Salarius Pharmaceuticals Reports Third Quarter 2021 Financial Results and Highlights Recent Company Progress

Cash and Cash Equivalents of $31.9 Million Sufficient to Fund Completion of Ongoing Clinical Trials for Lead Drug Candidate Seclidemstat

Added Five New Clinical Sites to Sarcoma Trial; 13 Active Sites Now Supporting Enrollment

Initial Ewing Sarcoma Combination Therapy Safety Lead-in Cohort Fully Enrolled, FET-Rearranged Sarcoma Patient Enrollment Continuing

Conference Call and Live Audio Webcast Scheduled for Today, November 4, 2021, 5:00 p.m. ET

HOUSTON, Nov. 04, 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 third quarter ended September 30, 2021.

"The progress made in the third quarter and recent weeks continues to support our intent to build a multi-pronged development pipeline investigating seclidemstat in cancers where LSD1 is known to be a factor," stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. "We made advances in our ongoing Phase 1/2 sarcoma trial exploring single-agent seclidemstat in advanced FET-rearranged sarcomas and we made advances in the same trial exploring seclidemstat in combination with chemotherapy in relapsed/refractory Ewing sarcoma. The initial safety lead-in portion of the Ewing sarcoma combination therapy cohort is fully enrolled, and we expect the seclidemstat recommended Phase 2 dose (RP2D) combination therapy in Ewing sarcoma to be underway by early 2022. Based on our current operating plan, we believe Salarius is sufficiently funded to support our current clinical programs through additional potential data readouts later this year and throughout 2022."

Recent Business and Corporate Highlights:

• Clinical Trial Agreements (CTAs) signed with five new sarcoma trial sites including: Cleveland Clinic (Cleveland OH), Fox Chase Cancer Center (Philadelphia, PA), Oncology Consultants (Houston, TX), Virginia Cancer Specialists (Fairfax, VA) and Washington University (St. Louis, MO)
  • Additional sarcoma clinical trial sites are expected to be added by year end
• Sarcoma clinical trial enrollment continues across all patient populations
  • The initial safety lead-in portion of the Ewing sarcoma combination therapy cohort evaluating seclidemstat in combination with the chemotherapy agents topotecan and cyclophosphamide (TC) is fully enrolled
  • Enrollment continues in the cohort evaluating single-agent seclidemstat in myxoid liposarcoma and other FET-rearranged sarcomas
  • Potential clinical trial data readouts later this year and in 2022
• Salarius added to FTSE Global Microcap Index, effective September 20, 2021
• Research partnership established with Cancer Epigenetics Institute (CEI) at Fox Chase Cancer Center
  • Research to be conducted in laboratory of Johnathan Whetstine, Ph.D., the institute's director, to help identify additional indications and potential biomarkers for seclidemstat
• Data presented by Nationwide Children's Hospital at 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics demonstrate that seclidemstat's differentiated mechanism of action drives unique anti-cancer activity in FET-rearranged sarcomas compared to other LSD1 inhibitors
  • Seclidemstat has a dual mechanism of action (MOA) that targets LSD1's enzymatic and scaffolding functions
  • Preclinical data suggests seclidemstat's more robust inhibition of LSD1's scaffolding function is essential for reducing viability of FET-rearranged sarcomas

"New collaborations are bolstering the breadth of our seclidemstat clinical and non-clinical research.   We believe our partnership with the Cancer Epigenetics Institute at Fox Chase Cancer Center will help identify additional indications and potential biomarkers for seclidemstat, and it also adds another prestigious cancer hospital to the growing list of those involved in seeking to identify new opportunities to expand the utility of seclidemstat," stated Mr. Arthur. "Furthermore, our collaboration with Nationwide Children's Hospital generated data presented at the 2021 AACR-NCI-EORTC Conference that showcased seclidemstat's unique ability to inhibit LSD1's non-enzymatic functions leading to anti-cancer activity in FET-rearranged sarcomas. Finally, we expect the investigator-initiated clinical trial underway at MD Anderson Cancer Center to result in additional data evaluating the use of seclidemstat in hematologic cancers."

Financial Highlights:

• Three-month and nine-month periods ended September 30, 2021, net loss per common share – basic and diluted – for continuing operations of $0.08 and $0.22, respectively, compared to $0.10 and $0.40, respectively, for the same periods last year
• Total working capital of $33.6 million as of September 30, 2021
• Receipt of $2.7 million disbursement from Cancer Prevention and Research Institute of Texas (CPRIT) announced on September 28, 2021
  
  

Three-Month and Nine Month Financial Results:

For the three-month period ended September 30, 2021, Salarius' reported net loss was $3.7 million, or $0.08 per basic and diluted share, compared to a net loss of $1.7 million, or $0.10 per basic and diluted share for the same period in 2020. The loss before other income for the three-month period ended September 30, 2021, increased by $2.0 million compared to the loss before other income for the same time span last year, primarily due to the absence of grant revenue as the Company has fully expended funds available under the CPRIT grant and higher overall spending.

For the nine-month period ended September 30, 2021, Salarius' reported net loss was $8.7 million, or $0.22 per basic and diluted share, compared to a net loss of $5.6 million, or $0.40 per basic and diluted share for the same period in 2020.   The loss before other income for the nine-month period ended September 30, 2021, increased by $2.6 million compared to the loss before other income for the same time span last year, primarily due to the aforementioned reduction of grant revenue and higher overall spending.  

Net cash used for operating activities during the nine-month period ended September 30, 2021 totaled $7.5 million, a decrease of approximately $1.5 million compared to the same span last year resulting from the receipt of $2.7 million from CPRIT more than offsetting increased overall spending.

Conference Call Information:

Salarius Pharmaceuticals will host a conference call and live audio webcast on Thursday, November 4, 2021, at 5:00 p.m. ET, to discuss its corporate and financial results for the third quarter 2021. Interested participants and investors may access the conference call by dialing either:

• (833) 423-0481 (U.S.)
• (918) 922-2375 (international)
• Conference ID: 1514667
  
  

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 November 4, 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 initiated by MD Anderson Cancer Center 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.

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 "aim," "believe," "can," "continue," "developing," "estimate," "expect," "look forward to," "opportunity," "potential," "progress," "could prove," "plan," "position," "potential," "suggest," "will," and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: the company's growth strategy; the value of seclidemstat as an alternative treatment for Ewing sarcoma, Ewing-related sarcomas and other cancers; the effectiveness of seclidemstat when compared to other LSD1 inhibitors; expanding the scope of the Company's research and focus to high unmet need patient populations; the status and anticipated progress and milestones of the company's current and future clinical trials, including timing of data readouts; initiating additional clinical programs in new indications; the company's belief as to being well-capitalized through the completion of its clinical trials for seclidemstat and beyond; the number of clinical trial sites and the Company's expectation or plans to add new sites; any outcomes or results from the Company's current and future partnerships; and the use of seclidemstat in combination with chemotherapy agents. 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 the company's capital resources; the ability of, and need for, the company to raise additional capital to meet the company's business operational needs and to achieve its business objectives and strategy; the company's ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of the company to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of results on the company; 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 the company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 and in the company's annual report on Form 10-K for the year ended December 31, 2020. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management's assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

Contact

Tiberend Strategic Advisors, Inc.

Maureen McEnroe, CFA (Investors)

(212) 375-2664

[email protected]

Johanna Bennett (Media)

(212) 375-2686 

[email protected]

SALARIUS PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

	9/30/2021				12/31/2020
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	31,903,727			$	11,118,614
Grants receivable from CPRIT	2,086,157				3,855,996
Prepaid expenses and other current assets	1,194,255				822,050
Total current assets	35,184,139				15,796,660
Property and equipment, net	11,570				22,639
Other assets	201,389				247,113
Goodwill	8,865,909				8,865,909
Total assets	$	44,263,007			$	24,932,321
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	1,234,922			$	1,853,756
Accrued expenses and other current liabilities	323,364				383,138
Note payable	—				477,028
Warrant liability	54,006				59,211
Total liabilities	1,612,292				2,773,133
Commitments and contingencies (Note 5)
Stockholders' equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; 0 issued and outstanding	—				—
Common stock, $0.0001 par value; 100,000,000 shares authorized; 45,172,535 and 23,810,541 shares issued at September 30, 2021 and December 31, 2020, and 45,172,535 and 23,808,546 shares outstanding at September 30, 2021 and December 31, 2020, respectively	4,517				2,381
Additional paid-in capital	70,738,517				41,585,761
Accumulated deficit	(28,092,319		)		(19,428,954		)
Total stockholders' equity	42,650,715				22,159,188
Total liabilities and stockholders' equity	$	44,263,007			$	24,932,321

SALARIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Three Months Ended September 30								Nine Months Ended September 30
	2021				2020				2021				2020
Revenue:
Grant revenue	$	—			$	1,378,239			$	1,840,216			$	3,754,379
Operating expenses:
Research and development	2,015,930				1,803,682				5,852,887				4,890,375
General and administrative	1,730,730				1,333,062				4,655,404				4,893,021
Total operating expenses	3,746,660				3,136,744				10,508,291				9,783,396
Loss before other income (expense)	(3,746,660		)		(1,758,505		)		(8,668,075		)		(6,029,017		)
Change in fair value of warrant liability	9,073				45,103				5,205				265,538
Government grants and other income	—				—				—				179,027
Interest income (expense), net	487				(3,230		)		(495		)		(254		)
Loss from continuing operations	(3,737,100		)		(1,716,632		)		(8,663,365		)		(5,584,706		)
Net loss	$	(3,737,100	)		$	(1,716,632	)		$	(8,663,365	)		$	(5,584,706	)
Loss per common share — basic and diluted	$	(0.08	)		$	(0.10	)		$	(0.22	)		$	(0.40	)
Weighted-average number of common shares outstanding — basic and diluted	44,804,741				17,968,664				40,064,119				13,833,410