Salarius Pharmaceuticals, Inc., a clinical-stage biotechnology company, focuses on developing epigenetic-based cancer treatments. Its lead candidate is Seclidemstat (SP-2577), a small molecular inhibitor which is in Phase I/II clinical trial for the treatment of advanced solid tumors, as well as Ewing sarcoma. The company also offers SP-3164, a small molecular protein degrader for the treatment of hematological and solid tumors. It has a strategic partnership with The University of Utah Research Foundation for the exclusive license with respect to patent rights protecting SP-2577 and related compounds; HLB Life Sciences to develop, produce, manufacture, use, and sell the drug in South Korea; and Cancer Prevention and Research Institute of Texas for product development activities, as well as a research partnership with the Cancer Epigenetics Institute at Fox Chase Cancer Center to identify new indications and biomarkers for SP-2577. The company is headquartered in Houston, Texas.
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Here are 1-3 brief analogies for Salarius Pharmaceuticals (SLRX):
- An early-stage Blueprint Medicines, but focused on epigenetic cancer drugs.
- A small, clinical-stage Genentech, but dedicated to novel epigenetic cancer treatments.
- An early-stage Agios Pharmaceuticals, but exclusively concentrated on epigenetic cancer therapies.
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- Seclinsastat (SP-2577): An investigational, orally bioavailable LSD1 inhibitor being developed for the treatment of various cancers, including Ewing sarcoma and myelofibrosis.
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Salarius Pharmaceuticals (SLRX) is a clinical-stage oncology company focused on the development of epigenetic therapies for cancer. As of current information, the company does not have any commercialized pharmaceutical products on the market.
Therefore, Salarius Pharmaceuticals does not currently have major commercial customers in the traditional sense of companies or individuals purchasing its products. Its activities are primarily focused on research and development, conducting clinical trials for its drug candidates, and securing funding for these operations.
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Mark J. Rosenblum Acting Chief Executive Officer, Executive Vice President, Chief Financial Officer
Mr. Rosenblum was appointed acting Chief Executive Officer of Salarius Pharmaceuticals on August 17, 2025, while continuing his roles as Executive Vice President and Chief Financial Officer, positions he has held since September 2019. He initially joined Salarius as a financial consultant to assist with the merger of Flex Pharma, Inc. and Salarius Pharmaceuticals, LLC. Prior to Salarius, Mr. Rosenblum served as Chairman and Chief Executive Officer of ActiveCare, Inc. (formerly NASDAQ: ACAR), which was acquired by Biotelemetry, Inc., now part of Royal Philips. He also held the position of Chief Financial Officer at Advaxis, Inc. (NASDAQ: ADXS) and various financial leadership roles at Wellman, Inc., a public chemical manufacturer.
Nadeem Q. Mirza, MD, MPH Senior Vice President, Clinical Development
Dr. Mirza serves as the Senior Vice President of Clinical Development at Salarius Pharmaceuticals.
Rebecca Griffith-Eskew Vice President, Clinical Operations
Mrs. Griffith-Eskew is the Vice President of Clinical Operations for Salarius Pharmaceuticals. She brings over 25 years of experience in clinical development and operations, specifically in oncology drug development across phases I-IV.
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Key Risks to Salarius Pharmaceuticals (SLRX)
Salarius Pharmaceuticals (SLRX) faces several significant risks that could impact its business operations and future viability. The most pressing concerns revolve around its precarious financial position, the uncertainties surrounding its proposed merger, and the inherent challenges of clinical-stage drug development.
- Financial Distress and Going Concern Uncertainty: Salarius Pharmaceuticals is in a highly challenging financial situation, marked by recurring losses and a lack of revenue from product sales. The company has explicitly stated that there is "substantial doubt about its ability to continue as a going concern". As of March 31, 2025, Salarius had limited cash and cash equivalents, necessitating continuous reliance on external funding to sustain operations. The company's probability of financial distress or bankruptcy is estimated to be very high.
- Risks Associated with the Proposed Merger with Decoy Therapeutics: Salarius has entered into a merger agreement with Decoy Therapeutics, which, while intended to be a strategic alternative to address financial challenges, introduces a new set of substantial risks. Key concerns include the potential failure to satisfy closing conditions, uncertainties regarding the timing and consummation of the merger, and the risk that the combined entity may not achieve expected synergies. Furthermore, if the merger is completed, Salarius stockholders face significant dilution, with Decoy investors expected to own approximately 86% of the outstanding shares of the merged company. There is also a risk that the combined company will not secure sufficient financing to execute its business plans or maintain Nasdaq listing standards. Should the merger not close, Salarius may be forced to seek alternative capital or consider winding down operations.
- Clinical Development and Regulatory Risks: As a clinical-stage biopharmaceutical company, Salarius' future is heavily dependent on the successful development and regulatory approval of its drug candidates. The company has already discontinued a Phase 1/2 clinical trial for SP-2577 in Ewing sarcoma due to financial constraints. The combined company (post-merger with Decoy Therapeutics) will face ongoing risks related to Decoy's product development plans and potential unanticipated issues with investigational new drug applications. Additionally, Salarius has previously experienced setbacks, including a partial clinical hold by the U.S. Food and Drug Administration following a Grade 4 adverse event in a clinical trial.
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Salarius Pharmaceuticals (SLRX) focuses on developing treatments for cancers with high unmet medical needs. The addressable markets for their main products and services, including those from the recently merged Decoy Therapeutics, are detailed below.
Seclidemstat (SP-2577)
- Ewing Sarcoma: The global market for Ewing sarcoma across the seven major markets (United States, EU4, United Kingdom, and Japan) was valued at approximately USD 49.8 million in 2024 and is projected to reach USD 78.2 million by 2035, growing at a Compound Annual Growth Rate (CAGR) of 4.2%. Another estimate places the global market at USD 250.94 million in 2025, anticipating it to exceed USD 436.84 million by 2035 with a CAGR of over 5.7%. The United States has the largest patient pool and represents the largest market for Ewing sarcoma treatment. Annually, around 500 new patients are diagnosed with Ewing sarcoma in the U.S..
- Myelodysplastic Syndromes (MDS): The market for myelodysplastic syndrome drugs across the top seven major markets (United States, EU4, United Kingdom, and Japan) was valued at USD 2.4 billion in 2024 and is projected to reach USD 4.8 billion by 2035, exhibiting a CAGR of 6.29%. The global MDS drug market was estimated at USD 2.2 billion in 2023 and is projected to reach USD 4.1 billion by 2030, with a CAGR of 9.1%. In 2024, the global myelodysplastic syndrome market size was valued at $2.56 billion and is expected to grow to $4.18 billion by 2029 at a CAGR of 10.1%. The United States accounts for the largest patient pool and market for MDS treatment.
- Chronic Myelomonocytic Leukemia (CMML): The global chronic myelomonocytic leukemia market is estimated to be valued at USD 1012.9 million in 2025 and is expected to reach USD 1584.4 million by 2032, with a CAGR of 6.6%. Another report indicates that the global CMML market was approximately USD 720 million in 2024 and is projected to reach USD 1.45 billion by 2034, with a CAGR of 7.1%. Approximately 1,500 new CMML cases are diagnosed annually in the United States. North America is currently the largest market for CMML.
SP-3164 (Targeted Protein Degrader)
SP-3164 has potential applications in both hematologic and solid tumors.
- Hematologic Malignancies: The global hematologic malignancies market size was estimated at USD 67,234.0 million in 2023 and is projected to reach USD 113,897.9 million by 2030, growing at a CAGR of 8.0%. North America represented the largest revenue-generating market in 2023, with the U.S. holding an 89.3% share within North America. In 2024, the global hematologic malignancies market was valued at USD 72.87 billion and is expected to reach USD 147.38 billion by 2033, exhibiting a CAGR of 8.14%.
- Solid Tumors: The global solid tumors market size was valued at USD 362.21 billion in 2024 and is projected to reach USD 1557.42 billion by 2032, with a CAGR of 20.00%. The solid tumors market across the top seven major markets (United States, EU4, United Kingdom, and Japan) reached USD 183.0 billion in 2024 and is expected to reach USD 406.4 billion by 2035, with a CAGR of 7.53%. North America dominates the solid tumors market. The U.S. solid tumor cancer treatment market size was valued at USD 1.32 billion in 2024 and is predicted to reach approximately USD 2.19 billion by 2034.
Decoy Therapeutics (Post-Merger Pipeline)
The combined company, Decoy Therapeutics, will focus on peptide conjugate therapeutics for respiratory viruses and cancer, with Decoy's pipeline targeting unmet needs in respiratory infectious diseases and gastroenterology (GI) oncology indications.
- Infectious Respiratory Diseases: The global infectious respiratory disease diagnostics market size was estimated at USD 54.58 billion in 2024 and is projected to reach USD 73.56 billion by 2030, with a CAGR of 5.3%. North America dominated the global market, accounting for 41.85% of revenue share in 2024. The U.S. infectious respiratory disease diagnostics market size was evaluated at USD 17.21 billion in 2024 and is predicted to be worth around USD 29.49 billion by 2034.
- Gastrointestinal (GI) Oncology: The global gastrointestinal cancer treatment market size was valued at approximately USD 12.5 billion in 2023 and is forecasted to reach nearly USD 21.4 billion by 2032, with a CAGR of 7.2%. The global gastrointestinal cancer market accounted for USD 27.46 billion in 2024 and is expected to reach USD 93.48 billion by 2035, growing at a CAGR of approximately 11.78%. North America holds a significant share of the global gastrointestinal cancer treatment market, with a value of approximately USD 4.5 billion in 2023 and a projection to reach nearly USD 7.5 billion by 2032.
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Expected Drivers of Future Revenue Growth for Salarius Pharmaceuticals (SLRX)
Over the next 2-3 years, the future revenue growth for Salarius Pharmaceuticals (SLRX), which is merging with Decoy Therapeutics to become Decoy Therapeutics, is expected to be driven by several key factors primarily related to the advancement and potential commercialization of their therapeutic pipeline.
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Advancement and Potential Approval of Seclidemstat (SP-2577) for Ewing Sarcoma: Salarius' lead candidate, seclidemstat (SP-2577), is a first-in-class LSD1 inhibitor currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma. This indication has a high unmet medical need and has received Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA), which could expedite its path to market. Successful clinical outcomes and subsequent regulatory approval would be a significant revenue driver.
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Clinical Progress and Potential Approval of Seclidemstat (SP-2577) for Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML): Seclidemstat is also being evaluated in an investigator-initiated Phase 1/2 clinical trial at MD Anderson Cancer Center for the treatment of MDS and CMML, where patient enrollment has resumed after a partial clinical hold was lifted. Promising interim results have been reported for this combination therapy, indicating a potential for seclidemstat in these hematologic cancers.
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Development and Commercialization of Decoy Therapeutics' Peptide Conjugate Pipeline: With the merger, the combined entity will focus on Decoy Therapeutics' pipeline of peptide conjugate therapeutics. This pipeline targets unmet needs in respiratory infectious diseases and gastroenterology (GI) oncology, representing new and potentially significant market opportunities for the company.
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Integration and Clinical Advancement of SP-3164 as a PROTAC Drug Candidate: Salarius' small molecule protein degrader, SP-3164, which was expected to begin clinical trials in 2023 for hematological and solid tumors, will be integrated into Decoy's pipeline. This integration as a peptide-based proteolysis targeting chimera (PROTAC) drug candidate could leverage Decoy's platform to enhance its development and potential market entry.
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Potential Strategic Alternatives for Seclidemstat: The company is actively evaluating strategic alternatives for seclidemstat while continuing its development for hematologic cancers. This could involve partnerships, licensing agreements, or out-licensing deals, which could provide non-dilutive funding or royalty streams, contributing to future revenue.
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Share Issuance
- Salarius Pharmaceuticals effected a 1-for-15 reverse stock split on August 15, 2025, to regain compliance with Nasdaq's minimum bid price requirement.
- In September 2025, the company sold 434,882 shares of common stock for aggregate gross proceeds of $2.4 million under an at-the-market (ATM) agreement and 367,887 shares for $3.8 million under a private purchase agreement with C/M Capital Master Fund, LP.
- In November 2025, Salarius Pharmaceuticals priced an underwritten public offering to raise approximately $7.0 million of gross proceeds through the sale of common shares and pre-funded warrants, each accompanied by Series A and Series B warrants.
Inbound Investments
- In January 2025, Salarius Pharmaceuticals entered into a definitive merger agreement for a business combination with Decoy Therapeutics, Inc., a privately held preclinical biopharmaceutical company.
- Under the terms of the merger, legacy Salarius stockholders are expected to retain approximately 7.6% of the combined company.
- Decoy Therapeutics has secured financing from institutional investors and non-dilutive capital from entities such as the Massachusetts Life Sciences Seed Fund, the Google AI startup program, the NVIDIA Inception program, and a QuickFire Challenge award from BARDA.
