This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

Alpha Cognition Inc.
3/31/2025
Greetings and welcome to the Alpha Cognition 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 then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Henry Du, Interim CFO. Thank you. You may now begin.
Thank you, Drew. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's fourth quarter and full year 2024 financial results conference call. Today, after the close of market, the company issued a press release announcing these results. On the call with me today are Alpha Cognition 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.alphaucognition.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 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. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on March 31, 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. Our recognition 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. Good afternoon, everyone. Thanks for taking time to join us on today's call. This is an exciting milestone for our company as it marks our first earnings report following the commercial launch of Zunvel for the treatment of mild to moderate Alzheimer's disease. The fourth quarter of 2024 was characterized by a successful capital raise, a cross list from the Canadian Securities Exchange to NASDAQ, commercial manufacturing progress, and preparation for our commercial launch of Zunvale. In November, the company executed a cross list from the Canadian Securities Exchange to NASDAQ and raised $52 million in gross proceeds during this process. The company was able to attract an excellent group of investors who recognize the Alzheimer's market represents a large but dissatisfied market primed for disruption. We believe the capital raised is sufficient for the company to move to break-even status in year three of launch, provided we execute and achieve our internal revenue forecast for years one through three, and we manage our expenses judiciously. During the quarter, the company made substantial progress on commercial manufacturing, initiating the commercial batches for the 5 and 10 milligram strengths, which have been followed by the 15 milligram strength in January, to complete our initial commercial supply for the market. CMC stability test results demonstrated a stable compound extending our API life to five years and finished goods to two years, which we feel is more than sufficient for commercialization activities. Finished product for all strengths is available for pharmacies to order. As a reminder, this is a retail pharmacy distribution model, meaning patients can obtain product with a prescription at any retail pharmacy provider. Long-term care pharmacies can order the product direct or through their wholesaler and all have access to Zunvel as we have this call. From a pipeline perspective, The company reclaimed two programs from Alpha 7 Therapeutics, a preclinical program for cognitive impairment with mild traumatic brain injury and an early stage program for acute pancreatitis. These programs will strengthen the company's pipeline and allow for more flexibility and speed in completing the preclinical work for both programs. We have initiated work to reformulate our sublingual formulation of Alpha 1062. This work will initiate an early Q2 to improve taste and disintegration of the formulation. We anticipate the work will be completed in the fourth quarter of 2025. The significance of this formulation is that it can be used for patients with Alzheimer's who have dysphagia or aphasia, which are difficulty or inability to swallow tablets or capsules. Estimates are that 20% of the Alzheimer's patient population may suffer from this malady, And currently, they have the option of a patch formulation or they must grind a tablet or mix the contents of a capsule in applesauce or something similar in order to take their medication. We believe, if ultimately approved, that some legal formulation can displace the current options available for these patients. Additionally, the company's bomb blast preclinical study with Alpha 1062 will conclude in late Q2 with results released in Q3. Now, this was a two-part study funded with a Department of Defense grant. The first part of the study concluded in Q4, and it demonstrated that Alpha-1062 administration reduced levels of neuroinflammation and neuropathology that occurs after bomb blast trauma. In the quarter, the company added to its IP portfolio, securing a new composition of matter patent in the U.S. covering tablet formulation of benzgalantamine. This patent extends Zunvell protection in the U.S. market through 2044. We have this patent under review in multiple other territories outside the U.S. and expect approvals throughout the world during the next 18 to 24 months. We've also made significant progress with our first ex-U.S. partner, CMS Pharmaceuticals, who is representing Zunvell R&D and distribution in China and greater Asian territories. We expect to hear from Chinese regulatory authorities on the regulatory path in Q3 and expect our first territory distribution initiation to occur the second half of 2025. Although expected revenues will be modest, the initiation of commercialization activities will allow CMS and AlphaCognition to learn from these activities ahead of potential product approval in China. I'll ask Lauren to discuss commercialization progress momentarily, but I'll turn the call over to Henry to speak to the financials of the company. Henry?
You're reading a preview of the ACOG Q4 2024 earnings call.
Free account.