Achieve Life Sciences reported a net loss of $14.4 million for the third quarter of 2025, a decline from the $12.5 million loss recorded in the same period last year. Operating expenses rose to $14.7 million, matching the prior‑year figure, while cash, cash equivalents, and market‑able securities stood at $48.1 million as of September 30, 2025. The company posted an earnings per share of –$0.28, missing the consensus estimate of –$0.24 by $0.04, a 16.7% negative surprise that reflects continued investment in the cytisinicline program and higher R&D and G&A costs.
For the nine‑month period ended September 30, 2025, Achieve posted a net loss of $40.0 million versus $27.5 million in the same period a year earlier, underscoring the escalating costs of late‑stage development. Operating expenses for the nine months were $40.1 million, up from $28.0 million in 2024, while cash reserves have been steadily depleted to $48.1 million, a level that the company expects to sustain operations into the second half of 2026.
Regulatory progress offset the financial headwinds. The U.S. Food and Drug Administration accepted the company’s cytisinicline New Drug Application for smoking cessation, setting a Prescription Drug User Fee Act target date of June 20, 2026. In addition, Achieve secured a Commissioner’s National Priority Voucher for vaping cessation, a landmark event that can accelerate the review of the vaping indication and position cytisinicline as a first‑in‑class therapy for e‑cigarette users.
CEO Rick Stewart emphasized the significance of the regulatory milestones, calling the priority voucher a “landmark event” that “accelerates the path to market for a product that addresses a critical unmet need.” He also noted that the company’s current cash runway is expected to fund operations through the second half of 2026, and that disciplined capital allocation will continue as the company advances toward key milestones.
The company reiterated its guidance that cash reserves will support operations into the second half of 2026, with no revenue expected in 2025. Management highlighted that the focus remains on advancing cytisinicline through clinical development and regulatory review, while maintaining a lean operating structure to preserve capital.
Market reaction to the earnings release was positive, with the stock rising 3.45% in pre‑market trading. The rally was driven primarily by the FDA NDA acceptance and the priority voucher, which investors viewed as significant de‑risking of the company’s core asset. The EPS miss was largely eclipsed by the regulatory progress, underscoring the importance of the drug‑development milestones for a pre‑revenue biotech firm.
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