HOUSTON, Aug. 05, 2021 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other hematologic and solid cancers, today reported important corporate events and its financial results for the second quarter ended June 30, 2021.
“The second quarter and recent weeks have continued a period of substantial development for Salarius, highlighted by significant progress in our clinical programs leading to multiple data readouts in 2021 and 2022. Importantly, we ended the quarter with $33.1 million in cash and cash equivalents which, based on our current operating plan, we believe is sufficient to support the achievement of these readouts,” stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals.
Mr. Arthur continued, “We have added the Fox Chase Cancer Center as our ninth sarcoma clinical trial site and are now actively recruiting and treating patients with seclidemstat in clinical trials across five patient groups, three in high unmet need sarcomas and two in high unmet need hematologic cancers. In addition, the data unveiled during ASCO 2021 demonstrated exactly what we wanted to see, and our Ewing sarcoma program is now providing the opportunity to explore seclidemstat in combination with chemotherapy agents where synergistic drug activity has been demonstrated. This combination with a commonly used second- or third-line chemotherapy, offers the opportunity for introducing seclidemstat earlier in the treatment continuum while improving patient outcomes and achieving objective responses. In the near future, we plan to initiate additional clinical programs in cancer indications where LSD1 overexpression is known to be a factor. In summary, we are pleased with how Salarius is positioned for the second half of 2021 and beyond.”
Recent Business and Corporate Highlights:
- MD Anderson Cancer Center in Houston, TX activated and is enrolling patients in an investigator-initiated trial in hematologic cancers, a Phase 1/2 study to determine safety, tolerability, maximum tolerated dose and overall response rate of seclidemstat in combination with azacytidine as a treatment for Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML).
- In roughly 1 in 3 patients, MDS or CMML can progress to a rapidly growing cancer of bone marrow cells called Acute Myeloid Leukemia (AML) which the American Cancer Association estimates had more than 19,000 new cases diagnosed in the U.S. in 2020.
- Fox Chase Cancer Center in Philadelphia, Pennsylvania added as an active clinical trial site in the ongoing dose-expansion stage of the Phase 1/2 sarcoma trial.
- Nine sites now actively recruiting for three patient groups across Ewing sarcoma and FET-rearranged sarcomas.
- Initial patients enrolled across both Ewing sarcoma and FET-rearranged sarcoma cohorts.
- Investor event showcased key opinion leaders (KOLs) in cancer research that we believe supports LSD1 inhibition and the potential of seclidemstat as a differentiated treatment for Ewing sarcoma, FET-rearranged sarcomas, and hematologic or blood cancers.
- Clinical trial data presented at ASCO showed seclidemstat has a manageable safety profile, has favorable pharmacokinetics that support twice-daily oral dosing, and established recommended Phase 2 dose at 900 mg BID.
- Evidence of preliminary anti-tumor activity in advanced, heavily pre-treated patient populations.
- Data supports continued exploration of seclidemstat in both Ewing sarcoma and FET-rearranged sarcomas.
Financial Highlights:
- Three-month period ended June 30, 2021, net loss per common share – basic and diluted – for continuing operations of $0.07, compared to $0.13 for the same period last year.
- Total working capital of $36.8 million as of June 30, 2021
Mr. Arthur concluded, “Key opinion leaders in cancer research recently noted that seclidemstat specifically inhibits the scaffolding properties of LSD1. This capability could prove effective against a broad range of cancers, including solid tumors, potentially further differentiating seclidemstat from other LSD1 inhibitors. Our ultimate aim as a company is to maximize the potential of seclidemstat as a treatment for cancer and we look forward to expanding the scope of our research into additional high unmet need patient populations. We are looking forward to updating investors and patients throughout 2021 and beyond.”
Three-Month Financial Results:
For the three-month period ended June 30, 2021, Salarius’ reported net loss was $3.1 million, or $0.07 per basic and diluted share, compared to a net loss of $1.8 million, or $0.13 per basic and diluted share for the same period in 2020. The loss before other income for the three-month period ended June 30, 2021, increased by $1.2 million compared to the loss before other income for the same time span last year, primarily due to lower grant revenue and overall higher operating expenses.
Net cash used for operating activities during the three-month period ended June 30, 2021 totaled $3.2 million, an increase of approximately $0.7 million compared to the same span last year due to higher overall spending during the second quarter 2021.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, sarcomas, and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and select additional sarcomas that share a similar biology to Ewing sarcoma, also referred to as Ewing-related or FET-rearranged sarcomas. Seclidemstat has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation for Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need, with a second Phase 1/2 clinical study in hematologic cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.
