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aerovate therapeutics Aerovate Therapeutics Announces Third Quarter 2021 Financial Results November 15 , 2021 WALTHAM , Mass . , Nov. 15 , 2021 ( 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 announced our financial results for the quarter ended September 30 , 2021 , and recent events . " We continue to make progress with clinical trial sites to participate in our global Phase 2b / 3 trial of AV - 101 in PAH and expect to initiate enrollment this year in the Phase 2b portion of the trial , " said Timothy Noyes , chief executive officer of Aerovate . " We are also pleased with investor support for our IPO , which we believe provides sufficient capital to fund Aerovate into the second half of 2025. " Recent Events Raised $ 126.9 Million in Net Proceeds from IPO . On July 2 , 2021 , we closed our initial public offering ( IPO ) raising gross proceeds of $ 139.8 million , which included full exercise of the underwriters ' option to purchase additional shares of common stock , at a public offering price of $ 14.00 per share . We raised net proceeds of approximately $ 126.9 million after deducting underwriting discounts and commissions and other offering expenses payable by us . Preparation Continues for Global Phase 2b / 3 Clinical Trial . We continued preparing for the initiation of our Phase 2b / 3 trial of AV - 101 , our dry powder inhaled formulation of imatinib for the treatment of pulmonary arterial hypertension , or PAH , a devastating disease impacting approximately 70,000 people in the United States and Europe . Drug supply has been manufactured and we have begun scheduling site activation meetings in the United States . We anticipate including experienced PAH centers from more than 20 countries in our Phase 2b / 3 trial . We have obtained orphan drug designation from the U.S. Food and Drug Administration and the European Medicines Agency for AV - 101 for the treatment of PAH in the United States and the European Union . Third Quarter 2021 Financial Results Cash and cash equivalents totaled $ 180.9 million as of September 30 , 2021 , compared to $ 59.2 million as of June 30 , 2021. The increase was primarily driven by net proceeds of $ 126.9 million from the Company's IPO , which closed on July 2 , 2021 , offset by operational costs for the three - month period ending September 30 , 2021 . R & D expenses : Research and development ( R & D ) expenses for the third quarter of 2021 were $ 3.4 million as compared to $ 2.0 million for the third quarter of 2020. The increase in R & D expenses was due primarily to increased clinical trial costs and manufacturing costs in the third quarter of 2021 as compared to the third quarter of 2020 . G & A expenses : General and administrative ( G & A ) expenses for the third quarter of 2021 were $ 2.8 million as compared to $ 0.3 million for the third quarter of 2020. The increase in G & A expenses was due primarily to increased headcount - related costs , insurance costs , legal fees , accounting fees and consulting expenses in the third quarter of 2021 as compared to the third quarter of 2020 . Net loss : Net loss for the third quarter of 2021 was $ 6.2 million as compared to $ 2.3 million for the third quarter of 2020. Net loss included stock - based compensation expense of $ 0.8 million for the third quarter of 2021 and $ 21,000 for the third quarter of 2020 . Financial guidance : We expect that our cash and cash equivalents will be sufficient to fund our operations into the second half of 2025 , based on our current operating plan . About Aerovate Therapeutics Aerovate is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease . Aerovate's initial focus is on advancing AV - 101 , our dry powder inhaled formulation of the drug imatinib for the treatment of pulmonary arterial hypertension , or PAH . For more information , please visit www.aerovatetx.com . 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 , " " look forward to , ” “ may , ” “ plan , ” “ potential , ” “ predict , ” “ project , ” “ potential , " seek , " " strategy , " " should , " " target , " " will , " " would " and similar expressions regarding future periods . These forward - looking statements include , but are not limited to , statements regarding the therapeutic potential of AV - 101 ; our expectations that we will initiate enrollment in the second half of 2021 for the Phase 2b portion of our Phase 2b / 3 trial of AV - 101 in PAH ; our expectations of identifying clinical site locations and recruitment of patients for our Phase 2b / 3 trial ; our belief that we will have capital to fund Aerovate into the second half of 2025 ; our business plans and objectives for AV - 101 , including expectations regarding timing and success of the our Phase 2b / 3 clinical trial , the therapeutic potential and clinical benefits of AV - 101 and potential regulatory submissions and approvals for AV - 101 ; and our growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress . Any forward - looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks , uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward- looking statements contained in this press release , including , without limitation , those risks and uncertainties related to the therapeutic potential of AV - 101 , and the timing associated with the identification of clinical sites , patient recruitment , initiation and continuation of our Phase 2b / 3 trial of AV - 101 in PAH patients , the impact of the COVID - 19 pandemic on our business , clinical trials , operations and goals , positive results from a clinical