Tag: Biotechnology

IRVINE, Calif., July 30, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that the company will host a conference call and webcast on Wednesday, August 6, 2025 at 4:30 p.m. ET to discuss updated clinical data from its ongoing open-label Phase 1b study evaluating tegoprubart for the prevention of rejection in subjects undergoing kidney transplantation. These data, from approximately 30 kidney transplant recipients, are being presented at the World Transplant Congress (WTC) in San Francisco, CA on August 6, 2025.

To join the conference call, please dial 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. The conference ID is 34575. Registration for the live webcast can be found here and available on the “Events” section of Eledon’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

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

Source: Eledon Pharmaceuticals, Inc.

Release – GeoVax Urges Immediate Action on Pandemic Preparedness as Biodefense Gaps Expose Fragile Supply Chains

Posted on July 30, 2025July 30, 2025 by aweinsoff@channelchek.com

With Mpox spreading globally, COVID-19 variants evading immunity, and bipartisan leaders demanding U.S.-based solutions, GeoVax calls for urgent investment in domestic manufacturing and vaccine diversification

Atlanta, GA – July 30, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies, today renewed its call for decisive U.S. action on pandemic preparedness and biodefense. With escalating outbreak risks, public health system strain, and growing bipartisan consensus for domestic solutions, GeoVax underscored the urgent need to modernize the nation’s countermeasure infrastructure and end foreign vaccine dependency.

“The warning signs are multiplying,” said David Dodd, Chairman and CEO of GeoVax. “We are facing the global expansion of virulent Mpox strains, immune-evasive COVID variants, and a national stockpile reliant on outdated, offshore platforms. Pandemic readiness must be built at home – with modern, American-made solutions and proactive government-industry leadership.”

GeoVax’s Domestic Platform for Emerging and Endemic Threats

GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine platform anchors two front-line candidates:

GEO-MVA for Mpox/smallpox, designed to protect against both Clade I and II Mpox strains.
GEO-CM04S1, a multi-antigen, next-generation COVID-19 vaccine targeting the 40 million U.S. immunocompromised through robust, durable, antibody and T-cell–driven immune protection.

The vaccine candidates are supported by Phase 2 clinical data (GEO-CM04S1) and favorable clinical development guidance from the European Medicines Agency (GEO-MVA) and current development plans include the implementation of an advanced MVA continuous avian cell line manufacturing process for U.S.-based, scalable production.

New Health Threats Demand Immediate Preparedness

Mpox: The World Health Organization maintains Mpox as a Public Health Emergency of International Concern. Clade I outbreaks have now spread to numerous continents, including sustained transmission in China and wastewater detection in the U.S. New data from the Democratic Republic of the Congo confirmed vertical transmission during pregnancy, raising fresh concerns for maternal and neonatal health.
COVID-19: The NB.1.8.1 (“Nimbus”) variant continues to gain dominance, prompting updated CDC guidance recommending boosters for vulnerable groups, including older adults and the immunocompromised. However, mRNA vaccine uptake remains low in these populations, reinforcing the need for broader, longer-lasting immunity options like GEO-CM04S1.

Alarmingly, the Strategic National Stockpile (SNS) remains overly dependent on a single foreign supplier for Mpox/smallpox MVA vaccine, which is reportedly unable to supply the current estimated global needs. Most concerning, the U.S. government has had to continuously shift MVA vaccine from the SNS, which is primarily intended for biosecurity purposes, resulting in a vicious cycle of SNS replenishment, followed by further reduction of the SNS as Mpox outbreaks continue.

“The cost of delay is steep, and the status quo is unacceptable,” said Dodd. “The United States needs increased MVA vaccine competition – not complacency and dependency on a foreign, monopolistic supplier.”

Bipartisan Momentum and Federal Mandate for Action

Policymakers across the aisle are rallying behind a more secure biodefense posture:

At BIO 2025, Administration for Strategic Preparedness and Response (ASPR) Chief of Staff Mark O’Neill emphasized the need for onshoring, platform diversification, and public-private partnerships to strengthen domestic pandemic response capabilities.
In Congress, Democrats and Republicans alike are advancing legislation to reduce foreign dependency and prioritize U.S.-based manufacturing and procurement for pandemic countermeasures.

“GeoVax supports and welcomes this emerging consensus,” Dodd added. “We’re aligned with ASPR and BARDA priorities – and we’re ready to deliver. Swift, decisive government action is needed.”

Preparedness Requires Investment – Before the Next Crisis

More than 120 nations have signed the new WHO Pandemic Agreement, and the U.S. is scaling its biodefense footprint through mobile biocontainment units, genomic surveillance, and expanded diagnostics. Yet, without domestically produced, next-generation vaccines and a diversified stockpile, those efforts will fall short.

“We commend HHS, BARDA, ASPR, and congressional leaders for sounding the alarm,” concluded Dodd. “Now is the time to fund, procure, and manufacture domestically – before the next emergency hits.”

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:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman

Release – GeoVax Accelerates Development of GEO-MVA Vaccine Amid Expanding Global Mpox Crisis and Reaffirmed WHO Emergency Designation

Posted on July 29, 2025July 29, 2025 by aweinsoff@channelchek.com

EMA Scientific Guidance, Global Surge in Clade I Mpox, and Aid Shortfalls Drive Urgent Need for Scalable, Equitable Vaccine Solutions

Atlanta, GA – July 29, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced an expedited development strategy for its GEO-MVA Mpox vaccine candidate, following newly reaffirmed global emergency status by the World Health Organization (WHO), a record-setting surge in Mpox cases across Africa, and recent favorable scientific advice from the European Medicines Agency (EMA) supporting an expedited development path for GEO-MVA.

These developments reinforce the urgent global need for diversified, scalable vaccine platforms amid critical shortages and growing international spread of more virulent Mpox strains.

Global Mpox Cases Surge Beyond 2024 Totals; Africa’s Health Systems Overwhelmed

More than 21,000 confirmed Mpox cases have been reported in 13 African countries so far in 2025 – exceeding the total case count for all of 2024 – with numbers expected to double by year-end. Sierra Leone, Malawi, and the Democratic Republic of the Congo (DRC) are among the most heavily impacted, with healthcare systems under severe strain due to significant U.S. and European aid reductions.

Only 700,000 Mpox vaccine doses have been administered across 11 countries, and key nations like Sierra Leone are still awaiting most of their requested supply. In the DRC alone, over 60,000 suspected cases and nearly 1,800 deaths have been reported. The crisis is being further complicated by armed conflict, collapsing infrastructure, and the emergence of Clade I and Clade 1a Mpox variants, which exhibit greater severity and transmissibility.

Global Spillover and WHO Emergency Status Highlight Urgency

The WHO’s International Health Regulations (IHR) Emergency Committee reconvened on July 5, 2025, and officially reaffirmed Mpox as a Public Health Emergency of International Concern (PHEIC). The WHO’s Situation Report #55, released July 11, underscores the worsening multi-country outbreak and mounting strain on surveillance, laboratory, and response systems.

International spread is accelerating. Clade I Mpox cases have now been confirmed in China, the United Kingdom, Italy, and the United States. U.S. health officials have identified five travel-related Clade I cases since late 2024, including a confirmed case in Massachusetts in June 2025, while wastewater testing confirms silent community transmission.

The CDC continues to emphasize surveillance efforts – including wastewater and diagnostic testing – but warns that current tools are insufficient to contain a broader outbreak without expanded vaccine access and supply.

EMA Guidance Supports Expedited GEO-MVA Pathway

GeoVax has received favorable scientific advice from the European Medicines Agency (EMA) regarding the development of GEO-MVA. The EMA guidance supports a streamlined regulatory pathway, enabling GeoVax to pursue expedited development and potential conditional approval of GEO-MVA as an additional Mpox vaccine candidate in the EU. This guidance strengthens the GEO-MVA development program’s relevance to global procurement programs, including those of WHO and UNICEF.

GeoVax Response: Acceleration, Scalability, and Equitable Access

In light of these developments, GeoVax is implementing a comprehensive, expedited development strategy:

Clinical Development Acceleration: Finalizing fill-finish manufacturing and initiating human trials to evaluate safety and immunogenicity against both Clade I and Clade II variants. Regulatory planning includes immuno-bridging studies for global deployment.
Advanced MVA Manufacturing Platform: Development is underway for GEO-MVA’s production using a continuous avian cell line system, enabling rapid, large-scale, and cost-effective production – addressing a key shortfall of the incumbent egg-based method.
International Collaboration: Engaging health authorities, NGOs, and regional partners across Africa to ensure vaccine readiness and coordinated deployment to underserved and high-risk populations.
Policy Engagement: Advocating for vaccine platform diversification and calling on governments and international donors to break the global reliance on a single supplier for Mpox vaccines.

David Dodd, Chairman & CEO of GeoVax, commented: “With Mpox cases rapidly rising across Africa and the WHO reaffirming global emergency status, the world must act urgently. The emergence of Clade I across multiple continents and the persistent lack of vaccine access underscore the need for scalable and diversified solutions. GEO-MVA is designed to meet this moment – leveraging our regulatory momentum from the EMA, efforts to accelerate implementation of our continuous manufacturing platform and an unwavering commitment to equitable access. We stand ready to be part of the solution, both scientifically and humanely.”

About GeoVax

Forward-Looking Statements

Company Contact:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman

Release – GeoVax Announces Research Program to Evaluate Needle-Free, Self-Administered GEO-MVA Vaccine Using Vaxxas Microarray Patch Technology

Posted on July 28, 2025July 28, 2025 by aweinsoff@channelchek.com

Study Aims to Validate Thermostable, Self-Administered MVA-Vaccine Platform for Pandemic Preparedness and Global Immunization

Atlanta, GA – July 28, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced the initiation of a research program to evaluate the immunogenicity and stability of GEO-MVA delivered via Vaxxas’ proprietary high-density microarray patch (HD-MAP) platform in preclinical models.

The proof-of-concept study, conducted at the University of Queensland (UQ) under a research agreement between GeoVax and UniQuest Pty Limited (UQ’s commercialization company), will assess the immune responses, delivery efficiency, and thermostability of GEO-MVA formulated and dried onto HD-MAPs for administration in mice. HD-MAPs offer a needle-free, skin-targeted delivery approach with the potential to enhance immunogenicity and enable distribution without refrigeration.

“This program represents a potential major step forward in our strategy to expand the versatility of GeoVax’s MVA platform and meet global needs for more accessible, ruggedized, and effective vaccines,” said David Dodd, Chairman and CEO of GeoVax. “Demonstrating that GEO-MVA can be delivered via HD-MAP could lead to more potent immune responses at lower doses, greater thermostability, and eliminate the need for needles – a very compelling profile for both routine immunization and rapid deployment during outbreaks.”

If successful, the study results will support the development of a thermostable, needle-free GEO-MVA vaccine for pandemic response, biodefense stockpiling, and immunization programs in low- and middle-income countries.

The HD-MAP platform offers several potential advantages over traditional needle-and-syringe delivery, including:

Self-administration in the home, pharmacy, or vaccination hubs;
Increased patient acceptance, especially among needle-phobic individuals;
Higher immunogenicity, enabling dose-sparing;
Thermostability, reducing cold chain reliance;
Elimination of sharps waste and needle-stick injuries;
Faster deployment in emergency settings with minimal training requirements.

The Vaxxas HD-MAP platform has demonstrated enhanced immunogenicity in multiple animal model and clinical studies and is being advanced in partnerships with leading pharmaceutical, government entities and foundations. GeoVax recently received favorable scientific advice from the European Medicines Agency (EMA) regarding the development of GEO-MVA. The EMA guidance supports a streamlined regulatory pathway, enabling GeoVax to pursue potential expedited development and approval pathways for GEO-MVA as an additional Mpox vaccine candidate in the EU.

The current study is supported by GeoVax and conducted by researchers led by A/Prof David Muller and Dr. Chris McMillan at the University of Queensland.

About GeoVax

Forward-Looking Statements

Company Contact:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman

Research News and Market Data on MAIA

Release – MAIA Biotechnology Receives FDA’s Fast Track Designation for Ateganosine as a Treatment for Non-Small Cell Lung Cancer

Posted on July 28, 2025July 28, 2025 by aweinsoff@channelchek.com

July 28, 2025 8:01am EDTDownload as PDF

Potential first-to-market small molecule telomere targeting agent targets a $34 billion NSCLC treatment market

Latest data in pivotal Phase 2 THIO-101 clinical trial shows median overall survival of 17.8 months

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 that the U.S. Food and Drug Administration (FDA) has 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). Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.

Ateganosine is a first-in-class small molecule that compromises telomere structure and function in cancer cells, leading to rapid tumor cell elimination and specific immune memory. Through telomerase-mediated action, ateganosine reverses intrinsic or acquired resistance to immune checkpoint inhibitors (ICIs).

“FDA’s Fast Track Designation recognizes ateganosine’s potential as a new therapeutic paradigm in cancer treatment science. Ateganosine is the first and only anticancer treatment of its kind that we are aware of in clinical development,” stated MAIA Chairman and CEO Vlad Vitoc, M.D. “If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year. If approved, ateganosine would have a first-to-market competitive position within a $34 billion NSCLC treatment market with significant unmet medical need.”

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

“This is an important milestone for MAIA’s clinical development program. Ateganosine has demonstrated robust preclinical efficacy and superior clinical median overall survival compared to other FDA-approved treatments for NSCLC patients with prior disease progression on platinum-based chemotherapy and anti-PD-(L)1 antibody. Additionally, advanced NSCLC is a devastating disease that clearly meets the criteria for a serious condition with unmet medical need. Both are key criteria for the Fast Track designation,” said K. Robinson Lewis, Vice President, Head of Regulatory and Quality at MAIA. “We intend to utilize the incentives of the Fast Track Program to expedite the development and review of ateganosine and bring patient access sooner.”

The FDA Fast Track is a process designed to facilitate development and expedite the review of drugs for treating serious conditions and filling an unmet medical need, as in providing a therapy where none exists or which may be potentially better than available therapy. 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).

MAIA’s most recent data from the pivotal Phase 2 THIO-101 clinical trial of ateganosine as of May 15, 2025 showed median overall survival (OS) of 17.8 months in a heavily pre-treated population. As of the data cut-off date, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown overall survival of 5 to 6 months.

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.

_____________________________

¹ Custom Market Insights, Global NSCLC Drug Market Size Likely to Surpass at a CAGR of 8.1% By 2033, Apr. 2024

View source version on businesswire.com: https://www.businesswire.com/news/home/20250728212094/en/

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

Source: MAIA Biotechnology, Inc.

Released July 28, 2025

Release – GeoVax to Advance Gedeptin(R) into First-Line Therapy Neoadjuvant Combination Trial Following Landmark KEYNOTE-689 Results

Posted on July 24, 2025July 24, 2025 by aweinsoff@channelchek.com

Revised Phase 2 Strategy Targets Event-Free Survival in Primary Head and Neck Cancer through Checkpoint Inhibitor Combination

ATLANTA, GA, July 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a strategic shift in its Gedeptin® clinical development program, with a new emphasis on evaluating Gedeptin as a neoadjuvant therapy in combination with pembrolizumab for patients with primary, resectable head and neck squamous cell carcinoma (HNSCC).

The revised strategy follows the landmark results of the KEYNOTE-689 Phase 3 trial, published in the New England Journal of Medicine on June 18, 2025, which demonstrated a significant improvement in event-free survival (EFS) with the addition of perioperative pembrolizumab in resectable, locally advanced HNSCC patients. These data represent the first validated use of PD-1 inhibition in curative-intent HNSCC and have catalyzed a major shift in treatment paradigms toward neoadjuvant immunotherapy.

GeoVax’s new Phase 2 trial (AdPNP-203) will evaluate the addition of intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab in patients eligible for curative surgery. The trial is designed to assess major pathological response (MPR) and associated immunologic and biomarker outcomes following two pre-surgical cycles of therapy as well as event-free survival over a one-year period. Gedeptin’s tumor-targeting, immune-sensitizing mechanism may help overcome the limitations of checkpoint monotherapy by enhancing immune activation within the tumor microenvironment. Trial initiation is planned for 2026.

“The KEYNOTE-689 results support our view that neoadjuvant checkpoint inhibition can transform the treatment of head and neck cancer,” said Dr. Kelly McKee, Chief Medical Officer at GeoVax. “By integrating Gedeptin into this emerging standard, we hope to improve both local tumor clearance and event-free survival, especially for high-risk or PD-L1-low patients.”

“This is a strategic shift in our program,” added David Dodd, Chairman and CEO of GeoVax. “We believe Gedeptin’s localized cytotoxic mechanism, when combined with systemic checkpoint inhibition for first-line treatment, can meaningfully improve therapeutic outcomes in patients with resectable HNSCC.”

Rationale for Combination Strategy

As highlighted in the NEJM editorial, the benefit in KEYNOTE-689 may be driven primarily by the neoadjuvant component of immunotherapy. However, many patients still experience local or distant relapse, underscoring the need for intensified strategies in the perioperative window. Gedeptin, with its dual cytotoxic and immune-priming mechanism, may serve as an ideal partner to checkpoint inhibitors by converting “cold” tumors into “hot” immunogenic targets.

About Gedeptin®

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) using a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP). Once delivered directly into tumors and followed by fludarabine, PNP enzymatically converts the prodrug into a cytotoxic compound, selectively targeting tumor cells while sparing healthy tissue. This localized approach aims to reduce toxicity, enhance immune visibility, and enable immune checkpoint synergy.

Gedeptin has received Orphan Drug Designation for oral and pharyngeal cancers and is backed by a robust intellectual property portfolio. GeoVax’s ongoing innovation in immune-sensitizing therapies supports a broader strategy to complement checkpoint inhibitors and overcome tumor immune resistance across solid tumor types.

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 UNCY

Release – Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology

Posted on July 24, 2025July 24, 2025 by aweinsoff@channelchek.com

July 24, 2025 8:00am EDT Download as PDF

OLC was well-tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden

LOS ALTOS, Calif., July 24, 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 publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dialysis in the Clinical Journal of the American Society of Nephrology.

The publication, entitled “A Phase 2 Clinical Trial of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia,” examines the safety and tolerability of OLC at clinically effective doses with a goal serum phosphate concentration of ≤5.5 mg/dL. Eighty-six patients were treated with OLC in this open-label single arm Phase 2 study. At screening, only 59% of patients had serum phosphate levels of ≤5.5 mg/dL (phosphate control). OLC was well tolerated and enabled serum phosphate control in >90% of patients with a low pill burden (two-thirds of patients receiving three or fewer tablets/day). Pharmacokinetic analysis showed that systemic absorption of OLC (measured as lanthanum) was minimal to none in CKD patients.

“With the favorable tolerability, strong efficacy and low pill burden highlighted in this prestigious publication, we continue to believe that OLC has the potential to offer patients a new option that could help improve adherence to treatment over time,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This pivotal study was the final clinical evidence needed for our NDA package. We continue to collaborate closely with the U.S. Food and Drug Administration as we address their outstanding manufacturing questions and align on a path forward to bring OLC to this underserved patient population as quickly as possible.”

Key Findings:

More than 90% of patients with hyperphosphatemia taking OLC achieved effective phosphate control.
Two-thirds of patients required three or fewer OLC tablets per day to achieve target serum phosphate levels, with most requiring no more than one tablet with each meal.
OLC was well tolerated in CKD patients on dialysis. The most common treatment-related adverse events were gastrointestinal (9% diarrhea; 6% vomiting) and only 4% of patients discontinued treatment due to treatment-related adverse events.

“Despite the various treatment options available, there remains a significant need in managing hyperphosphatemia, which heavily impacts people with chronic kidney disease on dialysis,” said Dr. Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator of the trial. “These data add to the growing body of clinical evidence supporting the potential of OLC as an innovative treatment option, demonstrating effective phosphate control and reducing pill burden. OLC’s unique profile offers a promising alternative with favorable tolerability, potentially transforming the standard of care for patients.”

The full publication can be accessed here and on the Presentations & Research page of Unicycive’s website.

About Oxylanthanum Carbonate (OLC)
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.¹ Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

¹Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.

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.

Source: Unicycive Therapeutics, Inc.

Released July 24, 2025

Release – GeoVax to Report Second Quarter 2025 Financial Results and Provide Corporate Update on July 28, 2025

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

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, July 22, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced that it will report second quarter 2025 financial results on Monday, July 28, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Conference Call Details

To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.

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.

Company Contact:

678-384-7220

Investor Relations Contact:

212-698-8696

Media Contact:

Jessica Starman

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

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