Aerovate Therapeutics Announces First Quarter Financial Results and Business Highlights
Aerovate Therapeutics (Nasdaq: AVTE) has announced its Q1 2024 financial results and business updates. Key developments include the expected topline data release in June 2024 from the Phase 2b IMPAHCT trial for AV-101 in pulmonary arterial hypertension (PAH). Enrollment for Phase 3 of IMPAHCT is ongoing, involving over 120 sites globally. The company will present Phase 2b baseline characteristics at the ATS 2024 Conference. Financially, Aerovate raised $23.6 million in April and reported $99.3 million in cash and short-term investments as of March 31, 2024. R&D expenses rose to $20.1 million, G&A expenses to $4.5 million, and the net loss for the quarter was $23.2 million. The firm projects a cash runway into 2026.
- Topline data from the Phase 2b portion of the IMPAHCT trial expected in June 2024.
- Enrollment for Phase 3 of the IMPAHCT trial ongoing with over 120 sites in 20+ countries.
- Presentation of Phase 2b baseline data at ATS 2024 Conference.
- Raised $23.6 million through an ATM program in April 2024.
- Cash runway projected to extend into 2026.
- Cash and short-term investments decreased to $99.3 million as of March 31, 2024, from $122.4 million on December 31, 2023.
- R&D expenses increased to $20.1 million in Q1 2024 from $13.5 million in Q1 2023.
- G&A expenses rose to $4.5 million in Q1 2024 from $4.2 million in Q1 2023.
- Net loss widened to $23.2 million in Q1 2024 compared to $16.5 million in Q1 2023.
Insights
The first quarter financial results of Aerovate Therapeutics show an expected increase in R&D expenses due to ongoing clinical trials and manufacturing costs, indicating the company is heavily investing in its pipeline, particularly the IMPAHCT trial. The net loss of
The progression of the Phase 2b/3 IMPAHCT trial is a key development. The seamless transition from Phase 2b to Phase 3 is efficient and suggests confidence in the AV-101's potential. The upcoming topline data in June 2024 will be a critical milestone. AV-101's formulation of the antiproliferative drug imatinib, if successful, represents a significant advancement for treating pulmonary arterial hypertension (PAH), a severe condition affecting about 70,000 people in the US and Europe. Investors should closely monitor the trial results, as positive outcomes could significantly enhance the company's valuation and market position. The pending data also add a layer of uncertainty and risk, which is typical in biopharma but needs to be factored into investment decisions.
The market for PAH treatments is relatively niche yet significant due to the high unmet medical need and severe nature of the disease. Aerovate's AV-101, if proven effective, could capture a substantial portion of this market by offering a self-administered, twice-daily treatment option that improves patient compliance and outcomes. This differentiates it from existing therapies and could lead to strong market adoption. Moreover, the company's current financial health, with a cash runway extending into 2026, positions it well to navigate the commercialization process, should AV-101 receive regulatory approval. However, market competition and the ability to meet FDA standards remain as potential challenges.
- Topline data expected in June 2024 from Phase 2b portion of the IMPAHCT global Phase 2b/Phase 3 clinical trial of AV-101 for pulmonary arterial hypertension (PAH)
- Enrollment continues into the Phase 3 portion of the IMPAHCT trial of AV-101
- Poster to be presented with baseline characteristics of the Phase 2b portion of the IMPAHCT trial at the ATS 2024 Conference on May 21
- Cash runway into 2026, based on our current operating plan
WALTHAM, Mass., May 13, 2024 (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, 2024, and recent business highlights.
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 a global 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 PAH. PAH is a devastating disease impacting approximately 70,000 people in the United States and Europe. We continue to expect to provide topline data in June 2024.
Enrollment Continues in the Phase 3 Portion of IMPAHCT. Due to the seamless trial design, we were able to enroll our first patient in the Phase 3 portion of the IMPAHCT trial in November 2023, simultaneously with completing enrollment in our Phase 2b portion of the IMPAHCT trial. Enrollment continues with over 120 clinical sites in over 20 countries participating in the Phase 3 portion of the trial. The timing for topline Phase 3 data and the size of the Phase 3 portion of the trial will be determined based upon the results from the Phase 2b portion of the trial.
Poster To Be Presented With Baseline Characteristics of the Phase 2b Portion of IMPAHCT at the ATS 2024 International Conference in May. At a poster presentation at the American Thoracic Society (ATS) 2024 International Conference on May 21, 2024 in San Diego, CA, we will present the baseline characteristics from patients enrolled in the dose-ranging Phase 2b portion of IMPAHCT.
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First Quarter 2024 Financial Results
Cash, cash equivalents and short-term investments totaled
R&D expenses: Research and development (R&D) expenses for the quarter ended March 31, 2024 were
G&A expenses: General and administrative (G&A) expenses for the quarter ended March 31, 2024 were
Net loss: Net loss for the quarter ended March 31, 2024 was
Financial guidance: We expect that our cash, cash equivalents and short-term investments will be sufficient to fund our operations into 2026, based on our current operating plan.
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 cellular hyperproliferation and resistance to apoptosis, driven by improper signaling in cells of the distal pulmonary arteries. 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 published in 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 AV-101 in adults with PAH.
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 continuously enrolled patients 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/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 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 X (formerly known as 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 U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts, the investor relations section of the Company website at ir.aerovatetx.com, and the Company’s X (formerly known as Twitter) account @AerovateTx in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD.
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 and clinical benefits of AV-101 in PAH; our anticipated timing for the release of topline data from the Phase 2b portion of the IMPAHCT trial; our expectations regarding continuing patient enrollment for the Phase 3 portion of the IMPAHCT trial; our belief that we will have capital to fund Aerovate into 2026; our business plans and objectives for AV-101, including expectations regarding timing and success of IMPAHCT; 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 patient enrollment, initiation, delivery of drug supply and continuation of our Phase 2b/Phase 3 trial of AV-101 in PAH patients; 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; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC 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 Consolidated Balance Sheets (Unaudited) (in thousands) | ||||||||
| March 31, | 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 | ||||||
| Liabilities and Stockholders' Equity | ||||||||
| Accounts payable and accrued and other current liabilities | $ | 15,073 | $ | 17,217 | ||||
| Other liabilities | 844 | 745 | ||||||
| Total liabilities | 15,917 | 17,962 | ||||||
| Total stockholders’ equity | 90,904 | 109,456 | ||||||
| Total liabilities and stockholders' equity | $ | 106,821 | $ | 127,418 | ||||
| Aerovate Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (in thousands, except share and per share amounts) | |||||||
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 20,080 | $ | 13,488 | |||
| General and administrative | 4,538 | 4,151 | |||||
| Total operating expenses (1) | 24,618 | 17,639 | |||||
| Loss from operations | (24,618 | ) | (17,639 | ) | |||
| Total other income | 1,432 | 1,119 | |||||
| Net loss | $ | (23,186 | ) | $ | (16,520 | ) | |
| Net loss per share, basic and diluted | $ | (0.83 | ) | $ | (0.67 | ) | |
| Weighted-average shares of common stock outstanding, basic and diluted | 27,795,827 | 24,777,847 | |||||
(1) Non-cash charges were
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FAQ
What is the expected date for the topline data release from the Phase 2b IMPAHCT trial for AV-101 in PAH?
How many clinical sites are participating in the Phase 3 portion of the IMPAHCT trial for AV-101?
When will Aerovate Therapeutics present the Phase 2b baseline characteristics of the IMPAHCT trial at the ATS 2024 Conference?
How much cash and short-term investments did Aerovate Therapeutics report as of March 31, 2024?
What were the R&D expenses for Aerovate Therapeutics in Q1 2024 compared to Q1 2023?
How much did Aerovate Therapeutics raise through the ATM program in April 2024?
What is the projected cash runway for Aerovate Therapeutics as of the latest financial update?
