Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary "Cell-in-a-Box" technology[135]. - The current product candidate is referred to as "CypCaps™" and is intended for use in therapies for several types of cancer, including LAPC[135]. - The company is currently conducting a pilot study involving two pigs to evaluate the safety and activity of its product candidate for pancreatic cancer[145]. - The encapsulation technology aims to protect genetically engineered live human cells, enhancing their survival and efficacy in producing active molecules[136]. - The company is also developing therapies for Type 1 diabetes using encapsulated genetically modified insulin-producing cells[139]. 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[131]. - The FDA has requested additional data and studies to lift the clinical hold, including genetic stability studies and a biocompatibility assessment[144]. - The company is currently addressing various regulatory requirements to lift the clinical hold on its IND for the planned clinical trial in LAPC[152]. Financial Performance - The total operating expenses for the three months ended October 31, 2022, increased by 2,318,620 from 1,004,843 in the same period in 2021, primarily due to increases in R&D costs, compensation, legal, and consulting expenses[155]. - R&D expenses for the three months ended October 31, 2022, were 177,996, reflecting a 32% increase from 400,420, a 51% increase from 1,971,034 to 2,028,194 in the same period in 2021[157]. - R&D expenses for the six months ended October 31, 2022, were 278,833 in the same period in 2021[158]. - Compensation expenses for the six months ended October 31, 2022, were 533,897 in the same period in 2021[158]. - General and administrative, legal, and professional expenses for the three months ended October 31, 2022, were 543,557 in the same period in 2021[156]. - General and administrative, legal, and professional expenses for the six months ended October 31, 2022, were 1,091,251 in the same period in 2021[158]. - The company had no revenues for the three and six months ended October 31, 2022, and 2021[154]. Cash Flow and Liquidity - Net cash used in operating activities for the six months ended October 31, 2022, was (2,626,834) for the same period in 2021, indicating an increase in operational losses[162]. - Cash and cash equivalents as of October 31, 2022, totaled approximately 87 million as of October 31, 2021, primarily due to increased operating expenses and stock repurchase[165]. - The cash used in financing activities for the six months ended October 31, 2022, was approximately 347,000, with a significant portion allocated to related parties[172]. - The company had no investing activities for the six months ended October 31, 2022, and 2021, indicating a focus on operational rather than investment expenditures[163]. - The company received gross proceeds of approximately (8,438,069) for the six months ended October 31, 2022, compared to an increase of $84,736,506 in the same period of 2021[162]. - The company has no off-balance sheet arrangements that could materially affect its financial condition, revenues, or expenses[170]. Corporate Governance - The company has entered into a Cooperation Agreement with Iroquois Master Fund Ltd. to reconstitute its Board and evaluate its business strategy[135]. - Spending on development programs has been curtailed pending the completion of the Business Review Committee's evaluation[142]. - The company is exploring new frameworks for its relationship with SG Austria, which may impact its development programs[135].
PharmaCyte Biotech(PMCB) - 2023 Q2 - Quarterly Report