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 12 months ended
December 31, 2022 and provided a business update.
Financial Highlights
- Cash and cash equivalents were
$12.1 million as of December 31, 2022, compared with $29.2 million
as of December 31, 2021. Subsequent to the close of 2022, the
company received $1.5 million from the Cancer Prevention and
Research Institute of Texas (CPRIT)
- Net loss for 2022 was $31.6
million, or $14.88 per share, compared with a net loss for 2021 of
$12.8 million, or $7.72 per share. The 2022 net loss included a
one-time non-cash expense of $8.9 million, or $4.17 per share due
to a loss on impairment of goodwill
- Net loss for the fourth quarter of
2022 was $6.4 million, or $2.83 per share, compared with a net loss
for the fourth quarter of 2021 of $4.1 million, or $2.27 per share,
reflecting higher operating expenses including an increase in
research and development expenses associated with the development
of our targeted protein degrader, SP-3164
“We believe Salarius had an extremely productive
fourth quarter and is well-positioned to take advantage of the
recently announced and encouraging SP-3164 preclinical cell line
and animal model data. We plan to file an IND with the FDA and
initiate an SP-3164 clinical trial this year," said David Arthur,
president and chief executive officer.
“In addition, we believe the seclidemstat
clinical trial data presented by MD Anderson Cancer Center
researchers at the 2022 American Society of Hematology Annual
Meeting and the Ewing sarcoma clinical trial data released by
Salarius confirm that seclidemstat represent a potential lifeline
to patients who are in desperate need of new treatment options.
While the partial clinical trial holds have been a setback, we are
optimistic about seclidemstat’s potential in treating Ewing sarcoma
as well as blood cancers, and we look forward to restarting
enrollment as quickly as possible,” Mr. Arthur added.
Targeted Protein Degrader (Molecular
Glue) Highlights
- Continued to advance plans for
filing an Investigational New Drug (IND) application with the U.S.
Food and Drug Administration (FDA) for SP-3164 in the first half of
2023 and begin a Phase 1/2 clinical trial in the second half of
2023
- SP-3164 data highlights from the
American Society of Hematology (ASH) Annual Meeting include:
- Significant single-agent activity
in diffuse large B-cell lymphoma (DLBCL) cell lines and mouse
models showed superiority to lenalidomide (Revlimid®)
- SP-3164 in combination with the
approved anti-CD20 drug, rituximab, resulted in complete tumor
regressions in 50% of mice, and performed significantly better than
the approved regimen of lenalidomide (Revlimid®) and rituximab
- Rapid and efficient Ikaros1
degradation compared with other studied molecular glues
- Antiproliferative effects across
several non-Hodgkin’s lymphoma (NHL) cell lines
- Two abstracts were accepted for
presentation at the American Association for Cancer Research (AACR)
Annual Meeting in April 2023:
- One presentation is titled
“SP-3164, a novel Ikaros and Aiolos1 molecular glue degrader with
preclinical activity in non-Hodgkin lymphomas” and demonstrates
that SP-3164 is a novel, orally available, cereblon-binding
molecular glue with significant anticancer activity in NHL cell
lines and mouse models
- The second presentation is titled
“SP-3164, a novel molecular glue degrader with activity in
preclinical models of multiple myeloma” and demonstrates that
SP-3164 is a potent cereblon-binding molecular glue with the
ability to rapidly degrade cancer-promoting transcription factors
proteins and induce cell death in multiple myeloma cell lines; in
multiple myeloma mouse models; and, that SP-3164 has superior
single agent and combination treatment activity compared to
approved molecular glues
- Announced the issuance of a new
composition of matter U.S. patent for a second, next-generation
targeted protein degrader, SP-3204
- The company’s targeted protein
degrader intellectual property portfolio now includes 16 issued
patents across six patent families
Seclidemstat (Targeted Protein
Inhibitor) Highlights
- MD Anderson researchers presented
data at ASH showing that in patients with myelodysplastic syndrome
or chronic myelomonocytic leukemia, the combination of seclidemstat
with azacitidine appeared safe at current dose levels and showed
initial signs of potential activity
- There was a 50% overall response
rate among eight evaluable patients who relapsed or progressed
after standard of care hypomethylating agent therapy
- Salarius reported interim data from
its Phase 1/2 study in Ewing sarcoma and FET-rearranged sarcomas
showing:
- A 60% confirmed disease control
rate and 7.4 months median time to tumor progression for Ewing
sarcoma first-relapse patients
- No disease progression observed in
either first- or second-relapse Ewing sarcoma patients who achieved
confirmed disease control
- During the fourth quarter,
enrollment of new patients in the Salarius-sponsored Phase 1/2
sarcoma clinical trial and the University of Texas MD Anderson
investigator-initiated hematologic clinical trial was voluntarily
paused, and then subsequently placed on partial clinical hold by
the FDA. Salarius has worked to gather and analyze requested data
and plans to submit its findings to the FDA with the goal of
restarting its clinical trials, while MD Anderson works in parallel
to provide its information to the FDA
“In summary, we believe our near-term future is
promising and that our protein degradation assets hold great
potential in treating blood cancers, and we are looking forward to
beginning the SP-3164 clinical trial later this year. We are also
excited about the encouraging seclidemstat clinical data generated
to date. I’m looking forward to a great 2023 and beyond,” concluded
Mr. Arthur.
1 Ikaros and Aiolos are transcription factors,
or proteins, that play a critical role in regulating B and T cell
development and have been associated with the development and
progression of hematologic or blood cancers
Fourth Quarter Financial
Results
Net loss for the fourth quarter of 2022 was $6.4
million, or $2.83 per share, compared with a net loss for the
fourth quarter of 2021 of $4.9 million, or $2.27 per share. The
increase was due to higher operating expenses including development
spending on SP-3164, which was acquired in January 2022.
Research and development expenses were $4.7
million in the fourth quarter of 2022, compared with $2.7 million
in the fourth quarter of 2021. The increase was principally due to
costs associated with SP-3164, partially offset by lower costs
related to SP-2577.
Net cash used for operating activities during
the fourth quarter of 2022 was $4.7 million, compared with $2.7
million during the same quarter in 2021, reflecting the
above-mentioned SP-3164 spending during the current period.
Full Year Financial Results
Net loss for 2022 was $31.6 million, or $14.88
per share, compared with a net loss for 2021 of $12.8 million, or
$7.72 per share. The increase was primarily due to a $8.9 million
one-time non-cash expense for impairment of goodwill, higher
research and development expenses primarily resulting from the
acquisition and development of SP-3164, higher seclidemstat
development costs and higher general and administrative expenses.
The 2021 period included grant revenue of $1.8 million, with no
such revenue in 2022.
Research and development expenses were $15.8
million in 2022, compared with $8.5 million in 2021. The increase
was principally due to costs associated with SP-3164, partially
offset by lower costs related to SP-2577.
General and administrative expenses were $7.1
million in 2022, compared with $6.1 million in 2021, with the
increase mainly driven by higher legal cost, public company cost
and personnel cost.
Net cash used in operating activities for 2022
was $17.6 million, compared with $10.2 million for 2021. The
increase was primarily due to higher research and development
expenses.
As of December 31, 2022, Salarius had cash, cash
equivalents and restricted cash of $12.1 million, compared with
$29.2 million as of December 31, 2021. Current cash and cash
equivalents are expected to fund the company’s planned operations
into the fourth quarter of 2023.
About Salarius
PharmaceuticalsSalarius 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, 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. Seclidemstat
is currently in a Phase 1/2 clinical trial for relapsed/refractory
Ewing sarcoma and certain additional sarcomas that share a similar
biology. This trial is currently on a partial clinical hold and is
not enrolling new patients. Seclidemstat has received fast track,
orphan drug and rare pediatric disease designations 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 an investigator-initiated Phase 1/2
clinical study in hematologic cancers at MD Anderson Cancer Center.
This trial is also currently on a partial clinical hold and is not
enrolling new patients. 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). SP-3164
is currently in IND-enabling studies and anticipated to enter the
clinic in 2023. 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: the future of the company’s
Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma
and FET-rearranged sarcomas following the recently announced
suspected unexpected severe adverse reaction (SUSAR) event and
resulting partial clinical hold by the U.S. Food and Drug
Administration (FDA); the advantages of protein degraders including
the value of SP-3164 as a cancer treatment; the timing of clinical
trials for SP-3164 and expected therapeutic options for SP-3164 and
related effects and projected efficacy; the impact that the
addition of new clinical sites will have on the development of
Salarius’ product candidates; the timing of Salarius’ IND
submissions to the FDA and subsequent timing for initiating
clinical trials; interim data related to Salarius’ clinical trials,
including the timing of when such data is available and made
public; Salarius’ growth strategy; 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; expanding
the scope of Salarius’ research and focus to high unmet need
patient populations; milestones of Salarius’ current and future
clinical trials, including the timing of data readouts. 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: Salarius’ ability to
continue as a going concern; it may take considerable time and
expense to resolve the partial clinical hold that has been placed
on Salarius’ Phase 1/2 trial of seclidemstat as a treatment for
Ewing sarcoma and FET-rearranged sarcomas by the FDA, and no
assurance can be given that the FDA will remove the partial
clinical hold; Salarius’ ability to resume enrollment in the
clinical trial following its review of the available data
surrounding the SUSAR; 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 RelationsKim
Sutton Golodetzkgolodetz@lhai.com212-838-3777
SALARIUS PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEETS
|
December 31,2022 |
|
December 31,2021 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
12,106,435 |
|
|
$ |
29,214,380 |
|
Grants receivable from CPRIT |
|
1,610,490 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
803,373 |
|
|
|
949,215 |
|
Total current assets |
|
14,520,298 |
|
|
|
30,163,595 |
|
Grants receivable from
CPRIT |
|
— |
|
|
|
1,610,490 |
|
Goodwill |
|
— |
|
|
|
8,865,909 |
|
Other assets |
|
130,501 |
|
|
|
193,874 |
|
Total assets |
$ |
14,650,799 |
|
|
$ |
40,833,868 |
|
Liabilities and
stockholders' equity (deficit) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,858,330 |
|
|
$ |
1,543,096 |
|
Accrued expenses and other current liabilities |
|
1,407,861 |
|
|
|
567,787 |
|
Total liabilities |
$ |
4,266,191 |
|
|
$ |
2,110,883 |
|
|
|
|
|
Commitments and contingencies
(NOTE 5) |
|
|
|
|
|
|
|
Stockholders' equity
(deficit): |
|
|
|
Preferred stock, $0.0001 par
value; 10,000,000 shares authorized; none issued or
outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par
value; 100,000,000 shares authorized; 2,255,899 and 1,809,593
shares issued and outstanding at December 31, 2022 and
December 31, 2021, respectively |
|
225 |
|
|
|
181 |
|
Additional paid-in
capital |
|
74,189,531 |
|
|
|
70,919,996 |
|
Accumulated deficit |
|
(63,805,148 |
) |
|
|
(32,197,192 |
) |
Total stockholders'
equity |
|
10,384,608 |
|
|
|
38,722,985 |
|
Total liabilities and
stockholders' equity |
$ |
14,650,799 |
|
|
$ |
40,833,868 |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
31-Dec |
31-Dec |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
Grant
revenue |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
1,840,216 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
4,685,658 |
|
|
2,695,633 |
|
|
15,836,828 |
|
|
8,548,520 |
|
General and administrative |
|
1,792,222 |
|
|
1,449,227 |
|
|
7,138,403 |
|
|
6,104,631 |
|
Loss
on impairment of goodwill |
|
- |
|
|
- |
|
|
8,865,909 |
|
|
- |
|
Total
operating expenses |
|
6,477,880 |
|
|
4,144,860 |
|
|
31,841,140 |
|
|
14,653,151 |
|
Loss
before other income (expense) |
|
(6,477,880 |
) |
|
(4,144,860 |
) |
|
(31,841,140 |
) |
|
(12,812,935 |
) |
Change in fair value of warrant liability |
|
1,884 |
|
|
39,488 |
|
|
14,454 |
|
|
44,693 |
|
Interest income (expense), net |
|
105,060 |
|
|
499 |
|
|
218,730 |
|
|
4 |
|
Net loss |
$ |
(6,370,936 |
) |
$ |
(4,104,873 |
) |
$ |
(31,607,956 |
) |
$ |
(12,768,238 |
) |
|
|
|
|
|
|
|
|
|
Loss
attributed to common stockholders |
$ |
(6,370,936 |
) |
$ |
(4,104,873 |
) |
$ |
(31,607,956 |
) |
$ |
(12,768,238 |
) |
Loss per common share — basic and
diluted |
$ |
(2.83 |
) |
$ |
(2.27 |
) |
$ |
(14.88 |
) |
$ |
(7.72 |
) |
Weighted-average number of common shares outstanding — basic
and diluted |
|
2,253,512 |
|
|
1,809,136 |
|
|
2,124,511 |
|
|
1,654,638 |
|
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