Core Viewpoint - GeoVax Labs reported strong second quarter 2025 results with significant revenue growth but raised concerns about increased operating costs and cash reserves [1][5][10] Financial Performance - GAAP revenue reached $0.85 million, exceeding analyst estimates of $0.39 million, marking a year-over-year increase of 183.6% from $0.30 million in Q2 2024 [2][5] - GAAP earnings per share were a loss of $(0.35), slightly worse than the expected $(0.34) but a significant improvement from $(1.99) in Q2 2024, reflecting an 82.4% year-over-year improvement [2][6] - Net loss for the quarter was $(5.37) million, a slight increase from $(5.06) million in Q2 2024, while research and development expenses rose by 10.5% to $4.73 million [2][6] Business Overview - GeoVax specializes in developing vaccines and immunotherapies for infectious diseases and cancer, focusing on unmet medical needs [3] - The clinical pipeline includes three main product families: GEO-CM04S1 (COVID-19 vaccine), GEO-MVA (mpox and smallpox vaccine), and Gedeptin (gene-directed immunotherapy for cancers) [3] Strategic Focus - The company aims to accelerate clinical trial progress, expand its intellectual property portfolio, and improve manufacturing scalability [4] - Key success factors include advancing clinical trials, securing regulatory approvals, and forming strategic partnerships [4] Pipeline Progress - Revenue growth was driven by government contract revenues from the BARDA/RRPV Project NextGen award, which has since been terminated [5][10] - The GEO-MVA vaccine received positive regulatory feedback from the EMA, with plans to initiate a pivotal Phase 3 trial in late 2026, representing a market opportunity over $10 billion [7] - The GEO-CM04S1 vaccine is targeting immunocompromised patients, showing enhanced immune responses in clinical trials [8] Manufacturing and Intellectual Property - GeoVax is developing scalable vaccine manufacturing methods to address supply bottlenecks and has secured new U.S. patents for a malaria vaccine and expanded Gedeptin use [9] Future Outlook - The company ended the quarter with $3.09 million in cash, down from $5.51 million, and raised $5.6 million through a public offering to extend its cash runway [10] - Management did not provide formal guidance but emphasized advancing vaccine and oncology programs and building U.S.-based manufacturing capacity [11]

Core Insights - Tonix Pharmaceuticals Holding Corp. presented new findings on TNX-801, a recombinant horsepox live virus vaccine, demonstrating its potential for durable immunity against mpox and smallpox with significantly reduced virulence compared to traditional vaccines [1][2][3] Group 1: TNX-801 Vaccine Development - TNX-801 is shown to be up to 100,000-fold less virulent than live smallpox vaccine strains, providing robust immunogenicity and protection for over one year in animal studies [1][2] - Subcutaneous administration of TNX-801 offers equivalent protection to traditional percutaneous methods, potentially reducing risks of administration-site infections and scarring [2][3] - Preclinical studies indicate that a single dose of TNX-801 generates strong antibody responses across various animal models, including immunocompromised subjects, with all vaccinated macaques surviving lethal mpox challenges [2][3] Group 2: Strategic Importance and Future Directions - The vaccine's unique risk-benefit profile may make it a critical tool for public health, particularly in response to mpox outbreaks and potential smallpox threats [2][3] - Tonix Pharmaceuticals aims to advance TNX-801 into clinical evaluation, focusing on subcutaneous delivery to streamline vaccination processes [2][3] - The ongoing classification of mpox as a public health concern by organizations like the WHO and CDC underscores the importance of developing effective vaccines like TNX-801 [3] Group 3: Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, for marketing authorization [4] - Tonix's infectious disease portfolio includes TNX-801 and TNX-4200, the latter being a broad-spectrum antiviral agent with a contract worth up to $34 million from the U.S. Department of Defense [4]

Ghana plans to ask India for support to develop a vaccine hub when Prime Minister Narendra Modi visits the West African nation this week https://t.co/c392lZq4ty ...

Core Insights - Tonix Pharmaceuticals will present at the World Vaccine Congress Washington 2025, focusing on a novel mpox vaccine and leading a panel discussion on vaccine development and biosecurity policy [1][2][3] Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, and has received Fast Track designation from the FDA [4] - Tonix's CNS portfolio includes TNX-1300 for cocaine intoxication, which has FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases [4] - The infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. DoD [4] Upcoming Events - The oral presentation will be led by Dr. Farooq Nasar on April 23, 2025, at 10:10 a.m., discussing a single-dose mpox vaccine [2] - A panel discussion moderated by Dr. Zeil Rosenberg will take place on the same day at 3:25 p.m., addressing mpox and smallpox threats [3]

As filed with the Securities and Exchange Commission on September 20, 2024 Registration No. 333-281834 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 IMUNON, INC. (Exact name of registrant as specified in its charter) DELAWARE 52-1256615 (State or other jurisdiction of incorporation or organization) 997 Lenox Drive, Suite 100 Lawrenceville, New Jersey 08648 (609) 896-9100 (Address, including zip code ...

As filed with the Securities and Exchange Commission on September 6, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 87-0455038 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1900 Lake Park Drive, ...

As filed with the Securities and Exchange Commission on August 6, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 87-0455038 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1900 Lake Park Drive, Su ...

As filed with the Securities and Exchange Commission on January 2, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 87-0455038 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 1900 Lake Park Drive, S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 As filed with the Securities and Exchange Commission on December 20, 2023 Registration No. 333- (Exact name of registrant as specified in its charter) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Imunon, Inc. (State or other jurisdiction of incorporation or organization) Delaware 2834 52-1256615 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 997 Lenox Drive, Suite 100 La ...

Table of Contents As filed with the Securities and Exchange Commission on March 31, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SOLIGENIX, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite B-10 Copies to: Drisco ...