GeoVax Labs(US:GOVX)2021-11-12 03:49Financial Data and Key Metrics Changes - Cash balances at September 30 were $18 million compared to just under $10 million at December 31 of the previous year [25] - Working capital increased to $17.8 million from $9.4 million [25] - Net loss for the nine-month period of 2021 was $4.8 million or $0.80 per share, compared to a net loss of $1.6 million or $2.85 per share in the prior year [28] Business Line Data and Key Metrics Changes - Grant and collaboration revenues were $220,000 in 2021 compared to $1.6 million in 2020, with 2021 revenues relating entirely to a grant from the NIH for the COVID-19 vaccine [26] - Research and development expenses rose to $2.7 million in 2021 from $1.7 million in 2020, attributed to license fees and increased activity related to COVID-19 vaccine programs [27] Market Data and Key Metrics Changes - The company has confirmed two additional clinical sites for the Gedeptin trial and initiated the IND transfer [9] - The Phase 2 clinical trial for the COH04S1 vaccine is the only one prospectively studying safety and effectiveness in blood cancer patients who have received bone marrow transplants or CAR-T therapy [12] Company Strategy and Development Direction - The company remains focused on delivering results in COVID-19 and immuno-oncology, aiming to secure resources for growth and development [6] - The exclusive license for the COH04S1 vaccine is expected to significantly accelerate development activities in the COVID-19 prevention market [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress and outlook for the company, highlighting successful entry into clinical development for both immuno-oncology and COVID-19 vaccine programs [7][8] - The company anticipates that existing cash reserves are sufficient to advance programs through mid-2022 [30] Other Important Information - The company is developing a portfolio of hemorrhagic fever virus vaccines with support from the federal government [10] - The Gedeptin program is being evaluated for potential expansion into first-line treatment options [45] Q&A Session Summary Question: Is there data showing mRNA vaccines are insufficient for immunocompromised patients? - Yes, existing data indicates that mRNA vaccines function sub-optimally in immunocompromised patients, which is why the focus is on this population [38] Question: What type of patient needs will be enrolled in the booster study? - The study will focus on healthcare workers who are healthy volunteers and have received the Pfizer vaccine [41] Question: What is the timeline for data readout from the Gedeptin program? - Currently, the company is in the process of transferring IND and expanding clinical sites, making it difficult to project a data readout timeline [43] Question: Will the clinical development of the 04S1 vaccine expand to other immunocompromised groups? - Yes, there is interest in expanding to other immunocompromised populations, but it will be data-driven based on initial results [50] Question: What is the status of pre-clinical studies for Marburg and Sudan viruses? - Ongoing tests are being conducted, and the decision to move into clinical trials will depend on market forces and federal funding priorities [53]