GEO-CM04S1 Demonstrates Durable T Cell and Antibody Responses in Healthy and Immunocompromised Populations
ATLANTA, GA, April 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today recapped the successful presentation of new clinical data on its multi-antigen SARS-CoV-2 vaccine candidate, GEO-CM04S1, delivered at the 25th Annual World Vaccine Congress in Washington, D.C.
The presentation, titled “Phase 2b Study Results That Evaluated and Compared GeoVax’s Multi-Antigen Vaccine Candidate (GEO-CM04S1) to an Approved Vaccine Against COVID-19,” was given by Don J. Diamond, Ph.D. on April 24, 2025. It highlighted results across several Phase 1 and 2 clinical trials, including studies involving healthy volunteers as well as immunocompromised patients such as stem cell transplant recipients and those with chronic lymphocytic leukemia (CLL).
GEO-CM04S1, based on the synthetic Modified Vaccinia Ankara (MVA) vector platform, uniquely expresses both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2—resulting in broad and durable immune responses even in populations that have historically responded poorly to mRNA vaccines.
Key Highlights from the Clinical Data Presented
Robust Immune Response in Healthy Adults
In a Phase 1 trial, 100% of participants (34/34) seroconverted (i.e., produced antibodies) for Spike IgG, and 94% (32/34) for Nucleocapsid IgG.
98% (48/49) demonstrated a T cell response to either antigen following vaccination.
No serious safety concerns were reported across varying dose levels.
Comparable Immunogenicity at Lower Doses (Phase 2 Booster Trial)
Healthy volunteers who had previously received mRNA or protein-based COVID-19 vaccines were boosted with GEO-CM04S1 at two dose levels (10⁷ vs 10⁸ pfu).
Spike, RBD, and Nucleocapsid IgG antibody responses, as well as neutralization titers against multiple COVID-19 variants (including XBB.1.5), increased significantly at both dose levels with no meaningful differences between them.
T cell responses increased significantly post-vaccination, regardless of baseline immunity.
Superior Performance in Immunocompromised Populations
In stem cell transplant recipients, GEO-CM04S1 induced ELISA antibody titers and T cell responses that exceeded those observed in healthy volunteers.
In a randomized Phase 2 trial comparing GEO-CM04S1 to the Pfizer-BioNTech (Comirnaty®) vaccine in patients with Chronic Lymphocytic Leukemia, GEO-CM04S1 demonstrated a significantly higher T cell response rate.
At Day 56 of the study: 6 of 15 patients in the GEO-CM04S1 arm achieved ≥3-fold increases in Spike or Nucleocapsid-specific T cells versus 2 of 14 in the Comirnaty arm.
The Data and Safety Monitoring Board (DSMB) recommended halting enrollment in the Pfizer arm due to underperformance, while continuing enrollment of the GEO-CM04S1 arm.
“We were pleased to share these promising results with global leaders in vaccinology,” said Don J. Diamond, Ph.D. “The data underscore the value of our dual-antigen approach, particularly for patients underserved by existing single-antigen vaccines. GEO-CM04S1 not only drives strong antibody and T cell immunity in healthy adults, but also in the immunocompromised—a population historically underserved by single-antigen mRNA vaccines.”
David A. Dodd, Chairman, President, and CEO of GeoVax, added: “The clinical performance of GEO-CM04S1 across diverse and high-risk populations supports our mission to deliver broad and lasting protection through next-generation vaccines. Our data continues to demonstrate strong, durable immune responses in both healthy and immunocompromised populations—a critical feature of our vaccine for public health preparedness. As we continue to advance this program, these results reinforce our confidence in the MVA platform as a foundation for addressing future public health threats.”
About GEO-CM04S1
GEO-CM04S1 is a next-generation COVID-19 vaccine based on the Modified Vaccinia Ankara (MVA) vector originally developed at City of Hope. Its multi-antigen design expresses both Spike and Nucleocapsid proteins of SARS-CoV-2, promoting broad, cross-reactive immunity. The vaccine is being evaluated in three ongoing Phase 2 clinical trials.
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. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. 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.
Norovirus GII.17 variants have overtaken GII.4 as the most prevalent strain and significantly increased norovirus outbreaks in the U.S. and European countries in 2024-2025
Cocrystal Pharma’s pan-viral protease inhibitor CDI-988 shows superior broad-spectrum antiviral activity against major norovirus variants including GII.4 and GII.17 strains
Company reported favorable safety and tolerability of CDI-988 in Phase 1 and plans to initiate a human challenge study in 2025 for the treatment and prevention of norovirus infection
BOTHELL, Wash., April 24, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its investigative drug candidate CDI-988 was shown to bind to the highly conserved region of the GII.17 protease with excellent potency, similar to that shown across a range of GII.4 norovirus variants that had been the dominant worldwide strains until this year. The high resolution GII.17 protease crystal structures used in determining CDI-988’s activity were obtained using the Company’s proprietary structure-based platform technology. Cocrystal plans to initiate a human norovirus challenge study in 2025 in the U.S. to evaluate CDI-988 as a potential prevention and treatment of norovirus infection.
“Norovirus is the most common cause of acute gastroenteritis worldwide, yet there are no approved antiviral treatments or vaccines available to combat it,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Norovirus antiviral and vaccine development has been extremely challenging due to high diversity among variants that include 10 genogroups and 49 genotypes. We are gratified to have determined the first crystal structure of GII.17 protease and demonstrated broad-spectrum antiviral activity of CDI-988 against newly circulating major norovirus GII.17 variants. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral antiviral to be used for both prevention and treatment of norovirus infection.”
Pan-Viral Inhibitor CDI-988 CDI-988 is a protease inhibitor specifically designed and developed as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. The Company has completed a single-center, randomized, double-blind Phase 1 study in healthy adults evaluating safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo.
Structure-Based Platform Technology Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. 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 to identify novel binding sites and allows for 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 best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance.
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 first- and best-in-class 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 Cocrystal’s plans to initiate a human challenge study in 2025 for its oral norovirus product candidate, the potential efficacy of such product candidate, and the potential market for such product candidate. 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, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for such studies by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulations affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed with our development programs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. 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.
TNX-801 is a single-dose,live virus vaccine in development to protect against mpox and smallpox
TNX-801 protects immunocompromised animals from a lethal challenge with clade IIa monkeypox virus
Durability of TNX-801 vaccination shown by six-month protection of animals from a lethal challenge with rabbitpox
Tolerability of TNX-801 demonstrated in immunocompromised animals by no spreading to blood or tissues, even at high doses
CHATHAM, N.J., April 24, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in an oral presentation at the World Vaccine Congress Washington 2025, held April 21-24, 2025, in Washington, D.C. The presentation titled, “A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine”, highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals from mpox and rabbitpox and was well tolerated, even in immunocompromised animals. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
“TNX-801 shows promise as a potential mpox and smallpox vaccine by providing protective immunity to animals with a single-dose,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-801 was generally well tolerated, even in immunocompromised animals. The new data show durable six-month protection against a lethal challenge with rabbitpox virus and protection of immunocompromised animals against a lethal challenge with monkeypox clade IIa virus. These new data build upon prior studies showing protection of animals against a lethal challenge with intratracheal clade Ia mpox virus. In all of these studies, after a single dose vaccination, TNX-801 prevented both clinical disease and formation of lesions.”
Dr. Lederman continued, “The ongoing clade IIb mpox epidemic that started in 2022, and the more recent and ongoing clade Ib mpox epidemic, highlight the need for additional vaccine options, particularly single-dose options. Both the 2022 clade IIb and the 2024 clade Ib mpox epidemics have been declared by the World Health Organization (WHO) to be Public Health Emergencies of International Concern (PHEICs). We believe TNX-801 has the potential to make an impact towards preventing mpox and controlling future mpox epidemics.”
TNX-801 is a minimally replicative, live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th century vaccinia live-virus vaccines in animals. In September 2024, Tonix announced that the WHO’s preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.
About TNX-801*
TNX-801 (recombinant horsepox virus) is a single-dose, attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 is based on synthesized horsepox which is believed to be more closely related to Dr. Jenner’s vaccine than 20th century vaccinia viruses.6 Smallpox vaccines descended from Jenner’s vaccine used prior to 1900 would be called horsepox by modern nomenclature. TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection than two-dose vaccines by eliminating drop-out between doses and limiting forward transmission. Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox. Tonix has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The Company believes TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines. The FDA-approved non-replicating mpox vaccine Jynneos® requires two doses and provides a relatively short duration of protection. FDA also recently approved ACAM2000, a live, replicating vaccinia vaccine for prevention of mpox. ACAM200 is a clone from DryVax®, a 20th century vaccinia vaccine derived from the NYCBH strain. Pre-clinical results from an mRNA vaccine recently showed some protection from a Clade I monkeypox challenge, but with multiple break-through lesions in vaccinated animals.
About Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. Department of Defense’s (DoD’s) Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Key Points: – UPS will acquire Canada-based Andlauer Healthcare Group for $1.6B to strengthen cold chain and healthcare logistics capabilities. – The deal gives UPS deeper access to Canadian markets and expands its global healthcare supply chain footprint. – AHG’s founder Michael Andlauer will continue to lead operations post-acquisition, helping to integrate and scale services under UPS Healthcare.
UPS is taking a significant leap forward in healthcare logistics with its agreement to acquire Canada-based Andlauer Healthcare Group (AHG) for approximately $1.6 billion USD (CAD $2.2 billion). The deal, set to close in the second half of 2025, marks a strategic expansion of UPS Healthcare’s cold chain capabilities and its broader push to become the global leader in complex healthcare logistics.
Under the terms of the acquisition, AHG shareholders will receive CAD $55.00 per share in cash, a substantial premium that reflects the value of AHG’s specialized supply chain and third-party logistics offerings tailored to the healthcare sector. The transaction is subject to shareholder approval and regulatory clearance but has already secured support from AHG’s controlling shareholder, Michael Andlauer.
This acquisition arrives at a critical moment for healthcare logistics. Demand for temperature-sensitive and high-precision delivery of pharmaceuticals, biologics, and medical devices has grown rapidly in recent years, driven by the rise of advanced therapies, clinical trials, and global vaccine distribution efforts. UPS is positioning itself to meet those demands with a highly integrated global network, now enhanced by AHG’s robust infrastructure and expertise.
AHG brings to the table a coast-to-coast Canadian distribution network, a suite of customized logistics solutions, and proven cold chain transportation capabilities. These services will become part of UPS Healthcare’s expanding footprint, which already boasts over 19 million square feet of cGMP and GDP-compliant distribution space across the globe.
Michael Andlauer, AHG’s founder and CEO, will continue to lead the company following the acquisition, heading UPS Canada Healthcare and helping to guide the integration. “UPS Healthcare and AHG employees share a similar customer and patient-centric culture,” said Andlauer. “Once the transaction is completed, the businesses will offer an even broader set of specialized logistics services to customers throughout Canada.”
Kate Gutmann, EVP and president of International, Healthcare and Supply Chain Solutions at UPS, said the move is aligned with UPS’s mission to be the premier global healthcare logistics provider. “This acquisition marks another important step in our declaration to be the number one complex healthcare logistics and premium international logistics provider in the world,” she said.
The acquisition is also expected to drive growth for UPS by expanding its cold chain capabilities and enhancing services for healthcare customers who require strict temperature control, visibility, and compliance throughout the logistics chain. As UPS builds out its global logistics infrastructure, this move strategically complements earlier investments in technology, infrastructure, and customer-driven healthcare solutions.
For investors in the healthcare logistics and small-cap space, the AHG acquisition underscores growing M&A interest in niche logistics providers with deep industry specialization. It also signals UPS’s continued focus on high-growth, high-margin sectors, and its commitment to staying ahead in the evolving global healthcare ecosystem.
Atlanta, GA, April 23, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report first quarter 2025 financial results on Thursday, May 1, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.
Conference Call Details
To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.
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. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. 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.
Recognized Biologics Executive to Oversee Critical Expansion of U.S.-Based Development Capabilities
ATLANTA, GA, April 22, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced the appointment of Senthil Ranganathan, Ph.D. as Vice President, Technical Development and CMC Operations. Dr. Ranganathan brings over 20 years of experience in biologics development to commercialization across vaccines, cell and gene therapies, monoclonal antibodies, and viral vector products.
This appointment comes at a pivotal time for GeoVax as it advances a comprehensive portfolio of infectious disease vaccines and cancer therapies, positioning the Company to address significant unmet medical needs, contributing to biodefense readiness, and improving vaccine and therapeutic equity through innovation and onshoring.
David Dodd, Chairman & CEO of GeoVax, stated: “We are delighted to welcome Senthil to GeoVax. His track record and expertise in a breadth of biologics development and preparation for registration and subsequent commercialization will support and enhance our progress as we proceed towards the authorization and subsequent commercialization stages for our exciting development portfolio.”
Dr. Ranganathan has held senior leadership roles across industry-leading biopharmaceutical companies, most recently serving as Head of Process Development CMC for the Boston site of National Resilience. He previously led global CMC and manufacturing operations at Athersys, Zymeworks, and Alder Biopharmaceuticals (acquired by Lundbeck Biopharmaceuticals). His career has spanned the development and validation of cell and gene therapies, vaccines, bispecific antibodies, and other biologics—from pre-IND through licensure and commercialization.
He holds a Ph.D. in Biochemistry from Loyola University Chicago and has authored numerous regulatory submissions and publications in support of breakthrough vaccines, biologics, and therapies.
“I am honored to join GeoVax during such a critical stage of the Company’s growth and development,” said Dr. Ranganathan. “I look forward to working with the outstanding GeoVax team as we develop and execute the roadmap that will bring the GeoVax portfolio to benefit patients and communities worldwide.”
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. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. 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.
Key Points: – Eli Lilly’s daily obesity pill orforglipron showed strong weight loss and blood sugar control results in its first late-stage diabetes trial. – The oral treatment, seen as a needle-free rival to Ozempic and Wegovy, positions Lilly to lead the $150B GLP-1 market.
Eli Lilly’s experimental weight-loss pill, orforglipron, has demonstrated promising results in its first late-stage clinical trial involving patients with type 2 diabetes, marking a significant advancement in the treatment of obesity and diabetes. The once-daily oral medication led to substantial weight loss and improved blood sugar control, positioning it as a potential game-changer in the rapidly expanding market for GLP-1 receptor agonists.
In the 40-week trial, patients taking the highest dose of orforglipron experienced an average weight loss of 7.9%, approximately 16 pounds, without reaching a plateau, indicating the possibility of continued weight reduction beyond the study period. Additionally, the drug lowered hemoglobin A1c levels—a key measure of blood sugar—by 1.3% to 1.6% across various doses, compared to a 0.1% reduction in the placebo group.
The safety profile of orforglipron was comparable to existing injectable GLP-1 therapies, with gastrointestinal side effects such as nausea, vomiting, and diarrhea being the most common. These side effects were generally mild to moderate and occurred primarily during the dose-escalation phase. Notably, only about 8% of participants discontinued treatment due to adverse effects, aligning with expectations for this class of drugs.
The trial results have generated significant enthusiasm in the pharmaceutical industry, with Eli Lilly’s shares rising by up to 17% following the announcement. Analysts highlight the convenience of a daily pill over weekly injections, which could enhance patient adherence and broaden the drug’s appeal. Furthermore, as a nonpeptide molecule, orforglipron is easier to manufacture and does not require dietary restrictions, potentially improving accessibility and affordability.
Eli Lilly plans to seek regulatory approval for orforglipron’s use in treating obesity by the end of 2025, with an application for type 2 diabetes treatment anticipated in 2026. The company is conducting seven late-stage studies on the pill, including five focused on diabetes and two on obesity, to support these applications.
If approved, orforglipron would be the first oral GLP-1 receptor agonist for weight loss, offering a needle-free alternative to popular injectable treatments like Ozempic and Wegovy. This innovation could significantly impact the global obesity treatment market, which some analysts project could exceed $150 billion annually by the early 2030s, with oral GLP-1 drugs comprising a substantial portion of that market.
While the initial results are promising, further data on cardiovascular outcomes and long-term safety are awaited to fully assess orforglipron’s potential. Nonetheless, the successful trial marks a pivotal step toward expanding treatment options for individuals with obesity and type 2 diabetes, potentially transforming the landscape of metabolic disease management.
Company Reaffirms Commitment to Innovation in COVID-19, Oncology, and Biosecurity Amid Strategic Program Developments
ATLANTA, GA, April 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today addressed the termination of its Project NextGen (PNG) award by the Biomedical Advanced Research and Development Authority (BARDA), effective April 11, 2025. The Company also provided a comprehensive business update across its core programs, including the next-generation COVID-19 vaccine (GEO-CM04S1), cancer immunotherapy (Gedeptin®), Mpox/smallpox vaccine (GEO-MVA), and advanced MVA manufacturing process.
GeoVax expressed disappointment in the HHS/BARDA action but remains committed to the critical medical need addressed by GEO-CM04S1, particularly among the more than 40 million immunocompromised Americans—and over 400 million people globally—who remain inadequately protected by the current authorized COVID-19 vaccines. Thus far, clinical data in support of GEO-CM04S1 demonstrate encouraging support of the potential of GEO-CM04S1 for providing (a) more robust immune response, (b) increased durability and (c) protective immunity for those patients with depleted immune systems inadequately responding to the current authorized COVID-19 vaccines.
The Company also noted recent public statements by HHS leadership acknowledging the potential enhanced value of multi-antigen vaccines addressing respiratory viruses. Of special note is that GEO-CM04S1 was the only multi-antigen/polyvalent COVID-19 vaccine candidate selected under the PNG initiative.
“While the recent HHS/BARDA Stop Work Order action was disappointing and surprising, our commitment to protecting vulnerable populations remains unchanged, and our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs,” said David Dodd, Chairman and CEO of GeoVax.
Continued Progress Across a Catalyst-Rich Pipeline
GEO-CM04S1: Advancing to Meet Unmet COVID-19 Needs
GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include:
Healthy Adult Booster Trial – Enrollment is complete; data readout expected in H1 2025.
CLL Patient Study (Immunocompromised patient study) – Ongoing enrollment; interim results resulted in continuation of the GEO-CM04S1 arm, whereas the Data Safety Review Board recommended early termination of the mRNA arm, which was subsequently implemented.
Stem Cell Transplant/CAR-T Trial (Immunocompromised patient study) – Enrollment and evaluation continue among hematological patients receiving stem cell transplantation or CAR-T therapy, comparing GEO-CM04S1 to mRNA COVID-19 vaccines.
GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines.
Gedeptin®: Advancing into Phase 2 in Solid Tumors
GeoVax’s oncology program, utilizing the Gedeptin® technology, is planned to progress to a Phase 2 trial in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. Gedeptin has received Orphan Drug designation for use among advanced head & neck cancer patients. The Gedeptin technology provides potential for expansion into other solid tumors including triple-negative breast cancer, melanoma, and soft tissue sarcoma.
GEO-MVA: Addressing Biosecurity and Global Vaccine Equity
GeoVax anticipates initiating clinical trials in 2025 for GEO-MVA, its Mpox/smallpox vaccine candidate. The Company has successfully produced cGMP clinical product and is focused on completing the vaccine vialing in support of initiating clinical evaluation during H2 2025. GEO-MVA positions GeoVax to offer a U.S.-developed alternative to foreign-sourced vaccines amid rising global biosecurity threats and constrained supply.
Advanced Manufacturing: Scaling MVA for Global Reach
GeoVax is advancing continuous cell line manufacturing for MVA-based vaccines, offering a path to scalable, cost-effective production—including localized manufacturing for low- and middle-income countries. This innovation addresses critical gaps in vaccine self-sufficiency and supply resilience.
Outlook for 2025
Despite the PNG award termination, GeoVax anticipates a milestone-rich 2025 across its portfolio. The Company will continue to engage with government and industry partners, pursue clinical trial completions, and drive innovation through expanded AI integration to optimize development, trial operations, and manufacturing efficiency.
“Our scientific foundation is strong and our strategy is clear,” added Dodd. “GeoVax remains committed to delivering transformative solutions for unmet medical needs in infectious disease and cancer. We’re advancing with purpose and fully prepared to deliver on the promise of our development program.”
For further details on GeoVax’s programs and progress, visit www.geovax.com.
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. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. 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.
Key Points: – Longevity Health and 20/20 BioLabs to merge, forming a $99M company focused on diagnostics and healthy aging. – 2025 revenue expected to double post-merger, driven by cross-sell opportunities and product synergies. – Combined firm targets expanding into MedSpas, retail, and clinical settings, reflecting a hybrid approach to wellness and diagnostics.
Longevity Health Holdings (Nasdaq: XAGE) is doubling down on its ambition to lead the healthy aging and diagnostics market with the announcement of a strategic all-stock merger with 20/20 BioLabs, a provider of cutting-edge diagnostic tests for early cancer detection and chronic disease risk management. The deal, which is expected to close in Q3 2025, marks another step in Longevity’s pivot toward becoming a vertically integrated longevity-focused healthcare platform.
The merger comes just months after Longevity’s acquisition of Elevai Skincare and follows the company’s March 2025 announcement outlining a broader strategy to combine diagnostics, bio-aesthetics, and nutrition under the unifying theme “Healthy Aging, Inside and Out™.” With 20/20’s technology and distribution capabilities, Longevity is adding a diagnostics engine to its growing wellness infrastructure and positioning itself as a unique player at the intersection of science, skincare, and preventative healthcare.
Under the terms of the agreement, 20/20 shareholders will own approximately 50.1% of the combined company, with Longevity shareholders retaining 49.9%—a sign of parity and the significance of what 20/20 brings to the table. The merged company will continue to trade under the ticker “XAGE” on the Nasdaq.
Founded in Gaithersburg, Maryland, 20/20 operates a CLIA-licensed and CAP-accredited laboratory and has developed OneTest™, a multi-cancer early detection (MCED) blood test capable of identifying over a dozen tumor types for under $200. The company has already integrated its tests into wellness protocols for firefighters and military veterans and is preparing to launch a new “longevity test” this spring that evaluates inflammatory markers tied to aging and disease risk.
Financially, the merger is set to double Longevity’s expected revenue for fiscal year 2025 from $3–4 million to $7–8 million and deliver at least $1 million in operational synergies. The combined company’s equity valuation is pegged at $99 million, offering a promising growth profile in a market that increasingly values integrated health solutions.
For small-cap investors, the deal highlights an emerging investment theme: convergence in wellness, biotech, and diagnostics. Longevity is carving out a niche in a crowded but high-potential market by integrating scientific, consumer-facing products with medical-grade diagnostics. This cross-disciplinary approach could make it more resilient than standalone players focused solely on aesthetics or lab testing.
Beyond the numbers, Longevity plans to offer 20/20’s tests through its network of physicians to inform more personalized bio-aesthetic treatment plans. Conversely, 20/20 will gain access to Longevity’s customer base—including thousands of firefighters—to introduce its diagnostics in new environments, including MedSpas and retail.
Leadership will be shared post-merger. Longevity’s Rajiv Shukla will remain Chairman, while 20/20’s Jonathan Cohen will step in as CEO, underscoring a collaborative transition.
As Longevity eyes further acquisitions, this deal positions it as a unique micro-cap consolidator in the rapidly evolving healthy aging space. Investors should watch closely as the company scales up from niche science to potentially mass-market longevity solutions.
Nutriband granted patent protecting its AVERSA abuse deterrent platform technology in Macao, a Special Administrative Region of the People’s Republic of China
April 11, 2025 07:00 ET
ORLANDO, Fla., April 11, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has received notification that its patent has been granted in Macao for its patent entitled, “Abuse and Misuse Deterrent Transdermal Systems,” which protects its AVERSA™ abuse deterrent transdermal technology.
The Macao Intellectual Property Office granted patent J/9010 on February 11, 2025 as recorded in Macao Official Bulletin No. 10 on March 5, 2025. Macao is a Special Administrative Region (SAR) of the People’s Republic of China that has its own patent system and patent laws which are separate and distinct from those of mainland China.
The AVERSA™ abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia as well as two regions of China: Hong Kong and Macao.
Nutriband’s AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse while making sure that these drugs remain accessible to those patients who really need them.
Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop its lead product, AVERSA™ Fentanyl, which incorporates Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system.
AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1
____________________________________________________ 1 Health Advances AVERSA Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
– Patient-reported outcomes from Phase 2 trial of oxylanthanum carbonate (OLC) demonstrate high patient satisfaction with OLC compared to their prior phosphate lowering therapy –
– Findings from a patient survey conducted in partnership with the National Kidney Foundation (NKF) showed excessive number and large size of phosphate binder pills to be top barriers to consistent medication use –
– Results to be presented in poster sessions at the NKF Spring Clinical Meetings –
LOS ALTOS, Calif., April 10, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced new patient-reported outcomes data from its pivotal Phase 2 study of OLC as well as from a new survey conducted by the National Kidney Foundation (NKF) with sponsorship from Unicycive. OLC is an investigational treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The findings will be presented today in poster sessions at the NKF Spring Clinical Meetings taking place in Boston.
OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis and set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
“As many as two out of three of patients with end-stage kidney disease undergoing dialysis don’t consistently adhere to their phosphate binder treatment; common barriers are side effects, pill burden, and unpalatable formulations,” said Dr. Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial. “These new patient-reported outcomes underscore the potential of OLC to enhance adherence, reduce treatment burden and improve patient satisfaction. OLC could be a welcome new phosphate binder choice for patients with hyperphosphatemia due to its favorable tolerability, small, easy-to-swallow size and low pill burden.”
Patient-Reported Outcomes Data Patient-reported outcomes from the open-label Phase 2 UNI-OLC-201 clinical trial compared patients’ satisfaction with their pre-trial phosphate binders versus OLC at the end of the study based on responses to a questionnaire completed by 80 patients. This research will be presented by Guru Reddy, PhD., in the poster titled “Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence” (Poster # G-018) on Thursday, April 10, from 5:15–7:30 p.m. ET.
Results:
OLC reduced pill burden by 50% – patients took a median of three tablets of OLC per day versus six tablets of phosphate binders prior to the trial.
OLC improved adherence – 70% of patients reported consistent adherence with OLC compared to 58% who reported adherence to their pre-trial phosphate binders.
OLC was preferred – 79% of patients indicated a preference for OLC versus 4% who preferred their pre-trial phosphate binder medications.
OLC improved patient satisfaction – 98% of patients agreed that OLC was easy to take versus 38% who said that about their pre-trial phosphate binder medication, and 89% reported they were satisfied with OLC treatment versus 49% who were satisfied with pre-trial phosphate binders.
Patient Survey Results In partnership with Unicycive, NKF conducted an online survey of patients undergoing dialysis to assess the top barriers to phosphate binder adherence and to better understand what treatment characteristics could improve adherence. A total of 200 patients aged 40 and older completed the online survey from February 15 to May 16, 2024. This research will be presented by Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities, in a poster titled “Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients” (Poster # G-297) on Thursday, April 10, from 5:15-7:30 p.m. ET.
Results showed:
Forgetfulness (63%) was the primary barrier to consistent medication use followed by excessive pill number (47%) and large pill size (47%).
Additional barriers to adherence included difficulties carrying pills (45%), gastrointestinal side effects (29%), unpleasant taste (20%), social embarrassment when taking medication (13%), and cost (10%).
Patients were more likely to prefer medication regimens with fewer and smaller pills, underscoring the impact of pill burden on adherence.
About Oxylanthanum Carbonate (OLC) Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
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 Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’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 candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; 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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1Reason Research, LLC 2022 survey. Results here. 2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030 3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
Continues to Strengthen its Pandemic Preparedness and Biodefense Vaccine Portfolio
ATLANTA, GA, April 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Patent Application No. 18/394,555 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover prevention of Marburg virus infection utilizing GeoVax’s proprietary MVA-based Marburg vaccine.
Previous presentations of data from nonhuman primate studies demonstrated that immunization with GeoVax’s vaccine candidate, GEO-MM01, conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected from viremia, weight loss and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. GeoVax is currently evaluating study designs to assess the potential for administering different dose levels of the vaccine and different routes of vaccine delivery to optimize utility and efficacy.
David Dodd, GeoVax President and CEO, commented, “While our focus and development priorities continue to be our next-generation COVID-19 vaccine, our Mpox/smallpox vaccine and cancer immunotherapy programs, developing vaccines against lethal hemorrhagic fever viruses represents our commitment to addressing highly fatal endemic threats throughout the world. Such viruses have mortality rates between 50%-90% depending on the specific virus strain. Our team is committed to supporting the successful advancement of such a vaccine, as we recognize the critically important medical and biodefense need, reflected by the inclusion of Marburg virus in the FDA Priority Review Voucher program. Within the critically needed area of hemorrhagic fever viruses, GeoVax has successfully developed vaccine candidates addressing Ebola Zaire, Ebola Sudan and Marburg, all having demonstrated impressive results when evaluated in non-human primates. The USPTO’s recognition of our Marburg vaccine technology further validates our approach and underscores the growing value of our wholly owned, co-owned, and in-licensed intellectual property estate, now standing at over 135 granted or pending patent applications spread over 23 patent families.”
Dodd continued, “Our focus extends beyond individual product candidates—we are building a broad, durable defense platform against hemorrhagic fever viruses. We believe this strategy, supported by compelling preclinical data and prioritized by global health authorities, positions GeoVax to play a central role in pandemic preparedness and biodefense.”
About Marburg Virus
Marburg virus (MARV) is a hemorrhagic fever virus of the Filoviridae family, which also includes Ebola virus, and causes severe human disease with up to a 90% fatality rate. The Marburg virus is transmitted to people from fruit bats, and human-to-human transmission occurs through direct contact with bodily fluids, or contaminated surfaces and materials. MARV is rated by the World Health Organization (WHO) as a Risk Group 4 Pathogen. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks it as a Category A Priority Pathogen and the Centers for Disease Control and Prevention lists it as a Category A Bioterrorism Agent. MARV typically appears in sporadic outbreaks throughout Africa and the virus continues to pose potential public health and biodefense threats. There are currently no licensed vaccines or therapeutics against the diseases caused by MARV.
About the GeoVax MVA Platform
GeoVax’s vaccine platform utilizes modified vaccinia Ankara (MVA), a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into virus-like particles (VLP) immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic the virus production that occurs in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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.
Agreement includes the use of Tonix’s TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana’s genetically engineered pig organs in xenotransplantation
Establishes framework for Makana’s kidney, heart and islet cell programs to utilize TNX-1500 for preclinical studies in support of regulatory filings for potential use in human recipients
CHATHAM, N.J. and MIAMI, April 09, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), (“Tonix”) a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, and Makana Therapeutics, Inc. (“Makana”), a global leader in the field of xenotransplantation, today announced a collaborative research agreement under which Tonix and Makana will study Tonix’s anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana’s human-compatible organs and cells for the treatment of organ failure. The preclinical research and development collaboration has the potential to span multiple Makana programs including kidney, heart and islet cell transplant. The goal of the preclinical studies is to support the submission of an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) to support compassionate use for patients undergoing xenotransplantation.
“We are excited to partner with Makana in support of our mutual goal to offer novel solutions for patients requiring organ or cellular transplantation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We believe this strategic agreement is a promising step towards utilizing xenotransplantation in the clinic. Makana’s novel genetically engineered (GE) pigs, which have deleted swine leukocyte antigen (SLA)2, has shown improved human compatibility and several other advantages over other technologies including high rates of fertility and birthing, which potentially increases their ability to produce viable organs to satisfy a commercial market globally.”
“Despite significant progress and momentum in the field of xenotransplantation, improving organ compatibility to prevent rejection remains an ongoing challenge,” said Joseph Tector, M.D., Ph.D., Founder of Makana and a practicing transplant surgeon. “This collaboration provides Makana the opportunity to combine its novel GE pig organs with TNX-1500 in our ongoing and future preclinical studies. We view anti-CD40L as a critical part of an effective immunomodulatory regimen for successful xenotransplantation. This collaboration enables us to pursue co-development of our GE organs with the TNX-1500, which has shown best-in-class pharmacokinetics and pharmacodynamics in a human study after showing best-in-class results in preventing rejection in 6-month studies of allo- and xenotransplantation in animals. Our mutual goal is to obtain the best human results as soon as possible.”
“We are thrilled with this collaboration utilizing TNX-1500 as an important element of our xenotransplant therapy. The collaboration with Tonix gives Makana the right product and the right partner to bring Makana toward clinical development,” said Mark Platt, President and Chief Executive Officer of Makana. “Most organ-failure patients today will never receive a lifesaving/life-changing transplant. Our achievement in developing the SLA DR knockout pig has yielded encouraging results with preclinical kidney xenografts and positions us to deliver strong outcomes in clinical development.”
TNX-1500 is an investigational, humanized Fc-modified IgG4 anti-CD40L antibody with high affinity for the CD40 ligand. CD40L is an attractive drug development target for transplant immunomodulation since the engagement of the CD40L plays a pivotal role in immune system activation by modulating both antibody and cellular immune responses.
About Makana’s Genetically Engineered (GE) Pigs
Makana began developing pigs for xenotransplantation in 2010. Makana’s 2013 creation of the Triple Knockout (TKO) Pig, lacking three key glycans responsible for hyperacute and acute organ rejection in humans, resulted in the first 1-year preclinical xeno-kidney survivor in animals1. This discovery revitalized the xeno-field and today Makana’s TKO genetics are employed across the xenotransplantation field.
Realizing that the first clinical xenografts failed because of antibody mediated rejection, Makana deferred rushing to the clinic and employed the same stepwise scientific approach to show that these early clinical failures occur because of the development of antibodies against SLA. The final result is that Makana has developed the new TKO plus SLA DR KO pig that eliminates the next barrier to clinical success. Now Makana is poised to achieve longer term clinical success.
Makana has achieved the field’s longest and most consistent preclinical survival without the need to insert human transgenes into its pig genetics. Rejection continues as a barrier to survival in the limited number of emergency IND human transplants performed with transgenic pigs, further supporting Makana’s focus on antigen discovery and deletion in lieu of relying on inserted transgenes to evade the human immune response.
Without the need for transgenes, the future commercialization of Makana’s xeno-organs through breeding will be straightforward. When compared to transgenic animals, Makana’s knockout-only pigs will breed with greater efficiency and eliminate the challenge of retaining transgenic expression. This is an important consideration, reducing both the cost of therapy and the complexity of GE pig production.
Makana’s preclinical successes with SLA-deleted pig kidneys in animal xenotransplantation has depended on the co-administration of primatized 5c8 anti-CD40L monoclonal antibody. Tonix’s TNX-1500 is an Fc-modified version of humanized 5c8, which maintains the activity of 5c8, while improving tolerability.
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154 or 5c8 Ag.4 The combining sites of TNX-1500 are derived from humanized 5c8 or ruplizumab, which showed promise in treating systemic lupus erythematosus.5 Chimeric primatized 5c8 showed promise in preventing rejection of organ rejection in animals.6 TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts and renal xenografts.7-9
*TNX-1500 is an investigational new biologic and is not approved for any indication
Citations
Estrada JL, et al. Xenotransplantation. 2015;22(3):194-202.
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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. All other marks are property of their respective owners.
About Makana Therapeutics
Founded in 2009, Makana Therapeutics is focused on developing swine with reduced xenoantigen expression, making human transplantation of cells, tissues and organs from these animals possible. Makana’s focus on scientifically validated genetics, optimized pig cloning techniques and careful patient selection is expected to streamline product development and result in safer more efficacious products. For more information on Makana, please visit www.makanatherapeutics.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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
