Category: Health

Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology

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May 27, 2026 7:00am EDT

Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection

Phase 2 investigator-initiated study in adult kidney transplant at Massachusetts General Hospital (MGH) expected to initiate in the 2nd half of 2026 pending U.S. Food and Drug Administration (FDA) clearance of MGH’s Investigational New Drug (IND) application

BERKELEY HEIGHTS, N.J., May 27, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed Journal of Clinical Immunology. TNX-1500 is an investigational, third-generation Fc-modified IgG4 anti-CD40L (also known as CD154) monoclonal antibody (mAb) in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. The manuscript can be accessed at https://pubmed.ncbi.nlm.nih.gov/42053701/.

“The CD40L is a validated target for preventing organ rejection in transplant and treating autoimmune disease, yet no anti-CD40L mAb has been approved for any indication,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a Phase 2 ready humanized mAb engineered to improve safety and tolerability relative to first-generation anti-CD40L mAbs, while preserving the durable half-life and certain effector functions associated with the Fc or crystallizable fragment. We believe the Phase 1 results show that these design objectives were achieved in TNX-1500.”

Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The Phase 1 study evaluated TNX-1500’s safety, tolerability, pharmacokinetics, and pharmacodynamics. TNX-1500 was generally well tolerated, demonstrated a favorable safety profile, suppressed the primary and secondary T cell-dependent antibody responses (TDARs) to keyhole limpet hemocyanin (KLH) antigen, and showed a half-life which supports monthly intravenous dosing. We expect a Phase 2, investigator-initiated study of TNX-1500 in the prevention of kidney allograft rejection at MGH to begin in the 2nd half of 2026 pending clearance of the IND by the FDA.”

The publication reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers. Participants were enrolled across three ascending dose cohorts (3, 10, and 30 mg/kg) or placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of KLH on days 2 and 29 to assess the TDAR, and monitored over a 120-day follow-up period. TNX-1500 blocked the primary T cell–dependent antibody response to KLH at all doses, blocked the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by ~70% relative to placebo at the 3 mg/kg dose.

TNX-1500 was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events. The only treatment-emergent adverse event (TEAE) deemed possibly related to study drug was aphthous ulcer, which occurred in 1 participant in each of the three TNX-1500 groups; all TEAEs were rated as mild and resolved in 2-10 days. No TEAEs were determined to be related to KLH administration. There were no administration or injection site reactions (one of the prespecified TEAEs of special interest). Pharmacokinetic analyses suggested approximately dose-proportional exposure across the 3 to 30 mg/kg range, with mean terminal elimination half-lives of 37.8 and 33.8 days at the 10 and 30 mg/kg dose levels, respectively. TNX-1500 at 10 and 30 mg/kg blocked the primary and secondary anti-KLH TDAR through day 120, and at 3 mg/kg reduced the peak secondary response by approximately 70% relative to placebo. Across all dose cohorts, TNX-1500 was associated with a rapid (less than one-hour post-dose) and sustained reduction in soluble CD40L (sCD154) over the 120-day study period.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a Phase 2 ready, humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases. Collaborations are ongoing with MGH on allo-heart and -kidney transplantation in nonhuman primates, as well as prevention of xenograft rejection, preclinical studies, and prevention of allograft rejection in sensitized patients. The Phase 2 investigator-initiated study by MGH is expected to initiate enrollment in the 2nd half of 2026, pending FDA clearance of the IND, to evaluate TNX-1500 in five kidney transplant recipients. The study is designed to assess the safety, tolerability, and activity of TNX-1500 in preventing kidney transplant rejection while decreasing the exposure to conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects, and various metabolic derangements with long term use.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts

Jessica Morris
Tonix Pharmaceuticals
(862) 799-8599
[email protected]

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts

Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

Source: Tonix Pharmaceuticals Holding Corp.

GeoVax Labs (GOVX) – Development To Focus On Best Opportunities In Infectious Disease and Oncology

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Wednesday, May 27, 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.

Resources To Focus On Current Market Needs. GeoVax has reviewed its pipeline products in infectious disease and oncology programs. Preparations will continue for the Phase 3 immunobridging trial in Mpox, expected to begin later this year.  A Phase 2 for Gedeptin is planned for FY2027. Development of CM-04S1 has been terminated, as the diminished need for a vaccine to protect immunocompromised patients from COVID-19 no longer justifies its continuation.

GEO-MVA and Infectious Diseases Remain A Priority. As discussed in our Research Note on May 19, 2026, GeoVax is preparing for a Phase 3 immunobridging trial in Mpox that could meet EMA requirements for accelerated approval. The trial is expected to begin in 2H26 with a planned enrollment of about 500 participants. The preclinical pipeline includes products for other infectious viruses that could be developed if grant or other funding were available.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Cocrystal Pharma (COCP) – Technology Platform Has Novel Therapeutics Against Hantavirus, Bunyavirus, and Influenza

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Wednesday, May 27, 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.

Proprietary Technology Has Produced A Large Library Of Novel Antivirals. Cocrystal has developed a library of antivirals based on its proprietary technology. While clinical development has prioritized products with clear medical needs and regulatory pathways to approval, it continues to research new compounds that can be moved into development as public health needs change. After the recent outbreaks of hantavirus, Ebola, and several previously lesser-known viruses, the company tested some of these compounds and found them to be effective.

Cocrystal’s Proprietary Technology Acts Early In The Viral Lifecycle. Cocrystal drugs target enzymes essential to the viral life cycle and reproductive process. These enzymes are highly conserved across viral families and rarely mutate, allowing compounds to show broad efficacy against multiple strains. This differs from vaccines that train the immune system to recognize and kill a virus. Vaccines often target surface proteins that can mutate, rendering the vaccine ineffective.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Cocrystal Pharma Announces Discovery of Pan-Viral Inhibitors Targeting Hantavirus, Bunyavirus and Influenza

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Cocrystal Pharma, Inc.

Research News and Market Data on COCP

May 26, 2026

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  • Novel, potent pan-viral inhibitors targeting the viral replication complex are under development for the treatment of hantavirus, bunyavirus and influenza
  • Hantavirus and bunyavirus infections represent significant unmet medical needs, contribute to ongoing global outbreaks and have no approved treatments or vaccines

BOTHELL, Wash., May 26, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its novel direct-acting antivirals demonstrate pan-viral activity against multiple viruses, including hantavirus, bunyavirus and influenza. These antiviral molecules target a highly conserved region of the viral replication enzyme, specifically the L-protein of Andes hantavirus, which is essential for viral replication and transcription. In vitro potency data show superior activity (IC50 <50 nM) against hantaan virus, which is closely related to the Andes hantavirus strain associated with recent outbreaks.

“We are thoughtfully leveraging our expertise in viral replication enzymes and structure-based drug discovery to develop the next generation of pan-viral replication inhibitors. Our first pan-viral protease inhibitor, CDI-988, recently advanced to a Phase 1b norovirus challenge study in the United States. Our research efforts have expanded to novel pan-viral replication inhibitors with the goal of developing a novel pan-viral lead molecule for multiple viral diseases caused by hantaviruses, bunyaviruses and influenza viruses,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal Pharma. “We are encouraged by our initial in vitro potency data against hantavirus and plan to evaluate in vitro antiviral activity against the Andes hantavirus replication enzyme. We look forward to exploring collaborations and partnerships to address these urgent unmet needs.”

The Andes hantavirus was recently responsible for a deadly outbreak on a cruise ship, infecting up to 11 passengers and crew, resulting in three deaths. Hantaviruses are primarily transmitted by rodents, although human-to-human transmission can occur through prolonged close contact. Andes hantavirus, a member of the genus Hantavirus, is endemic in Argentina and Chile and causes hantavirus cardiopulmonary syndrome (HCPS), which is associated with a case fatality rate of up to 50%. Currently, there are no approved antivirals or vaccines for Andes hantavirus or other hantaviruses.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal is leveraging its structure‑based drug discovery platform technology to design next‑generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off‑target effects, offering potentially safer, broad‑spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.

The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2) and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s research and development of pan-viral replication inhibitors and exploration of collaborations and partnerships with respect thereto. The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, risks arising from the research into a related virus was not done in animals and was necessarily early stage, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. 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.

Investor Contact:
Alliance Advisors IR
Bruce Voss
[email protected]
310-691-7104

# # #

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Source: Cocrystal Pharma, Inc.

Released May 26, 2026

Release – GeoVax Accelerates Focus on GEO-MVA Commercialization and Advancement of Oncology Program Gedeptin(R)

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GeoVax

Research News and Market Data on GOVX

Company Aligns Resources with Programs Demonstrating Strong Clinical, Regulatory, and Market Momentum

ATLANTA, GA — May 26, 2026 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines, today announced a strategic prioritization of its development portfolio to concentrate resources on its lead programs, GEO-MVA and Gedeptin®, reflecting increasing clinical, regulatory, and market alignment across these programs. As part of this decision, the Company has elected to discontinue active development activities related to its GEO-CM04S1 COVID-19 vaccine candidate.  This decision was not related to any safety concerns with the vaccine but reflects the continued evolution and contraction of the global COVID-19 vaccine market, and GeoVax’s focus on programs with clearer regulatory pathways, stronger demand visibility, and more immediate commercialization potential. GeoVax emphasized that portfolio prioritization is a standard and essential practice within the biotechnology industry, enabling companies to align resources with the highest-value opportunities as market conditions and scientific landscapes evolve.

“GeoVax is at an important inflection point, and this decision reflects a deliberate and disciplined focus on the programs we believe can deliver the greatest near-term and long-term value,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “As GEO-MVA advances toward clinical validation and potential commercialization, and as Gedeptin gains relevance within emerging immuno-oncology treatment paradigms, we are aligning our resources to support focused execution against these high-potential opportunities.”

GEO-MVA: Expedited Pathway and Near-Term Commercial Opportunity

GEO-MVA, GeoVax’s Modified Vaccinia Ankara (MVA) vaccine candidate targeting mpox and smallpox, is advancing under an expedited regulatory pathway supported by European Medicines Agency (EMA) scientific advice. This approach enables potential approval based on a single pivotal immunobridging study demonstrating non-inferiority to an approved MVA vaccine – significantly accelerating development timelines and reducing clinical risk.

The program has clinical-grade material manufactured and released in preparation for the planned Phase 3 immunobridging study. Following successful completion, GEO-MVA is expected to advance toward regulatory submission and potential commercialization within a streamlined timeframe, including potential Emergency Use Licensing.

GeoVax has initiated outreach with global procurement and preparedness stakeholders – including government agencies, international organizations, and biodefense programs – supporting potential vaccine supply agreements aligned with national stockpiling and outbreak response needs. These activities position GEO-MVA to serve as a critical additional supplier of MVA-vaccine supporting supply-chain resilience and biodefense preparedness.

Gedeptin®: Aligned with Emerging Immuno-Oncology Treatment Paradigm

Gedeptin®, GeoVax’s gene-directed enzyme prodrug therapy (GDEPT) platform, is being advanced in alignment with a rapidly evolving oncology landscape, highlighted by the landmark KEYNOTE-689 Phase 3 trial demonstrating improved event-free survival with neoadjuvant checkpoint inhibitor therapy in resectable head and neck cancers.

GeoVax’s planned Phase 2 study (AdPNP-203) will evaluate Gedeptin in combination with pembrolizumab and fludarabine in a neoadjuvant setting, with the objective of enhancing tumor immune visibility and improving clinical outcomes.

Gedeptin’s tumor-targeting mechanism is designed to significantly damage or destroy treated lesions through the localized, in situ generation of a potent chemotherapeutic agent. In addition, Gedeptin appears to sensitize tumors to checkpoint inhibitors, likely through the exposure and release of neoantigens from treated lesions, thereby enhancing responses in both treated and untreated lesions. This mechanism may expand response rates and improve durability of outcomes in patients who derive limited benefit from checkpoint inhibition alone. These developments underscore the growing relevance of Gedeptin within this evolving treatment paradigm and support GeoVax’s decision to prioritize its advancement within the Company’s portfolio.

“This is a strategic step forward for GeoVax,” Dodd added. “By concentrating our efforts on GEO-MVA and maintaining our oncology innovation with Gedeptin, we believe we are positioning the Company for a more focused, execution-driven path toward late-stage development, commercialization and long-term value creation”.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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 – Tonix Pharmaceuticals Presented Retrospective U.S. Real-World Claims Analysis Characterizing Patients with Fibromyalgia at The Professional Society for Health Economics and Outcomes Research (ISPOR) 2026 Annual Meeting

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May 26, 2026 7:00am EDTDownload as PDF

Real-world analysis of three years of closed claims data from Symphony Health focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia

Data underscore high comorbidity burden, multimodal treatment approach, and extensive healthcare resource utilization (HCRU) among patients with fibromyalgia

Tonix commercially launched TONMYA® in November 2025, the first new fibromyalgia drug for adults in the U.S. approved in over 15 years

BERKELEY HEIGHTS, N.J., May 26, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, presented data from a real-world claims analysis characterizing U.S. adults with fibromyalgia in a poster at ISPOR 2026, the Professional Society for Health Economics and Outcomes Research’s annual meeting, held May 17-20, 2026, in Philadelphia, Pennsylvania.

“Fibromyalgia is a chronic pain disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbance, cognitive dysfunction, and somatic symptoms, leading to substantial management challenges,”1-4 said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “More than 10 million adults in the U.S. suffer from fibromyalgia. In response to fibromyalgia’s complex and persistent symptoms, and extensive comorbidities, fibromyalgia patients face rotating treatment approaches, and high HCRU. These findings highlight the need for comprehensive disease management and more effective therapeutic interventions to reduce the clinical and economic burden of fibromyalgia. Tonix is focused on the commercial launch of TONMYA, a first-in-class, first-line, non-opioid analgesic medicine designed for daily bedtime administration and long-term use.”

Data presented at ISPOR 2026 represent a retrospective, multi-year, multi-cohort study using the Symphony Health closed claims database, encompassing administrative medical and pharmacy claims collected between April 2021 and April 2024. The study’s objective was to evaluate real-world characteristics, including demographics, comorbidities, and HCRU among adults diagnosed with fibromyalgia (ICD-10-CM diagnosis code M79.7). The Year 3 cohort (April 2023 to March 2024) included 261,776 adult patients, with a median age of 53 years. Most patients were female (92.1%). Patients were White non-Hispanic (49.6%), Hispanic (22.4%), Other (19.6%), and Black (8.3%).

Comorbidity burden was high, with 93.2% of patients having at least one fibromyalgia-related comorbidity, most commonly anxiety/depression (63.9%), dorsalgia/back pain (56.5%), hypertensive diseases (51.4%), and joint pain (48.4%). Among the 90.3% of patients with at least one co-existing condition (or comorbidity), 36.2% had four or more, and subgroups including Black/Brown women, women on opioids, women with gut health issues, and older women with sleep issues all carried higher rates of comorbidity than the overall cohort. Among insured patients (n=92,157), HCRU was extensive, and inpatient services represented the largest component of healthcare costs at $29,896 per patient annually, followed by pharmacy ($9,453) and outpatient ($6,196) costs, demonstrating the large burden on commercial and public healthcare programs. Antidepressants were the most frequently used medication class (48.2%), followed by NSAID analgesics (43.4%), anticonvulsants (41.6%), gastric acid secretion reducers (41.5%), skeletal muscle relaxants (40.7%), and opioid analgesics (39.4%). The medication use reflects reliance on multimodal pharmacologic strategies to manage fibromyalgia-related symptoms in routine clinical practice.

A copy of the Company’s poster presentation, “Characterizing Patients with Fibromyalgia: A U.S. Real-World Claims Analysis,” is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations/.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TONMYA® (cyclobenzaprine HCl sublingual tablets)

TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.

Citations

1. Bilge U, et al. Cardiovasc Dis. 2018;155:30–5.
2. Choy EH, Mease PJ. Rheum Dis Clin North Am. 2009;35(2):329–37.
3. Rivera FA, et al. Front Med (Lausanne). 2023;10:1301944.
4. Winslow BT, et al. Am Fam Physician. 2023;107(2):137–44.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS
TONMYA is contraindicated:

In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released May 26, 2026

Release – Cardiff Oncology Announces Webcast to Discuss Updated Phase 2 CRDF-004 Data for Onvansertib in First-Line RAS-Mutated mCRC

Posted on by [email protected]
Cardiff Oncology, Inc. logo

Research News and Market Data on CRDF

May 21, 2026

PDF Version

Updated Phase 2 CRDF-004 data to be presented during ASCO 2026 rapid oral session on June 2, 2026; investor webcast scheduled for June 3, 2026 at 8:30 am ET to review the data

SAN DIEGO, Calif., May 21, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced that it will host an investor webcast featuring members of management on June 3, 2026 at 8:30 am ET to review updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care regimens (FOLFIRI/bevacizumab or FOLFOX/bevacizumab) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).

The updated CRDF-004 data will first be presented during a rapid oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2026 at 8:00 am CT/9:00 am ET and will build on the CRDF-004 data previously presented in January 2026. More details about the oral presentation are available on the Company’s website here and the full abstract is now available on the ASCO website.

Investor Webcast Details
The investor webcast will take place on June 3 at 8:30 am ET. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
astr partners
[email protected]

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
[email protected]

Eledon Pharmaceuticals (ELDN) – Tegoprubart Data Update Scheduled For June 2026

Posted on by [email protected]


Friday, May 22, 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.

Data Updates To Be Presented In June 2026. Eledon has announced that additional data will be presented at the American Transplant Congress on June 22, 2026. The presentations will include long-term data from patients in the Phase 2 BESTOW trial and its extension study. We expect to see longer follow-up periods from additional patients than previously seen, showing outcomes, side-effect profiles, and organ survival in comparison with the standard of care, tacrolimus.

Conference Call Has Been Scheduled To Discuss Data. Eledon will hold a conference call at 8 AM on June 22 to discuss the data. This will be after the Saturday, June 20, poster presentation titled,” Phase 2 BESTOW Extension Trial Evaluating Tegoprubart’s Long-Term Safety and Efficacy in Preventing Kidney Transplant Rejection”, and before the Monday, June 22, oral presentation titled “Phase 2 BESTOW Trial: Evaluating Tegoprubart’s Safety and Efficacy in Preventing Kidney Transplant Rejection” at 12 PM.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Cardiff Oncology (CRDF) – 1Q26 Announced With Onvansertib Progress Toward Phase 3

Posted on by [email protected]


Friday, May 22, 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.

Cardiff To Present Data At ASCO. Cardiff Oncology reported a 1Q26 loss of  $12.4 million or $(0.18) per share. Important developments during the quarter include scheduling presentation of the Phase 2b trial, discussed in our Research Note on January 28, at the ASCO Annual Meeting from May 29 to June 2. A meeting with the FDA was held in April, with the Phase 3 trial still expected to begin in late FY2026. Cash on March 31, 2026, was $46.1 million.

End-of-Phase-2 Meeting With The FDA Completed. During 1Q26, the company held an End-of-Phase-2 Meeting with the FDA to obtain guidance on the Phase 3 design and regulatory approval requirements. As expected, the trial will enroll patients with RAS-mutated metastatic colorectal cancer (mCRC), treated with a combination of FOLFIRI with bevacizumab (Avastin) and the 30 mg dose of onvansertib. This is the regimen that produced the strongest results in the Phase 2b trial.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – GeoVax Comments on Escalating Bundibugyo Ebola Outbreak and Growing Need for Flexible Biodefense Vaccine Platforms

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Company Highlights Potential Role of MVA-Based Vaccine Technologies in Addressing Emerging Hemorrhagic Fever Threats, Including Ebola and Marburg Viruses

ATLANTA, GA – May 20, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today commented on the rapidly evolving Bundibugyo Ebola virus (BDBV) outbreak in Central Africa and the broader implications for global infectious disease preparedness and biodefense infrastructure.

The recent declaration by the World Health Organization (WHO) of a Public Health Emergency of International Concern (PHEIC) related to the outbreak has intensified concerns regarding global readiness for emerging viral threats, particularly less common Ebola species for which no broadly licensed vaccines currently exist.

GeoVax noted that its MVA-based hemorrhagic fever vaccine development programs have previously demonstrated encouraging preclinical protection signals across multiple filovirus targets, including Ebola and Marburg viruses. Key findings from previously completed studies include:

  • MVA-EBOV (Zaire Ebola): Demonstrated single-dose protection against lethal Zaire Ebola virus challenge in non-human primates, supporting the potential of MVA-based rapid-response filovirus vaccines.
  • MVA-SUDV (Sudan Ebola): Demonstrated protective efficacy in multiple preclinical challenge models, including single-dose protection in guinea pigs and survival benefit in non-human primates.
  • MVA-MARV (Marburg): Demonstrated significant survival protection in rigorous non-human primate challenge studies, supporting further development of MVA-based Marburg vaccine strategies.

“These outbreaks collectively reinforce a growing reality: preparedness against one viral strain does not necessarily ensure preparedness against the next,” said David A. Dodd. “The world is entering an era of continuous infectious disease emergence and re-emergence, where scalable vaccine platforms, diversified manufacturing capabilities, and flexible biodefense infrastructure will become increasingly important.”

Unlike prior Ebola outbreaks involving the Zaire ebolavirus species, the current outbreak involves the Bundibugyo species, which presently lacks a specifically approved vaccine for broad deployment. Public health experts have increasingly noted that the outbreak exposes limitations in existing strain-specific preparedness strategies and reinforces the importance of adaptable vaccine technologies capable of addressing multiple high-consequence pathogens.

The Company believes that MVA-based vaccine platforms may offer several important strategic advantages in responding to emerging infectious disease threats, including:

  • established safety and tolerability profiles,
  • flexibility for incorporation of multiple antigens,
  • potential applicability across multiple viral families,
  • suitability for rapid adaptation, and
  • the potential for development of multivalent single-dose vaccine approaches targeting multiple hemorrhagic fever pathogens simultaneously.

“Outbreaks involving Ebola, mpox, Marburg, hantavirus, and other emerging pathogens collectively reinforce the growing need for platform technologies capable of supporting rapid response against evolving threats,” added Mr. Dodd. “The lessons emerging from the current outbreak extend beyond Ebola itself and increasingly point toward the need for resilient, scalable, geographically distributed vaccine manufacturing capacity and second-source biodefense preparedness.”

GeoVax is currently advancing GEO-MVA, its MVA-based vaccine candidate targeting mpox and smallpox, designed to support growing global demand for orthopox preparedness while contributing to the development of domestic U.S.-based MVA manufacturing capability. The pivotal Phase 3 immunobridging study of GEO-MVA, in support of an expedited regulatory path provided by the European Medicines Agency (EMA), is scheduled to initiate in Q4 2026, with data results anticipated within approximately three months following trial initiation.

The Company believes the broader strategic relevance of MVA-based technologies continues to expand as governments and public health organizations increasingly prioritize:

  • supply-chain resilience,
  • domestic manufacturing,
  • flexible vaccine platforms, and
  • preparedness against multiple emerging infectious disease threats.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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] 

GeoVax Labs (GOVX) – Recent Events Put GeoVax Programs For Mpox, Ebola, and Infectious Disease Programs In The Spotlight

Posted on by [email protected]


Tuesday, May 19, 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.

WHO Has Declared Ebola A Public Health Emergency. On Sunday, May 17, the World Health Organization (WHO) declared Ebola a Public Health Emergency of International Concern (PHEIC), the highest level of global health alert it can issue. We believe the World Health Assembly in Geneva, Switzerland, held from May 18 to May 23, is increasing attention to outbreaks of Mpox, Ebola, and other infectious diseases. GeoVax is one of the few companies that has developed vaccines against these diseases.

GeoVax Has Overlooked Programs For Additional Infectious Diseases. GeoVax has completed pre-clinical work testing vaccines for hemorrhagic fever viruses, including Ebola, Sudan, and Marburg. It has developed these vaccines in collaborations with the National Institutes of Health, but has focused its resources on GEO-MVA, CM-04S1, and Gedeptin. The increased attention to Ebola could help obtain non-dilutive funding for these programs.


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Release – GeoVax Highlights Strategic Importance of Domestic MVA-Based Preparedness Infrastructure Amid Escalating Global Infectious Disease Threats

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

WHO Emergency Declaration of Ebola Outbreak and Ongoing Mpox Developments Reinforce the Importance of Diversified Vaccine Supply and Scalable U.S.-Based Manufacturing Capabilities

ATLANTA, GA – May 18, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today highlighted the growing strategic importance of scalable domestic vaccine manufacturing infrastructure and diversified vaccine supply capabilities amid a series of escalating global infectious disease developments.

Recent public health events, including the World Health Organization’s declaration of a Public Health Emergency of International Concern (“PHEIC”) related to the ongoing Ebola outbreak involving the Bundibugyo strain, continued international spread of Clade I mpox, and recent hantavirus-related public health concerns, underscore the increasingly dynamic nature of global biodefense and pandemic preparedness requirements.

“These developments reinforce the importance of scalable and flexible vaccine preparedness infrastructure,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “GeoVax’s primary strategic focus remains the advancement of GEO-MVA, our Modified Vaccinia Ankara (MVA) mpox and smallpox vaccine candidate, which we believe is well aligned with growing global emphasis on diversified vaccine supply, domestic manufacturing capability, and long-term biodefense preparedness.”

GeoVax is advancing GEO-MVA to support global orthopoxvirus preparedness efforts and help address the need for expanded and diversified vaccine supply infrastructure. The Company recently announced positive Scientific Advice from the European Medicines Agency supporting a Phase 3 immunobridging pathway toward potential regulatory approval.  This pivotal, Ph 3 trial is scheduled to initiate in Q4 ’26, with data results anticipated by mid-2027.

GeoVax believes recent infectious disease developments further reinforce the strategic importance of:
• diversified vaccine supply infrastructure;
• scalable domestic manufacturing capabilities;
• rapid-response vaccine platform technologies;
• and long-term investment in biodefense preparedness.

The Company also noted that the broader applicability of the MVA platform has been demonstrated across multiple infectious disease settings, including prior preclinical Ebola/hemorrhagic fever virus vaccine studies in which GeoVax’s MVA-based Ebola-Zaire vaccine candidate demonstrated complete protection in non-human primate lethal-challenge studies following Ebola virus exposure.

“Recent events continue to demonstrate that preparedness infrastructure cannot remain reactive or narrowly focused on individual outbreak cycles,” continued Mr. Dodd. “We believe the advancement of scalable domestic MVA-based manufacturing capability represents an important strategic objective for strengthening future biodefense readiness.”

About GEO-MVA

GEO-MVA is a next-generation Modified Vaccinia Ankara (MVA)-based vaccine candidate in development for the prevention of mpox and smallpox infection. GeoVax is advancing GEO-MVA as a potential differentiated MVA vaccine designed to support expanded global vaccine supply and diversified manufacturing capabilities. The program has received positive Scientific Advice from the European Medicines Agency supporting a Phase 3 immunobridging pathway toward potential regulatory approval.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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 – GeoVax Announces $3 Million Private Placement Financing Priced At-the-Market Under Nasdaq Rules

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

ATLANTA, GA – May 18, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today announced that it has entered into a securities purchase agreement with existing institutional investors for the purchase and sale of 2,027,027 shares of common stock (or common stock equivalents in lieu thereof) together with (i) Series A warrants to purchase up to 2,027,027 shares of common stock with an exercise price of $1.48 per share and a five-year term, and (ii) Series B warrants to purchase up to 2,027,027 shares of common stock with an exercise price of $1.48 per share and an 18-month term, for aggregate gross proceeds of approximately $3 million, before deducting placement agent fees and other offering expenses.

The closing of the offering is expected to occur on or about May 19, 2026, subject to the satisfaction of customary closing conditions. The Company expects to use the net proceeds from the offering for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the offering.

The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to the terms of the securities purchase agreement entered into with the investor, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) covering the resale of the shares of common stock and shares of common stock underlying common warrants sold in the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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. Forward-looking statements include, among other things, statements regarding the proposed closing of the transaction, the expected gross proceeds and the intended use of proceeds. 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]