Salarius Pharmaceuticals to Collaborate with Texas Biomedical Research Institute on Avian Flu Study

Rhea-AI Summary

Salarius Pharmaceuticals (Nasdaq: SLRX) announced a collaboration with Texas Biomedical Research Institute on Decoy Therapeutics’ peptide conjugate influenza fusion inhibitors, including testing across several influenza strains such as H5N1 avian flu (Dec. 1, 2025). The company says its IMP3ACT™ platform produced inhibitors with strong in silico free energy binding to the viral entry protein and seeks in vitro confirmation at Texas Biomed.

Salarius completed a merger with Decoy and an underwritten public offering raising $8 million on Nov. 13, 2025, and expects to file an IND for a pan-coronavirus lead asset within 12 months.

Positive

• Completed merger with Decoy Therapeutics on Nov. 13, 2025
• Raised $8 million in underwritten public offering
• Collaboration with Texas Biomed to run in vitro testing on H5N1
• Plans to file an IND within 12 months for pan-coronavirus lead

Negative

• Influenza inhibitors currently supported primarily by in silico binding data
• Programs remain preclinical with no reported clinical efficacy yet

Insights

Virology expert

Preclinical collaboration advances in vitro testing of peptide fusion inhibitors across influenza strains; evidence remains computational and early.

The collaboration with Texas Biomedical Research Institute establishes external in vitro testing capacity for Decoy Therapeutics' peptide conjugate fusion inhibitors, which show strong in silico free energy binding to the influenza entry protein. The release states the inhibitors will be tested across several strains including H5N1, which directly addresses a relevant pathogenic target and broadens the platform's scope beyond coronaviruses and paramyxoviruses.

Key dependencies include whether in vitro activity replicates the in silico binding and whether activity spans diverse viral isolates and relevant mutants; the announcement contains no empirical in vitro or in vivo data. Watch for published in vitro neutralization or viral entry assays and their timelines, and for any mention of potency metrics or EC50 values expected during the next 12 months. The factual baseline here is computational affinity plus a formal testing engagement, not demonstrated efficacy.

Biotech commercial/strategy analyst

The company positioned its IMP3ACT platform toward a broad respiratory antiviral program and disclosed recent financing and a merger, but clinical and commercial outcomes remain unproven.

The announcement highlights the goal of a single antiviral active versus influenza, COVID and RSV, and notes a completed underwritten public offering raising $8 million and a merger with Decoy Therapeutics on Nov. 13, 2025. It cites industry M&A interest using Merck’s acquisition of Cidara for $9.2 billion as contextual evidence of market demand. The company's near-term plan includes advancing a pan-coronavirus lead toward an IND within next 12 months.

Primary risks are that the current claims rest on in silico results and intent to test, not on validated preclinical efficacy or safety, and the disclosed $8 million gross raise is modest relative to typical IND-enabling programs. Monitor concrete milestones: publication or data release of in vitro results against H5N1 and other strains, IND filing status for the pan-coronavirus asset within the stated next 12 months, and any additional financing or partnerships that fund IND-enabling studies.

Salarius subsidiary Decoy Therapeutics’ influenza fusion inhibitors, designed using its proprietary IMP³ACT™ platform, show excellent in silico free energy binding to the viral target entry protein, supporting potential for anti-flu activity

IMP³ACT’s demonstrated capability to create a single antiviral therapeutic against influenza, COVID and RSV has potential to position Salarius to address large existing global commercial opportunity

CAMBRIDGE, Mass. and HOUSTON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Decoy Therapeutics, Inc. (Decoy), a preclinical biopharmaceutical subsidiary of Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) that is engineering the next generation of peptide conjugate therapeutics, and Texas Biomedical Research Institute (Texas Biomed), one of the world’s foremost independent biomedical research institutions dedicated to eradicating infection and advancing health, announce a collaboration to conduct in vitro testing of Decoy’s peptide conjugate fusion inhibitors across several influenza strains including H5N1 avian flu.

“We are highly optimistic our pan-influenza inhibitors will show in vitro activity in influenza regardless of strain due to in silico testing showing their strong binding affinity to the viral target. In fact, the in silico free energy of our influenza inhibitors is at least as good as our pan-coronavirus inhibitors, which have demonstrated excellent in vitro and in vivo activity,” stated Salarius Chief Scientific Officer Barbara Hibner, Ph.D.

“Our IMP³ACT platform is built around a rapid design-build-test-learn loop enabled by machine learning and rapid synthesis for the ‘design’ and ‘build’ steps,” Dr. Hibner added. “By working with Texas Biomed we are adding world-class capabilities for the ‘test’ step. We are proud to collaborate with Texas Biomed’s renowned scientists and to leverage their leading in vitro virology testing capabilities and look forward to expanding our relationship with their world-class scientific and medical resources as we advance our pipeline.”

“Seasonal influenza continues to be a global health concern, and the recent rise of H5N1 strains of avian flu currently circulating in the U.S. is heightening concern of another pandemic,” said Luis Martinez-Sobrido, Ph.D., a professor at Texas Biomed. “The rapid speed at which the avian virus can mutate when introduced to a new host increases its potential for human-to-human transmission. This underscores the pressing need for potent inhibitors with activity against multiple influenza strains and their mutations.”

The addition of pan-influenza inhibitors to Salarius’ previously designed pan-coronavirus and pan-paramyxovirus inhibitors supports the Company’s goal of using its IMP³ACT platform to create a single antiviral inhibitor that is broadly effective against the three viral families that are responsible for the majority of serious seasonal respiratory viral infections. Additionally, Salarius intends to explore the use of these peptides for agricultural health applications such as the treatment of egg-laying poultry flocks.

“Seasonal influenza-like illness – from flu to RSV and COVID – continue to be an enormous unmet medical need, responsible for more than 10 million medical visits every year in the U.S. alone. Merck's recent $9.2 billion acquisition of Cidara Therapeutics, maker of the long-acting antiviral for flu CD388 after Phase 2 trials, clearly demonstrates big pharma and investor interest in novel antivirals,” said Salarius Chief Executive Officer Rick Pierce. “We are leveraging the strengths of our IMP³ACT platform to create a single antiviral therapeutic that is broadly active across these respiratory viruses, positioning Salarius to potentially address a very large global commercial opportunity and possible future global respiratory viral pandemic threats.”

On November 13, 2025, Salarius completed an underwritten public offering raising gross proceeds of $8 million and consummated the previously announced merger with Decoy Therapeutics. The company is focused on advancing Decoy’s pipeline of peptide conjugate therapeutics engineered through its IMP³ACT platform that reduces the complexity of drug development and manufacturing.

During the next 12 months, Decoy expects to advance its lead asset, a pan-coronavirus antiviral, to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and to make progress on other programs including a novel broad-acting antiviral to treat flu, COVID-19 and respiratory syncytial virus (RSV), and a peptide drug conjugate targeting GI cancers.

About Influenza

Influenza is a major global health threat that may become more challenging to treat due to emerging influenza virus strains and mutations, including highly pathogenic avian influenza viruses, and the growing resistance to approved influenza antivirals. According to the World Health Organization, there are around a billion cases of seasonal influenza annually, including 3 million - 5 million cases of severe illness contributing to 290,000 to 650,000 respiratory deaths. An influenza pandemic is predicted to cost $60 billion annually.

About Decoy’s Peptide Conjugate Technology

Decoy’s’ drug design engine uses the power of computational tools and fast peptide synthesis technology pioneered in the laboratory of Brad Pentelute, Ph.D., Professor of Chemistry at MIT and Decoy co-founder, to rapidly engineer and synthesize novel antivirals that directly target highly conserved viral machinery. Its proprietary IMP³ACT peptide conjugate drug design and manufacturing platform leverages machine learning (ML) and artificial intelligence (AI) tools. IMP³ACT allows for the rapid computational design and manufacturing of innovative peptide conjugate therapeutics including rapid response to novel viral pathogens including H5N1 avian flu. Peptide conjugates are a new class of drug, perhaps best known for the popular diabetes and weight loss medications, that takes advantage of the strong activity and selectivity of peptides, and improves their targeting and durability by adding a lipid molecule. Salarius is expanding the use of this new drug class to indications including infectious diseases and cancer.

The IMP³ACT platform leverages peptide chemistry to design α-helical peptides using computational and machine learning tools. These peptides are transformed into multimeric conjugates by chemically linking a defined number of copies to lipids or other suitable membrane anchor moieties, enhancing their drug-like properties and dosing flexibility with extended pharmacokinetics. Salarius’ technology has produced peptide conjugates effective in vitro against multiple human coronaviruses, including all SARS-CoV-2 major variants of concern to date, and against RSV A, RSV B and hPIV3, and in vivo against the SARS-CoV-2 delta variant. By integrating machine learning algorithms in peptide design and synthesis, Salarius’ platform accelerates the creation of lead molecules for preclinical evaluations, simultaneously optimizing peptide conjugates for enhanced affinity, binding specificity, resistance to proteases, pharmacokinetic properties and manufacturability at early commercial scale.

About Texas Biomedical Research Institute

Texas Biomed is a nonprofit research institute dedicated to protecting the global community from infectious diseases. Through basic research, preclinical testing and innovative partnerships, we accelerate diagnostics, therapies and vaccines for the world’s deadliest pathogens. Our San Antonio campus hosts high containment laboratories and the Southwest National Primate Research Center. Our scientists collaborate with industry and researchers globally and have helped deliver the first COVID-19 vaccine, the first Ebola treatment and first Hepatitis C therapy. Learn more at txbiomed.org.

About Salarius Pharmaceuticals, Inc.

Salarius Pharmaceuticals subsidiary Decoy Therapeutics is a preclinical-stage biotechnology company that is leveraging ML and AI tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide conjugate drug candidates that target serious unmet medical needs. The company’s initial pipeline is focused on respiratory viruses and GI cancers. Decoy has attracted financing from institutional investors as well as significant non-dilutive capital from the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program among other sources. The company has also received QuickFire Challenge award funding provided by the Biomedical Advanced Research and Development Authority (BARDA) through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and BARDA within the Administration for Strategic Preparedness and Response.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the combined company, including without limitation, express or implied statements relating to, among other things, the Company’s combined business; the Company’s ability to engineer the next generation of peptide conjugate therapeutics, the Company’s product candidates and lead assets, including its influenza fusion inhibitors and IMP³ACT platform; expectations regarding preclinical and clinical milestones and future plans for its lead assets and product candidates; the Company’s ability to leverage the capability of its IMP³ACT platform to create a single antiviral therapeutic that is broadly effective against the three viral families that are responsible for the majority of serious seasonal respiratory viral infections; the Company’s ability to explore the use of its product candidates and technology for agricultural health applications; expectations regarding unmet medical need and potential commercial market opportunity for the Company’s product candidates and lead assets; the Company’s belief that the respiratory virus families are a likely source of the next viral pandemic; expectations regarding the Texas Biomedical Research Institute collaboration and the Company’s ability to leverage their leading in vitro virology testing capabilities; the Company’s belief that its pan-influenza inhibitors will show in vitro activity in influenza regardless of strain due to in silico testing showing their strong binding affinity to the viral target; the Company’s belief that in the next 12 months, it will advance its lead asset, a pan-coronavirus antiviral, to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and make progress on other programs including a novel broad-acting antiviral to treat flu, COVID-19 and respiratory syncytial virus (RSV), and a peptide drug conjugate targeting GI cancers; and the Company's expectations, beliefs, intentions, and strategies regarding the future and other statements that are not historical fact.

The Company may not actually achieve the plans, intentions, or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements.  These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: risks that the combined company will not achieve the anticipated synergies expected from the merger; risks that the combined company will not obtain sufficient financing to execute on their business plans; and risks related to the combined company’s product candidates, lead assets and related development plans, including unanticipated issues with any IND application process or future filings with the U.S. Food and Drug Administration, and the potential of the IMP³ACT platform. Readers are urged to carefully review and consider all additional risk factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

CONTACTS:

Salarius Pharmaceuticals
Rick Pierce, CEO
Pierce@decoytx.com
617-447-8299

Business Development:
Peter Marschel, CBO
Peter@Decoytx.com
617-943-6305

Investor and Media
Alliance Advisors IR
Jody Cain
jcain@allianceadvisors.com
310-691-7100

FAQ

What did Salarius (SLRX) announce on December 1, 2025 about influenza testing?

Salarius said Decoy Therapeutics will collaborate with Texas Biomed to perform in vitro testing of peptide fusion inhibitors against several influenza strains, including H5N1.

How much capital did Salarius (SLRX) raise in November 2025 and when?

Salarius completed an underwritten public offering on Nov. 13, 2025 raising $8 million in gross proceeds.

What is the IMP3ACT platform claim for Salarius (SLRX)?

The IMP3ACT platform is described as designing peptide conjugate antivirals with strong in silico free energy binding and rapid ML-enabled design-build-test cycles.

Does the December 2025 announcement say Salarius (SLRX) has clinical data for the antiviral candidates?

No; the announcement reports in silico binding and planned in vitro testing but does not report any clinical trial results.

What near-term regulatory milestone does Salarius (SLRX) expect to pursue?

Decoy expects to advance its pan-coronavirus lead to an IND filing with the FDA within 12 months.