Company Overview - Vaxcyte (PCVX) is a clinical-stage biotech company focused on developing vaccines for bacterial infectious diseases [1] - The company's shares have experienced a significant decline of 56% in the past month due to mixed results from a phase II study on its pneumococcal conjugate vaccine (PCV) [1][3] Stock Performance - Year-to-date, Vaxcyte's shares have plummeted over 62%, significantly underperforming the industry, which has seen an 8% decline [3] - The stock is trading below its 50 and 200-day moving averages, indicating weak market sentiment [3] Vaccine Study Results - Vaxcyte's recent mid-stage study evaluated its 24-valent PCV VAX-24 against Pfizer's Prevnar 20, which is approved for preventing invasive pneumococcal disease caused by 20 serotypes [6] - The mid-dose of VAX-24 met non-inferiority criteria for seroconversion and showed robust immune responses, but did not meet the criteria for four of the 24 serotypes compared to Prevnar 20, contributing to the stock's decline [7] - VAX-24 was well-tolerated and demonstrated a safety profile similar to Prevnar 20, with strong markers for protection against invasive pneumococcal disease [8] Future Development Plans - Based on the study results, Vaxcyte plans to advance the mid-dose formulation of VAX-24 into late-stage development [9] - The company is also conducting a mid-stage study on its investigational 31-valent PCV vaccine VAX-31, with top-line results expected in mid-2026, and plans to start a phase III study in infants with either VAX-24 or VAX-31 [10] Industry Context - The broader biotech and drug sector is facing challenges, including the resignation of a senior FDA official, raising concerns about the agency's ability to maintain innovation and regulatory clarity [2]

Financial Data and Key Metrics Changes - Dynavax reported record HEPLISAV-B product revenue of $71 million for Q4 2024, up 39% year-over-year, and $268 million for the full year, up 26% year-over-year [16][33] - The gross margin for HEPLISAV-B was 82% for the full year 2024, an increase from 76% in 2023, achieving the guidance of approximately 80% for 2024 [34] - The company achieved net income of $27 million for the full year, including $7 million in Q4 [36] - Non-GAAP adjusted EBITDA for Q4 was $13 million, an increase of over 200% year-over-year, and $52 million for the full year, up over 300% compared to the prior year [37] Business Line Data and Key Metrics Changes - HEPLISAV-B's total market share increased to 44% by the end of 2024, driven by strong commercial execution [15] - The overall hepatitis B vaccine dose growth increased by nearly 10% year-over-year in 2024, with HEPLISAV-B's dose growing by 25% annually [16][17] - The market opportunity for HEPLISAV-B expanded by approximately $90 million to $650 million in 2024, with expectations to peak over $900 million by 2030 [22] Market Data and Key Metrics Changes - The inclusion of adult hepatitis B vaccination in the HEDIS measure is expected to enhance focus and utilization in integrated delivery networks (IDNs) and large clinics [20][21] - The new Medicare policy allows access to hepatitis B vaccines at retail pharmacies, which is anticipated to support HEPLISAV-B's growth in 2025 [19][104] Company Strategy and Development Direction - The company aims to drive continued top-line growth for HEPLISAV-B, with projected net product sales between $305 million to $325 million in 2025 [8][41] - Dynavax is focused on advancing its clinical pipeline, particularly the shingles vaccine program Z-1018, which is expected to establish a differentiated product profile [9][10] - The company plans to pursue external opportunities to generate sustainable long-term value for shareholders while maintaining a balanced capital allocation strategy [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in 2025 being a transformational year for the development pipeline, with multiple programs advancing to important milestones [8] - The company is optimistic about the ongoing adoption of HEPLISAV-B and the positive market dynamics that will support long-term revenue opportunities [18][21] - Management highlighted the importance of maintaining commercial efforts to sustain market share and drive growth [92] Other Important Information - The company exited 2024 with cash equivalents and marketable securities of $714 million, down from $742 million at the end of 2023, partly due to share repurchase activities [38][39] - Dynavax plans to complete the remaining $100 million of authorized share repurchases by the end of 2025 [39] Q&A Session Summary Question: What barriers need to be overcome to drive continued market share growth? - Management highlighted the importance of access in the Medicare patient population and the impact of the HEDIS measure on market share gains [48] Question: What is the expected non-inferiority level for the shingles program? - The company aims for a CD4 response rate of 75% or greater compared to Shingrix, considering both quantity and quality of T cell responses [54][56] Question: How will the company approach the Phase III study for shingles? - The design and timeline for the Phase III study are still under evaluation, with plans to leverage Phase I/II data for regulatory discussions [127] Question: What is the potential market size for the plague vaccine program? - The market size will depend on government assessments of biological threats, with current efforts focused on the DoD [130] Question: What is the company's appetite for additional buybacks? - Management indicated that while they are committed to the current buyback program, they will consider additional buybacks based on future performance and opportunities [76]

As filed with the Securities and Exchange Commission on September 6, 2024 Registration No. 333- 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080 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 ...