- Phase 2 stage of its Phase 1b/2 clinical
trial of AST-008 is still expected to begin in 2nd quarter
- Research labs open for critical R&D
activity; progress continues on Friedreich’s Ataxia development and
collaboration programs
- Preliminary unaudited cash, cash equivalents,
and short-term investments as of February 29, 2020 was $107.7
million
Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
technology, today provided an update on the Company’s operations in
response to the global COVID-19 pandemic and the Company’s current
evaluation of the impact the pandemic may have on the Company’s
clinical trials, preclinical research and development (R&D) and
general business operations.
“Exicure is carefully monitoring the developing COVID-19 crisis
and we have taken active measures, both as required by government
regulation and as judgement suggests, to protect the health of our
employees, their families, our communities, as well as clinical
trial investigators, patients, and caregivers,” said Dr. David
Giljohann, Exicure’s Chief Executive Officer. “While health and
safety are our first priorities, we also have a strong commitment
to our fundamental mission of serving patients with unmet medical
needs. We are taking appropriate actions to continue our critical
research and development programs and are grateful to our employees
and their families for their commitment to this mission.”
Employees and Business Operations
On March 21, 2020, Governor Pritzker of Illinois announced a
“stay-at-home” order restricting all Illinois residents to their
homes, with few limited exceptions, until at least April 7, 2020.
However, the Governor also designated certain businesses, such as
biotechnology companies, as “essential” businesses, thereby
permitting Exicure to continue its R&D operations. The Company
continues to pursue its pre-clinical development programs and
clinical programs as further described below.
AST-008, for Immuno-oncology
Exicure continues to monitor its ongoing trial of AST-008. As
previously disclosed, the Company is completing the Phase 1b stage
of its Phase 1b/2 clinical trial of AST-008 in both Merkel cell
carcinoma and in cutaneous squamous cell carcinoma and is preparing
to begin the Phase 2 stage of dose expansion for intratumoral
AST-008 in patients with advanced or metastatic Merkel cell
carcinoma or cutaneous squamous cell carcinoma. At this time, and
given the severity of both of these indications, Exicure continues
to believe that the Phase 2 stage of the trial will begin as
expected in the second quarter of 2020. Exicure currently has seven
trial sites open. The Company continues to be in close
communication with its clinical sites and, among other things, has
confirmed that AST-008 is available for conduct of the trial at
each of the sites. Exicure remains committed to maintaining its
development plans of AST-008 and continues to monitor the rapidly
evolving situation.
AST-008, as an immune system adjuvant
In 2015, Exicure scientists published experimental results
examining the potential of immuno-stimulatory SNAs such as AST-008
to function as vaccine adjuvants. Those published studies
demonstrated that immuno-stimulatory, SNA–based, adjuvants induced
a significant and desired immunological memory response to a model
peptide in mice, indicating that SNAs may be useful in vaccines.
Exicure is considering various tactics for advancing this feature
of the SNA platform and the potential for collaboration with
government agencies and pharmaceutical companies in the vaccine
space.
Neurology
Exicure’s pre-clinical development program in Friedreich’s
ataxia is being conducted in the Company’s R&D labs.
Preclinical research is ongoing. The Company affirms its guidance
that IND-enabling studies for XCUR-FXN are expected in late
2020.
Collaborations
As previously disclosed, Exicure entered into a collaboration
with Allergan Pharmaceuticals International Limited in late 2019 to
pursue preclinical research and discovery in two pre-clinical
programs related to the treatment of hair loss disorders. R&D
activities continue to progress under this collaboration and, as of
the date of this press release, there is no current anticipated
effect on these activities. In early 2019, Exicure entered into a
collaboration agreement with Dermelix Biotherapeutics under which
Dermelix will develop a targeted therapy for the treatment of
Netherton Syndrome (NS). As of the date of this press release,
preclinical R&D activities under this collaboration remain
ongoing.
Cash Position
The Company is currently evaluating the impact of COVID-19 on
its 2020 financial guidance and expects to provide more detail, to
the extent practicable, in connection with its first quarter 2020
earnings update.
Exicure does not anticipate a change to its prior guidance and
continues to believes its current cash will finance operations into
early 2022. Preliminary unaudited cash, cash equivalents and
short-term investments as of February 29, 2020 was approximately
$107.7 million.
About Exicure
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 currently in a
Phase 1b/2 clinical trial in patients with advanced solid tumors.
Exicure is based outside of Chicago, IL and also has an office in
Cambridge, MA.
For more information, visit Exicure’s website at
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 other than statements of historical fact could
be deemed forward looking including, but not limited to, statements
about the Company’s financial condition, preliminary unaudited
financial information and cash runway; its plans, initiatives and
expectations in light of and in response to the COVID-19 pandemic
and its impacts on global healthcare systems and business; its
plans for development of AST-008, including its Phase 1b/2 clinical
trial; the ability for use of AST-008 to function as an immune
system vaccine adjuvant as well as the intent and potential to
pursue collaborations for further development of AST-008; the
timing of the Company’s 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
anticipated timing of clinical developments and the timing and
results of clinical studies, including with respect the impact of
COVID-19 on XCUR-FXN; the potential of the Company’s collaborations
and R&D efforts; the expected timing of guidance on the
Company’s financial outlook and the assessment and timing of the
Company’s employees returning to normal work practices. 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 further
delaying our ability to enroll and complete our ongoing Phase 1b/2
clinical trial, unexpected costs, charges or expenses that reduce
cash runway; that the Company’s pre-clinical 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 Exicure to protect its
intellectual property rights. Furthermore, data from preclinical
studies often fails to be indicative of outcomes in human trials.
For a discussion of other risks and uncertainties, and other
important factors, any of which could cause our actual results to
differ from those contained in the forward-looking statements, see
the section entitled “Risk Factors” in our most recent Form 10-K,
as well as discussions of potential risks, uncertainties, and other
important factors in our subsequent filings with the Securities and
Exchange Commission. All information in this press release is as of
the date of the release, and Exicure 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 pandemic could have a material
adverse impact on the Company’s business, operations and financial
results for an extended period of time.
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version on businesswire.com: https://www.businesswire.com/news/home/20200330005737/en/
Media: MacDougall Karen Sharma 781-235-3060
ksharma@macbiocom.com
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