Q1 2025 Achieve Life Sciences Inc Earnings Call
Nicole Jones: Greetings. Welcome to Achieve Life Sciences' first quarter, 2025 earnings conference call in webcasts. At this time, all participants aren't illicit only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to Nicole Jones, Achieve Investor Relations. Thank you. You may begin.
Nicole Jones: Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Rick Stewart, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Mark Oki, Chief Financial Officer. The management team will be available for Q&A following the prepared remarks.
Nicole Jones: As a reminder, a replay will be available later today by using the information provided in the earnings press release issued prior to this call or visiting the Achieve website.
Nicole Jones: Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of the
Nicole Jones: Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, these statements are not guarantees of future performance.
Nicole Jones: Times sensitive information may no longer be accurate at the time of any caliphonic or webcast replay. Actual results may differ materially as the results of risk uncertainties and other factors including, but not limited to, the factors set forth in the company's filings with the FCC.
Nicole Jones: Achieve undertakes no obligation to update or revise any of these forward-looking statements.
Nicole Jones: Please refer to Achieve Documents available on our website and filed with the SEC Conference concerning factors that could affect the company. I'll now turn the call over to Rick.
Rick Stewart: Thank you Nicole, and good morning to everyone, and thank you for joining us on today's call.
Rick Stewart: It's good to be able to say that Achieve is on track to submit the NDA for scientists in the
Rick Stewart: It's been a long road to get us here and all internal resources are now focused on a successful
Today's focus is primarily on the NDA submission.
Speaker Change: The role that cytosynically can play as a treatment for nicotine dependence is immense.
Speaker Change: In the U.S. alone, over 29 million adults smoke cigarettes, and 11 million adults vape.
Speaker Change: More than half want to quit, but fewer than 10% succeed because they have inadequate tools to help them overcome nicotine dependence successfully.
Speaker Change: Psychosinically, you can change that and improve the probability and the opportunity to quit smoking and vaping with excellent efficacy and tolerability.
Speaker Change: If approved, cytosinically in will be the first new nicotine dependence drug in nearly 20 years, providing achieved the opportunity to offer new hope to patients and their healthcare providers.
Speaker Change: We want to change the conversation, reminding the patient and medical community that nicotine dependence is a serious medical condition and needs to be treated as such.
It's not about willpower, it's about science.
Speaker Change: Nicotine is the third most addictive drug after heroin and cocaine. We believe that cytosynoclin can be a part of the solution and help reframe this medical condition much like GLB1's did for obesity.
Speaker Change: As Cindy will review shortly, we conducted a scientific advisory board meeting in March with experts in nicotine and tobacco cessation research to discuss scientists in the clean.
Speaker Change: and in April , we were pleased to have our Orca III clinical trial results published in JAMA Internal Medicine.
Speaker Change: Since our call in March further progress has been made and Achieve now has over a hundred of patients with the FDA's required one-year exposure to scientists in the Orca O.L. Open Label Study.
Speaker Change: The fact that so many patients remain on the study and continue on the drug is a testimony to scientifically used tolerability.
Speaker Change: Additionally, the Data Safety Monitoring Committee completed another successful review of the OrcaOL Safety Data, and the trial is continuing as planned.
Speaker Change: With that, I'll turn the call over to Cindy to provide more details on the Orca O.L. trial and the overall clinical development and regulatory process.
Cindy Jacobs: Thank you, Rick. We continue to keep up the momentum and driving towards the completion of the NBA, and we're in the final stages of submission preparation.
Cindy Jacobs: We are taking the necessary steps and focus on ensuring that we will file a high quality MBA in June .
Cindy Jacobs: So let's not turn to some recent highlights. In January , we hit a key milestone of having 300 participants in Orca, O.L. with Camilo T inside of Cinnacom's safety exposure data for a total of six months.
Cindy Jacobs: This was the gatekeeping requirement to be completed to move towards the NDA submission and we're now to check that box.
Cindy Jacobs: For the more in April , we reached the second requirement of having at least 100 participants with a cumulative fatty cyniclin safety exposure data for a total of one year.
Cindy Jacobs: Safety data for one year's exposure is being monitored and will be finalized to include it in the standard 120-day safety update that we will be submitting during the NDA review process as agreed upon with FDA.
Rick Stewart: As Rick mentioned earlier, just last week, we had our third Data Safety Monitoring Committee review of the Open Label Study Safety Data.
Rick Stewart: The committee once again reaffirmed excellent adherence to cited cyniclin treatment, reported no safety concern, and required no modifications to the trial conduct.
Rick Stewart: We are thrilled with how quickly the ORCA-OL has progressed.
Rick Stewart: Long-term studies are often difficult when it comes to retention of participants for one year treatment requirements, so it is encouraging to see so many participants choosing to stay on treatment.
Rick Stewart: of the 479 participants who enrolled by the end of September last year, approximately 75% remaining on Pytopiniclin in the study to date.
Speaker Change: The discussion focused on updating these key opinion leaders on our research progress and NDA filing preparations well how's it going and valuable insights from their sustained too.
Speaker Change: The presence of such respected experts from Harvard Yale and Stanford and UCSF among men underscores the excitement surrounding sided silicon and its potential to treat nicotine dependence.
Speaker Change: This excitement continues as we recently had our phase three Orca three trial results published in the journal of the American Medical Association Jama internal medicine.
Speaker Change: The office concluded that Orca three reaffirms. So it has an excellent efficacy and tolerability for helping adult smokers quit at both the six and 12 weeks treatment duration.
Speaker Change: The data showed not only higher quit rates compared to placebo, but also a meaningful reduction in nicotine cravings and sustained benefits out to 24 weeks.
Speaker Change: Even among the participants who didn't fully quit side incentive plan to help reduce their cigarette smoking as verified by a reduction in nicotine intake.
Speaker Change: This was demonstrated by decreased levels of Coatney achene nicotine metabolite as well as by overall lower craving scores.
Speaker Change: In fact, she's Dr. Marc Rubin.
Speaker Change: Well present data on the participants who didn't fully quit.
Speaker Change: At the American Thoracic Society 2025 International Conference next week, highlighting the importance of sides finished one's mechanism of action and helping to lower crazy and reduced nicotine intake.
Speaker Change: As we look to the future our enthusiasm continues to grow around the size of the citizens potential to set a new standard in treating nicotine dependence for smoking cessation.
Speaker Change: So nearly two decades, so it's a new prescription treatment has been approved by FDA and we believe side is finished then is well positioned to fill this high unmet need for patients and providers.
Speaker Change: I will now turn the call over to Mark to review the financials.
Mark Oki: Thank you Cindy and good morning.
Mark Oki: We work toward our NDA submission in June and continue laying the groundwork for potential commercial launch in 2026.
Mark Oki: Being laser focused on managing our resources wisely and we'll continue doing so.
Mark Oki: As of March 31, 2025, the company's cash cash equivalents and marketable securities were $23 $2 million.
Mark Oki: Now turning to our statement of operations. Our total operating expenses for the first quarter of 2025 were $12 $9 million and the corresponding net loss was $12 $8 million.
Mark Oki: We remain committed to strong financial discipline, making sure our spending directly supports our key priorities getting <unk> to market.
Mark Oki: Building, a foundation for our long term growth and creating lasting value for stockholders.
Rick Stewart: With that I'll turn it back to Rick for his closing remarks.
Rick Stewart: Thank you Mark and thanks to the entire achieve team for their support and tremendous assets and pushing the M D.
Speaker Change: <unk> line, we are on track and weeks away from reaching this milestone.
Speaker Change: Adding to marks remarks.
Speaker Change: Cash management remains a priority for the company and we're being prudent with expenditures to ensure achieves cash runway is extended.
Speaker Change: NDA remains the focus.
Speaker Change: Once the NDA is submitted we.
Speaker Change: Anticipate receiving a 74 day letter from the SBA acknowledging the acceptance of our submission from that we expect the NDA approvals should take approximately 12 months from the date of submission.
Speaker Change: Treating nicotine dependence is our primary focus.
Speaker Change: And as I've mentioned before such as clinically and can also help reduce the co morbidities and broader disease burden caused by smoking, particularly in conditions like COPD and asthma.
Speaker Change: Smoking is a major driver of multiple chronic conditions for example around 80% of people diagnosed with C. O P. D develop the disease due to smoking and about 6 million of the 16 million Americans diagnosed with COPD currently smoke.
Speaker Change: Today.
Speaker Change: And our two phase III trials. It was notable that smokers with C. O P D higher quit rates on snacks, you Sidney clean than those without the disease, a promising signal for COPD patients.
Speaker Change: Quintin can improve COPD treatment effectiveness, plus reduce exacerbations and hospitalizations in COPD patients, where smoking worsening symptoms and increases in severity. These.
Speaker Change: These findings highlight <unk> cynically as potential impact beyond just treating nicotine dependence alone.
Speaker Change: But she was a mission driven team together with support from key opinion leaders.
Speaker Change: Patients in our clinical program has built a strong foundation for success by amazing both patients and physician needs. We are ultimately positioned to deliver long lasting value to stockholders.
Speaker Change: Thanks again for spending time with US. This morning, we look forward to keeping you updated as we continue making progress in the months ahead with that I'll hand, you back over to the operator to begin the Q&A.
Speaker Change: Thank you.
Speaker Change: We will now be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: Confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue and for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment, while we poll for questions.
Gary Nachman: Our first question is from Gary Nachman with Raymond James. Please proceed.
Gary Nachman: Thanks, and congrats on the progress so.
Speaker Change: So a couple of questions first how long before we see the full safety data from the long term study how will you present that wont be after you update the NDA with the one year data.
Speaker Change: And when you say, 75% of the enrolled patients remain on treatment in the long term study, what's the average duration.
Speaker Change: If a patient is getting cytosine it clean and is that reflective of how it'll be used in the real world setting.
Speaker Change: And then what were some of the key takeaways from the <unk> meeting and how did that inform you for your filing and also for your commercial plans.
Cindy Jacobs: Thanks, Gary I'll hand that one over just Cindy.
Cindy Jacobs: Sure on the open label study currently we are looking at them completing all patients on this study in that June July August and a few in September So we'll have more.
Cindy Jacobs: Most of the subjects will have done over six months of treatment on that study.
Cindy Jacobs: So we'll be looking at compiling that information and presenting it after the NDA. Obviously is submitted and after we have the 120 day safety data submitted in October well be looking then at the end of this year into next year on what.
Cindy Jacobs: These we'd have at a conference to present that data, we don't have anything set at this moment.
Speaker Change: And okay. That's helpful. Yeah, what was that they'd be neither oh.
Speaker Change: Oh the S. A b meeting actually was really just interesting as far as discussing the applications that side of the Senate Glenn treatment could have from obviously individuals who want to stop smoking, but also in hospital situations.
Speaker Change: Where interactions with other medications this would be important since theres no nausea side effects. There were a lot of other avenues of interests in house side as silicon and wear side isn't it then could be used.
Speaker Change: Okay, great and if I can add something.
Speaker Change: Yes, please yes.
Gary Nachman: Yeah, Gary I was actually at that meeting and what was notable as far as I was concerned is that with the immense enthusiasm by the key opinion leaders.
Gary Nachman: Union leaders for the drug I think that as we expand our key opinion leader group is increasingly apparent.
Gary Nachman: As you know this.
Gary Nachman: Obviously this is the first new nicotine dependence treatments in over 20 years, but the increasing recognition of the importance of the like the efficacy and the tolerability of the drug. So I think the the view of the key opinion leaders is that this is clearly going to be a.
Gary Nachman: <unk> a drug that's going to make an immense impact on nicotine dependence area.
Gary Nachman: Okay. So just a follow up given that.
Gary Nachman: What are some of your plans just in terms of pre commercial efforts to continue to increase awareness and website, if cynically I could offer.
Gary Nachman: And then just lastly, you know the status of any partnership discussions ongoing that.
Gary Nachman: Could help provide some non dilutive capital where they're looking at a comorbid COPD study like you've talked about in the past or maybe a commercial partner U S or ex U S. Thanks.
Gary Nachman: Yeah first part I'll hand that one over to Jamie.
Jamie: Hi, Thanks for the question Gary Yeah. So army commercial readiness, what were really doing at the moment is making sure. We're focusing on three three key areas and one of those you mentioned is the awareness availability and access are two of our priorities. The first one I'm, making sure that we are driving the channel. So we've made some great strides.
Jamie: For the last several weeks to ensure that we are ready to actually sell the product and then on the actual fiber continuing work on our pricing and payer strategy as well and beginning to start thinking about how our free information our preapproval information exchange conversations will go with those payers on the awareness side were really.
Jamie: <unk> focus right now highly on the NDA and making sure that RPI in our label is what we will need to be able to support the claims that we hope to make some differentiates hypothetically from current treatment options.
Jamie: Alongside that you know we have some efforts to make with physician search to bring smoking cessation back to the conversation that they're having with their patients because for 20 years, they've had no new options to offer them and so they are quite frustrated.
Jamie: And so I think it's really important that we get out you know prior to launch to make sure. They know that area is going to be a new option in the same same old fae. When you know when those patients are coming in to have conversations they have something different to offer them. We've spent a lot of time sue on the awareness side just building out its more of a marketing focus so that's really how we're going.
Jamie: Going to be communicating with physicians. So we're building out our digital road map. So that we have an omni channel very efficient platform that we can reach our customers and make sure that we're meeting them, where they are and where they want to be finding information instead of trying to you know go to them and in channels that there, they're not really receptive to hearing from <unk>.
Jamie: So a lot of efforts on the commercial planning phase as well.
Jamie: And then the second part of your question yes.
Jamie: Okay.
Gary Nachman: Yes second half of the question Gary.
Gary Nachman: In terms of the strategic partnering I mean as far as nicotine dependence is concerned we believe we can launch it in the U S alone, but your question was very.
Gary Nachman: Appointed because as far as C. O P. D. Another kind of Comorbidities are concerned what we're doing at the moment is specifying exactly what we want from any kind of partnering with COPD asthma or respiratory partners I think it's really important to understand.
Gary Nachman: How 60 cynically you can play a role in the C O P D treatment regimen.
Gary Nachman: And we've been looking carefully at the anti IL 33 drugs, some of which have got difficulties in actually having efficacy in smokers. So really where we are right now as we we're specifying exactly what we believe is the opportunity in that space and that is about how old you design the click.
Nickel study, that's actually going to a.
Gary Nachman: Tease out the improvement in efficacy.
Gary Nachman: That's pretty much way way out of the way there are a number of potential candidates that we are in discussions with them, but I think it's important to get the foundations of what we're trying to achieve in place first.
Speaker Change: Okay, great. Thanks for all that color.
Gary Nachman: Appreciate it.
Speaker Change: Our next question is from Justin Walsh with Jones trading. Please proceed.
Justin Walsh: Hi, Thanks for taking my question I'd Love to hear if you've noticed any changes in your interactions with the FDA.
Speaker Change: Sidney that one's for you.
Speaker Change: At this point, we haven't seen any real changes there just as responsive as they have been we have had some interactions obviously as we get closer with the NDA submission and asking them over the last three to four months and their responses have been as normal and so we have not.
Speaker Change: Seen any changes to date them in the last few months.
Speaker Change: Great and maybe a quick follow up on that I'm. Just curious if you see potential opportunities with the the change in focus towards more chronic diseases, obviously, you're the specific FDA interactions.
Speaker Change: Have been sort of the same but I'm just curious from a.
Speaker Change: And if you're sort of thinking from a philosophical perspective, if the the current administration, if there's maybe some alignment with our with this type of product.
Speaker Change: Well I mean, obviously, it's hard to speculate but we would hope because we are very proud of the efficacy and the safety data that has the ability to use them use side, a cynic Glenn to address chronic diseases like C. O P D and all of the cardiovascular diseases as smoking.
Speaker Change: Causes them and we'll be up a play as far as when they're reviewing and looking at all of our efficacy and safety data.
Great. Thanks for taking my questions.
Speaker Change: Our next question is from Thomas Flaten with Lake Street capital markets. Please.
Speaker Change: We lost him. So our next question is from John with Andrew My son with Zacks Investment Research. Please proceed.
Speaker Change: Great. Thank you and good morning, you guys on the last call you mentioned that you'd be discussing pricing with payers I'm not sure if that happened yet, but if they have how those conversations gone.
Speaker Change: And are there any products that you're using as comparison to determine pricing and then also on that same topic are there any pharmacopeia economic elements guiding the discussion.
Speaker Change: Yeah.
Speaker Change: Jeremy.
Speaker Change: Okay.
Speaker Change: Yeah. So we did have some conversations with payers and we're just getting that information back in kind of calling through that through the data again, they're small samples on its blinded research. So it's directional but we won't really have strong perspective, and so when you go out and have those high exchanges and then also when we have our pricing, but I mean, what we have been hearing is basically the same.
Speaker Change: We've heard historically is ultimately formulary placement and reimbursement will depend on our price and that will help us understand where contracting will be required and what some rebate strategy might be so there's clear value. That's that's demonstrated with the product and they see that it's just a matter of of where theyre going to place it.
Speaker Change: Depending on where we set price.
Speaker Change: As far as.
Speaker Change: Yeah competitors of course, they're going to they're going to be looking at what's available in the face, but there's clear differentiation from from the generics and there's also you know when we consider this patient population. These are these are patients who have tried this multiple therapies and likely the ones that are on the market again mentioning that hasnt, we havent seen anything new in 20 years, and so enforcement of stuffing.
Speaker Change: I was just going to be challenging because either patients have tried and failed or are unwilling to try and so there's less issues around barriers to access from that perspective.
Speaker Change:
Speaker Change: And then did you have a third and then he had a pharma for economic studies, perhaps I mean.
Speaker Change: You know obviously there are some long term benefits that we all know intuitively.
Speaker Change: But are you going to do anything there that quantify that for you know 2025.
Speaker Change: Yeah, I don't think there's a need to repeat studies that have already been conducted that show a smoking causes. These chronic diseases that are very expensive. There's so much literature out there that we can leverage I think theres there is value in showing our biggest value proposition that we believe is that that increase adherence is going to lead to compliance which is going to them.
Prove outcomes and I think that's what we need to be able to to make a strong argument and a case for so instead of sending any resources on showing that chronic diseases caused by smoking are expensive you know as we know they're crossing the U S health care system over $300 billion, a year that data is strong and it because that's something we've done.
Speaker Change: Analysis in kind of a H O R gap analysis to show that that data is out there we're going to spend our time and energy on specifically how satisfied are clean can improve the results, but that they are seeing with current treatments are not thing with current treatments.
Speaker Change: Okay.
There are a number of.
Speaker Change: I don't know I guess you'd call maybe digital first commercialization companies out there like Sydney hasn't ended gene can they take up part of what you were doing you know maybe maybe focus on some of the areas where there are more.
Speaker Change: Derek and they have leverage and then you focus on the areas, where you have a competitive advantage is that is that something you might take advantage up or can you just do it all internally without using something like you know one of those guys.
Speaker Change: We will be heavily relying on and have been on our agency partners to help us implement our strategy. So we've been working with Omnicom, primarily and they have a strong digital company called Cordero that works across all industries and sectors and they have helped build out a highly strategic and <unk>.
Speaker Change: Vance model of what a digital launch roadmap would look like what our data requirements will be and how AI will help to inform every stage of the process from improving our targeting strategies to improving the the time any efficiencies gained with the development of content and that and the measurements of whether or not the content.
Speaker Change: Resonating with our target audience is so we are definitely partnering and leveraging external resources very heavily.
Speaker Change: Okay. It sounds like you've got some real time data there as is or is it during the process and the last question for me is.
Speaker Change: You should be a you know assuming assuming that the product's approved on time.
Speaker Change: About a year from now you'll start commercialization do you and are you you'll be free to start. It do you think you'll start right as soon as the approval is given or will you know when you take a little time to kind of set things up or I'm. Just was wondering kind of the timing from a model perspective on how we should anticipate.
Speaker Change: First sales too.
Speaker Change: Fall and next year.
Speaker Change: Yeah, I think it's fair to assume a company of our size is going to need a minute.
Speaker Change: That's sort of also getting dragon channels. So it's going to it's going to take us a little bit of time and I'm not sure. We can speak right now exactly how much time, but we certainly want to have a strong launch that's close to the timing of approval is possible, but again well probably.
Speaker Change: Probably be able to give some further instruction and direction on that as we get closer.
Speaker Change: Great Alright, thanks, Jeremy I appreciate it.
Speaker Change: You bet.
Speaker Change: There are no further questions at this time I would like to turn the call back over to Rick Stewart for closing remarks.
Rick Stewart: Thank you operator would once again like to thank you for joining achieved Q1 call.
Speaker Change: It's clear that size is clinically and then achieve can have a significant impact on the public health narrative in the U S. Today by providing patients and physicians with new improved tools to address the nicotine dependence crisis in the U S.
Speaker Change: Near term NDA submission is a major milestone for achieve for patients.
Speaker Change: Physicians and for our stockholders and we are confident of driving forward to a product launch in 2026. Thank you for joining the call.
Speaker Change: Thank you. This will conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.
Speaker Change: Okay.
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