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Cindy Jacobs

We continue to keep up the momentum in driving towards the completion of the NDA, and we're in the final stages of submission preparation. We are taking the necessary steps and focus on ensuring that we will file a high-quality NDA in June. So let's now turn to some recent highlights. In January, we hit a key milestone of having 300 participants in ORCA-OL with cumulative cytisinicline safety exposure data for a total of 6 months. This was the gatekeeping requirement to be completed to move toward the NDA submission, and we're proud to have checked that box.
Furthermore, in April, we reached the second requirement of having at least 100 participants with cumulative cytisinicline safety exposure data for a total of 1 year. Safety data for 1-year 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. As Rick mentioned earlier, just last week, we had our third data safety monitoring committee review of the open-label study safety data. The committee once again reaffirmed excellent adherence to cytisinicline treatment, reported no safety concerns and required no modifications to the trial conduct. We are thrilled with how quickly the ORCA-OL has progressed.
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. Of the 479 participants who enrolled by the end of September last year, approximately 75% remain on cytisinicline in the study to date. We believe their willingness to remain on cytisinicline speaks to its favorable side effect profile and possibly efficacy benefit and is a strong signal of the potential impact cytisinicline could have in clinical practice. Also during the quarter, we convened our Scientific Advisory Board with a roundtable of 10 leading experts in nicotine and tobacco cessation research.
The discussion focused on updating these key opinion leaders on our research progress and NDA filing preparations while gathering invaluable insights from this esteemed group. The presence of such respected experts from Harvard, Yale, Stanford and UCSF among them, underscores the excitement surrounding cytisinicline and its potential to treat nicotine dependence. This excitement continues as we recently had our Phase III ORCA-3 trial results published in the Journal of the American Medical Association, JAMA Internal Medicine. The authors concluded that ORCA-3 reaffirmed cytisinicline's efficacy and tolerability for helping adult smokers quit at both the 6- and 12-week treatment duration. 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.
Even among participants who didn't fully quit, cytisinicline helped reduce their cigarette smoking as verified by a reduction in nicotine intake. This was demonstrated by decreased levels of cotinine, a key nicotine metabolite as well as by overall lower craving scores. In fact, Achieve's Dr. Mark Rubinstein will present data on the participants who didn't fully quit at the American Thoracic Society 2025 International Conference next week, highlighting the importance of cytisinicline's mechanism of action in helping to lower cravings and reduce nicotine intake. As we look to the future, our enthusiasm continues to grow around cytisinicline's potential to set a new standard in treating nicotine dependence for smoking cessation.
It's been nearly two decades since a new prescription treatment has been approved by FDA, and we believe cytisinicline is well positioned to fill this high unmet need for patients and providers. I will now turn the call over to Mark to review the financials.

Mark Oki

As we work toward our NDA submission in June and continue laying the groundwork for a potential commercial launch in 2026, we're staying laser-focused on managing our resources wisely and we'll continue doing so. As of March 31, 2025, the company's cash, cash equivalents and marketable securities were $23.2 million. 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. We remain committed to strong financial discipline, making sure our spending directly supports our key priorities, getting cytisinicline to market, building a foundation for our long-term growth and creating lasting value for our stockholders.
With that, I'll turn it back to Rick for his closing remarks.

Richard Stewart

Thank you, Mark, and thanks to the entire Achieve team for their support and tremendous efforts in pushing the NDA over the goal line. We are on track and weeks away from reaching this milestone. Adding to Mark's remarks, cash management remains a priority for the company, and we're being prudent with expenditures to ensure Achieve's cash runway is extended and the NDA remains the focus. Once the NDA is submitted, we anticipate receiving a 74-day letter from the FDA, acknowledging the acceptance of our submission. And from there, we expect the NDA approval to take approximately 12 months from the date of submission.
Treating nicotine dependence is our primary focus. And as I have mentioned before, cytisinicline can also help reduce the comorbidities and broader disease burden caused by smoking. Particularly in conditions like COPD and asthma. Smoking is a major driver of multiple chronic conditions. For example, around 80% of people diagnosed with COPD develop the disease due to smoking and about 6 million of the 16 million Americans diagnosed with COPD currently smoke today.
In our 2 Phase III trials, it was notable that smokers with COPD had higher quit rates on cytisinicline than those without the disease, a promising signal for COPD patients. Quitting can improve COPD treatment effectiveness plus reduce exacerbations and hospitalizations in COPD patients, where smoking worsens symptoms and increases severity. These findings highlight cytisinicline's potential impact beyond just treating nicotine dependence alone. Achieve's mission-driven team, together with support from key opinion leaders and patients in our clinical program has built a strong foundation for success. By meeting both patient and physician needs, we are ultimately positioned to deliver long-lasting value to stockholders.
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.

Question and Answer Session

Operator

(Operator Instructions) Gary Nachman, Raymond James.

Gary Nachman

First, how long before we see the full safety data from the long-term study? How will you present that? Will it be after you update the NDA with the one-year data? And when you say 75% of the enrolled patients remain on treatment in the long-term study, what's the average duration for patients getting cytisinicline? And is that reflective of how it will be used in the real-world setting?
And then what were some of the key takeaways from the SAB meeting? And how did that inform you for your filing and also for your commercial plans?

Cindy Jacobs

On the open-label study, currently, we are looking at completing all patients on the study in that June, July, August and a few in September. Most of the subjects will have done over 6 months of treatment on that study. 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. We'll be looking then at the end of this year into next year on what opportunities we'd have at a conference to present that data. We don't have anything set at this moment.
The SAB meeting actually was really just interesting as far as discussing the applications that cytisinicline treatment could have from, obviously, individuals who want to stop smoking, but also in hospital situations, where interactions with other medications, this would be important since there's no nausea side effects. There were a lot of other avenues of interest on how cytisinicline and where cytisinicline could be used.

Richard Stewart

Gary, I was actually at that meeting. And what was notable as far as I was concerned was the immense enthusiasm by the key opinion leaders for the drug. I think that as we expand our key opinion leader group, it's increasingly apparent that obviously, this is the first new nicotine dependence treatment in over 20 years, but an increasing recognition of the importance of both the efficacy and the tolerability of the drug. I think the view of the key opinion leaders is that this is clearly going to be a drug that's going to make an immense impact on the nicotine dependence area.

Gary Nachman

So just a follow-up, given that, what are some of your plans just in terms of pre-commercial efforts to continue to increase awareness and what cytisinicline could offer? And then just lastly, the status of any partnership discussions ongoing that could help provide some nondilutive capital, whether looking at a comorbid COPD study like you've talked about in the past or maybe a commercial partner, US or ex-US.

Jaime Xinos

So on the commercial readiness, what we're really doing at the moment is making sure we're focusing on our three key areas. And one of those you mentioned is awareness. But availability and access are 2 of our priorities. The first one, making sure that we have drug in the channel. So we've made some great strides over the last several weeks to ensure that we are ready to actually sell the product.
And then on the access side, we're continuing to work on our pricing and payer strategy as well and beginning to start thinking about how our pre-approval information exchange conversations will go with those payers. On the awareness side, we're really, again, focused right now highly on the NDA and making sure that our PI and our label is what we will need to be able to support the claims that we hope to make to differentiate cytisinicline from current treatment options. Alongside that, we have some efforts to make with physicians 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're quite frustrated. And so I think it's really important that we get out prior to launch to make sure they know that there is going to be a new option and the same will apply when those patients are coming in to have conversations, they have something different to offer them. We've spent a lot of time, too, on the awareness side, just building out -- it's more of a marketing focus, but really how we're going to be communicating with physicians.
So we're building out our digital road map so that we have an omnichannel, 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 go to them in channels that they're not really receptive to hearing from pharma. So a lot of efforts on the commercial planning phase as well.

Richard Stewart

In terms of the strategic partnering, I mean, as far as nicotine dependence is concerned, we believe we can launch it in the US alone. But your question was really pointed because as far as COPD and other 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 or respiratory partners. I think it's really important to understand how cytisinicline can play a role in the COPD treatment regimen. 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 is we're specifying exactly what we believe is the opportunity in that space. And then it's about how do you design a clinical study that's actually going to tease out the improvement in efficacy. So that's pretty much where we are at the moment. There are a number of potential candidates that we are in discussions with, but I think it's important to get the foundations of what we're trying to achieve in place first.

Operator

Justin Walsh, JonesTrading.

Justin Walsh

I'd love to hear if you've noticed any changes in your interactions with the FDA.

Cindy Jacobs

At this point, we haven't seen any real changes. They're 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 3 to 4 months, and their responses have been as normal. And so we have not seen any changes to date in the last few months.

Justin Walsh

And maybe a quick follow-up on that. I'm just curious if you see potential opportunities with the change in focus towards more chronic diseases. Obviously, the specific FDA interactions have been sort of the same. But just curious, if you're sort of thinking from a philosophical perspective, if the current administration, if there's maybe some alignment with this type of product.

Cindy Jacobs

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 the ability to use cytisinicline to address chronic diseases like COPD and all of the cardiovascular diseases and smoking causes will be a play as far as when they're reviewing and looking at all of our efficacy and safety data.

Operator

John Vandermosten, Zacks Investment Research.

John Vandermosten

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, have those conversations gone? And are there any products that are using this comparison to determine pricing? And then also on that same topic, are there any pharmacoeconomic elements guiding the discussion?

Jaime Xinos

We did have some conversations with payers, and we're just getting that information back and kind of calling through the data. Again, they're small samples and it's blinded research. So it's directional, but we won't really have strong perspective until we go out and have those tie exchanges and then also when we have our pricing set. But I mean, what we have been hearing is basically the same that 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 strategies might be.
So there's clear value that's demonstrated with the product, and they see that. It's just a matter of where they're going to place it depending on where we set price. As far as comparators, of course, they're going to be looking at what's available in the space, but there's clear differentiation from the generics. And there's also when we consider this patient population, these are patients who have tried multiple therapies and likely the ones that are on the market, again, mentioning that we haven't seen anything new in 20 years. And so enforcement of stepping through those is 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.

John Vandermosten

On the pharmacoeconomic studies, perhaps. I mean, obviously, there's some long-term benefits that we all know intuitively. But are you going to do anything there that quantifies it for 2025?

Jaime Xinos

Yes. I don't think there's a need to repeat studies that have already been conducted that show smoking causes these chronic diseases that are very expensive. There's so much literature out there that we can leverage. I think there is value in showing our biggest value proposition that we believe is that increased adherence is going to lead to compliance, which is going to improve outcomes. And I think that's what we need to be able to make a strong argument in a case for.
So instead of spending any resources on showing that chronic diseases caused by smoking are expensive. As we know, they're costing the US healthcare system over $300 billion a year. That data is strong and it exists, and we've done analysis and kind of an AQR gap analysis to show that, that data is out there. We're going to spend our time and energy on specifically how cytisinicline can improve the results that they are seeing with current treatments or not seeing with current treatments.

John Vandermosten

Okay. And there are a number of, I guess you call maybe digital-first commercialization companies out there like Syneos and Indigene. Can they take up part of what you were doing, maybe focus on some of the areas where they're more generic and they have leverage and then you focus on the areas where you have a competitive advantage. Is that something you might take advantage of? Or can you just do it all internally without using something like one of those guys?

Jaime Xinos

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 Credera that works across all industries and sectors, and they have helped build out a highly strategic and advanced model of what a digital launch road map 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 time and the efficiencies gained with the development of content and the measurements of whether or not the content is resonating with our target audiences. So we are definitely partnering and leveraging external resources very heavily.

John Vandermosten

It sounds like you get some real-time data there as you're doing the process. And last question for me is you should be -- assuming that the product is approved on time, about a year from now, you'll start commercialization. You'll be free to start it. Do you think you'll start right as soon as the approval is given? Or will you take a little time to kind of set things up?
I'm just wondering kind of the timing from a model perspective on how we should anticipate first sales to fall in next year?

Jaime Xinos

Yes. I think it's fair to assume a company of our size is going to need a minute following approval to get drug in channel. So it's going to take us a little bit of time, and I'm not sure we could speak right now exactly to how much time. But we certainly want to have a strong launch as close to timing of approval as possible. But again, we'll probably be able to give some further instruction and direction on that as we get closer.

Operator

There are no further questions at this time. I would like to turn the call back over to Rick Stewart for closing remarks.

Richard Stewart

Thank you, operator. We'd once again like to thank you for joining Achieve's Q1 call. It's clear that cytisinicline and Achieve can have a significant impact on the public health narrative in the US today by providing patients and physicians with new improved tools to address the nicotine dependence crisis in the US. The near-term NDA submission is a major milestone for Achieve, for patients, for physicians and for our stockholders, and we are confident of driving forward to a product launch in 2026.
Thank you for joining the call.

Operator

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.