FDA Fast Track Designation Boosts ALS Treatment Outlook; Analyst Sees More Than 250% Upside Potential
Research Report

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Disclosures for D. Boral Capital, Coya Therapeutics Inc., May 12, 2026

Analyst Certification I, Jason Kolbert, certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) and subject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views expressed in this research report. Company-Specific Disclosures General Disclosures The information contained in Research Reports or other Research products produced by D. Boral Capital LLC is for informational purposes only and does not constitute solicitation of the sale or purchase of securities or other investments. The information in such products is derived from sources that are believed to be reliable. Prices, numbers, and similar data include past results, estimates, and forecasts, all of which may differ from actual data. These prices, numbers, and similar data may also change without prior notification. D. Boral Capital holds the copyright on this research report. Any unauthorized use or transmission of any part of this research report for any reason, whether by digital, mechanical, or any other means, is prohibited. If you have any questions, please contact your sales representative. Additional information is available upon request. Certain company names, product and/or service names that appear in this research report are trademarks or registered trademarks of D. Boral Capital or other companies mentioned in the report. Copyright 2026 D. Boral Capital LLC. D. Boral Capital rating definitions are expressed as the total return relative to the expected performance of S&P 500 over a 12-month period. BUY (B) - Total return expected to exceed S&P 500 by at least 10% HOLD (H) - Total return expected to be in-line with S&P 500 SELL (S) - Total return expected to underperform S&P 500 by at least 10% Distribution of Ratings/IB Services D. Boral IB Serv./Past 12 Mos. Rating Count Percent Count Percent BUY 39 86.67 13 33.33 HOLD 6 13.33 0 0.00 SELL 0 0.00 0 0.00

On May 12, 2026, analyst Jason Kolbert of D. Boral Capital reiterated a Buy rating and US$15.00 price target on Coya Therapeutics Inc. (COYA:NASDAQ), implying upside from the May 11, 2026, closing price of US$4.18, following the company's receipt of U.S. FDA Fast Track Designation for COYA 302 in amyotrophic lateral sclerosis (ALS).

Kolbert characterized the designation as an incremental regulatory positive that should support more frequent FDA engagement and potentially streamline review if the Phase 2 ALSTARS program generates supportive data. While the designation does not change the clinical risk profile, it reinforces the unmet need in ALS and validates COYA 302 as a program potentially eligible for a more efficient development and review path.

COYA 302 is a dual immunomodulatory therapy combining proprietary low-dose IL-2 with CTLA-4 Ig, designed to restore and enhance regulatory T cell (Treg) anti-inflammatory function while suppressing inflammatory activity from activated monocytes and macrophages. According to the report, this approach targets the underlying immune dysregulation and chronic inflammation believed to drive ALS progression, differentiating it from most approved or late-stage ALS therapies that primarily focus on neuronal protection or symptom management rather than actively rebalancing the immune system.

The key focus remains execution of ALSTARS, the ongoing Phase 2 randomized, multicenter, double-blind, placebo-controlled trial evaluating COYA 302 in ALS. The study is expected to be conducted across roughly 20-25 sites in the U.S. and Canada, with the next meaningful inflection points being enrollment progress, safety updates, and ultimately efficacy data sufficient to support a clearer regulatory path.

Looking ahead, Kolbert highlighted several catalysts for investors to monitor, including continued ALSTARS enrollment updates, any additional FDA feedback following Fast Track designation, potential expansion of COYA 302 into frontotemporal dementia following the accepted IND, and future data that could clarify whether Treg-enhancing therapy can produce a clinically meaningful benefit in ALS.

On the financial side, Coya reported total revenues of US$8 million in 2025, with estimates of US$0 million in 2026 and US$15 million in 2027. Total expenses were US$31 million in 2025, projected at US$30 million in both 2026 and 2027. GAAP EPS was US(1.27) in 2025, with estimates of US(1.27) in 2025, US (1.56) in 2026, and US(0.65) in 2027. The company has a market capitalization of US$98 million, an enterprise value of US$23 million, a book value of US$2.37, cash of US$28 million, and a quarterly burn rate of US (4) million. The 52-week range is US$3.94–US$7.75 with an average daily volume of 144,000 shares.

To arrive at the US$15.00 12-month price target, Kolbert modeled Coya's lead therapy COYA-302 in ALS, applying a probability of success factor of just 15% in addition to a discount rate of 30%, while assuming additional capital will be raised in the final share count. These projections were applied to Free Cash Flow to the Firm (FCFF), discounted EPS (dEPS), and sum-of-the-parts (SOP) models, which were equal-weighted, averaged, and rounded to the nearest whole number.

Risk factors identified in the report include Clinical and Regulatory Risk, Partnership Risk, Financial Risk, Commercial Risk, Legal and Intellectual Property Risk, and Market Share Risk.