Coya Therapeutics, Inc.
We are a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of regulatory T cells (“Tregs”). Tregs consist of CD4+CD25high hFOXP3+ cells, which are a sub-population of T-lymphocytes, a type of white blood cell that suppresses inflammatory responses.
We are initially focused on developing our Treg-based therapies for neurodegenerative, autoimmune and metabolic diseases where Treg dysfunction has been identified to be an important pathophysiological component of the disease and where new and effective therapies are urgently needed.
Since our inception in late 2020, we have generated preclinical and clinical data in multiple models and diseases. Our autologous Treg cell therapy program completed a Phase 1 study in 2017 and a Phase 2a study in 2021 in amyotrophic lateral sclerosis, or ALS. At the completion of the Phase 2a trial, we conducted a Pre-Investigational New Drug (“IND”) Application meeting with the U.S. Food and Drug Administration (the “FDA”) in Q4, 2021 in anticipation of a Phase 2b trial. In June 2021, we were granted an orphan drug designation (“ODD”) by the FDA for the active moiety (principal molecular structure) for our autologous Treg cell therapy in the treatment of ALS. The clinical data from these initial studies has served as an important confirmation of the underlying immunomodulatory properties of Tregs and their potential therapeutic benefits. These studies have also significantly expanded our own foundational knowledge of the biological activity of Tregs, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future targeted diseases and the overall advancement of our development pipeline.
We are developing multiple product candidates, COYA 301, COYA 302, COYA 201, COYA 206, and COYA 101, each using one of our three therapeutic modalities: (i) biologics, (ii) Treg-derived exosomes, and (iii) autologous regulatory T-cells. COYA 301 is a biologic for subcutaneous administration, and we are currently conducting chemistry, manufacturing, and controls (“CMC”) activities and investigational new drug (“IND”) enabling toxicology studies to support the filing of an IND application and the initiation of clinical trials for the treatment of frontotemporal dementia (“FTD”). Our other biologic product candidate, COYA 302, is a combination of two large molecules for subcutaneous and/or intravenous administration. We are currently conducting CMC activities and IND enabling toxicology studies to support the filing of an IND application and the initiation of clinical trials for COYA 302 for the treatment of neurodegenerative and autoimmune diseases.
|Address||5850 San Felipe St. Suite 500 Houston, TX 77057|
|Phone Number||(800) 587-8170|
|View Prospectus:||Coya Therapeutics, Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-10.77 mil (last 12 months)|
|Price range||$0.00 - $0.00|
|Est. $ Volume||$17.0 mil|
|Manager / Joint Managers||Chardan / Newbridge Securities Corp.|
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