Aerovate Therapeutics(US:AVTE)2024-05-13 20:39Business and Financial Overview Aerovate Therapeutics reported key clinical trial progress for AV-101 and strengthened its financial position, alongside an increased net loss in Q1 2024 driven by higher R&D expenses Business Highlights Aerovate Therapeutics anticipates topline Phase 2b data for AV-101 in June 2024 and extended its cash runway into 2026 through a $23.6 million capital raise - Topline data from the Phase 2b portion of the IMPAHCT global clinical trial for AV-101 in PAH is expected in June 202412 - Enrollment is ongoing for the Phase 3 portion of the IMPAHCT trial, with over 120 clinical sites participating across more than 20 countries3 - Baseline characteristics from the Phase 2b portion of the IMPAHCT trial will be presented at the ATS 2024 International Conference on May 21, 20243 - In April 2024, the company raised net proceeds of approximately $23.6 million through its 'at-the-market' (ATM) program from a single purchaser4 - The company projects its current cash, cash equivalents, and short-term investments are sufficient to fund operations into 202616 First Quarter 2024 Financial Results Aerovate reported a net loss of $23.2 million in Q1 2024, an increase from the prior year, primarily due to higher R&D expenses Q1 2024 Financial Performance vs. Q1 2023 (in millions) | Financial Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $20.1 | $13.5 | Increase | | G&A Expenses | $4.5 | $4.2 | Increase | | Net Loss | $23.2 | $16.5 | Increased Loss | | Stock-based Compensation | $4.2 | $2.4 | Increase | Cash Position (in millions) | Date | Cash, Cash Equivalents & Short-term Investments | | :--- | :--- | | March 31, 2024 | $99.3 | | December 31, 2023 | $122.4 | - The increase in R&D expenses was primarily due to higher clinical trial costs, manufacturing costs, and increased headcount5 - The company expects its cash and investments to fund operations into 2026, based on the current operating plan6 Corporate and Product Information This section details AV-101, an investigational inhaled therapy for PAH, and the design of its global IMPAHCT clinical trial About AV-101 AV-101 is an investigational, proprietary dry powder inhaled formulation of imatinib designed for direct lung delivery to treat pulmonary arterial hypertension - AV-101 is a proprietary dry powder inhaled formulation of the antiproliferative drug imatinib7 - It is designed to treat PAH by targeting cellular hyperproliferation and resistance to apoptosis in the distal pulmonary arteries7 - The drug is delivered via an easy-to-use dry powder inhaler directly into the lungs to limit systemic adverse effects7 About the IMPAHCT Trial The IMPAHCT trial is a global, placebo-controlled Phase 2b/Phase 3 study evaluating AV-101 in adults with PAH, assessing PVR in Phase 2b and 6MWD in Phase 3 - IMPAHCT is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with PAH, featuring continuous enrollment from Phase 2b to Phase 38 - The Phase 2b portion evaluates three doses of AV-101 over 24 weeks, with the primary endpoint being change in pulmonary vascular resistance (PVR)8 - The Phase 3 portion will use the optimal dose identified in Phase 2b, with the primary endpoint being the change in six-minute walk distance (6MWD) over 24 weeks8 Financial Statements This section presents Aerovate's condensed consolidated balance sheets and statements of operations for the recent periods Condensed Consolidated Balance Sheets Aerovate's total assets decreased to $106.8 million as of March 31, 2024, with a corresponding reduction in total stockholders' equity Condensed Consolidated Balance Sheets (Unaudited, in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and short-term investments | $99,334 | $122,439 | | Other assets | $7,487 | $4,979 | | Total assets | $106,821 | $127,418 | | Liabilities and Stockholders' Equity | | | | Accounts payable and accrued and other current liabilities | $15,073 | $17,217 | | Other liabilities | $844 | $745 | | Total liabilities | $15,917 | $17,962 | | Total stockholders' equity | $90,904 | $109,456 | | Total liabilities and stockholders' equity | $106,821 | $127,418 | Condensed Consolidated Statements of Operations and Comprehensive Loss For Q1 2024, the company reported a net loss of $23.2 million, or ($0.83) per share, primarily due to increased operating expenses Condensed Consolidated Statements of Operations (Unaudited, in thousands, except per share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $20,080 | $13,488 | | General and administrative | $4,538 | $4,151 | | Total operating expenses | $24,618 | $17,639 | | Loss from operations | $(24,618) | $(17,639) | | Total other income | $1,432 | $1,119 | | Net loss | $(23,186) | $(16,520) | | Net loss per share, basic and diluted | $(0.83) | $(0.67) |