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
six months ended June 30, 2020 and provided an update on corporate
progress.
“The second quarter was marked by important new expansion,” said
Dr. David Giljohann Exicure’s Chief Executive Officer. “We grew our
organization with the addition of neurology expert, Dr. Douglas
Feltner, as Chief Medical Officer, expanded our clinical team and
opened additional clinical sites in support of our Phase 2 clinical
trial in cancer patients using our drug candidate, cavrotolimod. In
July, we moved into our new 30,000 sq. ft. laboratory and corporate
headquarters where our R&D team continues to advance our
growing neurology therapeutic area,” concluded Dr. Giljohann.
XCUR-FXN, Exicure’s Friedreich’s ataxia therapeutic
candidate
- Despite the ongoing COVID-19 pandemic, our laboratories have
continued operations with limited impact on our research and
development activities.
- We remain on track to initiate IND-enabling studies for
Friedreich’s ataxia in the fourth quarter of this year.
Cavrotolimod (AST-008) Phase 1b/2 clinical trial is open and
actively enrolling patients
- In the second quarter of 2020, we began enrolling patients in
the Phase 2 dose expansion phase of the clinical trial of
intra-tumoral cavrotolimod in combination with approved checkpoint
inhibitors pembrolizumab or cemiplimab, to treat patients with
advanced or metastatic Merkel cell carcinoma or cutaneous squamous
cell carcinoma.
- Currently, 14 clinical trial sites are open, and we expect to
open up to 11 additional sites for a potential total of 25
sites.
- We are continuing to monitor the impact that COVID-19 may have
on the trial’s 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 trial continuity.
Second Quarter Financial Results, Financial Guidance and
Recent Developments
Cash Position: Cash, cash equivalents, and short-term
investments were $85.8 million as of June 30, 2020 as compared to
$98.8 million as of March 31, 2020.
Research and Development (R&D) Expenses: Research and
development expenses were $7.0 million for the quarter ended June
30, 2020, as compared to $3.4 million for the quarter ended June
30, 2019. We have increased full-time staffing in R&D from 23
at June 30, 2019 to 41 at June 30, 2020 and the associated increase
in activity, in addition to growth in cavrotolimod (AST-008)
clinical trial activities, has driven our increase in R&D
costs. The increase in staffing and associated increases in
platform and discovery related costs reflects increased preclinical
R&D activities associated with our collaboration with Allergan
plc, increased costs related to XCUR-FXN, our Friedreich’s ataxia
program, as well as other preclinical discovery work in neurology
and ophthalmology.
General and Administrative (G&A) Expenses: General
and administrative expenses were $2.2 million for the quarter ended
June 30, 2020 as compared to $2.0 million for the quarter ended
June 30, 2019. This increase is primarily due to higher legal costs
associated with operating as a public company, higher franchise tax
costs, and higher D&O insurance expense, partially offset by
lower travel and other costs.
Net Loss: We had a net loss of $4.3 million for the
quarter ended June 30, 2020 as compared to a net loss of $5.2
million for the quarter ended June 30, 2019. This decrease in net
loss of $0.9 million was driven principally by the recognition of
$4.8 million of revenue associated with our collaboration with
Allergan plc, offset by the increases in R&D expenses and
G&A expenses discussed above.
Capital Resources Guidance: We believe that, based on our
current operating plans and estimates of future expenses, as of the
date of this press release, our existing cash, cash equivalents and
short-term investments will be sufficient to fund our operations
into early 2022.
Response to COVID-19: With the global spread of the
ongoing COVID-19 pandemic in the first half of 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 trial continuity.
About our Pipeline
Neurology
- In December 2019, Exicure announced the development of
XCUR-FXN, an SNA–based therapeutic candidate for the treatment of
Friedreich’s ataxia (FA). FA is driven by triplet repeats in the
frataxin gene which compromises the patient’s ability to generate
adequate levels of frataxin protein. Exicure believes its SNA
technology has the potential to address this genetic challenge and
that its therapeutic strategy may lead to increases in the frataxin
protein. Exicure plans to design and develop XCUR-FXN with guidance
from, and in collaboration with, the Friedreich’s Ataxia Research
Alliance (FARA). Preclinical research is ongoing and IND-enabling
studies for XCUR-FXN are expected to commence in late 2020.
- Exicure is continuing preclinical research on the application
of its SNA technology in neurological conditions, building on its
early proof-of-concept work with nusinersen and its new therapeutic
candidate, XCUR-FXN. Exicure is currently exploring additional
neurological conditions, including spinocerebellar ataxia, Batten
disease, amyotrophic lateral sclerosis (ALS) and Huntington’s
disease.
Immuno-oncology; Cavrotolimod (AST-008)
- Cavrotolimod (AST-008) is an investigational SNA consisting of
toll-like receptor 9 (TLR9) agonists designed for immuno-oncology
applications. Exicure has now dosed 20 patients and completed
enrollment in the Phase 1b stage of the Phase 1b/2 clinical trial.
To date, we have not observed any treatment related serious adverse
events or any dose-limiting toxicity.
- Biomarker data from the Phase 1b stage of the clinical trial
showed dose-related systemic immune activation and a trend towards
increased tumor immune cell infiltration.
- In the second quarter of 2020, we dosed the first patient in a
Phase 2 dose expansion phase of our Phase 1b/2 clinical trial for
intra-tumoral cavrotolimod in combination with pembrolizumab or
cemiplimab to treat two cohorts of patients with advanced or
metastatic Merkel cell carcinoma or cutaneous squamous cell
carcinoma. Each cohort is expected to enroll up to 29
patients.
Collaborations
In late 2019, Exicure entered into a collaboration, option and
license agreement with Allergan plc, which was acquired by AbbVie
Inc. in May 2020, and is now actively engaged in preclinical
research and discovery in two programs related to the treatment of
hair loss disorders. In early 2019, Exicure also entered into a
collaboration agreement with Dermelix Biotherapeutics under which
Dermelix has the option to develop a targeted therapy for the
treatment of Netherton Syndrome (NS).
About FARA
The Friedreich's Ataxia Research Alliance (FARA) is a 501(c)(3),
non-profit, charitable organization dedicated to accelerating
research leading to treatments and a cure for Friedreich's ataxia.
www.CureFA.org.
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 is in a
Phase 1b/2 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 on the company’s business and
operations, including 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 address
the genetic challenges posed by Friedreich’s ataxia and other
neurological conditions; the potential of the company’s
collaborations and R&D efforts; and the company’s anticipated
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 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; 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 a serious adverse
impact on the economy, the severity and duration of which are
uncertain. Government stabilization efforts will only partially
mitigate 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 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 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)
June 30, 2020
December 31,
2019
ASSETS
Current assets:
Cash and cash
equivalents................................................................................................................................
$
17,198
$
48,460
Short-term
investments................................................................................................................................
68,579
62,326
Accounts
receivable................................................................................................................................
21
16
Unbilled revenue
receivable................................................................................................................................
3
19
Prepaid expenses and other
assets...............................................................................................................................
3,588
1,955
Total current
assets..................................................................................................................................
89,389
112,776
Property and equipment,
net..................................................................................................................................
4,464
2,099
Other noncurrent
assets..................................................................................................................................
2,266
388
Total
assets......................................................................................................
$
96,119
$
115,263
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Current portion of long-term
debt...............................................................................................................................
$
—
$
4,965
Accounts
payable...............................................................................................................................
1,540
1,814
Accrued expenses and other current
liabilities...............................................................................................................................
1,947
2,435
Current portion of deferred
revenue................................................................................................................................
10,880
21,873
Total current
liabilities..................................................................................................................................
14,367
31,087
Common stock warrant liability,
noncurrent..................................................................................................................................
—
414
Deferred revenue,
noncurrent..................................................................................................................................
—
2,956
Other noncurrent
liabilities..................................................................................................................................
—
59
Total
liabilities...................................................................................................................................
$
14,367
$
34,516
Stockholders’ equity:
Common stock, $0.0001 par value per share;
200,000,000 shares authorized, 87,206,346 issued and outstanding,
June 30, 2020; 86,069,263 issued and outstanding, December 31,
2019
9
9
Additional paid-in
capital...................................................................................................................................
165,863
162,062
Accumulated other comprehensive income
(loss)..................................................................................................................................
338
(27)
Accumulated
deficit..................................................................................................................................
(84,458)
(81,297)
Total stockholders' equity
81,752
80,747
Total liabilities and stockholders’
equity
$
96,119
$
115,263
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,
2020
2019
2020
2019
Revenue:
Collaboration
revenue......................................................................................
$
4,847
$
434
$
14,030
$
459
Total
revenue......................................................................................
4,847
434
14,030
459
Operating expenses:
Research and development
expense......................................................................................
7,008
3,433
13,083
6,828
General and administrative
expense......................................................................................
2,229
1,985
4,803
4,193
Total operating
expenses......................................................................................
9,237
5,418
17,886
11,021
Operating
loss......................................................................................
(4,390)
(4,984)
(3,856)
(10,562)
Other income (expense), net:
Dividend
income......................................................................................
4
82
43
187
Interest
income......................................................................................
267
1
627
2
Interest
expense......................................................................................
—
(203)
(128)
(386)
Other income (expense),
net......................................................................................
(192)
(116)
153
253
Total other income (expense),
net......................................................................................
79
(236)
695
56
Net
loss......................................................................................
$
(4,311)
$
(5,220)
$
(3,161)
$
(10,506)
Basic and diluted loss per common
share......................................................................................
$
(0.05)
$
(0.12)
$
(0.04)
$
(0.24)
Weighted-average basic and diluted common
shares
outstanding......................................................................................
87,174,533
44,368,174
87,126,847
44,363,115
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200812005150/en/
MacDougall Karen Sharma 781-235-3060 ksharma@macbiocom.com
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