Thomas Flaten (Lake Street Capital) asked Cindy Jacobs whether the 120-day safety update would include only 100 patients or the full ~290 now available.
Jacobs said Achieve will submit all subjects from the database cut that occurred in June — more than 100, but not the full 290 (or the 200+) currently available.
Thomas Flaten (Lake Street Capital) asked Rick Stewart how to think about the commercial-spending ramp ahead of a late-2026 launch — whether it is fully approval-dependent or begins in the first half of next year.
Stewart said the ramp will be incremental and disciplined: pre-commercial investment must occur before approval, spending will increase over the coming quarters once the NDA is accepted (but not excessively), with a larger increase upon approval.
Thomas Flaten (Lake Street Capital) asked Jaime Xinos whether a premium price relative to generic Chantix is achievable or whether pricing should be closer to the generic.
Xinos said Achieve views cytisinicline as a branded product warranting a premium price given its differentiated profile, and that payers they have engaged are not in disagreement with that positioning.
John Vandermosten (Zacks) asked Jaime Xinos to walk through the initial provider-contact methods (email, social) and how outreach would escalate based on response.
Xinos said the channel mix is still to be determined and will be tailored to individual physician needs — meeting them where they are across social, email, in-person reps where access is strong, and virtual reps — informed by the ongoing targeting exercise.
Gary Nachman (Raymond James) asked Cindy Jacobs whether the 12-month safety profile for the 290 patients is consistent with the six-month data, how it will be released, and whether there is FDA back-and-forth before the Day 74 acceptance letter, plus the odds of priority review.
Jacobs said the 120-day update will be submitted in October; the Data Safety Monitoring Committee has seen no different or unique safety signals and the data are consistent with six-month/one-year expectations; back-and-forth with the FDA is normal and ongoing; a standard review is anticipated, though priority review and the new Commissioner's National Priority Voucher have both been requested (neither viewed as likely).
Gary Nachman (Raymond James) asked Jaime Xinos what work is underway with Omnicom now and whether unbranded marketing to physicians makes sense pre-approval.
Xinos said all seven Omnicom agencies are engaged and operational, building the launch roadmap and AI-enabled commercial platform; early awareness efforts focus on restarting and elevating the conversation and reframing nicotine dependence as a medical condition, with product-specific work reserved for closer to launch so spend can be tied to prescribing.
Gary Nachman (Raymond James) asked Rick Stewart for updates on the synthetic version of cytisinicline and any partnership discussions, including comorbid conditions like COPD.
Stewart said work on the synthetic continues but focus has been on a successful NDA submission; the same applies to partnering, and now that the NDA is filed the company can begin to advance those discussions further.
Justin Walsh (Jones Trading) asked whether the Omnicom partnership would affect potential discussions with more traditional pharma partners.
Stewart said it is complementary — Omnicom sits at the center while other, more traditional routes can be built out, and the company will keep flexibility to deploy the right resources at the right time; Xinos added that Omnicom's track record (100+ launches over three years with Merck, J&J, Novartis, AbbVie and others) adds credibility that Achieve will have a complete launch package.
Boris Tolkachev (Freedom) asked whether to expect clinical development roadmap updates before year-end and whether Achieve would share interim ORCA-OL results ahead of full publication.
Jacobs said the full ORCA-OL database will be completed by the end of this year (it is the only ongoing trial), with publications and conference presentations targeted for 2026 (potentially by Q2); Stewart added that the one-year open-label data show strong tolerability in line with the phase III trials, and management is very interested in the long-term efficacy secondary endpoint.