The following is a summary of the Achieve Life Sciences, Inc. (ACHV) Q1 2024 Earnings Call Transcript:
Financial Performance:
Achieve Life Sciences reported having cash, cash equivalents, and restricted cash totaling $66.4 million as of March 31, 2024.
The company has secured up to $124 million in financing, providing cash coverage through the NDA submission, approval, and beyond, projecting a cash runway into the second half of 2025.
The company's total operating expenses in Q1 2024 were $6 million, compared to the $8.6 million in Q1 2023, marking a significant decrease.
A net loss of $6.5 million was reported for Q1 2024, which is less than the net loss of $9 million reported in Q1 2023.
Business Progress:
There has been an agreement with the FDA concerning the necessary long-term cytisinicline exposure data for the NDA filing, which is planned to be submitted in the first half of 2025.
Recent clinical data indicates cytisinicline's effectiveness in aiding in smoking and vaping cessation.
Enrollment for the ORCA-OL, an open-label study designed to provide safety data on long-term cytisinicline use, is expected to begin in the following weeks.
Phase 2 ORCA-V1 trial results show cytisinicline may be the first FDA-approved treatment specifically for e-cigarette cessation, with plans to discuss the expansion into e-cigarette cessation indication with the FDA in future meetings.
The initiation of prospective enrollment in the ORCA-OL trial is anticipated.
The company received confirmation that a separate long-term exposure trial for a vaping indication isn't required.
More details: Achieve Life IR
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