Financial Performance - FYARRO recognized net product sales of $6.2 million and $11.5 million for the three and six months ended June 30, 2024, respectively[101]. - Product sales for the three months ended June 30, 2024, were $6.2 million, consistent with the same period in 2023, while sales for the six months were $11.5 million, down from $12.1 million in 2023[119]. - Selling, general, and administrative expenses decreased to $7.9 million for the three months ended June 30, 2024, from $11.8 million in 2023, and to $18.5 million for the six months from $23.0 million[120]. - Research and development expenses for the three months ended June 30, 2024, were $13.1 million, slightly down from $13.3 million in 2023, while expenses for the six months increased to $26.7 million from $24.3 million[123]. - Other income for the three months ended June 30, 2024, was $1.0 million, down from $1.6 million in 2023, and for the six months, it was $2.2 million compared to $3.2 million[125]. - The company reported net losses of $14.6 million and $18.0 million for the three months ended June 30, 2024 and 2023, respectively, and $32.9 million and $33.2 million for the six months ended June 30, 2024 and 2023, respectively[126]. - Cash used in operating activities for the six months ended June 30, 2024 was $28.8 million, compared to $38.1 million for the same period in 2023[129]. - Cash provided by investing activities for the six months ended June 30, 2024 was $7.0 million, significantly lower than $66.9 million for the same period in 2023[130]. - Cash provided by financing activities for the six months ended June 30, 2024 was $0.1 million, compared to $0.3 million for the same period in 2023[131]. - The accumulated deficit as of June 30, 2024, was $301.8 million, primarily due to research and development costs and administrative expenses[109]. - The company has an accumulated deficit of $301.8 million as of June 30, 2024[126]. Research and Development - Research and development costs are expected to increase in 2024 due to significant expenses related to the PRECISION1 trial and other clinical programs[107]. - The company plans to increase investment in research and development to advance FYARRO in additional indications through clinical trials[114]. - The company is currently enrolling patients in Phase 2 trials for advanced or recurrent endometrioid endometrial cancer and neuroendocrine tumors[108]. - The PRECISION1 trial was fully enrolled in April 2024 and is expected to be completed by the end of 2024, with results anticipated in early 2025[102]. - The company has contracts with various organizations for research and development activities, including clinical trial management and drug manufacturing[132]. Commercialization and Sales - The company has built a cross-functional commercial team and expects a decrease in commercialization expenses compared to prior periods[107]. - The decrease in product sales for the six months ended June 30, 2024, was attributed to distributor ordering patterns and fewer new patient initiations[119]. - Royalties on net product sales under the BMS License Agreement were $0.5 million for the three months ended June 30, 2024, consistent with the same period in 2023[103]. - A payment of $5.8 million to BMS is due no later than August 26, 2024, under the BMS License Agreement[108]. - The EOC arbitration process is expected to yield a decision in the second half of 2024, which may significantly impact sales, general, and administrative expenses[108]. Cash and Financial Position - As of June 30, 2024, the company had $78.6 million in cash, cash equivalents, and short-term investments, expected to fund operations into Q4 2025[109]. - 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[127]. - The company entered into a lease for 10,615 square feet of office space in Morristown, New Jersey, with a term of seventy-three months[132]. Collaboration and Partnerships - The company terminated its collaboration with Mirati Therapeutics in May 2024, discontinuing enrollment in the Phase 1/2 trial[102].
Aerpio Pharmaceuticals(AADI) - 2024 Q2 - Quarterly Report