Aerovent

Aerovate Therapeutics Appoints Habib Dable To Its Board of Directors

Retrieved on: 
Tuesday, July 11, 2023

"We are excited to welcome Habib to Aerovate’s Board of Directors.

Key Points: 
  • "We are excited to welcome Habib to Aerovate’s Board of Directors.
  • Mr. Dable is currently a part-time Venture Partner at RA Capital Management, L.P., and previously served on the Board of Directors of the Biotechnology Innovation Organization (BIO).
  • “The appointment of Mr. Dable further enhances the diverse expertise of our Board as Aerovate continues to advance AV-101 through the clinic,” said Mark Iwicki, Chair of the Board.
  • “We look forward to having Habib on the Board as we support the company’s ongoing growth.”
    “I am honored to join the Board during a pivotal time for the company,” said Mr. Dable.

Aerovate Therapeutics Presents Nonclinical Pharmacokinetic Data in Support of AV-101, a Novel Dry Powder Inhaled Formulation of Imatinib, at the American Thoracic Society (ATS) 2023 International Conference

Retrieved on: 
Monday, May 22, 2023

WALTHAM, Mass., May 22, 2023 (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 presents results from a series of studies in nonclinical species assessing the pharmacokinetics of different formulations of imatinib at the American Thoracic Society (ATS) 2023 International Conference in Washington, D.C. Aerovate is developing inhaled imatinib as AV-101 for the treatment of pulmonary arterial hypertension (PAH). While oral imatinib has previously demonstrated clinically significant efficacy in PAH patients in the global Phase 3 IMPRES trial conducted by Novartis, the oral formulation was poorly tolerated due to adverse events.

Key Points: 
  • “The results from these nonclinical studies further support our development of AV-101, a dry powder formulation of imatinib administered by inhalation for the treatment of PAH,” said Ralph Niven, Ph.D., Chief Scientific Officer at Aerovate Therapeutics.
  • Repeat dosing of dry powder aerosol to rats and monkeys also suggested concentrations were maintained in the lungs after 24 hours.
  • Plasma time course profiles of imatinib after direct dry powder or suspension dosing in rats were indicative of dissolution-controlled absorption.
  • Aerovate expects to report topline data from the Phase 2b portion of the trial in the second quarter of 2024.

Aerovate Therapeutics Announces First Quarter Financial Results and Business Highlights

Retrieved on: 
Monday, May 15, 2023

WALTHAM, Mass., May 15, 2023 (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 financial results for the quarter ended March 31, 2023, and recent business highlights.

Key Points: 
  • WALTHAM, Mass., May 15, 2023 (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 financial results for the quarter ended March 31, 2023, and recent business highlights.
  • R&D expenses: Research and development (R&D) expenses for the first quarter ended March 31, 2023 were $13.5 million as compared to $7.3 million for the first quarter ended March 31, 2022.
  • Net loss: Net loss for the first quarter ended March 31, 2023 was $16.5 million as compared to $10.9 million for the first quarter ended March 31, 2022.
  • Net loss included stock-based compensation expense of $2.4 million and $1.0 million for the first quarter ended March 31, 2023 and March 31, 2022, respectively.

Aerovate Therapeutics Announces Full-Year 2022 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 29, 2023

WALTHAM, Mass., March 29, 2023 (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 financial results for the year ended December 31, 2022, and recent business highlights.

Key Points: 
  • WALTHAM, Mass., March 29, 2023 (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 financial results for the year ended December 31, 2022, and recent business highlights.
  • “Aerovate had a productive year in 2022 as evidenced by the progress made with our lead pipeline candidate AV-101 and strategic additions to our management team,” said Tim Noyes, Chief Executive Officer of Aerovate.
  • Cash, cash equivalents and short-term investments totaled $129.2 million as of December 31, 2022, compared to $142.6 million as of September 30, 2022.
  • Net loss included stock-based compensation expense of $5.5 million and $2.0 million for the years ended December 31, 2022 and December 31, 2021, respectively.

Aerovate Therapeutics Appoints Donald Santel To Its Board of Directors

Retrieved on: 
Monday, January 23, 2023

WALTHAM, Mass., Jan. 23, 2023 (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 Donald Santel as a member of Aerovate’s Board of Directors.

Key Points: 
  • WALTHAM, Mass., Jan. 23, 2023 (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 Donald Santel as a member of Aerovate’s Board of Directors.
  • With over 40 years of working in the industry, Mr. Santel brings to Aerovate extensive experience in building successful pharmaceutical companies.
  • "We are excited to welcome Don to Aerovate’s Board of Directors.
  • “The appointment of Mr. Santel further strengthens the breadth and depth of the Board’s capabilities, and we look forward to having Don on the Board as we support the company’s continued growth.”
    “I am thrilled to join the highly accomplished team of PAH veterans and cardiopulmonary experts at Aerovate,” said Mr. Santel.

Aerovate Therapeutics Publishes Results of Phase 1 Study Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension in ERJ Open Research

Retrieved on: 
Thursday, November 17, 2022

AV-101 is being developed to address abnormal cellular proliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the pathophysiology of pulmonary arterial hypertension (PAH).

Key Points: 
  • AV-101 is being developed to address abnormal cellular proliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the pathophysiology of pulmonary arterial hypertension (PAH).
  • This allows for the potential to maximize efficacy while limiting the adverse events observed with oral imatinib.
  • Aerovates Phase 2b/Phase 3 trial, called IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial), is underway to evaluate the safety and efficacy of inhaled AV-101 in adults with PAH.
  • IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with PAH that will continuously enroll patients as the study progresses from Phase 2b to Phase 3.

Aerovate Therapeutics Announces Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 14, 2022

WALTHAM, Mass., Nov. 14, 2022 (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 financial results for the quarter ended September 30, 2022, and recent business highlights.

Key Points: 
  • WALTHAM, Mass., Nov. 14, 2022 (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 financial results for the quarter ended September 30, 2022, and recent business highlights.
  • We expect to report topline data from the Phase 2b portion of the trial in the fourth quarter of 2023 or first quarter of 2024.
  • R&D expenses: Research and development (R&D) expenses for the third quarter ended September 30, 2022 were $10.8 million as compared to $3.4 million for the third quarter ended September 30, 2021.
  • Net loss: Net loss for the third quarter ended September 30, 2022 was $13.6 million as compared to $6.2 million for the third quarter ended September 30, 2021.

Aerovate Therapeutics Presents Novel Phase 2b/Phase 3 IMPAHCT Trial Design at CHEST Annual Meeting 2022

Retrieved on: 
Tuesday, October 18, 2022

WALTHAM, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today presents the design of IMPAHCT (Inhaled iMatinib for Pulmonary Arterial Hypertension Clinical Trial; AV-101-002), a Phase 2b/Phase 3 trial investigating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension (PAH), at the American College of Chest Physicians Annual Meeting (CHEST 2022) in Nashville, TN.

Key Points: 
  • WALTHAM, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today presents the design of IMPAHCT (Inhaled iMatinib for Pulmonary Arterial Hypertension Clinical Trial; AV-101-002), a Phase 2b/Phase 3 trial investigating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension (PAH), at the American College of Chest Physicians Annual Meeting (CHEST 2022) in Nashville, TN.
  • Part two (Phase 3): Part two begins immediately following enrollment of the last participant in the Phase 2b part of the trial and signifies the start of enrollment in the Phase 3 trial.
  • Part two uses the same dosing as in the Phase 2b part of the trial with participants randomized across three AV-101 doses and placebo.
  • Part three (Phase 3): This part of the trial will start once an optimal dose of AV-101 has been selected based on the Phase 2b results.

Aerovate Therapeutics Announces Second Quarter 2022 Financial Results

Retrieved on: 
Monday, August 15, 2022

WALTHAM, Mass., Aug. 15, 2022 (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 financial results for the quarter ended June 30, 2022, and recent business highlights.

Key Points: 
  • WALTHAM, Mass., Aug. 15, 2022 (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 financial results for the quarter ended June 30, 2022, and recent business highlights.
  • R&D expenses: Research and development (R&D) expenses for the second quarter ended June 30, 2022 were $8.4 million as compared to $4.3 million for the second quarter ended June 30, 2021.
  • G&A expenses: General and administrative (G&A) expenses for the second quarter ended June 30, 2022 were $3.9 million as compared to $1.4 million for the second quarter ended June 30, 2021.
  • Net loss: Net loss for the second quarter ended June 30, 2022 was $12.0 million as compared to $5.8 million for the second quarter ended June 30, 2021.

Aerovate Therapeutics to Present at Jefferies Global Healthcare Conference

Retrieved on: 
Thursday, June 2, 2022

WALTHAM, Mass., June 02, 2022 (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 diseases, today announced that Company management will present at the Jefferies Global Healthcare Conference on Thursday, June 9, at 3:30 p.m.

Key Points: 
  • WALTHAM, Mass., June 02, 2022 (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 diseases, today announced that Company management will present at the Jefferies Global Healthcare Conference on Thursday, June 9, at 3:30 p.m.
  • Aerovate is enrolling patients in the IMPAHCT Phase 2b/Phase 3 clinical trial to evaluate the safety and efficacy of different doses of AV-101 in adults with PAH.
  • A copy of the ATS conference Phase I data poster presentation is available in the Events & Presentations section of Aerovates website at ir.AerovateTx.com/events-presentations.
  • Aerovate is a clinical-stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease.