- Topline Phase 2b data now expected in the second quarter of 2024 for the IMPAHCT global Phase 2b/Phase 3 clinical trial of AV-101 for pulmonary arterial hypertension (PAH)
- More than 100 sites activated in 20 countries with the pace of enrollment increasing
- Sufficiently funded into second half of 2025
“One of our priorities over the past year was opening clinical trial sites globally, and we have made excellent progress on our stated objective with more than 100 sites currently activated,” said
Recent Highlights
Progress Continued on the IMPAHCT Global Phase 2b/Phase 3 Clinical Trial, Topline Phase 2b Data Expected in Q2 2024. IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a Phase 2b/Phase 3 trial of AV-101, our self-administered, twice daily dry powder inhaled formulation of the antiproliferative drug imatinib for the treatment of pulmonary arterial hypertension (PAH), a devastating disease impacting approximately 70,000 people in
First Quarter 2023 Financial Results
Financial guidance: We expect that our cash, cash equivalents and available-for-sale investments will be sufficient to fund our operations into the second half of 2025, based on our current operating plan.
Cash, cash equivalents and short-term investments totaled
R&D expenses: Research and development (R&D) expenses for the first quarter ended
G&A expenses: General and administrative (G&A) expenses for the first quarter ended
Net loss: Net loss for the first quarter ended
About AV-101
AV-101 is an investigational, proprietary dry powder inhaled formulation of the antiproliferative drug imatinib. Developed specifically for pulmonary arterial hypertension (PAH), AV-101 targets the abnormal cellular hyperproliferation in the distal pulmonary arteries, caused by an imbalance of activity between growth factors and apoptosis. By targeting the proliferation and accumulation of cells in the arteries of the lungs, we believe AV-101 has the potential to provide meaningful improvements for patients beyond the capabilities of currently approved therapies. AV-101 is designed for delivery by an easy-to-use dry powder inhaler, directly into the lungs to maximize potential clinical benefit and limit systemic adverse effects. Phase 1 results presented at the 2022
About the IMPAHCT Trial
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. The Phase 2b portion of the trial will evaluate three doses of AV-101 over 24 weeks, compared to placebo, to identify an optimal dose based on the primary endpoint, change in pulmonary vascular resistance (PVR), and safety, tolerability, and other clinical measures. The Phase 3 portion of the trial will compare patients taking the optimal dose of AV-101, selected from the Phase 2b data, to placebo. The primary endpoint of the Phase 3 portion of the trial will be change in six-minute walk distance (6MWD) over 24 weeks versus placebo. More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT05036135.
About
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 proprietary dry powder inhaled formulation of the drug imatinib for the treatment of patients with PAH. Learn more at aerovatetx.com or follow the company on Twitter and LinkedIn.
Available Information
Aerovate announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the
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,” 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 and clinical benefits of AV-101; our expectations regarding clinical site activation and patient enrollment for our Phase 2b/Phase 3 trial; our anticipated timing for the release of topline data from the Phase 2b portion of our clinical 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 our Phase 2b/Phase 3 clinical trial, potential regulatory submissions and approvals for AV-101; and our growth and goals as a company.
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 and clinical benefits of AV-101; the timing associated with the identification and activation of clinical sites, patient enrollment, initiation, delivery of drug supply and continuation of our Phase 2b/Phase 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
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)
2023 | 2022 | ||||
Assets | |||||
Cash, cash equivalents and short-term investments | $ | 118,929 | $ | 129,220 | |
Other assets | 5,464 | 6,081 | |||
Total assets | 124,393 | 135,301 | |||
Liabilities and Stockholders' Equity | |||||
Accounts payable and accrued and other current liabilities | $ | 10,264 | $ | 7,397 | |
Other liabilities | 1,034 | 1,161 | |||
Total liabilities | 11,298 | 8,558 | |||
Total stockholders’ equity | 113,095 | 126,743 | |||
Total liabilities and stockholders' equity | $ | 124,393 | $ | 135,301 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended | |||||||
2023 | 2022 | ||||||
Operating expenses: | |||||||
Research and development | $ | 13,488 | $ | 7,255 | |||
General and administrative | 4,151 | 3,764 | |||||
Total operating expenses (1) | 17,639 | 11,019 | |||||
Loss from operations | (17,639 | ) | (11,019 | ) | |||
Total other income | 1,119 | 109 | |||||
Net loss | $ | (16,520 | ) | $ | (10,910 | ) | |
Net loss per share, basic and diluted | $ | (0.67 | ) | $ | (0.45 | ) | |
Weighted-average shares of common stock outstanding, basic and diluted | 24,777,847 | 24,410,393 | |||||
(1) Non-cash charges were
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Investor Contact
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Source:
2023 GlobeNewswire, Inc., source