Coya Results and Update

 Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.

2023 Corporate Highlights

• Closed IPO in January 2023 for net proceeds of $14.1 million
• Reached agreement in March 2023 with Dr. Reddy’s Laboratories, Ltd. (Dr. Reddy’s) to in-license an Abatacept (CTLA4-Ig) biosimilar candidate for the development of COYA 302
• Presented positive results in March 2023 from a proof-of-concept academic clinical study in patients with Amyotrophic Lateral Sclerosis (ALS) demonstrating that patients administered a combination of low dose interleukin-2 (LD IL-2) and CTLA4-Ig exhibited no progression on the ALSFRS-R Rating Scale at 24 weeks and showed minimal decline at 48 weeks. COYA 302 is Coya’s combination of its proprietary LD IL-2 formulation with the immunomodulatory drug CTLA4-Ig.
• Presented positive results in May 2023 from an open-label, proof-of-concept academic clinical study in patients with Alzheimer’s disease (AD) that demonstrated LD IL-2 administration resulted in a statistically significant improvement vs. baseline in cognitive function after four mounts of treatment, as measured by the Mini Mental Status Exam (MMSE) rating scale, and no decline vs. baseline, as measured by the Clinical Dementia Rating Scale (CDR-SB) and the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog). COYA 301 is Coya’s proprietary LD IL-2 formulation.
• Investigator-initiated Ph. 2 study of LD IL-2 in patients with AD completed in October 2023
• Entered into an exclusive collaboration for the development and commercialization of COYA 302 with Dr. Reddy’s in December 2023 for the treatment of ALS in U.S., Canada, the EU, and the U.K. – Coya to receive up to $733 million in upfront and milestone payments plus low-to-mid teens product royalties
• Successfully closed a private placement in December 2023 that generated net proceeds of $24.0 million
• Strengthened the management team with appointments of Arun Swaminathan, Ph.D. as Chief Business Officer in March 2023, Dr. Michelle Frazier as Senior Vice President of Regulatory Affairs in June 2023, and Dr. Fred Grossman as President and Chief Medical Officer in July 2023
• Welcomed Dieter Weinand and Wilbur L. Ross, former U.S. Secretary of Commerce, to the Board of Directors in August 2023 and December 2023, respectively

Additional Recent Corporate Highlights

• Announced successful pre-IND and Type C meetings with FDA in January 2024 to advance the development of COYA 302 for the treatment of ALS - IND expected to be filed in 1H 2024 followed by initiation of Ph. 2 trial with COYA 302 in ALS
• Expanded pipeline of COYA 302 in January 2024 beyond ALS to also include Frontotemporal Dementia (FD), with an IND planned in 2H24, and Parkinson’s disease (PD), with animal data in PD to be released in 2H24
• Expanded patent estate surrounding next-generation immune modulatory biologics in February 2024 through a license from the University of Nebraska Medical Center to cover multiple LD IL-2 combinations, including those with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
• Expanded pipeline of COYA 302 in February 2024 to include AD – COYA 302 to now be explored in four neurodegenerative diseases (ALS, PD, FTD, and AD) – Coya to leverage data from the Ph. 2 LD IL-2 study in AD to inform on strategy and next steps for COYA 302 in AD
• Presented data in March 2024 on immune system and Regulatory T Cell (Treg) contribution in Frontotemporal Dementia (FTD) patients at the AD/PD 2024 Conference
• Presented novel biomarker data in March 2024 documenting serum levels of a biomarker (4-HNE) that strongly correlate with rate of progression and survival in patients with ALS at the Society of Neuroimmune Pharmacology conference. Coya has filed intellectual property on multiple uses of 4-HNE in ALS.

https://www.biospace.com/article/releases/coya-therapeutics-provides-a-corporate-update-and-reports-fiscal-2023-financial-results/