ACHV: Second Quarter 2025 NDA Submission – Small Cap Research
Achieve Life Sciences, Inc. (NASDAQ: ACHV) recently shared updates on its progress towards submitting a new drug application (NDA) for cytisinicline. The company’s Chief Medical Officer, Dr. Jacobs, and her team are actively working on compiling the necessary components for the NDA, with a targeted submission date set for late in the second quarter of 2025. Achieve has been making significant advancements in recent months, including appointing new board members and executives, as well as making progress on its ORCA-OL study, which is crucial for generating essential safety data to be included in the NDA for smoking cessation.
The Achieve team recently held an end-of-Phase II (EoP2) meeting with the FDA to finalize the study design for the pivotal vaping trial. Additionally, the company has been sharing its achievements at various investor events, including the Jefferies London Healthcare conference in November, the Piper Sandler Healthcare conference in December, and participating in one-on-one meetings during the JP Morgan Healthcare Conference in January and the Barclays Healthcare Conference.
Financially, Achieve reported its 2024 results, indicating no revenues for the year. Operating expenses amounted to $39.1 million, resulting in a net loss of ($39.8) million or ($1.24) per share. Research and development expenses totaled $22.8 million, a 44% increase from the previous year, primarily due to the initiation and enrollment of the ORCA-OL open label safety trial. General and administrative expenses also saw a 42% increase, totaling $16.3 million, attributed to higher employee expenses, commercial launch preparation costs, severance costs, and legal expenses associated with patent activities.
As of December 31, 2024, Achieve had cash and equivalents totaling $34.49 million, a significant increase from the previous year due to a successful equity raise in February 2024. Despite the financial challenges, Achieve remains optimistic about its operations, estimating that it has enough cash to support its activities until the third quarter of 2025.
The company is actively preparing for the commercial launch of cytisinicline, focusing on developing a comprehensive commercialization plan targeting providers and patients who are likely to benefit from the product. Launch readiness activities are centered around raising awareness, ensuring access, and making the product widely available. Achieve is in the process of engaging with payors to discuss pricing, payment, contract, and access requirements. A targeted digital campaign is also in the works to reach out to potential users.
Looking ahead, Achieve remains committed to completing its NDA submission by the second quarter of 2025. The company is progressing well with the compilation of study reports, finalizing efficacy and safety documents, and completing the Chemistry, Manufacturing, and Controls (CMC) section. After submitting the NDA to the FDA, Achieve will focus on analyzing data from the ORCA-OL safety trial and preparing for the pivotal vaping trial. Pre-commercialization activities are ongoing, with a focus on identifying key providers and patients to benefit from cytisinicline. Achieve anticipates FDA approval in the second quarter of 2026, with commercialization and sales expected to commence in the second half of 2026.
