Salarius Pharmaceuticals, Inc. (Nasdaq:
SLRX), a clinical-stage biopharmaceutical company using
protein inhibition and protein degradation to develop cancer
therapies for patients in need of new treatment options, today
reported financial results for the three and six months ended June
30, 2023 and provided a business update.
Financial and Business
Highlights
- Cash and cash equivalents were $11.5 million as of June 30,
2023, compared with $12.1 million as of December 31, 2022
- Net loss for the second quarter of 2023 was $3.9 million, or
$1.43 per share, compared with net loss for the second quarter of
2022 of $4.7 million, or $2.20 per share, reflecting lower spending
on seclidemstat and lower general and administrative expenses
- Raised gross proceeds of $6.0 million from a private placement
of common stock and warrants, and an additional $1.7 million from
an At the Market facility
- Announced plans to explore strategic alternatives and implement
measures to extend resources
“While the second quarter and recent weeks were
highlighted by significant advancements in both of our development
programs, after a review of each program’s future funding needs and
the current financial markets, the Board of Directors has made the
difficult decision to limit further drug development while we
explore strategic alternatives for Salarius,” said David Arthur,
president and chief executive officer of Salarius
Pharmaceuticals.
“It was an exceptionally difficult decision to
initiate our cost-savings plans and explore strategic alternatives
in light of the promising early seclidemstat Ewing sarcoma clinical
data, seclidemstat hematological clinical data and the recent FDA
clearance to begin the SP-3164 Phase 1 trial. Unfortunately, we
believe the current public financial markets make it extremely
challenging to raise sufficient capital to continue meaningful
clinical development activities on our own,” concluded Mr.
Arthur.
The Company is conducting a comprehensive review
of strategic alternatives focused on maximizing shareholder value
including, but not limited to, an acquisition, merger, reverse
merger, divestiture of assets, licensing or other strategic
transactions involving the Company. However, there is no set
timetable for this process and there can be no assurance that this
process will result in the Company pursuing a transaction or that
any transaction, if pursued, will be completed on attractive terms.
If the Company is unable to complete a transaction it may be
necessary to seek other alternatives for restructuring and
resolving its liabilities, including an orderly wind-down. Salarius
does not expect to disclose developments with respect to this
process unless and until the evaluation of strategic alternatives
has been completed or the Board of Directors has concluded that
disclosure is appropriate or legally required.
In connection with the evaluation of strategic
alternatives and in order to extend its resources, Salarius is
implementing a cost-savings plan that includes a reduction in
workforce by over 50% of its positions, with remaining employees
focusing primarily on limited drug-development activities,
completing the U.S. Food and Drug Administration (FDA) process to
determine the clinical trial registration requirements for the
seclidemstat Ewing sarcoma program and supporting the exploration
of strategic alternatives.
Second Quarter Financial
Results
Research and development expenses declined to
$2.4 million for the second quarter of 2023 from $2.9 million for
the second quarter of 2022, primarily due to lower spending on
seclidemstat offset by higher spending on SP-3164. Spending
associated with seclidemstat and SP-3164 for the second quarter of
2023 was $1.1 million and $1.3 million, respectively, compared with
$2.1 million and $0.8 million, respectively, for the second quarter
of 2022. General and administrative expenses were $1.6 million for
the second quarter of 2023, compared with $1.8 million for the
second quarter of 2022, with the decline due to lower annual
shareholder meeting expenses and overall compensation and benefit
costs.
Year-to-Date Financial
Results
Research and development expenses declined to
$6.1 million for the first half of 2023 from $7.4 million for the
prior-year period, primarily due to lower spending on seclidemstat
offset by higher spending on SP-3164. Spending associated with
seclidemstat and SP-3164 for the first half of 2023 was $2.4
million and $3.7 million, respectively, compared with $4.4 million
and $3.0 million, respectively, for the prior-year period.
Net cash used for operating activities during
the first half of 2023 was $7.6 million, an increase of $0.4
million from the same period a year ago. The increase is primarily
due to a decrease in accounts payable.
As of June 30, 2023, Salarius had cash, cash
equivalents and restricted cash of $11.5 million, compared with
$12.1 million as of December 31, 2022. Current cash and cash
equivalents are expected to fund the company’s planned operations
through the fourth quarter of 2023 and enable the evaluation and
implementation of strategic alternatives.
Seclidemstat Highlights
- The FDA removed its partial clinical hold on Salarius’ Phase
1/2 trial evaluating seclidemstat in combination with topotecan and
cyclophosphamide as a potential treatment for patients with Ewing
sarcoma
- The Company initiated the process with the FDA to determine the
clinical trial registration requirements for the seclidemstat Ewing
sarcoma program
- Previously reported interim data showed a 60% confirmed disease
control rate and 7.4 months median time to tumor progression for
first-relapse Ewing sarcoma patients, with no disease progression
observed in either first- or second-relapse patients who achieved
confirmed disease control
- The Company continues to monitor patients in the Ewing sarcoma
trial and plans to release updated survival data in the coming
months
- The FDA previously granted seclidemstat Fast Track, Orphan Drug
and Rare Pediatric Disease designations for Ewing sarcoma
- University of Texas MD Anderson Cancer Center (MDACC) is
working to restart their investigator initiated Phase 1/2 study
with seclidemstat in combination with azacytidine in patients with
myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia
(CMML)
- Researchers at MDACC previously reported interim clinical trial
results in patients who relapsed or progressed after
hypomethylating agent therapy. Of eight evaluable patients, four
(50%) had an objective response. These researchers reported a 90%
probability of patient survival for 11 months in patients receiving
seclidemstat plus azacitidine versus an expected survival of four
to six months
SP-3164 Highlights
- On July 11, 2023 Salarius announced that the FDA had cleared
the IND application to treat relapsed/refractory non-Hodgkin
lymphoma patients with SP-3164.
- Presented NHL preclinical data at the European Hematology
Association 2023 Hybrid Congress in June that showed:
- Potent degradation of Ikaros and Aiolos (I/A) in peripheral
blood mononuclear cells (PBMC) within 2 hours of dosing, which
increased in a dose- and time-dependent manner over 24 hours
- SP-3164 does not negatively impact PBMC at clinically relevant
concentrations up to 96 hours post-treatment
- In addition to having direct antitumor effects, SP-3164 also
induces an anticancer immunomodulatory effect as demonstrated
through the induction of cytokine secretion in human T cells
following treatment
- Presented two abstracts at the AACR Annual Meeting in April:
- One presentation demonstrated the robust protein degradation
effects of SP-3164 and its anticancer activity in NHL animal models
as well as SP-3164’s compelling antitumor activity in animal models
of follicular lymphoma, a type of NHL, as a single agent and in
combination with venetoclax (Venclexta®) or tazemetostat
(Tazverik®)
- The other presentation demonstrated SP-3164's compelling
anticancer activity in cell lines and animal models of multiple
myeloma. In animal models, SP-3164 demonstrated superior
single-agent activity compared with the approved agents
lenalidomide (Revlimid®) and pomalidomide (Pomalyst®), and the
combination of SP-3164 and bortezomib (Velcade®) was shown to be
superior to the combination of pomalidomide and bortezomib.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company developing therapies for patients with
cancer in need of new treatment options. Salarius’ product
portfolio includes seclidemstat, an oral novel small molecule
inhibitor of the LSD1 enzyme and Salarius’ lead candidate, which is
being studied as a potential treatment for pediatric cancers,
sarcomas and other cancers with limited treatment options, and
SP-3164, an oral small molecule protein degrader being developed
for the treatment of Non-Hodgkin’s Lymphoma. Salarius has received
financial support from the National Pediatric Cancer Foundation to
advance the Ewing program and was a recipient of a Product
Development Award from the Cancer Prevention and Research Institute
of Texas (CPRIT).
Seclidemstat has received fast track, orphan
drug and rare pediatric disease designations for Ewing sarcoma from
the U.S. Food and Drug Administration and is currently in a Phase
1/2 clinical trial for relapsed/refractory Ewing sarcoma. Salarius
is also exploring seclidemstat’s potential in several cancers with
high unmet medical need, with an investigator-initiated Phase 1/2
clinical study in hematologic cancers at MD Anderson Cancer
Center.
The SP-3164 Investigational New Drug (IND)
application was cleared by the U.S. Food and Drug Administration
(FDA) allowing a phase 1 safety clinical trial to begin. The phase
1 trial is also designed to assess the utility of a gene signature
to identify patients who are potentially sensitized to SP-3164 and
may be more likely to respond. 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
“will,” “believe,” “developing,” “expect,” “may,” “progress,”
“potential,” “could,” “look forward,” “encouraging,” “might,”
“should,” 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’ expectations
regarding the exploration of strategic alternatives, opportunities
to extend Salarius’ resources, the future of the Company’s
operations and product candidates; the future of the Company’s
preclinical studies and clinical trials and development activities;
the advantages of protein degraders including the value of SP-3164
as a cancer treatment; the value of seclidemstat as a treatment for
Ewing sarcoma, Ewing-related sarcomas, and other cancers and its
ability to improve the life of patients. 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 risk that exploration of strategic
alternatives may not result in any definitive transaction or
enhance stockholder value and may create a distraction or
uncertainty that may adversely affect our operating results,
business, or investor perceptions; expectations regarding future
costs and expenses; our product candidates being in early stages of
development; the uncertainty about the paths of our programs and
our ability to evaluate and identify a path forward for those
programs, particularly given the constraints we have as a small
company with limited financial, personnel and other operating
resources (including with respect to the allocation of our limited
capital and the sufficiency of our capital in the near term for any
path we do select); Salarius’ ability to continue as a going
concern; 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; future clinical trial results and
the impact of such results on Salarius; that the results of studies
and clinical trials may not be predictive of future clinical trial
results; risks related to the drug development and the regulatory
approval process; the competitive landscape and other
industry-related risks; and other risks described in Salarius’
filings with the Securities and Exchange Commission, including its
Annual Report on Form 10-K for the fiscal year ended December 31,
2022, as revised or supplemented by its Quarterly Reports on Form
10-Q and other documents filed with the SEC. 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:
LHA Investor Relations Kim
Sutton Golodetz kgolodetz@lhai.com 212-838-3777
(Tables to follow)
|
SALARIUS PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
6/30/2023 |
|
12/31/2022 |
|
(Unaudited) |
|
(Audited) |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
11,541,443 |
|
|
$ |
12,106,435 |
|
|
Grants receivable from CPRIT |
|
130,000 |
|
|
|
1,610,490 |
|
|
Prepaid expenses and other current assets |
|
284,807 |
|
|
|
803,373 |
|
|
Total current assets |
|
11,956,250 |
|
|
|
14,520,298 |
|
|
Other assets |
|
99,048 |
|
|
|
130,501 |
|
|
Total assets |
$ |
12,055,298 |
|
|
$ |
14,650,799 |
|
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,287,243 |
|
|
$ |
2,858,330 |
|
|
Accrued expenses and other current liabilities |
|
1,354,253 |
|
|
|
1,407,861 |
|
|
Total liabilities |
|
3,641,496 |
|
|
|
4,266,191 |
|
|
|
|
|
|
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;3,352,069 and 2,255,899 shares issued and outstanding at
June 30, 2023and December 31, 2022, respectively |
|
335 |
|
|
|
225 |
|
|
Additional paid-in capital |
|
81,436,696 |
|
|
|
74,189,531 |
|
|
Accumulated deficit |
|
(73,023,229 |
) |
|
|
(63,805,148 |
) |
|
Total stockholders' equity |
|
8,413,802 |
|
|
|
10,384,608 |
|
|
Total liabilities and stockholders' equity |
$ |
12,055,298 |
|
|
$ |
14,650,799 |
|
|
|
|
SALARIUS PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(Unaudited) |
|
|
Three Months Ended June 30 |
|
Six Months Ended June 30 |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
2,351,852 |
|
|
|
2,921,572 |
|
|
|
6,077,440 |
|
|
|
7,361,047 |
|
|
General and administrative |
|
1,619,543 |
|
|
|
1,836,395 |
|
|
|
3,314,618 |
|
|
|
3,514,149 |
|
|
Total operating expenses |
|
3,971,395 |
|
|
|
4,757,967 |
|
|
|
9,392,058 |
|
|
|
10,875,196 |
|
|
Loss before other income (expense) |
|
(3,971,395 |
) |
|
|
(4,757,967 |
) |
|
|
(9,392,058 |
) |
|
|
(10,875,196 |
) |
|
Interest income, net and other |
|
94,087 |
|
|
|
39,629 |
|
|
|
173,977 |
|
|
|
47,633 |
|
|
Loss from continuingoperations |
|
(3,877,308 |
) |
|
|
(4,718,338 |
) |
|
|
(9,218,081 |
) |
|
|
(10,827,563 |
) |
|
Net loss |
$ |
(3,877,308 |
) |
|
$ |
(4,718,338 |
) |
|
$ |
(9,218,081 |
) |
|
$ |
(10,827,563 |
) |
|
|
|
|
|
|
|
|
|
Loss per common share — basic and
diluted |
$ |
(1.43 |
) |
|
$ |
(2.20 |
) |
|
$ |
(3.45 |
) |
|
$ |
(5.42 |
) |
|
Weighted-average number of common shares
outstanding — basic and diluted |
|
2,709,104 |
|
|
|
2,140,899 |
|
|
|
2,671,148 |
|
|
|
1,996,357 |
|
|
|
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