Aerpio Pharmaceuticals(AADI) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - FYARRO product sales were $6.2 million for Q2 2024, consistent with the prior year and up 15$14.6 million, an improvement from $18 million in Q2 2023 [22] - Cash, cash equivalents, and short-term investments totaled$78.6 million at the end of Q2 2024, supporting operations into Q4 2025 [21] Business Line Data and Key Metrics Changes - FYARRO has achieved cumulative sales of $51.1 million since its launch in February 2022, with a 14$13.1 million, slightly down from $13.3 million in the prior year [21] - Selling, general, and administrative expenses decreased to$7.9 million from $11.8 million in Q2 2023, attributed to reduced commercial and legal expenses [21] Market Data and Key Metrics Changes - The market opportunity for TSC1 and TSC2 mutated cancers is projected to be between$300 million to $600 million in the U.S. alone [18] - Approximately 16,000 patients with TSC1 and TSC2 mutations exist across various tumor types, with nearly half of these tumors found in high NGS testing specialties [17] Company Strategy and Development Direction - The company is focused on expanding nab-sirolimus for larger indications across multiple types of mTOR-driven tumors, with ongoing trials in endometrial cancer and neuroendocrine tumors [8][9] - The PRECISION1 trial is a registration-intended tumor-agnostic study, fully enrolled with 120 patients, expected to complete by the end of the year [11][12] - The company aims to provide interim analysis results from PRECISION1 in Q3 2024, which could lead to discussions with the FDA regarding a potential submission [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical development plans and the potential for nab-sirolimus to address significant unmet needs in oncology [23] - The company anticipates a catalyst-heavy 2024 and 2025, with key data readouts expected to support future growth [10][23] Other Important Information - The company has seen a strong rebound in demand for FYARRO in Q2 2024, with expectations for continued incremental growth in Q3 and Q4 [38] - The design of the PRECISION1 trial aligns with the latest regulatory guidance for tumor-agnostic studies, enhancing confidence in its potential approval [15][16] Q&A Session Summary Question: Expectations for PRECISION1 interim data - Management indicated that the Q3 interim data will focus on the primary endpoint of overall response rate after a minimum of six months of follow-up [26] Question: Future adjustments to PRECISION1 trial - The trial is fully enrolled, and no adjustments are anticipated at this time, with results expected in early 2025 [36] Question: Growth expectations for FYARRO - Management remains positive about continued growth, citing strong demand and increased ordering accounts [38] Question: Specific tumor types for future trials - The company is conducting a tumor-agnostic trial and does not plan to bias enrollment towards specific tumor types [41] Question: Data disclosure for endometrial cancer program - Management plans to disclose overall response rates and any differences based on lines of treatment, depending on the data set [48] Question: Excitement in KOL community for nab-sirolimus - There is enthusiasm for both the TSC1/2 approach and the endometrial cancer program, with specialists looking for innovative treatments [56]