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 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 795,969 for the three months ended January 31, 2023, from 788,847, compared to other expense, net of 1,214,562, up from 2,667,898 to 2,884,313 in the same period of 2022[160] - General and administrative, legal, and professional expenses increased by 125% 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 2.9 million for the same period in 2022[167] - Cash and cash equivalents as of January 31, 2023, totaled approximately 87 million as of January 31, 2022[172] - The company reported a net cash used in financing activities of 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 157,000 attributed to related parties[180] - The company received gross proceeds 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]
PharmaCyte Biotech(PMCB) - 2023 Q3 - Quarterly Report