COYA 101 / Coya Therap - LARVOL DELTA

Coya Therapeutics, Inc. Provides Business Update and Reports FY 2022 Unaudited Financial Results (Businesswire) - "Coya Therapeutics...COYA 301 for FTD: IND filing and initiate Phase 1 (H2 2023); interim Data (H2 2023)....COYA 302 for neurodegenerative diseases: file IND and initiate Phase 1 (H2 2023)....COYA 201 for neurodegenerative, autoimmune, and metabolic diseases: Completion of Therapeutic Animal Model Studies (1H 2023)....COYA 101 for ALS: Initiate Phase 2b with grant funding or collaborative partnership (2024)."

Licensing / partnership • New P1 trial • New P2b trial • Alzheimer's Disease • Amyotrophic Lateral Sclerosis

Coya Therapeutics, Inc. Announces Peer-Reviewed Publication of Phase 2a Clinical Trial Data for COYA 101 in Amyotrophic Lateral Sclerosis (ALS) (GlobeNewswire) - P2a | N=N/A | “Coya Therapeutics, Inc…announced the publication of the Phase 2a clinical trial data for its first-in-class Treg cell therapy product candidate, COYA 101….The DB portion of the trial was curtailed due to COVID-19-related restrictions, and the limited number of patients enrolled made statistical analysis not feasible. However, the eight patients included in the OLE completed the 24-week study, and 75% (n=6) of them exhibited slow to no progression as measured by the ALSFRS-R (mean decline of -2.7 points). A sub-analysis of these six patients showed that four of them (50% of the intention-to-treat [ITT] patient population, n=8) exhibited no decline over the 24-week treatment period.”

P2a data • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Secures $10 Million Financing to Advance Clinical and Pre-Clinical Pipeline of Regulatory T Cell Therapeutics (GlobeNewswire) - “Coya Therapeutics, Inc…announced that it has raised approximately $10.3 million from institutional and accredited investors. The financing brings the total funding to date to over $20 million. Proceeds will be used to advance several key therapeutic programs which include: COYA 101, a scalable and expanded autologous Treg cell therapy for amyotrophic lateral sclerosis (ALS) patients, into a well-powered Phase 2b study; COYA 201, an autologous Treg-derived exosome therapeutic for ALS patients into Phase 1 studies; COYA 202, an allogeneic Treg-derived exosome therapeutic for frontal temporal dementia (FTD) into Phase 1 studies…Coya is also preparing a novel biologic program for IND submission for ALS, FTD, and Alzheimer’s disease patients.”

Financing • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Frontotemporal Lobar Degeneration

Coya Therapeutics Announces Annals of Neurology Publication Featuring Biomarker Data in ALS Patients Treated with Tregs Cell Therapy (Businesswire) - P1 | N=N/A | “Coya Therapeutics, Inc…announced the publication of results from a Phase 1 trial entitled ‘Tregs Attenuate Peripheral Oxidative Stress and Acute Phase Proteins in ALS.’ The paper detailing the evaluation of critical biomarkers of neuroinflammation and oxidative stress with the potential ability to select ALS patients exhibiting a greater chance of therapeutic response to Treg cell therapy (COYA 101) was published in the Annals of Neurology…The published study data support the proposed mechanism of action and biological activity of expanded Tregs, and these findings were consistent in a subsequent Phase 2a study in ALS patients....Regulatory T lymphocyte (Treg) cell therapy was assessed for suppression of oxidative stress (OS) and acute phase proteins (APP) responses in longitudinal serum samples...The first round of ex-vivo expanded Treg cell therapy suppressed levels of oxidized low-density lipoprotein (ox-LDL)."

Biomarker • P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders