Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
constructs, today reported financial results for the second quarter
ended June 30, 2019 and provided an update on corporate
progress.
“The first half of 2019 continued to bring advancements across
our pipeline,” said Dr. David Giljohann, Exicure’s chief executive
officer. “We are extremely pleased with the strong progress in both
our neurology and oncology franchises, while we simultaneously
strengthened our board leadership and balance sheet. Our non-human
primate data confirmed our enthusiasm for neurological applications
of our SNA platform. Our recent $63.3 million public offering,
which closed on August 2, 2019 provides the financial resources to
advance these opportunities,” he added.
Second Quarter Corporate Progress and Recent
Developments
- Announced important preclinical data supporting development
of SNA technology in the central nervous system (CNS)
- Presented results from a biodistribution study of SNAs in the
CNS of non-human primates.
- SNAs were observed in all 46 regions of the brain
examined.
- Preclinical research underway in indications including
Huntington’s disease, spinocerebellar ataxia type 3 (SCA3), SCA2,
SCA1, Friedreich's ataxia and Batten disease.
- Expect to nominate first candidate for neurological conditions
late in 2019.
- Expanded Board with experienced biotechnology leaders
- Jeffrey L. Cleland, Bosan Hau, Bali Muralidhar and Timothy
Walbert.
- AST-008 Phase 1b/2 clinical trial continues to
progress—AST-008 is an SNA consisting of toll-like receptor 9
agonists designed for immuno-oncology applications.
- Company expects to complete Phase 1b enrollment of this trial
by late 2019.
- 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 after deducting underwriters’ discounts and
commissions and estimated offering expenses.
- Insider participation of approximately $2.6 million from David
Walt, Jay Ventakensan and Chad Mirkin.
- Up-listed from the OTC to the Nasdaq Capital Market.
Second Quarter 2019 Financial Results and Financial
Guidance
Cash Position: As of June 30, 2019, Exicure had cash and
cash equivalents of $17.2 million compared to $26.3 million as of
December 31, 2018.
Research and Development (R&D) Expenses: Research and
development expenses were $3.4 million for the quarter ended June
30, 2019, compared to $3.8 million for the quarter ended June 30,
2018. The decrease in research and development expenses of $0.4
million was primarily due to lower clinical development programs
expense of $0.6 million, partially offset by higher platform and
discovery-related expenses of $0.1 million.
General and Administrative (G&A) Expenses: General
and administrative expenses were $2.0 million for the quarter ended
June 30, 2019, compared to $2.0 million for the quarter ended June
30, 2018. Higher costs for compensation, travel, stock-based
compensation and lease expenses were offset by lower legal
fees.
Net Loss: Net loss was $5.2 million for the quarter ended
June 30, 2019, compared to net loss of $6.8 million for the quarter
ended June 30, 2018. The $1.6 million reduction in net loss was due
to the addition of $0.4 million of revenue associated with the
Dermelix transaction, the $0.4 million reduction in R&D
expenses described above and the $0.8 million reduction in loss in
Other income attributable to the (non-cash) fair value adjustment
of our common stock warrant liability.
Cash Runway Guidance: Exicure believes that, based on its
current operating plans and estimates of expenses, as of the date
of this press release, its existing cash and cash equivalents will
be sufficient to meet its 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.
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)
June 30, 2019
December 31, 2018
ASSETS
Current assets:
Cash and cash
equivalents....................................................................................................
$
17,175
$
26,268
Unbilled revenue
receivable................................................................................................
—
3
Receivable from related
party..............................................................................................
11
10
Prepaid expenses and other
assets.......................................................................................
1,574
1,382
Total current
assets.................................................................................................................
18,760
27,663
Property and equipment,
net................................................................................................
963
1,061
Other noncurrent
assets.........................................................................................................
533
32
Total
assets....................................................................................................................................
$
20,256
$
28,756
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Current portion of long-term
debt.......................................................................................
$
4,859
$
—
Accounts
payable...................................................................................................................
917
500
Accrued expenses and other current
liabilities.................................................................
1,781
1,543
Current portion of deferred
revenue....................................................................................
541
—
Total current
liabilities..........................................................................................................
8,098
2,043
Long-term debt,
net................................................................................................................
—
4,925
Common stock warrant
liability..........................................................................................
541
797
Other noncurrent
liabilities..................................................................................................
226
39
Total
liabilities........................................................................................................
$
8,865
$
7,804
Stockholders’ equity:
Common stock, $0.0001 par value per share;
200,000,000 shares authorized, 44,369,790 issued and outstanding,
June 30, 2019; 44,358,000 issued and outstanding, December 31,
2018..........................................................................................................................
4
4
Additional paid-in
capital....................................................................................................
76,887
75,942
Accumulated
deficit...............................................................................................................
(65,500
)
(54,994
)
Total stockholders'
equity.....................................................................................
11,391
20,952
Total liabilities and stockholders’
equity
$
20,256
$
28,756
EXICURE, INC. UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands,
except share and per share data)
Three Months Ended, June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Revenue:
Collaboration
revenue......................................................................
$
434
$
19
$
459
$
55
Total
revenue......................................................................
434
19
459
55
Operating expenses:
Research and development
expense.....................................................................
3,433
3,835
6,828
7,110
General and administrative
expense.....................................................................
1,985
1,988
4,193
4,033
Total operating
expenses....................................................................
5,418
5,823
11,021
11,143
Operating
loss.............................................................................
(4,984
)
(5,804
)
(10,562
)
(11,088
)
Other income (expense), net:
Interest
expense.....................................................................
(203
)
(166
)
(386
)
(327
)
Other income (loss),
net..............................................................................
(33
)
(855
)
442
(919
)
Total other income (loss),
net..............................................................................
(236
)
(1,021
)
56
(1,246
)
Net
loss.............................................................................
$
(5,220
)
$
(6,825
)
$
(10,506
)
$
(12,334
)
Basic and diluted loss per common
share...........................................................................
$
(0.12
)
$
(0.17
)
$
(0.24
)
$
(0.31
)
Basic and diluted weighted-average common
shares
outstanding..............................................................
44,368,174
39,454,821
44,363,115
39,406,324
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version on businesswire.com: https://www.businesswire.com/news/home/20190808005173/en/
Media Contacts: MacDougall Karen Sharma 781-235-3060
ksharma@macbiocom.com
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