PharmaCyte Biotech(PMCB) - 2026 Q2 - Quarterly Report

Company Focus and Development - The company is focused on developing cellular therapies for cancer using its proprietary Cell-in-a-Box® technology, specifically targeting locally advanced, inoperable, non-metastatic pancreatic cancer (LAPC) with its product candidate CypCaps™[144] - The company has curtailed spending on development programs, including preclinical and clinical activities, pending a review by the newly formed Strategic Scientific Committee[145] - The FDA placed the company's Investigational New Drug Application (IND) for LAPC on clinical hold on October 1, 2020, requiring additional studies and data to be submitted[149] - The company has successfully completed stability studies for its product candidate, confirming its stability over 24 months when stored at -80°C[151] - Eight out of ten biocompatibility studies requested by the FDA have been completed successfully, confirming the bioinert nature of the capsule material[152] - The company is in ongoing discussions with SG Austria to prepare for the next steps in addressing FDA concerns and to add requested information to the drug master file[152] - The company is developing methods to test the physical stability and integrity of CypCaps™ under extreme pressure, requiring new equipment for validation[153] - The company is assessing the compatibility of CypCaps™ with delivery devices, ensuring that the quality of the capsules is maintained during the implantation process[153] - The company aims to resolve non-clinical issues to enable FDA review of a new clinical protocol that reflects the standard of care for LAPC[153] - The company has determined that it will no longer pursue research and development in the treatment of diabetes[144] Financial Performance - No revenues were reported for the three and six months ended October 31, 2025, and 2024[161] - Research and development expenses increased to $141,085 for the three months ended October 31, 2025, from $97,470 in the same period of 2024, marking a 44.7% increase[162] - General and administrative expenses for the three months ended October 31, 2025, were $1,234,966, an increase of 22% from $1,008,590 in 2024[164] - Other income (expenses), net, for the three months ended October 31, 2025, was $(6,041,924), compared to $(363,500) for the same period in 2024[166] - Net cash used in operating activities for the six months ended October 31, 2025, was $(2,973,504), compared to $(1,428,032) in 2024[169] - Cash used in investing activities for the six months ended October 31, 2025, was $(3,000,000), down from $(7,000,000) in 2024[169] - Cash provided by financing activities for the six months ended October 31, 2025, was $6,207,616, compared to $(20,912,124) in 2024[169] - As of October 31, 2025, the company had approximately $15.4 million in cash and cash equivalents, slightly up from $15.2 million at April 30, 2025[175] - The company expects its current cash and cash equivalents of approximately $21 million will be sufficient to support projected operating requirements for at least the next twelve months[175] - The company entered into a securities purchase agreement in August 2025, resulting in gross proceeds of $7 million from the sale of 7,000 shares of Series C convertible preferred stock[176] - The company expects to need additional capital to complete a clinical trial for pancreatic cancer treatment, with potential equity financing being significantly dilutive to current stockholders[178] - The total estimated cost for service agreements related to the clinical hold on the IND submission involving LAPC is approximately $591,000, with $157,000 allocated to related parties[180] Industry and Regulatory Environment - The company operates in an industry characterized by rapid technological change, competition, and government regulation, facing significant risks including financial, operational, and regulatory uncertainties[179] - There have been no material changes to the company's critical accounting estimates from the previous Annual Report on Form 10-K for the year ended April 30, 2025[181]