AchieveRx — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $201.5 million as of September 30, 2026, an increase from $187.3 million as of June 30, 2026, and $36.4 million as of December 31, 2025.
• Total operating expenses for the three months ended September 30, 2026, were $20.5 million, compared to $14.7 million in the same period of 2025; for the nine months ended September 30, 2026, expenses were $49.4 million versus $40.1 million in 2025.
• Research and development expenses were $6.2 million for the quarter (vs. $5.3 million in 2025) and $13.3 million for the nine months (vs. $19.1 million in 2025).
• General and administrative expenses were $14.3 million for the quarter (vs. $9.4 million in 2025) and $36.1 million for the nine months (vs. $21.0 million in 2025).
• Net loss for the three months ended September 30, 2026, was $12.1 million, compared to $14.4 million in 2025; for the nine months, net loss was $97.0 million compared to $40.0 million in 2025.
• Net loss for the quarter included a non-cash gain of $6.9 million related to the change in fair value of warrant liabilities.
• Basic and diluted net loss per share was $0.11 for the quarter (vs. $0.28 in 2025) and $1.15 for the nine months (vs. $0.99 in 2025).
• Total assets were $206.4 million as of September 30, 2026, compared to $41.8 million as of December 31, 2025.
• Stockholders' equity was $180.7 million as of September 30, 2026, compared to $21.5 million as of December 31, 2025.
• Current portion of convertible debt was $7.5 million as of September 30, 2026, compared to $3.7 million as of December 31, 2025.
• Non-current portion of convertible debt was $5.6 million as of September 30, 2026, compared to $11.2 million as of December 31, 2025.

Guidance and Future Outlook:

• The New Drug Application (NDA) resubmission remains on track for the fourth quarter of 2026.
• The Company anticipates potential FDA approval by the end of the second quarter of 2027, with a U.S. commercial launch to follow if approved.
• Management is prioritizing disciplined capital allocation to support NDA resubmission and readiness for a potential 2027 U.S. launch.

Business Segments and Product Lines:

• Cytisinicline is the Company's sole focus, an investigational oral tablet for smoking and e-cigarette cessation in adults.
• The FDA granted Breakthrough Therapy designation for the vaping cessation program and a Commissioner's National Priority Voucher.
• The NDA for smoking cessation is supported by two completed Phase 3 studies (ORCA-2 and ORCA-3) and an open-label long-term safety study (ORCA-OL).
• A Phase 2 study of cytisinicline in e-cigarette cessation (ORCA-V1) was completed, and an end-of-Phase 2 meeting with the FDA was held.
• Three commercial-scale stability batches for U.S.-based finished drug product manufacturing were completed at Adare Pharma Solutions.
• The Company transitioned finished drug product manufacturing to U.S.-based Adare Pharma Solutions.

Market and Competitive Landscape:

• The Company positions cytisinicline as potentially the first new FDA-approved prescription medicine for nicotine dependence in 20 years.
• 52-week ORCA-OL data presented at CHEST 2026 showed that among a hard-to-treat population (median of five prior quit attempts), quit rates rose from 25.5% at Weeks 9–12 to 31.2% at Weeks 49–52.
• At the end of treatment, 39.4% of participants new to cytisinicline had quit, and 27.8% of those who had taken cytisinicline in a prior trial had quit.
• Cytisinicline was generally well tolerated over 52 weeks with no new safety signals identified by the independent Data Safety Monitoring Committee.

Risks and Challenges:

• Potential risks include the ability to generate stability data sufficient to support the NDA resubmission on the anticipated timeline.
• Risks exist regarding whether the resubmission adequately addresses matters cited in the FDA's complete response letter or if the FDA requires additional data.
• The outcome of any pre-approval inspection of Adare or other manufacturers and their ability to supply cytisinicline is a risk factor.
• The outcome of the Company's dispute with Sopharma AD is a specific risk mentioned.
• The Company's ability to raise additional capital as needed is a potential challenge.
• The ability to successfully commercialize cytisinicline, if approved, is a key risk.

Management Commentary and Tone:

• CEO Andrew D. Goldberg, MD, stated the new brand reflects a shift from a clinical-stage company to one preparing to launch a potential new FDA-approved medicine.
• CFO Ben Halladay emphasized entering the next phase with a strong balance sheet and a priority on disciplined capital allocation.
• Management expressed confidence in being well-positioned to bring cytisinicline to market if approved, citing an experienced launch team and on-track regulatory timeline.

Other Key Points:

• Achieve Life Sciences, Inc. changed its business name to AchieveRx, The Quit Company, and began trading under the Nasdaq ticker symbol "QUIT" on November 9, 2026.
• The leadership team was expanded with the appointment of Ben Halladay as Chief Financial Officer and Kaitlyn Tuson as Senior Vice President, Marketing and Communications.
• These appointments build on previous senior hires: Ronald Dadino (SVP, CMC and Supply Chain) and Gloria Cosgrove (SVP, Global Quality).
• The increase in cash and marketable securities was primarily due to proceeds received from the exercise of previously issued warrants.