Greetings. Welcome to Alpha Cognition Fourth Quarter and Full Year 2025 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to Henry Du, Interim CFO. Thank you. You may begin.

Thank you, Sherry. Good afternoon, and thank you, everyone, for joining us today for Alpha Cognition's Fourth Quarter and Full Year Fiscal 2025 Results Call. Today, after the close of market, the company issued a press release announcing our financial results. Joining me on the call today are Alpha Cognition's Chief Executive Officer, Michael McFadden; and Chief Operating Officer, Lauren D'Angelo. Today's call is being made available via the Investors section of the company's website at www.alphacognition.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Alpha Cognition's current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements. Please review the note regarding forward-looking statements in our earnings press release was disseminated prior to this call for more information on forward-looking statements. Please also note that the company's actual consolidated financial results remain subject to completion of our annual audit procedures. Our actual audited consolidated financial results are expected to be reported in connection with the filing of our annual report which is expected to be filed on or about March 31, 2026. Our actual consolidated financial results may differ from the results discussed on this call, including as a result of audit adjustments and other developments that may arise between now and when the financials are finalized and filed. The results discussed on this call should not be viewed as a substitute for audited consolidated financial statements and related notes. Accordingly, you should not place undue reliance on the results discussed in this call, which have been prepared by and is a responsibility of our management. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on March 26, 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Alpha Cognition declines any obligation to update these forward-looking statements, except as required by applicable securities laws. I'll now turn the call over to Michael.

Thank you, Henry, and good afternoon, everyone. Thanks for taking time to join us on today's call. This quarter marks our third full quarter following the commercial launch of ZUNVEYL for the treatment of mild to moderate Alzheimer's disease. As a reminder, ZUNVEYL is the first new oral Alzheimer's treatment approved in more than 15 years, and we believe it has a meaningful opportunity in long-term care where symptom management, tolerability and behavioral management are central to care decisions. To sum up our results, the commercial launch progress and what we're focused on in 2026, the fourth quarter and fiscal year was characterized by the following: continued sales growth and ongoing demand expansion of ZUNVEYL, further traction in long-term care, including expanding both breadth and depth of prescribing in the $2 billion high-volume long-term care market; progress on payer access, including a second signed contract with a national PBM, which now gets us contracted with 2 out of the top 4 PBMs nationwide. The company raised $40 million in Q3, which enabled us to appropriately expand our commercial reach and payer engagement strategies. And importantly, we maintained a strong financial foundation, which we believe keeps the company well funded with a clear path toward operational profitability in 2027. In addition to the solid commercial and operational progress the company has made, we announced 3 real-world studies that are or will be initiated in 2026. These studies will provide further evidence to strengthen ZUNVEYL's positioning with payers and provide additional evidence for health care providers who need a therapy that's well tolerated and demonstrates behavioral and cognitive efficacy for their patients. Lauren, our COO, will come on later and talk a bit more about how our commercial strategy is progressing as well as comment on the payers who obviously pay an…

Thanks, Michael, and good afternoon, everyone. As I review our fourth quarter and full year 2025 results, please refer to today's press release or our Form 8-K filing. I'll begin with a review of our financial results for the fourth quarter and full year 2025, followed by an update on our balance sheet and expectations for 2026. Overall, the year reflected continued commercial progress for ZUNVEYL, supported by growing prescriber adoption and investments in our commercial infrastructure. Starting with revenue. For the fourth quarter, we generated total revenue of $2.8 million, driven primarily by $2.5 million in net product sales from ZUNVEYL, our lead commercial product. We also recognized $259,000 in licensing revenue from our collaboration with CMS Pharma. For the full year, total revenue was $10.2 million, including $6.8 million in net product sales from ZUNVEYL. These results reflect steady growth in adoption, and we continue to receive positive feedback from prescribers and caregivers regarding the impact ZUNVEYL is having on patients. Turning to operating expenses. Total operating expenses for the fourth quarter were $10.7 million, which included $258,000 in cost of goods sold and cost of revenues and $10.4 million in SG&A and R&D expenses. This compares to $2.7 million in operating expenses in the fourth quarter of 2024. For the full year of 2025, total operating expenses were $32.9 million, which included $1.9 million in cost of goods sold and cost of revenues compared with $12 million in 2024. The year-over-year increase primarily reflects higher SG&A expenses associated with the expanding commercialization organization, including personnel costs as we continue building our sales team and supporting the launch and commercialization of ZUNVEYL. As a result, we reported an operating loss of $7.9 million for the quarter compared to $2.7 million in the fourth quarter of last year. For…

Thank you, Lauren. The team is focused on executing these quality calls with high-value medical directors and psychiatry consultants. We're meeting with health plans to pull through our PBM contracts, and we're working to manage efficiently the reimbursement process with our customers. Our relationship with CMS Pharma continues to grow. We're working through the regulatory process with our partner to gain approvals for ZUNVEYL in 2 countries this year. This last quarter, our leadership team has met with over 40 prescribers. The clinical outcomes they're seeing with ZUNVEYL are robust. The tolerability they see in patients is very good. They see improvements in cognition and improvements or complete amelioration of behaviors, and they report that commonly to us during these meetings. This gives us confidence that when we reduce the friction points with payers, our demand will grow. More importantly, we believe the company is well funded to execute, and we are focused on driving toward operational profitability in 2027, while building a durable commercial franchise around ZUNVEYL. We'll now take questions. Operator?

[Operator Instructions] Our first question is from Ram Selvaraju with H.C. Wainwright.

Congratulations on all this recent progress. I wanted to, first of all, start with some commercial aspects. I was wondering if you could give us some additional color regarding your anticipated timing for conversion of the additional payers that you haven't already converted as well as when you anticipate potentially promoting into the neurologist prescriber base relative to the long-term care facilities and those specialist prescribers? Lauren D’Angelo: Sure. Thanks, Ram, for the question. First, so timing conversion for the payers. So as we've shared with you all, we're really excited that we signed 2 of the big 4. So that represents a significant percentage of our overall business. And if you look at both of those PBMs, right now in one of the PBMs, we have about 16% open business. So we're still working really, really hard to pull through the rest of the regional plans on that PBM. And then we just signed that second PBM at the end of last year. So we're working through now the downstream accounts. The biggest downstream accounts are really who were targeted. And the plan -- we're having great conversations with those regional payers. Our thoughts around when we're going to start to see adoption for those regional plans, we expect that we're going to see some acceleration in Q2. So a small amount of those plans will likely pick us up in Q2 with broad implementation in Q3 is where we expect to see significant pickup from the downstream. Now as far as promoting into the neurologist or the specialty space, our plan has always been that as we get closer to breakeven, profitability in 2027, that's when we would look to expand into neurology.

Okay. And then with respect to the clinical development plans, I wanted to drill down specifically on 2 of these initiatives, one of which is obviously a current clinical program for ZUNVEYL. I was wondering specifically if you could give us some additional color on the key -- what you hope to be the key aspirational takeaways, if I can put it that way, from the CONVERGE study, in particular, as this pertains to polypharmacy because clearly, this study will provide a lot of important information, but we wanted to just kind of get a sense of assuming that you get the information that you expect this study to deliver, how that is going to play into your long-term promotional strategy for ZUNVEYL? And to what extent this study is likely to be a fulcrum with prescribers?

That's a great question. So CONVERGE is a data analysis of the long-term care market, and we plan to evaluate polypharmacy in 3 ways. In the long-term care market for the Alzheimer's patient, polypharmacy is very common for patients with sleep disturbance that occurs with the other agents in the class, patients with GI disturbance that is very commonly seen with other agents in the class and to control behaviors, which other agents in the class have a modest or no effect on being able to control. We anticipate with the advent or utilization of ZUNVEYL that we've seen in these homes that we'll see a reduction in that polypharmacy, but the data will tell that story, and that will be one of the #1 things that the study will look at. It will also look at things like adherence, tolerability dosing and consistency across ZUNVEYL and other agents in the class. So we'll have a plethora of data looking at all of those areas. We think that will be really key for providers and also decision-makers into determining positioning for ZUNVEYL with health plans and determining how they want to use ZUNVEYL in the long-term care marketplace.

Okay. Great. And then just lastly on the preclinical sublingual formulation. Three quick questions here. Firstly, I was wondering if you could comment on any additional precision with which you expect this to enter the clinic in 2026 and what the prerequisite steps might be for that milestone to be reached. Secondly, I was wondering if you could maybe just sketch out for us what you expect the clinical development time line and paradigm to look like for the sublingual formulation. I presume that it would also fall under the 505(b)(2) pathway, but perhaps you could give us some additional color regarding how you expect it to move towards potential market entry. And of course, if you could give us some sense of timing with which it might reach the market? And also if you have thoughts at this early stage regarding assuming success in clinical development, how this sublingual formulation would play alongside ZUNVEYL, how this might broaden your overall reach into the Alzheimer's community? And also if there are any technical plans envisaged with respect to looking at the feasibility of formulating not only ZUNVEYL sublingually, but also potentially generating combination therapies. So this would essentially involve sublingual delivery of both benzgalantamine and potentially other anti-Alzheimer's medications in the same sublingual formulation.

A lot to unpack there. Let me start with the position in the market with the sublingual. Why are we investigating and trying to advance the sublingual. In the long-term care marketplace, it's estimated that up to 20% of patients have dysphagia or aphasia. That's an inability or difficulty in swallowing a tablet or capsule formulation of any medication. Currently, these patients with Alzheimer's who have this difficulty either use a patch or if there's a capsule or a tablet, it's crushed or opened and put into a feeding tube or mixed with apple sauce and it's administered to the patient. As you can imagine, that's very challenging and difficult. The sublingual, we believe, will displace a very difficult-to-use patch and displace a very challenging administration in apple sauce or in a tube by simply putting this under the tongue, it dissolves within seconds. So it's easy to administer provided that the data allows us to move forward with the compound. Let me talk about the things that we're looking at and the milestones that we need to undertake in conquer to move this to the clinic. First, we are going to initiate a PK comparative study with our sublingual versus our tablet and our intranasal formulation. If that PK data shows parity, we will use that as the basis to enter the clinic with FDA. Now we'll need to complete a Type C meeting, which would happen in the late summer with FDA. And post a positive Type C meeting, we would be advancing the sublingual formulation to the clinic likely in the very first part of 2027. This will all be dependent upon the data from the agency, but we believe that's all that's needed. We've completed all other data that we believe we need to complete to move the product to the clinic. If we're able to move to the clinic, we would take a modified 505(b)(2) path. Our current thinking is we would complete a 505(b)(2) study. And then we would follow that with a tolerability study with the sublingual that could be label-enabling for that asset to allow us to utilize that data for both promotion and the label for the sublingual. That is to be determined on how long that study needs to be. That will be part of our Type C meeting conversation with FDA. We also plan to use the sublingual formulation to advance our program for cognitive impairment with mild traumatic brain injury. It's an easy to take formulation that would be administered easily for that patient population. So we have a dual use for that asset and dual programs that we will utilize the asset for.

And one clarification -- sorry, go ahead.

Regarding combo therapy, combo therapy will follow both of those programs. Those programs are #1 and #2 on the company's priority for medical development at this time.

Okay. Just one commercial clarification. I assume that if the sublingual formulation reaches the market specifically in order to address dysphasia or aphasia in Alzheimer's patients that you would anticipate being able to leverage it using your existing sales and marketing infrastructure and you would not, at that time, need to bring on additional sales firepower. Is that an accurate assumption?

Yes, you're correct that there's 100% synergy with the sublingual and our existing sales infrastructure.

Our next question is from Dave Storms with Stonegate Capital.

I actually kind of wanted to follow up there with the sales rep expansion. Just maybe what are you seeing here? Is it complete? Are there still territories to fill? And then I guess a follow-up to that would be, as the sales team continues to grow, when should we maybe expect some sort of inflection here, if any? Just trying to think about ramp times and the like. Lauren D’Angelo: Sure, sure. No, thanks for the question, Dave. So over the past quarter, the team has been focused on increasing the sales force to ensure that we have greater reach and frequency on our customer base. I'm pleased to announce that our increase is fully filled. So I know you asked how many territories do we have left to fill. We moved very quickly. That's the beauty of having a very experienced long-term care leadership team. I think we've talked about that a lot on previous calls. So we were able to expand our sales force as of January. And really, we had almost 98% full and then we've recently added a couple more reps in March to complete our full sales force expansion. So that's one key mechanism that we believe is going to accelerate the business significantly. There's also a couple of other things that we've done with the sales force. So we've really honed in on behaviors and going deeper with psychiatry. That was a big reason or factor on why we did expand the sales force because we found that our drug, the feedback we're getting on our drug and the behavioral symptoms is far better than we expected, and we knew that we need to expand to the psychiatry customer within the long-term care setting. And so we've done that. We're putting these new reps, the expanded reps out there delivering that message. And then on top of that sales force, right, because we know payer is a friction point for us, we've increased our reimbursement team. And that will allow, as the team has expanded, we put additional sales reps on the ground. We now have additional field reimbursement team who can help pull their demand through from a payer perspective. So that's been a key mechanism for us as well. And then, of course, with the expanded sales force, I know you asked a question about sales force, but it kind of -- it is a domino effect on all the other mechanisms that we put into place to fully support that expansion is this training of the 48 thought leaders so that with the additional sales force, they'll be able to leverage the KOLs and get out there and support the peer-to-peer education. So we really believe that really those 4 key areas are the mechanisms they're going to help us accelerate. And we believe that when it does, it's going to be very meaningful.

That's great color. I appreciate that. Can I just circle back maybe on to something you mentioned in your answer about expanding to psychiatry customers. Now that ZUNVEYL has been in the market and you're starting to get the market reception of it, I guess how else is that marketing changing? Is the psychiatry -- yes, go ahead. Lauren D’Angelo: Sure. Yes. When we originally launch the product, and I think even for several years leading up to the launch, right, when we were planning the positioning of ZUNVEYL, it was all about the tolerability, right? The no GI, we know that's a significant issue with the acetylcholinesterase inhibitors. And so that's really where we leaned into. Then we -- at the same time when we launched, we talked about the dual mechanism of action, and that's how it differentiates us from the other acetylcholinesterase in the class. So that was really our core positioning when we launched ZUNVEYL. But very quickly, and I think you guys will remember from the last couple of calls, the feedback we were hearing from customers around how this drug was working on behaviors really was just overwhelming. And behaviors, what we learned is really what drives adoption in the nursing home because the behaviors are what the physicians are obviously very concerned about when you've got this frail population living in a nursing home. So we've shifted our positioning. We still hone in on strong tolerability. I mean, to date, we still only have 2 spontaneous reports of GI. We've been out there for almost a year now. I mean that's pretty incredible if you think about it. Not to say that it's not happening in other places, we just haven't heard about it. But we've really shifted more to this behavioral messaging…

That's super helpful. And I mean, I know it's anecdotal, but that is a great story. One more, if I could. Michael, just because I really appreciate your answer around the CONVERGE study. If I could compare it maybe the same phrasing for the BEACON trial. Maybe just any thoughts on what aspirational outlook is like for BEACON and maybe compare it to CONVERGE?

Yes. So BEACON is a different study in that it will look at ZUNVEYL tolerability, ZUNVEYL efficacy in treating cognition, ZUNVEYL efficacy in treating behavioral symptomatology. And so we hope with -- at the end of that study, aspirationally, we hope that the study demonstrates strong cognitive effect, strong behavioral symptomatology amelioration or improvement, along with great tolerability for ZUNVEYL. That would be the hope. We'll see what the data tells us. But it's a very important study for us because in the long-term care market or long-term care segment of the Alzheimer's market, there are very few completed studies. There's very few observational Phase IV and almost no Phase III studies to evaluate drug performance evaluate drug tolerability. And so this will be one of the first studies that provides a very good data set and 200 patients in the nursing home market. And we plan to use that data not only with our providers, the physicians who treat but the nursing homes who administer care for the patients and just as importantly, the payers who are making coverage decisions on behalf of ZUNVEYL. So we think that study is going to be very meaningful for the company.

That's great. And just a point of clarification. You mentioned in your prepared remarks that we should expect those results in Q4 of this year?

Yes. For BEACON in Q4 of 2026. And for CONVERGE, we'll have top line data in Q3 of 2026.

We have reached the end of our question-and-answer session. I would like to turn the conference back over to management for closing remarks.

Okay. Thanks, everybody, for attending the call today. I think you've heard our focus for 2026. I'll just reiterate, we plan to continue to focus on sales execution. We plan to focus on payer coverage and improvement in ZUNVEYL coverage with our payers. While doing that, we'll work diligently to complete our studies on time and with high quality and advance our R&D pipeline. And along with all of that, as we have done, to date, we'll manage our expenses appropriately to move to operating profitability in 2027. So you can look forward for updates on all of those items as you follow the company through the course of 2026. Thanks for attending.

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