Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Setting up fiscal 2026. We are adjusting our fiscal Q4 estimates to reflect updated expectations for the Medicare Advantage market, with a particular focus on recent regulatory changes affecting Special Needs Plans (SNPs). While these developments introduce near-term challenges, we believe SelectQuote is well-positioned heading into fiscal 2026. We expect the company to rebuild agent capacity ahead of the next Annual Enrollment Period (AEP), to support a trajectory of sustained revenue growth and adj. EBITDA margin expansion.
Special Needs changes. Our revised Q4 outlook is primarily driven by recent changes implemented by CMS that restructure Special Needs Plan switching rights. The policy shift narrows mid-year enrollment flexibility for a significant portion of dual-eligible consumers (those enrolled in non-integrated D-SNPs), leading to the prospect of a smaller pool of shopping beneficiaries during the middle of calendar 2025. In addition, we are accounting for SelectQuote’s reduced year-over-year agent count, which entered fiscal 2025 approximately 22% below the prior-year level due to capital constraints at the time. These factors combined create a more muted backdrop for near-term Medicare Advantage performance.
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In a major milestone for type 1 diabetes treatment, a groundbreaking clinical trial has shown that stem cell-derived islet cell transplantation can effectively eliminate the need for insulin in patients. This advancement marks a turning point in diabetes care and highlights the efforts of leading researchers, including Dr. Piotr Witkowski at the University of Chicago, and the collaborative work of Vertex Pharmaceuticals (VRTX) and Eledon Pharmaceuticals (ELDN).
Historically, islet cell transplantation involved harvesting pancreatic islets from deceased organ donors—a limited and logistically challenging source. Patients often required multiple transplants to see long-term benefits, and donor scarcity severely limited access to the therapy. But now, lab-manufactured islets derived from stem cells are changing the game, offering a consistent, scalable, and potentially off-the-shelf solution to treating the most severe forms of type 1 diabetes.
In the ongoing multicenter clinical trial, presented at the American Diabetes Association’s Scientific Sessions and published in the New England Journal of Medicine, 10 of 12 patients remained insulin-independent for over a year after just a single infusion of stem cell-derived islets. This level of success, particularly from a single dose, is unprecedented in the field and demonstrates the power of scientific innovation to transform chronic disease management.
Dr. Witkowski, a lead investigator and transplant surgeon at the University of Chicago, has been at the forefront of this effort. His involvement traces back to the early development of the clinical protocol in 2019 with Andrea Vergani at Semma Therapeutics. After Vertex Pharmaceuticals acquired Semma, Dr. Witkowski continued his work as a member of the Scientific Advisory Board and as a principal investigator performing transplants. As of last week, his team has successfully infused their 10th patient with Vertex’s stem cell-derived islets.
While these results are promising, patients receiving the treatment still require immunosuppressive therapy to prevent rejection—typically involving drugs like tacrolimus, which can be toxic over time. That’s where Eledon Pharmaceuticals (ELDN) enters the picture. In a parallel pilot study, researchers are evaluating Tegoprubart, Eledon’s novel immunosuppressive agent designed to reduce toxicity while maintaining immune protection. If successful, Tegoprubart could offer a safer path forward and expand access to islet transplantation for a broader population.
The future is bright. Trials are now underway to test the therapy in kidney transplant recipients—patients already on immunosuppressants—providing an ideal setting to further prove the therapy’s safety and effectiveness. With continued success, stem cell-derived islets could soon become a standard-of-care treatment, immediately benefitting the 40,000+ patients in the U.S. suffering from the most unmanageable forms of diabetes.
Thanks to the visionary work of scientists, clinicians, and companies like Vertex and Eledon, what was once a highly experimental and limited therapy is on track to become a scalable medical solution. As Dr. Piotr Witkowski and his team continue their work, the path to a functional cure for type 1 diabetes is finally within reach.
Zimmer Biomet (NYSE: ZBH), one of the world’s leading medical technology companies, announced a definitive agreement to acquire Monogram Technologies (NASDAQ: MGRM), a fast-growing robotics innovator, in a strategic move that could redefine the future of orthopedic surgery. The $177 million all-cash deal includes an upfront payment of $4.04 per share and a potential additional $12.37 per share via a non-tradeable contingent value right (CVR), contingent on milestones through 2030.
The acquisition marks a major milestone in Zimmer Biomet’s mission to deliver a next-generation surgical robotics platform. Monogram brings proprietary semi- and fully autonomous robotic systems designed for total knee arthroplasty (TKA), bolstered by FDA clearance in early 2025. The deal also positions Zimmer Biomet to be the first company in orthopedics to offer a fully autonomous surgical robot—a potential game-changer in an increasingly tech-driven sector.
Zimmer Biomet’s existing ROSA® Robotics platform already leads in imageless robotics and is nearing 2,000 global installations. By integrating Monogram’s AI-driven, CT-based surgical systems, the company expands its portfolio to address varying surgeon preferences—manual, semi-autonomous, or fully autonomous—and across different anatomical procedures.
This acquisition gives Zimmer Biomet a first-mover advantage in the race for orthopedic robotics innovation. With Monogram’s platform, the company aims to deliver safer, more efficient surgeries and drive adoption across hospitals and ambulatory surgery centers (ASCs) seeking digital and robotic enhancements.
Monogram’s technology complements Zimmer Biomet’s current development pipeline, including ROSA Knee with OptimiZe, ROSA Posterior Hip, and ROSA Shoulder—key components of its multi-year plan to remain the global leader in orthopedic robotics.
Financially, the acquisition is expected to be neutral to Zimmer Biomet’s adjusted earnings per share through 2027 and accretive thereafter. Management projects high-single-digit returns on invested capital by year five, fueled by accelerated robotic knee adoption, greater share of wallet, and broader customer reach in the U.S. and internationally.
Tariffs and broader market volatility have weighed on the healthcare sector in 2025, but Zimmer Biomet’s move signals a long-term, innovation-led growth strategy. By enhancing its robotics suite, the company is positioning itself to capture demand in one of the fastest-growing medtech segments.
With regulatory approval and Monogram shareholder consent still pending, the merger is expected to close later this year. Once complete, Zimmer Biomet will be uniquely positioned with the industry’s most flexible and comprehensive orthopedic robotics ecosystem.
This acquisition isn’t just a strategic bolt-on; it’s a forward-looking bet on where surgery is headed—autonomous, data-driven, and personalized. For investors seeking exposure to the convergence of AI, robotics, and healthcare, Zimmer Biomet’s expanding portfolio offers a compelling case for long-term value creation.
TNX-801 is up to 100,000-fold less virulent than live smallpox vaccine strains and a single dose provides robust immunogenicity and protection against mpox and rabbitpox (more than one year) in animals
Subcutaneous administration of TNX-801 yielded equivalent protection to the traditional percutaneous administration
CHATHAM, N.J., July 10, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of new findings on TNX-801 (recombinant horsepox, live virus vaccine) at the Vaccine Congress 2025 in Vienna on July 10, 2025, by Sina Bavari, PhD, Executive Vice President, Infectious Disease Research and Development.
“The data show that TNX-801 can deliver durable immunity while remaining highly attenuated, a balance that sets it apart from earlier orthopox vaccines,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “The novel finding that subcutaneous (s.c.) administration of TNX-801 provides equivalent protection to percutaneous administration, is leading us to develop the s.c. product first. Most live-virus vaccines are delivered s.c. and this route of administration has further potential benefits of decreased administration-site bacterial superinfection, scarring, or inadvertent transfer to other body sites by itching. We believe TNX-801 has the potential to become a critical tool for containing mpox and preparedness against the malicious reintroduction of smallpox. We look forward to advancing TNX-801 into the clinic by s.c. delivery.”
TNX-801 is a recombinant horsepox-derived vaccine candidate designed to prevent orthopox viruses and provide durable humoral and cellular immunity from a single dose. In primary human dermal cells, the virus replicates twenty-seven to one-hundred-nineteen-fold less than licensed vaccinia strains, and in interferon receptor knockout mice it is up to one-hundred-thousand-fold less virulent than those legacy vaccines. Preclinical studies further showed that a single dose of TNX-801 produced strong binding and neutralizing antibody responses across mice, rabbits, hamsters, and cynomolgus macaques, including immunocompromised animals. All vaccinated macaques survived lethal Clade I mpox challenge without lesions, and rabbit models remained fully protected for fourteen months.
“Our data show that TNX-801 delivers durable immunity without safety concerns of live virus vaccines,” said Dr Bavari. “TNX-801 dissociates immune protection from some of the side-effects associated with traditional vaccinia-based vaccines and potentially offers a unique risk-benefit profile for mpox and smallpox prevention. We are excited to advance this program toward clinical evaluation in collaboration with public-health partners worldwide.”
The World Health Organization and the Centers for Disease Control and Prevention continue to classify mpox as an ongoing public-health concern. A single-dose vaccine with the attenuation and immunogenicity profile demonstrated by TNX-801 could streamline outbreak response by reducing the need for approved multi-visit immunization schedules.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotech 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 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. 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.
BOTHELL, Wash., July 10, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that its first-in-class pan-viral protease inhibitor CDI-988 has been selected for an oral presentation at the 9th International Calicivirus Conference being held September 7-11, 2025 in Banff, Alberta, Canada. Sam Lee, PhD, the Company’s President and co-CEO, will present “Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results” on September 11.
“This year’s Calicivirus Conference will bring together the world’s leading norovirus experts, making it the ideal venue to share our pan-viral protease inhibitor CDI-988 Phase 1 data and clinical development strategy,” said Dr. Lee. “Norovirus causes a highly contagious gastrointestinal illness, triggering severe vomiting and diarrhea, and has a substantial economic impact with a societal cost of approximately $60 billion each year globally according to the CDC. There is no approved vaccine or antiviral therapeutics for norovirus infection. We are encouraged by our molecule’s novel pan-viral activity against all noroviruses including GII.4 and GII.17 strains.”
Pan-Viral Inhibitor CDI-988 CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum 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 represents a compelling first-in-class oral treatment for noroviruses, which are members of the calicivirus family, and for coronaviruses. Cocrystal has completed a single-center, randomized, double-blind, placebo-controlled Phase 1 study in healthy adults evaluating the safety, tolerability and pharmacokinetics of CDI-988, including a food effect cohort.
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 or shortened treatment time, are safe, well tolerated and easy to administer, and are effective against all viral subtypes that cause disease and have a high barrier to viral resistance.
About the Calicivirus Conference The International Calicivirus Conference is held every three years and unites scientists from across the globe who study calicivirus virology, evolution, pathogenesis, structural biology, diagnosis, epidemiology, treatment and prevention. The conference aims to foster open discussions, spark new collaborations and explore groundbreaking research. Delegates have the opportunity to engage with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.
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 influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential for the Company’s CDI-988 product candidate as a treatment for norovirus. 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 approval for and proceed with clinical trials including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies, our and our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, 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 regulation 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 without 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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
R&D Day Highlighted Science, Current Trials, Future Indications. We attended the Eledon R&D Day on July 9 to hear and evaluate the progress in tegoprubart development. The presentations focused on the current clinical indications in renal transplantation, islet cell transplantation, xenotransplants, and plans for liver and other solid organ transplants. Conference presentation dates for upcoming data announcements were also announced.
Phase 1b Data Update Is Planned For August. The Phase 1b open-label trial has been expanded to enroll up to 36 patients, an increase from the original 9 patients. Data is scheduled for presentation at the World Transplant Congress on August 9, 2025. Previous data presentations have included 13 patients. We expect to see follow-up data from more patients treated longer, with data from additional patients beyond the initial 12-month trial duration.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced dosing of the first patient in Taiwan in the expansion phase of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly larger patient pool for its evaluations of ateganosine (THIO). Screening for the trial is ongoing in Europe and Asia.
Trial Design: The expansion study evaluates ateganosine in heavily pre-treated patients in third-line (3L) NSCLC who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy. Two treatment arms are being studied: ateganosine sequenced with cemiplimab (Libtayo®) and ateganosine monotherapy. Regeneron is supplying Libtayo for the combination cohort.
Strategic Opportunity: NSCLC represents one of the largest global oncology indications. The market was valued at $34.1B in 2024, and is projected to reach $68.8B by 2033 with a projected CAGR of 8.1%.1
Current Data: As of May 15, 2025, the median overall survival (OS) for the 22 patients in the third-line treatment was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated in the trial’s heavily pre-treated population.2
Other studies of chemotherapy for NSCLC in a similar setting have shown overall survival of 5-6 months.3
“We are excited to have the expansion of the trial officially started. Ateganosine’s observed OS in third-line NSCLC exceeds all known benchmarks,” said MAIA’s Chief Executive Officer Vlad Vitoc, M.D. “This potentially positions us for first-mover advantage in a multibillion-dollar space with no currently approved standard of care.”
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward-Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
1 Custom Market Insights, Global NSCLC Drug Market Size Likely to Surpass at a CAGR of 8.1% By 2033, Apr. 2024 2 Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website. 3 Girard N, et al. J Thorac Onc 2009;12:1544-1549.
–Nasdaq compliance follows reverse stock split previously announced on June 17, 2025
LOS ALTOS, Calif., July 08, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced it has regained compliance with the Nasdaq Stock Market (“Nasdaq”) continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq Listing Qualifications. This update was disclosed in the Company’s Current Report on Form 8-K filed on July 8, 2025.
On July 7, 2025, the Company received confirmation from the Listing Qualifications Department of Nasdaq that as of July 3, 2025 the Company’s common stock has maintained an average closing share price of at least $1.00 immediately following the Company’s 1:10 reverse stock split that became effective on June 20, 2025 The Company’s shares are no longer considered to be below the minimum bid price requirement of Rule 5550(a)(2), and as a result the Company has regained compliance with the Nasdaq continued listing standard. Nasdaq now considers this matter closed.
About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
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.
Single dose vaccination with TNX-801 protects animals from a lethal challenge with monkeypox, the causative agent of mpox
TNX-801 confers durable protection after a single dose
TNX-801 is well tolerated in immunocompromised animals, without evidence of spreading to blood or tissues even at high doses
CHATHAM, N.J., July 07, 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, today announced that Sina Bavari, PhD, Executive Vice President of Infectious Disease Research and Development at Tonix Pharmaceuticals, will present new data on TNX-801 (recombinant horsepox virus, live vaccine) at the upcoming Vaccine Congress 2025.
TNX-801 is a minimally replicative, attenuated live virus vaccine candidate designed to generate durable humoral and cellular immunity after a single dose. Preclinical results in animals have demonstrated protection against mpox and other orthopoxviruses, supporting further clinical evaluation. TNX-801 also serves as an orthopoxvirus vaccine platform that can deliver multiple protective antigens against diverse viral pathogens.
Dr. Bavari will present the safety, immunogenicity, and efficacy findings to date and describe Tonix’s plans to advance the TNX-801 platform into clinical trials to protect against mpox and other viral diseases.
Presentation details
Location: Vienna, Austria Presentation Date / Time: July 10th / 11:20am GMT+2 Title: TNX-801, a single-dose live vaccine platform for Mpox and other emerging viral diseases: Safety, Immunogenicity, and Efficacy Speaker: Sina Bavari, PhD, Tonix Pharmaceuticals
A copy of the presentation will be posted in the Scientific Presentations section of the Tonix website following the session.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotech 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 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. 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.
With global cases rising and bipartisan momentum for pandemic preparedness, GeoVax’s GEO-MVA vaccine advances on an expedited development track toward commercialization and revenue generation
ATLANTA, GA — July 2, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today emphasized the growing global public health importance of its GEO-MVA Mpox/smallpox vaccine in response to rising public health threats and a rapidly evolving regulatory environment.
With favorable regulatory input from the European Medicines Agency (EMA), GEO-MVA is on an expedited path toward market access—accelerating GeoVax’s focus toward regulatory approval and commercialization.
“GeoVax is entering a value inflection phase,” said David Dodd, Chairman and CEO. “The EMA’s expedited development path brings us closer to regulatory registration and commercial readiness, providing the opportunity to address urgent public health needs, expanding the critically needed supply option of MVA-vaccine, addressing both expanding outbreak needs and stockpile opportunities.”
Modern Platform for Variant-Responsive Stockpiling
GeoVax’s development-stage continuous avian cell line process is anticipated to provide increased production of MVA-based vaccines, the ability to quickly respond to epidemics and pandemics, local implementation of MVA-based vaccine manufacturing and overall reduced production costs.
With confirmed Mpox cases across multiple U.S. states, throughout Europe and new clade Ib outbreaks in West and Central Africa, the urgency for additional MVA-vaccine supply options is increasingly, critically important.
“There is a clear need for diversity in stockpile planning,” Dodd added. “GEO-MVA is well-positioned to serve as a complementary or alternative solution where current, single-source options fall short. Ending the current monopoly of MVA-vaccine will benefit public health worldwide, providing an expanded supply option of this critically needed vaccine.”
EMA Scientific Advice and BARDA RRPV Proposal Expedite Readiness
GeoVax recently received favorable Scientific Advice from the EMA, confirming an expedited regulatory development path for GEO-MVA. This milestone enhances the product’s standing with international regulatory bodies and opens pathways to revenue-generating opportunities across Europe and beyond.
In parallel, GeoVax’s advanced MVA-based vaccine manufacturing proposal under BARDA’s Rapid Response Partnership Vehicle (RRPV) remains under active review. The program is designed to fund scalable vaccine platforms, eliminating the dependency for stockpiling of MVA-based vaccines relative to high-consequence threats such as smallpox.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Combination treatment of mTNX-1700 (mTFF2-MSA fusion protein) with anti-PD1 antibody was associated with increased survival and decreased metastases in animal models of gastric cancer relative to anti-PD1 treatment alone
mTNX-1700 treatment was associated with activation of cancer-killing CD8+ T Cells and limiting neutrophil-mediated immune evasion
TNX-1700 (hTFF2-HSA fusion protein) is in preclinical development for gastric and colorectal cancers
CHATHAM, N.J., July 02, 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, today announced the publication of a paper entitled, “A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis,”1 in the peer-reviewed journal Cancer Cell, that represents a collaboration between scientists at Tonix and Columbia University’s Medical School and presents data demonstrating that treatment with murine TNX-1700 (mTNX-1700) increased survival and decreased metastases in animal models of gastric cancer. The manuscript can be accessed here: http://bit.ly/3I7Wcvu.
“Addressing the root causes of resistance to immunotherapy in solid tumors is a hurdle for the successful application of immuno-oncology to anti-PD-1 resistant cancers,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The combination therapy of mTFF2-MSA with anti-PD1 treatment shows significant promise in reducing the ability of tumors to evade anti-PD-1 therapy in animal models. We believe the published data support further development of TNX-1700 as an approach to overcome resistance to anti-PD-1 immunotherapy in the treatment of gastric cancer and other tumors.”
The published studies examined mTNX-1700, which is a fusion protein of murine trefoil factor-2 (mTFF2) and murine serum albumin (MSA). The human version, TNX-1700 is a fusion protein of human TFF2 (hTFF2) and human serum albumin (HSA) that is under development for the treatment of gastric and colorectal cancers.
Dr. Lederman added, “The study showed that in several mouse models, mTNX-1700 plus anti-PD-1 shrank primary tumors, cut liver and lung metastases, and increased survival compared to anti-PD-1 alone. These data show that fine-tuned modulation of CXCR4 can dismantle neutrophil-driven immune suppression and revive checkpoint efficacy without compromising normal myelopoiesis. We are excited, through our collaboration with Columbia University, to continue studies to identify potential clinical biomarkers through preclinical models while enhancing our understanding of the relationship between the role of TFF2 in overcoming resistance to anti-PD1 therapy in the tumor microenvironment (TME).”
Immunosuppressive neutrophils, also known as polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs), are a major component in solid tumors that significantly hinder anti-tumor activity2,3. Despite being short-lived, the continuous replenishment of PMN-MDSCs from the bone marrow sustains their potent immunosuppression in the TME4. Stromal cells in the TME promote immunosuppression by recruiting MDSCs via secretion of CXCL12. Trefoil Factor 2 (TFF2), a secreted peptide of the trefoil factor family, has displayed activity as a partial agonist of CXCR45,6. The Cancer Cell publication describes data demonstrating that TFF2-MSA selectively reduces immunosuppressive neutrophils and cancer-driven granulopoiesis. Treatment with TFF2-MSA, in combination with an anti-PD1 antibody, induced robust anti-tumoral CD8+ T cell responses, inhibiting tumor invasion. This combination of the mTNX-1700 with anti-PD1 therapy has been shown to reduce tumor size and increase survival in these animal models. TFF2 reduction correlated with elevated PMN-MDSCs in gastric cancer patients, highlighting the potential negative correlation between TFF2 and PMN-MDSCs levels while promoting a T-cell rich microenvironment and inducing an increase in CD8+ T cells in the tumor.
About Trefoil Factor Family Member 2 (TFF2)
Human TFF2 is a secreted protein, encoded by the TFF2 gene in humans, that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in the spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms. Tonix is developing TNX-1700 for the treatment of gastric and colorectal cancers under a license from Columbia University. The inventor of the core technology at Columbia is Dr. Timothy Wang, who is an expert in the molecular mechanisms of carcinogenesis whose research has focused on the carcinogenic role of inflammation in modulating stem cell functions. Dr. Wang demonstrated that knocking out the mTFF2 gene in mice leads to faster tumor growth and that overexpression of TFF2 markedly suppresses tumor growth by curtailing the homing, differentiation, and expansion of MDSCs to allow activation of cancer-killing CD8+ T cells. He went on to show that a novel engineered form of recombinant murine TFF2 (mTFF2-CTP) had an extended half-life in vivo and was able to suppress MDSCs and tumor growth in an animal model of colorectal cancer. Later, he showed in gastric cancer models that suppressing MDSCs using chemotherapy enhances the effectiveness of anti-PD1 therapy and significantly reduces tumor growth. Dr. Wang proposed the concept of employing recombinant TFF2 in combination with other therapies in cancer prevention and early treatment.
1Qian, J. et al. Cancer Cell. 2025. on-line: https://doi.org/10.1016/j.ccell.2025.06.006. 2Kim W, et al. Gastroenterology. 2021. 160(3):781-796 3Veglia F, et al. J Exp Med. 2021. 218(4):e20201803. 4Colligan SH, et al. J Clin Invest. 2022. 132(23):e158661. 5Dubeykovskaya Z, et al. J Biol Chem. 2009. 284(6):3650-62. 6Dubeykovskaya Z, et al. Nat Commun. 2016. 7:10517.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biotechnology 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 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. 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.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Amended credit agreement. On June 30, the company announced an amendment to its credit agreement, extending the maturity of the company’s Class A Revolving Commitments from Q2 end to Q3 end. Moreover, any interest due on the revolver and refinanced term loans through that date will be paid in-kind. The amendment also waived financial covenant testing for Q2 and Q3, offering the company a temporary liquidity reprieve.
Cost of amendment. As part of the amendment, GoHealth will pay a 1.00% amendment fee to consenting lenders, which, along with all interest through September 30, will be paid in-kind and added to the principal balance of its loans. As a result, we estimate these provisions will increase the company’s outstanding debt by approximately $6 million.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Atlanta, GA, July 1, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive securities purchase agreements with several institutional and individual investors for the purchase and sale of approximately 9.2 million units, each comprised of one share of the Company’s common stock and warrants, as described below, to purchase shares of the Company’s common stock, at a price of $0.65 per unit in a public offering. The Company will issue warrants to purchase up to approximately 18.5 million shares of common stock. The warrants will have an exercise price of $0.65 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.
Roth Capital Partners is acting as the exclusive placement agent for the offering.
The gross proceeds to the Company from this offering are expected to be approximately $6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about July 2, 2025, subject to the satisfaction of customary closing conditions.
The shares in the offering described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-288085) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on June 30, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach, CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
