Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
technology, today reported financial results for the quarter and
nine months ended September 30, 2020 and provided an update on
corporate progress.
“Exicure has seen growth and clinical and pre-clinical
advancement during the third quarter of this year,” said Dr. David
Giljohann, Exicure’s Chief Executive Officer. “During the third
quarter of 2020, Exicure hosted a virtual KOL event where we
presented promising interim results from our ongoing Phase 1b/2
clinical trial of cavrotolimod (AST-008) and we announced that our
poster on the safety and preliminary efficacy of intertumoral
cavrotolimod (AST-008) in combination with pembrolizumab in the
Phase 1b stage was accepted for presentation at the 2020 SITC
Annual Meeting. We also entered into a $25.0 million senior secured
term loan during the third quarter of 2020 which extends our cash
runway into 2022,” concluded Dr. Giljohann.
Exicure’s candidate, XCUR-FXN
- Despite the ongoing COVID-19 pandemic, the Company’s
laboratories have continued operations with limited impact on our
research and development activities.
- The Company remains on track to initiate IND-enabling studies
for Friedreich’s ataxia in the fourth quarter of this year.
Exicure announced promising interim results from ongoing
Phase 1b/2 clinical trial of cavrotolimod (AST-008) in September
2020
- Confirmed overall response rate (ORR) of 21% in the
dose-escalation stage across all doses, confirmed ORR 33% at the
highest dose cohort and recommended Phase 2 dose.
- Target tumor shrinkage was observed in 37% of patients.
- Preliminary data show activity in patients with melanoma,
Merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma
(CSCC).
- Phase 2 arms in both MCC and CSCC are currently
recruiting.
Cavrotolimod (AST-008) Phase 1b/2 clinical trial is open and
actively enrolling patients
- In the second quarter of 2020, the Company began enrolling
patients in the Phase 2 dose expansion phase of its Phase 1/2
clinical trial of intra-tumoral cavrotolimod (AST-008) in
combination with approved checkpoint inhibitors pembrolizumab or
cemiplimab, for the treatment of patients with advanced or
metastatic MCC or CSCC.
- Currently, 14 clinical trial sites are open for enrollment and
7 additional sites are pending activation; the Company expects to
open up to 25 sites for the Phase 2 stage of the clinical
trial.
- We continue to monitor the impact that COVID-19 may be having
on patient enrollment and safety, site initiation, and study
integrity. We have put in place and continue to maintain a variety
of measures to mitigate the effects of COVID-19 and our top
priority is to maintain patient safety and clinical trial
continuity. During the third quarter of 2020, we have observed
delays in our enrollment plans for the Phase 2 dose expansion phase
of this clinical trial. The effects of the COVID-19 pandemic or its
impact may have contributed to such delays. As a result, we have
taken additional measures to increase the enrollment of patients,
including frequent interaction with our clinical trial sites
currently open as well as increasing the number of clinical trial
sites that potentially are activated for this clinical trial so
that we may continue to enroll patients as planned. However, these
delays have caused us to lengthen our clinical development timeline
for cavrotolimod (AST-008) and we now expect to report ORR results
in the first half of 2022 rather than by year-end 2021 as
previously guided.
Third Quarter Financial Results, Financial Guidance and
Recent Developments
Cash Position: Cash, cash equivalents, and short-term
investments were $94.1 million as of September 30, 2020 compared to
$85.8 million as of June 30, 2020, and the increase is attributed
to the borrowing of the first tranche ($17.5 million) of the $25.0
million senior secured term loan with MidCap Financial Trust
(MidCap), as agent, and Silicon Valley Bank (SVB).
Research and Development (R&D) Expenses: Research and
development expenses were $9.1 million for the quarter ended
September 30, 2020, as compared to $4.2 million for the quarter
ended September 30, 2019. The Company continues to increase
staffing in the R&D function, increasing headcount from 26 at
September 30, 2019 to 48 at September 30, 2020 and the associated
increase in hiring, in addition to growth in cavrotolimod (AST-008)
clinical trial activities, has driven the Company’s increase in
R&D costs. The associated increases in platform and
discovery-related costs reflected increased preclinical R&D
activities associated with the Company’s collaboration with AbbVie
Inc. (AbbVie), increased costs related to XCUR-FXN, as well as
other preclinical discovery work in neurology and
ophthalmology.
General and Administrative (G&A) Expenses: General
and administrative expenses were $2.4 million for the quarter ended
September 30, 2020, as compared with $2.2 million for the quarter
ended September 30, 2019.
Net Loss: The Company had a net loss of $8.8 million for
the quarter ended September 30, 2020 compared to a net loss of $5.8
million for the quarter ended September 30, 2019 reflecting a
higher net loss of $3.0 million. This increase in net loss was
driven principally by the increases in R&D expenses and G&A
expenses discussed above, partially offset by the recognition of
$2.4 million of revenue associated with our collaboration with
AbbVie.
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, its existing cash, cash equivalents
and short-term investments will be sufficient to fund its
operations into 2022.
Response to COVID-19: With the global spread of the
ongoing COVID-19 pandemic in 2020, we have been closely monitoring
developments and have taken active measures to protect the health
of our employees and their families, our communities, as well as
our clinical trial investigators, patients and caregivers. We
continue to carefully manage laboratory staffing and take other
appropriate managerial actions to maintain progress on our
preclinical and collaboration programs. We also continue to work
closely with our third-party manufacturers and other partners to
manage our supply chain activities and will take such action as we
believe appropriate with our clinical operations to maintain
patient safety and clinical trial continuity.
Resignation of Director: On November 10, 2020, Helen S.
Kim resigned as a Class II director of our Board of Directors, or
the Board, as well as from the Nominating and Corporate Governance
Committee of the Board, effective immediately. Ms. Kim’s decision
to resign was not the result of any disagreement between Ms. Kim
and our Company, management, the Board or any committee thereof, on
any matter relating to our operations, policies or practices. We
thank Ms. Kim for her six years of service on the Board.
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 our
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 an
SNA–based therapeutic candidate, for the 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 anticipated and potential
impact of the COVID-19 pandemic and its impact and effects on the
company’s business and operations, including the conduct of and
timeline for its ongoing Phase 1b/2 clinical trial for cavrotolimod
(AST-008); the company’s plans, initiatives and expectations in
light of and in response to the COVID-19 pandemic; the company’s
expectations regarding its ability to adapt its business to the
evolving COVID-19 pandemic, mitigate its impacts on the business
and maintain business continuity; the design, timing and results of
its Phase 1b/2 clinical trial of cavrotolimod (AST-008) including
patient enrollment expectations and opening of additional clinical
trial sites; the initiation, timing and results of its other
preclinical studies and clinical trials, including XCUR-FXN; the
potential of the company’s SNA technology to provide therapeutic
benefit to target diseases, including its ability to address the
genetic challenges posed by Friedreich’s ataxia and other
neurological conditions; the potential of the company’s
collaborations and R&D efforts; the company’s ability to
advance its clinical and pre-clinical pipelines; the company’s
expectations with respect to its continued growth; and the
company’s anticipated extended cash runway. 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 or its impact or effects may disrupt the
company’s business and/or the global healthcare system more
severely than it has to date or more severely than anticipated,
which may have the effect of impacting or delaying the company’s
ongoing Phase 1b/2 clinical trial; 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; regulatory
developments; risks that preliminary results from clinical trials
are not necessarily predictive of future clinical trial results;
and the ability of the company to protect its intellectual property
rights. 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, 2019, 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, except as
required by law. In addition, the COVID-19 pandemic and the
associated containment efforts have had and continue to have a
serious adverse impact on the economy, the severity and duration of
which are uncertain. Government stabilization efforts have only
partially mitigated the consequences. The extent and duration of
the impact on the company’s business and operations is highly
uncertain, and that impact includes effects on its clinical trial
operations, timelines and supply chain. Factors that will influence
the impact on the company’s business and operations include the
duration and extent of the pandemic, the extent of imposed or
recommended containment and mitigation measures, and the general
economic consequences of the pandemic. The COVID-19 pandemic or its
impact or effects could have a material adverse impact on the
company’s business, operations and financial results for an
extended period of time.
EXICURE, INC.
UNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEETS
(in thousands, except share
and per share data)
September 30,
2020
December 31,
2019
ASSETS
Current assets:
Cash and cash
equivalents.......................................................................................
$
31,459
$
48,460
Short-term
investments............................................................................................
62,621
62,326
Accounts
receivable.................................................................................................
59
16
Unbilled revenue
receivable....................................................................................
6
19
Prepaid expenses and other
assets...........................................................................
2,684
1,955
Total current
assets.....................................................................................................
96,829
112,776
Property and equipment,
net.......................................................................................
4,269
2,099
Right-of-use
asset.......................................................................................................
8,768
356
Other noncurrent
assets...............................................................................................
1,414
32
Total
assets...................................................................................................
$
111,280
$
115,263
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Current portion of long-term
debt............................................................................
$
—
$
4,965
Accounts
payable.....................................................................................................
2,006
1,814
Accrued expenses and other current
liabilities........................................................
2,124
2,435
Deferred revenue,
current........................................................................................
8,479
21,873
Total current
liabilities...............................................................................................
12,609
31,087
Long-term debt,
net.....................................................................................................
16,500
—
Common stock warrant liability,
noncurrent..............................................................
—
414
Deferred revenue,
noncurrent.....................................................................................
—
2,956
Lease liability, noncurrent
8,087
59
Other noncurrent
liabilities.........................................................................................
656
—
Total
liabilities.............................................................................................
$
37,852
$
34,516
Stockholders’ equity:
Common stock, $0.0001 par value per share;
200,000,000 shares authorized,
87,228,586 issued and outstanding,
September 30, 2020; 86,069,263
issued and outstanding, December 31,
2019................................................
9
9
Additional paid-in
capital...........................................................................................
166,499
162,062
Accumulated other comprehensive income
(loss)......................................................
200
(27)
Accumulated
deficit....................................................................................................
(93,280)
(81,297)
Total stockholders'
equity.............................................................................
73,428
80,747
Total liabilities and stockholders’
equity.....................................................
$
111,280
$
115,263
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,
2020
2019
2020
2019
Revenue:
Collaboration
revenue...................................................................................
$
2,443
$
527
$
16,473
$
986
Total
revenue..............................................................................
2,443
527
16,473
986
Operating expenses:
Research and development
expense...................................................................................
9,139
4,245
22,222
11,073
General and administrative
expense...................................................................................
2,424
2,228
7,227
6,421
Total operating
expenses..............................................................................
11,563
6,473
29,449
17,494
Operating
loss.......................................................................................
(9,120)
(5,946)
(12,976)
(16,508)
Other income (expense), net:
Dividend
income...................................................................................
2
228
45
415
Interest
income...................................................................................
205
1
832
3
Interest
expense...................................................................................
(27)
(203)
(155)
(589)
Other income (expense),
net...................................................................................
118
104
271
357
Total other income (expense),
net..............................................................................
298
130
993
186
Net
loss.......................................................................................
$
(8,822)
$
(5,816)
$
(11,983)
$
(16,322)
Basic and diluted loss per common
share.......................................................................................
$
(0.10)
$
(0.09)
$
(0.14)
$
(0.32)
Weighted-average basic and diluted common
shares
outstanding.......................................................................................
87,227,136
64,651,040
87,160,520
51,200,072
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version on businesswire.com: https://www.businesswire.com/news/home/20201112005225/en/
Media: Karen Sharma MacDougall 781-235-3060
ksharma@macbiocom.com Investors: Thomas Hoffmann Solebury
Trout +1-646-378-2931 thoffmann@troutgroup.com
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