Tag: Biotechnology

678-384-7220

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Release – GeoVax Highlights EMA Regulatory Milestone as Catalyst for Near-Term Revenue from GEO-MVA Mpox Vaccine

Posted on July 21, 2025July 21, 2025 by aweinsoff@channelchek.com

Positive EMA Scientific Advice Positions GeoVax for Expedited European Approval

ATLANTA, GA – July 21, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today reinforced the strategic and commercial significance of the recent positive Scientific Advice (SA) received from the European Medicines Agency (EMA) for its GEO-MVA vaccine targeting Mpox and smallpox.

The EMA’s feedback indicated that a single Phase 3 immuno-bridging trial—bypassing the need for Phase 1 and 2 studies—may be sufficient to support a Marketing Authorization Application (MAA) under the EU’s centralized procedure. The ability to proceed without Phase 1 and 2 clinical trials substantially reduces development risk and timelines, positioning GeoVax to achieve product commercialization and revenue generation significantly earlier than previously anticipated.

Immuno-bridging studies allow for vaccine approval by the immune response elicited by a candidate vaccine comparable to that of an already approved vaccine. This approach, when accepted by regulatory authorities, can reduce the need for large-scale efficacy trials, thereby reducing development time while maintaining regulatory standards for safety and immunogenicity.

“This EMA guidance is more than a regulatory milestone—it represents a potential commercial inflection point,” said David Dodd, Chairman and CEO of GeoVax. “We now have a clear, expedited path to commercialization in one of the world’s largest vaccine markets. With the Phase 3 trial in operational preparation, we are entering a potential revenue acceleration phase supported by growing global demand, regulatory momentum, and our progressing advanced MVA manufacturing platform.”

Key Investor Highlights:

Expedited Approval Path: EMA confirmed that one Phase 3 immuno-bridging trial—if successful—meets criteria for market authorization in all 27 EU countries.
De-Risked Development: Moving directly to a Phase 3 immuno-bridging trial significantly reduces development timelines, cost, and clinical execution risk.
Market Timing Advantage: EMA guidance coincides with the WHO’s fourth Mpox PHEIC declaration and Clade I outbreaks across multiple continents.
First-Mover Opportunity: GEO-MVA would be the only MVA-based Mpox vaccine alternative to Bavarian Nordic’s Imvanex/Imvamune, addressing global supply constraints and monopolistic risk.
Revenue Visibility: GeoVax expects to initiate its Phase 3 trial in 2H 2026.
Manufacturing Readiness: Current CEF-based production supports near-term supply; transition to AGE1 cell line to enable scalable, cost-efficient output for global procurement.

GeoVax is actively engaging with European regulatory bodies, public health stakeholders, and procurement agencies to advance GEO-MVA access and funding partnerships in support of both public health and commercial goals.

“From an investor perspective, this EMA development potentially shortens our path to revenue generation and significantly enhances our strategic value,” said Dodd. “GeoVax is now on the radar as a viable near-term commercial vaccine company, not just a development-stage biotech.”

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 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:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman

Research News and Market Data on OCGN

Release – Ocugen, Inc. Announces New Appointments to Retina Scientific Advisory Board & Executive Leadership Team

Posted on July 21, 2025July 21, 2025 by aweinsoff@channelchek.com

July 21, 2025

Research News and Market Data on OCGN

MALVERN, Pa., July 21, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced updates to its Retina Scientific Advisory Board (SAB) and Executive Leadership Team to enhance external guidance from key opinion leaders and strengthen the Company’s internal expertise in critical functions and as it pursues its goal of three BLAs in the next three years.

“As our novel modifier gene therapy programs continue to progress and demonstrate positive data in the clinic, it is now more important than ever to solidify an optimized Retina SAB reflecting the absolute best guidance in this space as we move closer to commercialization,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Additionally, it’s imperative that we ensure our leadership team includes top talent to most effectively execute our corporate strategy.”

Three renowned retinal surgeons who are at the forefront of research and cutting-edge advancements for retinal disease are joining the Retina SAB to help the Company bring meaningful, innovative therapeutic options for patients living with serious retina diseases.

New SAB members include:

Jeffrey S. Heier, MD, Director of the Vitreoretinal Service, and Director of Retina Research at Ophthalmic Consultants of Boston. Dr. Heier is one of the leading retinal clinical researchers in the country for new treatments in exudative and non-exudative macular degeneration, diabetic macular edema, venous occlusive disease, vitreoretinal surgical techniques and instrumentation, and diagnostic imaging of the retina. Dr. Heier has contributed extensively to the ophthalmic literature, having authored or co-authored many of the landmark publications in the retinal literature, including the New England Journal of Medicine, Lancet, and numerous other journals.

Peter K Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research, Cole Eye Institute, Cleveland Clinic and Professor of Ophthalmology Case Western Reserve School of Medicine. Dr. Kaiser is the director of the Center for Ocular Research and Evaluation (CORE) and is a major contributor to medical literature having authored seven textbooks, 30 book chapters, and more than 400 peer-reviewed manuscripts. He is Associate Editor of International Ophthalmology Clinics and serves on the editorial boards of American Journal of Ophthalmology, Retina, Retina Today, and Ocular Surgery News.

Arshad M. Khanani, MD, MA, FASRS, Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno School of Medicine. In 2021, Dr. Khanani founded the Clinical Trials at the Summit meeting to foster discussion on clinical trial design and data. Dr. Khanani has been recognized among the top 10 researchers globally on The Ophthalmologist Power List 2025 and has received numerous prestigious awards, including the Macula Society’s Lawrence J. Singerman Medal in 2025 and the American Society of Retina Specialists Presidential Award.

Drs. Heier, Kaiser, and Khanani join SAB chair, Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics, and Biomedical Engineering with Tenure at Duke University Eye Center; and existing SAB members David S. Boyer, MD, Senior Partner at Retina-Vitreous Associates Medical Group and Adjunct Clinical Professor of Ophthalmology at the University of Southern California/Keck School of Medicine, and Carl D. Regillo, MD, FACS, Professor of Ophthalmology at the Sidney Kimmel Medical College at Thomas Jefferson University, Chief of the Retina Service at Wills Eye Hospital, and founder and former director of the Wills Eye Clinical Retina Research Unit.

To optimize Ocugen’s R&D and clinical efforts and build upon positive momentum pursuing strategic partnerships and developing commercial strategy, the Company has made notable leadership appointments.

Vijay Tammara, PhD, has joined Ocugen in the newly created position of Chief Development Officer and brings over 32 years of global regulatory leadership with deep expertise in biotechnology, biosimilars, 505(b)(2), and complex regulatory submissions. Dr. Tammara has made significant contributions to the approval of nine Marketing Authorizations (MAs)—Biologics License Applications and New Drug Applications (NDAs), two biosimilar MAs in emerging markets, three Abbreviated New Drug Applications, 12 Orphan Drug Designations, seven Qualified Infectious Drug Product Designations, and filed over 62 investigational NDAs with clearance in the first review cycle with no clinical holds. He has successfully led regulatory strategy and operations across the U.S., EU, Latin America, and Asia—including Japan, China, and South Korea. Prior to joining Ocugen, he held senior advisory and leadership roles at the FDA and life sciences companies including Sanofi, Wyeth/Pfizer, and Merck, in addition to leading his own consulting firm.

Abhi Gupta, MBA, has been named Executive Vice President, Commercial and Business Development, following the retirement of Mike Shine. Abhi has more than 20 years of experience across commercial strategy, gene therapy, and corporate development in the biopharmaceutical industry. He has led commercialization planning for transformative rAAV gene therapies and played a pivotal role in building Pfizer’s $5.5B gene therapy portfolio across neuromuscular, hematologic, and cardiovascular indications. Before joining Ocugen, Mr. Gupta served as SVP and Head of Cell and Gene Therapies at Syneos Health and previously held leadership roles at Pfizer, Regeneron, and Johnson & Johnson, with a track record of successful product launches, strategic partnerships, and business development initiatives.

Ocugen is honored to partner with this distinguished group of advisors and delighted to welcome Dr. Tammara and Mr. Gupta as the Company sharpens its patient-centric focus to potentially deliver paradigm-changing gene therapies.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

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, 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. 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

Release – Ocugen, Inc. Announces First Patient Dosed in Phase 2/3 GARDian3 Pivotal Confirmatory Trial for OCU410ST—Novel Modifier Gene Therapy Candidate for Stargardt Disease

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

July 18, 2025

Research News and Market Data on ELDN

MALVERN, Pa., July 18, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies).

“Dosing the first patient is an especially significant milestone and brings us closer to our goal of addressing the unmet medical need that exists for all Stargardt patients—100,000 in the U.S. and Europe and 1 million worldwide,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Progressing our second modifier gene therapy candidate into a registration clinical trial is a pivotal step in potentially providing a one-time therapy for life for the millions of patients affected by inherited retinal diseases.”

The Phase 2/3 clinical trial for OCU410ST builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow up in evaluable treated eyes compared to untreated eyes. Additionally, evaluable treated eyes showed a statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line gain in best corrected visual acuity (BCVA) at 12-month follow-up when compared to untreated eyes.

“Initiating dosing in this pivotal Phase 2/3 study is an important advancement for Ocugen and more importantly for the Stargardt community,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “The adaptive design of this trial, including a masked interim analysis at 8 months on 24 subjects, enables us to efficiently evaluate early signals of efficacy and safety while optimizing study conduct. This ensures we generate robust and meaningful data to support our regulatory submissions for approvals.”

“Treating the first patient with this novel gene therapy in the GARDian3 trial is a proud and hopeful moment for our team and for families affected by Stargardt disease,” said Victor H. Gonzalez, MD, Principal Investigator and retinal surgeon at Valley Retina Institute, McAllen, Texas. “For decades, patients have faced the progressive loss of central vision with no approved treatment options. The encouraging Phase 1 results give us confidence that OCU410ST could meaningfully slow disease progression and help preserve vision. This trial brings us closer to the possibility of a one-time gene therapy that could transform patients’ quality of life for years to come.”

OCU410ST maintains a favorable safety and tolerability profile with no serious adverse events or adverse events of special interest, including ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization.

The Phase 2/3 study will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in BCVA and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the company’s planned Biologics License Application (BLA).

The OCU410ST Phase 2/3 pivotal confirmatory trial represents Ocugen’s second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its strategic goal of filing three BLAs over the next three years.

About OCU410ST
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

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.

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 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 preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical 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

Release – Updated Data from Eledon Pharmaceuticals’ Ongoing Phase 1b Trial of Tegoprubart in Patients Undergoing Kidney Transplantation to be Presented at the World Transplant Congress 2025

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

July 17, 2025

Research News and Market Data on OCGN

IRVINE, Calif., July 17, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that updated clinical data from its ongoing open-label Phase 1b study evaluating tegoprubart for the prevention of rejection in subjects undergoing kidney transplantation will be presented at the World Transplant Congress (WTC) taking place in San Francisco from August 2-6, 2025. The oral presentation will feature updated results from approximately 30 kidney transplant recipients and will be presented by Dr. John Gill from the University of British Columbia.

Details of the oral presentation are as follows:

Title: Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study
Session: Oral Presentation, Kidney Novel Immunosuppressant Strategies
Presenter: John Gill, MD, MS, University of British Columbia, Vancouver, Canada
Session Date and Time: Wednesday, August 6, 2025: 10:00 a.m. – 11:15 a.m. PT

Following the session, a copy of the presentation can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

The Company will also sponsor a satellite symposium at WTC titled: “What Truly Defines Kidney Transplant Success: Early Rejection or Lasting Function?”, to be held on Sunday, August 3, at 1:00 pm PT. Faculty include Allan Kirk, MD, Duke University School of Medicine, Oriol Bestard, MD, PhD, MD, Vall d’Hebron University Hospital, John Gill, MD, MS, University of British Columbia, Alexandre Loupy, MD, PhD, Necker Hospital and Deirdre Sawinski, MD, Weill Cornell Medical College.

In addition to the oral presentation, new preclinical data, utilizing tegoprubart for the prevention of rejection in non-human primates undergoing liver transplantation, will be presented by Dr. Andrew Adams in a poster session:

Title: Anti-CD154 Facilitates Long-Term Liver Allograft Survival in Non-Human Primates
Session: Poster Presentation
Presenter: Andrew Adams, MD, PhD, University of Minnesota
Date and Time: Sunday, August 3, 2025, 3:30 p.m. PT

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

Release – Ocugen to Host Conference Call on Friday, August 1 at 8:30 A.M. ET to Discuss Business Updates and Second Quarter 2025 Financial Results

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

July 17, 2025

Research News and Market Data on MAIA

MALVERN, Pa., July 17, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2025 financial results and provide a business update at 8:30 a.m. ET on Friday, August 1, 2025.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 9627149
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

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 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 preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical 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

Release – MAIA Biotechnology Announces Peer-Reviewed Journal Publication of Data Validating Second Generation Ateganosine Prodrugs for Anticancer Therapy

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

July 17, 2025 9:17am EDT Download as PDF

Manuscript featured in leading open-access peer-reviewed scientific journal Nucleic Acids Research

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic Acids Research (NAR), a leading open-access peer-reviewed scientific journal.The study, titled “Novel Telomere-Targeting Dual-Pharmacophore Dinucleotide Prodrugs for Anticancer Therapy,” details MAIA’s lead ateganosine (THIO)-derived second-generation prodrugs as promising new molecules in its strategy for enhancing cancer treatment and overcoming drug resistance. The manuscript with the data was published on June 26, 2025, in Volume 53, Issue 12 of the NAR journal.

In January 2023, MAIA nominated one lead new molecular entity candidate (designated as MAIA-2021-20) and one back-up new molecular entity candidate (MAIA-2022-12) for further advancement into preclinical GLP-toxicity and other studies. More than 80 ateganosine-like compounds have been developed as part of MAIA’s second-generation telomere targeting program.

In the featured study, MAIA designed and synthesized divalent dinucleotide prodrugs comprised of two nucleosides. The lead THIO-containing compounds, with two THIO pharmacophores, demonstrated the strongest anticancer efficacy in vivo and induced the strongest host immune-memory responses in vivo.

“The reported study data has shown that the sequential combination of MAIA-2022-12 or MAIA-2021-20 with an immune checkpoint inhibitor demonstrated a significantly lower 50% inhibitory concentration with superior anticancer efficacy compared with the corresponding monotherapies. The results suggest that MAIA-2022-12 and MAIA-2021-20 are promising candidates for future preclinical and clinical studies,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are working now to advance at least one of the candidates into human clinical trials upon completion of required GLP-toxicity and other evaluations.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250717795359/en/

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

Source: MAIA Biotechnology, Inc.

Released July 17, 2025

Release – GeoVax Highlights Growing Urgency for Diversified Mpox Vaccine Supply as Global Outbreaks Expand

Posted on July 16, 2025July 16, 2025 by aweinsoff@channelchek.com

European Medicines Agency Supports Streamlined Development Pathway for GEO-MVA Vaccine Candidate via a Single Phase 3 Immuno-bridging Trial

ATLANTA, GA – July 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement underscoring the increasing urgency of expanding global Mpox vaccine access, as recent data from the Airfinity July 2025 Mpox Report highlight significant new outbreaks and rising global transmission of Clade I and Clade II Mpox.

The company previously announced favorable Scientific Advice from the European Medicines Agency (EMA) supporting the company’s proposed expedited development pathway for GEO-MVA. EMA confirmed that a single Phase 3 immuno-bridging trial, combined with proposed preclinical data, would be sufficient to support a Marketing Authorisation Application (MAA) via the centralized procedure. Immuno-bridging studies allow for vaccine approval by demonstrating comparable immune responses—rather than requiring traditional large-scale efficacy trials—thereby reducing development time while maintaining regulatory rigor. GeoVax is now accelerating engagement with global and regional health authorities as Mpox re-emerges with more virulent and transmissible strains in vulnerable populations.

“The global Mpox situation is expanding in both scope and severity, especially with the silent spread of Clade I in China, Europe, and the United States,” said David Dodd, Chairman and CEO of GeoVax. “The increasing number of breakthrough infections, pregnancy-related complications, and international importation threats make the need for second-source MVA-based vaccines not only strategic—but urgent. We are encouraged by EMA’s endorsement of a streamlined regulatory approach, which enables us to accelerate clinical development and scale-up planning for GEO-MVA.”

Global Spread of Clade I Mpox Highlights Need for Vaccine Diversification

The Airfinity report shows:

Clade I Mpox cases now span all continents, with new detections confirmed in China, United Kingdom, Italy and the U.S., including wastewater tracing.
Local Clade I transmission in China raises concern of sustained spread in one of the world’s most populous regions.
Travel-linked cases from Ethiopia and the Democratic Republic of the Congo (DRC) indicate high exportation risk to G7 countries, including the U.S. and France.
New data from the DRC confirmed vertical transmission of Mpox—meaning the virus was passed from mother to child during pregnancy—prompting renewed calls for next-generation vaccines with broader safety data and global availability.

GEO-MVA Positioned as Scalable, Strategic Alternative

GeoVax’s GEO-MVA vaccine candidate is being positioned as a second source MVA-based vaccine to address emerging global needs with:

EMA Scientific Advice concurrence on the company’s proposed expedited development pathway offering a near-term alternative MVA supply option.
Planned transition to a modernized AGE1 continuous cell-line-based manufacturing system, offering the potential for scalable, lower-cost, and U.S.-based production.

“As the global MVA vaccine stockpile is stretched and a single supplier model becomes increasingly untenable, GEO-MVA offers both immediate and long-term solutions to expand access, improve durability, and restore resilience to the world’s Mpox vaccine infrastructure,” added Dodd.

GeoVax is actively engaging with global stakeholders, including the World Health Organization (WHO), Africa CDC, and Gavi, as well as the U.S. Administration for Strategic Preparedness and Response (ASPR) to explore advance purchase agreements, regional partnerships, and manufacturing alliances to enable rapid deployment of GEO-MVA in current and emerging hotspots.

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 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

Company Contact:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman

Research News and Market Data on COCP

Release – Cocrystal Pharma to Present Data from Phase 1 Study of First-in-Class Norovirus Protease Inhibitor CDI-988 at the 9th International Calicivirus Conference

Posted on July 10, 2025July 10, 2025 by aweinsoff@channelchek.com

July 10, 2025

Download as PDF

BOTHELL, Wash., July 10, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that its first-in-class pan-viral protease inhibitor CDI-988 has been selected for an oral presentation at the 9^th International Calicivirus Conference being held September 7-11, 2025 in Banff, Alberta, Canada. Sam Lee, PhD, the Company’s President and co-CEO, will present “Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results” on September 11.

“This year’s Calicivirus Conference will bring together the world’s leading norovirus experts, making it the ideal venue to share our pan-viral protease inhibitor CDI-988 Phase 1 data and clinical development strategy,” said Dr. Lee. “Norovirus causes a highly contagious gastrointestinal illness, triggering severe vomiting and diarrhea, and has a substantial economic impact with a societal cost of approximately $60 billion each year globally according to the CDC. There is no approved vaccine or antiviral therapeutics for norovirus infection. We are encouraged by our molecule’s novel pan-viral activity against all noroviruses including GII.4 and GII.17 strains.”

Pan-Viral 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. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a compelling first-in-class oral treatment for noroviruses, which are members of the calicivirus family, and for coronaviruses. Cocrystal has completed a single-center, randomized, double-blind, placebo-controlled Phase 1 study in healthy adults evaluating the safety, tolerability and pharmacokinetics of CDI-988, including a food effect cohort.

Structure-Based Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide structure activity relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action or shortened treatment time, are safe, well tolerated and easy to administer, and are effective against all viral subtypes that cause disease and have a high barrier to viral resistance.

About the Calicivirus Conference
The International 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 have the opportunity to engage with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies 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 for the Company’s CDI-988 product candidate as a treatment for norovirus. 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, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies, our and our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed without development programs. 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

# # #

Source: Cocrystal Pharma, Inc.

Release – MAIA Biotechnology Announces First Patient Dosed in Expansion of Phase 2 Trial for Ateganosine in Advanced Non-Small Cell Lung Cancer

Posted on July 9, 2025July 9, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

July 09, 2025 9:15am EDTDownload as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced dosing of the first patient in Taiwan in the expansion phase of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly larger patient pool for its evaluations of ateganosine (THIO). Screening for the trial is ongoing in Europe and Asia.

Trial Design: The expansion study evaluates ateganosine in heavily pre-treated patients in third-line (3L) NSCLC who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy. Two treatment arms are being studied: ateganosine sequenced with cemiplimab (Libtayo®) and ateganosine monotherapy. Regeneron is supplying Libtayo for the combination cohort.

Strategic Opportunity: NSCLC represents one of the largest global oncology indications. The market was valued at $34.1B in 2024, and is projected to reach $68.8B by 2033 with a projected CAGR of 8.1%.¹

Current Data: As of May 15, 2025, the median overall survival (OS) for the 22 patients in the third-line treatment 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. The treatment has been generally well-tolerated in the trial’s heavily pre-treated population.²

Other studies of chemotherapy for NSCLC in a similar setting have shown overall survival of 5-6 months.³

“We are excited to have the expansion of the trial officially started. Ateganosine’s observed OS in third-line NSCLC exceeds all known benchmarks,” said MAIA’s Chief Executive Officer Vlad Vitoc, M.D. “This potentially positions us for first-mover advantage in a multibillion-dollar space with no currently approved standard of care.”

About Ateganosine

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

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess 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 been generally well-tolerated 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 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.

¹ Custom Market Insights, Global NSCLC Drug Market Size Likely to Surpass at a CAGR of 8.1% By 2033, Apr. 2024
² Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website.
3 Girard N, et al. J Thorac Onc 2009;12:1544-1549.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250709705403/en/

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

Source: MAIA Biotechnology, Inc.

Released July 9, 2025

Release – Unicycive Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

Posted on July 8, 2025July 8, 2025 by aweinsoff@channelchek.com

Research News and Market Data on UNCY

July 08, 2025 8:30am EDT Download as PDF

–Nasdaq compliance follows reverse stock split previously announced on June 17, 2025

LOS ALTOS, Calif., July 08, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced it has regained compliance with the Nasdaq Stock Market (“Nasdaq”) continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq Listing Qualifications. This update was disclosed in the Company’s Current Report on Form 8-K filed on July 8, 2025.

On July 7, 2025, the Company received confirmation from the Listing Qualifications Department of Nasdaq that as of July 3, 2025 the Company’s common stock has maintained an average closing share price of at least $1.00 immediately following the Company’s 1:10 reverse stock split that became effective on June 20, 2025 The Company’s shares are no longer considered to be below the minimum bid price requirement of Rule 5550(a)(2), and as a result the Company has regained compliance with the Nasdaq continued listing standard. Nasdaq now considers this matter closed.

About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, 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 Contact:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:
Rachel Visi
Real Chemistry
redery@realchemistry.com

Source: Unicycive Therapeutics, Inc.

Released July 8, 2025

Release – GeoVax Responds to Growing Mpox Threat with Expedited EU Pathway and Platform Aligned to U.S. Biodefense Objectives

Posted on July 2, 2025July 2, 2025 by aweinsoff@channelchek.com

Last updated: 02 July 2025
Created: 02 July 2025

With global cases rising and bipartisan momentum for pandemic preparedness, GeoVax’s GEO-MVA vaccine advances on an expedited development track toward commercialization and revenue generation

ATLANTA, GA — July 2, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and cancer, today emphasized the growing global public health importance of its GEO-MVA Mpox/smallpox vaccine in response to rising public health threats and a rapidly evolving regulatory environment.

With favorable regulatory input from the European Medicines Agency (EMA), GEO-MVA is on an expedited path toward market access—accelerating GeoVax’s focus toward regulatory approval and commercialization.

“GeoVax is entering a value inflection phase,” said David Dodd, Chairman and CEO. “The EMA’s expedited development path brings us closer to regulatory registration and commercial readiness, providing the opportunity to address urgent public health needs, expanding the critically needed supply option of MVA-vaccine, addressing both expanding outbreak needs and stockpile opportunities.”

Modern Platform for Variant-Responsive Stockpiling

GeoVax’s development-stage continuous avian cell line process is anticipated to provide increased production of MVA-based vaccines, the ability to quickly respond to epidemics and pandemics, local implementation of MVA-based vaccine manufacturing and overall reduced production costs.

With confirmed Mpox cases across multiple U.S. states, throughout Europe and new clade Ib outbreaks in West and Central Africa, the urgency for additional MVA-vaccine supply options is increasingly, critically important.

“There is a clear need for diversity in stockpile planning,” Dodd added. “GEO-MVA is well-positioned to serve as a complementary or alternative solution where current, single-source options fall short. Ending the current monopoly of MVA-vaccine will benefit public health worldwide, providing an expanded supply option of this critically needed vaccine.”

EMA Scientific Advice and BARDA RRPV Proposal Expedite Readiness

GeoVax recently received favorable Scientific Advice from the EMA, confirming an expedited regulatory development path for GEO-MVA. This milestone enhances the product’s standing with international regulatory bodies and opens pathways to revenue-generating opportunities across Europe and beyond.

In parallel, GeoVax’s advanced MVA-based vaccine manufacturing proposal under BARDA’s Rapid Response Partnership Vehicle (RRPV) remains under active review. The program is designed to fund scalable vaccine platforms, eliminating the dependency for stockpiling of MVA-based vaccines relative to high-consequence threats such as smallpox.

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 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

Company Contact:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman

Release – GeoVax to Raise Approximately $6 Million of Gross Proceeds in Public Offering

Posted on July 1, 2025July 1, 2025 by aweinsoff@channelchek.com

Last updated: 01 July 2025

Atlanta, GA, July 1, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive securities purchase agreements with several institutional and individual investors for the purchase and sale of approximately 9.2 million units, each comprised of one share of the Company’s common stock and warrants, as described below, to purchase shares of the Company’s common stock, at a price of $0.65 per unit in a public offering. The Company will issue warrants to purchase up to approximately 18.5 million shares of common stock. The warrants will have an exercise price of $0.65 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of issuance.

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

The gross proceeds to the Company from this offering are expected to be approximately $6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about July 2, 2025, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-288085) previously filed with the Securities and Exchange Commission (the ‘SEC’) and declared effective by the SEC on June 30, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach, CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

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

About GeoVax

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

Company Contact:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman