Coya Therapeutics Reports 9-Month Financial Results, Collaboration Revenue Growth, and Strategic Advancements in Clinical Programs

Coya Therapeutics, Inc., a clinical-stage biotechnology company focused on developing therapies to enhance regulatory T cells (Tregs) for neurodegenerative and autoimmune diseases, reported its financial results for the nine months ended September 30, 2024. The company generated collaboration revenue of $3.6 million during this period, primarily from its agreement with Dr. Reddy's Laboratories (DRL). This represents a significant increase compared to the previous fiscal period, where collaboration revenue was not reported.

The company incurred total operating expenses of $16.7 million for the nine months ended September 30, 2024, a substantial rise from $9.7 million in the same period in 2023. This increase was driven by heightened research and development expenses, which surged to $9.9 million from $3.9 million year-over-year, reflecting intensified efforts on the COYA 302 program for amyotrophic lateral sclerosis (ALS). General and administrative expenses also rose to $6.7 million from $5.5 million, attributed to increased stock-based compensation and personnel costs.

Coya reported a net loss of $12.0 million for the nine months ended September 30, 2024, compared to a net loss of $9.3 million for the same period in 2023. The net loss for the third quarter of 2024 was $4.0 million, up from $3.4 million in the third quarter of 2023. The accumulated deficit as of September 30, 2024, stood at $37.8 million.

As of September 30, 2024, Coya had cash and cash equivalents of $31.1 million, a decrease from $32.6 million at the end of 2023. The company expects its current cash reserves, along with $10.0 million raised from a private placement in October 2024, to fund operations into 2026. However, additional financing will be necessary thereafter.

Strategically, Coya has made significant advancements in its clinical programs, including the submission of an Investigational New Drug (IND) application for COYA 302. The FDA has requested additional non-clinical data before the initiation of the Phase 2 study, which is expected to commence upon approval. The company also amended its agreement with DRL, receiving a one-time payment of $3.9 million and waiving the first $6.0 million in royalty payments.

In terms of leadership, Arun Swaminathan, Ph.D., succeeded Dr. Howard Berman as CEO effective November 1, 2024, while Dr. Berman continues as Executive Chair. The company remains focused on advancing its pipeline, which includes COYA 302 for ALS and potential expansions into other neurodegenerative diseases.