Coya Therapeutics Updates on Corporate and Q1 2024 Financials

HOUSTON-- Coya Therapeutics Inc. (Nasdaq: COYA), a clinical-stage biotechnology firm focused on developing biologics to enhance regulatory T cell (Treg) function, has provided a corporate update and announced its financial results for the quarter ending March 31, 2024.

Recent Corporate Highlights:
In January 2024, Coya had a successful pre-IND and Type C meetings with the FDA to advance COYA 302 for ALS treatment. An IND is expected to be filed in the second quarter of 2024, followed by a Phase 2 trial initiation. The company expanded its COYA 302 pipeline to include Frontotemporal Dementia (FTD) and Parkinson’s disease (PD), with an IND planned for FTD in the second half of 2024 and animal data for PD expected in the same period. 

February 2024 saw the expansion of Coya's patent estate through a license from the University of Nebraska Medical Center, covering multiple LD IL-2 combinations, including those with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). Additionally, the COYA 302 pipeline was broadened to include Alzheimer’s disease (AD), making it a target for four neurodegenerative conditions including ALS, PD, FTD, and AD. 

In March 2024, data on immune system and Treg contributions in FTD patients were presented at the AD/PD 2024 Conference. The same month, novel biomarker data showing serum levels of 4-HNE correlating with ALS progression and survival were presented at the Society of Neuroimmune Pharmacology conference. This biomarker data was updated in late April 2024 at the Johnson Center Symposium, demonstrating that 4-HNE levels predict ALS patient survival and are elevated at diagnosis in bulbar onset ALS compared to limb onset ALS.

Dr. Howard Berman, Coya’s CEO, noted that the company expanded its clinical pipeline with COYA 302 beyond ALS to include FTD, PD, and AD. He emphasized the dual mechanism of action of COYA 302, combining low-dose IL-2 and CTLA4-Ig, which holds significant potential in treating complex neurodegenerative diseases. This combination therapy aims to restore Tregs and inhibit inflammatory cell types, offering a new therapeutic approach.

COYA 302’s development includes a forthcoming IND for ALS in the second quarter, followed by a Phase 2 trial initiation. The company is currently in discussions with the FDA regarding the inclusion of the 4-HNE biomarker in the expected trial. Clinical data from a previously completed investigator-initiated trial in ALS patients is also anticipated in the second quarter. 

In Alzheimer’s disease, data from the Phase 2 trial of COYA 301 (low-dose IL-2 alone) is expected in summer 2024, which will guide further trial designs for COYA 302 in AD. The company also expects to file an IND for FTD in the second half of 2024 and initiate a Phase 2 trial thereafter. Data presented at the AD/PD 2024 Conference in Lisbon showed Treg suppressive function reduction and elevated inflammatory environment in FTD patients, supporting the combination approach of COYA 302.

Dr. Berman also highlighted a licensing agreement with Dr. Reddy’s Laboratories for COYA 302 in ALS patients in the U.S., Canada, EU, and U.K. Discussions for additional commercial partnerships for COYA 302 in other conditions are ongoing. Coya’s current cash and cash equivalents of $36.0 million provide financial runway into 2026, enabling strategic and patient commercial negotiations.

Unaudited Financial Results:
As of March 31, 2024, Coya reported $36.0 million in cash and cash equivalents. Research and development expenses rose to $3.1 million from $1.2 million the previous year, primarily due to increased preclinical and internal research expenses. General and administrative expenses increased to $2.4 million from $1.7 million, mainly due to higher personnel expenses and consulting fees. The net loss for the quarter was $5.1 million, compared to a $2.7 million net loss in the same period the previous year.

About Coya Therapeutics, Inc.:
Headquartered in Houston, TX, Coya Therapeutics, Inc. is developing proprietary treatments aimed at enhancing the function of regulatory T cells to address systemic and neuroinflammation. Dysfunctional Tregs are implicated in various conditions, including neurodegenerative and autoimmune diseases. The company's pipeline includes several therapeutic modalities to restore Treg function, notably COYA 302, a combination of COYA 301 (low-dose IL-2) and CTLA4-Ig, targeting multiple neurodegenerative diseases.

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