Coya Therapeutics, Inc. (COYA)

Coya Therapeutics, Inc. is a clinical-stage biotechnology company developing proprietary therapies that enhance the function of regulatory T cells (Tregs), the CD4+CD25high hFOXP3+ T-lymphocytes that suppress inflammatory responses and maintain immune homeostasis and self-tolerance. The company focuses on Treg dysfunction, which it views as an important driver of neurodegenerative, autoimmune and metabolic diseases. Its pipeline rests on three modalities: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy, the last of which has completed Phase 1 and Phase 2a studies in amyotrophic lateral sclerosis (ALS).

The lead asset, COYA 302, combines COYA 301 (proprietary low dose interleukin-2) with the immunomodulator CTLA4-Ig (an abatacept proposed biosimilar licensed from Dr. Reddy's Laboratories). Coya intends to file an IND for ALS in the first half of 2024 and then start a Phase 2 trial. It has also expanded COYA 302 into frontotemporal dementia (IND planned before the end of 2024), Parkinson's disease (animal studies planned in 2024) and Alzheimer's disease.

A proof-of-concept study in 4 ALS patients showed no or minimal decline in the ALSFRS-R scale at 24 and 48 weeks, and an 8-patient Alzheimer's study of low dose IL-2 showed enhanced Treg function and reduced inflammatory markers. A 38-patient double-blind, placebo-controlled Alzheimer's trial at Houston Methodist Hospital is expected to report top-line data in Q3 2024. Coya plans to use COYA 301 as a backbone for combination therapies, including with GM-CSF under a February 2024 license with UNeMed, and to develop next-generation targeted Treg exosomes (COYA 206) using technology in-licensed from Carnegie Mellon University.

Its research builds on work by Dr. Stanley Appel at Houston Methodist, under an exclusive patent and know-how license and sponsored research agreement. In December 2023, Coya signed a Development and License Agreement with Dr. Reddy's granting exclusive commercialization rights to COYA 302 for ALS in the U.S., Canada, the EU and the UK. The agreement includes a $7.5 million upfront payment, $8.4 million in development funding payments, up to $40.0 million in development milestones, up to $677.25 million in sales milestones and royalties in the low to mid-teens.

This builds on an April 2023 license and supply agreement covering other territories. Coya retains responsibility for clinical development and U.S. regulatory approval. It has no product revenue, funds operations through private and public sales of securities (including a roughly $26.5 million private placement in December 2023), reported net losses of $8.0 million for 2023 and $12.2 million for 2022, and expects to need substantial additional capital.