ATLANTA, June 21, 2024 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Aerovate Therapeutics, Inc. (“Aerovate” or the “Company”) (NASDAQ: AVTE) complied with federal securities laws. On June 17, 2024, Aerovate announced topline results from the Phase 2b portion of the Phase 2b/Phase 3 Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial and stated that “the study did not meet its primary endpoint for improvement in pulmonary arterial hypertension (“PVR”) compared to placebo for ...

Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, June 20, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Aerovate Therapeutics, Inc. (“Aerovate” or the “Company”) (Nasdaq: AVTE) investors that a class action has been filed on behalf of investors. Aerovate investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq. Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley ...

Aerovate Therapeutics’ (AVTE) shares plummeted 93.3% in the last trading session on Jun 17 after the company announced disappointing top-line results from the mid-stage portion of the IIb/III IMPAHCT study evaluating its lead candidate, AV-101, in adults with pulmonary arterial hypertension (PAH).The mid to late-stage IMPAHCT study evaluated the efficacy, safety and tolerability of three different doses of AV-101 compared with placebo.Per the data readout from the phase IIb portion of the IMPAHCT study, AV- ...

WALTHAM, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (NASDAQ:AVTE) today announced topline results from the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH). The objective of the Phase 2b portion of IMPAHCT was to assess the efficacy, ...

WALTHAM, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today announced topline results from the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH). The objective of the Phase 2b portion of IMPAHCT was to assess the efficacy ...

Solskin Aerovate Therapeutics, Inc. (NASDAQ:AVTE) is developing a drug known as AV-101, which is being used to treat patients with pulmonary arterial hypertension [PAH]. The use of this inhaled drug is being explored in the ongoing phase 2b/3 IMPAHCT trial. Speaking of inhaled drug, this is highly promising. The reason why I say that is because AV-101 is an inhaled version of imatinib. It had done well in clinical trial when given to patients orally, but the problem was systemic side effects. This is wh ...

Baseline characteristics reflect a PAH population with significant disease Topline data from Phase 2b portion of IMPAHCT study to be released in June 2024 Enrollment into the Phase 3 portion of IMPAHCT continues at more than 120 sites globally WALTHAM, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today presented a pos ...

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 ...