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 ended
March 31, 2020 and provided an update on corporate progress.
“Exicure has continued to execute on its core clinical and
preclinical objectives for 2020 thanks largely to the ongoing
commitment of our team and their families, as well as the patients
and caregivers involved in our clinical trials,” said Dr. David
Giljohann Exicure’s Chief Executive Officer. “We have continued to
advance our preclinical program in Friedreich’s ataxia and have
initiated our Phase 2 clinical trial of AST-008, our
immuno-oncology drug candidate for Merkel cell carcinoma and
cutaneous squamous cell carcinoma. While COVID-19 presents many
ongoing uncertainties, we are confident that our financial
resources will allow continued pursuit of our strategic
objectives,” concluded Dr. Giljohann.
AST-008 Phase 2 clinical trial is open and enrolling patients
in the second quarter of 2020
- We have dosed 20 patients and completed enrollment in the Phase
1b stage of our clinical trial. To date, we have not observed any
treatment-related serious adverse events or any dose-limiting
toxicity.
- In the second quarter of 2020, we will begin enrolling patients
in the Phase 2 dose expansion phase of the trial for intratumoral
AST-008 in combination with pembrolizumab or cemiplimab, approved
checkpoint inhibitors, to treat patients with advanced or
metastatic Merkel cell carcinoma or cutaneous squamous cell
carcinoma.
- Currently, seven clinical trial sites are open and we expect to
open up to eight additional sites.
- We are continuing to monitor the potential impact that COVID-19
may have on patient enrollment, site initiation, safety of patients
and study integrity. We are putting in place a variety of measures
to mitigate the effects of COVID-19 and maintain patient safety and
trial continuity.
First Quarter Financial Results, Financial Guidance and
Recent Developments
Cash Position: Cash, cash equivalents, and short-term
investments were $98.8 million as of March 31, 2020 compared to
$110.8 million as of December 31, 2019. During the quarter Exicure
repaid, pursuant to its terms, the outstanding principal balance of
$5.0 million on its loan with Hercules Technology Growth Capital
and classified $1.2 million of cash to other noncurrent assets. On
January 6, 2020 Exicure received gross proceeds of $3.0 million
pursuant to the partial exercise of the underwriters’ option to
purchase additional shares. This exercise represents additional
proceeds in connection with Exicure’s underwritten public offering
of Exicure common stock in December 2019.
Research and Development (R&D) Expenses: Research and
development expenses were $6.1 million for the quarter ended March
31, 2020, compared to $3.4 million for the quarter ended March 31,
2019. We have increased full-time staffing in R&D from 19 at
March 31, 2019 to 36 at March 31, 2020 and the associated increase
in activity has driven our increase in 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 $2.6 million for the quarter ended
March 31, 2020, compared to $2.2 million for the quarter ended
March 31, 2019. This increase is primarily due to costs related to
higher legal and accounting fees, higher D&O insurance expenses
and certain other costs associated with being a public company.
Net Income (Loss): Exicure had net income of $1.1 million
for the quarter ended March 31, 2020 compared to a net loss of $5.3
million for the quarter ended March 31, 2019, reflecting a
difference of $6.4 million. The increase in net income was driven
principally by the recognition of $9.2 million of revenue
associated with Exicure’s collaboration with Allergan. In November
of 2019, Exicure received an upfront payment of $25.0 million from
Allergan, which was then deferred, and is now being recognized as
revenue as we satisfy our obligations under the terms of the
Allergan collaboration agreement. The $9.2 million increase in
revenue was offset by the increases in R&D expenses and G&A
expenses as discussed above.
Capital Resources Guidance: Exicure believes that, based
on its current operating plans and estimates of expenses, as of the
date of this press release, its 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 quarter 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. Under social distancing guidelines for COVID-19, we
are operating with less than 50% of our research and development
staff on-site at any one time while our general and administrative
team has generally been working from home. We are carefully
managing laboratory staffing and taking other appropriate
managerial actions to maintain progress on our preclinical and
collaboration programs. We are also working closely with our
third-party manufacturers and other partners to manage our supply
chain activities and in our clinical operations we are taking such
action as we believe appropriate to maintain patient safety and
trial continuity.
Pipeline Updates
Neurology
- In December of 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 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; AST-008
- 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, Exicure has not observed any treatment related serious
adverse events or any dose-limiting toxicity.
- In the second quarter of 2020, we intend to enroll patients in
a Phase 2 dose expansion phase of its Phase 1b/2 study for
intratumoral AST-008 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
Exicure entered into a collaboration, option and license
agreement with Allergan plc in late 2019 and is now actively
engaged in preclinical research and discovery in two clinical
programs related to the treatment of hair loss disorders. Under the
terms of the collaboration, Exicure received a $25.0 million
upfront payment and is eligible to receive up to $725 million in
potential milestones. 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 drug candidate AST-008 is in a Phase 1b/2
trial in patients with advanced solid tumors. Exicure is based
outside of 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 the conduct of its ongoing Phase 1b/2
clinical trial for AST-008; the company’s plans, initiatives and
expectations in light of and in response to the COVID-19 pandemic
and its impacts on global healthcare systems and business; 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; its plans for
development of AST-008, including its Phase 1b/2 clinical trial and
the timing of such clinical development including its expectation
that it will start dosing patients in the Phase 2 stage of its
Phase 1b/2 clinical trial in the second quarter of 2020; 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 COVID-19
pandemic may disrupt the company’s business and/or the global
healthcare system more severely than anticipated, which may have
the effect of impacting or delaying the Phase 2 stage of 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)
March 31, 2020
December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents
$
24,577
$
48,460
Short-term investments
74,223
62,326
Accounts receivable
27
16
Unbilled revenue receivable
11
19
Prepaid expenses and other assets
2,906
1,955
Total current assets
101,744
112,776
Property and equipment, net
2,298
2,099
Other noncurrent assets
1,487
388
Total assets
$
105,529
$
115,263
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Current portion of long-term debt
$
—
$
4,965
Accounts payable
3,392
1,814
Accrued expenses and other current
liabilities
1,268
2,435
Current portion of deferred revenue
15,713
21,873
Total current liabilities
20,373
31,087
Common stock warrant liability
42
414
Deferred revenue non-current
—
2,956
Other noncurrent liabilities
—
59
Total liabilities
$
20,415
$
34,516
Stockholders’ equity:
Common stock, $0.0001 par value per share;
200,000,000 shares authorized, 87,150,447 issued and outstanding,
March 31, 2020; 86,069,263 issued and outstanding, December 31,
2019
9
9
Additional paid-in capital
165,269
162,062
Accumulated other comprehensive loss.
(17
)
(27
)
Accumulated deficit
(80,147
)
(81,297
)
Total stockholders' equity
85,114
80,747
Total liabilities and stockholders’
equity
$
105,529
$
115,263
EXICURE, INC. UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands,
except share and per share data)
Three Months Ended, March
31,
2020
2019
Revenue:
Collaboration revenue
$
9,183
$
25
Total revenue
9,183
25
Operating expenses:
Research and development expense
6,075
3,395
General and administrative expense
2,574
2,208
Total operating expenses
8,649
5,603
Operating income (loss)
534
(5,578
)
Other income (expense), net:
Dividend income
39
105
Interest income
360
1
Interest expense
(128
)
(183
)
Other income (expense), net
345
369
Total other income (expense), net
616
292
Net income (loss)
$
1,150
$
(5,286
)
Basic earnings (loss) per common share
$
0.01
$
(0.12
)
Diluted earnings (loss) per common
share
$
0.01
$
(0.12
)
Weighted-average basic common shares
outstanding
87,079,160
44,358,000
Weighted-average diluted common shares
outstanding
88,244,632
44,358,000
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200514005235/en/
Media Contact: MacDougall Karen Sharma 781-235-3060
ksharma@macbiocom.com
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