5/15/2025

speaker
Sakshi
Conference Operator

Greetings and welcome to the AlphaCognition earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Henry Du, AlphaCognition's interim CFO. Thank you. You may begin.

speaker
Henry Du
Interim Chief Financial Officer

Thank you, Sakshi. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's first quarter 2025 financial results conference call. Today, after the close of market, the company issued a press release announcing these results. On the call with me are Alpha Cognition Chief Executive Officer, Michael McFadden, and Chief Operating Officer, Lauren D'Angelo. Today's call is being made available by the investor section of the company's website at www.alphacognition.com. During the course of this call, the 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 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. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on May 15, 2025. 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. Mobile 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. Michael?

speaker
Michael McFadden
Chief Executive Officer

Thank you, Henry. Good afternoon, everyone, and thanks for taking the time to join us on today's call. This is an exciting quarter for Alpha Cognition, as it marks our first quarter of recorded revenue for Zunville, our treatment for mild to moderate Alzheimer's disease. The first quarter of 2025 was characterized by a successful ex-U.S. business development deal, an additional U.S. patent approval, and the commercial launch of Zunville. First, I'll make a few comments on the business development front. We've already made significant progress with our first ex-U.S. partner, CMS Pharmaceuticals, who's representing Zunville Research and Development and Distribution in China and other Asian territories. We expect our first territory distribution initiation in the second half of 2025 in a small territory and expect regulatory submission for approval in China in Q4 of 2025. The company anticipates modest royalty revenue from the CMS deal in 2026. The company is in advanced discussions with another company in an additional territory and expects an additional business development deal in the latter part of 2025. That deal, if consummated, will generate revenues for Alpha Cognition in 2026. In February, the company received patent notice from the U.S. Patent Office that our composition of matter patent coated tablets for pH-dependent release of benzgalantamine was approved. That patent adds to the AlphaCognition patent portfolio and provides additional patent protection through 2044. In April, the patent was accepted in the Orange Book. We've also received notice from FDA that the company request for a patent extension of an early method of use patent will be extended, and we expect to hear the date of that extension in Q3 of this year. Now, regarding our commercialization activities, we believe Zunval launch is off to a great start. The qualitative feedback is above our expectations, and we're hearing positive patient treatment stories that indicate the product works and patients are tolerating Zunval as our data indicated they would. Prescriptions are being written as early as the first call by our sales team, and this tells us the data is compelling and the need to treat is high. We have multiple abstracts accepted for presentation at the upcoming AAIC meeting in July and anticipate additional manuscripts accepted later in the year. Our goals in 2025 with our commercial launch are to establish Zunville as a core therapy, deliver breadth of prescriptions across nursing homes, and build our prescription-based experience with gerontology groups that will grow exponentially in 2026. We anticipate approximate size of our team will be fairly consistent year over year with single digit increases in headcount possible as the company grows its business or advances its pipeline. We continue to believe the capital the company has raised is sufficient for AlphaCognition to move to a positive cash flow position in year three if we execute according to our plan. After Henry provides an update on our financials, Lauren will provide more color on the launch and the metrics we're looking at. Henry?

Disclaimer

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