NASDAQ:ACHV
READ THE FULL ACHV RESEARCH REPORT
1Q:24 Operational and Financial Results
Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported first quarter 2024 results in a May 9th press release. The company subsequently held a conference call discussing preparations for the open label trial and what to expect over the next year. A Form 10-Q was filed with the SEC providing additional disclosures. 2024 year to date highlights include the closing of a capital raise that may provide up to $125 million in proceeds, agreement with the FDA on the structure of a study to evaluate long term exposure to cytisinicline, presentation at investor and scientific conferences and publication of cytisinicline results in the Journal of the American Medical Association (JAMA).
Following the agreement with the FDA regarding the design of the safety trial, Achieve announced it was preparing its open label 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 in 1H:26.
Milestones:
➢ 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
➢ Presentation at Life Science Innovation Northwest 2024 – April 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 1Q:24. Operating expense was $6.0 million producing a net loss of ($6.5) million or ($0.26) per share. For the quarter ending March 31, 2024 and versus the same comparable period in the prior year:
➢ Research & development expense totaled $2.8 million, down 49% from $5.5 million, as expenses in the prior year related to ORCA-3 and ORCA-V1 fell substantially and spending shifted towards preparation for the ORCA-OL trial;
➢ General & administrative expense was $3.2 million, up 5% from $3.0 million on stock-based compensation and consulting costs. The increased expenses were partially offset by a decrease in legal costs associated with general corporate activities;
➢ Net interest expense was ($445,000) vs. ($411,000) as higher debt balance and higher floating interest rates offset interest income;
➢ Net loss was ($6.5) million vs. ($9.0) million or ($0.26) and ($0.50) per share, respectively.
As of March 31st, 2024, cash and equivalents totaled $66.4 million. This amount compares to a $15.5 million balance in cash and equivalents held at the end of 2023. Achieve carries convertible debt of $17.1 million on the balance sheet which includes accrued interest. The term loan was modified last May and now matures in December 2024. Achieve’s February capital raise provided a gross $60 million and net $56 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 ($5.3) million versus ($8.3) million in the prior year period.
JAMA Publication
In early May, Achieve announced that the Journal of the American Medical Association (JAMA) Internal Medicine had published a paper detailing trial results for the ORCA-V1 Phase II trial. The piece was entitled Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial which appeared in the May issue. It reviewed the double-blind, placebo-controlled randomized clinical trial which compared 12 weeks of treatment with cytisinicline vs placebo, with follow-up to 16 weeks. Results from the trial demonstrated efficacy for cessation of e-cigarette use at end of treatment using cytisinicline. The product was well tolerated by adults. The intervention offers a potential pharmacotherapy option for treating nicotine e-cigarette use in adults who seek to quit vaping. To submit for approval, these results need to be confirmed in a larger trial with longer follow-up and Achieve will meet with the FDA later this year to determine a pivotal trial design.
Of the 160 randomized participants enrolled in ORCA-V1, 115 (71.9%) formerly smoked. Continuous e-cigarette abstinence in cytisinicline and placebo groups occurred in 34 of 107 participants (31.8%) vs 8 of 53 participants (15.1%) at the end of treatment and in 25 of 107 participants (23.4%) vs 7 of 53 participants (13.2%) during weeks 9 to 16. This produced a relative difference of 16.8 percentage points at the end of treatment and 10.2 percentage points during weeks 9 to 16. There was no evidence that cytisinicline efficacy differed in subgroups defined by demographic characteristics, vaping pattern, e-cigarette dependence or smoking history. Cytisinicline was well tolerated, with four participants (3.8%) discontinuing cytisinicline due to an adverse event.
ORCA-OL Trial
Achieve provided an update on preparations for the upcoming Ongoing Research of Cytisinicline for Addiction Program, Open Label (ORCA-OL) trial in its first quarter 2024 report. The trial arose from 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. Feedback from the investigators indicates a high level of enthusiasm from former trial participants with two-thirds indicating an interest in participating in the long-term safety study.
Achieve is targeting 29 sites that were involved with previous cytisinicline trials and the sites are actively contacting previous participants. All contracting and planning has been completed with clinical operations partners and vendors. Packaging of the drug substance has been completed and is being prepared for shipment to the sites.
Exit data from the ORCA studies have shown that patients are largely satisfied with cytisinicline and the drug is well tolerated. One notable takeaway from interactions the investigators have had with former trial participants is that 25% of them are not eligible for the trial as they longer using nicotine products. We expect to see Achieve make a formal announcement indicating when the trial starts.
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