株探米国株
日本語 英語
エドガーで原本を確認する
false 0000832489 0000832489 2025-11-13 2025-11-13
 
 
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549 
 

 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of report (Date of earliest event reported):  November 13, 2025
 

 
GEOVAX LABS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-39563
 
87-0455038
(State or other jurisdiction of
incorporation or organization)
 
(Commission File No.)
 
(IRS Employee Identification No.)
 
1900 Lake Park Drive, Suite 380
Smyrna, Georgia 30080
(Address of principal executive offices) (Zip code)
 
(678) 384-7220
(Registrant’s telephone number, including area code)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions.
 
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR240.14a-12)
 
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).
 
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13(e)-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
GOVX
The Nasdaq Capital Market
 
Indicate by check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (Section 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Section 240.12b-2 of this chapter).
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial reporting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
1
 
 
Forward-Looking Statements
 
This Current Report on Form 8-K and other reports filed by the Company from time to time with the Securities and Exchange Commission (collectively the “Filings”) contain forward-looking statements and information that are based upon beliefs of, and information currently available to, the Company’s management as well as estimates and assumptions made by the Company’s management. When used in the Filings the words “anticipate”, “believe”, “estimate”, “expect”, “future”, “intend”, “plan” or the negative of these terms and similar expressions as they relate to the Company or the Company’s management identify forward looking statements.  Such statements reflect the current view of the Company with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to the Company’s industry, operations and results of operations and any businesses that may be acquired by the Company. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Except as required by law, the Company does not undertake to update its forward-looking statements.
 
Item 2.02
Results of Operations and Financial Condition.
 
On November 13, 2025, GeoVax Labs, Inc. (the “Company”) issued a press release reporting its results of operations for the quarter ended September 30, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
 
 
Item 9.01
Financial Statements and Exhibits.
 
(d)     Exhibits
Exhibit No.
Description
99.1
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
2
 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: November 13, 2025
 
 
GEOVAX LABS, INC.
 
     
     
 
By:
/s/ Mark W. Reynolds
 
   
Mark W. Reynolds
 
   
Chief Financial Officer
 
       
 
 
3
EX-99.1 2 ex_887958.htm EXHIBIT 99.1 ex_887958.htm

Exhibit 99.1

 logosm.jpg

 

GeoVax Reports Third Quarter 2025 Financial Results and Provides Business Update

 

Quarter Highlighted by GEO-MVA Acceleration Amid Global Mpox Emergency, Gedeptin® Expansion into New Solid Tumor Programs, and Strong GEO-CM04S1 Clinical Data in Immunocompromised Patients

 

Company to host conference call today at 4:30 p.m. ET

 

ATLANTA, GA, November 13, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today reported its financial results for the quarter ended September 30, 2025, and provided a business update highlighting key corporate and clinical advancements across its vaccine and oncology programs.

 

“As highlighted in this report, during the third quarter GeoVax continued making important progress, advancing innovative vaccines and immunotherapies that address urgent and underserved medical needs,” said David Dodd, GeoVax’s Chairman and CEO. “With continued global Mpox spread and constrained vaccine supply, our GEO-MVA program represents a U.S.-based, scalable, next-generation MVA platform. Our EMA and BARDA-aligned program position GeoVax to accelerate regulatory readiness and commercial entry.

 

“For our GEO-CM04S1 COVID-19 vaccine program, recent clinical presentations validate our belief that multi-antigen vaccines—expressing both spike and nucleocapsid—are essential for breadth and durability in vulnerable immunocompromised populations. In particular, the robust immune responses demonstrated in Chronic Lymphocytic Leukemia (CLL) patients represents a meaningful step forward in addressing the unmet needs of over 40 million immunocompromised Americans.

 

“In our Gedeptin® oncology program, the expansion into multiple solid tumor indications builds upon a growing recognition that tumor-targeted immune priming can dramatically improve checkpoint outcomes. We are executing a clear path to clinical and commercial value creation.

 

Dodd concluded, “GeoVax continues to execute with purpose and discipline. Our multi-antigen vaccine and immunotherapy platforms position the Company squarely within the national call to strengthen America’s health security, expand domestic manufacturing, and deliver equitable global solutions.”

 

Third Quarter 2025 Operational Highlights

 

GEO-MVA (Mpox/Smallpox Vaccine): Expedited Development Amid Expanding Global Crisis

GeoVax accelerated development of its GEO-MVA vaccine in response to the World Health Organization’s reaffirmation of Mpox as a global public health emergency, as Clade I outbreaks continued across Africa, Europe, and the U.S.

Favorable scientific advice from the European Medicines Agency (EMA) supported a streamlined regulatory pathway for GEO-MVA, advancing the Company’s goal of becoming a critically important diversified supplier of MVA vaccine addressing the Mpox increasing threat.

A new research collaboration with the University of Queensland and UniQuest will evaluate needle-free delivery using Vaxxas’ high-density microarray patch (HD-MAP) platform, targeting improved thermostability, self-administration, and dose-sparing performance—features critical for pandemic preparedness and global vaccine equity.

 

MORE

 

GEO-CM04S1 (Multi-Antigen COVID-19 Vaccine): Strong Immunogenicity Data and CLL Trial Success

GeoVax advanced its Phase 2 clinical trials of GEO-CM04S1—its multi-antigen COVID-19 vaccine for immunocompromised populations—and released encouraging interim data from both blood cancer and chronic lymphocytic leukemia (CLL) patient cohorts.

At the 6th ESCMID Conference on Vaccines (Lisbon, Portugal) and iwCLL 2025 Workshop (Krakow, Poland), GeoVax presented data confirming the differentiated performance of GEO-CM04S1:

 

o

No serious adverse events attributed to GEO-CM04S1, confirming the strong safety profile of the MVA platform.

 

o

Robust T-cell and cross-variant antibody responses in CLL and hematologic cancer patients—immune activity that exceeded that of standard-of-care mRNA vaccines.

 

o

Primary endpoint achieved: The CLL trial met its immunogenicity target, prompting discontinuation of the comparator mRNA arm.

 

o

Durability: Sustained cellular responses were observed across multiple timepoints, indicating long-term protection potential for immunocompromised patients.

 

o

Next-generation construct: Incorporating the Omicron KP.2 Spike gene for enhanced variant coverage, planned for 2026 trial launch.

 

Gedeptin® (Oncolytic Gene-Directed Therapy): Expanding to New Solid Tumor Indications

Following publication of KEYNOTE-689 Phase 3 results confirming the role of perioperative checkpoint inhibition in head and neck cancer, GeoVax announced plans for a Phase 2 trial (AdPNP-203) evaluating Gedeptin + pembrolizumab + fludarabine in first-line, resectable HNSCC, with initiation targeted for 2H 2026.

Simultaneously, preclinical studies are expanding into triple-negative breast and cutaneous cancers in collaboration with Emory University’s Winship Cancer Institute, assessing checkpoint combination strategies.

 

Other Corporate and Strategic Updates

Alignment with U.S. Policy Priorities: GeoVax’s U.S.-based MVA platform directly supports the Administration’s and Congress’s bipartisan calls for onshoring, “Made in America,” and pandemic-preparedness investments, as echoed in recent ASPR, BARDA, and State Department initiatives.

 

o

The Company’s continuous avian cell line manufacturing process aligns with legislative goals to modernize domestic biomanufacturing and reduce dependency on foreign vaccine suppliers.

 

o

Engagements continue with ASPR, BARDA, CEPI, Africa CDC, WHO, and UNICEF, reinforcing the Company’s commitment to biodefense, preparedness, and equitable access.

Regulatory Alignment: Ongoing EMA interactions support an accelerated GEO-MVA commercialization pathway.

Global Health Equity Engagement: GeoVax sponsored the Dr. David Satcher Global Health Equity Summit to highlight its leadership in equitable vaccine innovation.

Public Health Credibility: The Company reaffirmed its commitment to evidence-based vaccine safety and transparency, emphasizing the longstanding safety record of the MVA platform in immunocompromised and special populations.

 

Third Quarter 2025 Financial Results

 

Net Loss: Net loss for the three-month period ended September 30, 2025, was $6,318,914, or $0.31 per share, as compared to $5,815,468, or $0.91 per share, for the comparable period in 2024. For the nine-month period ended September 30, 2025, the Company’s net loss was $17,046,348, or $0.97 per share, as compared to $16,729,642, or $4.52 per share, in 2024.

 

Revenue: During the three-month and nine-month periods ending September 30, 2025, the Company reported $-0- and $2,489,145 of government contract revenues associated with the BARDA/RRPV Project NextGen award, compared to $2,789,484 and $3,090,161 for the comparable periods in 2024. During April 2025 GeoVax received notification that BARDA determined to terminate the contract for convenience to the government.

 

MORE

 

R&D Expenses: Research and development expenses were $5,043,504 and $15,127,090 for the three-month and nine-month periods ended September 30, 2025, compared with $7,402,884 and $16,105,480 for the comparable periods in 2024, with the overall decrease primarily related to discontinued costs associated with termination of the BARDA/RRPV Contract, as well as lower costs for the GEO-CM04S1 clinical trials and manufacturing costs associated with the GEO-CM04S1 and Gedeptin programs. These lower costs were partially offset by higher personnel and consulting costs and manufacturing costs associated with the GEO-MVA development program.

 

G&A Expenses: General and administrative expenses were $1,329,711 and $4,559,346 for the three-month and nine-month periods ended September 30, 2025, compared to $1,241,176 and $3,784,559 for the comparable periods in 2024, with the overall increase primarily due to higher personnel costs, investor relations consulting and other programmatic expenses, and stock-based compensation expense.

 

Cash Position: GeoVax reported cash balances of $5,008,997 at September 30, 2025, as compared to $5,506,941 at December 31, 2024.

 

Summarized financial information is attached. Further information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

 

Conference Call Details

 

Management will host a conference call and live audio webcast today, November 13, 2025, at 4:30 p.m. ET to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.

 

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.

 

MORE

 

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

 

 

FINANCIAL TABLES FOLLOW

 

 

MORE

 

GEOVAX LABS, INC.

Condensed Consolidated Statements of Operations Information

(amounts in thousands, except common share information)

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2025

   

2024

   

2025

   

2024

 

Revenue from government contract

  $ -     $ 2,789     $ 2,489     $ 3,090  
                                 

Operating expenses:

                               
Research and development     5,043       7,402       15,127       16,105  
General and administrative     1,330       1,241       4,559       3,785  
      6,373       8,643       19,686       19,890  

Loss from operations

    (6,373 )     (5,854 )     (17,197 )     (16,800 )

Other income (expense)

    54       39       151       70  
                                 

Net loss

  $ (6,319 )   $ (5,815 )   $ (17,046 )   $ (16,730 )
                                 

Loss per common share

  $ (0.31 )   $ (0.91 )   $ (0.97 )   $ (4.52 )

 

 

Condensed Consolidated Balance Sheet Information

(amounts in thousands, except common share information)

 

   

Sep. 30,

2025

   

Dec. 31,

2024

 

Assets:

               

Cash and cash equivalents

  $ 5,009     $ 5,507  

Other current assets

    1,508       2,428  

Total current assets

    6,517       7,935  

Property and other assets, net

    214       221  

Total assets

  $ 6,731     $ 8,156  
                 

Liabilities and stockholders’ equity

               

Total liabilities

  $ 1,824     $ 3,107  

Stockholders’ equity

    4,907       5,049  

Total liabilities and stockholders’ equity

  $ 6,731     $ 8,156  
                 

Common shares outstanding

    29,705,360       10,536,875