ACHV: 2Q:23 Results
NASDAQ:ACHV
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Second Quarter 2023 Results
Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported second quarter 2023 results in a press release on August 14th and held a conference call the following morning. The company concurrently filed its Form 10-Q with the SEC. 2023 highlights to date include impressive topline results from the ORCA-V1 and ORCA-3 trials, participation in various investor and scientific conferences, publication of ORCA-2 results in the Journal of the American Medical Association (JAMA) and a capital raise that should provide sufficient funding to support operations for more than a year.
2023 achievements:
➢ Presentation at SRNT Annual Meeting – March
➢ Board of Director additions – March
➢ ORCA-V1 clinical trial results – April
➢ Refinancing of SVB Loan – May
➢ ORCA-3 topline results – May
➢ $16.5 million registered direct offering – May
➢ ORCA-2 smoking cessation trial published in JAMA – July
➢ Presentation at the American Society of Pharmacognosy 2023 Annual Meeting - July
No revenues were reported for 2Q:23. Operating expense was $7.7 million yielding a net loss of ($8.2) million or ($0.43) per share. For the quarter ending June 30, 2023 and versus the same ending June 30, 2021:
➢ Research & development expense totaled $4.6 million, down 36% from $7.2 million, as the ORCA-3 and ORCA-V1 trials wound down;
➢ General & administrative expense was $3.1 million, up 9% from $2.9 million on higher stock-based compensation and legal expenses resulting from corporate activities. Lower clinical trial awareness expenses partially offset this amount;
➢ Net interest expense was ($519,000) vs. ($404,000) due to a slightly higher debt balance and higher floating interest rates;
➢ Net loss was ($8.2) million vs. ($10.5) million or ($0.43) and ($1.09) per share, respectively.
As of June 30, 2023, cash and equivalents totaled $25.1 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 $15.7 million on the balance sheet and includes accrued interest. The term loan was modified in May and now matures in December 2024. 2Q:23 cash used in operations was ($6.7) million versus ($8.3) million in the prior year period. Cash flows from financing of $15.3 million reflected the May 2023 private placement.
May Direct Offering
Achieve sold 3.0 million shares of common stock at $5.50 per share and raised gross proceeds of $16.5 million and net proceeds of $15.3 million in a May 2023 transaction. No warrants were issued in conjunction with the transaction. Proceeds will be used to fund product development and regulatory activities, and for working capital and general corporate purposes.
Publications
Achieve’s ORCA-2 results were published in the July issue of the Journal of the American Medical Association (JAMA). Cytisinicline for Smoking Cessation highlighted the results of the 810 subject trial concluding that Both 6- and 12-week cytisinicline schedules, with behavioral support, demonstrated smoking cessation efficacy and excellent tolerability, offering new nicotine dependence treatment options.
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