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Alpha Cognition Inc.
11/13/2025
Welcome to Alpha Cognition's earnings conference 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.
Thank you, Vaughn. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's third quarter financial results conference call. Today, after the close of the 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.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 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 November 13, 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 findings with the SEC. Alpha Cognition declines any obligation to update these forward-looking statements, except as required by applicable security laws. I'll now turn the call over to Michael.
Thank you, Henry. Good afternoon, everyone, and thanks for taking the time to join us on today's call. This call marks our second quarter of earnings following the commercial launch of Zunbell for the treatment of mild to moderate Alzheimer's disease. The third quarter of 2025 was characterized by sales growth of Zunbell, continued engagement in the long-term care segment of the market, additional pricing action on Zunbell, progress with our business development partner, CMS Pharma, and additional publications that highlight Zumbel data and the Alzheimer's market opportunity. Post close of the quarter, the company raised additional capital that strengthened its balance sheet and will allow the company to invest in a significant growth opportunity that has emerged with symptom management of Alzheimer's disease. The capital will be used to accelerate growth and invest in sales, marketing, and research for Zumbel in treating behavioral symptoms that often emerge with Alzheimer's. During the quarter, the company made substantial progress on our commercial launch. The sales and marketing team has made contacts with over 1,850 prescribers in the long-term care market, and we saw prescriptions written in over 500 nursing homes. Launched to date, we've seen duplicative prescriptions written in 70% of these nursing homes, which is a strong indicator of product trial. We expect new and duplicative home numbers to rise significantly in the coming quarters. Regarding clinical performance, Zunvel appears to be performing well with anecdotal reports of cognition improvement, behavioral reduction or amelioration, and continued limited reports of adverse events. Reported GI adverse events continue to be in the low single digits, indicative of a well-tolerated medication. One of the company's focuses in 2025 has been to share Meckle information that provides rationale for Zunvel treatment of Alzheimer's. This quarter, the medical team had seven abstracts accepted for publication with three poster presentations made to LTC Pharmacy at ASCP. This is the Association of Consultant Pharmacists in October. Two poster presentations were made to psychiatrists and neuroscientists at the Neuroscience Education Institute last week, and two poster presentations will be made to Alzheimer's researchers at Clinical Trials for Alzheimer's Disease, or CTAD, in December. Our medical team continues to publish compelling data in the Alzheimer's segment regarding cognition and behavioral symptoms. Regarding research and development, the company will initiate two studies in long-term care setting, one in Q4 of 2025 and one in Q1 of 2026. The two studies, which we call CONVERGE and BEACON, will assess Zumbel cognitive benefits, effects on sleep and behaviors, and utilization parameters like polypharmacy. These studies will provide critical data for Zenvale and the patient population for our commercialization focus. We anticipate Converge will complete in Q3 of 2026, and Beacon will complete in Q4 2026. Both of these studies are lower-cost studies which are accounted for in our current spend, guidance for this year, and in 2026. The company will also initiate a prospective registered trial in Q1 of 2026 called Resolve. That will provide valuable data on Zumbel efficacy in treating behaviors that occur with Alzheimer's disease. The trial will also assess Zumbel's tolerability and caregiver burden. These are important measures all providers consider when choosing a treatment. And we think the data will be instrumental for Zumbel positioning with physicians and payers. More information will be communicated about the registry trial in Q1. From a business development perspective, our partner CMS filed in China for approval, and the file was accepted for review. We anticipate the 18-month review process will apply to our application, and the approval could occur at the end of 2026. We also continue to advance our sublingual formulation and anticipate formulation and tasting work to be completed in Q1 of 2026. The company plans to run a comparative PK study versus existing formulations and will use this data as a basis for submission of an IND in Q3 of 2026. The company continues to manage our expenses judiciously while preparing to capitalize on emerging opportunities at a long-term care market. Chief among these is Optimally Positioning Zunvale, which has clinically meaningful benefits across both cognitive and behavioral symptoms associated with Alzheimer's. Lauren will discuss our commercialization process momentarily, but first, Henry will speak to the financials for the company. Henry?
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