1. WALTHAM, Mass., Sept. 17, 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, announced it has been added to the Russell 2000® Index, effective after the market's close today, following the recent Russell US Indexes annual reconstitution.

    "We're pleased to be included in the Russell 2000® Index, as it provides a great opportunity to share our story with a broader audience of investors," said Timothy Noyes, chief executive officer of Aerovate. "We've built a strong team with deep cardiopulmonary disease experience, and raised capital needed to advance AV-101, our dry powder…

    WALTHAM, Mass., Sept. 17, 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, announced it has been added to the Russell 2000® Index, effective after the market's close today, following the recent Russell US Indexes annual reconstitution.

    "We're pleased to be included in the Russell 2000® Index, as it provides a great opportunity to share our story with a broader audience of investors," said Timothy Noyes, chief executive officer of Aerovate. "We've built a strong team with deep cardiopulmonary disease experience, and raised capital needed to advance AV-101, our dry powder inhaled formulation of the drug imatinib for the treatment of pulmonary arterial hypertension, or PAH. We expect to initiate enrollment this year in the Phase 2b portion of our Phase 2b/3 trial of AV-101 in PAH."

    The Russell 2000® Index measures the performance of the small-cap segment of the U.S. equity market. The index is a subset of the Russell 3000® Index and represents approximately 10 percent of the total market capitalization of that index. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell 2000® Index and the Russell indexes reconstitution, visit the FTSE Russell website.

    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," "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 potential benefits resulting from the inclusion in the Russell 2000® Index to our business and strategy; our expectations that we will initiate enrollment this year for the Phase 2b portion of our Phase 2b/3 trial of AV-101 in PAH; and our business plans and objectives, future plans for AV-101, including expectations regarding timing and success of the our Phase 2b/3 clinical trial and the therapeutic potential and clinical benefits of AV-101. 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 initiation or 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 study may not necessarily be predictive of the results of future or ongoing clinical studies, regulatory developments in the United States and foreign countries, and other risks identified in our filings with the Securities and Exchange Commission ("SEC"), including our Registration Statement on Form S-1, 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 any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the 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 its views as of any subsequent date.

    Media Contact:

    Julio Cantre

    jcantre@vergescientific.com

    202.930.4762

    Investor Contact:

    IR@Aerovatetx.com



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  2. 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…

    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," "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 belief that we will have capital to fund Aerovate into the second half of 2025; the statement that our phase 2b/3 trial with AV-101 for the treatment of PAH, if successful, could support a NDA submission; the statement that, if successful, our existing clinical program could support a marketing authorization application submission for regulatory approval in Europe; our business plans and objectives, future plans 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, 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 initiation or 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 study may not necessarily be predictive of the results of future or ongoing clinical studies, regulatory developments in the United States and foreign countries, and other risks identified in our filings with the Securities and Exchange Commission ("SEC"), including our Registration Statement on Form S-1, 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 any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the 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 its views as of any subsequent date.



             
     Aerovate Therapeutics, Inc.
     Condensed Balance Sheets
     (in thousands)
             
         June 30, December 31, 
         2021 2020 
     Assets      
     Current assets:    
      Cash and cash equivalents$59,150  $4,573  
      Prepaid expenses and other current assets 159   103  
     Total current assets 59,309   4,676  
      Property and equipment, net 35   39  
      Other long-term assets 3,090   -  
     Total assets $62,434  $4,715  
             
     Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit    
             
     Current liabilities:    
      Accounts payable$3,042  $618  
      Accrued and other current liabilities 1,151   1,156  
     Total current liabilities 4,193   1,774  
             
     Commitments and contingencies    
      Series A redeemable convertible preferred stock 75,819   12,285  
      Series Seed redeemable convertible preferred stock, $0.0001 par value; 4,000   4,000  
     Stockholders' deficit (21,578)  (13,344) 
     Total liabilities, redeemable convertible preferred stock and stockholders' deficit$62,434  $4,715  



     Aerovate Therapeutics, Inc.
     Condensed Statements of Operations and Comprehensive Loss
     (in thousands, except share and per share amounts)
             
      Three Months Ended June 30, Six Months Ended June 30,
       2021   2020   2021   2020 
     Operating expenses:       
     Research and development$4,327  $1,471  $6,523  $2,677 
     General and administrative 1,447   154   2,031   306 
     Total operating expenses 5,774   1,625   8,554   2,983 
     Loss from operations (5,774)  (1,625)  (8,554)  (2,983)
     Other expense:       
     Interest income (expense) 2   (37)  2   (75)
     Change in fair value of convertible promissory notes -   (540)  -   (580)
     Other expense (3)  -   (4)  - 
     Total other expense (1)  (577)  (2)  (655)
             
     Net loss and comprehensive loss$(5,775) $(2,202) $(8,556) $(3,638)
     Net loss per share, basic and diluted$(23.80) $(9.12) $(35.29) $(15.07)
     Weighted-average shares of common stock outstanding, basic and diluted 243,076   241,467   243,076   241,467 
             

    The following table sets forth certain condensed balance sheet items on an actual basis and on a pro forma basis, as if the IPO had occurred on June 30, 2021.

    • on a pro forma basis to reflect (i)  the automatic conversion of all shares of our convertible preferred stock into an aggregate of 14,182,854 shares of our common stock and the related reclassification of the carrying value of the convertible preferred stock to permanent equity immediately prior to the closing of this offering, as if such conversion had occurred on June 30, 2021, (ii) the filing and effectiveness of our amended and restated certificate of incorporation, which will be in effect immediately prior to the closing of this offering and (iii) our issuance and sale of 9,984,463 shares of our common stock, including 1,302,321 shares associated with the full exercise of the underwriters' option to purchase additional shares, at an offering price of $14.00 per share generating approximately $127.0 million in net proceeds.

    The pro forma information below is illustrative only.

    Aerovate Therapeutics, Inc. 
    (in thousands) 
          
      As of June 30, 2021 
      Actual Pro Forma 
    Cash and cash equivalents $59,150  $186,150 
    Redeemable convertible preferred stock  79,819   - 
    Common stock  -   2 
    Additional paid-in capital  407   207,224 
    Total shareholders' (deficit) equity $(21,578) $185,241 
          

    Contact:

    Julio Cantre

    Info@AerovateTx.com

    202.930.4762



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  3. BOSTON, July 19, 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 the appointment of Allison Dorval, chief financial officer of Voyager Therapeutics, Inc. ("Voyager"), as a member of Aerovate's Board of Directors.

    "The addition of Allison's corporate finance and broad operating expertise to our Board of Directors will serve Aerovate well as we seek to develop and commercialize AV-101, our novel dry powder inhaled formulation of the drug imatinib, for the treatment of pulmonary arterial hypertension, also known as PAH," said Timothy Noyes, chief executive…

    BOSTON, July 19, 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 the appointment of Allison Dorval, chief financial officer of Voyager Therapeutics, Inc. ("Voyager"), as a member of Aerovate's Board of Directors.

    "The addition of Allison's corporate finance and broad operating expertise to our Board of Directors will serve Aerovate well as we seek to develop and commercialize AV-101, our novel dry powder inhaled formulation of the drug imatinib, for the treatment of pulmonary arterial hypertension, also known as PAH," said Timothy Noyes, chief executive officer of Aerovate. "We are thrilled to welcome her to Aerovate and to benefit from her deep experience, which includes providing financial stewardship for publicly traded companies."

    Ms. Dorval currently serves as chief financial officer and principal finance and accounting officer at Voyager Therapeutics, and is a member of the Board of Directors of Puma Biotechnology, Inc. She has over twenty years of corporate finance, accounting and operating experience, including 14 years of life sciences executive finance experience. Prior to Voyager, Ms. Dorval served as vice president, controller, at Juniper Pharmaceuticals, Inc., and as chief financial officer at Insulet Corporation, where she led financial planning, reporting and accounting. Previously, Ms. Dorval held corporate finance positions with iBasis, Inc. and Digitas Inc. Ms. Dorval is a certified public accountant and began her career in public accounting at PricewaterhouseCoopers LLP, where she held positions of increasing responsibility and scope. Ms. Dorval obtained a Bachelor of Science in Business Administration from the University of Vermont.

    "Joining the Aerovate Board of Directors presents a unique opportunity to contribute to the development of a novel approach to treating pulmonary arterial hypertension," commented Ms. Dorval. "People suffering from PAH face a poor prognosis, despite the availability of multiple approved therapies. I am excited about helping Aerovate deliver a potential new treatment option for these underserved patients."

    About Aerovate Therapeutics, Inc.

    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.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the advancement of our clinical programs, our expectations of the therapeutic benefits related thereto, and our growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    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 advancement of our clinical program for AV-101, the expected impact and contribution of our Board of Directors and executives to our business, and other risks identified in our filings with the Securities and Exchange Commission ("SEC"), including our Registration Statement on Form S-1, 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 any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the 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 its views as of any subsequent date.



    Contact:
    
    Julio Cantre
    Info@aerovatetx.com
    202.930.4762
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  4. BOSTON, July 02, 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 the closing of its upsized initial public offering of 9,984,463 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,302,321 additional shares of common stock, at a public offering price of $14.00 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Aerovate, were approximately $139.8 million. All of the shares in the offering…

    BOSTON, July 02, 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 the closing of its upsized initial public offering of 9,984,463 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,302,321 additional shares of common stock, at a public offering price of $14.00 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Aerovate, were approximately $139.8 million. All of the shares in the offering were sold by Aerovate.

    Jefferies LLC, Cowen and Company, LLC, and Evercore Group L.L.C. acted as joint book-running managers for the offering. Wedbush Securities Inc. acted as a lead manager for the proposed offering.

    A registration statement relating to these securities was filed with the Securities and Exchange Commission ("SEC") and became effective on June 29, 2021. The offering was made only by means of a written prospectus. Copies of the final prospectus may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at 833-297-2926 or by email at PostSaleManualRequests@broadridge.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sale of these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

    About Aerovate Therapeutics, Inc.

    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.



    Contact:
    
    Julio Cantre
    Info@aerovatetx.com 
    202.930.4762
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  5. BOSTON, June 29, 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 the pricing of its upsized initial public offering of 8,682,142 shares of common stock at a public offering price of $14.00 per share, before underwriting discounts and commissions. In addition, Aerovate has granted the underwriters a 30-day option to purchase up to an additional 1,302,321 shares of common stock at the initial public offering price per share, less the underwriting discounts and commissions. All of the shares are being offered by Aerovate. The gross proceeds of the offering…

    BOSTON, June 29, 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 the pricing of its upsized initial public offering of 8,682,142 shares of common stock at a public offering price of $14.00 per share, before underwriting discounts and commissions. In addition, Aerovate has granted the underwriters a 30-day option to purchase up to an additional 1,302,321 shares of common stock at the initial public offering price per share, less the underwriting discounts and commissions. All of the shares are being offered by Aerovate. The gross proceeds of the offering, before deducting underwriting discounts and commissions, and other offering expenses payable by Aerovate, are expected to be approximately $121.5 million, excluding any exercise of the underwriters' option to purchase additional shares.

    The shares are expected to begin trading on the Nasdaq Global Market on June 30, 2021 under the ticker symbol "AVTE." The offering is expected to close on July 2, 2021, subject to the satisfaction of customary closing conditions.

    Jefferies LLC, Cowen and Company LLC, and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Wedbush Securities Inc. is acting as a lead manager for the proposed offering.

    A registration statement relating to these securities was filed with the Securities and Exchange Commission ("SEC") and became effective on June 29, 2021. The offering is being made only by means of a written prospectus. Copies of the final prospectus, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at 833-297-2926 or by email at PostSaleManualRequests@broadridge.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sale of these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

    About Aerovate Therapeutics, Inc.



    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.

    Forward-Looking Statements



    This press release includes certain disclosures that contain "forward-looking statements," including, without limitation, statements regarding Aerovate's expectations regarding the commencement of trading of its shares on the Nasdaq Global Market, the completion and timing of the closing of the offering and the anticipated gross proceeds from the offering. Forward-looking statements are based on Aerovate's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the satisfaction of customary closing conditions and the completion of the offering, and the risks inherent in biopharmaceutical product development and clinical trials. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" set forth in Aerovate's filings with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Aerovate undertakes no duty to update such information except as required under applicable law.



    Contact:
    
    Julio Cantre
    Info@aerovatetx.com
    202.930.4762
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