Tag: Biotechnology

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

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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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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

Release – Nutriband Inc. Quarterly Report Highlights Record Revenue for Q2, 2025 up 50.87% YOY and Strategic Progress Toward NDA Filing for AVERSA Fentanyl

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NTRB

September 10, 2025 09:15 ET | Source: Nutriband Inc.

    ORLANDO, Fla., Sept. 10, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) reported its financial results for the six months ended July 31, 2025. The company reported a strong cash position at quarter end, reinforcing its ability to advance the development of its lead product, AVERSA™ Fentanyl which has been granted a Type C meeting on September 18th.

    Nutriband is continuing to expand its kinesiology tape contract manufacturing services through its Pocono Pharma subsidiary. The company produced a record six months, reporting revenue of $1,289,884, up 50.87% YOY.

    Progress continues on the development of AVERSA Fentanyl, Nutriband is reminding exiting shareholders and updating new shareholders on its development pathway, emphasizing that the NDA will primarily rely on data from a single phase 1 Human Abuse Potential study. Importantly, no Phase 2 or Phase 3 clinical trials will be required before submission.

    If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch available globally. AVERSA Fentanyl is estimated to have the potential to reach peak annual sales of $80-$200 million, according to a market analysis report from Health Advances.

    AVERSA Buprenorphine, which is the company’s second application for AVERSA, is projected to reach peak annual sales of up to $130 million.

    As of July 31, 2025, Nutriband’s cash reserves stand at $6.9 million, supporting the company’s ongoing development and commercialization efforts for AVERSA Fentanyl. The company’s total assets are valued at $10.17 million, with stockholders’ equity amounting to $8.5 million.

    About Nutriband Inc.

    We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

    The Company’s website is www.nutriband.com. Any material contained in or derived from Company’s websites or any other website if not part of this press release.

    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, Form 10-K for the year ended January, 2025, filed April 28, 2025, the Forms 10-Q’s filed subsequent to the Form 10-K in 2025, 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.

    For more information, contact:

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

    Release – Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on COCP

    September 08, 2025

     Download as PDF

    • There are currently no approved vaccines or treatments for norovirus infection
    • Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
    • Phase 1b study is expected to start by year-end 2025

    BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the Company received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b challenge study evaluating CDI-988 for the prevention and treatment of norovirus infections. Cocrystal’s oral broad-spectrum antiviral candidate CDI-988 represents a potential breakthrough for norovirus – the most common cause of acute viral gastroenteritis. The Phase 1b challenge study is planned to begin before year-end 2025.

    CDI-988 is a novel pan-viral 3CL protease inhibitor developed for the treatment of norovirus and coronavirus infections. Preclinical data demonstrate that CDI-988 exhibits broad-spectrum antiviral activity by targeting a highly conserved region in the active site of the viral proteases. CDI-988 has shown effectiveness against major norovirus proteases including the prevalent GII.4 and GII.17. Data from the Phase 1 study showed oral CDI-988 to be well tolerated with a favorable safety profile. Currently, there are no approved vaccines or therapeutics for norovirus infections.

    “The FDA’s clearance of our CDI-988 study is an important milestone for Cocrystal and marks a significant step in advancing to the next stage of its clinical development. CDI-988 is the first novel, oral drug candidate for the prevention and treatment for norovirus infection and has demonstrated impressive data to date with broad antiviral activity,” said Sam Lee, PhD, President and co-CEO of Cocrystal Pharma. “We look forward to the planned initiation of our Phase 1b challenge study and further determining the potential efficacy of CDI-988 in norovirus-infected patients.”

    About Norovirus
    Norovirus infections affect millions globally, spreading rapidly through direct contact and contaminated food and surfaces. The virus is particularly problematic in confined environments such as cruise ships, hospitals, and military facilities. In the U.S., norovirus causes an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. Vulnerable populations, including infants, elderly and those immuno-compromised, can face more severe and prolonged infections. Individuals can remain contagious for weeks after symptoms are resolved, complicating containment efforts.

    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 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 our plans to initiate a human Phase 1b challenge study for our norovirus product candidate. 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 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, geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., economy, 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 study, and our ability to meet our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

    # # #

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    Source: Cocrystal Pharma, Inc.

    Released September 8, 2025

    Release – MAIA Biotechnology Abstract Selected for Poster Presentation at 2025 IASLC World Conference on Lung Cancer

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MAIA

    September 05, 2025 9:03am EDT

    Download as PDF

    Poster details durability and efficacy of ateganosine (THIO) treatment in non-small cell lung cancer (NSCLC)

    CHICAGO, Sept. 05, 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 announced that an abstract titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” was selected for poster presentation at the 2025 IASLC World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025, in Barcelona, Spain.

    “We are proud to accept IASLC’s invitation to present our exceptional ateganosine (THIO) data at its prestigious World Conference on Lung Cancer. Our participation gives us the opportunity to meet with elite scientists, researchers, and global industry leaders about our shared purpose in driving innovation in lung cancer treatments,” said MAIA Chairman and CEO Vlad Vitoc, M.D.

    “Ateganosine is demonstrating substantial efficacy in our ongoing THIO-101 trial, with a median overall survival (OS) of 17.8 months with a 95% confidence interval (CI) lower bound of 12.5 months. We believe our novel anticancer agent could become a breakthrough treatment for those suffering from late-stage non-small cell lung cancer,” said MAIA’s Senior Medical Director Victor Zaporojan, M.D. “We look forward to further discussing our observed progression free survival (PFS) at this year’s World Conference on Lung Cancer.”

    Conference details:

    • MAIA representatives: Victor Zaporojan, M.D., Sr. Medical Director; Tomasz Jankowski, M.D., THIO-101 lead investigator and abstract presenting author
    • Poster session: P1.11 – Metastatic Non-small Cell Lung Cancer – Immunotherapy
    • Session time: Sunday, September 7, 2025, from 10:30 a.m. to 12:00 p.m.
    • Poster available at maiabiotech.com/publications on the day of the presentation

    The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). MAIA intends to utilize the incentives of the Fast Track Program to expedite the regulatory process for ateganosine. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).

    About IASLC

    The IASLC is a global multidisciplinary organization dedicated to eradication of all forms of lung cancer. From provision of educational events around the world and virtually to research projects and publications that advance the science of lung cancer, the IASLC’s members are raising the bar for care of patients with lung cancer.

    IASLC’s annual World Conference on Lung Cancer has played an integral part in facilitating progress by providing a platform for sharing cutting-edge research, collaboration, and networking among industry leaders, experts, and visionaries from around the world.

    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 5, 2025

    Release – MAIA Biotechnology Announces Publication of Interim Clinical Data on Telomere Targeting Anticancer Agent in Peer-Reviewed Journal Cells

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MAIA

    August 27, 2025 9:01am EDT Download as PDF

    CHICAGO, Aug. 27, 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 announced that a manuscript detailing developments in its Phase 2 THIO-101 clinical trial was accepted and published in the international peer-reviewed open access scientific journal, Cells, in a special issue, “Cellular Mechanisms of Anti-Cancer Therapies”

    The manuscript, titled “Perioperative Management of Non-Small Cell Lung Cancer in the Era of Immunotherapy,” was authored by a group of oncology researchers in Turkey and the U.S. including MAIA scientists Sergei Gryaznov, Ph.D., Chief Scientific Officer and Ilgen Mender, Director of Biology Research, along with MAIA Scientific Advisory Board members Z. Gunnur Dikmen, M.D., Ph.D. and Saadettin Kiliçkap, M.D., M.Sc.

    MAIA Chairman and CEO Vlad Vitoc, M.D. commented, “The importance of the findings published in Cells cannot be overstated. While conventional immunotherapies have expanded treatment options for patients, intrinsic and acquired resistance by patients remains a challenge. Our novel combination strategy of ateganosine sequenced with a checkpoint inhibitor stands out, showing encouraging results in a population with high unmet medical need.”

    About Cells
    Cells (ISSN 2073-4409) is an international, peer-reviewed, open access journal which provides an advanced forum for studies related to cell biology, molecular biology and biophysics. It publishes reviews, research articles, communications and technical notes. Cells is an MDPI (Multidisciplinary Digital Publishing Institute) publication.

    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 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

    Primary Logo

    Source: MAIA Biotechnology, Inc.

    Released August 27, 2025

    Release – GeoVax Announces Allowance of Patent Protecting Multi-Antigen COVID-19 Vaccine Constructs

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on GOVX

      Expands Intellectual Property Portfolio Supporting Next-Generation COVID-19 Vaccine Candidates

      ATLANTA, GA, August 20, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 17/888,131, titled “Vaccines and Uses Thereof to Induce an Immune Response to SARS-CoV-2.”

      The allowed claims broadly cover recombinant Modified Vaccinia Ankara (MVA) viral vectors encoding multiple SARS-CoV-2 proteins – including Spike (S), Membrane (M), and Envelope (E) antigens – configured to generate virus-like particles (VLPs) upon expression. These constructs are designed to induce both antibody and T-cell responses, providing durable and broad immune protection against current and emerging variants of SARS-CoV-2.

      Key features of the allowed claims include:

      • Multi-antigen design (Spike, Membrane, and Envelope proteins) to mimic the natural virus structure and induce robust immune responses.
      • VLP formation within host cells, enabling presentation of antigens in their natural conformation for optimal immune recognition.
      • Coverage of both ancestral strain sequences and variant-associated mutations (e.g., K417N/T, E484K, N501Y) to address immune escape.

      David Dodd, GeoVax President and CEO, commented: “This Notice of Allowance represents an important strengthening of our intellectual property estate protecting our next-generation, multi-antigen COVID-19 vaccines. Unlike single-antigen vaccines, our MVA-based multi-antigen constructs are designed to elicit durable, broad-spectrum protection – even as the virus continues to evolve.”

      About GeoVax’s Multi-Antigen COVID-19 Vaccine Portfolio

      GeoVax is pioneering a differentiated, multi-antigen approach to COVID-19 vaccination. The newly allowed patent broadly covers constructs central to the Company’s CM01 and CM02 candidates, which express multiple SARS-CoV-2 proteins to generate virus-like particles (VLPs) in vaccinated individuals. These vaccine designs are intended to provide broad and durable protection by engaging both arms of the immune system and countering immune escape by new viral variants.

      Together with GEO-CM04S1, which is advancing through Phase 2 clinical trials in immunocompromised and healthy populations, CM01 and CM02 give GeoVax what CEO David Dodd describes as “the corner on the multi-antigen space.” This combined portfolio underscores GeoVax’s position as a leader in next-generation COVID-19 vaccine innovation, uniquely differentiated from single-antigen approaches such as 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 – Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease

      Posted on by aweinsoff@channelchek.com

      Research News and Market Data on UNCY

      August 18, 2025 7:05am EDT Download as PDF

      Ensures Intellectual Property Protection Until 2040

      LOS ALTOS, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the treatment of Acute Kidney Injury with UNI-494.

      “While we are focused on seeking FDA approval of our lead product oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This patent is part of a broader intellectual property portfolio for UNI-494, which supports potential partnership opportunities and future development efforts. We have completed a Phase I clinical study in healthy volunteers and have received Orphan Drug Designation for the prevention of delayed graft function (DGF) in patients undergoing kidney transplantation.”

      About UNI-494
      UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

      About Acute Kidney Injury
      Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

      About Unicycive Therapeutics
      Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

      Forward-looking statements
      Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

      Investor Contacts:

      Kevin Gardner
      LifeSci Advisors
      kgardner@lifesciadvisors.com

      Media Contact:

      Rachel Visi
      Real Chemistry
      redery@realchemistry.com

      SOURCE: Unicycive Therapeutics, Inc.