Achieve Life Sciences Inc SEC Filings

Achieve Life Sciences, Inc. (NASDAQ: ACHV) has launched a follow-on public offering of 15,000,000 shares of common stock bundled with five-year common warrants for an equal number of shares at an exercise price of $3.00. The securities are priced at $3.00 per share/warrant unit, versus the 26-Jun-2025 closing price of $3.51, implying a ~14% discount. Gross proceeds are projected at $45.0 million; after underwriting fees of $0.18 per unit, net proceeds before expenses total $42.3 million. An additional 30-day over-allotment option allows underwriters to purchase up to 2,250,000 extra shares and/or warrants, which could raise total net proceeds to $48.6 million.

The common warrants (and any pre-funded warrants chosen by investors) are immediately exercisable, subject to ownership caps, and expire five years from issuance. Neither the common warrants nor the pre-funded warrants will be listed, limiting secondary-market liquidity.

Management indicates the capital will support regulatory and pre-launch activities for cytisinicline, the company’s smoking-cessation therapy. On the same date, ACHV submitted its NDA to the FDA following two positive Phase 3 trials and an open-label safety study, and appointed Omnicom as commercial launch partner contingent on regulatory approval.

As a smaller reporting company, ACHV is using its July 8 2024 shelf registration (No. 333-280585). The offering is underwritten by Citizens Capital Markets and Raymond James, with settlement expected on 30-Jun-2025.

Key investor considerations:

• Financing materially strengthens cash reserves ahead of a potential U.S. launch.
• Issuance increases the share count and introduces 15 million warrants, creating dilution and overhang.
• Unlisted warrants may constrain liquidity for warrant holders.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) has filed a preliminary prospectus supplement (Form 424B5) for a public offering of (i) shares of common stock and accompanying five-year common warrants, or (ii) pre-funded warrants (exercise price $0.001) plus the same warrants, at the purchaser’s election. Exact share counts, warrant coverage and pricing are still blank in the preliminary document. Each unit is immediately separable; however, neither the pre-funded nor the common warrants will be listed on Nasdaq, limiting their liquidity. The company has granted underwriters Citizens Capital Markets and Raymond James a 30-day option to purchase additional shares and/or warrants.

Achieve qualifies as a smaller reporting company and intends to use reduced disclosure requirements. Its common stock last traded at $3.80 on 25 June 2025. Investors are urged to review the extensive risk factors beginning on page S-8.

Strategic and clinical updates disclosed in the filing:

• NDA submission (26 June 2025): Cytisinicline New Drug Application for adult smoking cessation filed with the FDA, supported by the Phase 3 ORCA-2 and ORCA-3 trials and long-term safety data from ORCA-OL.
• Breakthrough Therapy Designation: Previously received for a future vaping-cessation indication following a successful end-of-Phase 2 meeting with the FDA.
• Commercial readiness: Omnicom Group selected as strategic innovation partner and agency of record to prepare for a potential U.S. launch if FDA approves cytisinicline.

The transaction, once priced, is expected to provide fresh capital for regulatory, pre-launch and general corporate purposes but will dilute existing shareholders. No earnings, revenue or use-of-proceeds detail beyond standard language is provided in this preliminary filing.