Achieve Life Sciences Q2 2024 Financial Results and Corporate Update

Achieve Life Sciences, Inc. (NASDAQ: ACHV), a pharmaceutical firm focused on the development and commercialization of cytisinicline for smoking cessation and nicotine dependence, has reported its financial outcomes for the second quarter of 2024. The company also provided updates on its cytisinicline development program.

One of the significant highlights is the FDA's granting of Breakthrough Therapy designation for cytisinicline to help individuals quit nicotine e-cigarettes or vaping. This designation is intended to speed up the development and review of drugs that demonstrate substantial improvement over available therapies for serious conditions. Currently, no FDA-approved treatments exist specifically for vaping cessation. Achieve plans to organize an End-of-Phase 2 meeting with the FDA's multidisciplinary team by the end of the year under this designation.

In addition to the FDA milestone, Achieve has refinanced its outstanding loan with Silicon Valley Bank (SVB). The new agreement allows for up to $20 million and extends the maturity date from August 1, 2024, to December 1, 2027. The company fulfilled its obligations under the prior agreement and terminated it in favor of the new contingent convertible debt agreement.

Achieve has also been included in the U.S. Russell 3000® and Russell Microcap® Indexes as of July 1, 2024. This inclusion is expected to boost the company's visibility among investors, underscoring its strong business fundamentals and market potential for cytisinicline.

In May 2024, Achieve initiated the ORCA-OL clinical trial, which is focused on long-term exposure to cytisinicline in people who smoke or use nicotine e-cigarettes. The trial aims to gather safety data over extended periods, with up to one year of treatment. Enrollment is ongoing at 29 clinical trial sites across the U.S., with over half of the targeted 650 participants already enrolled. The data from this trial is anticipated to support a New Drug Application (NDA) submission in the first half of 2025.

Furthermore, findings from the Phase 2 ORCA-V1 vaping cessation trial were presented at the Society of General Internal Medicine (SGIM) Annual Meeting. The data revealed that cytisinicline more than doubled the likelihood of quitting nicotine e-cigarettes compared to a placebo, showcasing its potential as an effective treatment for nicotine addiction.

On the financial front, as of June 30, 2024, Achieve's cash, cash equivalents, restricted cash, and short-term investments totaled $61.3 million. Total operating expenses for the second quarter were $8.4 million, while the net loss for the same period was $8.5 million. Achieve had 34,341,303 shares outstanding as of August 13, 2024.

To discuss these updates and financial results, Achieve will host a conference call at 4:30 PM EDT today, Tuesday, August 13, 2024. The webcast can be accessed through the investor relations page on the Achieve website.

Achieve Life Sciences is committed to addressing the global smoking and nicotine addiction epidemic through the development and commercialization of cytisinicline. The plant-based alkaloid cytisinicline interacts with nicotine receptors in the brain, reducing withdrawal symptoms and the reward associated with nicotine products. There are currently over 29 million adults in the U.S. who smoke and more than 11 million who use e-cigarettes, with no FDA-approved treatments for vaping cessation available.

Cytisinicline is still an investigational product and has not yet received FDA approval for any indication in the U.S. For more details on cytisinicline and Achieve Life Sciences, you can visit their website.

Achieve's progress in the field of nicotine addiction treatment is noteworthy, given the high prevalence of smoking and vaping-related health issues. The company's recent milestones, including the FDA Breakthrough Therapy designation and the initiation of long-term clinical trials, position it strongly for future developments and potential market entry.