Category: Health

Release – GeoVax Reaffirms Urgent Need for Multi-Antigen COVID-19 Vaccines as CDC Shifts Recommendations

Posted on by aweinsoff@channelchek.com

Research news and Market Data on GOVX

    GEO-CM04S1 Demonstrates Superior Protection in Immunocompromised Populations; Fully Aligned with HHS Priorities for Durable, Broad-Spectrum Immunization

    ATLANTA, GA, May 20, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement in response to the U.S. Department of Health and Human Services’ (HHS) anticipated changes to COVID-19 vaccine recommendations.

    According to recent reports, HHS is preparing to limit blanket vaccine guidance in favor of a risk-based approach focused on older adults and those with chronic health problems. This pivot away from one-size-fits-all vaccine recommendations underscores the urgent need for next-generation immunization strategies—precisely the role that GeoVax’s multi-antigen COVID-19 vaccine, GEO-CM04S1, is designed to fulfill.

    “As public health strategy shifts toward protecting those most vulnerable, the demand increases for vaccines that work where others fall short,” said David Dodd, Chairman and CEO of GeoVax. “GEO-CM04S1 delivers broad, durable immunity even in immunocompromised patients—a population estimated at over 40 million adults in the U.S. that are inadequately served by the current authorized, single-antigen mRNA vaccines.”

    GEO-CM04S1: Purpose-Built for the New Vaccine Paradigm

    GEO-CM04S1 is based on the Modified Vaccinia Ankara (MVA) platform and expresses both Spike (S) and Nucleocapsid (N) proteins—offering multi-antigen protection against SARS-CoV-2. This broader design induces both antibody and T cell responses, essential for robust, durable protection against continually evolving COVID-19 variants and is especially critical in populations with weakened immune systems.

    Recent interim results from a Phase 2 clinical trial in patients with chronic lymphocytic leukemia (CLL) demonstrated a superior T cell response rate versus a leading mRNA vaccine. The trial’s independent Data Safety Monitoring Board recommended and implemented continuing enrollment in the GEO-CM04S1 arm while halting the underperforming mRNA comparator arm.

    Aligned with the New HHS Biosecurity Vision

    GEO-CM04S1 is fully aligned with the new strategic direction from HHS Secretary Kennedy, who has called for a focus toward multi-antigen vaccine technologies that can deliver durable, variant-adaptive immunity while prioritizing safety and domestic production.

    GeoVax’s MVA vaccines offer:

    • Multi-antigen breadth: Including both S and N antigens for protection across variants.
    • Durability: Sustained antibody and T cell immunity—even in immunocompromised individuals.
    • Safety: MVA is non-replicating and approved for use in vulnerable groups such as transplant patients, pregnant women, and children.
    • Domestic advanced manufacturing: Using an avian continuous cell line platform that eliminates reliance on specialized pathogen-free eggs and a slow vaccine manufacturing process, enabling scalable U.S.-based vaccine production aligned with President Trump’s recent Executive Order on pharmaceutical onshoring.

    “The HHS call for broader, more resilient vaccine solutions is well-founded,” Dodd added. “GEO-CM04S1 is not only scientifically advanced but strategically aligned with our nation’s public health and biosecurity goals.”

    Multiple Trials Support Path to Licensure

    GEO-CM04S1 is currently in three active Phase 2 trials, evaluating its use among:

    1. Immunocompromised blood cancer patients in preparation for stem cell transplantation or CAR-T therapy (in comparison to mRNA-based vaccine),  
    2. Immunocompromised patients with Chronic Lymphocytic Leukemia (in comparison to mRNA vaccine), and
    3. Healthy adults, previously vaccinated with a mRNA vaccine as a more robust, more durable booster following mRNA vaccination.

    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. 

    Company Contact:                 

    info@geovax.com                   

    678-384-7220                          

    Investor Relations Contact:

    geovax@precisionaq.com

    212-698-8696

    Regeneron Acquires 23andMe for $256 Million Amid Bankruptcy

    Posted on by slightbourne@noblecapitalmarkets.com
    Key Points:
    – Regeneron to acquire 23andMe’s assets, including its vast genetic data bank, for $256 million.
    – The deal raises significant privacy concerns among customers and regulators.
    – Despite bankruptcy, 23andMe’s consumer services will continue under Regeneron’s oversight.

    In a major move with wide-reaching implications for healthcare, privacy, and small-cap investors, Regeneron Pharmaceuticals has announced its acquisition of embattled DNA-testing company 23andMe for $256 million. The deal comes as 23andMe, once valued at over $6 billion following its 2021 public debut, filed for Chapter 11 bankruptcy earlier this year after prolonged profitability issues.

    The acquisition includes 23andMe’s flagship Personal Genome Service, its Total Health and Research Services businesses, and a massive biobank of consumer genetic data collected over the years. While this trove of genetic information presents an invaluable asset for advancing personalized medicine, it also ignites fresh concerns about consumer privacy, data protection, and ethical oversight.

    Regeneron, a major player in biotechnology and pharmaceuticals, has committed to maintaining 23andMe’s existing privacy protections and compliance with applicable laws. A court-appointed ombudsman will oversee the company’s plans for handling consumer data, and Regeneron has pledged transparency and high standards in its management of the sensitive dataset.

    “We assure 23andMe customers that we are committed to protecting the 23andMe dataset with our high standards of data privacy, security and ethical oversight and will advance its full potential to improve human health,” said Aris Baras, a senior vice president at Regeneron.

    The transaction, expected to close in Q3 2025, ensures that 23andMe’s genome services will continue without interruption. However, many former customers remain uneasy. When the company filed for bankruptcy, California Attorney General Rob Bonta advised users to request deletion of their genetic data and destruction of any physical samples stored by the company.

    Despite reassurances from both Regeneron and 23andMe that existing privacy policies—designed to prevent data sharing with employers, insurers, law enforcement, and public databases—will remain in effect, skepticism lingers. This is particularly relevant in an age where genetic data is increasingly valuable for drug development, disease prediction, and targeted therapies.

    For small-cap investors, this deal is noteworthy for several reasons. First, it reflects a growing trend of larger pharmaceutical firms acquiring innovative—but financially struggling—startups to bolster their pipelines and data assets. Second, it highlights the inherent volatility and risks associated with investing in biotech startups, especially those that go public with limited monetization strategies.

    23andMe’s rise and fall underscore the importance of business sustainability in data-centric healthcare models. Meanwhile, Regeneron’s acquisition offers a potential long-term payoff through access to a highly unique, large-scale genomic dataset that could fuel years of research and development.

    Investors will be watching closely how Regeneron integrates 23andMe’s assets and navigates the complex ethical landscape surrounding personal genetic data.

    Eledon Pharmaceuticals (ELDN) – 1Q25 Reported With Phase 2 Results Expected In 4Q25

    Posted on by slightbourne@noblecapitalmarkets.com


    Monday, May 19, 2025

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

    Refer to the full report for the price target, fundamental analysis, and rating.

    1Q25 Had Lower Expenses Than We Projected. Eledon reported a loss of $6.5 million or $(0.08) per share, including a gain of $10.1 million related to fair value of warrant liabilities. Without this one-time item, the loss would have been $16.6 million or $(0.21) per share, as Research and Development expense increased less from the previous quarters than we anticipated. We expect R&D to be relatively steady as the Phase 1b and Phase 2 BESTOW trials conclude later in FY2025. Cash on March 31, 2025, was $124.9 million.

    Phase 1b Trial Data Expected Mid-Year. The Phase 1b open-label trial is testing an anti-rejection regimen using tegoprubart in kidney transplantation. We see this as important data, since the Phase 2 BESTOW trial is testing this regimen against the standard regimen with tacrolimus. Since historical data for the tacrolimus regimen has been published, we believe the Phase 1b data has some predictive value for the Phase 2 BESTROW trial.


    Get the Full Report

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

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

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

    Cocrystal Pharma (COCP) – 1Q25 Reported With Clinical Trial Milestone Updates

    Posted on by slightbourne@noblecapitalmarkets.com


    Monday, May 19, 2025

    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), hepatitis C viruses and noroviruses. 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.

    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.

    Fourth Quarter Included New Data On Norovirus Variants. Cocrystal reported a 1Q25 loss of $2.3 million or $(0.23) per share. During the quarter the company announced Phase 1 results from its CDI-988 study in norovirus. Importantly, preclinical data showed efficacy against new norovirus variants. We believe this provides additional support to Cocrystal’s method of targeting highly-conserved viral replication enzymes to make effective drugs against both current and future variants. Cash on March 31, 2025 was $6.9 million.

    CDI-988 Activity Includes New Variant Strains. CDI-988 is a protease inhibitor in development for norovirus and corona virus. CDI-988 has shown activity against multiple strains, with new preclinical data in April 2025 showing efficacy against the GII.17 and GII.4 strains that have recently been most prevalent. Results from the Phase 1 high-dose cohort in healthy subjects is expected to be announced in 2Q2025. A human challenge trial is planned for later in FY2025 to evaluate CDI-988 for treatment and prophylaxis against norovirus.


    Get the Full Report

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

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

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

    Zomedica (ZOMDF) – Restructuring Begins To Bear Fruit In 1Q25

    Posted on by slightbourne@noblecapitalmarkets.com


    Friday, May 16, 2025

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

    Refer to the full report for the price target, fundamental analysis, and rating.

    1Q25 Showed Expected Year-Over-Year Growth. Zomedica reported 1Q25 loss of $63.9 million or $(0.07) per share, including an Impairment Expense of $55.8 million related to the company’s lower market capitalization and stock price. Excluding this charge, Net Loss would have been about $8.0 million. Revenues of $6.5 million showed an annual increase of 3.8% over 1Q24. As expected, there was a seasonal decline from 4Q24 due to the year-end effect on equipment spending. Cash and equivalents on March 31, 2025 were $64.6 million.

    Product Mix Reflects Growing User Base. During the quarter, Consumables increased to 70% of sales with Capital Equipment at 30% of sales. This shifting product mix reflects an increasing total number of instruments in use and more assay offerings to increase utilization of each instrument. We expect the consumable segment to continue its growth as additional capital equipment sales add to the user base and introduction of new assays increases the number of tests run on each instrument.


    Get the Full Report

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

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

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

    Release – Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CVKD

    PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy.

    Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway.

    “We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,” said Quang X. Pham, Chairman & CEO. “This is a key milestone as we support our clinical development strategy and tecarfarin’s potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.”

    About Cadrenal Therapeutics, Inc.

    Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects.

    Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

    Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/ and connect with us on LinkedIn.

    Safe Harbor

    Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding tecarfarin’s potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

    Corporate and Investor Relations

    Paul Sagan

    LaVoieHealthScience

    (617) 865-0041

    psagan@lavoiehealthscience.com

    Media

    Andrew Korda

    LaVoieHealthScience

    (617) 865-0043

    akorda@lavoiehealthscience.com

    Release – Cocrystal Pharma Reports First Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on COCP

    May 15, 2025

    In vitro testing with CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants

    BOTHELL, Wash., May 15, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

    “Our oral pan-viral protease inhibitor CDI-988 is a potential breakthrough first-in-class treatment and prophylaxis for norovirus, a debilitating gastrointestinal infection that strikes millions globally each year,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “By precisely targeting the virus’ core replication machinery, we believe CDI-988 effectively combats all major strains of this highly contagious pathogen with exceptional in vitro activity demonstrated against the current circulating GII.17 and GII.4 strains. We’re preparing to launch a U.S. human challenge study in the coming months – a critical step in advancing this transformative therapy to patients worldwide.

    “Our novel, broad-spectrum drug candidates have the potential to fundamentally transform how we fight viral threats worldwide,” said James Martin, CFO and co-CEO of Cocrystal. “We’re advancing development of these assets for multibillion-dollar markets while remaining committed to a capital-efficient business model to maximize shareholder value.”

    Antiviral Product Pipeline Overview

    We harness our revolutionary structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our platform technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. Our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.

    Influenza Programs
    Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually.

    • Oral CC-42344 for the treatment of pandemic and seasonal influenza A
      • Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
      • In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
      • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
      • In May 2024 we completed enrollment in the Phase 2a human challenge study.
      • In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
      • In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants.
    • Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
      • Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
      • Dry powder inhalation formulation development and toxicology studies have been completed.
    • Influenza A/B program
      • Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing.

    Norovirus Program
    Norovirus is a common and highly contagious virus that causes symptoms of acute gastroenteritis among people of all ages including nausea, vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration. Norovirus infection can be significantly more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. Norovirus outbreaks occur most commonly in semi-closed communities and have become notorious for their occurrence in hospitals, nursing homes, childcare facilities, cruise ships, schools, disaster relief sites and military settings.

    In the U.S. alone, noroviruses are responsible for an estimated 21 million cases annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited.

    • Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
      • Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.
      • CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.
      • In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy subjects.
      • In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses.
      • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
      • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
      • In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and European countries in 2024-2025.
      • We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.
      • We plan to initiate a human challenge study in the U.S. in the coming months to evaluate CDI-988 as a norovirus treatment and prophylaxis.

    SARS-CoV-2 and Other Coronavirus Program
    By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031.

    • Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
      • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
      • In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
      • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
      • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
      • We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.

    First Quarter Financial Results

    Research and development (R&D) expenses for the first quarter of 2025 were $1.4 million, compared with $3.0 million for the first quarter of 2024, with the decrease primarily due to a reduction in personnel costs and the timing of clinical study costs. General and administrative (G&A) expenses for the first three months of 2025 were $1.0 million, compared with $1.2 million for the first three months of 2024, with the decrease primarily due to a reduction in insurance costs and other expenses.

    Net loss for the first quarter of 2025 was $2.3 million, or $0.23 per share, compared with net loss for the first quarter of 2024 of $4.0 million, or $0.39 per share.

    Cocrystal reported unrestricted cash as of March 31, 2025 of $6.9 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first quarter of 2025 was $2.9 million, compared with $4.5 million for the first quarter of 2024. The Company had working capital of $6.9 million and 10.2 million common shares outstanding as of March 31, 2025.

    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. 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 our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidate, our plans to initiate a human challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344 The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., 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, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 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.

    Investor Contact:
    Alliance Advisors IR
    Jody Cain
    310-691-7100
    jcain@allianceadvisors.com

    View full release here.

    Release – MAIA Biotechnology Accepted for Poster Presentation at American Society of Clinical Oncology (ASCO) 2025 Annual Meeting

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MAIA

    May 15, 2025 11:05am EDT Download as PDF

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that an abstract about the efficacy data from the Phase 2 THIO-101 clinical trial was accepted for poster presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3, 2025, in Chicago, Illinois. The poster is scheduled for presentation on May 31, 2025, from 01:30pm to 04:30pm CDT in the Lung Cancer track.

    “We continue to believe that our telomere targeting agent ateganosine (THIO) could become a best-in-class anticancer treatment with the potential to challenge the standard of care for NSCLC,” said MAIA CEO Vlad Vitoc, M.D. “Treatment with ateganosine has shown excellent efficacy in third-line NSCLC to date and we look forward to presenting our findings at ASCO 2025 on May 31st.”

    Poster Presentation Details

    Poster title: “Phase 2 Study of Telomere-Targeting Agent THIO Sequenced With Cemiplimab in Third-Line Immune Checkpoint Inhibitor–Resistant Advanced NSCLC: Evaluation of Overall Survival”

    Session date and time: May 31, 2025, 01:30pm to 04:30pm CDT

    Presenter: Tomasz Jankowski, M.D.

    MAIA’s poster will be available on the Publications page of MAIA’s website on the day of the presentation.

    About ASCO 2025

    The 2025 ASCO Annual Meeting will feature over 200 sessions and more than 5,000 posters complementing the theme, “Driving Knowledge to Action: Building a Better Future,” reflecting the meeting’s tradition of inspiring and advancing the oncology field with the power of the latest knowledge in cancer 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 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 2 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 ateganosine, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

    Forward Looking Statements

    MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

    Investor Relations Contact
    +1 (872) 270-3518
    ir@maiabiotech.com

    Source: MAIA Biotechnology, Inc.

    Released May 15, 2025

    Unicycive Therapeutics (UNCY) – 1Q25 Reported As OLC PDUFA Date Approaches

    Posted on by slightbourne@noblecapitalmarkets.com


    Thursday, May 15, 2025

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

    Refer to the full report for the price target, fundamental analysis, and rating.

    Counting Down To The OLC PDUFA Date. Unicycive reported a 1Q25 loss of $21.2 million or $(0.61) per share, consistent with our estimates. We continue to expect approval of OLC (oxylanthanum carbonate) around its PDUFA date of June 28, followed by its launch later in the year. The company had $19.8 million in cash on March 31, 2025.

    OLC Reduces Pill Burden To Improve Compliance. OLC is Unicycive proprietary formulation of lanthanum carbonate. It was developed to reduce serum phosphate levels in renal dialysis patients with only two small pills per day. We expect OLC to compete against Fosrenol (from Shire), the approved formulation of lanthanum, that requires chewing 3 to 6 large pills each day. This difference makes patient compliance easier.


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

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

    Release – Tonix Pharmaceuticals Announces Appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on TNXP

    May 14, 2025 7:00am EDT Download as PDF

    Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene

    Served on Celgene’s Executive Committee and played a key leadership role in the BMS transaction, the integration of Celgene into BMS, and the divestiture of Otezla® to Amgen

    Appointment marks a key addition as Tonix readies for the potential approval of TNX-102 SL for the management of fibromyalgia next quarter

    CHATHAM, N.J., May 14, 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 appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations, effective immediately. Mr. Hand brings significant leadership experience across multiple functions, including legal, business development, human resources and information technology operations.   

    “Joe’s strong track record of delivering company growth, driving transformative initiatives, and negotiating complex transactions makes him an important strategic addition to the Tonix team at a pivotal inflection point in the Company’s history,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The breadth of Joe’s expertise and his focus on operational excellence will serve our mission as we prepare for the launch of TNX-102 SL for the management of fibromyalgia, upon receiving FDA marketing authorization.”

    Prior to joining Tonix, Mr. Hand’s experience includes nearly a decade at Celgene Corporation, concluding his tenure as Executive Vice President, Global Human Resources and Corporate Services and a member of the Executive Committee. In that capacity, Mr. Hand was responsible for all employee-related activities including talent development, recruiting, and compensation and benefits. He was also responsible for the management of Celgene’s global facilities footprint and played a key strategic role in various transactions, including the $74 billion acquisition of Celgene by Bristol Myers Squibb and subsequent integration, and the $13.4 billion divestiture of Otezla® to Amgen. Subsequent to Celgene, Mr. Hand was Chief Administrative Officer at Phathom Pharmaceuticals, responsible for recruiting over 300 employees into various functions, including the build-out of the company’s commercial sales force. Mr. Hand has previously practiced as a litigation attorney at the international law firm of Jones Day. Mr. Hand holds a BBA from the University of Notre Dame and a JD from New York University School of Law.

    “I’m honored to join Tonix at such an exciting time and grateful for the opportunity to work alongside an incredibly talented and dedicated leadership team and group of employees,” said Mr. Hand. “I look forward to contributing to the Company’s momentum and helping to position Tonix for long-term growth while advancing our mission to deliver meaningful therapies to patients.”

    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 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, Maryland. 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 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.

    Investor Contact

    Jessica Morris
    Tonix Pharmaceuticals
    investor.relations@tonixpharma.com
    (862) 799-8599

    Peter Vozzo
    ICR Healthcare
    peter.vozzo@icrhealthcare.com
    (443) 213-0505

    Media Contact

    Ray Jordan
    Putnam Insights
    ray@putnaminsights.com
    (949) 245-5432

    About Zembrace SymTouch and Tosymra

    Indication and Usage

    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.

    Primary Logo

    Source: Tonix Pharmaceuticals Holding Corp.

    Released May 14, 2025

    Release – Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on UNCY

    May 14, 2025 7:15am EDT Download as PDF

    – Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025

    – New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC

    LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update.

    “We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.”

    Key Highlights & Upcoming Milestones

    • The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access.
    • Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings.
      • Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills.
      • New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction.  

    Financial Results for the Quarter Ended March 31, 2025

    Research and Development (R&D) expenses were $2.2 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs.

    General and Administrative (G&A) expenses were $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation.

    In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from $4.8 million as of December 31, 2024 to $7.6 million as of March 31, 2025.

    Other income was $8.6 million for the three months ended March 31, 2025, compared to an expense of $11.8 million for the three months ended March 31, 2024, primarily due to a decrease in the fair value of our warrant liability.

    Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, compared to a net loss attributable to common stockholders of $21.2 million for the three months ended March 31, 2024. The net income for the three-month period ended March 31, 2025, was primarily due to a decrease in the fair value of our warrant liability.

    As of March 31, 2025, cash and cash equivalents totaled $19.8 million.

    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 about Unicycive, 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; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. 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.

    Investor Contacts:

    Kevin Gardner
    LifeSci Advisors
    kgardner@lifesciadvisors.com

    Media Contact:

    Rachel Visi
    Real Chemistry
    redery@realchemistry.com

    SOURCE: Unicycive Therapeutics, Inc.

    View full release here.

    Release – MAIA Biotechnology Announces Director Participation in Recent Private Placement

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MAIA

    May 14, 2025 10:15am EDT

    Download as PDF

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that two of the Company’s independent directors, Stan V. Smith, Ph.D. and Ramiro Guerrero, JD, LL.M., purchased common stock and warrants in the Company’s private placement offering which closed on May 8, 2025. Gross proceeds from the offering across all investors totaled $1.08 million.

    Dr. Smith purchased a total of 66,666 shares and 66,666 warrants for an aggregate purchase price of approximately $100,000. Mr. Guerrero purchased a total of 20,000 shares and 20,000 warrants for an aggregate purchase price of $30,000.

    “Stan, Ramiro and our other independent directors have been consistent investors in the Company’s financings, which I believe signals the Board’s confidence in our strategic direction and future market prospects for our novel cancer immunotherapies,” said MAIA Chairman and CEO Vlad Vitoc, M.D.

    Dr. Smith commented, “I have participated in nearly all of MAIA’s financings since its founding, and my conviction in the Company is stronger than ever. In my opinion, the clinical and regulatory strategies are thorough, and, as a potential first-in-class cancer telomere targeting treatment, the commercial opportunity for ateganosine is substantial.”

    “Based on ateganosine’s clinical results to date, I continue to believe that MAIA’s telomere targeting science could eventually become the standard of care for several high-mortality cancer types,” said Mr. Guerrero.

    Additional details on the private placement can be found in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 6, 2025, at www.sec.gov.

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

    About 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 MAIA Biotechnology, Inc.

    MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

    Forward Looking Statements

    MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

    Investor Relations Contact
    +1 (872) 270-3518
    ir@maiabiotech.com

    Source: MAIA Biotechnology, Inc.

    Released May 14, 2025

    Release – Tonix Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Highlights

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on TNXP

    May 12, 2025 4:30pm EDT

    FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years

    Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders

    Cash and cash equivalents of $131.7 million reported as of March 31, 2025; Current cash sufficient to fund operations into the second quarter of 2026

    CHATHAM, N.J., May 12, 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 financial results for the first quarter ended March 31, 2025, and provided an overview of recent operational highlights.

    “We believe TNX-102 SL (cyclobenzaprine HCl sublingual tablets)* is on track to become a new therapeutic option for patients suffering with fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “TNX-102 SL would be the first member of a new class of FDA approved drugs for fibromyalgia. TNX-102 SL is a non-opioid analgesic that targets fibromyalgia’s characteristic disturbed sleep to improve the widespread pain of fibromyalgia, while also being well tolerated. Our focus continues to be on the upcoming U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on the market authorization on TNX-102 SL for the management of fibromyalgia. We are building out our commercial team for the anticipated product launch in the fourth quarter of this year. Tonix believes it has sufficient cash to fund operations beyond these key milestones.”

    Dr. Lederman continued, “Beyond TNX-102 SL for fibromyalgia, we are encouraged by the continued achievements in our pipeline, including positive Phase 1 results for TNX-1500, a next generation anti-CD40L Fc-modified humanized monoclonal antibody (mAb) in development for prevention of kidney transplant rejection and pre-clinical results for TNX-801, a live-virus vaccine in development for preventing mpox and smallpox. We look forward to providing additional updates to each of these promising programs in 2025.”

    Key Investigational Product Candidates* — Recent Highlights

    Central Nervous System (CNS) Pipeline

    TNX-102 SL (cyclobenzaprine HCl sublingual tablets): 5.6 mg, once-daily at bedtime small molecule for the management of fibromyalgia (FM) – a centrally-acting, non-opioid analgesic.

    • In March 2025, Tonix announced that FDA will not require an Advisory Committee meeting to discuss the Company’s New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
    • In December 2024, the NDA for TNX-102 SL for fibromyalgia was accepted by FDA with a PDUFA goal date of August 15, 2025. The NDA was based upon two Phase 3 studies of TNX-102 SL in fibromyalgia that showed statically significant reduction in the chronic, widespread pain associated with fibromyalgia. TNX-102 SL was generally well tolerated and has no known addictive properties. If approved by the FDA, TNX-102 SL would be the first member of a new class of tertiary amine tricyclic (TAT) non-opioid analgesic drugs for fibromyalgia and the first new drug available for treating fibromyalgia in more than 15 years. Fibromyalgia affects more than 10 million adults in the U.S., most of whom are women.
    • In April 2025, Tonix presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting, held in Austin, Texas, in a poster presentation titled, “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials.”
    • In March 2025, the Company presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the 7th International Congress on Controversies in Fibromyalgia, held in Vienna, Austria, in an oral presentation titled, “Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Treatment of Fibromyalgia at Bedtime to Target Non-Restorative Sleep Showed Durable Pain Reduction in Two Double-Blind Randomized Phase 3 Studies.”

    TNX-102 SL in development for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

    • The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial will be conducted by the University of North Carolina under an investigator-initiated investigational new drug (IND) application. The OASIS trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department (ED) after a motor vehicle collision. Fourteen days of bedtime TNX-102 SL will be dosed and tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL to target trauma-related sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD. The program has the potential to provide military personnel with a new treatment option that improves warfighter performance and resilience when administered in the early aftermath of traumatic events in the war theater. The study is expected to be initiated in the second quarter of 2025.

    TNX-1300 (recombinant double mutant cocaine esterase): under investigation for biologic for cocaine intoxication

    • The National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) previously awarded Tonix a Cooperative Agreement grant for approximately $5 million to support development of TNX-1300.
    • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
    • The Company discontinued enrollment and terminated the Phase 2 CATALYST study of its TNX-1300 double-mutant cocaine esterase 200 mg, i.v. solution product candidate for the treatment of cocaine intoxication because enrollment in this emergency department-based study was slower than projected. The Company is evaluating new study designs and new endpoints for further development of TNX-1300. The CATALYST study was not discontinued for safety or efficacy reasons.

    Immunology Pipeline

    TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection and treatment of autoimmune disorders.

    • In February 2025, Tonix announced positive topline results from its Phase 1, single ascending dose (SAD) first-in-human trial of TNX-1500 in healthy participants. The objectives of the Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase 2 trial in kidney transplant recipients, pending alignment with the FDA. All objectives were met and support proceeding to a Phase 2 trial. TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses, showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses (supporting monthly dosing for future efficacy trials) and was generally well-tolerated with a favorable safety profile.
    • The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including the treatment of autoimmune diseases. Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications.   Pharmacokinetic data support a monthly i.v. dosing regimen. This analysis together with TNX-1500’s activity and tolerability in animal models, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals.

    Infectious Disease Pipeline

    TNX-801 (recombinant horsepox virus, minimally replicative live vaccine): potential vaccine to protect against mpox and smallpox.

    • In April 2025, the company presented data on TNX-801 in an oral presentation at the World Vaccine Congress Washington 2025, held 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. Durable protection of rabbits from lethal rabbitpox infection was present six months after vaccination. 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.
    • In March 2025, Tonix announced it was awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801. The grant will allow Tonix to develop a commercialization plan for TNX-801.

    Corporate and Partnerships – Recent Highlights*

    • In April 2025, the Company announced it has entered into a collaborative research agreement with Makana Therapeutics, a global leader in the field of xenotransplantation, to study Tonix’s anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana’s human-compatible pig organs and cells for the treatment of organ failure. TNX-1500 is an investigational, humanized Fc-modified IgG4 anti-CD40L antibody with high affinity for CD40L. The preclinical research and development collaboration has the potential to span multiple Makana programs including kidney, heart and islet cell xenotransplant.
    • In April 2025, Tonix announced the launch of TONIX ONE™, a fully-integrated digital platform designed to provide resources to help patients better understand and manage their migraine condition. TONIX ONE provides an intuitive, comprehensive journey for patients by offering educational resources about migraine and the limitations of oral medications which can sometimes lead to delayed or ineffective symptom relief. The platform also connects patients directly to independent migraine specialists via telehealth services and e-prescription requests, simplifying and accelerating access to treatment.  
    • During the first quarter of 2025, the Company announced the promotion of Siobhan Fogarty to Chief Technical Officer and the appointment of Gary Ainsworth as its new Vice President, Market Access.

          Financial – Recent Highlight

    As of March 31, 2025, Tonix had $131.7 million of cash and cash equivalents, compared to $98.8 million as of December 31, 2024. Net cash used in operations was approximately $16.6 million for first quarter 2025, compared to net cash used in operations of $17.6 for the same period in 2024.

    On July 30, 2024, the Company entered into a Sales Agreement with AGP pursuant to which the Company may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $250.0 million in at-the-market sales. During the three months ended March 31, 2025, the Company sold approximately 2.7 million shares of common stock for net proceeds of approximately $59.8 million. Subsequent to March 31, 2025, the Company sold 0.6 million shares of common stock under the Sales Agreement, for net proceeds of approximately $9.9 million.

    The Company believes that its cash resources at March 31, 2025, along with the net proceeds of $9.9 million raised from equity offerings in the second quarter of 2025, will meet its planned operating and capital expenditure requirements into the second quarter of 2026.

    Subsequent to March 31, 2025, the Company repurchased 150,000 of its shares of common stock outstanding under a share repurchase program, for a gross aggregate cost of approximately $2.9 million.


    First Quarter 2025 Financial Results

    Net product revenue for the first quarter 2025 was approximately $2.4 million compared to $2.5 million for the same period in 2024. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®. Cost of Sales for the first quarter 2025 was approximately $0.9 million compared to $1.7 million for the same period in 2024.

    Research and development expenses for the first quarter 2025 were $7.4 million, compared to $12.9 million for the same period in 2024. This decrease is predominantly due to decreased clinical, non-clinical, manufacturing and employee-related expenses.

    Selling, general and administrative expenses for the first quarter 2025 were $10.1 million, compared to $9.3 for the same period in 2024. The increase was primarily due to an increase in sales and marketing expenses offset by a decrease in employee-related expenses resulting from a reduction in workforce in earlier 2024.

    Net loss available to common stockholders was $16.8 million, or $2.84 per share, basic and diluted, for the first quarter 2025, compared to net loss of $14.9 million, or $535.72 per share, basic and diluted, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the first quarter 2025 was 5,927,231 compared to 27,886 shares for the same period in 2024.

    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. In March 2025 the FDA guided that no Advisory Committee Meeting will be required for this NDA. 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. 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, Tosymra and TONIX ONE are 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.

    View full release here.