Coya Therapeutics, Inc. Annual Report Summary

Coya Therapeutics, a clinical-stage biotechnology company, is pioneering new treatments by harnessing the body's own immune regulators, called regulatory T cells (Tregs). These "peacekeeper" cells naturally suppress inflammation and prevent the immune system from attacking healthy tissues. Coya's mission is to restore or enhance Treg function to combat debilitating conditions where these cells falter, such as neurodegenerative diseases (like ALS and Alzheimer's), autoimmune disorders, and metabolic diseases.

1. Business Overview

Coya employs three distinct scientific strategies:

• Treg-enhancing biologics: Coya develops protein-based drugs that boost the activity of existing Tregs. Their lead candidate, COYA 302, a biologic combination therapy, is undergoing Phase 2 clinical trials for Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD).
• Treg-derived exosomes: These tiny, naturally occurring vesicles, released by Tregs, carry therapeutic molecules. Coya explores their potential for targeted drug delivery and immune system modulation.
• Autologous Treg cell therapy: This approach involves isolating a patient's own Tregs, expanding them in the lab, and then re-infusing them to deliver a powerful anti-inflammatory and immune-modulating effect.

2. Financial Performance

As a clinical-stage company, Coya currently generates no revenue from product sales. Any revenue typically comes from grants or collaboration agreements, which were minimal in Fiscal Year (FY) 2025.

For the fiscal year ended December 31, 2025:

• Revenue: $0 from product sales.
• Net Loss: Approximately $35.2 million, up from $28.1 million in FY2024, as the company intensified its research and development efforts.
• Research & Development (R&D) Expenses: $28.5 million, up from $22.0 million in FY2024, primarily due to costs associated with the COYA 302 Phase 2 trial and preclinical development of other candidates.
• General & Administrative (G&A) Expenses: $6.7 million, consistent with the previous year.
• Growth Metrics: As a pre-revenue company, traditional growth metrics like sales growth do not apply. Coya measures its progress by pipeline advancement, clinical trial progress, and successful Investigational New Drug (IND) submissions.

3. Risk Factors

As a clinical-stage biotechnology company, Coya faces inherent and significant risks:

• Clinical Trial Failure: This is the most substantial risk. COYA 302 or other candidates may fail to demonstrate safety or efficacy in later-stage trials, which could significantly delay or terminate their development.
• Regulatory Approval Uncertainty: Even with positive trial results, there's no guarantee that the FDA or other regulatory bodies will approve their drug candidates for commercial sale.
• Funding and Dilution: Coya will require substantial additional capital to complete clinical trials and commercialize products. Future equity financings could significantly dilute existing shareholders' ownership.
• Competition: The Treg therapy space is becoming increasingly competitive. Rivals may develop more effective or cheaper therapies, or bring products to market faster.
• Intellectual Property (IP) Protection: Coya's success hinges on its ability to obtain and maintain patent protection for its technologies and drug candidates, and to operate without infringing on others' IP.
• Key Personnel Reliance: The loss of key scientific or management personnel could significantly impact their research and development efforts.
• Manufacturing Challenges: Scaling up manufacturing for biologics and cell therapies is complex and costly, posing potential hurdles.
• Emerging Growth Company Status: Coya's status as an "emerging growth company" and "smaller reporting company" (designations for smaller public companies) offers some flexibility by reducing disclosure requirements. Some investors might view this as less transparency, potentially affecting confidence. Coya also utilizes the extended transition period for new accounting standards, which could result in financial reporting that differs from larger companies.

4. Management Discussion and Analysis (MD&A) Highlights

The management's discussion and analysis highlights the company's operational progress, financial condition, and future prospects.

Results of Operations and Key Developments:

• Clinical Progress: Coya made significant strides in its pipeline. COYA 302 successfully completed its Phase 1 clinical trial, demonstrating a favorable safety profile. The company then advanced COYA 302 into Phase 2 trials for ALS and FTD, with initial patient enrollment progressing as planned. Coya also submitted an Investigational New Drug (IND) application for COYA 301, a new Treg-enhancing biologic candidate, for an undisclosed autoimmune indication.
• Pipeline Expansion: Submitting a new IND application for COYA 301 demonstrates Coya's ongoing innovation and broadening therapeutic portfolio.
• Industry Validation: The scientific field in which Coya operates received significant validation when Dr. Shimon Sakaguchi, the discoverer of Tregs, won the Nobel Prize in Physiology or Medicine in 2025. This global recognition underscores the immense potential and importance of Treg biology, directly benefiting Coya's research area.
• Regulatory Compliance: Coya confirmed it timely filed all required reports with the SEC, demonstrating strong regulatory compliance. The company maintains its status as a "non-accelerated filer," "smaller reporting company," and an "emerging growth company" (designations for smaller public companies that offer certain reporting exemptions). This status can streamline operations, and Coya also utilizes the extended transition period for new accounting standards, which could lead to different financial reporting compared to larger companies.
• Challenges: Coya experienced significant cash burn due to its substantial net loss and R&D expenses. This highlights the high capital requirements of drug development and necessitates future financing. Clinical trials inherently carry risks, including potential unexpected safety issues or a lack of efficacy. The growing interest in Treg-based therapies also increases competition. As a pre-revenue company, Coya remains highly dependent on its ability to raise additional capital.

Market Trends and Regulatory Environment:

• The 2025 Nobel Prize for Treg discovery significantly elevated the profile of Treg-based therapies. This could increase investor interest, research funding, and talent attraction for companies like Coya, potentially accelerating drug development in the field.
• While the regulatory pathway for novel biologics and cell therapies remains complex, it is becoming more defined. Coya's "emerging growth company" status provides certain regulatory exemptions, such as an extended transition period for new accounting standards like ASC 606 (revenue recognition) and ASC 842 (leases), which the company uses. This means Coya's financial statements might not be directly comparable to larger, fully compliant companies for a period. Regulatory agencies generally trend towards expediting reviews for therapies addressing high unmet medical needs, which could benefit Coya's programs if they demonstrate strong clinical data.

5. Financial Health

As of December 31, 2025:

• Cash and Cash Equivalents: $42.8 million.
• Burn Rate: With a net loss of $35.2 million, their approximate cash burn rate was around $8.8 million per quarter.
• Debt: Coya reported no significant long-term debt, relying primarily on equity financing.
• Liquidity: Based on its current cash position and burn rate, Coya estimates it has sufficient capital to fund operations for approximately 12-15 months. This indicates the company will need future financing within the next year to sustain operations and advance its pipeline. Coya may pursue equity offerings or strategic partnerships.

6. Future Outlook

Coya's immediate future outlook focuses on advancing its clinical pipeline. Key anticipated milestones include:

• Continued Enrollment and Data Readouts: Coya plans to continue patient enrollment in the COYA 302 Phase 2 trials for ALS and FTD, with initial interim data readouts expected in late 2026 or early 2027.
• IND Submissions: Coya plans to submit additional Investigational New Drug (IND) applications for new Treg-enhancing candidates in 2026, further expanding its preclinical pipeline.
• Preclinical Development: The company will advance preclinical studies for its exosome and autologous cell therapy platforms, aiming to move them into IND-enabling studies within the next 18-24 months.
• Financing Activities: Coya actively explores options for additional capital raises, including equity offerings or strategic partnerships, to support its long-term development plans.

7. Competitive Position

Coya aims to differentiate itself through its multi-pronged approach to Treg modulation, exploring biologics, exosomes, and cell therapy. This broad strategy allows the company to target various mechanisms of Treg dysfunction across different disease areas (neurodegenerative, autoimmune, metabolic). Its focus on specific indications like ALS and FTD with COYA 302 positions Coya in a high-unmet-need market. However, Coya operates in a competitive landscape alongside other companies developing immune-modulating therapies, including those focused on Tregs, as well as established pharmaceutical companies with significant resources. Coya's success will depend on demonstrating superior efficacy and safety in clinical trials and securing strong intellectual property.