PharmaCyte Biotech(US:PMCB)2025-09-15 20:37Cellular Therapies and Technology - The company is focused on developing cellular therapies for cancer using its proprietary Cell-in-a-Box® technology, with the current product candidate named CypCaps™[105] - The company is reevaluating its relationship with SG Austria, which holds critical know-how related to the Cell-in-a-Box® technology[106] - The company has identified alternative approaches to expand its prodrug/activator technology for cancer treatment[109] FDA Interactions and Clinical Trials - The FDA placed the company's Investigational New Drug Application (IND) for LAPC on clinical hold, requiring additional studies and data submissions to lift the hold[110] - The company is in ongoing discussions with the FDA to potentially forego large animal studies based on existing human clinical trial data[113] - The company aims to lift the clinical hold on its IND to commence the planned clinical trial in LAPC, contingent on meeting FDA requirements[114] - The company is actively working to address FDA requests, including providing additional data and conducting required studies to support its clinical trial application[113] Financial Performance - Revenue for the three months ended July 31, 2025, was $0, consistent with the same period in 2024[116] - Research and development expenses decreased to $95,157 for the three months ended July 31, 2025, from $96,016 in 2024, a decrease of 0.9%[117] - General and administrative expenses decreased by $419,723, or 36%, to $753,148 for the three months ended July 31, 2025, compared to $1,172,871 in 2024[118] - Other income (expenses), net, for the three months ended July 31, 2025, was $(7,511,791), a significant decline from $24,690,242 in 2024[119] - Net cash used in operating activities was $(1,993,981) for the three months ended July 31, 2025, compared to $(373,297) in 2024[121] - As of July 31, 2025, the company had approximately $13.2 million in cash and cash equivalents, down from $15.2 million at April 30, 2025[125] - The company expects its current cash and cash equivalents of approximately $15.7 million will be sufficient for projected operating requirements for at least the next twelve months[125] Capital Needs and Financing - In August 2025, the company entered into a securities purchase agreement to sell 7,000 shares of Series C convertible preferred stock, resulting in gross proceeds of $7 million[126] - The company anticipates needing additional capital to complete a clinical trial for pancreatic cancer treatment, which may involve dilutive financing[128] - The company has entered into service agreements estimated at approximately $591,000 related to the clinical hold on its IND submission involving LAPC[129] Cost Management - The company has curtailed spending on development programs, including preclinical and clinical activities, pending a review by the Strategic Scientific Committee and the Board[106] - Eight out of ten biocompatibility studies requested by the FDA have been completed successfully, confirming the bioinert nature of the capsule material[112] - The company has successfully completed stability studies for its product candidate, confirming its integrity over 24 months at -80C[112]