PharmaCyte Biotech(PMCB) - 2022 Q3 - Quarterly Report

Product Development - The company is focused on developing cellular therapies for cancer and diabetes using its proprietary Cell-in-a-Box technology[139]. - The current product candidate, CypCaps™, is intended for a Phase 2b clinical trial in locally advanced pancreatic cancer (LAPC) but is currently on clinical hold by the FDA since October 1, 2020[139][148]. - The company is also developing a potential therapy for Type 1 diabetes using encapsulated insulin-producing cells[144]. - The encapsulation technology aims to optimize the delivery of cancer prodrugs directly to tumors, potentially improving treatment efficacy[142]. - The company is exploring the development of therapies involving cannabinoids for cancer treatment, pending the resolution of the clinical hold[145]. - The company is developing a protocol to measure the break and glide force of syringes used in clinical trials[153]. - A pig study has been designed to address biocompatibility and long-term implantation of CypCaps™[153]. Regulatory and Clinical Trials - The FDA has requested several additional studies and information to lift the clinical hold, including stability studies and genetic stability assessments[150]. - The company has completed a product stability study for CypCaps™ after 3, 6, 9, 12, and 18 months of storage at -80C, with the next analysis scheduled for 24 months[151]. - Six out of eight biocompatibility studies have been successfully completed, with ongoing studies to assess the safety of the product candidate[151]. - The COVID-19 pandemic has caused significant delays in clinical trials, impacting the company's operations and the timeline for addressing the FDA's clinical hold[152]. - The company has retained Biologics Consulting to assist with regulatory compliance and to perform a regulatory gap analysis[151]. Financial Performance - No revenues were reported for the three and nine months ended January 31, 2022, and 2021[157]. - Total operating expenses for the three months ended January 31, 2022, increased by $99,272 compared to the same period in 2021, primarily due to a $93,022 increase in R&D expenses[158]. - Total operating expenses for the nine months ended January 31, 2022, increased by $296,275 from the same period in 2021, with R&D expenses rising by $205,031[160]. - Net cash used in operating activities for the nine months ended January 31, 2022, was $2,925,479, compared to $2,390,586 for the same period in 2021[163]. - Cash provided by financing activities for the nine months ended January 31, 2022, was $87,362,049, significantly higher than $4,586,002 in the same period in 2021[163]. - As of January 31, 2022, cash totaled approximately $86.6 million, up from approximately $3.1 million as of January 31, 2021[168]. - Working capital was approximately $87 million as of January 31, 2022, compared to approximately $2.5 million as of January 31, 2021[168]. - Funding of approximately $86.2 million was provided by investors during the nine months ended January 31, 2022, to support operations and R&D[169].