Core Insights - Valneva SE and Serum Institute of India have mutually agreed to discontinue their license agreement for Valneva's single-shot chikungunya vaccine, allowing Valneva to regain full rights and control over its supply chain and commercialization efforts in endemic high-risk countries [1][2] Group 1: Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [5] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [6] - Valneva's revenue from its growing commercial business supports the advancement of its vaccine pipeline, which includes a Lyme disease vaccine candidate partnered with Pfizer and a Shigella vaccine candidate [7] Group 2: Chikungunya Vaccine Context - Chikungunya virus (CHIKV) is a mosquito-borne disease causing severe joint pain, fever, and other symptoms, with significant economic and medical burdens expected to grow due to climate change [3][4] - Since 2004, chikungunya has spread to over 110 countries, with more than 3.7 million cases reported in the Americas between 2013 and 2023, highlighting the disease as a major public health problem according to the WHO [4] Group 3: Strategic Partnerships and Funding - Valneva's strategic intent to regain rights to the chikungunya vaccine aligns with its commitment to support access in low-and-middle-income countries, as outlined in a funding agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) [2] - CEPI aims to accelerate vaccine development and ensure equitable access, having supported over 70 vaccine candidates against high-risk pathogens [8] Group 4: Serum Institute of India Overview - Serum Institute of India is a global leader in vaccine manufacturing, with an annual capacity of 4 billion doses and a presence in over 170 countries [10][11] - The company focuses on producing affordable vaccines and has played a significant role in reducing the prices of essential vaccines, including those for Diphtheria, Tetanus, and COVID-19 [11]

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) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S. Employer Identification Number) 1955 Lake Park Drive, Suite 300, Smyrna, Georgia 30080, (678) 384-7220 (Address, includin ...

Financial Data and Key Metrics Changes - Total revenues reached EUR 127 million for the nine months ended September 30, 2025, representing a growth of almost 9% compared to the same period in 2024 [4][16] - Product sales increased to EUR 119.4 million, up 6.2% from EUR 112 million in the first nine months of 2024 [14] - Operating loss reported at EUR 53.9 million compared to an operating profit of EUR 34.2 million in the prior year, primarily due to the sale of a priority review voucher in 2024 [18][19] Business Line Data and Key Metrics Changes - IXIARO sales increased by 12.5% to EUR 74.3 million, driven by sales to the U.S. Department of Defense and increased sales in Europe [14] - DUKORAL sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and a transition to a new distributor in Germany [14][15] - IXCHIQ sales surged to EUR 7.6 million from EUR 1.8 million, aided by the supply of doses during a chikungunya outbreak [15] Market Data and Key Metrics Changes - The gross margin on commercial products, excluding IXCHIQ, improved to 57.2% from 48.6% in the prior year, driven by better manufacturing performance [16] - IXIARO's gross margin reached 63.2%, up from 58.8%, while DUKORAL's gross margin improved to 52.3% from 34.8% [16] Company Strategy and Development Direction - The company aims to focus on strategic investments in R&D and anticipates continuous growth in product sales, particularly from the Lyme disease vaccine, VLA15, expected to be a significant growth driver [21][22] - Valneva is working on expanding IXCHIQ into low- and middle-income countries (LMICs) and is exploring new partnerships to enhance market access [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme vaccine data, which could lead to sustained profitability post-commercialization [21][22] - The company is focused on reducing cash burn and maintaining a strong cash position to support future growth initiatives [4][19] Other Important Information - The company successfully completed debt refinancing, enhancing financial flexibility [5] - Cash at the end of September 2025 was reported at EUR 143.5 million, down from EUR 168.4 million at the end of 2024 [19] Q&A Session Summary Question: Timeline for FDA response regarding IXCHIQ - Management indicated there is no predefined process for the FDA response and hopes for a collaborative interaction, although no specific timeline can be provided [29][30] Question: Impact of currency and distributor shift on DUKORAL - Management acknowledged currency impacts and noted a technical delay in sales due to the transition to a new distributor in Germany, expecting continued growth for DUKORAL [31][32] Question: Timing for Lyme phase III readout - Management stated that Pfizer controls the process and is taking steps to ensure timely results, with no major delays anticipated [36][38] Question: IXCHIQ BLA suspension and proposed remedies - The response to the FDA focused on medical evidence and a positive risk-benefit ratio, with ongoing pharmacovigilance reviews [40][41] Question: Launch timeline for VLA15 - Management confirmed that timelines communicated by Pfizer support a launch in the autumn of 2027, contingent on regulatory submission next year [46] Question: Future growth drivers for IXCHIQ - Management sees growth opportunities in travel and endemic countries, with ongoing discussions for market access in various territories [47][48] Question: Funding considerations for Zika vaccine candidate - Management highlighted uncertainties around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [54][55]

Financial Data and Key Metrics Changes - Total revenues reached EUR 127 million for the nine months ended September 30, 2025, representing a growth of almost 9% compared to EUR 112.5 million in the same period of 2024 [4][16] - Product sales increased to EUR 119.4 million, up 6.2% from EUR 112 million in the first nine months of 2024 [14] - Operating loss reported at EUR 53.9 million compared to an operating profit of EUR 34.2 million in the prior year, primarily due to the sale of a priority review voucher in the previous year [18] Business Line Data and Key Metrics Changes - IXIARO sales reached EUR 74.3 million, increasing 12.5% year-over-year, driven by sales to the U.S. Department of Defense and increased sales in some European countries [14] - Ducoral sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and lower sales during the transition to a new distributor in Germany [14][15] - Exchange sales significantly increased to EUR 7.6 million from EUR 1.8 million, including the supply of doses to combat a chikungunya outbreak [15] Market Data and Key Metrics Changes - The company is focusing on expanding into low- and middle-income countries (LMICs) and new territories for IXIARO, leveraging its differentiated product profile [20][21] - The Lyme disease vaccine, VLA15, is expected to be a major growth driver, with regulatory submissions anticipated in 2026 and a potential launch in autumn 2027 [20][31] Company Strategy and Development Direction - The company aims to achieve sustainable profitability post-approval and commercialization of the Lyme disease vaccine, which is seen as a significant growth catalyst [20][21] - Valneva is actively identifying new opportunities for its R&D pipeline, aiming to build a coherent strategy for future vaccine candidates [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme disease vaccine data, which is expected to be a pivotal moment for the company [20][37] - The company is focused on reducing cash burn and ensuring sufficient runway to reach key inflection points, with cash at September 30 reported at EUR 143.5 million [18][19] Other Important Information - The company successfully completed debt refinancing, enhancing financial flexibility [5] - Research and development expenses increased to EUR 59.7 million, partly due to costs related to the Shigella vaccine candidate [17] Q&A Session Summary Question: Timeline for FDA response regarding exchange - Management indicated there is no predefined process for the FDA response and hopes for a collaborative interaction [24][25] Question: Impact of currency and distributor shift on Ducoral sales - Management noted that the transition to a new distributor in Germany caused a technical delay in purchases, but growth for Ducoral is expected to continue [25][26] Question: Timing for Lyme phase 3 readout - Management stated that Pfizer controls the process and is taking steps to ensure an early readout, with no major delays anticipated [27][28] Question: Remedies proposed to FDA for exchange BLA suspension - The response to the FDA focused on medical evidence and positive risk-benefit ratios, with ongoing pharmacovigilance reviews [29] Question: Launch timeline for VLA15 - Management confirmed that timelines communicated by Pfizer support a launch in the autumn of 2027, contingent on regulatory submissions next year [30][31] Question: Funding considerations for Zika vaccine candidate - Management highlighted uncertainty around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [33][36]

Financial Performance - Total revenues for the first nine months of 2025 reached €127.0 million, an 8.9% increase compared to the same period in 2024, despite headwinds and reduced third-party sales [11] - Product sales amounted to €119.4 million, a 6.2% increase from €112.5 million in the first nine months of 2024 [51] - IXCHIQ® sales saw significant growth, reaching €7.6 million, a 330% increase compared to €1.8 million in the same period of 2024 [51] - The company experienced a significant reduction in operating cash burn, with €28.4 million compared to €76.7 million in the first nine months of 2024 [11] - Valneva anticipates product sales between €155 million and €170 million for 2025 [59] Product & Pipeline Updates - IXIARO®/JESPECT® sales increased by 12.5%, reaching €74.3 million compared to €66.0 million in the first nine months of 2024 [51] - DUKORAL® sales decreased slightly by 3.4%, with sales of €21.5 million compared to €22.3 million in the first nine months of 2024 [51] - Valneva completed all vaccinations in the VALOR Phase 3 study for VLA15 (Lyme disease vaccine) and expects efficacy read-out in H1 2026 [16, 27] - The global market for Shigella vaccine is expected to exceed $500 million annually [48] Strategic Initiatives - Valneva successfully refinanced its debt, enhancing financial flexibility to Q4 2030 [11] - The company secured a new $32.8 million IXIARO® contract with the U.S Department of Defense [16] - Valneva responded to the French government's call for IXCHIQ® to combat chikungunya outbreaks in La Réunion and Mayotte [16]

Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $17.2 million, a decrease of $24.5 million compared to Q3 2024, while revenues for the nine months ended September 30, 2025, were $74.8 million, down $54.7 million year-over-year [14] - Total operating expenses for Q3 2025 were $33.7 million, down from $52.4 million in Q3 2024, and for the nine months ended September 30, 2025, total operating expenses were $119.8 million compared to $191.8 million in the prior year [14][15] - The net loss for Q3 2025 was approximately $13.5 million or $0.49 per diluted share, compared to a net loss of $6.9 million or $0.26 per diluted share in Q3 2024 [16] Business Line Data and Key Metrics Changes - The ARCT-032 program for cystic fibrosis is progressing with a planned 12-week study to begin in the first half of 2026, following positive interim data from the ongoing phase 2 clinical trial [5][9] - The ARCT-810 program for ornithine transcarbamylase deficiency is preparing for regulatory meetings in 2026 to discuss pivotal trial strategies for both pediatric and adult populations [9][10] Market Data and Key Metrics Changes - The Costave COVID-19 vaccine program has faced delays in the BLA filing due to regulatory changes by the FDA, impacting commercial visibility in the U.S. [13] - The Japanese partner, Meiji Seika Pharma, has launched a two-dose vial of Costave updated for the JN.1 variant in Japan, marking the first distribution of this presentation [10] Company Strategy and Development Direction - The company is focused on advancing its mRNA therapeutics and vaccines pipeline, with a commitment to addressing the unmet medical needs in cystic fibrosis and OTC deficiency [9][18] - Cost reductions are being implemented to extend the runway for the cystic fibrosis and OTC programs, while expecting continued support from CSL for commercialization in Asia and Europe [13][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for ARCT-032 to address significant unmet medical needs in cystic fibrosis [7][8] - The company remains in a strong financial position with a cash runway extended into 2028, allowing for the achievement of near-term milestones [17] Other Important Information - The company plans to add additional sites for the upcoming 12-week study to accelerate enrollment, particularly targeting countries with higher prevalence of class one CF patients [78] - The FDA's stance on CT imaging as a potential endpoint for approval is still under discussion, with management indicating that it may serve as a supportive endpoint rather than a primary one [54] Q&A Session Summary Question: Have you been able to do some PK/PD modeling for the third-dose cohort? - Management confirmed that the third cohort is being evaluated similarly to the first two cohorts, with additional data collection planned for the 12-week study [21] Question: What are the optionalities for the OTC pivotal programs? - Management indicated that separate discussions with regulatory agencies will be held for adult and pediatric populations, focusing on different biomarkers for each group [24] Question: Do you expect improvements in mucus over time in the CF study? - Management noted that mucus plugs form in smaller airways and that improvements are expected over time, with the 12-week study designed to assess this [28] Question: What metrics will drive the go/no-go decision for the 15-mg dose? - Management stated that safety and tolerability will be key metrics, along with observing a dose response in mucus plug reduction [37] Question: When should we expect to see data from the 15-mg cohort? - Data from the 15-mg cohort is expected in the first quarter of next year, with plans to transition quickly to the 12-week study thereafter [44] Question: What is the age range for the pediatric population in the OTC program? - Management indicated that the age cutoff for pediatric patients will be determined in discussions with regulatory agencies [80]

As Filed with the Securities and Exchange Commission on October 17, 2025 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) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S. Employer Identification Number) 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080, (678) 384-7220 (Address, incl ...

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Baike Biotechnology Co., Ltd., received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its adsorbed acellular DTPa-Hib combined vaccine [1] Group 1 - The approved Hib vaccine is in a lyophilized form, which, when used in conjunction with the liquid form of the DTPa vaccine, reduces the number of injections required [1] - This combination aims to improve vaccination compliance among infants and young children [1]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively participating in the World Vaccine Congress–Europe 2025, showcasing its advancements in vaccine development, particularly the TNX-801 Mpox vaccine, which is aimed at enhancing vaccine effectiveness against infectious diseases [1][3]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a diverse pipeline of development candidates, focusing on central nervous system disorders, immunology, rare diseases, and infectious diseases [4]. - The company has received FDA approval for Tonmya, a first-in-class non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [4]. - Tonix's development portfolio includes treatments for acute migraine, acute stress reaction, major depressive disorder, organ transplant rejection, autoimmune diseases, and infectious diseases [4]. Upcoming Conference Details - Dr. Sina Bavari will present on the safety, durability, and protection of the single-dose TNX-801 Mpox vaccine on October 15, 2025 [3]. - A panel discussion moderated by Dr. Zeil Rosenberg will focus on enhancing vaccine effectiveness, using Mpox as a model, featuring experts from Tonix and other institutions [3].

Summary of Novavax Conference Call Company Overview - **Company**: Novavax - **Industry**: Biotechnology, specifically vaccine development Key Points and Arguments 1. **Company Transformation**: Novavax has transitioned from a single-product company focused on COVID-19 vaccines to a more diversified biotech firm, reducing expenses and strengthening its balance sheet while maintaining capabilities for future growth [8][78]. 2. **Vaccine Approval**: The company received full approval for its COVID-19 vaccine for individuals aged 65 and older, supported by data from clinical trials involving nearly 30,000 individuals and a safety database of over 5 million vaccinated individuals [11][12]. 3. **Partnership with Sanofi**: Novavax has partnered with Sanofi for the commercialization of its COVID-19 vaccine, with Sanofi taking over responsibilities and expected to drive significant growth in the vaccine market [22][28]. 4. **Financial Milestones**: The transition to Sanofi will trigger milestone payments of $50 million and an additional $75 million upon successful tech transfer, highlighting the financial benefits of the partnership [23][24]. 5. **Market Potential**: The global vaccine market is projected to grow from $57 billion in 2023 to over $75 billion by 2030, with Novavax positioned to benefit from this growth through its partnerships and innovative technology [36][48]. 6. **Combination Vaccines**: There is a strong consumer and physician preference for combination vaccines, which Novavax aims to develop in collaboration with Sanofi, leveraging their expertise in flu vaccines [45][47]. 7. **Royalties and Cash Flow**: For every billion dollars in sales of the COVID vaccine, Novavax expects to receive approximately $200 million in royalties, with additional opportunities from combination vaccines [52][54]. 8. **Research and Development Pipeline**: Novavax is expanding its R&D pipeline, focusing on multiple assets, including oncology, RSV, and pandemic flu vaccines, with the potential for significant market opportunities [34][70]. 9. **Cost Management**: The company has made significant strides in cost-cutting and debt management, targeting non-GAAP profitability by 2027, with a projected reduction in operating costs by 85% from peak levels [78][79]. 10. **Matrix M Adjuvant**: Novavax's proprietary Matrix M adjuvant is expected to facilitate the development of combination vaccines and enhance immune responses while reducing the required antigen amount [59][60]. Additional Important Content - **Post-Marketing Commitments**: Novavax is committed to ongoing studies to evaluate the safety and efficacy of its vaccines post-approval, which is standard for vaccine manufacturers [20][21]. - **Regulatory Landscape**: The company is actively preparing for future clinical trials and regulatory submissions, emphasizing the importance of safety and immunogenicity data [61][62]. - **Public Health Impact**: Novavax aims to address significant unmet medical needs, particularly in areas like C. diff and shingles, which could provide substantial public health benefits [72][74]. This summary encapsulates the critical insights from the Novavax conference call, highlighting the company's strategic direction, financial outlook, and market opportunities in the evolving vaccine landscape.