aweinsoff@channelchek.com, Author at Channelchek

Release – Greenwich LifeSciences Provides Additional Updates on FLAMINGO-01 and Corporate Strategy

Posted on December 22, 2025December 22, 2025 by aweinsoff@channelchek.com

Download as PDFDecember 22, 2025 6:00am EST

STAFFORD, Texas, Dec. 22, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on FLAMINGO-01 and the Company’s corporate strategy.

Corporate Strategy

The Company recently attended a Noble Capital conference on December 3, 2025, where further details of the Company’s FLAMINGO-01 clinical strategy, financing strategy, and partnering strategy were discussed in a fireside chat with the Noble analyst. The video is now available on the Company’s website at the bottom of the Welcome page: https://greenwichlifesciences.com/

Below are highlights from the discussion with additional information:

Clinical strategy – The FLAMINGO-01 clinical strategy continues to evolve with various options to further reduce risk and increase the chances of marketing approval supported by the current financing strategy that is supporting the current burn rate, the increasing interest from investigators and patients, cost reduction activities, and continued interest to add additional sites and countries to the study.
- Approximately 140 sites are actively enrolling patients, and there are plans to activate an additional 10 already approved sites in 2026 and additional EU countries.
- Quality improvement and cost reduction may be realized by moving more clinical trial operations internally and ending the use of a CRO for the US operations and global management.
- The study has transitioned from strong interest from principal investigators to patient driven interest, including the formation of wait lists at certain sites.
- The Company has entered into discussions with leading clinical sites in the United Kingdom and Canada regarding joining the study, which would require regulatory approval in each country, independent from the FDA and EMA regulatory approval that the Company has already received.
Financing strategy – The ATM financing is being used judiciously and efficiently to keep up with the burn rate in 2025, potentially exceeding the burn rate by year end. This ATM strategy reduces the likelihood of the Company doing a near term financing, increasing the chances for non-dilutive strategic partnerships at any time before or after an interim analysis.
- The Company’s annual burn rate was approximately $7 million in 2024 and 2023. The income statements for these periods have been reported as losses of $16 million and $9 million respectively, but the cash flow used for operations is much lower at $7 million due to the non-cash stock and options expenses added to the income statements.
- For the first three quarters of 2025, the burn rate is approximately $7 million, representing a gradual increase in burn rate over 2024, but not a substantial increase due to the Company’s lean structure and ongoing cost saving initiatives. In addition, a large part of the clinical expenses is from the upfront costs and the first 6 months of monthly vaccinations or Primary Immunization Series, after which the cost per patient should be lower when boosters are given once every 6 months.
Partnering strategy – The Company continues to attend partnering conferences.
- Large pharma dominates the breast cancer drug market, including acquiring or partnering with smaller biotechs who have promising new breast cancer drugs.
- We believe patent filings for treating non-HLA-A*02 patients with GLSI-100 will strengthen the patent portfolio for GLSI-100, in addition to the biologics data exclusivity available to GLSI-100 in the US.

FLAMINGO-01 Data Safety Monitoring Board (DSMB) & Steering Committee

The FLAMINGO-01 DSMB met twice in 2025, most recently in December 2025, and recommended to continue the study as is without modification. The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01. The planned modifications subject to regulatory approval include:

increasing the size of the study, which would increase the power of the study thus decreasing the risk by designing the study to assume more recurrences even though fewer recurrences may be anticipated and observed,
doubling or quadrupling the enrollment rate, which will increase the patient years in the study more rapidly thus proportionately increase the event rate, which may shorten the time to reach an interim analysis or milestone,
continuing to enroll past the interim analyses so that the current momentum at the clinical sites continues,
using the interim analysis to potentially resize the study or to change the subsequent interim analysis, to change the number of events triggering an analysis, or to change the timing of the study based on recommendations by an independent committee, and
using a recently manufactured GP2 commercial drug product lot in FLAMINGO-01

CEO Snehal Patel commented, “We are looking forward to continuing our financing strategy and implementing the planned Phase III trial derisking modifications, pending regulatory approvals. The discussions with clinicians at SABCS 2025 were encouraging, as the study has become more widely recognized by the breast cancer community, leading to patient and investigator driven interest to expand FLAMINGO-01 into the United Kingdom and Canada. The potential for GLSI-100 to save lives by preventing metastatic breast cancer recurrences and thus reduce overall healthcare costs was also highlighted at the Noble conference. The open label data of FLAMINGO-01 in the non-HLA-A*02 arm has helped to increase the probability of success, while potentially doubling the market for GLSI-100, and will continue to be analyzed as we may provide updates or publications at any time.”

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

Release – GeoVax to Raise Approximately $3.2 Million of Gross Proceeds in Public Offering

Posted on December 19, 2025December 19, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Atlanta, GA, December 19, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive securities purchase agreements with several institutional and individual investors for the purchase and sale of approximately 13.2 million units, each comprised of one share of the Company’s common stock and warrants, as described below, to purchase shares of the Company’s common stock, at a price of $0.245 per unit in a public offering. The Company will issue warrants to purchase up to approximately 26.5 million shares of common stock. The warrants will have an exercise price of $0.245 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $3.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about December 22, 2025, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-292127) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on December 19, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

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

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent 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.

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com

Release – Nutriband Inc. Signs Letter of Intent with Qvanta Group of Companies to Explore Advanced Technology Solutions for Abuse-Deterrent Pharmaceutical Innovation Strategic Exploration

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on NTRB

The LOI Aligns with Federal Priorities on Fentanyl Crisis, Artificial Intelligence, and Quantum Technology

December 18, 2025 08:00 ET | Source: Nutriband Inc.

ORLANDO, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) (“Nutriband” or the “Company”), a developer of transdermal pharmaceutical products including abuse-deterrent technologies, today announced the signing of a non-binding Letter of Intent (“LOI”) with the Qvanta Group of Companies.

The Qvanta Group comprises Qvanta LLC and its subsidiaries, Qvanta Foundry LLC and Qvanta Capital LLC (collectively, “Qvanta”). Qvanta is a U.S.-based advanced technology organization developing the BigΔx Quantum Defense Fabric, an integrated quantum-AI cybersecurity and computing platform designed to support enterprise, government, and high-security research environments.

The announcement comes amid heightened federal focus on three converging national priorities. On December 15, 2025 President Trump signed an Executive Order designating illicit fentanyl as a Weapon of Mass Destruction, recognizing the substance as a direct threat to U.S. national security (https://www.whitehouse.gov/presidential-actions/2025/12/designating-fentanyl-as-a-weapon-of-mass-destruction/).

In parallel, the Administration’s America’s AI Action Plan emphasizes accelerating the responsible adoption of artificial intelligence across regulated sectors, including healthcare and pharmaceuticals (https://www.whitehouse.gov/articles/2025/07/white-house-unveils-americas-ai-action-plan/).

Additionally, the Genesis Mission Executive Order establishes quantum information science as a national priority, underscoring the strategic importance of advanced computing technologies in addressing complex national challenges (https://www.whitehouse.gov/presidential-actions/2025/11/launching-the-genesis-mission/).

Nutriband believes that Qvanta’s quantum-AI simulation capabilities, secure high-performance computing infrastructure, and advanced cybersecurity technologies may provide meaningful support for Nutriband’s research, innovation efforts, and long-term product development initiatives.

Under the LOI, the parties plan to explore potential collaboration areas including secure AI and analytics platforms for regulated pharmaceutical data, cybersecurity and data-integrity frameworks that support abuse-deterrent technologies, and advanced modeling and simulation capabilities enabled by quantum-ready infrastructure. Any discussions would emphasize regulatory compliance, strong data protection, and responsible technology use.

The LOI is non-binding and does not establish a partnership, joint venture, equity investment, licensing arrangement, or other binding commercial relationship. Any future collaboration would be subject to additional technical and regulatory review, due diligence, and the execution of definitive agreements. There can be no assurance that a definitive agreement will be reached or that any transaction will ultimately occur.

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ technology directly addresses the fentanyl crisis by incorporating aversive agents into transdermal patches designed to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The Company’s lead product under development is an abuse-deterrent fentanyl transdermal system, protected by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

Nutriband Inc. (NASDAQ: NTRB) develops transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch incorporating proprietary AVERSA™ technology. For more information, visit www.nutriband.com.

About Qvanta Group of Companies

The Qvanta Group of Companies (https://qvanta.io) develops AI-driven and quantum-ready infrastructure solutions for national security, enterprise resilience, and regulated industries. The group comprises Qvanta LLC (operating entity), Qvanta Foundry LLC (R&D), and Qvanta Capital LLC (investment solutions).

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

SOURCE: Nutriband Inc.

Release – GeoVax Receives Formal EMA Scientific Advice Supporting Pivotal Phase 3 Immunobridging Trial for GEO-MVA

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

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

Forward-Looking Statements

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com

Release – MariMed Statement on Historic Rescheduling of Cannabis

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MRMD

December 18, 2025 1:52pm EST Download as PDF

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.

Media Contact:
Zach Galasso
DPA Communications
Email: zach@dpacommunications.com
Phone: (978) 604-5423

Company Contact:
Howard Schacter
Chief Communications Officer
Email: hschacter@marimedinc.com
Phone: (781) 277-0007

Source: MariMed Inc.

Released December 18, 2025

Release – GeoVax Announces Publication of Study Demonstrating Cross-Variant Protection Using the Multi-Antigen GEO-CM04S1 Vaccine

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

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

Forward-Looking Statements

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com

Release – SKYX Announces Launch at U.S Leading Retailer Target of its Ceiling Plug & Play SKYFAN & TURBO HEATER

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on SKYX

December 18, 2025 09:00 ET | Source: SKYX Platforms Corp.

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.

Link to SKYFAN & Turbo Heater in Target :https://www.target.com/b/skyx/-/N-q643lekuybt

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.

Investor Relations Contact:
Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/4f56ec5f-6048-4639-a4e3-c2604e3fecb9

https://www.globenewswire.com/NewsRoom/AttachmentNg/d28c7717-198e-482e-9b67-93e3f692b358

https://www.globenewswire.com/NewsRoom/AttachmentNg/6cb538cc-1acf-4f9a-8518-eb37416cb390

Release – Cocrystal Pharma Receives IRB Approval from Emory University School of Medicine for Phase 1b Human Challenge Study with CDI-988 for Prevention and Treatment of Norovirus

Posted on December 18, 2025December 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on COCP

December 18, 2025

Download as PDF

Subject enrollment expected to begin in Q1 2026
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.

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 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.

Contact:

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

# # #

Source: Cocrystal Pharma, Inc.

Released December 18, 2025

Release – Xcel Brands Announces $2.05 Million Private Placement

Posted on December 17, 2025December 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on XELB

PDF Version

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.

For further information please contact:
Seth Burroughs
Xcel Brands, Inc.
sburroughs@xcelbrands.com

Source: Xcel Brands, Inc

Release – GeoVax Announces Completion of GEO-MVA Fill-Finish, Supporting Phase 3 Immunobridging Clinical Trial Start-Up in Early 2026

Posted on December 17, 2025December 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

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

Forward-Looking Statements

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com

Release – V2X Wins $72 Million Contract to Enhance Battlefield Connectivity and Situational Awareness for the Army

Posted on December 17, 2025December 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on VVX

December 17, 2025

Download(opens in new window)

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

View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-wins-72-million-contract-to-enhance-battlefield-connectivity-and-situational-awareness-for-the-army-302644697.html

SOURCE V2X, Inc.

Release – Snail Inc. Holds Successful Investor Day Event, Showcasing Its Digital Ecosystem Plans, Stablecoin $USDO Reveal, and New ARK Content Roadmap

Posted on December 16, 2025December 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on SNAL

December 16, 2025 at 4:05 PM EST

PDF Version

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

Release – MAIA Biotechnology Announces $1.51 Million Private Placement

Posted on December 16, 2025December 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 16, 2025 4:15pm EST Download as PDF

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.

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

Source: MAIA Biotechnology, Inc.

Released December 16, 2025