On May 14, 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 first quarter ended March 31, 2020 (Press release, Salarius Pharmaceuticals, MAY 14, 2020, View Source [SID1234558045]).
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Financial Highlights:
•Closed $11 million gross proceeds in an underwritten public offering
•Three-month period ended March 31, 2020 net loss per common share – basic and diluted – for continuing operations of $0.22, compared to $0.64 for the same period ended March 31, 2019
•Total cash and cash equivalents of $9.65 million as of March 31, 2020
•Up to $9.10 million remains available to draw from the Cancer Prevention and Research Institute of Texas (CPRIT) Award, upon meeting certain requirements
•National Pediatric Cancer Foundation (NPCF) continues to provide significant funding for Ewing sarcoma study
Recent Business and Corporate Highlights:
•Phase 1/2 clinical study of seclidemstat in Ewing sarcoma advanced into the sixth level dosing cohort with Maximum Tolerated Dose (MTD) expected to be reached in mid-2020
•Scientific paper published highlighting potential of combining seclidemstat with cancer immunotherapies
•In vitro data shows that seclidemstat helps overcome tumor resistance to checkpoint inhibitors
•European Patent Office (EPO) issued a notice of allowance for Patent EP274430 for seclidemstat
•William "Bill" McVicar, Ph.D., named as new Chairman of the Board of Directors
"Salarius is anticipating the potential for multiple clinical data releases and value building events throughout 2020 and beyond," said David Arthur, President and CEO of Salarius. "Our clinical programs for seclidemstat continue to progress, and in the first quarter, we advanced dose-escalation in our Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma. We eagerly anticipate releasing data from both the Ewing sarcoma clinical trial and our second clinical trial in advanced solid tumors (AST) in 2020."
Mr. Arthur continued, "Salarius has worked to adapt to the unexpected and challenging circumstances resulting from the COVID-19 pandemic. At this time, we are experiencing minimal COVID-19 disruptions to our ongoing clinical programs and continue to enroll patients in our clinical trials."
Mr. Arthur concluded, "Our goal is to maximize the potential of seclidemstat and bring hope to patients fighting rare, pediatric and other cancers. To that end, Salarius is well-capitalized and has the resources, including $9.1 million in non-dilutive funding that remains available from the 2016 $18.7 million CPRIT award, that we believe will advance both our Ewing sarcoma and AST programs, as well as early research on the potential for combining seclidemstat with immunotherapies, well into 2021."
Three-Month Financial Results:
For the three-month period ended March 31, 2020, Salarius’ reported net loss was $2.08 million, or $0.22 per basic and diluted share, compared to a net loss of $1.52 million, or $0.64 per basic and diluted share for the same period in 2019. The loss before other income for the three-month period ended March 31, 2020 increased by $0.84 million compared to the loss before other income for the same time span last year, which was primarily due to an increase of $0.94 million in research and development expenses resulting from increased clinical trial expenses and drug manufacturing costs. Salarius also reported a net increase of $0.37 million in general and administrative costs resulting from Salarius’ transformation into a public company and increased personnel expenses during the current quarter, somewhat offset by lower professional fees and legal costs compared to same period in 2019.
As of March 31, 2020, total cash, cash equivalents and restricted cash was $9.65 million, compared to $5.77 million as of March 31, 2019 and $3.74 million at year-end 2019.
$11 Million Underwritten Public Offering
On February 11, 2020, Salarius completed a public offering with total gross proceeds of approximately $11 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering for general working capital purposes.
Summary of Corporate and Operational Events:
Ewing Sarcoma Dose Escalation Clinical Trial Advances into Sixth Dosing Cohort
Salarius is conducting two Phase 1/2 clinical trials for the company’s lead investigational drug candidate, seclidemstat – one in patients with relapsed or refractory Ewing sarcoma and the second in patients with advanced solid tumors (AST) resistant to standard-of-care therapies. The trials are designed as open-label dose-finding studies with a primary objective to characterize the pharmacokinetics (PK), Maximum Tolerated Dose (MTD), and initial safety profile of seclidemstat and a secondary objective to assess the preliminary efficacy.
In Q1 2020, the Safety Review Committee overseeing the Ewing sarcoma clinical trial approved the advancement of the study to the sixth dosing cohort (1,200mg BID) out of seven potential cohorts, and patient enrollment is ongoing. Thus far, PK data from the trial suggest that plasma drug levels measuring the concentration of seclidemstat in a patient’s plasma remain dose proportional and there is no evidence of a plateau in exposure levels.
Dose escalation continues with the Phase 1/2 clinical trial in AST, which is now in the fourth dosing cohort (600mg BID) out of seven possible cohorts. The AST study enrolls patients with a focus on prostate, breast, ovarian, melanoma, colorectal, non-Ewing sarcomas and other cancers where seclidemstat demonstrated single-agent preclinical activity.
Based on current projections, Salarius believes both clinical trials are on track to reach MTD in 2020, and shortly after, begin the dose-expansion phase of each study. Salarius expects to report early safety and pharmacokinetic data before year-end 2020.
Scientific Paper Highlights Use of Seclidemstat in Combination with Checkpoint Inhibitors
Salarius is exploring additional indications for seclidemstat to expand the drug’s market potential, and this includes seclidemstat’s potential for use in combination with a type of cancer immunotherapy commonly known as checkpoint inhibitors. Checkpoint inhibitors, estimated at $15 billion in annual global sales, are designed to unleash an immune attack on cancer cells. However, these therapies do not work in about 70% of cancer patients, and in patients who do show an initial response, many suffer a return of the disease.
On February 4, 2020, a scientific paper entitled, "The Novel Reversible LSD1 Inhibitor SP-2577 Promotes Anti-Tumor Immunity in SWItch/Sucrose-NonFermentable (SWI/SNF)1," was published on bioRxiv.com. The paper highlighted data from in vitro studies conducted by Sunil Sharma, M.D., Salarius’ scientific founder, and his team at the Translational Genomic Institute (TGen) in Phoenix, Ariz., that demonstrate the potential for seclidemstat (also known as SP-2577) to be used in combination with checkpoint inhibitors to treat cancers with identifiable mutations in proteins of the SWI/SNF complex. In this study, seclidemstat modulated the tumor microenvironment to help overcome the resistance to checkpoint inhibitors
The SWI/SNF complex plays an important role in modulating gene expression, and mutations in proteins of the SWI/SNF complex occur in roughly 20% of human cancers. In this study, Dr. Sharma’s team investigated the ability of seclidemstat to promote anti-tumor immunity and T-cell infiltration in two types of ovarian cancer – small cell carcinoma of the ovary hypercalcemic type and ovarian clear cell carcinoma — that both carry mutations in proteins of the SWI/SNF complex.
Salarius Strengthens IP Portfolio Around Seclidemstat
On March 4, 2020, Salarius announced the continued enhancement of the U.S. and global intellectual property (IP) portfolio governing seclidemstat. The European Patent Office issued a notice of allowance for Patent EP274430 exclusively licensed to Salarius from the University of Utah Research Foundation indicating that the agency is satisfied that the patent application meets all EPO requirements.
In all, Salarius holds 22 issued patents in the U.S. and abroad. The company’s current IP estate includes five patents issued in the U.S. and another 17 patents issued in Europe, Australia, Brazil, China, Eurasia, Israel, India, Japan, Korea, Mexico, New Zealand, Singapore, and South Africa. Meanwhile, Salarius has 11 patent applications pending approval in Europe, Brazil, Canada, Israel, India, Korea, Mexico, Singapore, and China. All 22 issued patents and the 11 pending applications are directed to seclidemstat or structurally similar compounds.
Salarius Names New Chairman of the Board
On April 29, 2020, Salarius announced that Board member William "Bill" McVicar, Ph.D., was named by the Board as its new Chairman. Dr. McVicar is a seasoned pharmaceutical industry executive with more than 30 years of clinical development experience. He recently served as Chief Executive Officer of Flex Pharma, and previously served as Chief Scientific Officer and President at Inotek Pharmaceuticals.
Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Thursday, May 14, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the first quarter 2020. 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 May 14, 2020.