On May 12, 2021 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, reported important corporate events and its financial results for the first quarter ended March 31, 2021 (Press release, Salarius Pharmaceuticals, MAY 12, 2021, View Source [SID1234579802]).
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Financial Highlights:
Total cash and cash equivalents of $36.6 million as of March 31, 2021 resulting from financing activities including $23.0 million gross proceeds in an underwritten public offering closed March 8, 2021; Cash position sufficient to fund the current seclidemstat clinical trials through completion
Three-month period ended March 31, 2021 net loss per common share – basic and diluted – of $0.06, compared to $0.22 for the same period ended March 31, 2020
"The first quarter of 2021 and recent months were a period of significant activity for Salarius, with the company accomplishing several key milestones, including strengthening our capital position with more than $30 million gross proceeds raised during the quarter, the completion of the dose-escalation stage of the Phase 1/2 trial of seclidemstat in Ewing sarcoma, and the initiation of the dose-expansion stage of the trial, which now also includes FET-rearranged sarcomas, also known as Ewing-related sarcomas which share biology similar to Ewing sarcoma," said David Arthur, President and CEO of Salarius. "As a result, Salarius is operating from a position of strength as we work to advance our clinical trials exploring seclidemstat as a potential treatment for Ewing sarcoma, select FET-rearranged sarcomas, advanced solid tumors and hematologic cancers. By mid-year 2021, we expect up to three total active clinical trials in up to five patient populations evaluating single-agent seclidemstat and up to three combination therapies."
Recent Business and Corporate Events:
Completion of dose escalation in Phase 1/2 Ewing sarcoma clinical trial determined seclidemstat’s safety profile and established recommended Phase 2 dose (RP2D)
A refractory Ewing sarcoma patient treated with single-agent seclidemstat for 168 days (six 28-day cycles) demonstrated preliminary signal of drug activity
Full findings from dose escalation to be disclosed in poster presentation session followed by a poster discussion during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting; one of three abstracts accepted for poster presentation during the ASCO (Free ASCO Whitepaper) Annual Meeting
Preliminary efficacy from an ongoing Phase 1 dose-escalation trial of seclidemstat in patients with advanced solid tumors (AST) supports inclusion of FET-rearranged sarcomas in Ewing sarcoma trial
Subset of FET-rearranged sarcoma patients treated with seclidemstat in the AST clinical trial demonstrated encouraging signs of drug activity
Preliminary efficacy findings from the dose-escalation stage of AST trial to be reported in a poster session during 2021 ASCO (Free ASCO Whitepaper) Annual Meeting
Dose expansion initiated; actively recruiting three patient groups across Ewing sarcoma and FET-rearranged sarcomas; data expected in 2022
Ewing sarcoma patients to be treated with seclidemstat in combination with topotecan and cyclophosphamide as a second- or third-line therapy
FET-rearranged sarcoma patients, including myxoid liposarcoma, to be treated with single-agent seclidemstat as second-, third- or fourth-line therapy
Mr. Arthur continued, "With initiation of the dose-expansion stage of the trial in Ewing and FET-rearranged sarcomas, we have positioned seclidemstat as a second- and third-line Ewing sarcoma therapy in combination with a common chemotherapy treatment. This increases the number of available patients and should make it easier for physicians to treat patients earlier in the continuum of patient care. Expanding the trial to include myxoid liposarcoma and other FET-rearranged sarcoma patients provides a potential new therapy for patients who are relapsed or refractory to standard of care treatment. Our goal is to make a difference in the lives of patients fighting cancer, and we believe making seclidemstat available to these patients is a step forward in this journey. In the coming months, we look forward to announcing new clinical trials studying seclidemstat in additional patient populations."
Three-Month Financial Results:
For the three-month period ended March 31, 2021, Salarius’ reported net loss was $1.9 million, or $0.06 per basic and diluted share, compared to a net loss of $2.1 million, or $0.22 per basic and diluted share for the same period in 2020. The loss before other income for the three-month period ended March 31, 2021 decreased by $0.6 million compared to the loss before other income for the same time span last year, primarily due to lower general and administrative costs that more than offset an increase in research and development costs.
Net cash used for operating activities during the three-month period ended March 31, 2021 totaled $2.7 million, a decline of approximately $1.0 million compared to the same span last year due to a $0.9 million payment received under the Company’s contract with the Cancer Prevention and Research Institute of Texas (CPRIT).
Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Wednesday, May 12, 2021, at 5:00 p.m. ET, to discuss its corporate and financial results for the first quarter 2021. Interested participants and investors may access the conference call by dialing either:
An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on May 12, 2021.