Universal influenza vaccine

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PDS Biotech Announces Additional Details on Two Preclinical Universal Influenza Presentations at IMMUNOLOGY2025™ Annual Meeting
Globenewswire· 2025-05-08 12:00
Core Insights - PDS Biotechnology Corporation is advancing its investigational flu vaccine, Infectimune, which has shown promising preclinical immune response data at the IMMUNOLOGY2025™ Annual Meeting [1][2] - The vaccine has demonstrated a significantly greater frequency of multifunctional, influenza-specific CD4 T cells compared to current vaccine approaches, indicating its potential effectiveness [2] - Infectimune-based universal flu vaccines have shown excellent breadth of protective immune response against multiple strains of influenza in preclinical studies [3] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to target and kill cancers and infectious diseases [1][5] - The company is currently conducting a pivotal clinical trial for its lead program, Versamune HPV, aimed at treating advanced HPV16-positive head and neck squamous cell cancers [5] - PDS Biotech is leveraging collaborations to enhance its research while focusing resources on its immuno-oncology programs [4]
GeoVax Labs(GOVX) - 2025 Q1 - Earnings Call Transcript
2025-05-01 20:30
Financial Data and Key Metrics Changes - Revenues associated with the BARDA contract were $1.6 million in Q1 2025 compared to zero in Q1 2024, as the contract began in June 2024 [19] - The net loss for Q1 2025 was approximately $5.4 million or $0.45 per share, compared to a net loss of $5.9 million or $2.47 per share in Q1 2024 [21] - Cash balances at March 31, 2025, were $7.4 million, up from $5.5 million at December 31, 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.4 million in Q1 2025 from $4.4 million in Q1 2024, representing a 21% increase [20] - General and administrative expenses rose to $1.7 million in Q1 2025 from $1.5 million in Q1 2024, a 16% increase [21] Market Data and Key Metrics Changes - The company estimates that over 40 million adults in the U.S. have medical conditions rendering them inadequately responsive to first-generation vaccines, with a global estimate of over 400 million at such risk [11] Company Strategy and Development Direction - The company aims to advance its product candidates, including GEO CM04S1, GEO MVA, and Gideptin, focusing on unmet healthcare needs and expedited registration paths [6][14] - The advanced MVA manufacturing process is expected to provide a competitive advantage in the production of MVA-based vaccines and therapies [6] - The company is committed to establishing U.S.-based manufacturing for its MVA vaccines, with ongoing discussions with government stakeholders [55][56] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the BARDA Project NextGen stop work order but emphasized that it would not impact ongoing clinical trials [10] - The company remains optimistic about the potential of its multi-antigen COVID-19 vaccine, CM04S1, particularly for immunocompromised populations [11][46] - Management highlighted the significant governmental interest in U.S.-based supply chains and the need for expanded MPOXX vaccine supply [15][16] Other Important Information - The company plans to present clinical results for CM04S1 at multiple conferences throughout 2025, which may serve as catalysts for strategic partnerships [12] - The company is exploring various funding strategies to support its development programs, including strategic partnerships and non-dilutive funding [22] Q&A Session Summary Question: Comparison with Vaxart's program and implications of the stop work order - Management noted distinct differences between Vaxart's program and its own, emphasizing that Vaxart had already dosed patients before the halt [26][28] Question: Impact of recent comments on placebo-controlled vaccine trials - Management confirmed ongoing trials and expressed confidence in the multi-antigen approach, which they believe offers enhanced value [34][37] Question: Next steps for trials based on upcoming results - The focus remains on immunocompromised populations, with plans for expanded trials if current results are encouraging [42][46] Question: Safety and efficacy of the MPOXX vaccine - Management confirmed that MVA has been recognized for its safety and has not shown concerning side effects in their products [52] Question: Support for U.S.-based manufacturing - Management indicated ongoing discussions with government representatives to establish U.S.-based manufacturing for MVA vaccines [55][56]