Press Release
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Salarius Pharmaceuticals Reports Business Highlights and Third Quarter 2020 Financial Results
Recent Business and Corporate Events:
- Ewing sarcoma Phase 1/2 clinical trial is completing dose escalation to establish maximum tolerated dose (MTD) and is expected to advance into Phase 2 dose-expansion in Q1 2021
- Ewing sarcoma clinical trial expansion phase expanded to include patients with Ewing-related sarcomas such as myxoid liposarcoma, desmoplastic small round cell tumors and other sarcomas with similar biology to Ewing sarcoma
º Ewing sarcoma and Ewing-related sarcomas represent rare cancers affecting both children and adults where there is a high unmet need for additional treatment options
Financial Highlights:
- Total cash and cash equivalents of
$9.6 million as ofSeptember 30, 2020 due in part to$6.2 million gross proceeds in an underwritten public offering closedAugust 3, 2020 - Three-month period ended
September 30, 2020 net loss per common share – basic and diluted - of$0.10 , compared to$0.73 for the same period endedSeptember 30, 2019
“The events of the third quarter of 2020 affirm the company’s growth strategy and demonstrate the potential of seclidemstat as a treatment for cancers with high unmet need,” said
Ewing Sarcoma Clinical Trial Expanded
On
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. As Salarius previously disclosed, a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions. Target lesions generally represent a patient’s largest measurable tumors. However, at eight weeks, an increase in non-target lesions resulted in an overall patient classification of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
The amendment to the ongoing clinical 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.
Additional Clinical Trials to Expand Development Program
Three-Month Financial Results:
For the three-month period ended
As of September 30, 2020, total cash, cash equivalents and restricted cash were $9.6 million, compared to
On
Conference Call Information:
- (833) 423-0481 (
U.S. ) - (918) 922-2375 (international)
- Conference ID: 1277839
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 5:30 p.m. ET, on November 11, 2020.
About Salarius Pharmaceuticals
Forward-Looking Statements
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,” “developing,” 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’ growth strategy; the value of seclidemstat as a potential treatment for Ewing sarcoma and other cancers; the status and anticipated progress and milestones of Salarius’ clinical trials in advanced solid tumors and Ewing sarcoma including statements related to when Salarius will reach the maximum tolerated dose in the Phase 1 portion of the study and when Salarius will begin the Phase 2 expansion portion of any study; the expansion of Salarius’ clinical trials to include Ewing-related sarcomas; Salarius’ belief as to being well-capitalized; statements related to Salarius’ ability to obtain or the availability of any additional amount from the CPRIT award; the anticipated use of proceeds from Salarius’ recent public offering to advance and expand the seclidemstat development pipeline; Salarius’ goal to maximize the potential of seclidemstat; Salarius’ developing seclidemstat for several cancers with high unmet medical need; and Salarius plans to announce two additional clinical trials. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the sufficiency of Salarius’ capital resources; the ability of, and need for, Salarius to raise additional capital to meet Salarius’ business operational needs and to achieve its business objectives and strategy; Salarius’ ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of Salarius to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in Salarius’ quarterly report on Form 10-Q for the quarter ended
Contact
(212) 375-2664 / 2694
mmcenroe@tiberend.com
mmiller@tiberend.com
(212) 375-2686
jbennett@tiberend.com
SALARIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
2020 |
2019 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 9,557,813 | $ | 3,738,900 | |||
Grants receivable from CPRIT | 3,212,678 | — | |||||
Prepaid expenses and other current assets | 1,148,667 | 955,899 | |||||
Total current assets | 13,919,158 | 4,694,799 | |||||
Property and equipment, net | 15,635 | 25,016 | |||||
8,865,909 | 8,865,909 | ||||||
Other assets | 262,509 | 308,674 | |||||
Total assets | $ | 23,063,211 | $ | 13,894,398 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,195,063 | $ | 1,790,966 | |||
Accrued expenses and other current liabilities | 448,862 | 160,783 | |||||
Note payable | 761,096 | 502,332 | |||||
Deferred revenue | — | 541,701 | |||||
Warrant liability | 52,224 | 317,762 | |||||
Total liabilities | 2,457,245 | 3,313,544 | |||||
Commitments and contingencies (Note 6) | |||||||
Stockholders' equity: | |||||||
Preferred stock, |
— | — | |||||
Common stock, |
1,981 | 451 | |||||
Additional paid-in capital | 38,265,391 | 22,657,103 | |||||
Accumulated deficit | (17,661,406 | ) | (12,076,700 | ) | |||
Total stockholders' equity | 20,605,966 | 10,580,854 | |||||
Total liabilities and stockholders' equity | $ | 23,063,211 | $ | 13,894,398 |
SALARIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended September 30 |
|||||||
2020 | 2019 | ||||||
Revenue: | |||||||
Grant revenue | $ | 1,378,239 | $ | 874,949 | |||
Operating expenses: | |||||||
Research and development | 1,803,682 | 1,140,909 | |||||
General and administrative | 1,333,062 | 3,494,205 | |||||
Total operating expenses | 3,136,744 | 4,635,114 | |||||
Loss before other income (expense) | (1,758,505 | ) | (3,760,165 | ) | |||
Change in fair value of warrant liability | 45,103 | 1,130,848 | |||||
Government grants and other income | — | — | |||||
Interest income (expense), net | (3,230 | ) | (752 | ) | |||
Loss from continuing operations | (1,716,632 | ) | (2,630,069 | ) | |||
Income from discontinued operations | — | 2,348 | |||||
Net loss | $ | (1,716,632 | ) | $ | (2,627,721 | ) | |
Loss per common share — basic and diluted | $ | (0.10 | ) | $ | (0.73 | ) | |
Weighted-average number of common shares outstanding — basic and diluted | 17,968,664 | 3,605,913 |
Source: Salarius Pharmaceuticals, Inc.