Exicure, Inc.® (NASDAQ: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
technology, today reported financial results for the quarter ended
September 30, 2021 and provided an update on corporate
progress.
“I would first like to recognize the amazing work from the
high-quality team members at Exicure as we continue to invest into
driving value from our SNA platform technology, most notably being
recognized in the third quarter through the consummation of another
strategic partnership which brought in additional non-dilutive
capital,” said Exicure CEO Dr. David Giljohann. “It is important to
note our SNA platform is grounded in 15 years of intensive and
rigorous scientific development across industry and academia.
Although a recent claim of improprieties from one researcher,
specifically related to our FXN program, are concerning, we are
highly confident in our platform technology which delivers DNA and
RNA into cells and tissues more effectively. I remain proud of the
team members at Exicure who continue to work hard to bring new
medicines to patients in need.”
Corporate Updates
As previously reported, on November 9, 2021, the Audit Committee
of the Board of Directors of the Company was notified of a claim
made by a former Company senior researcher regarding alleged
improprieties that researcher claims to have committed with respect
to the Company’s XCUR-FXN preclinical program for the treatment of
Friedreich’s ataxia. The Audit Committee has retained external
counsel to conduct an internal investigation of the claim. The
Company is currently unable to predict the timing or outcome of the
investigation.
Pipeline Highlights & Updates
Neurology
Ipsen Collaboration
- On August 2, 2021, Ipsen Biopharm Limited (Ipsen) and Exicure
announced an exclusive collaboration agreement to research,
develop, and commercialize novel Spherical Nucleic Acids (SNAs) as
potential investigational treatments for Huntington’s disease (HD)
and Angelman syndrome (AS). Under the terms of the collaboration:
- Exicure received a $20 million upfront payment and is eligible
to receive up to $1 billion in option exercise fees and milestone
payments should Ipsen opt into both programs, as well as tiered
royalties.
- Collaborative efforts associated with the Ipsen partnership
commenced in the third quarter of 2021, and the upfront payment was
recorded as deferred revenue on the Company’s balance sheet and
will be recognized as revenue on the Company’s income statement
related to services as the Company’s performance obligations are
satisfied.
XCUR-FXN–Friedreich’s Ataxia
- Exicure remains committed to maintaining its development plans
and to pursuing its business strategy in the best interests of its
stockholders as well as the patients it looks to serve; however, it
acknowledges that, at this point in time, it is unable to determine
the potential impact of the asserted claim on its research and
development activities or the timing of completion of its current
research and development of its XCUR-FXN preclinical program for
the treatment of FA, as the investigation of the asserted claim
remains ongoing.
Immuno-Oncology
Cavrotolimod (AST-008)
- The Phase 1b/2 clinical trial of intra-tumoral cavrotolimod in
combination with approved checkpoint inhibitors pembrolizumab or
cemiplimab, for the treatment of patients with advanced or
metastatic Merkel cell carcinoma (MCC) or cutaneous squamous cell
carcinoma (CSCC), is open and actively enrolling patients, and as
of November 4, 2021:
- the Company had 25 clinical trial sites activated and 2
additional sites pending activation of an approximate target of 27
total clinical trial sites; and
- 37 patients had been dosed with 32 mg of cavrotolimod (AST-008)
in the Phase 2 portion of the clinical trial.
- As a result of enrollment delays contributed to by COVID-19,
the Company now expects to report top-line overall response rates
(ORR) results in the second half of 2022 rather than the first half
of 2022.
Third Quarter Financial Results and Financial
Guidance
Cash Position: Cash, cash equivalents, short-term investments,
and restricted cash were $62.0 million as of September 30, 2021
compared to $57.3 million as of June 30, 2021.
Research and Development (R&D) Expenses: R&D expenses
were $16.5 million for the quarter ended September 30, 2021,
compared to $9.1 million for the quarter ended September 30, 2020.
The Company has increased full-time headcount in R&D from 48 as
of September 30, 2020 to 65 as of September 30, 2021. The increase
in R&D expense reflects this increased headcount and the
related increase in R&D activities, in addition to increased
clinical trial activities.
General and Administrative Expenses: General and administrative
expenses were $2.9 million for the quarter ended September 30,
2021, compared to $2.4 million for the quarter ended September 30,
2020. This increase is primarily due to costs related to new hires
needed to grow the Company as it evolves, as well as higher legal
costs.
Net Loss: Exicure had a net loss of $23.5 million for the
quarter ended September 30, 2021 compared to a net loss of $8.8
million for the quarter ended September 30, 2020. The increase in
net loss was primarily driven by higher R&D costs to advance
Exicure’s pipeline as discussed above, as well as lower non-cash
revenue during the period largely impacted by the reversal of
non-cash revenue associated with Exicure’s collaboration with
AbbVie Inc. (AbbVie). During the third quarter of 2021, as a result
of a change in the workplan for the AbbVie collaboration, we
increased the estimated total project hours to complete our
research services associated with the AbbVie collaboration, which
resulted in less progress occurring to date compared to the
increased estimate of total project hours and thus requiring an
adjustment to cumulative revenue recognized through September 30,
2021.
Cash Runway Guidance: The Company believes that, based on its
current operating plans and estimates of future expenses, as of the
date of this press release, it is uncertain whether the Company’s
existing cash and cash equivalents is sufficient to fund operations
over the next twelve months. As a result, there is substantial
doubt about the Company’s ability to continue as a going
concern.
For further financial information for the period ending
September 30, 2021, please refer to the financial statements
appearing at the end of this release.
About Exicure, Inc.
Exicure, Inc. is a clinical-stage biotechnology company
developing therapeutics for neurology, immuno-oncology,
inflammatory diseases and other genetic disorders based on its
proprietary Spherical Nucleic Acid, or SNA technology. Exicure
believes that 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 is in preclinical development of XCUR-FXN, a
lipid-nanoparticle SNA–based therapeutic candidate, for the
intrathecal treatment of Friedreich’s ataxia (FA). Exicure’s
therapeutic candidate cavrotolimod (AST-008) is in a Phase 1b/2
clinical trial in patients with advanced solid tumors. Exicure is
based in Chicago, IL and in Cambridge, MA. For more information,
visit Exicure’s website at www.exicuretx.com.
Exicure Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements in this press release other than statements of
historical fact could be deemed forward looking including, but not
limited to, statements regarding the Company’s exclusive
collaboration with Ipsen, including the ability of the Company to
realize contingent milestone payments and royalties under the
collaboration agreement with Ipsen; statements regarding the
design, timing and results of the Company’s Phase 1b/2 clinical
trial of cavrotolimod, including patient enrollment expectations
and opening of additional clinical trial sites; the potential of
cavrotolimod to provide therapeutic benefit to patients with MCC
and CSCC; the initiation, timing and results of the Company’s other
preclinical studies and clinical trials, including XCUR-FXN; the
ability of SNAs to potentially enhance drug delivery to previously
inaccessible target tissues and other benefits of SNAs, including
their ability to address the genetic challenges posed by
Friedreich’s ataxia and the potential to provide therapeutic
benefit to patients with Huntington’s disease and Angelman
syndrome; the advancement, timing and success of the Company’s
preclinical and clinical programs; the Company’s ability to advance
its clinical and preclinical pipeline to benefit patients with
unmet medical need; the Company’s expectations with respect to its
continued growth; the Company’s anticipated cash runway; statements
regarding the internal investigation being conducted by the Audit
Committee including, but not limited to, the timing and scope of
the investigation; and the Company’s business plans and objectives.
Words such as “plans,” “expects,” “will,” “anticipates,”
“continue,” “expand,” “advance,” “believes,” “guidance,” “target,”
“may,” “remain,” “project,” “outlook,” “intend,” “project,”
“estimate,” “could,” “should,” and other words and terms of similar
meaning and expression are intended to identify forward-looking
statements, although not all forward-looking statements contain
such terms. The forward-looking statements in this press release
speak only as of the date of this press release, and the Company
undertakes no obligation to update these forward-looking
statements. Forward-looking statements are based on management’s
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: the risks that the ongoing COVID-19
pandemic may disrupt the Company’s business and/or the global
healthcare system (including its supply chain) more severely than
it has to date or more severely than anticipated; unexpected costs,
charges or expenses that reduce the Company’s capital resources;
the Company’s preclinical 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 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; risks that
preliminary results from preclinical studies and clinical trials
are not necessarily predictive of future results; the ability of
the Company to collaborate successfully with strategic partners;
regulatory developments; exposure to litigation, including patent
litigation, and/or regulatory actions; and the ability of the
Company to protect its intellectual property rights; the time
necessary for the Audit Committee to complete its investigation and
review; the diversion of management attention to the internal
investigation; the final conclusions and outcome of the Audit
Committee and board of directors following the completion of its
investigation and review, including any related investigations or
proceedings. Given these risks and uncertainties, you are cautioned
not to place undue reliance on such forward-looking statements. For
a discussion of other risks and uncertainties, and other important
factors, any of which could cause the Company’s actual results to
differ from those contained in the forward-looking statements, see
the section titled “Risk Factors” in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2020, as updated by the
Company’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information or to publicly announce the results of any revisions to
any of such statements to reflect future events or developments,
except as required by law.
EXICURE, INC.
UNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEETS
(in thousands, except share
and per share data)
September 30,
2021
December 31,
2020
ASSETS
Current assets:
Cash and cash equivalents
$
51,885
$
33,262
Short-term investments
8,953
48,818
Accounts receivable
—
11
Prepaid expenses and other assets
3,309
4,231
Total current assets
64,147
86,322
Property and equipment, net
4,171
4,123
Right-of-use asset
8,117
8,606
Other noncurrent assets
1,465
1,393
Total assets
$
77,900
$
100,444
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
2,485
$
1,866
Accrued expenses and other current
liabilities
5,480
3,525
Deferred revenue, current
14,015
8,343
Total current liabilities
21,980
13,734
Long-term debt, net
16,801
16,589
Deferred revenue, noncurrent
16,929
—
Lease liability, noncurrent
7,551
7,959
Other noncurrent liabilities
656
656
Total liabilities
$
63,917
$
38,938
Stockholders’ equity:
Preferred stock, $0.0001 par value per
share; 10,000,000 shares authorized, no shares
issued and outstanding, September 30, 2021 and December 31,
2020
—
—
Common stock, $0.0001 par value per share;
200,000,000 shares authorized, 88,108,543 issued
and outstanding, September 30, 2021; 87,651,352
issued and outstanding, December 31, 2020
9
9
Additional paid-in capital
170,217
167,379
Accumulated other comprehensive (loss)
income
(1
)
83
Accumulated deficit
(156,242
)
(105,965
)
Total stockholders' equity
13,983
61,506
Total liabilities and stockholders’
equity
$
77,900
$
100,444
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,
2021
2020
2021
2020
Revenue:
Collaboration revenue
$
(3,677
)
$
2,443
$
(2,601
)
$
16,473
Total revenue
(3,677
)
2,443
(2,601
)
16,473
Operating expenses:
Research and development expense
16,457
9,139
37,562
22,222
General and administrative expense
2,947
2,424
8,937
7,227
Total operating expenses
19,404
11,563
46,499
29,449
Operating loss
(23,081
)
(9,120
)
(49,100
)
(12,976
)
Other (expense) income, net:
Dividend income
2
2
5
45
Interest income
8
205
139
832
Interest expense
(455
)
(27
)
(1,314
)
(155
)
Other (expense) income, net
(5
)
118
(7
)
271
Total other (expense) income, net
(450
)
298
(1,177
)
993
Net loss before provision for income
taxes
(23,531
)
(8,822
)
(50,277
)
(11,983
)
Provision for income taxes
—
—
—
—
Net loss
$
(23,531
)
$
(8,822
)
$
(50,277
)
$
(11,983
)
Basic and diluted loss per common
share
$
(0.27
)
$
(0.10
)
$
(0.57
)
$
(0.14
)
Weighted-average basic and diluted common
shares outstanding
88,105,066
87,227,136
88,001,222
87,160,520
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211119005281/en/
Media: Karen Sharma MacDougall 781-235-3060
ksharma@macbiocom.com
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