- Continues to advance preclinical discovery of its SCN9A
research program, anticipates reporting results from initial in
vivo animal studies by year-end 2022
- Continues progression of work with partnered programs, with
plan of meeting potential pre-clinical milestones in 2023
Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
technology, today reported full year financial results for the
quarter and year ended December 31, 2021 and provided an update on
its business strategy and corporate progress.
“This past year brought significant challenges to our
organization that prompted strategic decisions at year-end to
refocus our business strategy on our next generation pipeline and
investments in neuroscience in order to be cash efficient,” said
Matthias Schroff, Ph.D., Chief Executive Officer of Exicure.
“Entering 2022, I believe we are off to a good start as we have now
fully aligned our resources to support development of our
preclinical programs targeting SCN9A for the treatment of pain and
advancement of ongoing discovery associated with our Ipsen and
AbbVie partner programs. I want to acknowledge our team for their
commitment to moving our company forward during this difficult time
and thank them for their continued dedication in our mission to
pursue treatments for patients with unmet medical needs,” concluded
Dr. Schroff.
Corporate Progress
Corporate highlights for 2021 include:
- Entered into an exclusive collaboration targeting rare
neurodegenerative disorders with Ipsen in July 2021 to research,
develop, and commercialize novel Spherical Nucleic Acids (SNAs) as
potential investigational treatments for Huntington’s disease (HD)
and Angelman syndrome (AS).
- Completed a strategic review in fourth quarter of 2021, which
resulted in a restructuring and pipeline focus on preclinical
programs targeting SCN9A in pain and partnered programs.
- Completed a $11.5 million registered direct offering in
December 2021.
Priorities for 2022 include:
- Advancement of the Company’s SCN9A preclinical discovery
program. Exicure anticipates results from initial in vivo animal
studies by year-end 2022 with goal of therapeutic candidate
selection in the second half of 2023.
- Progressing work with the Company’s partnered programs, with
plan of meeting potential pre-clinical milestones in 2023.
- Actively pursuing strategic out-license opportunities for
cavrotolimod.
- Ongoing pursuit of near-term partnering opportunities for pain
and other neuroscience programs.
2021 Financial Results
Cash Position: Cash, cash equivalents and short-term
investments were $48.3 million as of December 31, 2021, as compared
to $83.3 million as of December 31, 2020. The Company expects that
its cash and cash equivalents will fund its current operations into
the fourth quarter of 2022.
Revenue: Revenue was $(0.5) million during the year ended
December 31, 2021, reflecting a decrease of $17.1 million from
revenue of $16.6 million for the year ended December 31, 2020. The
decrease in revenue is mostly due to a decrease in non-cash revenue
of $19.3 million associated with the Company’s collaboration with
AbbVie partially offset by the recognition of non-cash revenue of
$2.3 million associated with the Company’s collaboration with
Ipsen. Revenue recognized (reversed) associated with the Company’s
collaboration with AbbVie for the year ended December 31, 2021
reflects the cumulative catchup adjustment (reduction) of revenue
in connection with the change in estimate that resulted from a
change in workplan related to the Company’s collaboration with
AbbVie during the third quarter of 2021.
Research and Development (R&D) Expense: Research and
development expenses were $49.0 million for the year ended December
31, 2021, as compared to $32.1 million for the year ended December
31, 2020. The increase is due to an increase in clinical trial
activities during the year as well as the impact of higher than
average headcount during 2021 as compared to the prior year
period.
General and Administrative (G&A) Expense: General and
administrative expenses were $13.1 million for the year ended
December 31, 2021, as compared with $10.0 million for the year
ended December 31, 2020. The increase is mostly due to costs
related to new hires needed to grow the Company as it evolved,
one-time severance costs of $0.6 million associated with the
December 2021 restructuring, as well as higher legal costs and
other costs associated with being a public company.
Net Loss: The Company had a net loss of $64.1 million for
the year ended December 31, 2021, as compared to a net loss of
$24.7 million for the year ended December 31, 2020. The increase in
net loss was primarily driven by lower non-cash revenue during the
period largely impacted by the reversal of non-cash revenue in 2021
associated with Exicure’s collaboration with AbbVie as well as
higher R&D and G&A costs as discussed above.
Going Concern: The Company’s expectation to continue to
generate operating losses and negative operating cash flows in the
future and the need for additional funding to support its planned
operations raise substantial doubt regarding its ability to
continue as a going concern within one year after the date that its
consolidated financial statements for the year ended December 31,
2021 are issued. The Company will require additional financing to
address the Company’s working capital and other financing
needs.
About Exicure
Exicure, Inc. is a an early-stage biotechnology company
developing nucleic acid therapies targeting ribonucleic acid
against validated targets to neurological disorders and hair loss.
Exicure believes that its proprietary Spherical Nucleic Acid, or
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 based in
Chicago, IL. For further information, see www.exicuretx.com.
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 may be deemed forward looking including, but not
limited to: statements regarding the Company’s business plans and
objectives; the substantial doubt about the Company’s ability to
continue as a going concern; the Company’s anticipated cash runway;
the Company’s ability to grow its strategic partnerships and the
potential achievement of any clinical trial milestones pursuant to
license and collaboration agreements; the continuation of
pre-clinical discovery of potential therapeutic candidates and the
ability to develop, and possibly partner, product candidates for
the treatment of neurological conditions; the potential advantages
and clinical benefit of the Company’s SNA platform and advancement
of SCN9A preclinical discovery and the timing of results from
initial studies and therapeutic candidate selection; the pursuit of
out-license opportunities for cavrotolimod; the future prospects of
the Company; and the Company’s ability to execute on programs and
reduce overall costs. Words such as “plans,” “expects,” “will,”
“anticipates,” “continue,” “expand,” “advance,” “develop”
“believes,” “guidance,” “target,” “may,” “remain,” “project,”
“outlook,” “intend,” “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. 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: market
and other conditions; the Company’s ability to adequately finance
its business and seek alternative sources of financing 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 unproven approach of the Company’s
SNA platform; the Company’s preclinical programs do not advance
into clinical or result in approved products on a timely or cost
effective basis or at all; the results of early clinical trials are
not always being predictive of future results; 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; regulatory developments; the ability of the
Company to obtain or maintain its existing or future
collaborations, licenses or contractual relationships and/or
collaborate successfully with strategic partners; regulatory
developments; exposure to litigation, including patent litigation,
and/or regulatory actions; the ability of the Company to protect
its intellectual property rights; and the impact of the completion
of the Company’s previously reported internal investigation on the
Company’s business and diversion of management time and attention
on related issues, including any related investigations or
proceedings, shareholder lawsuits, reputational harm, or the
possibility that executives or other employees may resign. 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 Quarterly Report on Form 10-Q for
the quarter ended September 30, 2021 filed with the Securities and
Exchange Commission on November 19, 2021, 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)
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
34,644
$
33,262
Short-term investments
4,497
48,818
Accounts receivable
—
11
Prepaid expenses and other assets
4,525
4,231
Total current assets
43,666
86,322
Property and equipment, net
3,927
4,123
Right-of-use asset
7,950
8,606
Other noncurrent assets
9,325
1,393
Total assets
$
64,868
$
100,444
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Current portion of long-term debt
$
6,873
$
—
Accounts payable
3,413
1,866
Accrued expenses and other current
liabilities
6,464
3,525
Deferred revenue, current
17,317
8,343
Total current liabilities
34,067
13,734
Long-term debt, net
—
16,589
Deferred revenue, noncurrent
11,509
—
Lease liability, noncurrent
7,404
7,959
Other noncurrent liabilities
656
656
Total liabilities
$
53,636
$
38,938
Stockholders’ equity:
Preferred stock, $0.0001 par value per
share; 10,000,000 shares authorized, no shares issued and
outstanding, December 31, 2021 and December 31, 2020
—
—
Common stock, $0.0001 par value per share;
200,000,000 shares authorized, 108,783,144 issued and outstanding,
December 31, 2021; 87,651,352 issued and outstanding, December 31,
2020
11
9
Additional paid-in capital
181,290
167,379
Accumulated other comprehensive (loss)
income
(2
)
83
Accumulated deficit
(170,067
)
(105,965
)
Total stockholders' equity
11,232
61,506
Total liabilities and stockholders’
equity
$
64,868
$
100,444
EXICURE, INC.
UNAUDITED CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share
and per share data)
Year Ended December
31,
2021
2020
Revenue:
Collaboration revenue
$
(483
)
$
16,613
Total revenue
(483
)
16,613
Operating expenses:
Research and development expense
48,979
32,094
General and administrative expense
13,087
9,955
Total operating expenses
62,066
42,049
Operating loss
(62,549
)
(25,436
)
Other (expense) income, net:
Dividend income
8
47
Interest income
141
972
Interest expense
(1,691
)
(573
)
Other (expense) income, net
(11
)
322
Total other (expense) income, net
(1,553
)
768
Net loss before provision for income
taxes
(64,102
)
(24,668
)
Provision for income taxes
—
—
Net loss
$
(64,102
)
$
(24,668
)
Basic and diluted loss per common
share
$
(0.72
)
$
(0.28
)
Weighted-average basic and diluted common
shares outstanding
88,617,332
87,203,588
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220325005435/en/
Media: Karen Sharma MacDougall 781-235-3060
ksharma@macbiocom.com
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