HOUSTON, Dec. 10, 2020 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric, solid tumor and other cancers, today announced it had received a payment of $0.8 million as part of anticipated payments $1.7 million in payments under his contract with the Cancer Prevention and Research Institute of Texas (CPRIT). The payments are part of an original non-dilutive grant of up to $18.7 million awarded in 2016 to support Salarius’ operations and the development of its lead drug candidate Secldemstat to treat Ewing’s sarcoma and other cancers. Seclidemstat is a reversible LSD1 inhibitor being studied in two clinical trials – one in relapsed/refractory Ewing’s sarcoma, a rare and deadly pediatric bone cancer, and a second in advanced solid tumors (AST).
With the recent disbursement of CPRIT funds and gross proceeds of $6.2 million from a public offering completed in August 2020, Salarius believes it is well capitalized to advance seclidemstat’s clinical programs through multiple short-term, value-added milestones with announcements expected to move forward from 2020 in late 2020 and into the second half of 2021. These milestones include establishing the Maximum Tolerated Dose (MTD) in his Ewing Sarcoma Study, publishing early safety and clinical data from both clinical trials and moving into the dose expansion phase of the Ewing’s sarcoma trial in early 2021 and expanding the same trial to include additional select sarcomas that share biology with Ewing’s sarcoma, also known as Ewing-related sarcomas.
“The non-dilutive financial support that CPRIT has provided to Salarius since 2016 has been instrumental in our success in advancing seclidemstat,” said David Arthur, President and CEO of Salarius. “Since the original CPRIT grant, Salarius has received multiple special approvals from the FDA to accelerate drug development and we have initiated clinical trials in Ewing’s sarcoma and advanced solid tumors. Looking ahead, we expect to establish the maximum tolerated dose in the Ewing’s Sarcoma clinical trial and to move into the dose expansion phase of the trial as planned in Q1 2021. This is an important milestone as it allows us to extend the recommended dosing regimen and begin treating a broader group of patients with Ewing and Ewing-associated sarcomas.”
CPRIT was founded in 2007 with a $3 billion bond issue and recently expanded to include another $3 billion bond issue. CPRIT funds cancer research and prevention services in Texas. Salarius received a product development research grant for the development of seclidemstat in May 2016 and the payouts are based on Salarius’ achievement of specific goals and objectives. These $1.7 million payments will bring CPRIT’s total payout to $11.3 million. Under the grant agreement, Salarius must provide equivalent 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 related funds in the State of Texas on Texas-based employees or contractors.
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Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients who need them most. Salarius’ lead candidate, seclidemstat, is being investigated 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’s sarcoma, for which the US Food and Drug Administration has granted fast track designation, orphan drug designation, and received rare pediatric disease status. Salarius is also developing Secldemstat in multiple cancers with high unmet medical need, with a second Phase 1/2 clinical trial in advanced solid tumors, including prostate, breast and ovarian cancer. Salarius previously announced that a patient with refractory Ewing’s sarcoma treated with Secldemstat for six months showed an over 80% reduction in prospectively defined target lesions. Target lesions generally represent the largest measurable tumors in a patient. However, after eight weeks, an increase in non-target lesions resulted in the patient’s overall classification as progressive disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Salarius has received funding from the National Pediatric Cancer Foundation to advance the Ewing’s Sarcoma clinical program and also received a product development award of up to $18.7 million from the Cancer Prevention and Research Institute of Texas (CPRIT) . For more information, please visit www.salariuspharma.com or continue to follow the company Twitter and LinkedIn.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact, are forward-looking statements. These forward-looking statements may be identified by terms such as “anticipate”, “potential”, “progress”, “design”, “estimate”, “continue”, “will”, “target”, “may”, “believe”, “plan”, “allow”, “expect”, “intend”, “goal”, “provide”, “may”, “position”, “project”, “develop” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements regarding: Salarius’ plans to leverage this CPRIT drawdown, Salarius’ growth strategy; the value of Secldemstat as a potential treatment for Ewing’s sarcoma and other cancers; the status and anticipated progress and milestones of Salarius’ clinical trials in advanced solid tumors and Ewing’s sarcoma, including when Salarius will reach the maximum tolerated dose in the Phase 1 portion of the trial and when Salarius will be phased out -2-extension part will start each study; the expansion of Salarius clinical trials to include Ewing-related sarcomas; Salarius’ belief in being well capitalized; statements regarding Salarius’ ability to receive or be available additional funds from the CPRIT grant; the expected use of the proceeds from the recent IPO of Salarius Salarius’ developed Seklidemstat for multiple cancers with high unmet medical needs; and Salarius plans to initiate further clinical trials. Salarius may not actually achieve the plans disclosed in the forward-looking statements, realize the intentions, or meet the expectations or goals. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results and performance to differ materially from those projected in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: Salarius’s adequate capitalization; Salarius’ ability and need to raise additional capital to meet Salarius’ operational needs and achieve its business objectives and strategy; Salarius’ ability to forecast future capital requirements and cash utilization, the timing and the accuracy thereof; the ability of Salarius to access the remaining funds available under the CPRIT grant; future clinical trial results and impact of the results on Salarius; that results of studies and clinical trials may not be predictive of future clinical trial results; the adequacy of Salarius’ intellectual property protections; risks associated with drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions that may affect Salarius’ ability to raise additional capital; the possibility of unanticipated expenditures or other uses of Salarius’ cash funds; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those risks 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 assumptions and estimates made by management as of that date. Salarius disclaims any intention or obligation to update these forward-looking statements to reflect events or circumstances after the date on which they are made.
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