Achieve Life Sciences Announces Major \$354 Million Private Placement to Fund Cytisinicline Development and Leadership Changes

Key Investment Highlights

• Up to \$354 Million Private Placement Announced: Achieve Life Sciences, Inc. (Nasdaq: ACHV) has entered into a securities purchase agreement with top-tier healthcare investors for a private placement totalling up to \$354 million in gross proceeds. This includes an initial upfront funding of approximately \$180 million and up to an additional \$174 million available from warrants, exercisable within 20 days of FDA approval of cytisinicline for smoking cessation.
• Led by Prominent Investors: The financing is led by Frazier Life Sciences, TPG Life Sciences Innovations, venBio Partners, Paradigm BioCapital Advisors, and Marshall Wace, with participation from existing and new investors such as Coastlands Capital, Dialectic Capital, Janus Henderson Investors, LifeSci Venture Partners, Logos Capital, Propel Bio Partners, Spruce Street Capital, Venrock Healthcare Capital Partners, Vivo Capital, and Wellington Management.
• Significant Share Issuance: The deal involves the sale of 49,418,069 shares of common stock at \$3.635 per share, or 100,500 pre-funded warrants at \$3.634 per warrant, each with a nominal exercise price of \$0.001. Accompanying warrants to purchase up to 49,518,569 shares of common stock (or pre-funded warrants) are included, exercisable at \$3.51 per share (or \$3.509 per pre-funded warrant).
• Milestone-Driven Warrants: The accompanying warrants are exercisable after issuance and expire on the later of the 20th business day after FDA approval announcement of cytisinicline or the date the company notifies warrant holders, with extensions if there are insufficient authorized shares at the time of approval.

Strategic Leadership Appointment

• New CEO Appointed: Upon closing, Andrew Goldberg, MD, a dual board-certified physician with expertise in healthcare investment, commercial strategy, and clinical medicine, will become Chief Executive Officer and join the board of directors. Richard Stewart, the current President and CEO, will remain on the board.

Use of Proceeds and Company Outlook

• Funding for Critical Programs: Proceeds from this offering will support a Phase 3 clinical trial for cytisinicline in e-cigarette (vaping) cessation, the broader commercialization of cytisinicline, and general corporate purposes and working capital.
• Upcoming NDA Milestone: Achieve Life Sciences’ New Drug Application (NDA) for cytisinicline as a treatment for nicotine dependence (smoking cessation) was accepted for FDA review in September 2025. The Prescription Drug User Fee Act (PDUFA) target action date is June 20, 2026.
• Market Opportunity: There are approximately 25 million adult smokers and 18 million adult e-cigarette users in the U.S.—with no FDA-approved therapies for e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation and the FDA Commissioner’s National Priority Voucher for vaping cessation, highlighting its potential impact.
• Securities Registration Commitment: The securities issued in this offering are unregistered but Achieve Life Sciences has agreed to file a registration statement for resale within 30 days of closing, increasing liquidity for investors.

Details of the Private Placement

• Pricing Structure: Common shares are priced at \$3.635 each, with pre-funded warrants available at \$3.634 each. Each security comes with an accompanying warrant for additional shares.
• Warrant Terms: Pre-funded warrants do not expire and are immediately exercisable, while accompanying warrants become exercisable after issuance and expire after the FDA approval milestone, or two years after shareholder approval to increase authorized shares if needed.
• Anti-Dilution Provision: If shares purchased in the offering are sold before the warrant expiration date, the number of shares underlying the accompanying warrants will be proportionally reduced.

Potential Price-Sensitive and Shareholder-Relevant Information

• Significant Capital Inflow: The size and structure of this financing round are substantial and could materially impact Achieve Life Sciences’ cash position, funding runway, and ability to execute on late-stage clinical and commercial plans.
• Leadership Change: Appointment of a new CEO with a strong background in both healthcare investing and clinical practice is a notable strategic shift, potentially affecting company direction and investor confidence.
• Regulatory and Commercial Milestones: The financing is closely linked to FDA approval of cytisinicline, a major upcoming event that could be a significant share price catalyst.
• Potential Dilution: Issuance of a large number of shares and warrants will dilute existing shareholders, but proceeds are earmarked for high-impact programs with strong regulatory momentum.
• New Market Opportunity: Achieve is targeting the large, underserved market for vaping cessation, which currently has no FDA-approved therapies—positioning the company for potential first-mover advantage.

Transaction and Legal Details

• Placement Agent: Morgan Stanley is serving as the sole placement agent for the private placement.
• Closing Schedule: The transaction is expected to close on April 17, 2026, subject to customary closing conditions.
• Regulatory Compliance: The securities are being sold pursuant to Section 4(a)(2) of the Securities Act of 1933 and applicable exemptions; they cannot be freely traded in the U.S. until registered or an exemption applies.

About Achieve Life Sciences and Cytisinicline

Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on cytisinicline, a plant-derived alkaloid being developed for both smoking and e-cigarette cessation. Cytisinicline acts on nicotinic receptors, reducing cravings and the satisfaction derived from nicotine products. The company has completed two Phase 3 studies in smoking cessation and a successful Phase 2 study in vaping cessation, and is awaiting a pivotal FDA decision.

Investor Relations Contact

Nicole Jones
Vice President, Strategic Communications and Stakeholder Relations
[email protected]
(425) 686-1510

Disclaimer

This article is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. Investors should be aware that forward-looking statements are subject to risks and uncertainties, including those detailed in Achieve Life Sciences’ public filings. No assurance can be given that the described events will occur as planned. Readers are advised to consult with their own financial advisors before making investment decisions. Achieve Life Sciences undertakes no obligation to update forward-looking statements except as required by law.

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