February 3, 2021
Coya Therapeutics, Inc., (Coya), a clinical-stage biotechnology company developing first-in-class approaches that utilize autologous regulatory T cells (Tregs) and allogeneic exosome therapeutics with a focus on neurodegenerative and autoimmune diseases, today announced that it has concurrently completed a merger with Nicoya Health, Inc. and raised $10 million in Series A financing from institutional and accredited investors.
The merger and financing, which include conversion of outstanding debt, was led by Allele Capital Partners LLC. Howard Berman, Ph.D., has been appointed as Chief Executive Officer and a member of the Company’s Board of Directors.
Proceeds from the financing will be used to advance Coya Therapeutics lead therapeutic program, ALS001: an off-the-shelf, autologous, expanded Treg cell therapy for amyotrophic lateral sclerosis (ALS) patients. The Company will also use proceeds to introduce clinical pipeline candidates targeting Parkinson’s disease, Alzheimer’s disease, frontal temporal dementia (FTD) and other autoimmune diseases, as well as advance its non-cell based exosomes, combined therapy programs, and small molecule candidates into the clinic. Additionally, funds will be allocated to further optimize and scale manufacturing capabilities and establish best in class Regulatory T Cell and Exosome Chemistry Manufacturing Controls (CMC) Readiness.
“Patients with neurodegenerative diseases are in desperate need of transformative therapeutic options; harnessing the neuro-protective effects of Treg cell therapy shows great potential in unlocking a new treatment paradigm and may enable us to revolutionize care for patients with devastating neurodegenerative diseases,” said Dr. Stanley H. Appel. “We have successfully demonstrated, in a phase 1 trial, the safety and tolerability of autologous infusions of expanded Tregs in ALS patients, with the potential of slowing or halting disease progression. Ongoing studies provide a transformative framework for advanced clinical trials in ALS and other neurodegenerative disorders.”
Coya Therapeutics leverages the innovations of Stanley H. Appel, M.D., Co-Director of Houston Methodist Neurological Institute and Chair of the Stanley H. Appel Department of Neurology at Houston Methodist Hospital. Dr. Appel is an internationally renowned researcher and neurologist, as well as one of the nation’s foremost experts on ALS treatment advances. The seminal discovery by Dr. Appel documented the intimate relationship of neurodegeneration and ALS progression with dysfunctional and decreased levels of Tregs driving the disease process, and the ability to isolate, “repair”, and expand these Tregs outside the body for reinfusion to the patient.
This transformational work is the basis for Coya Therapeutics proprietary and patented TAI™ (Tregs Against Inflammation) platform, which offers therapeutic approaches to address the unmet and significant medical needs of patients with ALS, Parkinson’s, Alzheimer’s, FTD and other autoimmune diseases. Coya’s CTregTM platform (cryopreservation for Tregs) is the first in the industry to expand, freeze, and re-thaw Tregs, while maintaining viability and suppressive function, thus solving manufacturing and supply-chain limitations and providing an ‘off the shelf’ Treg cell therapy that enables serial and monthly infusions.
Howard Berman, Ph.D., CEO of Coya Therapeutics commented, “I’m excited to have the opportunity to lead Coya at such an exciting and pivotal phase of growth— Coya has pioneered the ability to isolate dysfunctional Tregs from a patient, convert them to a highly functional and neuroprotective condition, and expand these cells into the billions for intravenous reinfusion back to the patient.”
Berman concluded, “The ability to manufacture and cryopreserve a 12-month patient’s supply of cells from one manufacturing run overcomes prior limitations and revolutionizes supply chain management, allowing for maintenance monthly infusions. Through our sponsored research program in conjunction with Dr. Appel, we look forward to continuing advancement of this promising work and translating this work into a meaningful therapy for patients.”
Tribal Capital Markets, LLC acted as sole placement agent for the offering. Allele Capital Partners, LLC through Tribal Capital Markets, LLC was responsible for sourcing, investing and executing the $10 million offering.