Coya Therapeutics Announces Conference Call to Report Results from an Investigator-Initiated Phase 2 Trial of Low-Dose Interleukin-2 in Patients with Mild to Moderate Alzheimer’s Disease

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) announces an upcoming conference call on Tuesday, October 29, at 8am ET to discuss results from a placebo-controlled, investigator-initiated Phase 2 clinical trial of low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer's Disease. The results will be simultaneously presented at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid, Spain. The study was led by Dr. Alireza Faridar and Dr. Stanley Appel from Houston Methodist Research Institute, with funding from the Alzheimer's Association, Gates Foundation, and National Institute on Aging.

Positive

• Study received funding support from major institutions including Alzheimer's Association, Gates Foundation, and National Institute on Aging
• Phase 2 trial reached completion stage with results ready for presentation

Negative

• None.

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces it will conduct a conference call on Tuesday, October 29, at 8am ET to discuss results from a placebo-controlled, investigator-initiated Phase 2 clinical trial of low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer's Disease (AD). These clinical results will be presented simultaneously via a poster on Tuesday, October 29, at the 17th Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid, Spain.

The Phase 2 study was led by KOLs Dr. Alireza Faridar and Dr. Stanley Appel from the Houston Methodist Research Institute, and it received funding from the Alzheimer's Association, the Gates Foundation, and the National Institute on Aging, with additional support from Coya.

Dr. Faridar will present a summary of the clinical results on the conference call, and Coya’s Chief Business Officer and incoming Chief Executive Officer Arun Swaminathan, Ph.D. will discuss the Company’s strategy. A question-and-answer session will follow.

The conference call will be available through a live webcast that can be accessed here. Participants who may be interested in asking a question during the question-and-answer session can also join the call by dialing 1-866-807-9684 (domestic) or 1-412-317-5415 (international) and asking to join the Coya Therapeutics conference call.

A webcast replay of the call will be available approximately one hour after the live call until October 29, 2025.

Event:			CTAD Data Readout – Phase 2 Trial of LD-IL-2 in Patients with Mild to Moderate AD
Presentation Date:			Tuesday, October 29, 2024
Time:			8:00 AM ET
Register for Conference Call:			Webcast Link

About Alzheimer’s Disease

Alzheimer's disease is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer's disease accounts for up to 80% of dementia cases, affecting an estimated 5.7 million Americans. In more than 90% of people with Alzheimer’s, symptoms do not appear until after age 60. The incidence of the disease increases with age and doubles every 5 years beyond age 65. Alzheimer's is a progressive disease, where dementia symptoms gradually worsen over a number of years. In its early stages, memory loss is mild, but with late-stage Alzheimer's, individuals lose the ability to carry on a conversation and respond to their environment. It is the sixth leading cause of death among all adults and the fifth leading cause for those aged 65 or older. On average, a person with Alzheimer's lives 4 to 8 years after diagnosis but can live as long as 20 years, depending on other factors. ^1,2

		1.		Alzheimer’s Association (www.alz.org)
		2.		Centers for Disease Control and Prevention (www.cdc.gov)

About COYA 301

COYA 301 is the company’s proprietary investigational low-dose interleukin-2 (IL-2) intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and is designed for subcutaneous administration. COYA 301 is an investigational product not yet approved by the FDA or any other regulatory agency.

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in a lack of homeostasis of the immune system.

Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

COYA 302 – the Company’s lead biologic investigational product or “Pipeline in a Product”– is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone.

For more information about Coya, please visit www.coyatherapeutics.com

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241028411053/en/

Investor Contact

David Snyder, CFO

david@coyatherapeutics.com

CORE IR

Bret Shapiro

brets@coreir.com

561-479-8566

Media Contacts

For Coya Therapeutics:

Kati Waldenburg

media@coyatherapeutics.com

212-655-0924

Source: Coya Therapeutics, Inc.

FAQ

When will Coya Therapeutics (COYA) announce its Phase 2 Alzheimer's trial results?

Coya Therapeutics will announce the Phase 2 trial results for low-dose interleukin-2 in Alzheimer's Disease on Tuesday, October 29, 2024, at 8am ET via a conference call.

What is the Phase 2 trial by Coya Therapeutics (COYA) investigating?

The Phase 2 trial is investigating low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer's Disease, focusing on enhancing regulatory T cell function.

Where will Coya Therapeutics (COYA) present its Alzheimer's trial data?

The trial data will be presented at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid, Spain on October 29, 2024.