Aerpio Pharmaceuticals(AADI) - 2024 Q3 - Quarterly Report

Financial Performance - FYARRO recognized net product sales of $7.2 million and$18.7 million for the three and nine months ended September 30, 2024, respectively[95]. - Product sales for the three months ended September 30, 2024, were $7.2 million, an increase of 20.9$6.0 million for the same period in 2023[114]. - Total revenue for the nine months ended September 30, 2024, was $18.7 million, compared to$18.0 million for the same period in 2023, reflecting strong demand for FYARRO[114]. - The accumulated deficit as of September 30, 2024, was $314.4 million, with net losses of$12.5 million for the three months ended September 30, 2024[123]. Operational Changes - The company halted the PRECISION1 trial based on interim analysis results, indicating it was unlikely to meet the efficacy threshold for accelerated approval[97]. - A workforce reduction of 22 employees, representing approximately 32% of the workforce, was approved by the Board of Directors[98]. - The company expects to decrease investment in research and development due to the halt of the PRECISION1 study and paused enrollment in two Phase 2 trials[103]. - Restructuring charges for the three and nine months ended September 30, 2024, were $2.6 million, resulting from a workforce reduction of 32$62.6 million in cash, cash equivalents, and short-term investments as of September 30, 2024, expected to fund operations into the second half of 2026[104]. - For the nine months ended September 30, 2024, cash used in operating activities was $44.5 million, resulting from a net loss of$45.4 million[125]. - Cash provided by investing activities for the nine months ended September 30, 2024 was $12.1 million, related to maturities of short-term investments of$50.0 million[128]. - The company received funding of $72.2 million from a private investment in public equity financing on September 22, 2022[124]. Strategic Initiatives - The company is conducting a comprehensive strategic review to maximize shareholder value[97]. - The company has a shelf registration statement allowing it to sell up to$150.0 million of various securities, providing flexibility for future capital needs[124]. - The company has sufficient supply of FYARRO for at least the next two years based on estimated demand and is seeking to enter into a new agreement for its manufacture[131]. Expenses - Selling, general and administrative expenses decreased by $4.0 million to$7.2 million for the three months ended September 30, 2024, compared to $11.2 million for the same period in 2023[115]. - Research and development expenses for the three months ended September 30, 2024, were$10.0 million, a decrease of $1.9 million from$11.9 million in 2023[119]. - Other income for the three months ended September 30, 2024, was $0.9 million, down from$1.5 million in 2023, primarily due to a decrease in short-term investments[122]. Legal and Compliance - The arbitration panel found that the company did not breach the EOC License Agreement, resulting in no liability for damages to EOC[98]. - The commercial sale of FYARRO was launched on February 22, 2022, marking a significant milestone in the company's operations[103].