HOUSTON, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (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 $0.8 million payment as part of an expected $1.7 million in payments under its 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 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 cancer, and a second trial in advanced solid tumors (AST).
With the latest disbursement of CPRIT funds 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 with anticipated announcements beginning in late-2020 and continuing into the second half of 2021. 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 since 2016 has been instrumental to our success in advancing the development of seclidemstat,” stated David Arthur, President and CEO of Salarius. “Since the original CPRIT grant, Salarius has received several special designations from the FDA to expedite drug development and we launched our clinical trials in Ewing sarcoma and Advanced Solid Tumors. Looking ahead, we expect to establish maximum tolerated dose in the Ewing sarcoma clinical trial and, as planned, advance to the dose-expansion phase of the study in the first quarter of 2021. This is an important milestone as it allows us to establish the recommended dosing regimen and begin treating a broader group of patients with Ewing and Ewing-related sarcomas.”
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. This $1.7 million in payments will bring the total disbursement from CPRIT to $11.3 million. 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 previously disclosed that a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions. Target lesions generally represent a patient’s largest measurable tumors. However, at eight weeks, an increase in non-target lesions resulted in an overall patient classification of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). 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 salariuspharma.com or follow the Company 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,” 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 expansion of Salarius’ clinical trials to include Ewing-related sarcomas; Salarius’ belief as to being well-capitalized; statements related to Salarius’ ability to obtain or the availability of any additional amount from the CPRIT award; the anticipated use of proceeds from Salarius’ recent public offering 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
mmcenroe@tiberend.com
mmiller@tiberend.com
Johanna Bennett (media)
(212) 375-2686
jbennett@tiberend.com
Source: Salarius Pharmaceuticals, Inc.
