Aerovate Therapeutics Reports Q1 Financials and Business Highlights

Aerovate Therapeutics, Inc., a biopharmaceutical company based in Waltham, Massachusetts, has released its financial results for the quarter ending March 31, 2024, along with notable updates on its ongoing clinical trials and business operations.

The company is currently advancing its global Phase 2b/Phase 3 clinical trial of AV-101, known as the IMPAHCT trial, designed to address pulmonary arterial hypertension (PAH). This trial is examining the effectiveness of AV-101, an inhaled formulation of the drug imatinib, which is self-administered twice daily using a dry powder inhaler. The goal is to improve symptoms and outcomes for PAH, a severe condition that affects approximately 70,000 individuals in the U.S. and Europe.

Aerovate expects to announce topline data from the Phase 2b portion of the trial in June 2024. This segment of the trial aims to determine the optimal dosage by assessing changes in pulmonary vascular resistance (PVR) and evaluating safety and tolerability over a 24-week period. The Phase 3 portion, which seamlessly follows the Phase 2b segment, is currently in progress, having started patient enrollment in November 2023. This later stage will focus on changes in six-minute walk distance (6MWD) over 24 weeks compared to a placebo group.

A significant number of clinical sites are participating in the Phase 3 portion, with over 120 locations across more than 20 countries. Patient enrollment is ongoing, and the results from the Phase 2b trial will influence the size and timing of the Phase 3 trial outcomes.

In addition to clinical trial updates, Aerovate announced that baseline characteristics from the Phase 2b portion will be presented at the American Thoracic Society (ATS) 2024 International Conference on May 21, 2024, in San Diego, California.

Financially, Aerovate secured approximately $23.6 million in net proceeds in April 2024 through its "at-the-market" (ATM) program. As of March 31, 2024, the company reported cash, cash equivalents, and short-term investments totaling $99.3 million, down from $122.4 million as of December 31, 2023. The decrease is largely attributed to operational expenses incurred during the first quarter of 2024.

The company’s research and development (R&D) expenses for the first quarter of 2024 were $20.1 million, an increase from $13.5 million in the same period in 2023. This rise is primarily due to higher costs associated with clinical trials, manufacturing, and increased personnel. General and administrative (G&A) expenses also saw a slight increase from $4.2 million in the first quarter of 2023 to $4.5 million in 2024, driven by higher headcount, travel, and miscellaneous costs.

Aerovate reported a net loss of $23.2 million for the quarter ended March 31, 2024, compared to a net loss of $16.5 million for the same period in 2023. The net loss includes stock-based compensation expenses of $4.2 million for the quarter.

Looking forward, the company projects that its current cash reserves will support operations into 2026, based on its existing financial plan.

AV-101, the focus of Aerovate’s clinical development, is a proprietary dry powder inhaled formulation of imatinib intended for PAH treatment. By targeting abnormal cell growth and resistance to cell death in the pulmonary arteries, AV-101 aims to offer significant therapeutic benefits beyond those provided by existing treatments. Phase 1 results indicated that AV-101 is generally well-tolerated, with no serious adverse events reported.

The IMPAHCT trial is a multi-national, placebo-controlled study that continuously enrolls patients from Phase 2b to Phase 3. The trial's primary objectives are to evaluate the efficacy of AV-101 in improving PVR and 6MWD, along with assessing its safety and tolerability.

Aerovate Therapeutics remains committed to enhancing the lives of patients with rare cardiopulmonary diseases through innovative drug development, with AV-101 representing their leading initiative in this mission.