Financial Performance - The company recognized net product sales of $7.1 million for the nine months ended September 30, 2025, from its lead drug product FYARRO, which was launched in the U.S. for the treatment of advanced malignant PEComa[164]. - Total revenue for the nine months ended September 30, 2025, was $7.1 million, down from $18.7 million in 2024, primarily due to the cessation of FYARRO sales[188]. - The company reported a net income of $2.7 million for the nine months ended September 30, 2025, compared to a net loss of $45.4 million for the same period in 2024[199]. - Other income for the nine months ended September 30, 2025, was $92.2 million, significantly up from $3.1 million in 2024, primarily due to a gain on the sale of a business[197]. Research and Development - The company plans to submit three investigational new drug (IND) applications to the FDA by mid-2026, targeting solid tumors, cancers of female origin, and neuroendocrine cancers[161][162]. - The company plans to increase investment in research and development related to ADC Therapies, continuing to incur significant expenses in this area[182]. - Research and development expenses for the three months ended September 30, 2025, increased to $14.3 million from $10.0 million in 2024, driven by higher clinical drug product manufacturing costs[192]. - Research and development expenses for the nine months ended September 30, 2025, were $71.9 million, up from $36.7 million in 2024, reflecting a $38.0 million upfront license fee paid to WuXi Biologics[193]. Cash and Investments - The company has $162.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, which is expected to support operations into 2028[175]. - Cash used in operating activities for the nine months ended September 30, 2025, was $80.2 million, compared to $44.5 million for the same period in 2024[207][210]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $94.4 million, primarily from the 2024 PIPE Financing[213]. - Cash used in investing activities for the nine months ended September 30, 2025, included $125.8 million for short-term investments[211]. Business Transactions - The company completed the divestiture of the FYARRO Business for a cash payment of $102.4 million on March 25, 2025, resulting in a significant gain on sale contributing to net income for the nine months ended September 30, 2025[165]. - The company entered into a License Agreement with WuXi Biologics for the development and commercialization of three next-generation antibody drug conjugates (ADCs), with potential milestone payments totaling $805 million[166]. - The company entered into a Sales Agreement with Cowen for an "at the market offering" of common stock with gross proceeds of up to $75.0 million, with no shares sold as of September 30, 2025[201]. - The Shelf Registration Statement allows the company to sell up to $150.0 million of various securities, providing flexibility for future capital needs[203]. Management and Strategy - The company has a strong management team with extensive experience in oncology therapeutics, positioning it well to execute its strategy for ADC Therapies and future pipeline assets[163]. - The company has incurred an accumulated deficit of $330.0 million as of September 30, 2025, primarily due to research and development costs and operational expenses[175]. - The accumulated deficit as of September 30, 2025, was $330.0 million, with net losses incurred in each year since inception except for the nine months ended September 30, 2025[199]. - The company expects to continue incurring significant expenses and operating losses in the foreseeable future due to ongoing research and development activities[175]. Expenses - Selling, general and administrative expenses for the three months ended September 30, 2025, were $5.2 million, down from $7.2 million in 2024, a decrease of $2.0 million[189]. - Rent expense for the Pacific Palisades and Morristown leases was $34.0 thousand and $0.1 million for the three months ended September 30, 2025, respectively[217].
Aerpio Pharmaceuticals(AADI) - 2025 Q3 - Quarterly Report