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Mar 31, 2023
Aerovate Q1 2023 Earnings Report
Aerovate Therapeutics reported financial results for Q1 2023 and provided business highlights.
Key Takeaways
Aerovate Therapeutics announced its Q1 2023 financial results, highlighting progress on its IMPAHCT clinical trial with topline Phase 2b data expected in Q2 2024. The company's cash reserves are expected to fund operations into the second half of 2025.
Topline Phase 2b data for the IMPAHCT trial of AV-101 for pulmonary arterial hypertension is now expected in the second quarter of 2024.
More than 100 clinical trial sites have been activated across 20 countries, with patient enrollment steadily increasing.
The company's current funding is sufficient to support operations into the second half of 2025.
Research and development expenses increased due to clinical trial and headcount-related costs.
Aerovate
Aerovate
Forward Guidance
Aerovate expects that its cash, cash equivalents and available-for-sale investments will be sufficient to fund its operations into the second half of 2025, based on its current operating plan.
Positive Outlook
- Cash, cash equivalents and short-term investments will be sufficient to fund operations into the second half of 2025.
- Progress continued on the IMPAHCT Global Phase 2b/Phase 3 Clinical Trial.
- More than 100 clinical sites activated in 20 countries.
- Pace of enrollment is increasing.
- Clinical investigators and KOLs globally continue to express enthusiasm for AV-101 and our clinical trial.
Challenges Ahead
- Topline Phase 2b data now expected in the second quarter of 2024.
- Patient enrollment has been slower than expected, in part related to post-COVID factors.
- Decrease in cash, cash equivalents and short-term investments was primarily driven by operational costs.
- 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.
- Loss from operations was $(17,639) as compared to $(11,019).