Aerovate Therapeutics Announces First Quarter Financial Results and Business Highlights

• Topline data expected in June 2024 from the Phase 2b portion of the global IMPAHCT Phase 2b/Phase 3 clinical trial of AV-101 for pulmonary arterial hypertension (PAH)

• Enrollment Continues in Phase 3 IMPAHCT Trial of AV-101

• Poster to be presented with basic characteristics of the Phase 2b portion of the IMPAHCT study at the ATS 2024 Conference on May 21

• Cash flow until 2026, based on our current operating plan

WALTHAM, Mass., May 13, 2024 (GLOBE NEWSWIRE) – Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing medicines that significantly improve the lives of patients with rare cardiopulmonary diseases, today announced financial results for the quarter ended March 31, 2024 and recent business highlights.

Recent highlights

Topline data expected in June 2024 from the phase 2b portion of the global phase 2b/phase 3 IMPAHCT clinical trial. IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a global Phase 2b/Phase 3 trial of AV-101, our twice-daily self-administered inhaled dry powder formulation of the antiproliferative drug imatinib for the treatment of PAH. PAH is a devastating disease that affects approximately 70,000 people in the United States and Europe. We continue to expect to provide topline data in June 2024.

Registration continues in phase 3 of IMPAHCT. Due to the perfect study design, we were able to enroll our first patient in the Phase 3 IMPAHCT study in November 2023, simultaneously with the completion of enrollment in our Phase 2b portion of the IMPAHCT study. Enrollment continues with more than 120 clinical sites in more than 20 countries participating in phase 3 of the study. The timing of Phase 3 pivotal data and the size of the Phase 3 portion of the trial will be determined based on results from the Phase 2b portion of the trial.

Poster to be presented with basic characteristics of the Phase 2b part of IMPAHCT at the ATS 2024 International Conference in May. In a poster presentation at the American Thoracic Society (ATS) 2024 International Conference on May 21, 2024 in San Diego, CA, we will present baseline characteristics of patients enrolled in the dose-ranging Phase 2b portion of IMPAHCT.

It sold US$24 million in April under the ATM Program. As of April 2024, we raised net proceeds of approximately $23.6 million from a single purchaser through Aerovate’s existing “at-the-market” (ATM) program.

First Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments totaled US$99.3 million as of March 31, 2024 (before considering the US$23.6 million in net proceeds collected in April under the ATM program), compared to US$122.4 million as of December 31, 2023. The decrease was primarily driven by operating costs for the three-month period ending March 31, 2024.

The story continues

R&D Expenses: Research and development (R&D) expenses for the quarter ended March 31, 2024 were $20.1 million, compared to $13.5 million for the quarter ended March 31, 2023. The increase in R&D expenses was mainly due to clinical trial costs, manufacturing costs and increased costs related to the number of employees in 2024 compared to 2023.

General and Administrative Expenses: General and administrative (G&A) expenses for the quarter ended March 31, 2024 were $4.5 million compared to $4.2 million for the quarter ended March 31, 2023. The increase in expenses G&A was primarily due to increased costs related to headcount, travel and other miscellaneous costs in 2024 compared to 2023.

Net loss: Net loss for the quarter ended March 31, 2024 was $23.2 million compared to $16.5 million for the quarter ended March 31, 2023. Net loss included compensation expense based in shares of US$4.2 million and US$2.4 million for the quarters ending March 31, 2024 and March 31, 2023, respectively.

Financial guidance: We expect our cash, cash equivalents and short-term investments to be sufficient to fund our operations through 2026, based on our current operating plan.

About AV-101

AV-101 is an experimental, patented inhaled dry powder formulation of the antiproliferative drug imatinib. Developed specifically for pulmonary arterial hypertension (PAH), AV-101 targets cellular hyperproliferation and resistance to apoptosis driven by inappropriate signaling in distal pulmonary artery cells. By targeting the proliferation and accumulation of cells in the arteries of the lungs, we believe AV-101 has the potential to provide significant improvements to patients beyond the capabilities of currently approved therapies. AV-101 is designed to be administered via an easy-to-use dry powder inhaler directly into the lungs to maximize potential clinical benefit and limit systemic adverse effects. Phase 1 results published in ERJ Open Research showed that AV-101 administered by dry powder inhalation was generally well tolerated by healthy adult volunteers, with no reports of serious adverse events. Aerovate has completed enrollment in the Phase 2b IMPAHCT clinical trial and is currently enrolling patients in Phase 3 to evaluate the safety and efficacy of AV-101 in adults with PAH.

About the IMPAHCT trial

IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a Phase 2b/Phase 3, placebo-controlled, multinational trial in adults with PAH that has continuously enrolled patients from Phase 2b to Phase 3. The Phase 2b portion of the trial will evaluate three doses of AV-101 over 24 weeks, compared to placebo, to identify an optimal dose based on the primary endpoint, change in pulmonary vascular resistance (PVR), and safety, tolerability, and other clinical measures. The Phase 3 portion of the study will compare patients taking the optimal dose of AV-101, selected from Phase 2b data, with placebo. The primary endpoint of the phase 3 study will be change in six-minute walk distance (6MWD) over 24 weeks versus placebo. More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT05036135https://clinicaltrials.gov/ct2/show/NCT05036135.

About Aerovate Therapeutics, Inc.

Aerovate is a clinical-stage biopharmaceutical company focused on developing medicines that significantly improve the lives of patients with rare cardiopulmonary diseases. Aerovate’s initial focus is on advancing AV-101, its proprietary inhaled dry powder formulation of the drug imatinib for the treatment of patients with PAH. Learn more at aerovatetx.com or follow the company on X (formerly known as Twitter) and LinkedIn.

Available information

Aerovate announces material information to the public about the Company, its products and services and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts, investor relations section of the Company’s website at ir.aerovatetx.com, and the Company’s FD.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by words such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “future”, “goal”, “intend”, “expect”. to”, “may”, “plan”, “potential”, “predict”, “project”, “potential”, seek”, “strategy”, “should”, “target”, “will”, “would ” and similar expressions in relation to future periods. These forward-looking statements include, but are not limited to, statements regarding the therapeutic potential and clinical benefits of AV-101 in PAH; our anticipated timeline for the release of pivotal data from phase 2b of the IMPAHCT study; our expectations regarding continued patient recruitment for the phase 3 IMPAHCT trial; our belief that we will have the capital to fund Aerovate through 2026; our business plans and objectives for AV-101, including expectations regarding the timing and success of IMPAHCT; and our growth and goals as a company.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and factors that could cause actual events or results to differ materially from those expressed or implied by any forward-looking statement. statements contained in this press release, including, without limitation, the risks and uncertainties relating to the therapeutic potential and clinical benefits of AV-101; the timing associated with patient enrollment, initiation, delivery of drug supply, and continuation of our Phase 2b/Phase 3 study of AV-101 in patients with PAH; clinical trials, operations and objectives; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; as well as the risks and uncertainties set forth in more detail under the heading “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise such statements to reflect any change in expectations or in events, conditions or circumstances on which such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date.

(1) Non-cash charges were $4.2 million and $2.4 million for the three months ended March 31, 2024 and 2023, respectively.

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