Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage
biopharmaceutical company developing cancer therapies for patients
in need of new treatment options, today reported important
corporate events and its financial results for the first quarter
ended March 31, 2022.
“We have high expectations for 2022 as we build
on the progress achieved during the first quarter and recent
weeks,” stated David Arthur, CEO of Salarius Pharmaceuticals.
“Recent highlights include our acquisition of an intellectual
property portfolio, including the drug candidate SP-3164, which is
now the foundation of our new drug development program focused on
targeted protein degradation (TPD), and the subsequent completion
of SP-3164’s pre-IND meeting process with the FDA. TPD is a
fast-growing field of cancer drug research with significant
potential to improve patient’s lives and a market potential
estimated in the billions of dollars. Coupled with our
existing clinical programs for seclidemstat, our most advanced
cancer drug candidate, Salarius is now pursuing multiple drug
development programs built around two exciting approaches to cancer
drug development – protein inhibition and protein degradation.”
Financial
Highlights:
- Cash and cash equivalents totaled $24.2 million on March 31,
2022; $2.3 million direct offering with institutional investors
closed on April 26, 2022; Estimated cash runway extends into
2023.
- For the three-month period ended March 31, 2022, net loss per
common share, basic and diluted, of $0.13, compared to $0.06 for
the same period in 2021
Recent Business and Corporate
Highlights:
- 2022 Annual Meeting of Stockholders announced for June 15,
2022; Company is seeking stockholder approval or authorization of
four proposals and is encouraging stockholders to participate and
vote their shares of Salarius Pharmaceuticals stock.
- Advancing new TPD cancer drug development program built around
an intellectual property portfolio acquired from DeuteRx LLC in
January 2022. The lead development candidate is SP-3164 for which
the company has:
- Completed the FDA Pre-IND meeting process, which has informed
planned IND-enabling studies and activities; and
- Initiated preclinical studies to support the potential
submission of an Investigational New Drug (IND) application with
initial preclinical data anticipated in the second half of 2022 and
potential for first clinical trial in 2023.
- Salarius continues its enrollment activities to advance
clinical exploration of seclidemstat in the treatment of sarcomas,
while MD Anderson Cancer Center is enrolling patients in the
investigator-initiated trial exploring seclidemstat as a treatment
for hematologic cancers.
- Data updates expected in 2022 from both ongoing Phase 1/2
clinical trials.
“As both CEO and a stockholder of Salarius, I am
excited about the upcoming value-building opportunities we expect
to achieve” continued Mr. Arthur. “On June 15, the Company will
hold its Annual Meeting of Stockholders, where Salarius is asking
stockholders to vote on several proposals that we believe will
augment these opportunities. All stockholders are encouraged to
vote their shares through their brokerage website or through the
proxy materials.”
“We believe the combination of multiple drug
development programs built around two exciting approaches to cancer
drug development – protein inhibition and protein degradation –
coupled with upcoming value-building opportunities will benefit
both current and future stockholders” concluded Mr. Arthur.
Three-Month Financial
Results:
For the three-month period ended March 31, 2022,
Salarius’ reported net loss was $6.1 million, or $0.13 per basic
and diluted share, compared to a net loss of $1.9 million, or $0.06
per basic and diluted share for the same period in 2021. The loss
for the three-month period ended March 31, 2022, increased by $4.2
million compared to the same time span last year, primarily because
the Company had higher research and development costs and no grant
revenue in the current period.
Net cash used for operating activities during
the three-month period ended March 31, 2022, totaled $3.5 million,
compared to $2.7 million during the same span last year.
As of March 31, 2022, total cash, cash
equivalents, and restricted cash were $24.2 million, compared to
$36.6 million as of March 31, 2021. The decrease in cash was
primarily driven by the Company’s continued spend on operating
activities, especially research and development activities and less
financing activities involved since Q1 2021. Current cash and cash
equivalents are expected to fund our current planned operations
into 2023.
Conference Call
Information:
Salarius Pharmaceuticals will host a conference
call and live audio webcast on Thursday, May 12, 2022, at 5:00 p.m.
ET, to discuss its corporate and financial results for the first
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: 8798303
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 12, 2022.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company developing cancer
therapies for patients in need of new treatment options. Salarius’
product portfolio includes seclidemstat, 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 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 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 StatementsThis
press release contains information that includes or is based upon
“forward-looking statements” within the meaning of the Securities
Litigation Reform Act of 1995. Forward-looking statements provide
our expectations or forecasts regarding future events. You can
identify these statements by the fact they do not relate strictly
to historical or current facts. They may use words such as
“anticipate,” “believe,” “indicate,” “estimate,” “expect,”
“underway,” “will,” and other terms of similar meaning in
connection with a discussion of future operating or financial
performance. In particular, forward-looking statements include
statements relating to intended future actions; the potential size
of the commercial market for our drug candidates; the focus of our
drug development programs; whether we will realize or achieve any
value-building opportunities or other benefits to stockholders; the
functionality and capabilities of our drug candidates; our ability
to expand our pipeline into new areas of drug research; the
continuation or advancement of new and existing clinical trials;
timing of updates from our clinical trials and other activities;
plans to file INDs or other regulatory filings; and ability of cash
and cash equivalents to fund our operations into the future. Any or
all of our forward-looking statements here and elsewhere may turn
out to be wrong. They can be affected by inaccurate assumptions or
by known or unknown risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements and from expected or historical results. Many such
factors will be important in determining our actual future results.
Consequently, no forward-looking statement can be guaranteed. In
particular, you should read those risks described under the heading
“Risk Factors” in our Securities and Exchange Commission filings,
including in our annual and quarterly reports. We undertake no
obligation to correct or update any forward-looking statements,
whether as a result of new information, future developments, or
otherwise, except to the extent required by applicable law. These
forward-looking statements (except as may be otherwise noted) speak
only as of the date of this press release. Factors or events that
could cause our actual results to differ may emerge from time to
time, and it is not possible for us to predict all of them. You are
advised to consult any further disclosures we make on related
subjects in our reports to the SEC.
Contacts
Tiberend Strategic Advisors, Inc.
Investor RelationsJason Rando/Daniel
Kontoh-Boatengjrando@tiberend.com dboateng@tiberend.com
Media RelationsBill
Bordenbborden@tiberend.com
|
SALARIUS PHARMACEUTICALS, INC.CONSOLIDATED BALANCE
SHEETS |
|
|
3/31/2022 |
|
12/31/2021 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
24,193,554 |
|
|
$ |
29,214,380 |
|
Prepaid expenses and other current assets |
|
662,854 |
|
|
|
949,215 |
|
Total current assets |
|
24,856,408 |
|
|
|
30,163,595 |
|
Grants receivable from CPRIT |
|
1,610,490 |
|
|
|
1,610,490 |
|
Property and equipment,
net |
|
4,190 |
|
|
|
7,880 |
|
Other assets |
|
170,907 |
|
|
|
185,994 |
|
Goodwill |
|
8,865,909 |
|
|
|
8,865,909 |
|
Total assets |
$ |
35,507,904 |
|
|
$ |
40,833,868 |
|
Liabilities and
stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,693,398 |
|
|
$ |
1,543,096 |
|
Accrued expenses and other current liabilities |
|
390,233 |
|
|
|
553,269 |
|
Warrant liability |
|
8,710 |
|
|
|
14,518 |
|
Total liabilities |
|
2,092,341 |
|
|
|
2,110,883 |
|
|
|
|
|
|
|
|
|
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; 46,697,194 and 45,241,808
shares issued and outstanding on March 31, 2022 and
December 31, 2021, respectively |
|
4,669 |
|
|
|
4,524 |
|
Additional paid-in
capital |
|
71,717,311 |
|
|
|
70,915,653 |
|
Accumulated deficit |
|
(38,306,417 |
) |
|
|
(32,197,192 |
) |
Total stockholders'
equity |
|
33,415,563 |
|
|
|
38,722,985 |
|
Total liabilities and
stockholders' equity |
$ |
35,507,904 |
|
|
$ |
40,833,868 |
|
SALARIUS PHARMACEUTICALS, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
|
Three Months Ended |
|
|
|
March 31 |
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
Grant revenue |
$ |
— |
|
|
$ |
1,268,829 |
|
Operating expenses: |
|
|
|
Research and development |
|
4,439,475 |
|
|
|
1,740,655 |
|
General and administrative |
|
1,677,754 |
|
|
|
1,332,769 |
|
Total operating expenses |
|
6,117,229 |
|
|
|
3,073,424 |
|
Loss before other income
(expense) |
|
(6,117,229 |
) |
|
|
(1,804,595 |
) |
Change in fair value of
warrant liability |
|
5,808 |
|
|
|
(46,054 |
) |
Interest income (expense),
net |
|
2,196 |
|
|
|
(1,247 |
) |
Loss from continuing
operations |
|
(6,109,225 |
) |
|
|
(1,851,896 |
) |
Net loss |
$ |
(6,109,225 |
) |
|
$ |
(1,851,896 |
) |
|
|
|
|
Loss per common
share — basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.06 |
) |
Weighted-average number of common shares outstanding — basic
and diluted |
|
46,255,210 |
|
|
|
30,551,316 |
|
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