Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.0001 per share AVTE The Nasdaq Global Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition ...

[Business and Financial Overview](index=1&type=section&id=Business%20and%20Financial%20Overview) 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](index=1&type=section&id=Business%20Highlights) 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 2024**[1](index=1&type=chunk)[2](index=2&type=chunk) - Enrollment is ongoing for the Phase 3 portion of the IMPAHCT trial, with over **120 clinical sites** participating across more than **20 countries**[3](index=3&type=chunk) - Baseline characteristics from the Phase 2b portion of the IMPAHCT trial will be presented at the ATS 2024 International Conference on **May 21, 2024**[3](index=3&type=chunk) - In April 2024, the company raised net proceeds of approximately **$23.6 million** through its 'at-the-market' (ATM) program from a single purchaser[4](index=4&type=chunk) - The company projects its current cash, cash equivalents, and short-term investments are sufficient to fund operations into **2026**[1](index=1&type=chunk)[6](index=6&type=chunk) [First Quarter 2024 Financial Results](index=1&type=section&id=First%20Quarter%202024%20Financial%20Results) 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 headcount[5](index=5&type=chunk) - The company expects its cash and investments to fund operations into **2026**, based on the current operating plan[6](index=6&type=chunk) [Corporate and Product Information](index=3&type=section&id=Corporate%20and%20Product%20Information) This section details AV-101, an investigational inhaled therapy for PAH, and the design of its global IMPAHCT clinical trial [About AV-101](index=3&type=section&id=About%20AV-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 imatinib[7](index=7&type=chunk) - It is designed to treat PAH by targeting cellular hyperproliferation and resistance to apoptosis in the distal pulmonary arteries[7](index=7&type=chunk) - The drug is delivered via an easy-to-use dry powder inhaler directly into the lungs to limit systemic adverse effects[7](index=7&type=chunk) [About the IMPAHCT Trial](index=3&type=section&id=About%20the%20IMPAHCT%20Trial) 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 3[8](index=8&type=chunk) - 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](index=8&type=chunk) - 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 weeks**[8](index=8&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents Aerovate's condensed consolidated balance sheets and statements of operations for the recent periods [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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)** |

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-40544 Aerovate Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1377888 (Stat ...

Exhibit 99.1 Aerovate Therapeutics Announces Full-Year 2023 Financial Results and Business Highlights ● Topline data expected in June 2024 from Phase 2b portion of the IMPAHCT global Phase 2b/Phase 3 clinical trial of AV-101 for pulmonary arterial hypertension (PAH) ● Completed enrollment in the Phase 2b portion and enrolled first patient into the Phase 3 portion of the IMPAHCT trial of AV-101 in November 2023 ● Expanded intellectual property portfolio with two issued patents in 2023 ● Board of Directors ex ...

WALTHAM, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (NASDAQ:AVTE), a clinical stage biopharmaceutical company focused on developing drugs that improve the lives of patients with rare cardiopulmonary disease, today announced that its Board of Directors has elected current Board member, Habib Dable, as Chair of the Board. Mr. Dable succeeds Mark Iwicki, who will continue to serve on the Board. "We are pleased to have Habib take on the role of Chair of the Board," said Tim Noyes, Chi ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.0001 per share AVTE The Nasdaq Global Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transit ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.0001 per share AVTE The Nasdaq Global Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition p ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.0001 per share AVTE The Nasdaq Global Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-40544 Aerovate Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1377888 (Stat ...

Meaningfully Improving the Lives of Patients with Rare Cardiopulmonary Disease Targeting the Hyperproliferative Cause of Pulmonary Arterial Hypertension Disclaimer; Forward-Looking Statements This presentation has been prepared by Aerovate Therapeutics, Inc. ("we," "us," "our," "Aerovate" or the “Company”) and is made for informational purposes only. The information set forth herein does not purport to be complete or to contain all ofthe information you may desire. Statements contained herein are made as of ...