3/26/2026

speaker
Sherry
Operator

Greetings. Welcome to Alpha Cognition, fourth quarter and full year 2025 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Henry Du, interim CFO. Thank you. You may begin.

speaker
Henry Du
Interim Chief Financial Officer

Thank you, Sherry. Good afternoon, and thank you, everyone, for joining us today for Opel 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 Opel Cognition's Chief Executive Officer, Michael McFadden, and Chief Operating Officer, Lauren D'Angelo. Today's call is being made available via the investor section of the company's website at www.opelcognition.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 Opel 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 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 the 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.

speaker
Michael McFadden
Chief Executive Officer

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 Zunvel for the treatment of mild to moderate Alzheimer's disease. As a reminder, Zunvel 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 Zunville. 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 the National PBM and which now gets us contracted with two out of the top four 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's made, we announced three real-world studies that are or will be initiated in 2026. These studies will provide further evidence to strengthen Zunvale's positioning with payers and provide additional evidence for healthcare 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 integral part of our market penetration strategy. Before I discuss our leading indicators in demand and adoption, let me briefly speak to revenues. For the fourth quarter, we generated total revenues of $2.8 million, including net product revenues of $2.5 million from Zunvell. Launched to date through year-end 2025, Alpha Cognition has generated total revenues of $10.2 million. We view these results as an early important foundation for the company. At the same time, we recognize that in the initial phase of launch, reported revenue can be influenced by the pace of payer coverage and the national ramp in prescribing behavior, and they may not fully reflect long-term potential of the product. That's why our emphasis remains on the leading indicators that tell us whether Zumbel is building a durable, scalable trajectory in a long-term care setting. Today, what we're most focused on is the underlying demand indicators and durability of adoption, particularly repeat ordering behavior, increased provider confidence, and expanding payer access, which we believe are the most reliable predictors of sustained performance and future growth. In terms of demand indicators in Q4, we dispensed 4,941 bottles of Zunvel, including 1,859 bottles in December alone, our strongest month since launch. And our sales team reached almost 2,000 nursing homes during the quarter, bringing our launch to date to nearly 4,000 unique facilities. We're also encouraged by what we're seeing in terms of depth of prescribing. Prescribing doctors increased 50% versus Q3, and cumulative homes with prescriptions increased 69% in Q4, which is an early indicator of expanding adoption across our commercial footprint. Taking a step back, we believe the adoption curve is doing what we would expect in long term. Providers start cautiously. They treat a small number of patients. They observe the tolerability and the clinical outcomes for these patients, and then they move toward broader use. Speaking of payers, payer access remains a major friction point with prescription approvals, but it also presents a major opportunity for the company. The team is working with payers to demonstrate compelling data that we believe will improve coverage for Zunvel in the coming quarters. I'm pleased to announce that we executed a second national PBM contract during the quarter in addition to the first PBM contract previously announced. That means we now have agreements with two of the four major PBMs that are relevant to our long-term care business. Our execution now shifts to downstream pull-through, ensuring that contracted coverage translates into practical access at the plan level with fewer or no restrictions and a smoother prior authorization process. We believe progress here can be a meaningful accelerant to new starts and sustained growth. Lauren will speak more on this in detail, including timing expectations for early traction and broad implementation. Regarding clinical performance, Zunvell appears to be performing consistently with few adverse events reported. Reported GI adverse events continue to be in the low single digits. Spontaneous adverse event reporting is still limited to two GI adverse events at the end of the quarter. And we would have expected reports in the triple digits at this point during the launch. Regarding medical progress, the company completed the year with 15 abstracts and posters submitted and presented at medical meetings and conferences. We believe these data set a good baseline for acetylcholinesterase education to the market, which has been severely lacking in the last decade. The medical team now turns its attention this year to Zunvell data focused on adverse events, behavioral response, and MOA, or method of action, all of which we believe differentiates Zunvale from other drugs in the class. The company announced three studies in the last quarter, two in long-term care, one called Beacon and the second Converge, and one in the outpatient setting, that study's named Results. We believe the long-term care data will be differentiating with our customers as there are very few studies completed in long-term care. Beacon will provide Zenveld data focused on tolerability, cognitive, and behavioral efficacy. We initiated this study in February, and we're very pleased already with the quality and quantity of researchers who are participating in this study. We expect top-line data in Q4 of 2026. Converge will initiate in April, and with the construct of that study, top-line data will be reported quickly in Q3 of 2026. and Resolve will initiate in Q2 in the outpatient setting. We believe data from Resolve will be promotional for the commercial team, and it could be label enabling for the company. Regarding R&D, the company continues to make progress with the sublingual formulation, and we will initiate a comparative PK study versus our tablet and intranasal formulations in Q2 of this year. The company believes a local toxicity study and an equivalent PK data set will be sufficient to advance the product to the clinic. From a business development perspective, our partner in Asia, CMS Pharma, continues to work through the regulatory process with multiple countries in Asia. We anticipate two strategic product approvals in 2026, which could provide incremental long-term growth opportunities for the company. The company still awaits approval of a business development milestone payment, which is contingent on a regulatory approval with the Chinese government. We anticipate this payment will materialize in 2026, although we cannot say when. We believe it's not a question of approval, but of timing. We're working constructively on this process with the Chinese regulatory authorities. The company continues to capitalize on emerging opportunities in the long-term care market. Chief among these is Optimally Positioned Zumbel, which has clinically meaningful benefits both cognitively and behaviorally to treat symptoms associated with Alzheimer's. As noted, the company raised $40 million in Q3, and we immediately put the capital to work. We've increased our field team reach with long-term care medical directors and consultant psychiatry community. We also initiated marketing resources that will better position Zunvell as a treatment of choice for symptom management of Alzheimer's disease. Our sales force increases, and the improved marketing efforts will position the company to take advantage of these opportunities in the coming quarter. With this investment, combined with the early demand indicators we're seeing, we believe the company is well-funded to execute our commercial strategy, and we're focused on driving toward operating profitability in 2027. Lauren will discuss more on our commercialization process momentarily, but first Henry will speak to the financials for the company. I'll now turn it over to Henry.

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