On March 10, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options, reported important corporate events and its financial results for the full year and the fourth quarter ended December 31, 2021 (Press release, Salarius Pharmaceuticals, MAR 10, 2022, View Source [SID1234609950]).
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We believe the progress made by Salarius Pharmaceuticals during 2021 and the early weeks of 2022 has once again been remarkable, including the Company’s recent expansion into the field of targeted protein degradation (TPD)," stated David Arthur, CEO of Salarius Pharmaceuticals. "TPD is a fast-growing field of cancer drug development with commercial market potential estimated in billions of dollars and enticing significant investment from some of the world’s largest pharmaceutical companies. TPD has the ability to develop drugs for historically undruggable cancer-promoting targets and our new TPD development program, built around the portfolio of assets acquired by Salarius in January 2022, is led by the product candidate SP-3164. Salarius now boasts a multipronged pipeline built around two exciting approaches to cancer drug development – protein inhibition and targeted protein degradation."
Financial Highlights:
•Cash and cash equivalents total $29.2 million on December 31, 2021, with an estimated runway into 2023
•For the three-month and 12-month periods ended December 31, 2021, net loss per common share, basic and diluted, of $0.09 and $0.31, respectively, compared to $0.10 and $0.50, respectively, for the same periods in 2020
Recent Business and Corporate Highlights:
•Acquisition of TPD assets from DeuteRx LLC in January 2022 expands Salarius’ oncology pipeline into a fast-growing area of drug research focused on pursuing historically undruggable cancer-promoting targets with estimated multi-billion-dollar commercial market potential
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◦Acquisition included the drug candidate SP-3164, additional targeted protein degrader programs, and a related intellectual property (IP) portfolio that includes issued composition of matter patents
◦SP-3164 is an orally administered cereblon-binding targeted protein degrader developed as a next-generation version of the widely studied molecular glue, avadomide (CC-122) with the potential for an improved efficacy and safety profile
▪SP-3164 leverages the data from 10 clinical trials investigating avadomide in more than 400 patients
▪Preclinical data suggests the potential for SP-3164 to be more efficacious than avadomide
▪Salarius will continue collaborating with DeuteRx scientists to complete Investigational New Drug (IND) enabling studies for SP-3164
▪First clinical trial expected in 2023
◦Consideration consists of cash and stock, with an upfront payment of $1.5 million in cash and 1 million shares of restricted stock; future payments linked to clinical, regulatory, and commercial milestones, and net sales royalties
•Salarius continues to advance clinical development of seclidemstat; data updates expected in 2022 from two Phase 1/2 clinical trials
◦Sarcoma trial investigating seclidemstat in combination with chemotherapy agents topotecan and cyclophosphamide (TC), in patients with relapsed/refractory Ewing sarcoma advanced to second lead-in safety dosing cohort treating patients with seclidemstat at 900 mg BID
◦Sarcoma trial investigating seclidemstat as a single-agent therapy in Myxoid Liposarcoma and other FET-rearranged sarcomas continues enrollment
◦Enrollment continues in investigator-initiated trial (IIT) at MD Anderson Cancer Center exploring seclidemstat in combination with azacytidine as a treatment for hematologic cancers; updates on biomarkers including immature cells (blasts) and drug activity measures expected during 2022
◦Research underway to identify new indications for seclidemstat in established large markets
Mr. Arthur concluded, "2022 is a year of significant optimism at Salarius given the potential value-building opportunities and milestones on the horizon. Salarius is moving to rapidly advance the development of SP-3164 with plans to file an IND and initiate our first clinical trial for that program in 2023. Building on our optimism around SP-3164 and based on the abundance of preclinical and clinical data collected around its predecessor, avadomide, it is our belief that SP-3164 will establish a superior safety profile with the potential to be more effective. Additionally, we continue advancing the clinical exploration of seclidemstat, our oral, reversible LSD1 inhibitor and Salarius’ most advanced investigational cancer drug candidate. We look forward to providing data updates in the coming months."
Three-Month and 12-Month Financial Results:
For the three-month period ended December 31, 2021, Salarius’ reported net loss was $4.1 million, or $0.09 per basic and diluted share, compared to a net loss of $1.8 million, or $0.10 per basic and diluted share for the same period in 2020. The loss for the three-month period ended December 31, 2021, increased by $2.3 million compared to the same time span last year, primarily because the Company had higher overall costs and no grant revenue in the current period.
For the 12-month period ended December 31, 2021, Salarius’ reported net loss was $12.8 million, or $0.31 per basic and diluted share, compared to a net loss of $7.4 million, or $0.50 per basic and diluted share for the same period in 2020. The loss for the 12-month period ended December 31, 2021, increased by $5.4 million compared to the loss from operations for the same period last year, resulting from increased charges related to R&D personnel and higher clinical trial costs more than offsetting lower drug development costs.
Net cash used for operating activities during the 12-month period ended December 31, 2021, totaled $10.2 million, essentially the same as approximately $10.3 million in the prior year. During 2021, the Company collected approximately $4.1 million on its outstanding grant receivable compared to $0.8 million in the prior year.
As of December 31, 2021, total cash, cash equivalents, and restricted cash were $29.2 million, compared to $11.1 million at year-end 2020. The increase in cash was primarily driven by the sale of equity securities during the first quarter of 2021. Current cash and cash equivalents are expected to fund our current planned operations into 2023.
Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Thursday, March 10, 2022, at 5:00 p.m. ET, to discuss its corporate and financial results for the fourth quarter and full-year 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 6:00 p.m. ET on March 10, 2022.