Salarius Pharmaceuticals Announces Plans to Explore Strategic Alternatives and Implement Measures to Extend its Resources

HOUSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today announced plans to explore strategic alternatives and implement measures to extend its resources.

"The second quarter and recent weeks were highlighted by significant advancements in both of our development programs, but after a review of each program's future funding needs and the current financial markets, the Board of Directors has made the difficult decision to limit further drug development while we explore strategic alternatives for both Salarius and continued development of our drugs. This was an exceptionally difficult decision in light of the promising early seclidemstat Ewing sarcoma clinical data, seclidemstat hematological clinical data and the recent U.S. Food and Drug Administration (FDA) clearance to begin the SP-3164 Phase 1 trial," said David Arthur, president and chief executive officer of Salarius Pharmaceuticals.

The Company has retained Canaccord Genuity, LLC to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value including, but not limited to, an acquisition, merger, reverse merger, divestiture of assets, licensing or other strategic transactions involving the Company. However, there is no set timetable for this process and there can be no assurance that this process will result in the Company pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. If the Company is unable to complete a transaction, it may be necessary to seek other alternatives for restructuring and resolving its liabilities, including an orderly wind-down of operations. Salarius does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded that disclosure is appropriate or legally required.

In connection with the evaluation of strategic alternatives and in order to extend its resources, Salarius is implementing a cost-savings plan that includes a reduction in workforce by over 50% of its positions, with remaining employees focusing primarily on limited drug development activities, completing the FDA process to determine the clinical trial registration requirements for the seclidemstat Ewing sarcoma program and supporting the exploration of strategic alternatives.

"I want to express my sincere thanks, first and foremost, to our patients as well as to our investigators and collaborators for their participation in our drug development efforts. I also want to sincerely thank all of our employees, who have been supporting our mission to develop new cancer treatments for patients in need of new treatment options," concluded Mr. Arthur.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius' product portfolio includes seclidemstat, Salarius' lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader being developed for the treatment of Non-Hodgkin's Lymphoma. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.

About Seclidemstat

Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme and has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the U.S. Food and Drug Administration (FDA). Seclidemstat is currently in a Phase 1/2 clinical trial evaluating seclidemstat used in combination with topetecan and cyclophophsomide for the treatment of relapsed/refractory Ewing sarcoma. In December 2022, Salarius reported interim Ewing sarcoma clinical data that showed a 60% confirmed disease control rate and 7.4 months median time to tumor progression for first-relapse patients, with no disease progression observed in either first- or second-relapse patients who achieved confirmed disease control. Salarius has continued to monitor patients in the Ewing sarcoma trial and plans to release updated survival data in the coming months.

Seclidemstat is also being evaluated in an investigator-initiated Phase 1/2 clinical study in hematologic cancers at MD Anderson Cancer Center (MDACC). Researchers at MDACC previously reported interim clinical trial results evaluating seclidemstat in combination with azacitidine for the treatment of the myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients who relapsed or progressed after hypomethylating agent therapy. Of eight evaluable patients, four (50%) had an objective response. These researchers reported a 90% probability of patient survival for 11 months in patients receiving seclidemstat plus azacitidine versus an expected survival of four to six months.

About SP-3164

SP-3164, is an oral small molecule protein degrader being developed for the treatment of Non-Hodgkin's Lymphoma (NHL) and has received Investigational New Drug (IND) clearance from the FDA to begin a Phase 1 study with SP-3164 in NHL. Evidence suggests that DLBCL patients with certain immune phenotypes may have increased sensitivity to SP-3164 and the Phase 1 study is designed to confirm this retrospectively, data could then be used to develop a companion/complementary diagnostic for patient selection.

Recent preclinical data has shown that SP-3164 induces an anticancer immunomodulatory effect as demonstrated through the induction of cytokine secretion in human T cells following treatment. IN addition, SP-3164 showed potent degradation of Ikaros and Aiolos (I/A) in peripheral blood mononuclear cells (PBMC) within 2 hours of dosing, which increased in a dose- and time-dependent manner over 24 hours and does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment. Other recent preclinical studies demonstrated the robust protein degradation effects of SP-3164 and its anticancer activity in NHL animal models; and also demonstrated was SP-3164's compelling antitumor activity in animal models of follicular lymphoma, a type of NHL, as a single agent and in combination with venetoclax (Venclexta^®) or tazemetostat (Tazverik^®). Another preclinical study demonstrated SP-3164's compelling anticancer activity in cell lines and animal models of multiple myeloma; in animal models, SP-3164 demonstrated superior single-agent activity compared with the approved agents lenalidomide (Revlimid^®) and pomalidomide (Pomalyst^®), and the combination of SP-3164 and bortezomib (Velcade^®) was shown to be superior to the combination of pomalidomide and bortezomib.

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 the following: Salarius' expectations regarding the exploration of strategic alternatives, opportunities to extend Salarius' resources, the future of the Company's operations and product candidates; the future of the Company's preclinical studies and clinical trials and development activities; the advantages of protein degraders including the value of SP-3164 as a cancer treatment; the value of seclidemstat as a treatment for Ewing sarcoma, Ewing-related sarcomas, and other cancers and its ability to improve the life of patients;. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the risk that exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions; expectations regarding future costs and expenses; our product candidates being in early stages of development; the uncertainty about the paths of our programs and our ability to evaluate and identify a path forward for those programs, particularly given the constraints we have as a small company with limited financial, personnel and other operating resources (including with respect to the allocation of our limited capital and the sufficiency of our capital in the near term for any path we do select); Salarius' ability to continue as a going concern;; the sufficiency of Salarius' capital resources; the ability of, and need for, Salarius to raise additional capital to meet Salarius' business operational needs and to achieve its business objectives and strategy; future clinical trial results and the impact of such results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; and other risks described in Salarius' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as revised or supplemented by its Quarterly Reports on Form 10-Q 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.