Coya Therapeutics Provides a Corporate Update and Reports Unaudited Third Quarter 2024 Financial Results

HOUSTON--(BUSINESS WIRE)--November 06, 2024-- 

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 quarter ended September 30, 2024.

Recent Corporate Highlights

   -- Announced positive results from an investigator initiated double-blind 
      study of low-dose interleukin-2 (LD IL-2) in patients with mild to 
      moderate Alzheimer's Disease (AD) at the Clinical Trials on Alzheimer's 
      Disease Conference (CTAD24) in Madrid 
 
   -- Filed patents for COYA 301 in combination with Glucagon-Like Peptide-1 
      (GLP-1) receptor agonists 
 
   -- Promoted Arun Swaminathan, Ph.D. to Chief Executive Officer, effective 
      November 1, 2024, while Howard Berman has transitioned from CEO to 
      Executive Chairman 
 
   -- Announced anti-inflammatory effects of COYA 302 in the brain from a 
      preclinical inflammatory mouse model of Parkinson's disease $(PD)$ 
 
   -- Aligned with FDA on the non-clinical data needed to support the planned 
      randomized, double-blind, placebo-controlled, Phase 2b trial of COYA-302 
      in patients with Amyotrophic Lateral Sclerosis (ALS). 
 
   -- A Phase 1 investigator-initiated trial (IIT) combining LD IL-2 + CTLA4-Ig 
      began in patients with Frontotemporal Dementia (FTD) 

Upcoming Expected Catalysts for 2025

   -- Q1 2025: Additional clinical data to be released in the Phase 2 LD IL-2 
      investigator-initiated trial (IIT) study in patients with AD. Publication 
      and release of additional and comprehensive blood immune panels and 
      inflammatory cerebrospinal fluid $(CSF.AU)$ biomarkers comparing LD IL-2 arms 
      to placebo arm 
 
   -- Q1/Q2 2025: COYA 301/GLP-1 combination data submission for publication 
      and additional intellectual property filings 
 
   -- Q2 2025: Submission of additional data to support the start of the 
      COYA-302 Phase 2 trial in patients with ALS 
 
   -- Upon IND acceptance and first patient dosing of COYA-302 in ALS, eligible 
      to receive milestone payments of $8.4 million from strategic partner, Dr. 
      Reddy's Laboratories (DRL) 
 
   -- Q2 2025: ALS Biomarker data. Publication of longitudinal data on 
      Neurofilament Light Chain (NfL) and oxidative stress markers in patients 
      with ALS 
 
   -- 2H 2025: Top-line clinical data release for an investigator-initiated 
      trial combining LD IL-2 + CTLA4-Ig in patients with FTD 
 
   -- 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with 
      FTD* (*Clinical trial initiated upon FDA IND approval) 

"We are pleased with the constructive discussion we have had with the FDA," said Coya CMO, Dr. Fred Grossman. "We have clarity on the non-clinical data needed to support the start of our Phase 2 study of COYA-302 in patients with ALS and we are fully aligned with the FDA. We are confident in the path forward towards the completion of this important potential pivotal trial. Following FDA acceptance of the Coya 302 IND in ALS, we expect to submit the IND for COYA 302 in FTD, likely in the second half of 2025."

Coya CEO Arun Swaminathan, Ph.D. said:

"As the new CEO of Coya, I am very encouraged by our progress in 2024. I believe our progress opens a wide array of strategic opportunities in 2025, both with existing and new partners. I will be keenly focused on delivering shareholder value over the next year.

"During the third quarter of 2024 we continued to advance our pipeline of neurodegenerative treatments, all aimed at neurodegenerative diseases with high unmet need, including AD, PD, and ALS.

"Our drug candidates all target neuroinflammation, which we see as a major contributing factor towards disease progression in the neurological conditions we are addressing. Moreover, our approach to potential combination therapies for treatment of these neurodegenerative diseases differentiates us from other companies and offers, what we believe, a new treatment paradigm that could lead to the creation of meaningful shareholder value.

"We anticipate 2025 will be a busy and productive year filled with multiple milestones, clinical data and catalysts. In Q1 of 2025, we will be presenting additional clinical data from the investigator-initiated phase 2 trial in AD and later in the year clinical data from another investigator-initiated clinical trial in FTD, this time with the combination of LD IL-2 and CTLA-4 Ig. We are also excited to begin our Coya sponsored phase 2 trials for our combination biologic COYA 302 in both ALS and FTD.

"During the CTAD conference in Madrid at the end of October, encouraging Phase 2 data was presented from an investigator-initiated trial that highlighted the benefits of LD IL-2 in treating patients with mild to moderate Alzheimer's disease. This data increased our confidence in our combination drug candidate, COYA 302, which combines COYA 301, our proprietary LD IL-2 candidate, with the fusion protein CTLA4-Ig, or Abatacept for the potential treatment of neurodegenerative diseases, such as ALS and FTD. We believe LD IL-2 enhances and restores Treg function, lowering inflammation, while CTLA4-Ig inhibits other inflammatory cell types and so may sustain and create more durable Treg functionality. While we were encouraged with the promising LD IL-2 monotherapy data in AD, we believe that our combination approach with CTLA-4 Ig provides numerous advantages by targeting multiple immune pathways which are critical in these complex diseases.

"We also believe there is potential for strategic opportunities combining COYA-301 with other therapeutic agents as potential therapeutics for patients with AD or other neurodegenerative and autoimmune diseases.

"Finally, our recent capital raise provides additional flexibility and cushion for us to execute on our corporate, clinical, and regulatory goals. As of October 31, 2024, our interim cash and cash equivalents (unaudited) was $39.8 million. We continue to be in discussions with our partners and potential partners looking for opportunities to reach our goals quicker and in the best way possible. I look forward to sharing additional corporate, clinical, and regulatory progress as appropriate," concluded Swaminathan.

Unaudited Financial Results

As of September 30, 2024, Coya had cash and cash equivalents of $31.1 million.

Research and development expenses were $2.2 million for the three months ended September 30, 2024, compared to $1.6 million for the three months ended September 30, 2023. The increase was due to a $0.3 million increase in our preclinical expenses primarily due to our preclinical advancement of COYA 302 in ALS and a $0.3 million increase in internal research and development expenses.

General and administrative expenses were $2.2 million for the three months ended September 30, 2024, and $2.0 million for the three months ended September 30, 2023, a change of approximately $0.2 million. The increase was primarily due to a $0.4 million increase in stock-based compensation and employee headcount, partially offset by a $0.2 million decrease in corporate fees.

Net loss was $4.0 million for the three months ended September 30, 2024, compared to net loss of $3.4 million for the three months ended September 30, 2023.

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells ("Tregs") to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system.

Coya's investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya's therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

COYA 302 -- the Company's lead biologic investigational product or "Pipeline in a Product" -- is a proprietary combination of COYA 301 (Coya's proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson's Disease, and Alzheimer's Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone.

For more information about Coya, please visit www.coyatherapeutics.com.

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November 06, 2024 08:00 ET (13:00 GMT)