Salarius Pharmaceuticals Receives Second Installment of $1.7 Million in Payments from the Cancer Prevention and Research Institute of Texas

HOUSTON, Jan. 13, 2021 (GLOBE NEWSWIRE) -- . (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, today announced the receipt of a $0.9 million payment as the second installment of $1.7 million in scheduled payments to Salarius under its contract with the Cancer Prevention and Research Institute of Texas (CPRIT). The payments, which include the previously announced receipt of an $0.8 million disbursement announced on December 10, 2020, are part of an original non-dilutive grant awarded in 2016 to support Salarius’ operations and development of its lead drug candidate, seclidemstat, for the treatment of Ewing sarcoma and other cancers. Seclidemstat is a reversible LSD1 inhibitor being studied in two clinical trials — one trial in relapsed/refractory Ewing sarcoma, a rare and deadly pediatric bone and soft tissue cancer, and a second trial in advanced solid tumors (AST). Up to $4.8 million in funding remains available to Salarius under the original 2016 CPRIT Award.

With the full $1.7 million disbursement of CPRIT funds, the $3.6 million gross proceeds from the warrant inducement transaction announced in December 2020 and the $6.2 million gross proceeds from a public offering completed in August 2020, Salarius believes it is well-capitalized to advance the seclidemstat clinical programs through several near-term, value-creating milestones. These milestones include establishing maximum tolerated dose (MTD) in its Ewing sarcoma trial, releasing early safety and clinical data from both clinical trials, advancing into the dose-expansion phase of the Ewing sarcoma trial in early 2021, as well as expanding the same trial to include additional select sarcomas that share a similar biology to Ewing sarcoma, also known as Ewing-related sarcomas.

“The non-dilutive financial support Salarius has received from CPRIT during the past four years has been instrumental in advancing the development of seclidemstat and the growth of our company,” stated David Arthur, President and CEO of Salarius. “Today’s payment, combined with other recent financial transactions undertaken by Salarius continue to strengthen our balance sheet and prepare us for delivering our future milestones.”

Founded in 2007 with a $3 billion bond issue and recently extended with an additional $3 billion bond issue, CPRIT funds cancer research and prevention services in Texas. Salarius was awarded a product development research grant in May 2016 for the development of seclidemstat and the disbursements are based upon Salarius’ achievement of specific goals and objectives. Under the grant agreement, Salarius must provide matching funds equal to 50 percent of the CPRIT funding and make a good faith effort to spend at least half of the CPRIT grant and matching monies within the State of Texas with Texas-based employees or contractors.

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients that need them the most. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma, for which it has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation 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 advanced solid tumors, including prostate, breast, and ovarian cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also the recipient of an up to $18.7 million Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit .

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,” 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’ plans for the use of this CPRIT drawdown, Salarius’ growth strategy; the value of seclidemstat as a potential treatment for Ewing sarcoma and other cancers; the status and anticipated progress and milestones of Salarius’ clinical trials in advanced solid tumors and Ewing sarcoma including statements related to when Salarius will reach the maximum tolerated dose in the Phase 1 portion of the study and when Salarius will begin the Phase 2 expansion portion of any study; the sufficiency of Salarius’ capital resources to fund its current programs and the need to seek additional financing; the expansion of Salarius’ clinical trials to include Ewing-related sarcomas; Salarius’ belief as to being well-capitalized;; the anticipated use of proceeds from Salarius’ recent public offering; the anticipated use of proceeds from Salarius’ warrant excise; Salarius’ developing seclidemstat for several cancers with high unmet medical need; and Salarius plans to initiate additional clinical trials. 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, and need for, 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; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; 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 September 30, 2020 and in Salarius’ annual report on Form 10-K for the year ended December 31, 2019. 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

Tiberend Strategic Advisors, Inc.

Maureen McEnroe, CFA/Miriam Miller (investors)

(212) 375-2664 / 2694

Johanna Bennett (media)

(212) 375-2686