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aerovate therapeutics Aerovate Therapeutics Announces Second Quarter 2021 Financial Results August 16 , 2021 WALTHAM , Mass . , Aug. 16 , 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 its financial results for the quarter ended June 30 , 2021 , and recent events . " It has been an exciting quarter for Aerovate as we received scientific advice from the EMA , received regulatory guidance from the FDA at our end - of - Phase 1 meeting , and we expect to initiate enrollment this year in the Phase 2b portion of our Phase 2b / 3 trial of AV - 101 in PAH , " said Timothy Noyes , chief executive officer of Aerovate . " We are also pleased with investor confidence in Aerovate to support our IPO and provide sufficient capital which we believe will fund Aerovate into the second half of 2025. " Recent Events FDA Guidance Supports 6MWD as Primary Endpoint for Phase 3. At our April 14 , 2021 end - of - Phase 1 meeting with the Food and Drug Administration ( FDA ) , we received regulatory guidance that our Phase 2b / 3 trial with AV - 101 for the treatment of pulmonary arterial hypertension ( PAH ) , if successful , could support a New Drug Application ( NDA ) submission using the change in six minute walk distance ( 6MWD ) compared to placebo as the primary endpoint in the Phase 3 portion of the trial . Received Scientific Advice from EMA Regarding Requirements for Approval . We completed the formal process of seeking scientific advice and regulatory guidance from the European Medicines Agency ( EMA ) regarding its requirements for approval . We believe that , if successful , our existing clinical program could support a marketing authorization application submission for regulatory approval in Europe . Orphan Drug Designation Granted by FDA and EMA . We have obtained orphan drug designation from FDA for AV - 101 for the treatment of PAH in the United States and received in May 2021 a positive opinion for orphan drug designation for AV - 101 for the treatment of PAH from the EMA's Committee for Orphan Medicinal Products in the European Union . Raised $ 127.0 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 $ 127.0 million after deducting underwriting discounts and commissions and other offering expenses payable by us . Board of Directors and management team strengthened . We appointed to the Board , and to chair of the Audit Committee , Allison Dorval , who is chief financial officer at Voyager Therapeutics , Inc. and is a member of the Board of Puma Biotechnology , Inc. Ms. Dorval has over twenty years of corporate finance , accounting and operating experience , including 14 years of life sciences executive experience . In addition , Aerovate hired Timothy Pigot as senior vice president , commercial to oversee our pre - commercial activities . Mr. Pigot has over 25 years of industry experience working to launch and commercialize a range of products over multiple therapeutic areas . Mr. Pigot gained significant experience in PAH during his 12 years at Gilead Sciences , Inc. and 11 years at Pfizer , Inc. where his responsibilities included the launches of Revatio and Letairis for the treatment of PAH . Second Quarter 2021 Financial Results Cash and cash equivalents totaled $ 59.2 million as of June 30 , 2021 , compared to $ 4.6 million as of December 31 , 2020. The increase was primarily driven by the issuance of Series A Redeemable Convertible Preferred Stock during the second quarter of 2021 for $ 55.5 million in gross proceeds offset by operational costs for the six - month period ending June 30 , 2021. Pro forma cash and cash equivalents at June 30 , 2021 totaled $ 186.2 million , when including $ 127.0 million in net proceeds from our IPO that closed on July 2 , 2021 . R & D expenses : Research and development ( R & D ) expenses for the second quarter of 2021 were $ 4.3 million as compared to $ 1.5 million for the second quarter of 2020. The increase in R & D expenses was due primarily to increased clinical trial costs and manufacturing costs in the second quarter of 2021 as compared to the second quarter of 2020 . G & A expenses : General and administrative ( G & A ) expenses for the second quarter of 2021 were $ 1.4 million as compared to $ 0.2 million for the second quarter of 2020. The increase in G & A expenses was due primarily to increased legal fees , accounting fees and consulting expenses in the second quarter of 2021 as compared to the second quarter of 2020 . Net loss : Net loss for the second quarter of 2021 was $ 5.8 million as compared to $ 2.2 million for the second quarter of 2020. Net loss included stock - based compensation expense of $ 0.3 million for the second quarter of 2021 and $ 6,100 for the second quarter of 2020 . Financial guidance : We expect that our cash and cash equivalents along with net proceeds from our IPO will be sufficient to fund its 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 , its 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 , "