Salarius Pharmaceuticals and Fox Chase Cancer Center Launch Research Partnership

PHILADELPHIA (September 22, 2021)—Salarius Pharmaceuticals Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other hematologic and solid tumors, today announced a research partnership with the Cancer Epigenetics Institute at Fox Chase Cancer Center. The research, to be carried out by the laboratory of Johnathan Whetstine, PhD, the institute’s director, will help identify new indications and potential biomarkers for Salarius’ lead drug candidate, seclidemstat.

Seclidemstat (SP-2577) is a novel, oral, reversible inhibitor of lysine-specific histone demethylase 1, also referred to as LSD1, an enzyme that plays a key role in the development and progression of several cancers. Therapies designed to inhibit LSD1’s cancer-promoting activity represent a growing field of research.

Salarius believes seclidemstat uses a unique approach compared to other LSD1 inhibitors now in development by simultaneously targeting the enzymatic activity of LSD1 and its scaffolding properties, creating a dual mechanism of action that could provide differential therapeutic activity in several cancer types, including solid tumors. To date, the therapeutic activity of LSD1 inhibitors in clinical development has largely been confined to hematological cancers and myeloproliferative neoplasms.

“We are excited to be working with Salarius to further explore the potential of seclidemstat and LSD1 inhibition in new indications. Overexpression of the LSD1 enzyme is associated with poor prognosis across a variety of cancer types. Building on our prior research expertise and knowledge, we will explore the impact of LSD1 depletion and LSD1 catalytic inhibition on the transcriptome in order to better understand the enzyme’s catalytic and non-catalytic functions and the impact of seclidemstat on those functions,” Whetstine said.

“Seclidemstat’s ability to target the scaffolding property of the LSD1 enzyme has high relevance in several cancer types and could lead to potent inhibition with advantageous therapeutic properties. Insights into these aspects of LSD1 regulation could significantly impact our understanding about LSD1 function and therapeutic intervention,” added Whetstine, who has consulted for Salarius and served the company in an advisory capacity.

A Phase 1/2 clinical trial is now underway exploring seclidemstat as a therapy for sarcomas. This trial is treating patients with myxoid liposarcoma and other FET-rearranged sarcomas with single-agent seclidemstat and evaluating seclidemstat in combination with the chemotherapy agents topotecan and cyclophosphamide as a potential second- and third-line therapy for Ewing sarcoma, a deadly pediatric bone cancer. Fox Chase is one of nine clinical trial sites now enrolling patients.

Recently, Salarius’ clinical program for seclidemstat expanded into hematologic cancers, with the MD Anderson Cancer Center in Houston initiating a Phase 1/2 clinical trial studying seclidemstat in combination with azacytidine in myelodysplastic syndromes and chronic myelomonocytic leukemia.

“This is an exciting opportunity to advance our development of seclidemstat by harnessing the scientific expertise of a renowned cancer research center and one of the rising stars in the field of LSD1 inhibition,” stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. “To have Fox Chase and a scientist of Dr. Johnathan Whetstine’s caliber involved in this project is a strong validation of our work with seclidemstat. With the help of Fox Chase Cancer Center and Dr. Whetstine, our ultimate aim is to bring new treatment options and hope to more patients and their families fighting hard-to-treat cancers.”

About The Cancer Epigenetics Institute

The Cancer Epigenetics Institute (CEI) at Fox Chase is a national hub for epigenetics study and collaboration that is focused on mechanisms promoting cancer and therapeutic resistance.  CEI aims to promote fundamental discovery in cancer epigenetics, while identifying novel biomarkers and therapeutic targets.  Its mission is to translate these scientific insights into a positive impact on patients by facilitating academic-to-industry and academic-to-academic partnerships.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and select additional sarcomas that share a similar biology to Ewing sarcoma, also referred to as Ewing-related or FET-rearranged sarcomas. Seclidemstat has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation for Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study in hematologic cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit or follow Salarius on Twitter and LinkedIn.

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 “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” “developing,” “advance,” “lead to,” “impact,” “bring,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following:  identifying the specific functions or attributes of any medical treatment, examining the impact or relationship of any medical treatment on a particular medical condition, or the successful development of treatment for any medical condition. 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 sufficiency of Salarius’ capital resources; the ability of Salarius to raise additional capital to meet Salarius’ business operational needs and to achieve its business objectives and strategy; Salarius’ ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of Salarius to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in Salarius’ quarterly report on Form 10- Q for the quarter ended June 30, 2021 and in Salarius’ annual report on Form 10-K for the year ended December 31, 2020. 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.

Fox Chase Cancer Center (Fox Chase), which includes the Institute for Cancer Research and the American Oncologic Hospital and is a part of Temple Health, is one of the leading comprehensive cancer centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase is also one of just 10 members of the Alliance of Dedicated Cancer Centers. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence six consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship, and community outreach. It is the policy of Fox Chase Cancer Center that there shall be no exclusion from, or participation in, and no one denied the benefits of, the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.

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