On August 12, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting cancers caused by dysregulated gene expression, reported its corporate and financial results for the second quarter ended June 30, 2020 (Press release, Salarius Pharmaceuticals, AUG 12, 2020, View Source [SID1234563509]).
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Financial Highlights:
$6.2 million gross proceeds in underwritten public offering closed August 3, 2020
Three-month period ended June 30, 2020 net loss per common share – basic and diluted – of $0.13, compared to $0.30 for the same period ended June 30, 2019
Total cash and cash equivalents of $7.2 million as of June 30, 2020
o Up to $9.10 million remains available under the Cancer Prevention and Research Institute of Texas (CPRIT) Contract, subject to meeting certain requirements or approvals
Recent Business and Corporate Highlights:
Ewing sarcoma clinical trial expanded to include Ewing-related sarcomas supported by clinical observations including observation of seclidemstat activity in a patient with refractory Ewing sarcoma
Ewing sarcoma phase 1/2 clinical trial and advanced solid tumor (AST) phase 1/2 clinical trial continue to enroll patients during COVID-19
Salarius presented seclidemstat data to Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee (ODAC)
European Patent Office (EPO) issued Patent EP2744330 for seclidemstat
"The second quarter of 2020 and recent weeks have proven to be a period of substantial progress for Salarius, highlighted by several events that we believe affirm the company’s growth strategy and demonstrate the value of seclidemstat as a potential treatment for Ewing sarcoma and other cancers," said David Arthur, President and CEO of Salarius. "These highlights included a new EU patent for seclidemstat, our data presentation at ODAC and the ongoing progress of our clinical trials in advanced solid tumors and Ewing sarcoma; the latter of which is now being expanded to include Ewing-related sarcomas where seclidemstat has potential to demonstrate activity."
Mr. Arthur concluded, "Patient enrollment in our clinical trials for seclidemstat in Ewing sarcoma and advanced solid tumors continue and we expect to reach important development milestones this year and in 2021. These milestones support our ultimate goal to maximize the potential of seclidemstat and bring hope to patients and their families fighting rare, pediatric and other cancers. To that end, we believe Salarius remains well-capitalized including up to $9.1 million in non-dilutive funding that remains available from the CPRIT award."
Three-Month Financial Results:
For the three-month period ended June 30, 2020, Salarius’ reported net loss was $1.8 million, or $0.13 per basic and diluted share, compared to a net loss of $0.9 million, or $0.30 per basic and diluted share for the same period in 2019. The loss before other income for the three-month period ended June 30, 2020 increased by $1.0 million compared to the loss before other income for the same time span last year, which was primarily due to an increase of $0.6 million in research and development expenses resulting from increased clinical trial expenses and drug manufacturing costs. Salarius also reported a net increase of $0.7 million in general and administrative costs resulting from Salarius’ transformation into a public company and increased personnel expenses during the current quarter.
As of June 30, 2020, total cash, cash equivalents and restricted cash were $7.2 million, compared to $3.7 million at year-end 2019. Increases in cash balances result from the Company’s public offering of stock in the first quarter 2020.
$6.2 Million Underwritten Public Offering
On August 3, 2020, Salarius completed an underwritten public offering with total gross proceeds of approximately $6.2 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering to fund the expansion of the Ewing sarcoma clinical trial and ongoing company operations.
Ewing Sarcoma Clinical Trial Expanded
On July 29, 2020, Salarius announced the expansion of its ongoing Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma to include additional select sarcomas that share a similar biology to Ewing sarcoma, also known as Ewing-related sarcomas. Sarcomas of interest include myxoid liposarcoma, desmoplastic round cell tumors and other sarcomas that harbor similar FET family gene rearrangements to Ewing sarcoma, i.e. Ewing-related sarcomas.
These Ewing-related sarcomas were chosen based on their underlying biology as well as preclinical data and early clinical observations involving seclidemstat that suggest the drug may demonstrate activity and may have applicability in several sarcomas that share key characteristics of Ewing sarcoma.
The planned amendment to the ongoing trial will allow up to 30 patients with Ewing-related sarcomas to enroll in the trial’s upcoming dose-expansion phase, which is in addition to the 20 Ewing sarcoma patients also planned to be treated in the dose-expansion phase.
Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Wednesday, August 12, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the second quarter 2020. Interested participants and investors may access the conference call by dialing either:
(833) 423-0481 (U.S.)
(918) 922-2375 (international)
Conference ID:9367616
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 August 12, 2020.