SLRX Salarius Pharmaceuticals Inc

Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that patient enrollment will resume in the investigator-initiated Phase 1/2 clinical trial evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The trial is being conducted at the University of Texas MD Anderson Cancer Center (MDACC) and is listed as recruiting on clinical trials.gov – trial NCT04734990.

Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme. Inhibiting LSD1 in preclinical in vivo hematologic models has previously demonstrated reprogramed cancer cell differentiation, reduced tumor burden and prolonged survival of treated animals studied.

As previously announced at the June 2024 European Hematology Association Annual Meeting, researchers at MDACC reported interim clinical trial results from this trial including a 43% overall response rate among 14 predominantly higher-risk MDS and CMML patients who previously failed or relapsed after hypomethylating agent therapy. In addition, researchers reported median overall survival of 18.5 months (95% CI, range 6.1-30.9 months) with median event-free survival of 7.2 months (95% CI, range 6.3-8.2 months). As reported, overall survival after failing therapy with hypomethylating agents is typically four to six months.

In July 2024 the U.S. Food and Drug Administration (FDA) placed the MDACC investigator-initiated trial under a partial clinical hold following a serious and unexpected adverse event. MDACC has addressed the FDA’s questions, and the partial clinical hold has been lifted.

“Coming off partial clinical hold is welcome news for Salarius stakeholders and for patients with advanced MDS and CMML, and we are excited for MDACC to enroll additional patients and build upon seclidemstat’s growing clinical database,” said David Arthur, President and CEO of Salarius Pharmaceuticals.

As announced on January 13, 2025, Salarius signed a definitive agreement under which Decoy Therapeutics, Inc. will merge with a wholly owned subsidiary of Salarius Pharmaceuticals, subject to certain closing conditions in the agreement. The newly formed company will be named Decoy Therapeutics. The proposed transaction is expected to facilitate multiple value-creating inflection points with Decoy’s pipeline of peptide conjugate therapeutics engineered by its IMP3ACT™ platform, which 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. Decoy’s product pipeline targets unmet needs in respiratory infectious diseases and gastroenterology (GI) oncology indications.

In addition, the combined company intends to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimera (PROTACS) drug candidate. The ongoing development of Salarius’ seclidemstat for hematologic cancers in the investigator-initiated Phase 1/2 clinical trial at MDACC will be supported while the company evaluates strategic alternatives for seclidemstat.

Salarius Pharmaceuticals, Inc.Salarius Pharmaceuticals 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 MDS and CML 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 (CPRIT). For more information, please visit www.salariuspharma.com.

About Decoy Therapeutics, Inc.Decoy Therapeutics is a preclinical-stage biotechnology company that is leveraging machine learning and artificial intelligence 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 Gates Foundation, the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program. The company has also received QuickFire Challenge award funding provided by BARDA through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response. For more information, please visit www.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 facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “believe,” “developing,” “expect,” “may,” “progress,” “potential,” “could,” “look forward,” “encouraging,” “might,” “should,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to: Salarius, Decoy, the proposed merger and other related matters, including without limitation, statements relating to the combined company and plans and expectations relating to the business, the combined company’s products and product candidates including expected achievement of milestones for its lead asset and future prospects of Decoy and the combined company; Salarius’ expectation that the proposed transaction will facilitate multiple value-creating inflection points with Decoy’s pipeline of peptide conjugate therapeutics engineered by its IMP3ACT™ platform; the combined company’s intention to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimera (PROTACS) drug candidate; Salarius’ belief that the ongoing development of Salarius’ seclidemstat for hematologic cancers in the investigator-initiated Phase 1/2 clinical trial at MDACC will be supported while the company evaluates strategic alternatives for seclidemstat.

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 announced transaction with Decoy may not close; the risk that the conditions to the closing of the merger 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. Readers are urged to carefully review and consider the various disclosures made by us in our reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as revised or supplemented by its Quarterly Reports on Form 10-Q and the risk factors contained in Salarius’ Current Report on Form 8-K filed on January 13, 2025 which attempt to advise interested parties of the risks and factors that may affect the merger and other documents filed with the SEC. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

CONTACT:

Alliance Advisors IRJody Cainjcain@allianceadvisors.com310-691-7100