Achieve Life Sciences, Inc. Q2 FY2025 earnings call

Rick Stewart highlighted the successful submission of the new drug application (NDA) for cytisinicline as a treatment for nicotine dependence to the FDA, a strategic commercial partnership with Omnicom, and a $49 million capital raise. Cindy Jacobs discussed the NDA submission details, including the inclusion of clinical trial results from ORCA-2 and ORCA-3, and long-term safety data from the ORCA-OL study. Jaime Xinos outlined commercial launch preparations, including collaboration with Omnicom, an AI-enabled commercial platform, and progress on availability, access, and awareness pillars. Mark Oki provided financial updates, noting a $45 million public offering, cash position of $55.4 million as of June 30, 2025, and operating expenses for the quarter.

Anticipates NDA acceptance in mid-September, plans to launch cytisinicline in late 2026, expects incremental commercial spending ahead of approval, and remains focused on regulatory and commercial initiatives.

Q: Cindy, just a quick one for you just to confirm, in the 120-day safety update, will you submit only 100 patients or the full 290 that you now have access to?

A: We'll be submitting all of the subjects at the time of the database cut that occurred in June. So it will be more than 100, but not exactly the 290 over the 200 that we have right now.

Q: And Rick, you mentioned launch in late '26. And if we assume an approval in late June, how should we think about your ramp in commercial spending ahead of launch? Is it going to be completely approval dependent? Or will you begin ramping that spend, let's say, first half of next year?

A: Yes, it will be incremental. I mean we have to invest in the pre-commercial activities prior to the approval. So I think you'll see an increase over the coming quarters. But as soon as we reach approval, then you'll see an increase. But I think the key message here is that we keep a very disciplined approach to that commercial investment. But again, I think you'll look at this once we've got the NDA acceptance, you'll start to see a ramp-up, but not excessive.

Q: And then one final one, if I may, for Jaime. I might be getting ahead of the pricing work you're already doing, but are you assuming that a premium price relative to the generic CHANTIX will be available to you? Or should we be thinking about something closer to the generic pricing that we see today?

A: I think -- thanks for the question. We would view this as a branded product at a premium price. And also, I think that resonates based on the profile and what we are able to differentiate versus the current options. And that's what we've been going in and having discussions with payers about. They aren't in disagreement with that.

Q: I had a question -- also had a question for Jaime on just the initial contact method for reaching out to providers. I think in the presentation you mentioned e-mail and social. And perhaps you can walk us through all those initial contact methods. And then I guess, the flow chart based on the response, how you move to different levels and communicating with everyone.

A: Yes. Thanks for the question. So I think that's still yet to be determined because as we've noted in a lot of our conversations, we really want to identify the individual needs of the physicians that we are targeting and meet them where they are. And so I think there are obviously opportunities for engagement across all of those channels that you mentioned, such as social and e-mail, putting reps where it is appropriate, where they can get strong access and where they need to have those conversations in person. Virtual reps as well will be another option that we'll be looking at. But again, it's really going to depend on what we define further through our targeting exercise as where they want to have those engagements with pharma.

Q: Congrats on all the progress. So back to the full safety data for the 290 patients at 12 months. Any commentary just on the overall safety profile, if it was consistent with the 6-month data? And how will you be releasing that, assuming after you provide the updated safety data to FDA at 120 days? And then are there any communications with the FDA prior to the day 74 letter? Or is that the first time that you hear back from them? And then I have a follow-up.

A: Sure. For the 120 safety day update, we will be submitting it in October. And the data currently right now, and we've obviously made this public, has been reviewed by the Data Safety Monitoring Committee throughout this process, and there's been no different or unique safety signals that have been seen. So it is consistent with what we would expect at 6 months in 1 year. The next, I think, question was -- sorry, what was the second question?

Q: Yes. Just how you -- well, in terms of your communications with the FDA at the day 74 letter, is that the next time you hear from them? Or is there any back and forth prior to that?

A: Normally, at this time, there's back and forth with FDA, and that's what we're experiencing, and that's what's happening. So it's all normal procedures in that regard. They're contacting us, asking where various things are. We're very responsive, letting them know where they are in the NDA. And so it is a back-and-forth process that's been and it's normal.

Q: Okay. And any chance for a priority review or I guess you're anticipating a standard review, that's the most likely scenario?

A: Well, at this point, we are. However, we're always hopeful for a priority review. We have requested it. And also there is the new Commissioners National Priority Voucher that they just published a couple of weeks ago, how to kind of request it, and we have requested it. We don't view that, that is a likely possibility. But in all of our interactions, we are trying as best as we can to highlight this submission and NDA review process for priority as best as we can.

Q: Okay. Great. And then, Jaime, regarding the Omnicom partnership, any specific work that you're doing together right now in the early days while you wait for the approval or certainly until you have better visibility on time lines. Does it make sense to do any unbranded marketing to physicians to get them comfortable? Obviously, they know the unmet need in nicotine dependence, but you want to reframe the message. So what are you doing on that front to position you better for the launch?

A: Yes. I'll start with the first part of that question. We have engaged all 7 of our agencies and are fully operational with various work streams that we view as high-priority activities that need to be conducted now to better inform what we need to do at launch and how we will deploy resources going forward. So across all of the functional areas that I mentioned on the call as well as, I think, in the press release, we have teams who are activated. And we are also working very aggressively towards building our launch road map and our AI-driven our AI-enabled platform, which will allow each of those functional areas to work as one team seamlessly in one ecosystem where all of the data are coming in, being analyzed and then helping us to inform decision-making and then eventually performance metrics down the road. So all of that is underway, and we are obviously working very hard as a lean team within Achieve. We have leadership across all the work streams and then we've got leadership within the Omnicom organizations moving this launch forward. So we are well underway. Regarding awareness activities, our early focus is going to be driving that message that the conversation needs to get started again because it's been so long, 20 years since something new has come to the market. So we think it's important that they know that there will be a new treatment, and we also need to elevate the seriousness of those conversations. So that's the work that we'll be doing early on. The more product-specific work will come closer to launch because we want whatever efforts and whatever resources we dedicate towards that awareness to go directly to prescribing, so we can track and monitor the effectiveness of those communications. So the early work will be more around elevating the conversation, making sure we have the right patient identified for physicians who should be -- this product should be prescribed for and changing that medical conversation that this is not a moral or a lifestyle choice. This is actually a medical -- this is a medical condition that needs to be treated with a medical solution.

Q: Okay. Great. And then just last one quickly for Rick. Just any update on the synthetic version of cytisinicline, timing of that potentially? And also if there are any partnership discussions that have progressed, specifically with some comorbid conditions like COPD?

A: Yes. Thanks, Gary. Yes, we're continuing to work on the potential for the synthetic. But frankly, our focus really has been on the NDA submission and ensuring that, that's been a success. So yes, we continue to work on it. In terms of partnering, I'd say exactly the same thing. Our focus has remained on a successful NDA submission. And I would suggest that once the NDA has now been submitted that we can start to have further discussions around that.

Q: Congrats on all the progress. I'm wondering if you expect your partnership with Omnicom to impact potential discussions with more traditional pharma partners.

A: Yes. I think it's all complementary, right? As you build this out, at the center of all of this, we've got the Omnicom partnership, but there are going to be other opportunities to build out more traditional routes. But for now, again, we're focused very much on ensuring that the Omnicom platform is fully functional, and we'll bring in additional resources as required. I think the market right now is pretty dynamic, and we need to maintain our flexibility to ensure that we've got the right resources at the right time and ultimately targeting the right patients and physicians.

Q: It might be too early to ask. However, I was wondering if we could expect any updates on future clinical development road map before the end of the year? And also, do you plan to share any interim results from the ORCA-OL trial ahead of full publication?

A: I'm not sure I heard the first question. This is Cindy. But we are planning on completing the entire database for the ORCA-OL study, and that's going to happen quickly actually by the end of this year. And we will be looking at conferences as well as getting publications ready early next year for hopefully a conference maybe by quarter 2 or during the 2026 year, a number of times that we can present the data because there will be a lot of safety as well as efficacy data for us to present. That is the only ongoing trial we have right now. So obviously, our focus on that trial will allow us to hopefully proceed quickly with getting results in 2026 out to everyone.

Q: Boris, we see great value in the data from an open-label safety study. I think with 1 year's exposure to the drug, so far, we've seen an important element, which is the tolerability of the drug to patients during that period. And we think that's going to stand us in good stead in the future. So as Cindy said in her prepared remarks, the safety profile looks pretty much in line with what we've seen in the Phase III trials. And of course, the secondary endpoint is efficacy. And we're really, really interested to see what that long-term efficacy data will look like.