Coya Therapeutics Updates and Reports Q2 2024 Financial Results

Coya Therapeutics, Inc. (Nasdaq: COYA), a clinical-stage biotechnology company based in Houston, has recently provided an update on its corporate activities and financial performance for the quarter ending June 30, 2024.

Significant Corporate Developments

In late April 2024, Coya presented updated biomarker data at the 2nd Annual Johnson Center Symposium. The data indicated that 4-HNE levels could predict survival in ALS (Amyotrophic Lateral Sclerosis) patients, with elevated levels observed at diagnosis in bulbar onset ALS compared to limb onset ALS.

Coya received a $5.0 million strategic investment from the Alzheimer’s Drug Discovery Foundation (ADDF). This funding is intended to support the development of COYA 302 for treating Frontotemporal Dementia (FTD). Additionally, the company received $3.85 million from a First Amendment and License Agreement with Dr. Reddy's Laboratories, Inc., which is designated for funding a Phase 2 clinical trial of COYA 302 in ALS in the U.S.

In April 2024, a peer-reviewed manuscript titled “A Phase 1 Proof-of-Concept Study Evaluating Safety, Tolerability, and Biological Marker Responses with Combination Therapy of CTLA4-Ig and Interleukin-2 in Amyotrophic Lateral Sclerosis” was published in the medical journal Frontiers in Neurology. The study showed promising clinical efficacy and suppression of biomarkers related to oxidative stress, neuroinflammation, and neuronal degeneration in ALS patients over 24 weeks.

Coya expanded its research collaboration with the Houston Methodist Research Institute, entering into a sponsored research agreement covering various initiatives, including the advancement of patented modalities of exosomes.

Looking ahead, Coya anticipates key data presentations. Notably, Dr. Alireza Faridar will present data from a randomized, double-blind, placebo-controlled, investigator-initiated trial in Alzheimer's disease at the 17th Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid from October 29 to November 1, 2024. This study, backed by the Gates Foundation and the Alzheimer’s Association, assesses low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer's disease.

The company also announced the expansion of its pipeline and intellectual property portfolio with new U.S. patent filings for COYA 301 in combination with GLP-1 receptor agonists. On August 9, 2024, the FDA provided feedback requiring additional non-clinical toxicology and pharmacology data before starting the planned Phase 2 study of COYA 302 in ALS patients. Coya intends to discuss these recommendations with the FDA in Q4 2024 to align on a revised non-clinical package.

Howard Berman, Ph.D., CEO of Coya, emphasized the company’s progress: “We bolstered our corporate and strategic efforts in the second quarter of 2024 and continue to expect a busy second half of the year with COYA 302, our ‘Pipeline in a Drug.’ The dual mechanism of action of COYA 302, a combination of our proprietary LD IL-2 and CTLA4-Ig, could prove vital to addressing complex neurodegenerative diseases such as ALS, AD, FTD, and Parkinson’s disease.”

Financial Overview

As of June 30, 2024, Coya reported cash and cash equivalents of $36.6 million. The company’s research and development (R&D) expenses were $4.6 million for the three months ending June 30, 2024, a significant increase from $1.1 million for the same period in 2023. This rise was primarily due to preclinical advancement costs for COYA 302 in ALS and increased internal research and development expenses.

General and administrative expenses amounted to $2.1 million for Q2 2024, compared to $1.8 million in Q2 2023. The net loss for the quarter was $2.9 million, down from $3.1 million in Q2 2023, primarily due to collaboration revenue from the Dr. Reddy's partnership and increased other income, despite higher operating expenses.

In summary, Coya Therapeutics has made substantial progress in its corporate and clinical ventures, particularly with the development of COYA 302. The company is well-positioned to advance its research and clinical trials with a solid financial foundation and continued strategic investments.