PharmaCyte Biotech(PMCB) - 2026 Q3 - Quarterly Report

Product Development and Regulatory Status - The company is focused on developing cellular therapies for cancer using its proprietary Cell-in-a-Box® technology, with the current product candidate referred to as CypCaps™[142]. - The company has curtailed spending on development programs, including preclinical and clinical activities, pending a review by the Strategic Scientific Committee and the Board[143]. - The FDA placed the company's Investigational New Drug Application (IND) for LAPC on clinical hold, requiring additional studies and data to be submitted[147]. - The company has successfully completed various stability studies for its product candidate, including a 24-month stability study at -80°C[149]. - Eight out of ten biocompatibility studies requested by the FDA have been completed successfully[150]. - The company is in ongoing dialogue with the FDA to address the clinical hold and hopes to meet manufacturing standard requirements for the LAPC treatment[150]. - The company aims to lift the clinical hold on its IND to commence the planned clinical trial in LAPC[151]. - The company is exploring alternative approaches to expand its prodrug/activator technology for cancer treatment[146]. - The company has determined not to pursue research and development in diabetes treatment[142]. - The Strategic Scientific Committee is reviewing risks associated with the company's development programs and its relationship with SG Austria, which may lead to a new framework for collaboration[143]. Financial Performance - No revenues reported for the three and nine months ended January 31, 2026, and 2025[159]. - R&D expenses decreased by $25,083 to $93,113 for the three months ended January 31, 2026, but increased by $17,673 to $329,355 for the nine months ended January 31, 2026[160][161]. - General and administrative expenses increased by 141% to $2,024,989 for the three months ended January 31, 2026, primarily due to stock-based compensation and increased legal fees[162]. - Other income (expenses), net, for the three months ended January 31, 2026, was $2,864,962 compared to $(2,085,076) for the same period in 2025[164]. - Net cash used in operating activities was $(3,760,352) for the nine months ended January 31, 2026, compared to $(1,937,925) for the same period in 2025[167][168]. - Cash provided by investing activities for the nine months ended January 31, 2026, included $5,000,000 from the collection of a note receivable[169]. - Cash provided by financing activities totaled $6,751,395 for the nine months ended January 31, 2026, primarily from a private placement of Series C convertible preferred stock[171]. Compliance and Stock Performance - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement, with a compliance deadline of June 1, 2026[154][156]. - The company intends to actively monitor its stock price and may consider a reverse stock split to regain compliance with Nasdaq listing requirements[158]. Capital and Funding Needs - As of January 31, 2026, the company had approximately $20.2 million in cash and cash equivalents, an increase from $15.2 million at April 30, 2025[173]. - The company expects its current cash and cash equivalents of approximately $19 million will be sufficient to support projected operating requirements for at least the next twelve months[173]. - In August 2025, the company raised $7 million through a private placement of 7,000 shares of Series C convertible preferred stock and warrants to purchase up to 7 million shares of Common Stock[174]. - In September 2025, the company agreed to purchase QCLS Series H convertible preferred stock for an aggregate price of $3 million, initially convertible into 600,000 shares of QCLS Common Stock[175]. - The company anticipates needing additional capital to complete a clinical trial for pancreatic cancer, with potential equity financing likely to be dilutive to current stockholders[176]. - The company has entered into service agreements estimated at approximately $591,000 related to clearing a clinical hold on its IND submission involving LAPC[178]. - The related party portion of the service agreements is estimated to be approximately $157,000, with spending on this program curtailed until a review is complete[178]. Industry and Accounting - The company operates in an industry subject to rapid technological change and significant risks, including regulatory approval and capital raising challenges[177]. - There have been no material changes to the company's critical accounting estimates since the last Annual Report[179]. - The company's filings, including Annual Reports and Quarterly Reports, are available on its website and the SEC's website[180].