Coya Therapeutics Receives $5 Million Investment from the Alzheimer’s Drug Discovery Foundation

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Coya Therapeutics announced that it has received a $5 million strategic investment from the Alzheimer’s Drug Discovery Foundation (ADDF). According to the company, the investment consisted of 603,136 shares of stock at $8.29 per share. Coya intends to use the funding for supporting the development of Coya 302, its lead therapeutic candidate, mainly in an upcoming Phase II trial targeting frontotemporal dementia (FTD). Reportedly, the investment was made through a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, aiming to file a registration statement with the SEC for resale of the securities.¹

“We are grateful that a world-renowned organization like the ADDF has chosen to support our corporate mission as well as the clinical development of Coya 302 through this equity investment,” said Howard Berman, PhD, CEO, Coya, in a press release. “The ADDF’s scientists have extensively vetted COYA 302 for the treatment of FTD, a disease that is driven by a pronounced peripheral and central nervous system inflammatory response. Like Coya, the ADDF believes that combination therapies are the future of Alzheimer’s and related dementia treatments, including FTD, aligning our strategic approach to combatting such a complex disease that has no current treatment options. We look forward to working with the ADDF to potentially bring a new treatment paradigm to these patients.”

Coya 302 works to tackle neuroinflammation in neurodegenerative diseases by targeting multiple inflammatory pathways. In March, the company presented promising ALS biomarker data at the Society of Neuroimmune Pharmacology Conference. According to the company, the data showed a strong predictive value of levels of an oxidative stress biomarker (4-HNE) with the rate of disease progression and survival in 50 ALS patients from a longitudinal patient registry cohort. Additionally, another proof-of-concept study in patients with ALS, low dose interleukin-2 (LD IL-2) and CTLA-4 Ig appeared to lower 4-HNE and other proinflammatory biomarker levels.²

“At six months, we showed that instead of declining six or seven or eight points, which you would typically see, there was no decline in all four of our patients. Then at 12 months, where you would typically see a decline of maybe 14 points on the scale, there was only a very minor decline of 1.5 points. So, it means that the treatment is first of all reducing inflammation, reducing oxidative stress and different biomarkers we've discovered, and it seems to be well tolerated. It also seems to somehow slow or stop the progression of the disease. Of course, it's a small study, but we've seen it in all four patients. Correlating with the biomarkers, we're doing a larger trial, which is in process and we're filing the IND very soon,” said Berman, in an interview with Pharm Exec.³

Coya agreed to file a registration statement with the Securities and Exchange Commission for the resale of any securities issued to ADDF less than 30 days after the definitive agreement, with a registration statement being required less than 75 days following the date of the definitive agreements.¹

“Inflammation has emerged as a promising novel pathway for chronic neurological diseases like FTD. A combination drug, like COYA 302, is an innovative approach being developed to suppress neuroinflammation by targeting multiple inflammatory pathways,” said Howard Fillit, MD, co-founder, chief science officer, ADDF, in the press release. “Combination therapy will be integral to slowing – and eventually halting – cognitive decline for a disease as complex as FTD, and exploring combined therapeutic modalities is an important advancement in the development of future care regimens.”

References

1. Coya Therapeutics Announces $5 Million Strategic Investment by the Alzheimer’s Drug Discovery Foundation (ADDF). BusinessWire. May 20, 2024. Accessed May 20, 2024. https://www.businesswire.com/news/home/20240520242949/en/Coya-Therapeutics-Announces-5-Million-Strategic-Investment-by-the-Alzheimer%E2%80%99s-Drug-Discovery-Foundation-ADDF

2. Coya Therapeutics Presents ALS Biomarker Data at Society of Neuroimmune Pharmacology Conference. Coya Therapeutics. March 12, 2024. Accessed May 20, 2024. https://ir.coyatherapeutics.com/news/news-details/2024/Coya-Therapeutics-Presents-ALS-Biomarker-Data-at-Society-of-Neuroimmune-Pharmacology-Conference/default.aspx

3. Coya Therapeutics CEO Discusses Recent Data Discovery from a Study of Coya 302, a Potential Treatment for ALS. Pharm Exec. April 18, 2024. Accessed May 20, 2024. https://www.pharmexec.com/view/coya-therapeutics-ceo-discusses-recent-data-discovery-from-a-study-of-coya-302-a-potential-treatment-for-als