone in the advancement and protection of GeoVax’s oncology pipeline,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “It underscores our commitment to progressing Gedeptin, both as a monotherapy and in synergistic combination with other oncology treatment approaches as we work to deliver meaningful treatment options for patients with difficult-to-treat solid tumors.”

The Company is actively preparing for a Phase 2 clinical trial evaluating Gedeptin as a first-line therapy in combination with pembrolizumab (Keytruda®) in resectable head and neck cancer, in line with the recent shift toward neoadjuvant checkpoint strategies. Additional preclinical programs are assessing Gedeptin across other tumor types, including breast and cutaneous cancers.

About Gedeptin®

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) designed for targeted use in solid tumors. Delivered via a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP) and followed by systemic fludarabine, Gedeptin generates localized cytotoxic activity within tumors while minimizing systemic toxicity. The therapy has demonstrated safety and disease control in a multi-center Phase 1/2 trial in patients with advanced head and neck cancer and has received FDA Orphan Drug Designation for oral and pharyngeal cancers.

GeoVax plans to advance Gedeptin into a Phase 2 trial in combination with pembrolizumab (Keytruda®) as a neoadjuvant regimen for resectable head and neck squamous cell carcinoma, supported by recent clinical data validating the role of immune checkpoint inhibitors in perioperative settings. Additional preclinical work is underway to assess Gedeptin combinations across other solid tumors.

Key Advantages of Gedeptin

  • Localized, tumor-selective cytotoxicity
  • Tumor agnostic – expansion potential across multiple solid tumors
  • Synergistic potential with checkpoint inhibitors
  • Favorable safety profile and orphan drug designation
  • Strong patent protection through 2045

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] 

NeuroSense Therapeutics Ltd. (NRSN) – Webinar Highlight Regulatory and Clinical Trial Progress

Posted on by [email protected]


Tuesday, December 09, 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.

Discussions Of Clinical Trials, Regulatory Developments, Partnerships. NeuroSense held a webinar to review recent regulatory developments related to its Phase 3 PARAGON trial, early approval for ALS in Canada, the Phase 2 study in Alzheimer’s Disease, and product partnerships. There was also a detailed discussion of the Phase 3 PARAGON trial design and milestones for the coming year.

Phase 3 PARAGON Trial Is Expected To Begin In Mid-2026. NeuroSense has received clearance from the FDA to begin the Phase 3 trial testing PrimeC in ALS (Amyotrophic Lateral Sclerosis). The trial design is based on the data from the Phase 2b PARDIGM trial that showed improved survival with biomarkers correlating with slowing disease progression and reduction in markers of the disease process.


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Release – GeoVax Announces JCO Oncology Advances Publication Highlighting Favorable Safety and Evidence of Disease Stability of Gedeptin® in Recurrent Head & Neck Cancer

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Research News and Market Data on GOVX

  • Last updated: 08 December 2025
  • Created: 08 December 2025
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Phase 1/2 trial confirms safety with repeated dosing supporting further development in early-stage disease and combination treatment settings

ATLANTA, GA – December 8, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing novel immunotherapies and vaccines for solid tumor cancers and infectious diseases, today announced the publication of a peer-reviewed article in JCO Oncology Advances, the American Society of Clinical Oncology’s (ASCO) open-access journal.

The manuscript, titled “A Phase 1/2 Study of Intratumoral Ad/PNP (Gedeptin) with Fludarabine Phosphate in Subjects with Recurrent Head and Neck Cancer”, reports findings from a multi-center clinical trial evaluating repeated cycles of Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT), administered via intratumoral injection followed by systemic fludarabine.

Study Overview: Evaluating Repeated Dosing in a Highly Refractory Population

The Phase 1/2 trial enrolled patients with recurrent head and neck cancers who had exhausted all standard treatment options and had undergone a median of four prior lines of systemic therapy. Patients received therapy on a 28 day schedule, each consisting of intratumoral Gedeptin injections followed by intravenous fludarabine.

Key results from the publication include:

  • Acceptable safety profile with no new safety signals: Serious adverse events were uncommon and generally unrelated to treatment. No deaths were attributed to study therapy.
  • Clinical evidence of disease stability: Three of eight patients (37.5%) in this cohort of patients with end-stage disease achieved stable disease.
  • Successful tumor transduction and PNP transgene expression: Tumor biopsies confirmed uptake and expression of the therapeutic E. coli PNP transgene in all evaluable patients, supporting the mechanistic foundation of the Gedeptin platform.

Study results suggest that earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy (e.g., with immune checkpoint inhibitors) may further increase efficacy. Preclinical findings cited in the manuscript show that Gedeptin-mediated tumor destruction may sensitize tumors to checkpoint inhibitors, offering a promising path forward.

J. Marc Pipas, MD, Executive Medical Director, Oncology of GeoVax, stated: “This publication reinforces the strong scientific rationale underpinning the Gedeptin platform. Even in a highly refractory patient population with extensive prior treatment, repeated intratumoral dosing of Gedeptin demonstrated a favorable safety profile and evidence of disease stability. Importantly, correlative analyses confirmed robust tumor transduction and PNP expression, a critical mechanistic milestone for gene-directed enzyme prodrug therapy.”

Kelly T. McKee, MD, MPH, Chief Medical Officer of GeoVax, added: “These results support the continued development of Gedeptin in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies, particularly with immune checkpoint inhibitors, may amplify therapeutic benefit. This aligns with our strategy to advance Gedeptin into neoadjuvant studies for surgically resectable recurrent head and neck cancers.”

David Dodd, Chairman & CEO of GeoVax, stated: “The publication in the ASCO journal underscores both the scientific significance of this trial and the need for new approaches to treat recurrent head and neck cancers. Gedeptin’s targeted mechanism, combined with its repeat-dosing feasibility, offers a promising therapeutic option for patients. We look forward to expanding development into earlier disease settings and into rational combination regimens.”

About the Gedeptin® Platform

Gedeptin is a non-replicating adenoviral vector delivering the E. coli purine nucleoside phosphorylase (PNP) gene directly into tumor tissue. Following intratumoral injection, patients receive systemic fludarabine, which is converted in PNP-expressing tumor cells into a potent cytotoxic metabolite (2-fluoroadenine, F-Ade).

Key characteristics include:

  • Tumor-agnostic mechanism of action, driven by localized intratumoral activation of fludarabine into the potent cytotoxin F-Ade, enabling activity independent of tumor histology or proliferation rate.
  • Strong bystander effect, in which the activated F-Ade diffuses to neighboring cancer cells – allowing Gedeptin to kill tumor cells even when only a small fraction is directly transduced.
  • Immune-sensitizing properties that enhance tumor antigen visibility and may improve responses to immune checkpoint inhibitors.
  • Favorable safety profile, demonstrated across early Phase 1 and Phase 1/2 studies and supported by consistent tolerability in heavily pretreated solid tumor patients.

Gedeptin is now progressing toward combination-therapy in a neoadjuvant clinical program. Building on robust preclinical data showing that Gedeptin enhances tumor sensitivity to immune checkpoint blockade, GeoVax is advancing plans to evaluate Gedeptin with agents such as pembrolizumab aiming to strengthen antitumor immune activation.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumors. 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  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  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 – Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01

Posted on by [email protected]

Research News and Market Data on GLSI

 Download as PDFDecember 08, 2025 6:00am EST

STAFFORD, Texas, Dec. 08, 2025 (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 announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01.

In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are currently planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types (non-HLA-A*02) are planned to be treated with GLSI-100 in a third open label arm. The non-HLA-A*02 patients do not have the HLA-A*02 allele from either parent and represent about 55% of the patient population in FLAMINGO-01.

  • FLAMINGO-01 has achieved a major milestone by completing enrollment in the 250 patient open label non-HLA-A*02 arm of the Phase III trial, which is a result of the high screen rate and ensuing enrollment rate. The Company is continuing its review of the most recent data of this arm, including recurrence rates, which can be updated and/or published at any time.
  • The Company stopped enrolling in this arm earlier this year and is now approaching regulatory agencies to seek approval to continue enrollment of new non-HLA-A*02 patients in a randomized manner with a control arm. The Company has continued to screen a large number of these patients so that rapid enrollment of these screened patients can commence if regulatory approval is received.
  • The Company previously reported promising observations earlier this year showing that the immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the primary immunization series, 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, where breast cancer recurrences were reduced up to 80% or more and no metastatic breast cancer recurrences were reported. A preliminary analysis suggests that these promising trends are continuing.

CEO Snehal Patel commented, “As we continue to analyze the immune response, safety, and recurrence rate data of the 250 patient non-HLA-A*02 data set, it is important to remember that all 250 patients received GLSI-100, which is 5 times more than the approximately 50 patients treated in the Phase IIb trial. We can compare the open label recurrence rate data of these 250 treated patients to the expected historical recurrence rate for this population, which is well known and recently reported, to the HLA-A*02 arms of FLAMINGO-01, and to the Phase IIb study. In addition, we may be able to compare the recurrence rate during the first 6 months of vaccination, also called the primary immunization series or PIS, to the recurrence rate after the PIS is completed and after peak immunity is achieved. We look forward to providing updates on this analysis at any time, including publications at conferences as we have previously done for the Phase IIb trial from 2020-2022.”

Mr. Patel added, “The use of GLSI-100 in the non-HLA-A*02 patient population is an invention by the Company, and the Company believes that any patent claims related to this invention are not subject to any license, royalties, or milestone payments. These patent claims should complement other patent claims that the Company has recently filed to potentially extend patent protection of GLSI-100 beyond 2040. The Company believes that this patient population could double the number of US and European patients eligible for GLSI-100 treatment to approximately 88,000 new patients per year with a market potential using the drug prices per year of Kadcyla or Enhertu in the range of $8-10 billion per year.”

Additional updates:

  • The non-HLA-A*02 types that are most commonly being enrolled in FLAMINGO-01 continue to be HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33.
  • The enrollment of HLA-A*02 patients in the 500 patient randomized arms continues, unaffected by the end of enrollment in the non-HLA-A*02 arm, while the Company also seeks to increase the size of these HLA-A*02 arms such that enrollment is not stopped prior to any interim analyses.
  • Enhertu (trastuzumab Deruxtecan [T-DXd]) treated patients continue to be eligible for enrollment in FLAMINGO-01. The Company believes that GLSI-100 will synergize with any trastuzumab based treatment in the neoadjuvant or adjuvant settings, including Enhertu.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of 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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Released December 8, 2025

Release – NeuroSense to Hold Pre-NDS Meeting with Health Canada in April 2026

Posted on by [email protected]

Research News and Market Data on NRSN

CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada (“Agency”), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS).

After outlining the remaining requirements, Health Canada confirmed that NeuroSense’s proposed next steps align with the Agency’s expectations. With additional clinical data recently generated and further supportive analyses underway, NeuroSense is now preparing for a pre-NDS meeting with Health Canada currently contemplated in April 2026.

Pending a successful outcome of this meeting and completion of the final submission components, the Company currently anticipates a potential NDS submission by mid-2026.

“This positive engagement reinforces our confidence in the regulatory pathway in Canada,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “We appreciate the constructive dialogue with Health Canada as we work to bring PrimeC to people living with ALS.”

Additional details regarding the Canadian submission and contemplated timelines will be provided during NeuroSense’s upcoming investor webinar on December 8th, 2025. Registration for the webinar is available here.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

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 Alzheimer’s Disease (AD) that contribute to motor 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 include statements regarding the timing of a pre-NDA meeting with Health Canada and the timing of a potential NDS submission, and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of commencement of the Phase 3 trial. Further, certain forward-looking statements 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 risk that the pre-NDA meeting with Health Canada will be delayed or not occur; that the potential NDS submission will be delayed or not occur; Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; 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.

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SOURCE NeuroSense

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

Mirum Pharmaceuticals’ Acquisition of Bluejay Therapeutics Strengthens Its Global Rare Disease Leadership

Posted on by [email protected]

Mirum Pharmaceuticals (NASDAQ: MIRM) has announced a definitive agreement to acquire privately held Bluejay Therapeutics in a transformative deal that expands Mirum’s leadership in rare liver diseases and adds a high-potential late-stage asset to its growing pipeline. The acquisition, valued at $620 million upfront in cash and stock — plus up to $200 million in milestone payments — brings worldwide rights to brelovitug, a fully human monoclonal antibody currently in Phase 3 development for chronic hepatitis delta virus (HDV).

For Mirum, a company already recognized for developing and commercializing rare disease therapies—including LIVMARLI, CHOLBAM and CTEXLI—the deal aligns directly with its strategic focus: advancing life-changing medicines for overlooked patient populations. HDV, the most severe form of viral hepatitis, represents a large, high unmet-need market with no FDA-approved treatments, affecting more than 230,000 people across the U.S. and Europe.

Brelovitug has already gained international attention. The therapy holds FDA Breakthrough Therapy designation and the European Medicines Agency’s PRIME and Orphan designations. In Phase 2 trials, it demonstrated strong antiviral activity and a 100% HDV RNA response rate, along with improvements in liver enzyme levels. Its safety profile has been favorable, with the most notable adverse event being injection-site reactions.

The drug is currently being evaluated in the global, registrational AZURE Phase 3 program, which is enrolling patients worldwide. Top-line results are expected in the second half of 2026, with a potential BLA submission and commercial launch in 2027. If approved, brelovitug could become the first widely available treatment for chronic HDV.

Mirum CEO Chris Peetz emphasized that the acquisition fits squarely within Mirum’s mission and capabilities. “Brelovitug in HDV leverages our deep expertise in rare liver disease and builds on the relationships we’ve established with key providers through the volixibat and LIVMARLI programs,” he said. Bluejay’s founder and CEO, Keting Chu, echoed that sentiment, noting that Mirum’s rare disease specialization makes it “the right company to carry this program forward globally.”

The acquisition will be funded through a combination of cash, Mirum common stock, and a concurrent $200 million private placement with healthcare investors. Proceeds from the placement will support both clinical development and future commercial activities. The deal not only adds a late-stage asset to Mirum’s portfolio but also positions the company for four potential registrational readouts within the next 18 months—an unusually rich pipeline for a rare-disease-focused biotech.

Implications for the Biotech Landscape

The acquisition underscores a broader trend in the biotechnology sector: rare disease companies with commercial infrastructure are increasingly seeking late-stage assets to accelerate revenue growth and expand global presence. For small and mid-cap biopharma firms, especially those with single or early-stage assets, partnerships or acquisitions by specialized players like Mirum remain attractive pathways to scale.

Bluejay itself represents a textbook example of a high-quality private biotech that rapidly advanced a novel therapy—from development candidate to global Phase 3 program in four years—making it an appealing target in a competitive rare-disease market.

Pending regulatory approvals, the transaction is expected to close in the first quarter of 2026. If successful, brelovitug could mark one of the most important therapeutic advancements in liver disease in decades—and a major milestone in Mirum’s evolution into a global leader in rare hepatology.

Release – Greenwich LifeSciences Provides Global Update on FLAMINGO-01, Screening Over 1,000 Patients to Date

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Research News and Market Data on GLSI

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December 03, 2025 6:00am EST

STAFFORD, Texas, Dec. 03, 2025 (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 global update on FLAMINGO-01.

Flamingo-01 Progress to Date

The Company has achieved a major milestone by screening over 1,000 patients in Flamingo-01, continuing its screening rate of approximately 150 patients per quarter or the equivalent of 600 patients per year in approximately 40 US sites and 100 EU sites for a total of 140 active sites. The Company is considering a strategy to continue enrolling in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses are conducted and the appropriate size of each arm can be further assessed.

CEO Snehal Patel commented, “Reaching 1,000 screened patients confirms that the interest from doctors and patients is high. The clinical site start-up activities in Europe in 2025 have further increased the momentum in the study. We are also receiving interest from other countries to join FLAMINGO-01, driven by patient interest. The high screening rate will give the Company many options, including the opportunity to continue enrollment through multiple interim analyses, the potential to realize higher enrollment rates and event rates, and the potential to maximize indications by analyzing efficacy across multiple HLA types in larger patient populations.”

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of 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 will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will 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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Released December 3, 2025

Release – MAIA Biotechnology Announces Open Market Purchases by CEO and Directors

Posted on by [email protected]

Research News and Market Data on MAIA

December 01, 2025 9:17am EST Download as PDF

CHICAGO, Dec. 01, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the CEO and certain members of the Company’s Board of Directors purchased approximately 182,445 shares of MAIA common stock at market price between November 21 and 28, 2025. The average common stock price was $1.06.

Vlad Vitoc, M.D., Chairman and CEO of MAIA, purchased 94,300 shares between November 21 and 28, 2025, at an average price of $1.08 per share. Other board members, Cristian Luput and Stan V. Smith, Ph.D., purchased a combined total of 88,145 shares in the open market at an average price of $1.04 per share.

“Along with my fellow MAIA Board members, we are pleased to report that we recently acquired shares of MAIA in the open market, reflecting our confidence in ateganosine’s ongoing clinical development,” said Dr. Vitoc. “With 38% response rates and 17.8 months overall survival in our Phase 2 THIO-101 clinical trial to date, we believe in ateganosine’s potential to improve the lives of patients diagnosed with non-small cell lung cancer and become a new standard of care.”

“I firmly believe MAIA’s cancer-therapy platform can redefine the landscape of cancer research and treatment,” said Mr. Luput. “As a longtime investor, I believe the company’s strategic focus and scientific momentum position it to deliver significant value for shareholders in the years ahead,” added Mr. Smith.

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 December 1, 2025

Release – Cadrenal Therapeutics Appoints Dr. Lee Golden to Board of Directors

Posted on by [email protected]

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Dec. 01, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today announced the appointment of Lee Scott Golden, M.D., to its Board of Directors, effective immediately. Dr. Golden will serve as an independent director.

Dr. Golden currently serves as Executive Vice President and Chief Medical Officer at PTC Therapeutics, Inc. (Nasdaq: PTCT), where he leads global clinical development across a broad rare disease pipeline. Before joining PTC, Dr. Golden served as the Chief Medical Officer at Espero BioPharma, Inc., a development-stage cardiovascular pharmaceutical company focused on developing drugs for unmet needs in thrombosis and cardiac rhythm control, and as Chief Medical Officer at Gemphire Therapeutics, Inc. He also serves as Chairman of the Advisory Board for Coagulation Sciences LLC. Previously, Dr. Golden held senior roles at Pfizer, Actelion, Eisai, Mesoblast, and others, with a long-standing focus on cardiovascular and hematologic drug development.

“We are delighted to welcome Dr. Golden to our Board,” said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Lee’s deep experience in late-stage clinical development, particularly in cardiovascular medicine and anticoagulation, is highly aligned with our mission to deliver safer, more predictable anticoagulant options for patients with significant unmet needs. His track record in guiding therapies through clinical development and regulatory pathways will be invaluable as we continue to advance tecarfarin and our broader pipeline.”

“Cadrenal Therapeutics is working in an area of high clinical importance, where better anticoagulation options could meaningfully impact outcomes for patients with complex cardiovascular conditions,” said Dr. Golden. “I look forward to working with the Board and the leadership team to help guide the Company’s strategy and clinical programs as we seek to bring differentiated therapies to patients and create value for shareholders.”

Dr. Golden has more than 25 years of industry experience, with increasing responsibilities, managing global, cross-functional teams responsible for creating and deploying strategic and clinical development plans. He has extensive experience across multiple therapeutic areas and with orphan diseases. Dr. Golden received a B.S. from the University of Michigan and an MD from New York University School of Medicine, where he also completed his Internal Medicine residency. He then completed Fellowships in Cardiology at the University of Miami and Interventional Cardiology at George Washington University Hospital, where he also served as an adjunct instructor.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company with a mission to develop novel and differentiated biopharmaceutical products that bridge critical gaps in current acute and chronic anticoagulant therapy. We bridge these gaps by developing novel and differentiated anticoagulants, or blood thinners, designed to provide greater predictability, increased stability, more precise control, and fewer bleeding complications. We currently have two clinical-stage assets: tecarfarin, an oral vitamin K antagonist (VKA) for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. By targeting underserved patient populations and advancing therapies designed for both chronic and acute use, we aim to reshape standards of care in anticoagulation. 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 developing transformative therapeutics to overcome current gaps in anticoagulation therapy, the expected contribution of Dr. Golden and continuing to advance tecarfarin and the Company’s broader pipeline. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to develop transformative therapeutics to overcome current gaps in anticoagulation therapy, Dr. Golden’s ability to help guide the Company’s strategy and clinical programs, the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected 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:

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

Release – The Oncology Institute Announces Resignation of Board Member Gabe Ling

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Research News and Market Data on TOI

Dec 01, 2025

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CERRITOS, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), one of the largest value-based oncology groups in the United States, today announced that Gabe Ling has resigned from the Board of Directors, effective December 1, 2025. A formal search process has been initiated to add new independent directors with complementary healthcare, clinical, and value-based care expertise.

“On behalf of the Board of Directors, I want to thank Gabe for his service during an important chapter in The Oncology Institute’s development,” said Anne McGeorge, Chairman of the Board. “We appreciate the contributions he made throughout his time on the Board and the valuable guidance he provided as the Company navigated its first few years in the public markets. As we continue to strengthen our governance structure, we remain focused on enhancing the Board’s capabilities by bringing on strategic and experienced members who will support The Oncology Institute’s mission and long-term growth goals.”

About The Oncology Institute
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better. For more information, visit www.theoncologyinstitute.com

Contacts

Media

The Oncology Institute, Inc.
[email protected]

Investors

ICR Healthcare
[email protected]

Transatlantic HCLS M&A: The Talent Integration Mandate

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Bridging the Compensation, Culture, and Compliance Gaps for Value Realization in 2025

The Healthcare and Life Sciences (HCLS) sector continues to be a powerhouse for global Mergers & Acquisitions (M&A) activity, driven by digitalization, specialized therapeutics, and the imperative for integrated care models. When European entities acquire US counterparts, the primary risk to deal value shifts from financial modeling to human capital integration. In 2025, transatlantic HCLS deals face an unprecedented trifecta of challenges: navigating the US’s competitive, burnout-driven talent market; identifying and realizing true operational synergies; and bridging the fundamental divide between US and EU compensation and benefits philosophies. Successfully integrating talent across these vastly different labor ecosystems is now the defining feature of deal success.

The Fierce Pursuit of Specialized US HCLS Talent

The US HCLS talent market in 2025 is defined by scarcity, rising costs, and high turnover – especially for highly specialized roles in advanced therapeutics, bioinformatics, and AI-driven diagnostics. Would-be European acquirers of US HCLS companies must move beyond reactive hiring to adopt future-ready strategies:

  • Skills-First & AI Operationalization: The industry is moving toward skills-based hiring, particularly for critical roles that drive transformation and innovation (e.g., Gene Editing, GenAI). While AI is being widely operationalized to streamline administrative burdens (scheduling, screening, drafting job descriptions), it has yet to be proven as a strategic tool for high-level talent strategy or predicting cultural fit. Smart integration plans, therefore, should prioritize leveraging AI to accelerate efficiency while reserving human expertise for assessment and strategic sourcing.
  • EVP and Retention over Recruitment: High turnover, burnout, and the rise of non-traditional healthcare employers (tech, consulting) have made retention the top priority. The Employer Value Proposition (EVP) must be hyper-personalized and focused on fostering Equity, Inclusion, and Belonging (EIB), shifting the focus from simply who is hired to who stays, grows, and thrives. Post-merger, US employees often prioritize clear career pathways, flexibility, and supportive management when choosing to remain with the combined entity.
  • Proactive Pipelining: Due to the shrinking talent pool, organizations might rely heavily on talent pipelining and targeted outbound campaigns, establishing relationships with specialized talent before roles are officially posted. Integration teams could leverage the European target’s existing academic partnerships or regional centers of excellence to feed into the US-side pipeline for highly technical roles.

Operational Synergies: A Shift to Scope and Capability

Transatlantic HCLS M&A is increasingly dominated by scope deals—acquisitions focused on new technology, market access, or specific clinical capabilities, rather than simple scale. Synergy capture in these deals is more complex and requires aggressive planning that goes beyond traditional cost-cutting:

  • Revenue Synergies in R&D and Market Access: The most significant value tends to be found in revenue synergies, such as combining the European acquirer’s innovative R&D capabilities and global footprint with the US target’s vast commercialization strength and specialized talent access. Due diligence must build complex synergy models to validate these revenue forecasts, which are inherently more difficult to predict than cost savings.
  • Consolidating Back-Office Functions: Classic operational synergies still apply, particularly in consolidating redundant non-patient-facing functions. Examples include streamlining financial administration, IT infrastructure, and back-office services like Revenue Cycle Management (RCM) or billing. This consolidation can lead to immediate cost savings and process standardization but must be executed early in the integration lifecycle to realize value.
  • Cultural Alignment as a Synergist: Synergy capture is often derailed by poor cultural alignment. Integration planning should prioritize blending cultural elements early on. For a European company acquiring a US firm, navigating different approaches to hierarchy, risk tolerance, and work-life balance will be crucial to retaining the very R&D or specialized operational talent the deal was meant to secure.

Navigating the Transatlantic Compensation & Benefits Chasm

The starkest challenge in harmonizing US and EU operations lies in aligning compensation, benefits, and labor practices, which reflect fundamentally different societal models:

  • The Salary and Contribution Divide: US salaries are generally higher, often dramatically so for specialized roles (e.g., mid-level tech salaries can show a 30–50% gap). However, the underlying employer cost structure differs significantly. US employers bear steep costs for private, market-driven healthcare ($8,000 to $16,000+ per employee annually), while EU employers bear heavy social charges and payroll contributions that fund state-backed universal healthcare and pensions. Integration teams should employ dual benchmarks, modeling both equal salaries (for equity assessment) and market-specific total compensation (for budget control).
  • Mandated Benefits and Labor Law: Europe offers generous, often legally mandated benefits, including a minimum of 20+ paid vacation days, comprehensive parental leave, and stricter labor protections regarding notice periods and dismissal costs. In contrast, US benefits are a competitive tool, varying widely by state and company size. Attempting to impose a US-centric “low vacation, high private insurance” model on EU operations could result in catastrophic talent loss and non-compliance with local labor law.
  • Compliance Complexity: The US operates under a fragmented legal structure of both federal (e.g., ACA and COBRA and state-specific laws (sick leave, minimum wage, worker classification), whereas the EU operates under centralized directives, but implementation varies across 27 Member States (e.g., Spain and Portugal requiring 14-month salaries). HR teams must deploy local expertise to avoid compliance pitfalls, particularly around worker classification and termination processes.

In conclusion, successful transatlantic HCLS M&A requires HR integration teams to treat human capital as a strategic asset, not just a line item. Value is realized when the best of both labor ecosystems is preserved, harmonizing compensation and benefits while leveraging the combined entity’s specialized talent pools through proactive, skills-focused strategies.

In the next installment of our Europe-US Cross-Border HCLS M&A series, we move from people to data, tackling the ultimate transatlantic compliance hurdle: the clash between GDPR and HIPAA. Learn how European acquirers can avoid major fines and deal breaks by meticulously auditing and integrating data governance across two radically different legal frameworks.

About the Authors:

Nathan Cali is a Managing Partner at Noble Capital Markets with more than 18 years of Capital Markets experience. He has been a lead Managing Director/Head of the Healthcare and Life Sciences Investment Banking and Advisory franchise at NOBLE since 2017 and was previously a sell-side equity analyst for 9 years. Nathan is a Board Member of Precise Bio, a tissue engineering, biomaterials, and cell technologies company, including cardiology, orthopedics, and dermatology. He was previously a board observer of Eledon Pharmaceuticals (ELDN:NASDAQ, f.k.n.a. Anelixis Therapeutics, Inc.), a phase II biotechnology company. Prior to joining NOBLE, Nathan gained investment experience as a portfolio account analyst/manager at Franklin Templeton Investments. Nathan also currently holds series 7, 79, 86, and 87 FINRA designations.

Hinesh Patel, MCMI ChMC is a Partner in CNM LLP’s Los Angeles Office with over 20 years of experience in accounting. He leads and oversees the firm’s Accounting and Transaction Advisory practice. He brings a vast knowledge of US GAAP, technical accounting, and International Financial Reporting Standards (IFRS) reporting requirements to his role at CNM. Hinesh primarily focuses on technical accounting, IPO readiness, SEC reporting, and mergers and acquisitions. Prior to joining CNM, Hinesh worked as a Senior Manager at Deloitte with a primary focus in the technology, manufacturing, consumer business and entertainment industries for both public and private companies. He has assisted various companies through the IPO process and advised on a range of accounting services including technical accounting, financial reporting, and new business processes requirements.

Matthew (Matt) Podowitz is the founder and Principal Consultant of Pathfinder Advisors LLC, bringing experience on 400+ global M&A engagements to his clients. He specializes in the critical operational and technology aspects of M&A transactions, providing due diligence, carve-out, integration, and value creation services. Known for practical, actionable advice derived from extensive hands-on experience with healthcare and life sciences transactions, Matt helps companies, investment banks, and private equity firms navigate complex cross-border HCLS M&A through every step of the transaction lifecycle. Leveraging his perspective as a dual US/EU citizen, he provides seamless support for transactions in both markets. His background includes leadership roles at firms like Ernst & Young, Grant Thornton, and CFGI.

Chris Raphaely is the Co-Chair of Cozen O’Connor’s Health Care & Life Sciences Practice where he provides sophisticated transactional and regulatory counsel to an array of health care providers and investors in the health care industry. His practice focuses on mergers, acquisitions, and divestiture transactions for health care clients and the comprehensive regulatory schemes requisite to doing business in the health care space. Chris routinely handles matters involving payer negotiations, payment disputes and contract enforcement, accountable care organizations, management services organization, clinically integrated networks, value based payment arrangements, pharmacy benefit management and third party administrator contracts for self-insured employers, digital health, organizational and governance structures, HIPAA, information privacy and security, tax exemption, Stark Law, fraud and abuse matters, clinical integration, medical staff relations, facility and professional licensing, Pennsylvania’s Medical Marijuana Act, and general compliance. Prior to joining the firm, Chris served as the deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

Release – NeuroSense Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS

Posted on by [email protected]

Research News and Market Data on NRSN

CAMBRIDGE, Mass., Nov. 24, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS).

With the FDA’s clearance, NeuroSense is preparing for trial initiation and aims to have its first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial.

The global pivotal Phase 3 trial, PARAGON, is powered at over 95% to achieve its primary endpoint and to expand upon the results of NeuroSense’s Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favorable safety and tolerability profile.

“This FDA clearance marks a meaningful advancement for NeuroSense and for people living with ALS. We believe this progress lays a strong foundation for additional achievements across several fronts in the near future,” stated Alon Ben-Noon, Chief Executive Officer of NeuroSense. “We recognize the significant unmet need of people living with ALS and remain committed to delivering a meaningful therapy through our efforts.” 

Based on prior successful discussions with the FDA and in line with its recent comments and recommendations, PARAGON is expected to be conducted in the U.S. and EU and include 300 people living with ALS randomized in a ratio of 2:1 (PrimeC : Placebo). The prospective, double-blind, 12-month placebo-controlled trial, has an open label extension to evaluate safety and efficacy of PrimeC. The trial will employ an adaptive design allowing for interim analyses to optimize sample size and assess early efficacy and futility boundaries.

Additional details regarding the PARAGON trial design and timelines will be provided in NeuroSense’s upcoming investor webinar on December 8th, 2025 and on NeuroSense’s website. Registration to the webinar is available here.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

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 Alzheimer’s Disease (AD) that contribute to motor 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 commencement of the Phase 3 trial. Further, certain forward-looking statements 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 risk that the Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; 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.

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SOURCE NeuroSense

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