Aerovate Therapeutics, Inc. announced that it has continued on the IMPAHCT Global Phase 2b/Phase 3 Clinical Trial. IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a Phase 2b/Phase 3 trial of AV-101, self-administered, twice daily dry powder inhaled formulation of the antiproliferative drug imatinib for the treatment of pulmonary arterial hypertension (PAH), a devastating disease impacting approximately 70,000 people in the United States and Europe. The increase in R&D expenses was due primarily to clinical trial costs, manufacturing costs, and increased headcount-related costs in 2022 as compared to 2021.

Aerovate is enrolling patients in the IMPAHCT Phase 2b/Phase 3 clinical trial to evaluate the safety and efficacy of different doses of AV-101 in adults with PAH. IMPAHCT (Inhaled iMatinib pulmonary Arterial Hypertension clinical trial) is a Phase 2b and Phase 3 trial of AV- 101, self-administered, two daily dry powder inhaled formulation the antiproliferative drug Imatinib for the treatment of lung arterial hypertension (PAH). The increase in R&D costs was due primarily to clinical trial cost, manufacturing costs, and increased Headcount-related costs in 2022 As compared to 2021.

Aerovates is enrolling patients in theIMPAHCT Phase 2b and Phase 3 clinical trial to evaluate the Safety and efficacy of different doses ofAV-101 in adults with PA H. IMPAHCT (inhaled iMatinibulmonary Arterial Hypert Extension Clinical Trial) is a multi-national, placebo-controlled Phase 2b/Phase 3 trials in adults with PAH that will continuously enroll patients as the study progresses from Phase 2b to Phase 3. These forward-looking statements include, but are not limited to, statements regarding the therapeutic potential and clinical benefits of AV-101; expectations regarding clinical site activation and patient enrollment for Phase 2b/Phase 3 study; anticipated timing for the release of topline data from the Phase 2b portion of clinical trial; belief that will have capital to fund Aerovate into the second half of 2025; our expectations regarding the strength of our intellectual property portfolio globally; our business plans and objectives for AV-101, including expectations regarding timing and success of our Phase 2b/Phase 3 clinical trial, potential regulatory submissions and approvals for AV-101; the anticipated contribution of the members of our board of directors and management team to our operations and progress; and our growth and goals as a company.