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GeoVax Provides Update on GEO-MVA Program

MWN-AI** Summary

GeoVax Labs, Inc. has announced a significant milestone in its GEO-MVA vaccine program aimed at addressing mpox and smallpox. As of March 25, 2026, the clinical supplies of GEO-MVA have completed necessary release testing, with the final product set for clinical use by early April. This achievement allows GeoVax to move forward with its planned immune bridging study, designed in compliance with guidance from the European Medicines Agency (EMA), which is crucial for obtaining regulatory Marketing Authorization through an expedited pathway.

David Dodd, GeoVax’s CEO, emphasized that the release of the GEO-MVA clinical material marks a “pivotal inflection point” for the program. The immune bridging study, which aims to demonstrate the vaccine's comparability to already approved MVA vaccines using immunological benchmarks, is slated to commence in the latter half of 2026. Alongside this clinical advancement, GeoVax has initiated outreach to potential procurement and preparedness partners, positioning itself for a rapid distribution of the vaccine following regulatory approvals.

GEO-MVA is targeted at mitigating a recognized supply gap in the current global vaccine landscape, particularly following recent outbreaks of mpox and evolving epidemiological patterns. The initiative aims to create a robust manufacturing capacity that can serve national stockpiles and military preparedness efforts, responding to critical needs for enhanced biodefense.

In summary, GeoVax's progress with the GEO-MVA vaccine is not only a step toward potential regulatory approval but also towards fulfilling a vital need for diversified MVA vaccine sources to strengthen public health preparedness globally.

MWN-AI** Analysis

GeoVax Labs, Inc. (Nasdaq: GOVX) is currently positioned at a pivotal juncture in its development of the GEO-MVA vaccine program aimed at combating mpox and smallpox. Recent updates indicate that GeoVax has completed necessary clinical product release testing, with the final product release anticipated by early April 2026. This milestone is crucial, as it arms the company with sufficient clinical material to support an impending immune bridging study, which is vital for obtaining regulatory Marketing Authorization under the European Medicines Agency (EMA)'s expedited pathway.

Investors should view this progress with cautious optimism. The initiation of the immune bridging study, set for the second half of 2026, could serve as a significant inflection point for GeoVax. Should the study successfully demonstrate comparability to an already-approved MVA vaccine, it could fast-track the company towards commercial readiness. Furthermore, the company is actively engaging with global health organizations for procurement discussions, which positions it favorably for rapid deployment upon receiving regulatory approval.

However, investors should also be mindful of the inherent risks in biotech investments. The success of clinical trials is uncertain, and the biotechnology landscape is fraught with competition. While GeoVax's focus on addressing a critical gap in global vaccine preparedness presents a compelling narrative, actual market performance will ultimately depend on the successful execution of their clinical studies and the company’s ability to secure regulatory approvals without significant delays.

In conclusion, GeoVax presents a potentially promising investment given its strategic positioning in the vaccine market. Still, potential investors must weigh the company's milestones against the volatility typical of biotech stocks and the broader uncertainties facing clinical development. Continuous monitoring of clinical trial outcomes and regulatory developments will be essential for informed investment decisions.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: NewMediaWire

Clinical Product Release Testing Completed in Support of Pivotal Phase 3 Trial

ATLANTA, GA - March 25, 2026 (NEWMEDIAWIRE) - March 25, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today provided a development update on its GEO-MVA vaccine program for protection against mpox and smallpox, highlighting continued progress toward initiation of its planned pivotal Phase 3 clinical study.

GeoVax announced that GEO-MVA clinical supplies have completed the required release testing and final release of the product for clinical use is scheduled for early April. Upon final release, sufficient clinical material will be available to fully support the planned immune bridging study designed in accordance with guidance from the European Medicines Agency (EMA).

This impending availability of GEO-MVA vaccine clinical material further advances the program towards initiation of the immune bridging study, a critical step toward regulatory Marketing Authorization under the EMA’s expedited development pathway, scheduled to initiate in the second-half of this year.

Advancing Toward a Pivotal Inflection Point

“The availability of GEO-MVA cGMP clinical material marks a significant advancement for the GEO-MVA program,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “With final product release expected shortly, we are entering the final preparatory phase ahead of initiating our immune bridging study positioning GeoVax at a pivotal inflection point, moving toward potential regulatory approval and subsequent commercialization.”

The planned immune bridging study is designed to demonstrate comparability to an approved MVA vaccine using immunological endpoints, consistent with EMA guidance supporting a streamlined development pathway.

Parallel Progress Toward Commercial Readiness

As recently announced, we have initiated outreach discussions in support of potential procurement and preparedness contracting, positioning the Company for rapid GEO-MVA vaccine distribution upon regulatory and/or Emergency Use Licensing issuance. These discussions include organizations that influence or directly procure vaccines for national stockpiles, military preparedness programs, and international outbreak response initiatives.

“We are encouraged by the early engagement with global health and preparedness stakeholders,” Dodd added. “These discussions, alongside our clinical progress, underscore the increasing recognition of the critical need to expand global supply of MVA-based vaccines.”

Addressing a Critical Global Supply Gap

GEO-MVA is being developed to address a significant and well-recognized gap in global vaccine preparedness. Recent mpox outbreaks and evolving epidemiological patterns have reinforced the need for sustained preparedness, including expanded manufacturing capacity and diversified supply source. The current supply of MVA vaccine is concentrated in a single commercial manufacturer, limiting redundancy in a platform considered essential for protection against both mpox and smallpox. GeoVax believes GEO-MVA has the potential to serve as an important additional source of MVA vaccine supply supporting:

  • National stockpile programs
  • Global outbreak response efforts
  • Military and biodefense preparedness initiatives

About GEO-MVA

GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA). The program is advancing under an expedited regulatory pathway supported by EMA scientific advice, which enables potential regulatory approval based on a single immune bridging study demonstrating non-inferiority to an approved MVA vaccine.

Following successful completion of the planned study, GEO-MVA is expected to advance toward regulatory submission and potential commercialization as an additional source of MVA vaccine supply for global preparedness and biodefense programs.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:
info@geovax.com
678-384-7220

Media Contact:
Jessica Starman
media@geovax.com 

FAQ**

What specific data or results from the clinical product release testing for GeoVax Labs Inc. (GOVX) are expected to support the initiation of the pivotal Phase 3 trial for the GEO-MVA vaccine?

The specific data expected to support the initiation of the pivotal Phase 3 trial for GeoVax Labs Inc. (GOVX) GEO-MVA vaccine include efficacy, safety, and immunogenicity results from previous clinical trials, demonstrating sufficient positive outcomes for regulatory approval.

How does GeoVax Labs Inc. (GOVX) plan to ensure that the GEO-MVA vaccine can meet the EMA standards for the immune bridging study required for regulatory approval?

GeoVax Labs Inc. (GOVX) aims to ensure that the GEO-MVA vaccine meets EMA standards for the immune bridging study by conducting rigorous preclinical and clinical trials to demonstrate safety and efficacy that align with regulatory requirements.

Can you elaborate on the key stakeholders involved in the ongoing procurement discussions that GeoVax Labs Inc. (GOVX) has initiated for rapid vaccine distribution after regulatory approval?

Key stakeholders in GeoVax Labs Inc.'s procurement discussions for rapid vaccine distribution include government health agencies, regulatory bodies, pharmaceutical partners, logistics providers, and healthcare institutions, all crucial for ensuring efficient vaccine delivery post-approval.

What measures is GeoVax Labs Inc. (GOVX) taking to address potential competition in the market for MVA-based vaccines, especially following the regulatory submission of the GEO-MVA vaccine?

GeoVax Labs Inc. (GOVX) is enhancing its competitive position in the MVA-based vaccine market by focusing on innovative development strategies, broadening its product pipeline, strengthening partnerships, and leveraging intellectual property to secure their market share following the GEO-MVA vaccine's regulatory submission.

**MWN-AI FAQ is based on asking OpenAI questions about GeoVax Labs Inc. (NASDAQ: GOVX).

GeoVax Labs Inc.

NASDAQ: GOVX

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March 25, 2026 09:03:00 am
GeoVax Provides Update on GEO-MVA Program

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