SLRX Salarius Pharmaceuticals Inc

Decoy Therapeutics Inc. (Decoy), a privately held preclinical biopharmaceutical company engineering the next generation of peptide-conjugate therapeutics, announced that a series of antiviral drug candidates previously designed by its IMP3ACT™ platform to be broadly effective against viruses of the paramyxoviridae family also showed promising in silico activity against measles and Nipah viruses. As announced on January 13, 2025, Decoy and Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) signed a definitive merger agreement pursuant to which Decoy will merge with a wholly owned subsidiary of Salarius, subject to satisfaction of the closing conditions set forth in the definitive agreement. Upon consummation of the merger, the newly formed company will be named Decoy Therapeutics.

Decoy’s IMP3ACT platform strategy for antiviral therapeutics focuses on a mechanism that is broadly conserved across viruses, making it possible to use artificial intelligence (AI) and machine learning (ML) to design peptide-conjugate antiviral drug candidates with unprecedented activity against multiple viruses. Unlike preventive vaccines, these candidates act directly on the virus, and not on human cells or the immune system, to potentially stop or slow the virus from replicating, thereby reducing the severity or shortening the duration of the disease in infected persons. As demonstrated by these candidates, Decoy believes the IMP3ACT platform has the potential to change the economics of antiviral drug development by addressing multiple high health burden viruses such as RSV and hPIV and preparing the world for emerging future threats, like measles, with a single drug.

“Our proprietary peptide-conjugate technology platform for antivirals and cancer drug discovery, IMP3ACT, is adaptable in antivirals to develop potential treatments for existing viral diseases and new viral threats. I am proud of the Decoy team and their rapid in silico design of a drug candidate that is broadly active against multiple viruses, including RSV, hPIV, measles, Nipah and likely others. With this compound, we are developing a highly topical engineering application using Decoy’s platform technology and we are just getting started,” stated Decoy’s Co-founder and Chief Executive Officer Rick Pierce.

“By integrating machine learning algorithms and molecular dynamics modeling in peptide design and synthesis, Decoy’s platform accelerates the creation of lead molecules for preclinical evaluation,” he added. “These novel peptide-conjugates are simultaneously optimized in silico for enhanced affinity, binding specificity, resistance to proteases and pharmacokinetic properties, and for rapid manufacturability at early commercial scale. Indeed, using these computational tools we were able to identify measles antiviral binding in only five days.”

“Decoy’s goal is to create a pipeline of self-administered direct-acting antivirals that prevent infection, decrease viral shedding, minimize transmission and treat patients with existing infections, all with the same drug. Given the high structural and functional conservation of the enveloped viral entry machinery, we believe that a single peptide-conjugate antiviral can be designed to have activity across multiple related viruses,” added Barb Hibner, Ph.D., Decoy’s Chief Scientific Officer. “As COVID has shown us, we need multiple approaches for infectious disease, including therapies and vaccines. We are taking advantage of the unprecedented advancements in computing technologies and applying them to a very defined biological problem: broadly inhibiting viral infections by directly targeting the virus.”

Upon consummation of the merger, the combined company is expected to integrate Decoy’s expertise and resources with Salarius’ to advance a diversified infectious disease and oncology pipeline. The newly formed company is expected to focus on discovering and developing high-impact antiviral and cancer drugs engineered leveraging Decoy’s proprietary IMP3ACT platform.

About Measles and the Current Outbreaks

Measles is a member of the paramyxovirus family, along with RSV, mumps, metapneumovirus and parainfluenzavirus. Once exposed, measles first infects a person’s respiratory tract, causing flu-like symptoms, including runny nose, cough and fever, followed by a rash that appears several days later. It is believed to be the most contagious airborne virus known to date, spreads easily from an infected person via coughing or sneezing, and can remain in the air for up to two hours. Measles can lead to severe pneumonia with approximately 20% of patients requiring hospitalization, and in 1:1,000 cases the patient develops encephalitis (brain swelling). The measles virus can wipe out a person’s immune system, creating “immune amnesia” and destroying antibodies, leaving the patient more susceptible to a wide range of other infections.

While vaccines are 97% effective in preventing measles, there are no approved therapeutics developed specifically for its treatment. With the apparent post-Covid rise in vaccine skepticism, Decoy believes there is a growing need for new broad-acting antiviral drugs to treat viral infections. The current, ongoing measles outbreak that started in West Texas now includes more than 320 cases, with one confirmed death in Texas and one suspected death in New Mexico. Measles cases have been reported in at least 12 other states.

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 ML and AI tools. IMP3ACT allows for the rapid computational design and manufacturing of innovative peptide-conjugate therapeutics, including rapid response to novel viral pathogens, such as avian H5N1 flu. Peptide conjugates are a new type of drug, perhaps best known for the popular diabetes and weight loss medications. This drug class takes advantage of the strong activity and selectivity of peptides, and improves their targeting and durability by adding a lipid molecule. Decoy is expanding the use of this new drug class to indications, including infectious diseases and cancer.

The IMP3ACT platform leverages peptide chemistry to design a-helical peptides using computational and ML 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. Decoy’s 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 ML algorithms in peptide design and synthesis, Decoy’s 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 Decoy Therapeutics Inc.

Decoy 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 gastrointestinal 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. For more information, please visit www.DecoyTx.com.

About Salarius Pharmaceuticals, Inc.

Salarius is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center as a potential treatment for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas. For more information, please visit www.salariuspharma.com.

About the Proposed Transaction

Definitive agreements were executed with unanimous approvals by the Boards of Directors of Salarius and Decoy. The closing consideration will consist primarily of nonvoting preferred stock of Salarius, and it is expected that following closing and a post-closing stockholder vote to approve the conversion of the preferred shares into common stock, Decoy investors would own approximately 86% of the outstanding shares of the merged company and Salarius stockholders would own approximately 14% of the outstanding shares, subject to adjustment, in each case exclusive of any shares issued in any financing, including the qualifying financing(s) necessary to consummate the merger transaction. For further details on the transaction and conditions for closing of the merger, please refer to the Form 8-K Salarius filed with the U.S. Securities and Exchange Commission (SEC) on January 13, 2025 at www.sec.gov.

Non-Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No public offer of securities in connection with the merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Salarius, Decoy, the proposed merger and other matters, including without limitation, statements relating to the expected ownership percentages of the combined company and plans and expectations relating to the business, products, including expected achievement of milestones for its lead asset and future prospects of Decoy and the combined company. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Salarius, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. 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 conditions to the closing are not satisfied, including uncertainties as to the timing of the consummation of the proposed merger; the ability of each of Salarius and Decoy to consummate the merger; risks related to Salarius’ ability to estimate and manage its operating expenses and its expenses associated with the proposed merger pending the closing; risks that the combined company will not achieve the synergies expected from the proposed merger; risks that Salarius and the combined 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 Salarius in its reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, 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, Salarius’ actual results may vary materially from those expected or projected.

CONTACTS:

Decoy Therapeutics, Inc.Rick Pierce, CEOPierce@decoytx.com617-447-8299

Business Development:Peter Marschel, CBOPeter@Decoytx.com617-943-6305

Salarius Pharmaceuticals, Inc.Alliance Advisors IRJody Cainjcain@allianceadvisors.com310-691-7100