Based on the provided financial report, the title of the article is: "Form 10-Q for the Quarterly Period Ended March 31, 2025" This is a quarterly report filed with the Securities and Exchange Commission (SEC) by Achieve Life Sciences, Inc., a publicly traded company. The report provides an overview of the company's financial performance and operations for the quarter ended March 31, 2025.

Cytisinicline Advances Towards Regulatory Approval and Commercialization

Cytisinicline, a smoking and vaping cessation drug developed by our company, has made significant progress in its clinical development and regulatory pathway over the past year. In the third quarter of 2024, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for cytisinicline as a treatment for nicotine e-cigarette, or vaping, cessation. This designation is intended to expedite the development and review of drugs that show potential for substantial improvement over available therapies.

In December 2024, we announced the completion of an end-of-Phase 2 meeting with the FDA to review and receive guidance on our proposed Phase 3 clinical program for a future supplemental New Drug Application (sNDA) to expand cytisinicline’s use for vaping cessation. The FDA agreed with our proposed single Phase 3 study design and the additional requirements for submitting the sNDA. Pending availability of funding, we plan to initiate the Phase 3 clinical development of cytisinicline for nicotine dependence from e-cigarettes/vaping in the first half of 2026, with an expected completion approximately 12 months after initiation.

Ongoing Open-Label Safety Trial

In May 2024, we initiated the ORCA-OL open-label exposure trial to evaluate the long-term safety of 3 mg cytisinicline dosed three times daily in U.S. adults who want to quit smoking or vaping. The trial enrolled 479 subjects at 29 clinical sites across the United States.

In January 2025, we announced that the ORCA-OL trial had reached the goal of at least 300 subjects completing six months of cumulative cytisinicline treatment. These safety data will be included in our planned New Drug Application (NDA) submission in June 2025. In April 2025, we reached the second milestone with at least 100 subjects completing one year of cumulative cytisinicline treatment. These additional safety data will be submitted with the standard 120-day safety update following the NDA submission, during the NDA review period.

In May 2025, the Data Safety Monitoring Committee completed its third independent review of the ORCA-OL trial and reported no unexpected treatment-related adverse events, noting excellent participant adherence to cytisinicline. The overall safety data remain consistent with previous findings, and the committee recommended the study continue as planned.

License and Supply Agreements

We have license and supply agreements with Sopharma, our cytisinicline supplier. Under these agreements, we were granted access to Sopharma’s manufacturing, efficacy and safety data, as well as a patent related to new oral dosage forms of cytisinicline. We also have the exclusive right to use and sublicense certain cytisinicline trademarks.

Recently, we communicated to Sopharma that we have concerns regarding their ability to pass an FDA pre-approval inspection. If these concerns are not resolved, we plan to engage third-party manufacturers and include them in our NDA submission until Sopharma is able to pass an FDA inspection. Sopharma has alleged that our potential engagement of third-party manufacturers is a breach of our agreement, which we have disputed.

Financial Performance

For the three months ended March 31, 2025, our research and development (R&D) expenses increased to $7.1 million, up from $2.8 million in the same period of 2024. This increase was primarily due to costs associated with the ongoing ORCA-OL open-label safety trial, which was in full enrollment during the quarter, compared to primarily planning activities in the prior year period.

General and administrative (G&A) expenses for the three months ended March 31, 2025 increased to $5.8 million from $3.2 million in the same period of 2024. This increase was driven by higher employee expenses, including $0.8 million in increased stock-based compensation and a $0.3 million increase related to headcount, as well as $1.1 million in higher commercial launch preparation costs.

Interest income decreased to $0.3 million in the first quarter of 2025 from $0.4 million in the same period of 2024, primarily due to lower average cash balances and interest rates. Interest expense decreased to $0.2 million in the first quarter of 2025 from $0.8 million in the same period of 2024, due to a lower principal balance on our new convertible term loan compared to the previous loan.

We recognized a $0.1 million loss in the fair value of the contingent consideration related to our 2015 acquisition of Extab Corporation for both the first quarters of 2025 and 2024.

Liquidity and Capital Resources

As of March 31, 2025, we had a cash, cash equivalents and marketable securities balance of $23.2 million and a positive working capital balance of $17.9 million. For the three months ended March 31, 2025, net cash used in operations was $11.1 million.

We have historically financed our operations through equity and debt financings and government grants. While we believe we can settle our commitments and liabilities in the normal course of business over the next 12 months, as a late-stage clinical company with no current revenue, we are dependent on our ability to raise additional funds to support the ongoing advancement of our clinical trials and other operations.

Substantial doubt exists about our ability to continue as a going concern. Our ability to continue as a going concern is subject to material uncertainty and dependent on our success at raising additional capital sufficient to meet our obligations. If we fail to obtain additional financing when needed, we may be unable to complete the development, regulatory approval and commercialization of cytisinicline.

We will need to raise substantial additional capital, potentially through the sale of our securities, debt financing, strategic alliances or other sources, in order to advance cytisinicline and finance our operations. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development, regulatory review and commercialization efforts.

Convertible Debt Financing

In July 2024, we entered into a $10 million convertible debt agreement with Silicon Valley Bank and First-Citizens Bank & Trust Company, with the potential for up to an additional $10 million in future tranches. The loan matures in December 2027, with an interest-only period until at least December 2025.

The lenders have the right to convert part or all of the outstanding loan, plus accrued interest, into shares of our common stock at a conversion price of $7.00 per share for the initial $10 million tranche, and at a higher conversion price for any future tranches. The loan also includes an automatic conversion feature if our stock price meets certain thresholds.

We also entered into a registration rights agreement to register the resale of the shares issuable upon conversion of the debt.

Equity Financing

In February 2024, we raised approximately $56.1 million in net proceeds from a registered direct offering of common stock and a concurrent private placement of warrants.

We also have an at-the-market equity offering program in place with Jefferies LLC, under which we can sell up to $50 million of our common stock. As of March 31, 2025, the full $50 million remained available under this program.

Outlook and Conclusion

We have made significant progress in advancing cytisinicline towards regulatory approval and commercialization. The FDA’s Breakthrough Therapy designation and alignment on our Phase 3 vaping cessation trial design are important milestones. The ongoing ORCA-OL open-label safety trial is also generating valuable long-term safety data to support our planned NDA submission.

However, as a clinical-stage company without any product revenue, we remain dependent on our ability to raise additional capital to fund our operations and complete the development and commercialization of cytisinicline. The current macroeconomic environment and capital market conditions present challenges, but we are actively pursuing various financing options to secure the necessary resources.

Substantial doubt exists about our ability to continue as a going concern, underscoring the critical importance of our success in obtaining additional funding. If we are unable to raise sufficient capital, we may be forced to delay, scale back or eliminate key development and commercialization activities, which would adversely affect our prospects.

Overall, the progress with cytisinicline’s clinical development and regulatory pathway is encouraging, but the company’s long-term viability hinges on our ability to secure the necessary financing to advance the program and achieve commercial success. Careful monitoring of our financial position and ongoing capital-raising efforts will be crucial in the months and years ahead.