PharmaCyte Biotech(PMCB) - 2023 Q3 - Quarterly Report

Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary "Cell-in-a-Box" technology[140] - The current product candidate is referred to as "CypCaps™" and is intended for use in various cancer therapies, including LAPC[140] - The company is developing therapies for Type 1 diabetes using encapsulated genetically modified insulin-producing cells[144] - The encapsulation technology has shown potential in laboratory settings to create a micro-environment for cell survival and production of active molecules[141] - The company is also exploring therapies for malignant ascites using the same encapsulated cells employed for pancreatic cancer[143] Regulatory Challenges - Due to a clinical hold placed by the FDA on the IND for LAPC, the company is facing delays and increased costs in its development efforts[135] - The FDA has requested additional data and studies to lift the clinical hold, including genetic stability studies and compatibility assessments of delivery devices[149] - The company is conducting various studies requested by the FDA, including biocompatibility studies and stability studies for its product candidate for pancreatic cancer[154] - The company has retained Biologics Consulting for regulatory expertise and gap analysis to assist with IND resubmission[153] Financial Performance - The company reported no revenues for the three and nine months ended January 31, 2023, and 2022[159] - Total operating expenses for the three months ended January 31, 2023, increased by $696,864 to $1,552,983 from $856,119 in the same period of 2022[160] - Research and Development (R&D) expenses decreased by 71% to $45,393 for the three months ended January 31, 2023, compared to $158,039 in 2022[161] - Director fees increased by 838% to $795,969 for the three months ended January 31, 2023, from $84,897 in the same period of 2022[161] - Other income, net, for the three months ended January 31, 2023, was $788,847, compared to other expense, net of $44,829 for the same period in 2022[164] - Interest income for the nine months ended January 31, 2023, was $1,214,562, up from $71,078 in the same period of 2022[165] - Total operating expenses for the nine months ended January 31, 2023, increased by $2,667,898 to $5,552,211 from $2,884,313 in the same period of 2022[160] - General and administrative, legal, and professional expenses increased by 125% to $3,238,824 for the nine months ended January 31, 2023, compared to $1,437,324 in 2022[163] Cash Flow and Liquidity - Net cash used in operating activities for the nine months ended January 31, 2023, was approximately $3.5 million, compared to $2.9 million for the same period in 2022[167] - Cash and cash equivalents as of January 31, 2023, totaled approximately $73 million, down from approximately $87 million as of January 31, 2022[172] - The company reported a net cash used in financing activities of approximately $9.3 million, primarily due to the repurchase of common stock[171] - The increase in operating expenses was approximately $3.5 million, contributing to the decrease in cash[172] - The company had no investing activities for the nine months ended January 31, 2023, and 2022[170] - The company expects to use existing cash balances and may consider additional debt or equity issuances to meet liquidity needs[179] - Total estimated cost for service agreements related to clinical hold is approximately $214,000, with $157,000 attributed to related parties[180] - The company received gross proceeds of approximately $70 million from a registered direct offering and concurrent private placement in August 2021[175] - The company reported a net increase (decrease) in cash and cash equivalents of approximately $(12.76) million for the nine months ended January 31, 2023[172] - The company has a history of operating losses, which may affect its ability to raise capital on acceptable terms[179] Strategic Initiatives - The company has entered into a Cooperation Agreement with Iroquois Master Fund Ltd. to reconstitute its Board and evaluate its business strategy[140] - The company has curtailed spending on its development programs pending the completion of a review by the Business Review Committee[147] - The company is not currently allocating resources to its Cannabis Program until it receives FDA approval for its LAPC clinical trial[145]