Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
technology, today reported financial results for the third quarter
ended September 30, 2019 and provided an update on corporate
progress.
“Throughout the third quarter we have continued to execute
against the strategic goals we set early in the year,” said Dr.
David Giljohann, Exicure’s chief executive officer. “Our
immuno-oncology clinical trial is progressing as anticipated, while
we continue to lay the groundwork for expanding our SNA platform in
neurology. This scientific progress has been matched with expanded
financial resources arising from our recent $63.3 million public
offering and Nasdaq listing. In the coming quarters we look forward
to building our organization to enhance our strategic execution,”
concluded Dr. Giljohann.
Third Quarter Corporate Progress and Recent
Developments
- AST-008 Phase 1b/2 clinical trial on track
- As of November 1, 2019, we have dosed 13 patients in the first
four cohorts of the Phase 1b stage of the clinical trial;
- No treatment related adverse events or dose-limiting toxicity
was observed;
- Expect to disclose preliminary results from the Phase 1b in
December of 2019.
- Presented Positive Biomarker Results from Clinical Trial of
XCUR17
- Presentation at Oligonucleotide Therapeutics Society
highlighted work by Dr. James Krueger at The Rockefeller
University, in collaboration with Exicure, which examined the
effects of XCUR17 on skin biopsies collected from patients in the
Phase 1 trial;
- Clinical findings in the Phase 1 trial matched reductions in
keratin 16 protein and epidermal thickness observed in the patient
biopsies;
- Clinical findings were also shown to be correlated with
downstream psoriasis-related inflammation markers including
reductions in beta defensin 4A, interleukin 19, and interleukin 36A
versus psoriatic skin at baseline.
- Enhanced Financial Resources
- Closed oversubscribed underwritten public offering of
31,625,000 shares of common stock at $2.00 per share for gross
proceeds of $63.3 million with net proceeds of approximately of
$58.8 million;
- Up-listed from the OTC to the Nasdaq Stock Market.
Third Quarter 2019 Financial Results and Financial
Guidance
Cash Position: Cash and cash equivalents were $70.4
million as of September 30, 2019 compared to $26.3 million as of
December 31, 2018.
Research and Development (R&D) Expenses: Research and
development expenses were $4.2 million for the quarter ended
September 30, 2019, compared to $4.0 million for the quarter ended
September 30, 2018. The increase was primarily due to higher
employee-related expenses of $0.5 million and higher platform and
discovery related expense of $0.1 million, partially offset by
lower clinical development program expenses of $0.4 million.
General and Administrative (G&A) Expenses: General
and administrative expenses were $2.2 million for the quarter ended
September 30, 2019, compared to $1.9 million for the quarter ended
September 30, 2018. This increase is primarily due to costs related
to the recruitment of two new board members and an open executive
position, as well as incurred Nasdaq listing costs.
Net Loss: Net loss was $5.8 million for the quarter ended
September 30, 2019, compared to net loss of $5.3 million for the
quarter ended September 30, 2018. This increase was due to a $0.4
million reduction in Other income attributable to the (non-cash)
fair value adjustment of our common stock warrant liability, the
$0.3 million increase in G&A expenses described above, the $0.2
million increase in R&D expenses described above, partially
offset by the addition of $0.5 million of revenue associated with
the Dermelix transaction.
Cash Runway Guidance: We believe that, based on our
current operating plans and estimates of expenses, as of the date
of this press release, our existing cash and cash equivalents will
be sufficient to meet our anticipated cash requirements in excess
of twelve months.
About Exicure, Inc.
Exicure, Inc. is a clinical-stage biotechnology company
developing therapeutics for immuno-oncology, inflammatory diseases
and genetic disorders based on our proprietary Spherical Nucleic
Acid, or SNA technology. Exicure believes its proprietary SNA
architecture has distinct chemical and biological properties that
may provide advantages over other nucleic acid therapeutics and may
have therapeutic potential to target diseases not typically
addressed with other nucleic acid therapeutics. Exicure's lead
program is in a Phase 1b/2 trial in patients with advanced solid
tumors. Exicure is based outside of Chicago, IL and in Cambridge,
MA. www.exicuretx.com
Forward Looking Statements
This press release contains forward-looking statements
(including within the meaning of Section 21E of the United States
Securities Exchange Act of 1934, as amended, and Section 27A of the
United States Securities Act of 1933, as amended) concerning the
Company, the Company’s technology, potential therapies, cash
requirements and projections and other matters. Forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and
include words such as “may,” “will,” “should,” “would,” “expect,”
“plan,” “believe,” “intend,” “look forward,” and other similar
expressions among others. Statements that are not historical facts
are forward-looking statements. Forward-looking statements are
based on current beliefs and assumptions that are subject to risks
and uncertainties and are not guarantees of future performance.
Actual results could differ materially from those contained in any
forward-looking statement as a result of various factors,
including, without limitation: unexpected costs, charges or
expenses that reduce cash runway; that Exicure’s pre-clinical or
clinical programs do not advance or result in approved products on
a timely or cost effective basis or at all; the cost, timing and
results of clinical trials; that many drug candidates that have
completed Phase 1 trials do not become approved drugs on a timely
or cost effective basis or at all; the ability to enroll patients
in clinical trials; possible safety and efficacy concerns;
regulatory developments; and the ability of Exicure to protect its
intellectual property rights. Risks facing the Company and its
programs are set forth in the Company’s filings with the SEC.
Except as required by applicable law, the Company undertakes no
obligation to revise or update any forward-looking statement
(including without limitation its cash runway guidance) or to make
any other forward-looking statements, whether as a result of new
information, future events or otherwise.
EXICURE, INC.
UNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEETS
(in thousands, except share
and per share data)
September 30, 2019
December 31, 2018
ASSETS
Current assets:
Cash and cash equivalents
$
70,392
$
26,268
Unbilled revenue receivable
—
3
Receivable from related party
16
10
Prepaid expenses and other assets
1,345
1,382
Total current assets
71,753
27,663
Property and equipment, net
1,597
1,061
Other noncurrent assets
456
32
Total assets
$
73,806
$
28,756
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Current portion of long-term debt
$
4,912
$
—
Accounts payable
1,110
500
Accrued expenses and other current
liabilities
2,237
1,543
Current portion of deferred revenue
14
—
Total current liabilities
8,273
2,043
Long-term debt, net
—
4,925
Common stock warrant liability
437
797
Other noncurrent liabilities
144
39
Total liabilities
$
8,854
$
7,804
Stockholders’ equity:
Common stock, $0.0001 par value per share;
200,000,000 shares authorized, 75,994,790 issued and outstanding,
September 30, 2019; 44,358,000 issued and outstanding, December 31,
2018
8
4
Additional paid-in capital
136,260
75,942
Accumulated deficit
(71,316
)
(54,994
)
Total stockholders' equity
64,952
20,952
Total liabilities and stockholders’
equity
$
73,806
$
28,756
EXICURE, INC. UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands,
except share and per share data)
Three Months Ended, September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Revenue:
Collaboration revenue
$
527
$
57
$
986
$
112
Total revenue
527
57
986
112
Operating expenses:
Research and development expense
4,245
4,001
11,073
11,111
General and administrative expense
2,228
1,919
6,421
5,952
Total operating expenses
6,473
5,920
17,494
17,063
Operating loss
(5,946
)
(5,863
)
(16,508
)
(16,951
)
Other income (expense), net:
Interest expense
(203
)
(170
)
(589
)
(497
)
Other income (loss), net
333
709
775
(210
)
Total other income (loss), net
130
539
186
(707
)
Net loss
$
(5,816
)
$
(5,324
)
$
(16,322
)
$
(17,658
)
Basic and diluted loss per common
share
$
(0.09
)
$
(0.13
)
$
(0.32
)
$
(0.44
)
Basic and diluted weighted-average common
shares outstanding
64,651,040
41,527,922
51,200,072
40,121,295
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version on businesswire.com: https://www.businesswire.com/news/home/20191107005256/en/
MacDougall Karen Sharma 781-235-3060 ksharma@macbiocom.com
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