Exicure, Inc. Reports First Quarter 2019 Financial Results and Reviews Corporate Progress

May 8, 2019 Off By BusinessWire

CHICAGO & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
constructs, today reported financial results for the first quarter ended
March 31, 2019 and provided an update on corporate progress.

“Exicure continues to drive our SNA technology into the clinic and
expand our therapeutic areas of interest. In the first quarter of 2019,
we opened four clinical sites and began enrolling patients in the Phase
1b/2 trial of AST-008 for patients with advanced or metastatic solid
tumors including, Merkel cell carcinoma, melanoma, squamous carcinoma
and squamous cell carcinoma of the head and neck,” said Dr. David
Giljohann, Chief Executive Officer of Exicure. “We are also pursuing
significant unmet medical need in rare dermatological indications
through our partnership with Dermelix and are expanding our platform in
neurology.”

Corporate Progress

  • Launched Phase 1b/2 clinical trial of AST-008—AST-008 is an SNA
    consisting of toll-like receptor 9, or TLR9, agonists designed for
    immuno-oncology applications.

    • Received authorization from the FDA for a Phase 1b/2 clinical
      trial of AST-008
    • Opened four clinical sites and began dosing patients
    • Expects to release results of the Phase 1b stage of this trial
      late in 2019
  • Entered into partnership with Dermelix for rare dermatological
    conditions—
    Dermelix will initially develop a targeted therapy for
    the treatment of Netherton Syndrome (NS) and Exicure is currently
    screening sequences against the target genes.
  • Presented a scientific poster at ARVO 2019—This poster showed
    that in a rat eye model, our SNAs distributed to both the back and the
    front of the eye, persisted in the eye longer than did conventional
    oligonucleotides, and did not cause inflammation. These data support
    the therapeutic potential of SNAs for treating retinal and corneal eye
    diseases.
  • Presented a scientific poster at AAN 2019—This poster
    demonstrated that SNAs containing the same sequence as the approved
    SMA drug nusinersen, delivered by intrathecal injection to rats,
    widely distributed throughout the CNS and persisted to a greater
    extent than did nusinersen. These data support the therapeutic
    potential of SNAs for treating CNS disorders.

First Quarter 2019 Financial Results and Financial Guidance

Cash Position: As of March 31, 2019, Exicure had cash and cash
equivalents of $22.2 million compared to $26.3 million as of December
31, 2018.

Research and Development (R&D) Expenses: Research and
development expenses were $3.4 million for the quarter ended March 31,
2019, compared to $3.3 million for the quarter ended March 31, 2018. The
increase in research and development expense of $0.1 million was
primarily due to higher platform and discovery-related expense of $0.2
million and higher employee related expenses of $0.2 million, mostly
offset by lower clinical development programs expense of $0.3 million.

General and Administrative (G&A) Expenses: General and
administrative expenses were $2.2 million for the quarter ended March
31, 2019, compared to $2.0 million for the quarter ended March 31, 2018.
The increase in general and administrative expenses of $0.2 million was
primarily due higher compensation and travel expenses, partially offset
by lower legal fees.

Net Loss: Net loss was $5.3 million for the quarter ended March
31, 2019, compared to net loss of $5.5 million for the quarter ended
March 31, 2018. The $0.2 million reduction in net loss is due to the
$0.5 million in other income attributable to the (non-cash) fair value
adjustment of our common stock warrant liability, partially offset by
the increase in operating expenses of $0.3 million as described above.

Cash Runway 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 and cash equivalents as of March 31, 2019,
will be sufficient to meet its anticipated cash requirements into early
2020.

About Exicure, Inc.

Exicure, Inc. is a clinical-stage biotechnology company developing
therapeutics for immuno-oncology, inflammatory diseases and genetic
disorders based on our proprietary Spherical Nucleic Acid, or SNA™
technology. We believe Exicure’s 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’s lead program is in a Phase1b/2 trial in patients
with advanced solid tumors. Exicure is based outside of Chicago, IL. www.exicuretx.com

Forward Looking Statements

This press release contains forward-looking statements (including within
the meaning of Section 21E of the United States Securities Exchange Act
of 1934, as amended, and Section 27A of the United States Securities Act
of 1933, as amended) concerning the Company, the Company’s technology,
potential therapies, cash requirements and other matters.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as “may,” “will,” “should,” “would,”
“expect,” “plan,” “believe,” “intend,” “look forward,” and other similar
expressions among others. Statements that are not historical facts are
forward-looking statements. Forward-looking statements are based on
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: unexpected costs, charges or expenses that reduce
cash runway; that Exicure’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 that have completed Phase 1 trials 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. Risks facing the Company
and its programs are set forth in the Company’s filings with the SEC.
Except as required by applicable law, the Company undertakes no
obligation to revise or update any forward-looking statement (including
without limitation its cash runway guidance) or to make any other
forward-looking statements, whether as a result of new information,
future events or otherwise.

EXICURE, INC.
UNAUDITED CONDENSED CONSOLIDATED
BALANCE SHEETS

(in thousands, except share and per
share data)

     
March 31,
2019
December 31,
2018
 
ASSETS
Current assets:
Cash and cash equivalents $ 22,196 $ 26,268
Accounts receivable 3
Unbilled revenue receivable 3
Receivable from related party 3 10
Prepaid expenses and other assets 1,414   1,382  
Total current assets 23,616 27,663
Property and equipment, net 977 1,061
Other noncurrent assets 591   32  
Total assets $ 25,184   $ 28,756  
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current portion of long-term debt $ 4,807 $
Accounts payable 848 500
Accrued expenses and other current liabilities 1,591 1,543
Current portion of deferred revenue 975    
Total current liabilities 8,221 2,043
Long-term debt, net 4,925
Common stock warrant liability 428 797
Other noncurrent liabilities 380   39  
Total liabilities $ 9,029 $ 7,804
 
Stockholders’ equity:
Common stock, $0.0001 par value per share; 200,000,000 shares
authorized, 44,358,000 issued and outstanding, March 31, 2019 and
December 31, 2018
4 4
Additional paid-in capital 76,431 75,942
Accumulated deficit (60,280 ) (54,994 )
Total stockholders’ equity 16,155   20,952  
Total liabilities and stockholders’ equity $ 25,184   $ 28,756  

EXICURE, INC.
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS

(in thousands, except share
and per share data)

   
Three Months Ended,
March 31,
2019   2018
Revenue:
Collaboration revenue $ 25   $ 36  
Total revenue 25 36
Operating expenses:
Research and development expense 3,395 3,275
General and administrative expense 2,208   2,045  
Total operating expenses 5,603   5,320  
Operating loss (5,578 ) (5,284 )
Other income (expense), net:
Interest expense (183 ) (161 )
Other income (loss), net 475   (64 )
Total other income (loss), net 292   (225 )
Net loss $ (5,286 ) $ (5,509 )
 
Basic and diluted loss per common share $ (0.12 ) $ (0.14 )
Basic and diluted weighted-average common shares outstanding 44,358,000 39,357,289

Contacts

Media Contacts:
MacDougall
Karen Sharma
781-235-3060
[email protected]