PharmaCyte Biotech(PMCB) - 2024 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[130]. - The current product candidate generation is referred to as "CypCaps™" and is intended for use in therapies for various cancers, including LAPC[130]. - The company is conducting a pilot study involving two pigs to assess the safety and activity of its product candidate for pancreatic cancer, with plans for a larger study involving 90 pigs[140]. - The company is developing a potential therapy for Type 1 diabetes using encapsulated genetically modified insulin-producing cells, designed to function as a bio-artificial pancreas[134][136]. - The company is exploring therapies for malignant ascites using encapsulated cells placed in the peritoneal cavity, administered with ifosfamide[133]. - The company has completed eight out of ten biocompatibility studies requested by the FDA, with ongoing studies expected to be completed soon[142]. - The company has successfully completed stability studies for its clinical trial product candidate for pancreatic cancer, confirming the product's integrity over 36 months[141]. Regulatory and Clinical Trials - The FDA placed the company's Investigational New Drug (IND) application on clinical hold on October 1, 2020, requiring additional data and studies to lift the hold[138]. - The company has curtailed spending on development programs pending a review by the Business Review Committee and the Board, which may delay timelines for addressing the FDA clinical hold[130][137]. - The total estimated cost for service agreements related to the clinical hold on the IND submission involving LAPC is approximately $332,000[162]. Financial Performance - Total operating expenses for the three months ended January 31, 2024, were$1,868,946, an increase of 20.3% compared to 1,552,983 for the same period in 2023[145]. - Research and Development (R&D) expenses increased by 179% to 126,732 for the three months ended January 31, 2024, compared to $81,339 in the same period in 2023[146]. - Compensation expenses rose by 147$620,777 for the three months ended January 31, 2024, compared to $369,221 in the same period in 2023[146]. - Other income for the three months ended January 31, 2024, was$1,249,409, an increase from $788,847 in the same period in 2023, primarily due to increased interest income[149]. - Net cash used in operating activities for the nine months ended January 31, 2024, was$1,818,499, a decrease from $3,505,343 in the same period in 2023[152]. - Total operating expenses for the nine months ended January 31, 2024, were$5,353,792, a decrease of 3.6% compared to $5,552,211 for the same period in 2023[145]. - Interest income for the nine months ended January 31, 2024, was$2,651,721, compared to $1,214,562 in the same period in 2023, reflecting an increase in interest rates[150]. - As of January 31, 2024, cash and cash equivalents totaled approximately$61 million, down from approximately $73 million as of January 31, 2023, indicating a decrease of about 16.4$62 million as of January 31, 2024, compared to approximately $68 million as of January 31, 2023, reflecting a decrease of about 8.8$27 million during the nine months ended January 31, 2024[156]. - The gross proceeds from the Private Placement on May 10, 2023, were $35 million, with potential additional proceeds of approximately$35 million if all Warrants are exercised[157]. - The company entered into a Purchase Agreement to acquire senior unsecured convertible notes worth $5 million, convertible at a price of$1.18 per share[159]. - The company expects to use existing cash balances and may consider additional issuances of debt or equity securities to meet liquidity needs[158]. - The Series B Preferred Stock is classified as temporary equity due to its redeemable nature upon certain contingent events[171]. - Basic net income (loss) per share is computed using the weighted-average number of shares of common stock outstanding[172]. - The company’s future capital requirements are difficult to forecast and will depend on various factors, but it believes current cash on hand will fund operating expenses for at least the next 12 months[158]. Management and Partnerships - The company is evaluating its relationship with SG Austria, which may impact the development of programs dependent on this partnership[130]. - The company has experienced significant management changes, which could increase control risks and adversely affect business operations[127]. - The company is not currently allocating resources to its Cannabis Program until the FDA allows the commencement of its clinical trial in LAPC[135].