Tag: Biotechnology

Release – GeoVax Highlights Positive Interim Results for Multi-Antigen COVID-19 Vaccine in Immunocompromised Patients at World Vaccine Congress Europe 2025

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Research News and Market Data on GOVX

Presentations Underscore Favorable Safety Profile and Robust T-Cell Responses of GEO-CM04S1 in Vulnerable Populations

ATLANTA, GA – October 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced presentations by its senior scientific leadership at the World Vaccine Congress Europe 2025, held October 13–16 at the RAI Amsterdam Convention Centre in Amsterdam, Netherlands.

Presentation Highlights

Mark J. Newman, PhD – Chief Scientific Officer
Workshop Presentation: “Vaccine design to address the immunocompromised: T-lymphocyte driven…Balanced immunity – Broader specificity – Increased memory.”

  • Highlighted the limitations of current “one-size-fits-all” vaccines for immunocompromised populations.
  • Presented Phase 2 data showing GEO-CM04S1 elicits strong T-cell responses to both Spike (S) and Nucleocapsid (N), exceeding responses induced by mRNA boosters.
  • Demonstrated broad, durable immunity in preclinical and early clinical data, including responses against Omicron subvariants.
  • Reinforced the potential of GEO-CM04S1 to provide longer-lasting protection and reduce the need for frequent vaccine reformulations.

Kelly T. McKee, Jr., MD, MPH – Chief Medical Officer
Poster Presentation: “Interim Safety and Reactogenicity of GEO-CM04S1, an MVA-vectored, multi-antigen COVID-19 vaccine, in adults with hematologic malignancies receiving cellular therapies.”

  • Reported interim safety results from a Phase 2 trial in patients with hematologic malignancies post-hematopoietic stem cell transplant or chimeric antigen receptor (CAR)-T cell therapy.
  • GEO-CM04S1 showed a safety profile comparable to mRNA vaccines, with only mild-to-moderate treatment-emergent adverse events, predominantly injection site reactions, fatigue, and myalgia… observed.
  • No vaccine-related serious adverse events, myocarditis, or pericarditis have been reported to date.
  • Breakthrough infections occurred but were mild-to-moderate in severity.

“These data continue to support our conviction that GEO-CM04S1 has the potential to fill a critical gap for immunocompromised patients who are not adequately protected against severe COVID-19 by existing vaccines,” said David Dodd, Chairman & CEO of GeoVax. “Our MVA-based, multi-antigen approach is designed to provide broader, more durable protection, and we are encouraged by the consistent safety profile emerging across the ongoing trials.”

About GEO-CM04S1

GEO-CM04S1 is a synthetic, next-generation COVID-19 vaccine candidate that co-expresses spike (S) and nucleocapsid (N) antigens using GeoVax’s MVA vector platform. Designed to induce both antibody and T-cell responses, GEO-CM04S1 is being evaluated in three Phase 2 clinical trials:

  1. As a primary vaccine for immunocompromised individuals (including post-transplant and hematologic cancer patients),
  2. As a booster for patients with chronic lymphocytic leukemia (CLL), and
  3. As a durable booster for healthy adults previously immunized with mRNA vaccines

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 – GeoVax Leadership to Participate in Key European Meetings to Advance Partnering Discussions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Executives to Participate at World Vaccine Congress Europe (Amsterdam, Oct 13–16) and BIO-Europe Fall (Vienna, Nov 3–5), and Meet With NGOs, Industry Partners and Academic Collaborators

ATLANTA, GA – October 13, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced that senior leadership will be in Europe over the coming weeks to advance partnering and collaboration engagement across the Company’s portfolio.

Chairman & Chief Executive Officer David A. Dodd and John Sharkey, PhD, Vice President, Business Development & Executive Lead for Mpox/Smallpox, together with other members of GeoVax’s senior team, will attend and host meetings at:

  • World Vaccine Congress Europe 2025 – October 14–16, 2025 | Amsterdam, Netherlands
  • BIO-Europe 2025 Fall – November 3–5, 2025 | Vienna, Austria

In addition to conference activities, the team will conduct meetings with global NGOs, including WHO, UNICEF, CEPI, Gavi, and the Africa CDC, as well as with established and prospective academic institutional collaborators across Europe.

“We are focused on solidifying durable relationships that can accelerate development in support of expanded access to critical vaccines and immunotherapies,” said David A. Dodd, Chairman & CEO of GeoVax. “We’re engaging with global health leaders and prospective partners to align on near-term opportunities in mpox/smallpox preparedness, addressing the critically unmet needs of immunocompromised patients relative to COVID-19, expanding the development breadth of Gedeptin® as neoadjuvant cancer therapy, and to explore complementary collaborations across our broader platform.”

Partnering Focus Areas

GeoVax will highlight opportunities spanning its pipeline and technology platforms, including (but not limited to):

  • GEO-MVA (Mpox/Smallpox vaccine candidate): U.S.-based MVA program designed to accelerate access to a second-source of the critically needed GEO-MVA vaccine and rapid, scalable MVA manufacturing.
  • GEO-CM04S1 (multi-antigen COVID-19 vaccine): Designed to elicit robust T-cell and antibody responses; partnering priorities focused on addressing the current unmet needs of an estimated over 400 million immunocompromised patients worldwide.
  • Gedeptin® (gene-directed enzyme prodrug therapy): A tumor-targeted immuno-oncology approach with potential combination synergies with checkpoint inhibitors, providing a potential new neoadjuvant therapy against solid tumors.
  • Broader MVA platform applications: Hemorrhagic fever and Zika programs; continuous cell-line manufacturing and potential technology-transfer collaborations.

“We continue to receive compelling interest from governments, NGOs, and potential industry collaborators, seeking diversified, resilient vaccine supply and clinically differentiated immunotherapies,” added Dr. John Sharkey. “Our goal is to convert that interest into structured collaborations that accelerate development, manufacturing readiness, and regional availability.”

Request a Meeting

Organizations interested in meeting with GeoVax during WVC Europe (Amsterdam, Oct 14–16) or BIO-Europe Fall (Vienna, Nov 3–5) – or at separate times/locations in Europe – are encouraged to contact:

Additional information about GeoVax and its programs is available at www.geovax.com.

About GeoVax

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

October 02, 2025

 Download as PDF

BOTHELL, Wash., Oct. 02, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that James Martin, CFO and co-CEO, will present a company overview at the Noble Capital Markets Emerging Growth Virtual Equity Conference on Thursday, October 9, 2025 at 12:00 pm Eastern time (9:00 a.m. Pacific time). The formal presentation will be followed by a hosted question-and-answer session with questions welcomed from the live virtual audience.

Those interested in viewing the live Cocrystal presentation can register for the event here. A video webcast of the presentation will be available within 48 hours following the event on the Company’s website and archived for 90 days.

Mr. Martin will be available throughout the conference for virtual one-on-one meetings with registered, qualified investors. Meetings can be scheduled by contacting Giorgia Pigato here at Noble Capital Markets.

About Noble Capital Markets, Inc. 
Noble Capital Markets is a research-driven investment bank that has supported small and microcap companies since 1984. As a FINRA and SEC licensed broker dealer, Noble provides institutional-quality equity research, merchant and investment banking, and order execution services. In 2018, Noble launched Channelchek—an investor community dedicated exclusively to public small and micro-cap companies and their industries. Channelchek is the first service to offer investors free institutional-quality research without a subscription.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

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

# # #

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Source: Cocrystal Pharma, Inc.

Released October 2, 2025

Release – Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access

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Research News and Market Data on TNXP

September 30, 2025 8:30am EDT Download as PDF

Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix

On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years

US Launch of Tonmya expected in the fourth quarter of 2025

CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the appointment of Ganesh Kamath as Head of Market Access, effective September 29, 2025.

“Ganesh brings deep expertise in market access and a history of delivering results at leading global organizations, including Bayer HealthCare, Hutchmed International, and CuriaGlobal,” said Thomas Englese, EVP Commercial of Tonix Pharmaceuticals. “As we prepare for the commercial launch of Tonmya™ and continue advancing our pipeline, his leadership in pricing, contracting, and payer engagement will help ensure patients have timely access to our therapies while driving operational momentum across the business.”

Most recently, Mr. Kamath served as Vice President of FP&A, Business Development, and Sales Operations at CuriaGlobal, where he led strategic initiatives to strengthen business development and operational performance. Prior to that, he was Senior Vice President and Chief Financial Officer at Hutchmed International, where he established pricing governance frameworks and advanced market access strategies. Earlier in his career, he held senior leadership roles at Bayer HealthCare within Finance and Market Access, overseeing strategic pricing, contracting, reimbursement and gross to net management across a portfolio of more than 25 brands. Mr. Kamath is a Chartered Accountant and holds a Bachelor of Science from the University of Calicut.

“Joining Tonix at this pivotal time presents an opportunity to help unlock the commercial value of Tonmya as we prepare to bring it to market for patients with fibromyalgia,” said Ganesh Kamath. “I look forward to working with Tonix’s leadership team to drive operational execution, and position the company for long-term growth across the portfolio.”

Tonix Pharmaceuticals Holding Corp.*

Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. 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 a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

* Tonix’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.

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.

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

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com

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.

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Source: Tonix Pharmaceuticals Holding Corp.

Released September 30, 2025

Release – MAIA Biotechnology Announces $2.25 Million Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

September 29, 2025 4:30pm EDT Download as PDF

CHICAGO, IL, Sept. 29, 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 1,733,766 shares of common stock at a purchase price of $1.30 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 $1.57 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 October 1, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $2.25 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

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Source: MAIA Biotechnology, Inc.

Released September 29, 2025

Genmab to Acquire Merus in $8 Billion Deal, Strengthening Oncology Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Danish biotechnology company Genmab (Nasdaq: GMAB) has agreed to acquire Dutch oncology firm Merus (Nasdaq: MRUS) in an all-cash transaction valued at roughly $8 billion, a move that significantly expands Genmab’s late-stage pipeline and accelerates its push toward a fully owned operating model.

Under the terms of the deal, Genmab will pay $97.00 per share for all outstanding common shares of Merus, representing a premium of more than 40% over Merus’ most recent closing price. The boards of both companies have unanimously approved the transaction, which is expected to close by the first quarter of 2026 pending regulatory and shareholder approvals.

The acquisition brings Merus’ lead asset, petosemtamab, into Genmab’s pipeline. The bispecific antibody therapy, currently in Phase 3 clinical trials, has received two Breakthrough Therapy Designations from the U.S. Food and Drug Administration for treatment of head and neck cancers. Recent Phase 2 data presented at the 2025 ASCO meeting indicated promising efficacy, with outcomes surpassing standard of care benchmarks.

The addition of petosemtamab is expected to bolster Genmab’s transition to a fully owned model, reducing reliance on partnerships and collaborations. By 2027, Genmab anticipates four proprietary programs reaching the commercial stage, positioning the company for multiple new product launches within oncology.

Petosemtamab’s potential launch as early as 2027 could deliver significant commercial impact, with projections suggesting annual sales of $1 billion by 2029 and the possibility of multi-billion-dollar revenues in the longer term. Genmab expects the acquisition to become accretive to EBITDA before the end of the decade.

The $8 billion consideration will be financed through a combination of cash on hand and approximately $5.5 billion in debt, backed by commitments from Morgan Stanley Senior Funding. Genmab stated it remains committed to deleveraging, with a target of reducing gross leverage below three times within two years of closing.

A tender offer for Merus shares will launch in the coming weeks. If successful, the transaction will result in Merus becoming a wholly owned subsidiary of Genmab. Shareholders who do not tender their shares are expected to receive equivalent value through statutory buy-out proceedings in the Netherlands.

The deal highlights the intense competition among biotech companies to secure late-stage oncology assets with strong regulatory momentum. By integrating Merus’ multispecific antibody expertise, Genmab gains not only a promising drug candidate but also a platform that complements its own antibody development technologies.

For Merus, the acquisition provides the scale and resources of a global biotechnology leader to advance petosemtamab through late-stage development, regulatory review, and potential commercialization.

With a strong balance sheet, an expanded pipeline, and an emphasis on proprietary innovation, Genmab is positioning itself to compete more directly with larger global oncology players in the second half of the decade.

Release – MAIA Biotechnology Awarded $2.3 Million Grant by National Institutes of Health for THIO-101 Phase 2 Trial of Cancer-Fighting Agent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

September 24, 2025 8:01am EDT Download as PDF

THIO-101 Phase 2 trial to enroll patients in the U.S. as part of the expansion of the study in third-line treatment for advanced non-small cell lung cancer (NSCLC)

CHICAGO, Sept. 24, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, announced today that the National Institutes of Health (NIH) has awarded a $2.3 million grant for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer (NSCLC). 

The grant is intended to support expenses related to the enrollment of U.S. patients who are resistant to chemo and immunotherapy. The NIH grant allocations will be distributed over three years from 2025-2027.

“We are thrilled to receive this prestigious NIH grant for the expansion of our Phase 2 trial. It’s a great honor to have the support of the National Institutes of Health as we seek to further validate the efficacy of our lead agent ateganosine and its potential to be a breakthrough treatment within the vastly underserved NSCLC market,” said CEO Vlad Vitoc, M.D. “With the clearance of FDA Investigational New Drug (IND) for THIO-101 in 2023, we can begin enrolling U.S. patients in the expansion phase of the trial immediately.”

“The NIH grant is a tremendous achievement and a testament to the dedication, collaboration, and hard work of everyone involved in the clinical development of ateganosine,” added Victor Zaporojan, M.D., MAIA’s senior medical director. “Ateganosine represents a potential solution for the significant unmet clinical need in third-line NSCLC, where no established standard of care exists and where the overall survival outcomes observed with ateganosine have not been achieved by other therapies. By enrolling patients in the United States, our trial will gain access to a substantially larger patient pool across multiple continents, further strengthening the impact and relevance of our study.”

In Parts A and B of THIO-101, median overall survival (OS) for the 22 patients in third-line treatment was 17.8 months as of June 30, 2025, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown overall survival of 5 to 6 months. The first patient in the expansion of the trial was dosed in July 2025 in Taiwan.

Research referenced in this press release is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA309843. The content is solely the responsibility of MAIA and does not necessarily represent the official views of the National Institutes of Health.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

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Source: MAIA Biotechnology, Inc.

Released September 24, 2025

Release – GeoVax Showcases Positive Phase 2 Data for GEO-CM04S1 in CLL Patients at the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Multi-Antigen COVID-19 Vaccine Candidate Outperforms mRNA Comparator; Enrollment Now Limited to GEO-CM04S1 Arm

ATLANTA, GA – September 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today showcased positive interim results for its lead COVID-19 vaccine candidate, GEO-CM04S1 at the XXI International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2025) in Krakow, Poland.

The presentation by Alexey V. Danilov, MD, PhD, Professor, Department of Hematology and Transplantation at City of Hope, detailed data from an ongoing randomized Phase 2 trial (NCT05672355) comparing GEO-CM04S1 to a standard-of-care mRNA vaccine in patients with chronic lymphocytic leukemia (CLL).

Key Takeaways

  • Differentiated Performance: The proportion of CLL patients receiving GEO-CM04S1 that achieved the study’s primary immune endpoint met the statistical requirement to continue enrollment, while those in the mRNA COVID-19 vaccine arm did not.
  • Enrollment Shifted to GEO-CM04S1: Following interim analysis and following the recommendation of the Data Safety Monitoring Board, further enrollment is proceeding exclusively in the GEO-CM04S1 arm.
  • Durable Market Potential: CLL patients represent a high-need, underserved market where first-generation COVID-19 vaccines are often inadequate.
  • Favorable Safety Profile: Both vaccines were well tolerated, with no grade ≥3 adverse events reported.

“These data reinforce the value proposition of our multi-antigen MVA platform,” said David Dodd, Chairman & CEO of GeoVax. “Immunocompromised patients, including those with CLL, have not been adequately protected by current vaccines. GEO-CM04S1 is demonstrating the ability to overcome this gap, representing not only a clinical breakthrough but also a compelling commercial opportunity.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine built on a Modified Vaccinia Ankara (MVA) vector. Unlike first-generation vaccines, GEO-CM04S1 encodes both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2 to drive broad, cross-variant, and durable immune protection. The vaccine is currently in three Phase 2 clinical trials:

  1. As a primary vaccine for immunocompromised patients with blood cancers or post-transplant status,
  2. As a booster in CLL patients, and
  3. As a more robust COVID-19 booster in previously mRNA-vaccinated healthy adults.

Strategic Opportunity

With millions of immunocompromised patients worldwide, including those with CLL and other hematologic malignancies, GEO-CM04S1 addresses a significant unmet medical and commercial need. The vaccine’s ability to induce nucleocapsid-specific responses sets it apart from existing single-antigen mRNA products, positioning GeoVax to lead in a multi-billion-dollar market segment where durable protection remains elusive.

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 – Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

September 15, 2025

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  • Upfront fees and near-term development milestone payments totaling up to $7.5 million
  • Potential sales milestones of $180 million or more in first 10 years of commercialization
  • Royalties equaling 25% of net sales
  • Ocugen to manufacture and supply OCU400

MALVERN, Pa., Sept. 15, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today executed a licensing agreement with Kwangdong Pharmaceutical, Co., Ltd., (“Kwangdong”) one of the leading pharmaceutical companies in Korea, for the exclusive Korean rights to OCU400—Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).

Pursuant to the License Agreement, Ocugen will receive upfront license fees and near-term development milestones equaling up to $7.5 million. The Company will be entitled to sales milestones of $1.5 million for every $15 million of sales in Korea, projected to reach $180 million or more in the first 10 years of commercialization. Additionally, Ocugen will receive a royalty of 25% on net sales of OCU400 generated by Kwangdong. Ocugen will manufacture the commercial supply of OCU400 under terms of a supply agreement.

There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately 7% of the U.S. market. OCU400 provides the opportunity for our partner to help thousands of patients facing vision loss. Upon regulatory approval of OCU400 in Korea, we believe Kwangdong will become a leader in the field of ophthalmic gene therapy in Korea.

“We are excited to partner with Kwangdong as our first regional partner in the development and commercialization of our modifier gene therapies across the globe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “OCU400 is a potential one-time therapy for life to treat RP and upon local regulatory approval, patients in Korea with this devastating condition will be able to access OCU400 through Kwangdong.”

Kwangdong, a top five pharmaceutical and healthcare company in Korea, has a diverse portfolio of products including prescription pharmaceuticals and over-the-counter healthcare products. The company is actively involved in research and development innovation including transformational late-stage, high-impact technologies.

“Kwangdong is very excited to have the opportunity to provide a new treatment option to Korean patients suffering from RP and the healthcare professionals treating them,” said SungWon Choi, CEO & Chairman of Kwangdong. “From the company’s perspective, this deal with Ocugen is especially meaningful as it allows us to further strengthen our ophthalmology portfolio, alongside our existing pipeline for presbyopia and pediatric myopia. Once the ongoing clinical trial of OCU400 is completed, Kwangdong will make every effort to bring the product to the Korean market as quickly as possible.”

Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. Biologics License Application (BLA) filing in 2026.

Kwangdong intends to utilize Ocugen’s clinical data and BLA filing as part of their regulatory submission for approval in Korea.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

About Kwangdong Pharmaceutical Co., Ltd
Kwangdong Pharmaceutical Co., Ltd is a South Korean human healthcare company founded in 1963. The company focuses on the development, manufacture, and sale of pharmaceutical products, as well as health drinks and functional foods. The company’s business is segmented into Pharmacy Sales, Hospital Sales, Distribution Sales, and Water Sales, each focusing on different aspects of the healthcare market. Kwangdong Pharmaceutical’s vision is to become a leading human healthcare brand company with a strong focus on innovation, research, and development. Kwangdong is consistently ranked as one of the top 10 pharmaceutical and healthcare companies in Korea by multiple metrics.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated benefits to Ocugen of the definitive license agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that the license agreement with Kwangdong will not lead to the current anticipated benefits to Ocugen, including projected sales royalties and milestones, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Greenwich LifeSciences, Inc. (GLSI) – Fast Track Designation Gives Benefits Now And In The Future

Posted on by slightbourne@noblecapitalmarkets.com


Monday, September 15, 2025

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

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

GLSI-100 Received Fast Track Designation. Greenwich LifeSciences announced that GLSI-100 has received Fast Track designation from the FDA. In the near term, this designation allows GLSI increased communications and more FDA meetings regarding regulatory requirements for its clinical trial data and use of biomarkers. Once the FLAMINGO-01 trial is completed, GLSI will be eligible to apply for Accelerated Approval and Priority Review, potentially shortening the time to market.

The Designation Mirrors The Trial Entry Criteria. GLSI-100 has received Fast Track Designation from the FDA for the treatment of “patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival…” This includes the clinical trial entry criteria and endpoints for the current double-blind arms of the trial.


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

Release – Cocrystal Pharma, Inc. Announces Up To $13 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

September 12, 2025

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$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants

BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced that it has entered into definitive agreements for the purchase and sale of 2,764,710 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.70 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 5,529,420 shares of common stock at an exercise price of $1.50 per share that will be exercisable upon issuance and will expire twenty-four months from the effective date of the registration statement covering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about September 15, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $4.7 million. The potential additional gross proceeds to the Company from the warrants, if fully-exercised on a cash basis, will be approximately $8.3 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The common stock (or common stock equivalents in lieu thereof, but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-271883) that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 26, 2023. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering 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 H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The unregistered warrants 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 such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered 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 any of the securities described herein, 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 Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Forward-Looking Statements

The information in this press release includes “forward-looking statements.” Any statements other than statements of historical fact contained herein, including statements as to the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.

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

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Source: Cocrystal Pharma, Inc.

Released September 12, 2025

Release – Cocrystal Pharma Showcases CDI-988, the First Oral Antiviral in Development for Norovirus Infection, in a Podium Presentation at the International Calicivirus Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

September 12, 2025

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BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9th International Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a potential first oral antiviral for the prevention and treatment of norovirus infection.

“It was an honor to share highlights of our CDI-988 Phase 1 data with global norovirus experts at the leading calicivirus scientific meeting,” said Dr. Lee. “The recent completion of Phase 1 study and U.S. Food and Drug Administration’s (FDA) Investigation New Drug (IND) clearance for the next study mark significant milestones for our clinical development of CDI-988.”

In “Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results,” Dr. Lee emphasized CDI-988’s favorable safety profile in human intestinal tissue, the primary site of norovirus infection, along with its high exposure in small intestine, suggesting a potential GI-targeted norovirus antiviral.

CDI-988 was rationally designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In vitro potency data and high-resolution crystal structures have shown broad-spectrum antiviral activity against multiple norovirus genogroups including GII.4 and GII.17, the strain responsible for the majority of circulating infections.

Dr. Lee also discussed previously reported Phase 1 results demonstrating CDI-988’s favorable safety and tolerability profile, with no serious adverse events. Earlier this week, Cocrystal announced FDA authorization to proceed with a Phase 1b human challenge study to evaluate CDI-988 as a potential norovirus prophylaxis and treatment. The study is expected to begin before year end.

The Calicivirus Conference is held every three years and unites scientists from across the globe who study calicivirus virology, evolution, pathogenesis, structural biology, diagnosis, epidemiology, treatment and prevention. The conference aims to foster open discussions, spark new collaborations and explore groundbreaking research. Delegates at this year’s conference engaged with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.

Protease Inhibitor CDI-988
CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. It targets a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases.

Norovirus Infection
Norovirus, the leading cause of viral gastroenteritis worldwide, spreads rapidly in community settings such as hospitals, nursing homes, childcare facilities, schools and cruise ships. It causes nausea, vomiting, diarrhea, abdominal pain and dehydration, and is responsible for an estimated $60 billion worldwide in direct healthcare costs and lost productivity.

Cocrystal Structure-Based Platform Technology
CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CDI-988 as a potential antiviral for the prevention and treatment of norovirus infection, and the Company’s plan to initiate a Phase 1b study in 2025. 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, the risks and uncertainties arising from the ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials and our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

# # #

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Source: Cocrystal Pharma, Inc.

Released September 12, 2025

Release – MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

September 11, 2025 9:27am EDT

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CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care therapy regimens.

As of June 30, 2025,

  • Estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months. The comparable PFS threshold in standard of care treatments is 2.5 months1.
  • Estimated median overall survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months, consistent with the prior data readout (May 15, 2025).
  • Across patients of all treatment lines, 2 patients have completed 33 cycles of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer patient survival.

“THIO-101 continues to reveal impressive efficacy with observed progression free survival of 5.6 months, which is more than double the standard of care PFS of just 2.5 months. The data also demonstrates the durability of ateganosine treatment through extended treatment cycles, which is in line with consistent tolerability and low toxicity,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are seeking further validation of ateganosine’s strong efficacy in our THIO-101 Phase 2 expansion trial, which began enrolling patients in July 2025.”

Details of THIO-101, including efficacy data and safety findings, are included in MAIA’s poster for the 2025 IASLC World Conference on Lung Cancer (WCLC), available at maiabiotech.com/publications.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

1 Shepherd F, et al. N Engl J Med 2005;353:123-132, Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

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Source: MAIA Biotechnology, Inc.

Released September 11, 2025