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HOUSTON - Coya Therapeutics, Inc. (NASDAQ: COYA), a $109.1 million market cap biotechnology company focusing on regulatory T cell (Treg) function enhancement, has reported positive biomarker data from a Phase 2 study in Alzheimer’s disease (AD) patients. The company’s stock has shown strong momentum with an 11.4% gain over the past week. According to InvestingPro data, the company maintains robust liquidity with a current ratio of 15.3, indicating strong short-term financial stability. The study, conducted at Houston Methodist Hospital, evaluated the effects of low-dose interleukin-2 (LD IL-2) on inflammation and cognitive decline over a five-month period.
The double-blind, placebo-controlled exploratory study indicated that LD IL-2 treatment led to statistically significant reductions in proinflammatory markers in the blood and improvements in beta amyloid 42 clearance, a protein associated with AD, in the cerebrospinal fluid. While the company reported promising clinical results, InvestingPro analysis shows current financial challenges with an EBITDA of -$11.1 million in the last twelve months. Additionally, patients showed stabilization of cognitive decline, as evidenced by a 4.93-point improvement in the ADAS-Cog score compared to placebo over the 21-week treatment period.
Coya’s Chief Medical (TASE:PMCN) Officer, Fred Grossman, DO, emphasized the significance of targeting Tregs in AD, suggesting that LD IL-2 therapy’s immunomodulatory strategy could be beneficial for treating AD and other neurodegenerative disorders.
The trial included 38 participants with varying degrees of AD severity, who received either monthly or biweekly LD IL-2 treatments. The results showed that monthly treatments had a more substantial impact on inflammatory factors than biweekly administrations. LD IL-2 was well-tolerated with no serious adverse events reported, and the most common side effects were mild injection site reactions and a slight increase in eosinophil counts.
Coya’s CEO, Arun Swaminathan, Ph.D., expressed optimism about the potential for LD IL-2 monotherapy in AD and the possibility of combining it with other immunomodulatory treatments for enhanced effects.
The study was funded by the Alzheimer’s Association, the Gates Foundation, and the National Institute on Aging, with additional support from Coya. The comprehensive data set from the study will be presented throughout 2025 and included in a peer-reviewed publication.
These findings, initially presented at the Clinical Trials on Alzheimer’s Disease Conference in Madrid in October 2024, support the therapeutic potential of LD IL-2 in AD. However, as an investigational product, LD IL-2 has not yet received approval from the FDA or any other regulatory agency. Coya plans to continue publishing and presenting study results in the coming year, based on a press release statement. Analyst expectations remain optimistic, with price targets ranging from $14 to $18 per share, suggesting significant upside potential. For comprehensive financial analysis and additional insights, investors can access more than 30 key metrics and exclusive ProTips through InvestingPro.
In other recent news, Coya Therapeutics, a clinical-stage biotech company, is making significant strides in advancing its investigational pipeline. The company is progressing COYA 303, a biologic designed to treat inflammatory diseases, with results from a preclinical study expected in the first half of 2025. Concurrently, Coya has enrolled five out of eight planned subjects in a Phase 1 study for Frontotemporal Dementia (FTD) treatment, which is expected to inform the design of a subsequent Phase 2 trial.
Boral (OTC:BOALY) Capital, an independent financial services firm, has initiated coverage on Coya Therapeutics, assigning a Buy rating based on the company’s innovative approach to treating neurodegenerative disorders. This rating comes as Coya outlines its strategic focus for 2025, emphasizing upcoming clinical trials in neurodegenerative diseases.
The company plans to advance its lead biologic investigational product, COYA 302, through various stages of clinical development. Among the planned activities are a Phase 2 study of COYA 302 in patients with Amyotrophic Lateral Sclerosis (ALS) and the release of additional data from an investigator-initiated trial of Low Dose IL-2 in Alzheimer’s Disease patients. These are recent developments that reflect Coya Therapeutics’ commitment to advancing the treatment of neurodegenerative diseases.
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