In the news release, Decoy Therapeutics Exploring Pan-Filovirus Program via FDA Animal Rule Pathway and Non-Dilutive Funding, issued 22-Sep-2026 by Decoy Therapeutics, Inc over PR Newswire, we are advised by the company that the original version contained incorrect information introduced by PR Newswire during transmission. The complete, corrected release follows, with additional details at the end:

Decoy Therapeutics Exploring Pan-Filovirus Program via FDA Animal Rule Pathway and Non-Dilutive Funding

Next-Generation D-MAVs™ Demonstrate Potent In Vitro Activity Against Ebola Zaire and Marburg Viruses; Targeting High-Value FDA Priority Review Voucher Eligibility

CAMBRIDGE, Mass., Sept. 22, 2026 /PRNewswire/ -- Decoy Therapeutics, Inc. (NASDAQ:DCOY), a biotechnology company pioneering Designable Multi-Antivirals (D-MAVs™) to target major respiratory and high consequence viral threats, today announced a refined corporate strategy to explore its D-MAVs for additional candidates, including a pan-filovirus program along the U.S. Food and Drug Administration (FDA) Animal Rule pathway for expedited regulatory approval. Based on recent encouraging discussions, the Company is actively pursuing non-dilutive government grants and public health partnerships to support the preclinical and clinical development of its broad-spectrum biodefense pipeline with monetization potential upon approval via Priority Review Voucher (PRV) opportunities.

Platform Velocity & Preclinical Breakthroughs

Following the discovery of initial cross-viral activity from Decoy's pan-coronavirus fusion inhibitors against wild-type Ebola Zaire and Lassa fever virus (announced July 27, 2026), Decoy initiated a dedicated program to de novo design filovirus fusion inhibitors using its AI/ML-driven IMP³ACT™ computational engine. Key highlights include:

Ebola Zaire Potency: A first-generation de novo candidate achieved a low-micromolar half-maximal inhibitory concentration (IC₅₀) of 1.56 μΜ against wild-type Ebola Zaire virus in cell-based assays, a > five-fold improvement in potency vs. the pan-coronavirus lead, and a 7-fold improvement over the benchmark antiviral, remdesivir.
Marburg Virus Activity: This candidate also demonstrated potent cross-family activity against Marburg virus (IC₅₀ = 1.04 μΜ).
Pan-Filovirus Objective: Decoy is executing generative design campaigns to establish a single, broad-spectrum pan-filovirus D-MAV for pre- and post-exposure prophylaxis against all human-infecting filoviruses.

Engineered for Extended Protection & Prophylactic Utility

Effective prophylaxis against high-consequence viral pathogens requires sustained drug levels at the site of infection ingress. Beyond optimizing binding potency, Decoy's IMP³ACT platform structurally engineers molecules for extended tissue residence time and long systemic plasma half-lives, with potential for weekly dosing.

Addressing the Filovirus Threat and Outbreak Dynamics

Filoviruses, including the Ebola and Marburg viruses, cause severe hemorrhagic fevers with historical mortality rates between 40% and 90%. The ongoing outbreak of Bundibugyo virus highlights the critical vulnerability of existing therapeutics, which are largely single-strain specific.

Decoy's pan-filovirus approach targets the highly conserved helical fusion core shared across filovirus glycoproteins. By neutralizing the fundamental mechanism of viral entry, Decoy aims to deliver a unified prophylactic solution capable of protecting against Ebola Zaire, Marburg, Sudan, and Bundibugyo viruses simultaneously.

"Our recent filovirus data illustrate the speed and precision of our IMP³ACT platform," said Rick Pierce, Chief Executive Officer of Decoy Therapeutics. "In a single optimization cycle, we achieved potent activity against both Ebola Zaire and Marburg viruses. Crucially, by engineering our D-MAVs for extended residence time at key mucosal entry points, we are building therapies designed to offer durable protection. Advancing this program via the FDA Animal Rule path could allow us to efficiently address urgent biodefense needs through non-dilutive funding while expanding our multi-viral pipeline and proprietary computational database."

The Animal Rule Regulatory Path

The FDA's Animal Rule enables expedited approval for therapeutics targeting lethal pathogens where human efficacy trials are neither ethical nor feasible. Regulatory approval is established through well-controlled animal model efficacy studies combined with human safety and PK evaluation. This streamlined path significantly reduces clinical timelines and overhead, and positions successful candidates for government procurement and Strategic National Stockpile (SNS) inclusion. Decoy intends to fund its D-MAV filovirus and MERS programs primarily through non-dilutive government grants, industry and strategic biodefense partnerships.

In addition to addressing an urgent biodefense need, qualifying filovirus approvals offer substantial commercial value through the FDA's Tropical Disease Priority Review Voucher (PRV) Program:

Priority Review Voucher Eligibility: Filoviruses and Lassa fever are designated qualifying tropical diseases under FDA regulations. Upon FDA approval of an eligible filovirus candidate, Decoy would be eligible to receive a PRV.
Significant Non-Dilutive Capital Value: A PRV grants priority review status to a subsequent drug application or can be sold to another pharmaceutical company. Recent PRV market transactions have ranged between $100 million and $180 million, offering a major potential source of non-dilutive capital to drive corporate growth.

About Decoy Therapeutics, Inc.

Decoy Therapeutics (NASDAQ:DCOY) is a biotechnology company developing Designable Multi-Antivirals (D-MAVs™) powered by its proprietary IMP³ACT™ platform. By combining generative AI structural design with advanced peptide-conjugate chemistry, Decoy creates single therapeutics that target conserved viral entry machinery across entire viral families. Decoy's pipeline includes programs targeting endemic coronaviruses for immunocompromised patients and MERS, paramyxoviruses (RSV, hPIV, Nipah, Measles), and filoviruses (Ebola, Marburg). For more information, visit decoytx.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding Decoy's strategy, preclinical development, regulatory approval pathways (including the FDA Animal Rule), non-dilutive funding, and potential dosing regimens, are forward-looking statements. These statements are based on current management expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the Company will not obtain sufficient financing to execute on their business plans and risks related to Decoy's products and development plans, including unanticipated issues with any IND application process and the potential of the IMP3ACT™ platform. Readers are urged to carefully review and consider the various disclosures made by the Company in its reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, Decoy's actual results may vary materially from those expected or projected.

Contacts

Business Development

Peter Marschel, CBO

Peter@decoytx.com

617-943-6305

Media Relations

Tara Mulloy, TMC Studio

tara@tmc-studio.com

978-855-5219

Correction:  An earlier version of this release was missing information from the first two bullet points under "Platform Velocity & Preclinical Breakthroughs."

View original content to download multimedia:https://www.prnewswire.com/news-releases/decoy-therapeutics-exploring-pan-filovirus-program-via-fda-animal-rule-pathway-and-non-dilutive-funding-302885511.html

SOURCE Decoy Therapeutics, Inc.