PharmaCyte Biotech(PMCB) - 2024 Q2 - 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[136] - The current product candidate is referred to as "CypCaps™" and is intended for use in treating locally advanced pancreatic cancer (LAPC)[136] - The company is exploring therapies for Type 1 diabetes using encapsulated genetically modified insulin-producing cells[140] - The company has also been developing therapies for malignant ascites using encapsulated cells placed in the peritoneal cavity[139] - The company is conducting a pig study to assess biocompatibility and long-term implantation of CypCaps™, with the first phase completed and preliminary data being evaluated[152] Regulatory and Clinical Trials - The FDA placed the company's Investigational New Drug (IND) application for LAPC on clinical hold, requiring additional data and studies to lift the hold[144] - The company is in the latter stages of conducting studies to address the FDA's requests, including genetic stability studies and compatibility evaluations of delivery devices[146] - The company completed various additional studies requested by the FDA, including a 36-month stability study on cells from the Master Cell Bank (MCB)[148] - The company has retained Biologics Consulting to perform a regulatory "Gap Analysis" to assist with the resubmission of the IND[147] - The company is in the process of updating its IND submission documentation, including discussions on immunological aspects of its treatment for LAPC[152] Financial Performance - No revenues were reported for the three and six months ended October 31, 2023 and 2022[151] - Total operating expenses for the three months ended October 31, 2023 were $1,409,520, a decrease of$909,100 (39%) compared to the same period in 2022[153] - Research and Development (R&D) expenses for the three months ended October 31, 2023 were $82,033, a decrease of$95,963 (54%) from $177,996 in 2022[154] - Other income for the three months ended October 31, 2023 was$4,199,416, significantly higher than $438,113 in the same period of 2022, primarily due to interest income[156] - Net cash used in operating activities for the six months ended October 31, 2023 was$1,641,395, an improvement from $2,963,642 in 2022[159] - Total operating expenses for the six months ended October 31, 2023 decreased by$514,382 to $3,484,846 compared to the same period in 2022[155] Cash and Capital Management - As of October 31, 2023, cash and cash equivalents totaled approximately$73 million, down from $77 million as of October 31, 2022, indicating a decrease of about 5.19$68 million as of October 31, 2023, compared to approximately $76 million as of October 31, 2022, reflecting a decline of about 10.53$26.6 million during the six months ended October 31, 2023[162] - The gross proceeds from the private placement of preferred shares and warrants amounted to $35 million, with potential additional proceeds of approximately$35 million if all warrants are exercised[164] - The company expects to fund operating expenses for at least the next 12 months using existing cash balances and may consider additional debt or equity issuances[165] Corporate Governance - The company has entered into a Cooperation Agreement with Iroquois Master Fund Ltd. to reconstitute its board and form a Business Review Committee to evaluate its strategy and operations[136] - The Board is reviewing risks associated with the company's relationship with SG Austria, which may affect development timelines[136] - Spending on development programs has been curtailed pending the completion of the Business Review Committee's evaluation[143] - A service agreement was entered into for approximately $392,000 related to clearing a clinical hold on an IND submission, with$157,000 allocated to related parties[171] - The Board established a Strategic Scientific Committee to enhance oversight of scientific initiatives, with Dr. Michael Abecassis as Chair[169] - Non-employee directors were granted a cash retainer fee of $60,000 and options to purchase shares at an exercise price of$2.18 per share[167] Accounting and Compliance - The company’s financial statements are prepared in accordance with U.S. GAAP, with management regularly reviewing critical accounting estimates and policies[172]