Salarius Pharmaceuticals Reports First Quarter 2020 Financial Results
Seclidemstat Advances Dose Escalation in Phase 1/2 Ewing Sarcoma Clinical Trial; On Track to Report Early Data in 2020
Conference Call and Live Audio Webcast Scheduled for Today,
$11 milliongross proceeds in an underwritten public offering
- Three-month period ended
March 31, 2020net loss per common share – basic and diluted – for continuing operations of $0.22, compared to $0.64for the same period ended March 31, 2019
- Total cash and cash equivalents of
$9.65 millionas of March 31, 2020
- Up to
$9.10 millionremains 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
- Up to
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
Three-Month Financial Results:
For the three-month period ended
As of March 31, 2020, total cash, cash equivalents and restricted cash was $9.65 million, compared to
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
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
In all, Salarius holds 22 issued patents in the
Conference Call Information:
- (833) 423-0481 (
- (918) 922-2375 (international)
- Conference ID: 6281273
An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website http://investors.salariuspharma.com/. An archive of the webcast will remain available for 90 days beginning at approximately 6:00 p.m. ET, on May 14, 2020.
About Salarius Pharmaceuticals
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: Salarius’ anticipation of the potential for multiple clinical data releases and value building events throughout 2020 and beyond; the anticipated progress of Salarius’ clinical programs for seclidemstat; the anticipated release of data from both the Ewing sarcoma clinical trial and Salarius’ second clinical trial in advanced solid tumors (AST) in 2020; the availability of funds available from CPRIT and NPCF; expectations as to the impact of the COVID-19 pandemic on the company’s business and Salarius’ enrollment of patients in clinical studies; Salarius’ goal to maximize the potential of seclidemstat; Salarius’ belief that it is well-capitalized with the resources to advance its Ewing sarcoma and AST programs, as well as early research on the potential for combining seclidemstat with immunotherapies, well into 2021; the intended use of proceeds from its recent public offering; the status (including with respect to patient enrollment), design, conduct, and objectives of Salarius’ two Phase 1/2 clinical trials for seclidemstat; Salarius’ belief, based on current projections, that both clinical trials are on track to reach MTD in 2020, and shortly after, begin the dose-expansion phase of each study; Salarius’ anticipated reporting of early safety and pharmacokinetic data before year-end 2020; Salarius’ exploration of additional indications for seclidemstat to expand the drug’s market potential, including seclidemstat’s potential for use in combination with checkpoint inhibitors; the estimated global sales of
SALARIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||9,646,940||$||3,738,900|
|Grants receivable from CPRIT||591,129||—|
|Prepaid expenses and other current assets||646,360||955,899|
|Total current assets||10,884,429||4,694,799|
|Property and equipment, net||21,889||25,016|
|Liabilities and stockholders' equity (deficit)|
|Accrued expenses and other current liabilities||795,567||160,783|
|Stockholders' equity (deficit):|
|Additional paid-in capital||32,161,718||22,657,103|
|Total stockholders' equity||18,002,613||10,580,854|
|Total liabilities and stockholders' equity||$||20,065,374||$||13,894,398|
SALARIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended
||Three Months Ended
|Research and development||1,643,371||699,929|
|General and administrative||1,859,017||1,488,490|
|Total operating expenses||3,502,388||2,188,419|
|Loss before other income (expense)||(2,369,558||)||(1,532,784||)|
|Change in fair value of warrant liability||283,070||—|
|Interest income net||2,672||10,708|
|Loss per common share — basic and diluted||$||(0.22||)||$||(0.64||)|
|Weighted-average number of common shares outstanding — basic and diluted||9,534,842||2,372,940|
Source: Salarius Pharmaceuticals, Inc.