NASDAQ:ACHV
READ THE FULL ACHV RESEARCH REPORT
Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported full year 2023 results in a March 28th press release. The company subsequently held a conference call discussing recent events and what to expect over the next year. A Form 10-K was filed with the SEC providing additional disclosures. Highlights since the third quarter earnings call include attendance at investor conferences and presentation of results at scientific conferences including results from the three most recent ORCA trials at SRNT Europe. Most importantly, following October’s pre-NDA meeting, the FDA voiced its desire to see long term safety data. As a result, Achieve has designed a safety trial designated ORCA-OL which will begin enrolling in 2Q:24. Based on the safety trial design and anticipated availability of data, NDA submission is expected in 1H:25 with a target action date expected one year later in 1H:26.
Milestones:
➢ Pre-NDA meeting with the FDA – October 2023
➢ Clarification regarding FDA request for additional safety data – December 2023
➢ Capital raise of $60 million – February 2024
➢ Agreement regarding long-term safety study with FDA – February 2024
➢ Three presentations at SRNT Annual Meeting (Edinburgh, Scotland) – March 2024
➢ Launch of ORCA-OL trial – 2Q:24
➢ End of Phase II meeting with FDA to determine Phase III vaping cessation trial design – 2H:24
➢ Data from 300 patients with six months exposure to cytisinicline – year-end 2024
➢ Submission of new drug application (NDA) – 1H:25
➢ Data from 100 patients with twelve months exposure to cytisinicline – mid-year 2025
➢ FDA target action date for cytisinicline NDA – 1H:26
Financial Results
No revenues were reported for 2023. Operating expense was $27.3 million producing a net loss of ($29.8) million or ($1.50) per share. For the year ending December 31, 2023 and versus the same comparable period in the prior year:
➢ Research & development expense totaled $15.8 million, down 47% from $30.1 million, as expenses in the prior year related to ORCA-3 and ORCA-V1 fell substantially and spending shifted towards the three ancillary support studies required for cytisinicline NDA submission and FDA preparatory efforts;
➢ General & administrative expense was $11.4 million, up 7% from $10.7 million on higher employee expenses associated with stock-based compensation, legal expenses as a result of general corporate activities, investor relation activities and commercial market planning activities. The increased expenses were partially offset by a decrease in costs associated with clinical trial media and awareness as both the ORCA-3 trial and ORCA-V1 trial were fully enrolled in the third and fourth quarter of 2022, respectively, and lower patent filing expenses as a result of a decrease in patent associated activities in 2023;
➢ Net interest expense was ($2.0) million vs. $0.2 million as higher debt balance and higher floating interest rates offset interest income;
➢ Net loss was ($29.8) million vs. ($42.4) million or ($1.50) and ($4.00) per share, respectively.
As of December 31, 2023, cash and equivalents totaled $15.5 million. This amount compares to a $24.8 million balance in cash and equivalents held at the end of 2022. Achieve has assumed $15 million of convertible debt related to its loan facility originally with SVB and now with First Citizens Bank & Trust Company. It is carried at $16.7 million on the balance sheet and includes accrued interest. The term loan was modified last May and now matures in December 2024. Achieve is in the process of negotiating the loan further and may pay the amount in cash using equity raise proceeds. In 2024, Achieve closed a capital raise that provided $60 million in upfront financing and a warrant component that may raise an additional $64 million. The warrants have a 42-month life, but can be called following acceptance of a new drug application (NDA) by the FDA which is expected in 1H:25. 2023 cash used in operations was ($24.5) million versus ($37.5) million in the prior year.
Poster Presentations at SRNT 2024
Achieve and its representatives participated in the 2024 Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting which was held in Edinburgh, Scotland from March 20 to 23. The oral presentations featured data from both of the Phase III ORCA trials and from the Phase II ORCA-V1 vaping trial. Below we summarize the presentations and include a link to related materials.
➢ Post-Trial Surveys from two Phase 3 Trials (ORCA-2 and ORCA-3) of Cytisinicline in Adult Smokers
o Presented by Achieve’s Director of Clinical Operations, Roxann Becco on March 21st
o Discusses patient-reported outcomes from the Phase 3 ORCA-2 and ORCA-3 clinical trials. Data collected include trial participants’ experiences, such as cravings and withdrawal symptoms, personal impact on overall health, and opinions on future use.
o Presented by Achieve’s Chief Medical Officer Dr. Cindy Jacobs on March 22nd
o Reviewed data from the second, completed Phase 3 ORCA-3 trial that evaluated the efficacy and safety of cytisinicline in 792 adult smokers in the United States. Findings confirmed results from the previous Phase 3 ORCA-2 trial demonstrating that cytisinicline, when dosed at the 3 mg, three times daily schedule for either 6 or 12 weeks, increased smoking abstinence when compared with placebo and was very well-tolerated with no treatment-related serious adverse events reported.
➢ Cytisinicline for Vaping Cessation Among Adult Nicotine E-Cigarette Users
o Presented by Dr. Nancy Rigotti, ORCA-V1 Principal Investigator and Professor of Medicine at Harvard Medical School on March 23rd
o Discussed data from the Phase 2 ORCA-V1 trial. ORCA-V1 evaluated the effectiveness and safety of cytisinicline in users of nicotine e-cigarettes who wanted to quit vaping. Similar to the efficacy and tolerability findings observed in the combustible cigarette cessation Phase 3 trials, ORCA-V1 participants who received cytisinicline had increased successful vaping cessation rates, compared with placebo, and reported minimal rates of adverse events.
Virtual Life Sciences Conference Participation
On March 7th, 2023, Achieve Life Sciences’ CEO John Bencich participated in the OTC Markets’ Life Sciences Virtual Investor Forum. He was joined by Zacks Small Cap Research’s Senior Life Sciences Analyst John Vandermosten. The 30-minute CEO Chat updated investors on the new open label safety trial, ORCA-OL, and its recent capital raise. Other topics address work on the vaping indication, M&A trends and competing products for nicotine addiction. Follow the link here for the replay.
ORCA-OL Trial
Achieve provided an update to its December 11th announcement regarding the FDA’s desire for additional long-term cytisinicline exposure data to adequately assess safety risk. Despite an initial anticipated treatment duration of six to twelve weeks, cytisinicline could be used for chronic, repeat or intermittent use if a patient relapses. With this possibility guiding its interactions with drug sponsors, the FDA and Achieve have reached an agreement that a single, open-label study evaluating long-term safety exposure of cytisinicline will meet the safety requirement. Details of the arrangement were provided in a February 29th press release and are described further below.
The study will include safety data on at least 300 subjects that have received cumulative cytisinicline treatment for six months. This data will be included with the new drug application (NDA), which we expect in the first half of 2025. Additionally, one year of exposure safety data from at least 100 subjects treated with cytisinicline will be submitted prior to approval. Subjects for the trial will be drawn from the pool of individuals that participated in the ORCA-1, ORCA-2 and ORCA-V1 trials with a preference for subjects who received 12 weeks of treatment. The desired exposure data is cumulative rather than continuous, giving credit to the duration of therapy already received. We anticipate that the minimum 300 subjects could require an additional 14 weeks of treatment to satisfy the 6-month threshold.
To satisfy the safety requirement, Achieve will launch an Ongoing Research of Cytisinicline for Addiction Program, Open Label (ORCA-OL) trial that will recruit from the more than 1,700 subjects who have already participated in Achieve’s previous studies. 1,100 of these subjects have been treated with six or twelve weeks of cytisinicline. The company may target recruitment of up to 650 subjects to account for an anticipated dropout rate.
Achieve has already activated 30 sites that were involved with previous cytisinicline trials and the sites are actively contacting previous participants. Exit data from the ORCA studies have shown that patients are largely satisfied with cytisinicline and the drug is well tolerated. See the link to “Post Trial Surveys” under the Poster Presentations section for more detail on patient satisfaction. Drug product is in the process of being packaged and should be available in the next few weeks.
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