EMA Concurrence Enables Acceleration Toward Phase 3 Initiation and Represents a Major Milestone on GeoVax’s Path to Commercialization
ATLANTA, GA – December 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced that it has received formal Scientific Advice (SA) from the European Medicines Agency (EMA) confirming regulatory alignment on the Company’s proposed pivotal Phase 3 immunobridging trial design for GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of Mpox and smallpox.
The EMA’s feedback concurs with GeoVax’s proposed strategy to evaluate GEO-MVA through a single, pivotal Phase 3 immuno-bridging study versus the approved MVA vaccine, Imvanex®, and supports the Company’s plan to proceed directly into this trial without the need for additional Phase 1 or Phase 2 clinical studies. Receipt of this formal Scientific Advice represents a significant regulatory milestone and enables GeoVax to accelerate operational planning toward implementation and initiation of the Phase 3 program, currently projected to begin in the second half of 2026.
“This formal Scientific Advice from EMA represents a pivotal step forward for GEO-MVA and meaningfully de-risks our regulatory path in Europe,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “EMA’s concurrence positions GeoVax to move efficiently toward a single, registrational Phase 3 study. This is a major milestone on our path toward commercialization.”
The Scientific Advice confirms that non-inferiority immunogenicity endpoints are acceptable to support a future Marketing Authorization Application (MAA) and that GeoVax’s proposed clinical safety database is sufficient to support registration, assuming successful trial outcomes. Importantly, EMA’s feedback provides clarity and confidence across proposed clinical and quality dimensions, allowing the Company to focus on execution rather than redesign of its development strategy.
The receipt of this advice follows GeoVax’s previous announcement of favorable preliminary EMA guidance announced in June 2025 and marks the transition from regulatory alignment to regulatory execution. Together, these milestones substantially strengthen GEO-MVA’s development profile and reinforce its potential role in expanding global Mpox and smallpox vaccine supply beyond the current single-supplier paradigm.
“With formal EMA Scientific Advice now in hand, GEO-MVA moves from a conceptual regulatory pathway to a clearly defined and executable development plan,” Dodd added. “As global health authorities continue to emphasize preparedness, resilience, and diversification of vaccine supply, we believe GEO-MVA is well positioned to play an important role.”
About GEO-MVA
GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine candidate being developed for the prevention of Mpox and smallpox. GEO-MVA leverages the well-characterized MVA platform and is designed to support both civilian public health needs and broader preparedness objectives.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
NORWOOD, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed”) (CSE: MRMD) (OTCQX: MRMD), a leading multi-state cannabis operator committed to improving lives every day, issued the following statement from CEO Jon Levine today.
“We commend President Trump and the Trump Administration for reclassifying cannabis as a Schedule III drug. This is the single greatest cannabis reform in US history and will have far-reaching benefits for years to come. Most important, the reclassification means the Federal government officially acknowledges that cannabis has widely accepted medical uses and low abuse potential.
Rescheduling will accelerate accredited medical research into medications derived from cannabis and should result in a significant increase of consumers who will embrace cannabis as a qualified alternative to opioids for chronic pain, sleep, anxiety and other ailments.
Additionally, state-legal cannabis businesses will no longer be subject to the IRS Section 280E tax penalty. Compliant operators like MariMed will finally be taxed like other consumer packaged goods sectors, materially improving profitability and free cash flow.”
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Animal Models Show Full Protection Against Omicron Variant Despite Absence of Neutralizing Antibodies, Highlighting Critical Importance of T-cell Immunity for Next-generation COVID-19 Vaccines
ATLANTA, GA – December 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today announced the publication of a peer-reviewed article in Frontiers in Immunology titled: “Multi-antigen MVA-vectored SARS-CoV-2 vaccine, GEO-CM04S1, induces cross-protective immune responses to ancestral and Omicron variants.”
The study provides definitive preclinical evidence that GeoVax’s multi-antigen COVID-19 vaccine candidate, GEO-CM04S1, delivers full cross-variant protection, driven predominantly by robust T-cell responses, even in the absence of neutralizing antibodies.
The findings reinforce the design philosophy behind GeoVax’s MVA-based, multi-antigen platform and provide mechanistic insight that is increasingly relevant for immunocompromised individuals, who often fail to respond optimally to the first-generation COVID-19 vaccines.
Study Highlights: Multi-Antigen Breadth and T-Cell Immunity Drive Protection
The study evaluated GEO-CM04S1 in the K18-hACE2 lethal mouse model, comparing immune responses and efficacy to experimental MVA-vectored vaccine constructs expressing spike alone (S) or nucleocapsid alone (N). Key findings include:
Full protection against both ancestral B.1 and Omicron XBB.1.5: Only GEO-CM04S1 (S+N) maintained 100% survival, preventing weight loss, severe lung inflammation, and virus replication in both upper and lower airways.
Protection against XBB.1.5 occurred despite no detectable neutralizing antibodies: Neutralization assays showed zero detectable neutralizing activity against XBB.1.5 in any group – yet GEO-CM04S1-vaccinated animals were fully protected. This indicates immunity was not antibody-dependent.
CD4+ T cells were identified as the critical effector of protection: Antibody-mediated depletion studies showed:
Loss of CD4+ T cells eliminated vaccine protection, leading to high viral loads and severe lung pathology.
Depletion of CD8+ T cells or B cells had minimal impact on vaccine efficacy.
These results confirm T cell responses as the critical component of vaccine-induced immune responses capable of providing cross-variant protection.
Multi-antigen design (Spike + Nucleocapsid) outperformed spike-only vaccines: GEO-CM04S1 delivered broader and more durable immunity than spike-only MVA vaccines – especially when spike was mismatched to circulating variants.
“This publication provides significant evidence supporting the unique value of a multi-antigen designed to induce high levels of T-cell responses and validates the core design principles that differentiate our vaccine from first-generation, spike-only approaches,” said Mark Newman, PhD, Chief Scientific Officer of GeoVax.
Dr. Newman added: “These findings support the belief that the GEO-CM04S1 vaccine could be a highly relevant product for use in immunocompromised patients, because of the ability to protect through strong, multi-antigen T-cell immunity.”
“This peer-reviewed study provides a compelling scientific foundation for the ongoing clinical advancement of GEO-CM04S1,” stated David Dodd, Chairman & CEO of GeoVax. “As SARS-CoV-2 continues to evolve, it is increasingly clear that next-generation vaccines must move beyond spike-only strategies. GEO-CM04S1 demonstrates the breadth, durability, and variant-proof characteristics that global public-health leaders have been calling for.”
Dodd continued: “More than 40 million immunocompromised individuals in the U.S. alone remain underserved by existing vaccines. The results published in Frontiers in Immunology strengthen the rationale behind our multiple ongoing Phase 2 studies in immunocompromised patient populations.”
About GEO-CM04S1
GEO-CM04S1 is an MVA-vectored vaccine encoding both the Spike (S) and Nucleocapsid (N) proteins from SARS-CoV-2, designed to induce:
Strong CD4+ and CD8+ T-cell responses
Durable immunity supported by conserved N-protein recognition
Multi-antigen breadth that mitigates loss of protection as the virus mutates
GEO-CM04S1 is currently being evaluated in multiple Phase 2 clinical trials in immunocompromised patients, including individuals with hematologic cancers and chronic lymphocytic leukemia.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Management Anticipates Significant Growth in Target Channel During 2026
Driven by Strong Demand, SKYX Expects Additional Winter Launches at Several Other Leading U.S. Retailers and Big-Box Chains
Management Expects the Turbo Heater & Ceiling Fan to Generate Significant Revenue Beginning this Winter and Continuing throughout Fiscal Year 2026
The Company Anticipates that the Winter Launch Will Advance its Path to Cash-Flow Positivity
The Ceiling Fan and Space Heater Categories Represent a Multi-Billion-Dollar Annual Market, with Tens of Millions of Units Sold Each Year in North America
MIAMI, Dec. 18, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 100 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today announced it will launch its newly patented all-in-one ceiling plug & play SKYFAN & TURBO HEATER at U.S. leading retailer Target. Management anticipates significant growth in its Target business during 2026.
The innovative product—combining a ceiling fan with a built-in turbo heater—offers a safer, more efficient alternative to traditional space heaters and addresses a large year-round market opportunity across both winter and summer seasons. The combined ceiling fan and portable heater category is a multi-billion-dollar market, with tens of millions of units sold annually in North America.
In response to strong demand, SKYX intends to offer the product in six colors to serve both residential and commercial markets. Production is now underway with the Company’s manufacturing partners, and SKYX expects to continue its broad rollout in Q4 2025 and Q1 2026 to align with the winter season.
To view a video of SKYX’s turbo heater ceiling fan Click here
Rani Kohen, Founder and Executive Chairman of SKYX Platforms Corp., stated; “We are excited to begin launching our ceiling SKYFAN and Turbo Heater at a leading retailer such as Target, and we expect to continue expanding our presence across additional leading retailers and big-box chains. This product exemplifies our commitment to innovation, safety, and scalable global solutions. We believe this all-in-one offering will drive meaningful value for customers, partners, and shareholders.”
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target,” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
CDI-988 is the first oral broad-spectrum antiviral drug candidate for potential prevention of norovirus outbreaks and treatment of acute viral gastroenteritis caused by norovirus infection
There are no approved treatments or vaccines currently available for norovirus infection
BOTHELL, Wash., Dec. 18, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the approval from the Institutional Review Board (IRB) at Emory University School of Medicine to initiate a Phase 1b human challenge study with CDI-988. This study aims to evaluate CDI-988 as both a preventive and treatment for norovirus infections. Initial screening of study subjects is currently underway, with enrollment expected to begin in the first quarter of 2026. The IRB approval from Emory University School of Medicine follows Cocrystal’s prior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its investigational New Drug (IND) application.
CDI-988 is the first oral antiviral drug candidate developed for the prevention and treatment of norovirus acute gastroenteritis. It was specifically designed as a broad-spectrum inhibitor by targeting a highly conserved region of the viral 3CL protease of all noroviruses, including GII.4 and recently re-emerging GII.17.
The randomized, double-blind, placebo-controlled Phase 1b study will be conducted at Emory University and involve up to 40 healthy subjects ages 18-49. Participants will be screened and infected with the norovirus GII.2 (Snow Mountain Virus). The study’s primary efficacy endpoint is to assess the reduction in incidence of clinical symptoms, while the secondary efficacy endpoint focuses on the reduction in viral shedding and disease severity. The study will also assess the safety and pharmacokinetic profile of CDI-988. Additional information is available on clinicaltrials.gov.
“This approval from the Emory IRB marks a significant milestone in advancing our Phase 1b norovirus challenge study,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are very excited about collaborating with the Emory team, given their exceptional expertise in norovirus and experience in human challenge studies.
“Cocrystal’s norovirus challenge study is a critical step in addressing the global burden of norovirus outbreaks, which account for an estimated 700 million cases each year worldwide. We are committed to delivering innovative medicine for norovirus outbreaks and chronic norovirus infection among immunocompromised patients,” added Dr. Lee.
“CDI-988 may revolutionize the management of the highly contagious norovirus, which is known for quickly spreading in hospitals, nursing homes, cruise ships, schools, disaster relief sites, military settings and other semi-closed environments,” said James Martin, CFO and co-CEO. “Used as a prophylaxis, oral CDI-988 could offer a potential solution and add a new layer of defense.”
CDI-988 was designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In August 2025 Cocrystal announced favorable Phase 1 safety and tolerability data from all CDI-988 dose cohorts including the highest dose of 1200 mg. In September 2025 the Company received a Study May Proceed Letter from the FDA for the Phase 1b challenge study.
About Norovirus
Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. This debilitating illness causes an estimated 200,000 deaths worldwide each year, with a societal cost of approximately $60 billion. In the U.S., norovirus is responsible for about 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, with an estimated annual economic burden of $10.6 billion.
Cocrystal Pharma’s Structure-Based Drug Discovery Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our initiation of the norovirus study in the first quarter of 2026 and the potential of CDI-988 for norovirus infections. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, the impact of future interest rate changes on the economy, tariffs and the resulting litigation, and geopolitical conflicts including those in Ukraine and Middle East on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with the planned norovirus study or subsequent studies as well as similar problems with our vendors and our current and any future clinical research organizations (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, 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 and any adverse developments which may arise 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 and the Prospectus dated September 25, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
NEW YORK, Dec. 17, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), announces today that it has entered into a securities purchase agreement for a private investment in public equity (“PIPE”) financing that is expected to result in gross proceeds to the Company of approximately $2.05 million, before deducting placement agent fees and offering expenses.
The Company intends to use the net proceeds from the offering for general corporate purposes and working capital.
Pursuant to the terms of the securities purchase agreement, the Company is selling an aggregate of 1,670,055 shares of common stock (or pre-funded warrants in lieu thereof) and common stock purchase warrants to purchase up to 835,023 shares of common stock at a purchase price of $1.2275 per share (or pre-funded warrants in lieu thereof) and one-half common stock purchase warrant, subject to certain beneficial ownership limitations set by each holder. The warrants issued in the offering are exercisable at an exercise price of $3.00 per share, subject to adjustment as provided therein, and will expire five years from the date of issuance.
Wellington Shields & Co. LLC acted as the sole placement agent for the PIPE financing.
The unregistered shares of common stock, pre-funded warrants and warrants sold in the PIPE financing described above were offered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the warrants and the shares of common stock underlying the pre-funded warrants and warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the terms of the securities purchase agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered shares of common stock and the shares issuable upon exercise of the unregistered pre-funded warrants and warrants.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Xcel Brands
Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the co-branded collaboration brands TowerHill by Christie Brinkley, Trust. Respect. Love by Cesar Millan, and GemmaMade by Gemma Stafford, and also holds noncontrolling interests or long-term license agreements in Orme Live, and Mesa Mia Live by Jenny Martinez. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing, LLC. Xcel is pioneering a modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retailers, and e-commerce channels to be everywhere its customers shop. The company’s previously owned and current brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone, and over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches in excess of 46 million social media followers with broadcast reach into 200 million households. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.
Milestone Advances Clinical Readiness and Reinforces Urgent U.S. Need for Domestic MVA Vaccine Capacity
ATLANTA, GA – December 17, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced the successful completion of fill-finish for the initial clinical batch of GEO-MVA, its next-generation Mpox/smallpox vaccine. The product has now entered final release evaluation, the concluding quality-control and compliance process required before shipment for clinical use, positioning the Company for Phase 3 immunobridging trial start-up activities in Q1 2026.
Clinical and Regulatory Milestone
Fill-finish – the sterile, cGMP-regulated process of filling, sealing, and packaging vaccine vials – marks the last manufacturing step before a vaccine may enter clinical study supply channels. With fill-finish complete and GEO-MVA now undergoing final release evaluation, GeoVax has moved into the final pre-clinical-deployment phase of its EMA-aligned clinical program.
In June 2025, the European Medicines Agency (EMA) Scientific Advice confirmed that a single Phase 3 immunobridging study demonstrating immune comparability to the approved MVA vaccine, Imvanex®, would be sufficient to evaluate GEO-MVA’s efficacy. This provides a clear, accelerated regulatory path to licensure.
Strengthening U.S. and Global Pandemic Preparedness
This milestone coincides with increasing Mpox activity globally – including expanding Clade I outbreaks in Africa and emerging cases in the United States – exposing vulnerabilities associated with global dependence on a sole foreign MVA vaccine supplier. GEO-MVA is designed to expand supply, diversify sources, and strengthen biodefense infrastructure.
David Dodd, Chairman & CEO of GeoVax, commented: “Completion of fill-finish for GEO-MVA and progression into final release evaluation represent critical steps toward Phase 3 initiation and a pivotal advancement in our mission to support U.S. and global health security. America cannot remain dependent on a single foreign manufacturer for MVA-based biodefense vaccines. GEO-MVA provides a clear path toward a diversified and domestically controlled second-source supply – an essential component of modern pandemic preparedness. This milestone also underscores the strong operational progress we are delivering for our shareholders and partners.”
About GEO-MVA
GEO-MVA is a Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine designed to expand global vaccine availability at a time of constrained stockpiles and growing demand for resilient, scalable, and geographically diversified manufacturing capacity. GEO-MVA is a core asset within GeoVax’s broader MVA platform, which also includes next-generation COVID-19 and other infectious disease programs.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
RESTON, Va., Dec. 17, 2025 /PRNewswire/ — V2X, Inc. (NYSE: VVX) announced it has been awarded a $72 million contract to provide support and engineering services for the Gateway Mission Router (GMR).
The GMR is a cyber-hardened solution that enhances air-to-ground operations and adapts to evolving mission needs through open-standard interfaces. By intelligently routing datalinks and platform capabilities, the GMR enables a unified common operating picture that merges situational awareness and command-and-control data across multiple formats.
The system’s versatility supports the Department of War, also known as the Department of Defense’s, Combined Joint All Domain Command and Control initiative, which aims to connect systems across domains into a unified network for faster, data-driven decision-making.
“This award represents an important milestone as we continue to advance and expand the Gateway Mission Router and our C6ISR work,” said Richard Caputo, Senior Vice President of Aerospace Systems at V2X. “The GMR has broad applicability across numerous aviation and ground platforms, and we see strong potential for growth beyond this award. We remain committed to investing in the solution to deliver greater processing capability at reduced size, weight, and power for critical missions.”
This award builds upon a previous $49 million contract as V2X continues to advance the GMR program and expand its use across the U.S. military’s mission systems. The contract has an estimated completion date of June 25, 2030.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
CHICAGO, IL, Dec. 16, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,233,488 shares of common stock at a purchase price of $1.224 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.36 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about December 18, 2025, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be approximately $1.51 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.
The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
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 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) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) 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.
CULVER CITY, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, unveiled major advancements across its growing digital ecosystem during its 2025 Investor Day at the NASDAQ MarketSite in New York City. Company executives shared new developments in crypto and long-term content expansion for the company’s leading game franchise ARK.
During the event, Snail introduced its upcoming stablecoin initiative, revealing the name, $USDO and the official branding. Product Owner, Matthew Harper, symbolically minted the first official coin live on stage, marking a significant milestone in the company’s strategy to integrate secure, utility focused digital payments across its ecosystem.
Snail also debuted Golden Poop, a commemorative digital meme collectible created to humorously acknowledge gaming culture and industry satire.
The event wrapped with a showcase of the new ARK: Lost Colony teaser trailer, confirming that the DLC will launch on December 18. Snail closed the presentation with a multi-year content roadmap presented by Jeremy Stieglitz, Studio Wildcard Co-founder and Lead Designer for ARK, showcasing the resilient and well-defined ARK pipeline that provides the Company clear visibility and continuous franchise support through 2027.
ARK Roadmap 2026: Survival of the Fittest by Studio Sirens Bob’s True Tales: Tides of Fortune ARK: World Creator ARK: Dragontopia
ARK Roadmap 2027: ARK: Atlantis Bob’s True Tales: Galaxy Wars ARK: Legacy of Santiago Part 1
A replay of the Investor Day will be available on the Company’s Events and Presentation section of its investor relations website here.
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and in certain of our public filings with the SEC and include, but are not limited to statements regarding the Company’s major advancements and new developments in crypto and long-term content expansion. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed by the Company with the SEC on March 26, 2025 and other documents filed by the Company from time to time with the SEC, including the Company’s Forms 10-Q filed with the SEC. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 SNAL@gateway-grp.com
BOCA RATON, FL / ACCESS Newswire / December 16, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced that the Company has renewed its carriage agreement with YouTube TV, one of the nation’s leading live streaming television platforms.
As part of the multiyear deal, the Newsmax channel will continue to be available in YouTube TV’s Base Package.
In addition to locking down Newsmax’s distribution on YouTube TV, the Newsmax streaming service, Newsmax+, will be available through YouTube’s Primetime Channels app store beginning in early 2026.
YouTube TV also recently added Newsmax en Espanol, the first and only U.S.-based news channel to use advanced AI technology to dub its content into another language on a live basis. Newsmax en Espanol is available in YouTube TV’s Spanish Plan and Spanish Plus add-on package.
“This agreement keeps Newsmax, the fastest growing cable network in the U.S., on YouTube TV, the fastest growing pay TV platform in the U.S., for years to come,” said Andy Biggers, Newsmax’s Senior Vice President of Distribution.
“YouTube TV have been great partners, and we look forward to continuing to grow together,” Biggers continued.
Newsmax, the fourth highest-rated cable news channel, is carried by every major pay TV operator in the United States, reaching nearly 60 million households with its trusted, independent news coverage.
This milestone places Newsmax’s reach on par with legacy networks such as CNN and Fox News, a remarkable achievement for one of America’s fastest-growing news brands.
About Newsmax
Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 50 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches over 22 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”
Forward-Looking Statements This communication contains forward-looking statements. From time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Forward-looking statements can be identified by those that are not historical in nature. The forward-looking statements discussed in this communication and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. Newsmax does not guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this communication to conform our prior statements to actual results or revised expectations, and we do not intend to do so. Factors that may cause actual results to differ materially from current expectations include various factors, including but not limited to the factors set forth in the sections entitled “Risk Factors” in Newsmax’s Annual Report on Form 10-K for the twelve months ended December 31, 2024, Newsmax’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, and other filings Newsmax makes with the Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Undue reliance should not be placed on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein.
Non-opioid analgesic shows efficacy in several animal pain models, including diabetic and chemotherapy-induced neuropathic pain
Compelling safety and pharmacokinetic profiles in animals support IND-enabling studies
CHATHAM, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced licensing exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small-molecule Sigma-1 receptor (S1R) antagonist with demonstrated analgesic activity in multiple models of neuropathic pain.
“Sigma-1 receptor antagonism has generated considerable scientific interest as a promising class of non-opioid, non-addictive analgesics,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “With our extensive experience studying and developing an FDA approved non-opioid analgesic we are well-positioned to oversee this new development program. We believe TNX-4900 has the potential to be best-in-class.”
Dr. Youyi Peng, co-inventor of TNX-4900, formerly a Senior Bioinformatics Specialist at the Rutgers Cancer Institute of New Jersey and now a consultant to Tonix, added, “We used computer-aided and AI-driven approaches to design this new class of selective Sigma-1 receptor antagonists. TNX-4900 showed robust analgesic efficacy in multiple pain models and an encouraging safety profile, supporting its potential as a new non-opioid approach to treating neuropathic pain.”
TNX-4900 was created from a structure-based drug design program led by Dr. Youyi Peng and Dr. William Welsh at Rutgers University that produced a series of potent and selective triazole-based S1R antagonists. The compound binds the human Sigma-1 receptor with nanomolar affinity (Ki = 7.5 nM), demonstrates > 100-fold selectivity over the Sigma-2 receptor, and exhibits high blood-brain barrier penetration and favorable adsorption, distribution, metabolism and elimination (ADME) properties, including oral bioavailability of approximately 28%.
“Our foundational research into TNX-4900 represents an important step toward developing non-opioid solutions for chronic pain. We are pleased to see this innovation progress toward potential clinical application, which could address a critical need for safer pain management options,” said Dr. William Welsh, Distinguished Professor in the Department of Pharmacology at Rutgers Robert Wood Johnson Medical School (RWJMS).
In preclinical models of diabetic and chemotherapy-induced neuropathic pain, TNX-4900 produced significant and durable reductions in pain behaviors after both acute and chronic dosing without evidence of tolerance or motor impairment. Tonix plans to advance TNX-4900 through expanded pharmacokinetic, formulation, and safety studies to support IND-enabling development.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYATM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready 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 rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality 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’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 under development.
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 successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set 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.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Vancouver, British Columbia–(Newsfile Corp. – December 15, 2025) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) announces that its Board of Directors has approved grants of incentive restricted share units (“RSU”) and stock options.
Restricted Share Units
Under the Company’s Restricted Share Unit Plan (the “Plan”), RSUs may be granted to directors, employees, and contractors of the Company. At the discretion of the Company’s Board of Directors, the Plan permits the Company to either redeem RSUs for cash or by issuance of Hemisphere’s common shares.
On December 12, 2025, the Company awarded 930,000 incentive RSUs to directors and officers of Hemisphere, all of which will vest one-third annually over a three-year period and will expire on December 15, 2028.
Stock Options
Additionally, in accordance with the Company’s Stock Option Plan, Hemisphere has granted 48,000 incentive stock options to its investor relations service provider on December 15, 2025 at an exercise price of $2.01 per share which will vest quarterly over 12 months and expire on December 15, 2030.
About Hemisphere Energy Corporation
Hemisphere is a dividend-paying Canadian oil company focused on maximizing value-per-share growth with the sustainable development of its high netback, ultra-low decline conventional heavy oil assets through polymer flood enhanced oil recovery methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.
For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:
Don Simmons, President & Chief Executive Officer Telephone: (604) 685-9255 Email: info@hemisphereenergy.ca
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
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