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.
**Note: Revenue and net loss figures are for the 12 months that ended Sept. 30, 2022.
(Note: Coya Therapeutics Inc. priced its IPO on Dec. 28, 2022 – in sync with the terms in its prospectus – 3.05 million shares of stock and non-listed warrants to buy up to 1.525 million shares of stock – at a combined IPO price of $5.00 per unit to raise $15.25 million. The stock started trading on Dec. 29, 2022, on the NASDAQ. Coya Therapeutics filed an S-1/A on Dec. 5, 2022, disclosing terms for its IPO: 3.05 million shares of stock and warrants to buy up to 1.525 million shares of stock at an assumed public offering price of $5.00. Estimated IPO proceeds: $15.25 million. Each unit consists of one share of common stock and a warrant to buy one-half of a share – to be sold at the IPO price of $5.00. The company has applied to list the stock under the proposed symbol “COYA” on the NASDAQ. Coya Therapeutics does not anticipate listing the warrants. The S-1 was filed on Nov. 18, 2022.)
|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||$5.00 - $5.00|
|Est. $ Volume||$15.3 mil|
|Manager / Joint Managers||Chardan / Newbridge Securities Corp.|
|CO-Managers||Joseph Gunnar & Co.|
|Expected To Trade:||12/29/2022|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|