• SP-3164 demonstrates compelling antitumor activity in animal models of follicular lymphoma and compelling antitumor activity in animal models of multiple myeloma
• Preclinical findings support the Company’s planned clinical development of SP-3164 in hematologic cancers

HOUSTON, April 20, 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 the presentation of two posters related to the company’s novel molecular glue, SP-3164, at the American Association for Cancer Research (AACR) Annual Meeting. Both abstracts highlight preclinical findings with SP-3164, with one focused on non-Hodgkin lymphoma (NHL) and the other on multiple myeloma (MM).

“These two studies presented at the prestigious AACR Annual Meeting are adding to the growing body of SP-3164 preclinical data demonstrating anticancer activity alone and in combination with standard-of-care treatments,” said David Arthur, president and chief executive officer of Salarius. “In addition, we were excited at the level of interest – at both poster presentations – by representatives from large pharmaceutical companies, biotech companies, and cancer researchers.”

Research presented at AACR by Daniela Santiesteban, Ph.D., director of protein degradation development at Salarius, in a poster titled “SP-3164, a novel Ikaros and Aiolos molecular glue degrader with preclinical activity in non-Hodgkin lymphomas,” demonstrated:

• The robust protein degradation effects of SP-3164 and validated it as the active anticancer species of avadomide; and
• SP-3164’s compelling antitumor activity of SP-3164 in animal models of follicular lymphoma, a type of NHL, as a single agent and in combination with approved agents, venetoclax (Venclexta^®) or tazemetostat (Tazverik^®).

The other poster was presented by Aundrietta Duncan, Ph.D., director of non-clinical development at Salarius, and was titled “SP-3164, a novel molecular glue degrader with activity in preclinical models of multiple myeloma.” These studies demonstrated the protein degradation and antitumor activity of SP-3164 in both cell line and animal models of multiple myeloma. In addition, the data showed SP-3164 induced apoptosis in multiple myeloma cell lines. In animal models, SP-3164 demonstrated superior single-agent activity compared to both lenalidomide (Revlimid^®) and pomalidomide (Pomalyst^®). Also in MM animal models, the combination treatment of SP-3164 and the approved therapy bortezomib (Velcade^®) was superior to the combination of pomalidomide and bortezomib.

Both posters are available on Salarius’ website at www.salariuspharma.com.

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. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma. This trial is currently on a partial clinical hold and is not enrolling new patients. Seclidemstat has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers at MD Anderson Cancer Center. This trial is also currently on a partial clinical hold and is not enrolling new patients. 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). SP-3164 is currently in IND-enabling studies and anticipated to enter the clinic in 2023. For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.

Forward-Looking Statements

This press release and the referenced presentations contain “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 and the referenced presentations are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “believe,” “developing,” “expect,” “excited,” “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: the future of the company’s Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas following the recently announced suspected unexpected severe adverse reaction (SUSAR) event and resulting partial clinical hold by the U.S. Food and Drug Administration (FDA); the advantages of protein degraders including the value of SP-3164 as a cancer treatment; the timing of clinical trials for SP-3164 and expected therapeutic options for SP-3164 and related effects and projected efficacy; the impact that the addition of new clinical sites will have on the development of Salarius’ product candidates; the timing of Salarius’ IND submissions to the FDA and subsequent timing for initiating clinical trials; interim data related to Salarius’ clinical trials, including the timing of when such data is available and made public; Salarius’ growth strategy; 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; expanding the scope of Salarius’ research and focus to high unmet need patient populations; milestones of Salarius’ current and future clinical trials, including the timing of data readouts. 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: Salarius’ ability to continue as a going concern; it may take considerable time and expense to resolve the partial clinical hold that has been placed on Salarius’ Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas by the FDA, and no assurance can be given that the FDA will remove the partial clinical hold; Salarius’ ability to resume enrollment in the clinical trial following its review of the available data surrounding the SUSAR; 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 and the referenced presentations speak only as of the date of this press release and the referenced presentations 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.

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