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Topline data expected in June 2024 from the Phase 2b portion of the global Phase 2b/3 clinical trial IMPAHCT of AV-101 for Pulmonary Arterial Hypertension (PAH)
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Enrollment in the Phase 3 portion of the IMPAHCT trial for AV-101 continues.
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Poster showing baseline characteristics of the Phase 2b portion of the IMPAHCT trial will be presented at the ATS 2024 conference on May 21
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Cash runway through 2026 based on current operating plans
WALTHAM, Mass., May 13, 2024 (Globe Newswire) — Aerobate Therapeutics, Inc. A clinical-stage biopharmaceutical company (Nasdaq: AVTE) focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary diseases, today announces financial results for the quarter ending March 31, 2024 and recent business highlights. Did.
recent highlights
Topline data expected in June 2024 from the Phase 2b portion of the IMPAHCT Global Phase 2b/Phase 3 clinical trial. IMPAHCT (Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial) is an international Phase 2b/3 study of AV-101, a twice-daily self-administered dry powder inhaled formulation of the antiproliferative drug imatinib for the treatment of PAH . PAH is a devastating disease that affects approximately 70,000 people in the United States and Europe. Topline data is still expected to be available in June 2024.
Enrollment continues for Phase 3 portion of IMPAHCT. Seamless study design allows us to enroll the first patient into the Phase 3 portion of his IMPAHCT trial in November 2023, while at the same time he completes enrollment into the Phase 2b portion of the IMPAHCT trial Did. Enrollment continues, with more than 120 clinical sites in more than 20 countries participating in the Phase 3 portion of the trial. The timing of Phase 3 topline data and the size of the Phase 3 portion of the study will be determined based on the results of the Phase 2b portion of the study.
Poster showing baseline characteristics of Phase 2b portion of IMPAHCT to be presented at ATS 2024 International Conference in May. Baseline characteristics of patients enrolled in the Phase 2b portion of the IMPAHCT dose range will be presented in a poster presentation at the American Thoracic Society (ATS) 2024 International Conference on May 21, 2024 in San Diego, California is.
ATM program sold $24 million in April. In April 2024, the Company raised approximately $23.6 million in net proceeds from one purchaser through Aerovate's existing “at the market” (ATM) program.
Financial results for the first quarter of 2024
Cash, cash equivalents and short-term investments totaled $99.3 million at March 31, 2024, compared to $122.4 million at December 31, 2023 (under the ATM program). (before taking into account the $23.6 million in net proceeds raised in April). This was primarily driven by operating costs for the three months ended March 31, 2024.
Research and development expenses: Research and development (R&D) expense was $20.1 million for the quarter ended March 31, 2024, compared to $13.5 million for the quarter ended March 31, 2023, primarily due to the increase in R&D expense. This was due to increases in clinical trial costs, manufacturing costs, and medical costs. His 2024 employee-related costs compared to 2023.
General and administrative expenses: General and administrative (G&A) expenses were $4.5 million for the quarter ended March 31, 2024, compared to $4.2 million for the quarter ended March 31, 2023, primarily due to the increase in general and administrative expenses. This was due to increases in personnel-related costs, travel expenses and other expenses. 2024 expenses compared to 2023.
Net loss: Net loss for the quarter ended March 31, 2024 was $23.2 million and net loss for the quarter ended March 31, 2023 was $16.5 million. Net loss included stock-based compensation expense of $4.2 million and $2.4 million for the quarter ended March 31, 2024. March 31, 2023, respectively.
Financial guidance: Based on our current operating plans, we expect our cash, cash equivalents and short-term investments to be sufficient to fund our operations through 2026.
About AV-101
AV-101 is a proprietary dry powder inhalation formulation in research and development of the antiproliferative drug imatinib. Developed specifically for pulmonary arterial hypertension (PAH), AV-101 targets cell hyperproliferation and resistance to apoptosis caused by inappropriate signaling in cells of the distal pulmonary artery. By targeting the proliferation and accumulation of cells within the pulmonary arteries, we believe AV-101 has the potential to provide meaningful improvements for patients beyond the ability of currently approved treatments. AV-101 is designed to be delivered directly to the lungs via an easy-to-use dry powder inhaler to maximize potential clinical benefits and limit systemic side effects. The results of phase 1 are: ERJ Open Research showed that AV-101 delivered by dry powder inhalation was generally well tolerated by healthy adult volunteers, with no serious adverse events reported. Aerovate has completed enrollment in the Phase 2b portion of the IMPAHCT clinical trial and is currently enrolling patients in the Phase 3 portion to evaluate the safety and efficacy of her AV-101 in adults with PAH.
About the IMPAHCT study
IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a multinational, placebo-controlled, Phase 2B/Phase 3 study in adults with PAH, enrolling patients continuously from Phase 2B to Phase 3. In part 2b of the exam he will be assessed on three items. Doses of AV-101 were compared to placebo over 24 weeks to identify the optimal dose based on the primary endpoint, change in pulmonary vascular resistance (PVR), safety, tolerability, and other clinical assessments. The Phase 3 portion of the trial will compare patients taking her AV-101 at the optimal dose selected from Phase 2B data to a placebo. The primary endpoint for the Phase 3 portion of the trial is the change in his six-minute walk distance (6MWD) over 24 weeks compared to placebo. For more information about this trial, please visit https://clinicaltrials.gov/ct2/show/NCT05036135https://clinicaltrials.gov/ct2/show/NCT05036135.
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 diseases. Aerovate's initial focus will be on advancing AV-101, a proprietary dry powder inhalation formulation of the drug imatinib for the treatment of patients with PAH. Learn more at aerovatetx.com or follow the company on X (formerly Twitter) and LinkedIn.
Information available
Aerovate communicates important information about the company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, conference calls, webcasts, and investor relations. Announce information to the public. The ir.aerovatetx.com section of our website and our will be used. .
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 may include forward-looking statements that may include forward-looking statements such as “anticipates,” “believes,” “continues,” “may,” “estimates,” “expects,” “future,” “goals,” “intends,” It can be identified by words such as “future-proofing.” “will”, “may”, “plan”, “could”, “predict”, “project”, “could”, seek, “strategy”, “should” ”, “target”, “will”, “will” and similar expressions referring to future periods. These forward-looking statements include, but are not limited to, statements regarding the therapeutic potential and clinical benefits of his AV-101 in PAH. Anticipated timing of release of topline data from the Phase 2b portion of the IMPAHCT trial. the Company's expectations regarding continued patient enrollment in the Phase 3 portion of the IMPAHCT trial; that we believe we have the capital to fund Aerovate through 2026; AV-101's business plans and objectives, including expectations regarding the timing and success of IMPAHCT; Growth and goals as a company.
The forward-looking statements in this press release are based on management's current expectations and beliefs and could cause actual events or results to differ materially from those expressed or implied by the forward-looking statements. are subject to a number of risks, uncertainties and important factors. Statements contained in this press release include, but are not limited to, risks and uncertainties related to the therapeutic potential and clinical benefits of AV-101. timing related to patient enrollment, initiation, drug delivery and continuation of the Phase 2b/3 trial of AV-101 in patients with PAH; Clinical trials, surgeries, goals. Positive results obtained in clinical studies are not necessarily predictive of the results of future or ongoing clinical studies. Regulatory developments in the United States and abroad. Additionally, these risks and uncertainties are further described under the caption “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and in subsequent filings with the SEC. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date they are made. We do not release such statements publicly to reflect expectations or changes in events, conditions or circumstances on which such statements are based or that may affect the likelihood that actual results will differ from those stated. We do not undertake any obligation to update or revise it periodically. Forward-Looking Statements. The forward-looking statements contained in this press release represent our views only as of the date of this press release and should not be relied upon as representing our views as of any subsequent date.
Aerobate Therapeutics, Inc. |
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March 31st |
|
December 31 |
|
||||
2024 |
2023 |
|
||||||
assets |
||||||||
Cash, cash equivalents and short-term investments |
$ |
99,334 |
$ |
122,439 |
||||
Other assets |
7,487 |
4,979 |
||||||
Total assets |
106,821 |
127,418 |
||||||
Debt and equity |
||||||||
Accounts payable and other current liabilities |
$ |
15,073 |
$ |
17,217 |
||||
Other debts |
844 |
745 |
||||||
Total debt |
15,917 |
17,962 |
||||||
Total shareholders' equity |
90,904 |
109,456 |
||||||
Total debt and equity |
$ |
106,821 |
$ |
127,418 |
Aerobate Therapeutics, Inc. |
|||||||
For a three-month period ending March 31st |
|||||||
2024 |
2023 |
||||||
Operating expenses: |
|||||||
Research and Development |
$ |
20,080 |
$ |
13,488 |
|||
General and administration |
4,538 |
4,151 |
|||||
Total project cost (1) |
24,618 |
17,639 |
|||||
operating loss |
(24,618 |
) |
(17,639 |
) |
|||
Total other income |
1,432 |
1,119 |
|||||
net loss |
$ |
(23,186 |
) |
$ |
(16,520 |
) |
|
Basic and diluted net loss per share |
$ |
(0.83 |
) |
$ |
(0.67 |
) |
|
Weighted average number of common, basic and diluted shares outstanding |
27,795,827 |
24,777,847 |
(1) Non-cash expenses for the three months ended March 31, 2024 and 2023 were $4.2 million and $2.4 million, respectively.
media contact
info@aerovatx.com
Investor contact information
ir@aerovatetx.com