/C O R R E C T I O N -- Decoy Therapeutics, Inc/

Decoy is steering its filovirus and MERS programs toward FDA Animal Rule approval, targeting PRV monetization and largely non-dilutive funding.

Rhea-AI Summary

Decoy Therapeutics (DCOY) outlined a refined strategy to develop its D‑MAV™ antivirals into a pan‑filovirus program via the U.S. FDA Animal Rule pathway, supported primarily by non‑dilutive government grants and biodefense partnerships.

A first‑generation de novo filovirus fusion inhibitor generated with the IMP³ACT™ engine showed an IC50 of 1.56 μM against wild‑type Ebola Zaire in cell assays, over five‑fold more potent than Decoy’s pan‑coronavirus lead and about seven‑fold more potent than benchmark antiviral remdesivir, and also demonstrated activity against Marburg virus with an IC50 of 1.04 μM. Decoy is running generative design campaigns to create a single pan‑filovirus D‑MAV for pre‑ and post‑exposure prophylaxis and aims to engineer molecules for extended tissue residence and weekly dosing. Eligible filovirus approvals could earn a transferable FDA Priority Review Voucher, with recent market values of $100–$180 million.

Positive

• Ebola Zaire IC50 1.56 μM, >5x more potent than pan‑coronavirus lead and ~7x vs remdesivir
• Marburg virus IC50 1.04 μM demonstrates cross‑family antiviral activity from the same candidate
• Pursuit of FDA Animal Rule path may shorten timelines and enable government stockpile procurement
• Filovirus and MERS programs targeted for funding via non‑dilutive grants and partnerships
• Potential FDA Priority Review Voucher with recent sale values of $100–$180 million

Negative

• None.

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Details

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Key Figures

Ebola Zaire IC50: 1.56 μM Potency improvement: >5-fold Benchmark improvement: 7-fold +2 more

Ebola Zaire IC50

1.56 μM

Wild-type Ebola Zaire cell-based assay

Potency improvement

>5-fold

Versus the pan-coronavirus lead

Benchmark improvement

7-fold

Versus remdesivir

Marburg virus IC50

1.04 μM

Cross-family activity in cell-based assays

PRV transaction range

$100 million-$180 million

Recent Priority Review Voucher market transactions

Historical Context

1 past event · Latest: Jul 27

1 event

1. Jul 27

   Ebola activity announcement

   24h Move

   -25.8%

   Initial in vitro Ebola and Lassa activity expanded the D-MAV program into filoviruses

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

animal rule, half-maximal inhibitory concentration (ic50), priority review voucher, non-dilutive funding, +1 more

5 terms

animal rule regulatory

"FDA Animal Rule pathway for expedited regulatory approval"

A regulatory pathway that allows safety and effectiveness of drugs or vaccines to be judged primarily from well-controlled animal studies when human trials would be unethical or impossible, such as for treatments against rare, lethal exposures. It matters to investors because approval via this route can speed a product to market for urgent or niche needs but carries extra scientific and regulatory risk—think of it as accepting a high-quality dress rehearsal instead of a live show, with requirements for strong animal models and often additional post-approval obligations.

half-maximal inhibitory concentration (ic50) medical

"low-micromolar half-maximal inhibitory concentration (IC50) of 1.56"

The half-maximal inhibitory concentration (IC50) is the concentration of a drug, antibody, or other molecule required to reduce a specific biological activity (such as enzyme action, cell growth, or receptor signaling) by 50% in a controlled lab assay. It measures potency: lower IC50 means a smaller amount of substance is needed to produce that half‑reduction, like needing less salt to make a soup noticeably less salty. For investors, IC50 helps compare how potent competing drug candidates are and informs early-stage development, dosing expectations, and risk assessments.

priority review voucher regulatory

"FDA's Tropical Disease Priority Review Voucher (PRV) Program"

A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.

non-dilutive funding financial

"actively pursuing non-dilutive government grants"

Non-dilutive funding is money a company raises that does not require issuing new shares or reducing existing owners’ percentage ownership, such as grants, certain loans, contract revenue, or licensing deals. It matters to investors because it lets a company finance growth or research without shrinking shareholder stakes or changing control, much like topping up a car’s gas tank instead of selling part of the car to pay for the trip.

in vitro technical

"demonstrate potent In Vitro Activity Against Ebola Zaire"

In vitro describes laboratory tests performed on cells, tissues, or biological molecules outside a living body—literally “in glass,” such as in test tubes or dishes. For investors, in vitro results are an early sign that a drug or technology has a desired effect under controlled conditions, but they don’t guarantee it will work or be safe in animals or people; think of them as a prototype tested on a bench rather than in real-world use.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Decoy Therapeutics trying to achieve with its pan-filovirus D-MAV program?

Decoy is running generative design campaigns to establish a single, broad‑spectrum pan‑filovirus D‑MAV for pre‑ and post‑exposure prophylaxis against all known human‑infecting filoviruses, including Ebola Zaire, Marburg, Sudan, and Bundibugyo viruses. The molecules are being engineered for extended tissue residence and long plasma half‑lives, with potential for weekly dosing.

How does the FDA Animal Rule pathway apply to Decoy Therapeutics’ programs?

The FDA Animal Rule allows approval of drugs for lethal pathogens when human efficacy trials are not ethical or feasible. Efficacy is demonstrated in well‑controlled animal models, supported by human safety and pharmacokinetic data. Decoy plans to advance its filovirus and MERS D‑MAV programs under this framework, which the company views as reducing clinical timelines and overhead while supporting potential inclusion in the Strategic National Stockpile.

What commercial benefit could a Priority Review Voucher provide Decoy Therapeutics?

Filoviruses and Lassa fever are designated qualifying tropical diseases. Upon FDA approval of an eligible filovirus candidate, Decoy would be eligible to receive a Priority Review Voucher (PRV). A PRV can be used to obtain priority review for another drug application or sold to another company. Recent PRV transactions have ranged between $100 million and $180 million, representing a possible source of substantial non‑dilutive capital.

What correction was made compared with the earlier version of this release?

The company states that a prior version contained incorrect information introduced during transmission. The corrected release restores missing information from the first two bullet points under the "Platform Velocity & Preclinical Breakthroughs" section, clarifying the detailed potency data for the filovirus candidate.