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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