Company advancing SCN9A preclinical discovery
program
Exicure, Inc. (Nasdaq: XCUR), an early-stage biotechnology
company focused on the development of next generation nucleic acid
therapies targeting RNA to address both genetic and non-genetic
neurological and hair loss disorders, today reported financial
results for the quarter ended June 30, 2022 and provided an update
on its business strategy and corporate progress.
“Exicure continues to make progress with our preclinical SCN9A
program for the treatment of pain with ongoing initial in vivo
animal studies to support candidate selection in 2023,” commented
Matthias Schroff, Ph.D., Chief Executive Officer of Exicure. “We
also continue to advance our partnered programs with Ipsen and
AbbVie,” concluded Dr. Schroff.
Corporate Progress
Corporate highlights for the second quarter of 2022 include:
- We advanced the Company’s SCN9A preclinical discovery program.
Exicure anticipates results from initial in vivo animal studies by
year-end 2022, with the goal of therapeutic candidate selection in
the second half of 2023.
- We progressed work with partnered programs towards potential
pre-clinical milestones in 2023.
- We actively pursued out-license opportunities for the Company’s
clinical asset, cavrotolimod.
- We are continuing to pursue near-term partnering opportunities
for pain and other neuroscience programs.
- On June 28, 2022, we filed a Certificate of Amendment to our
Amended and Restated Certificate of Incorporation (the “Amendment”)
with the Secretary of State of the State of Delaware to effect a
one-for-thirty (1-for-30) reverse stock split of our outstanding
common stock. The Amendment became effective at 5:00 p.m. Eastern
Time on June 29, 2022.
- At the effective time of the Amendment, every thirty (30)
shares of our issued and outstanding common stock were
automatically combined and converted into one issued and
outstanding share of common stock, without any change in par value
per share. No fractional shares of the Company’s common stock was
issued to any stockholders in connection with the reverse stock
split and holders of record received a cash payment in lieu of
fractional shares.
- Our common stock began trading on The Nasdaq Capital Market on
a split-adjusted basis when the market opened on Thursday, June 30,
2022. The new CUSIP number for our common stock following the
reverse stock split is 30205M 200.
- On May 18, 2022, we closed the previously announced $5 million
private placement transaction priced at market premium.
- We sold an aggregate of 867,369 shares of the Company’s common
stock to certain accredited investors in a private placement in
public equity (“PIPE”) financing at a purchase price of $5.81 per
share, representing an approximately 45% premium to the 10-day
volume weighted-average share price from May 9, 2022.
- New investor CBI USA, Inc. led the transaction; existing
investor, Abingworth LLP, also participated.
- Net proceeds from the transaction are expected to support the
Company’s advancement of its preclinical program, including the
development of its SCN9A product candidate, as well as other
working capital and general corporate purposes.
Second Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and short-term
investments, and restricted cash were $23.4 million as of June 30,
2022, as compared to $48.3 million as of December 31, 2021. The
Company expects that its existing cash and cash equivalents, and
short-term investments will enable it to fund its current
operations early into the first quarter of 2023.
Revenue: Revenue was $2.5 million for the quarter ended
June 30, 2022, reflecting an increase of $2.4 million from revenue
of $0.1 million for the quarter ended June 30, 2021. The increase
in revenue of $2.4 million is mostly due to the recognition of
non-cash revenue of $1.8 million associated with the Company’s
collaboration with Ipsen Biopharm Limited, as well as an increase
in revenue of $0.6 million associated with the Company’s
collaboration with AbbVie Inc.
Research and Development (R&D) Expense: Research and
development expenses were $6.7 million for the quarter ended June
30, 2022, as compared to $10.8 million for the quarter ended June
30, 2021. The decrease in R&D expense for the three months
ended June 30, 2022 of approximately $4.1 million reflects a
reduction in employee headcount and fewer discovery, preclinical,
and clinical program activities resulting from the restructuring
activities that the Company announced in December 2021.
General and Administrative (G&A) Expense: General and
administrative expenses were $3.2 million for the quarter ended
June 30, 2022, as compared to $3.1 million for the quarter ended
June 30, 2021. The increase in G&A expense of approximately
$0.1 million for the three months ended June 30, 2022 was mostly
due to higher legal costs and retention award expense for current
employees, partially offset by lower compensation and related costs
in connection with a lower average headcount during the period
resulting from the restructuring activities that were announced in
December 2021, as well as lower costs for consulting, investor
relations, and board fees.
Net Loss: The Company had a net loss of $7.5 million for
the quarter ended June 30, 2022, as compared to a net loss of $14.3
million for the quarter ended June 30, 2021. The decrease in net
loss was primarily driven by lower R&D expense and higher
non-cash revenue during the period.
Going Concern: Given the Company’s current cash position,
operating plans and forecasted negative cash flows from operating
activities over the next twelve months, management believes there
is substantial doubt regarding the Company’s ability to continue as
a going concern within one year after the date that its unaudited
condensed consolidated financial statements for the quarter ended
June 30, 2022 are issued. The Company will require substantial
additional financing to address the Company’s working capital and
other financing needs to pursue its business strategy.
About Exicure
Exicure, Inc. is an early-stage biotechnology company developing
nucleic acid therapies targeting ribonucleic acid against validated
targets to neurological disorders and hair loss. The team includes
a diverse scientific group with expertise in nucleic acid
chemistry, drug development and neuroscience. Headquartered in
Chicago, Illinois, the Company conducts its discovery and
development efforts in-house with a dedicated 30,000 square foot
facility, including rapid and automated high throughput nucleic
acid synthesis and screening. 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 current business
plans and objectives; the Company’s ability to continue to meet
stock exchange listing standards; the use of proceeds of the PIPE;
the substantial doubt about the Company’s ability to continue as a
going concern; the Company’s requirements for substantial
additional financing to address the Company’s working capital and
other financing needs; the Company’s anticipated cash runway; the
Company’s ability to continue to advance its strategic partnerships
and the potential achievement of any clinical trial milestones
pursuant to such 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 timing and development of the Company’s preclinical pipeline
and achievement of expected near- and long-term milestones,
including timing of results from initial in vivo animal studies and
planned therapeutic candidate selection; the potential advantages
and clinical benefit of the Company’s SNA platform and advancement
of SCN9A preclinical discovery; the future prospects of the
Company, including of the outlicensing of its cavrotolimod program.
Words such as “plans,” “expects,” “will,” “anticipates,”
“continue,” “advance,” “believes,” “target,” “may,” “intend,”
“could,” 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; the
ability of the Company to comply with continued listing standards;
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 Annual Report on Form 10-K for the year
ended December 31, 2021 filed with the Securities and Exchange
Commission on March 25, 2022, 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)
June 30,
2022
December 31,
2021
ASSETS
Current assets:
Cash and cash equivalents
$
21,198
$
34,644
Short-term investments
997
4,497
Prepaid expenses and other assets
2,526
4,525
Total current assets
24,721
43,666
Property and equipment, net
3,325
3,927
Right-of-use asset
7,609
7,950
Other noncurrent assets
1,300
9,325
Total assets
$
36,955
$
64,868
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Current portion of long-term debt
$
—
$
6,873
Accounts payable
1,593
3,413
Accrued expenses and other current
liabilities
3,308
6,464
Deferred revenue, current
14,755
17,317
Total current liabilities
19,656
34,067
Deferred revenue, noncurrent
9,035
11,509
Lease liability, noncurrent
7,101
7,404
Other noncurrent liabilities
—
656
Total liabilities
$
35,792
$
53,636
Stockholders’ equity:
Preferred stock, $0.0001 par value per
share; 10,000,000 shares authorized, no shares issued and
outstanding, June 30, 2022 and December 31, 2021
—
—
Common stock, $0.0001 par value per share;
200,000,000 shares authorized, 4,962,231 issued and outstanding,
June 30, 2022; 3,626,073 issued and outstanding, December 31,
2021
—
—
Additional paid-in capital
187,053
181,301
Accumulated other comprehensive loss
(5
)
(2
)
Accumulated deficit
(185,885
)
(170,067
)
Total stockholders' equity
1,163
11,232
Total liabilities and stockholders’
equity
$
36,955
$
64,868
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,
2022
2021
2022
2021
Revenue:
Collaboration revenue
$
2,471
$
79
$
5,036
$
1,076
Total revenue
2,471
79
5,036
1,076
Operating expenses:
Research and development expense
6,749
10,843
13,889
21,105
General and administrative expense
3,205
3,098
6,367
5,990
Total operating expenses
9,954
13,941
20,256
27,095
Operating loss
(7,483
)
(13,862
)
(15,220
)
(26,019
)
Other income (expense), net:
Dividend income
16
2
18
3
Interest income
1
43
3
131
Interest expense
—
(450
)
(595
)
(859
)
Other expense, net
(4
)
(2
)
(24
)
(2
)
Total other income (expense), net
13
(407
)
(598
)
(727
)
Net loss before provision for income
taxes
(7,470
)
(14,269
)
(15,818
)
(26,746
)
Provision for income taxes
—
—
—
—
Net loss
$
(7,470
)
$
(14,269
)
$
(15,818
)
$
(26,746
)
Basic and diluted loss per common
share
$
(1.66
)
$
(4.86
)
$
(3.71
)
$
(9.12
)
Weighted-average basic and diluted common
shares outstanding
4,503,983
2,934,770
4,268,955
2,931,607
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version on businesswire.com: https://www.businesswire.com/news/home/20220815005576/en/
Media: Karen Sharma MacDougall 781-235-3060
ksharma@macdougall.bio
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