NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical
company developing drug-device combinations for central nervous
system (CNS) disorders, today announced financial results for the
first quarter ended March 31, 2017.
“We are pleased with our continued clinical
progress for our lead product candidates, and remain on track to
achieve our anticipated milestones for ND0612 and ND0701,” stated
Oded Lieberman, PhD, CEO of NeuroDerm. “Our recently announced
preclinical, life cycle management product candidate ND0901
demonstrates our long term commitment to the treatment of
Parkinson's Disease and to continuous levodopa delivery, and we are
excited to be developing another potential treatment option for
patients suffering from this debilitating disease. We had the
opportunity to meet with many patients during the Parkinson’s Unity
Walk, which took place in New York City last month, and their
support of our efforts was both gratifying and an important
reminder of the urgency with which new treatments are needed.”
Recent Highlights
Announced ND0901, a continuous,
subcutaneous, follow-on life cycle management product for the
treatment of Parkinson’s disease
At its first Investor Day this past April, the
Company announced a new drug-device candidate for continuous
subcutaneous LD/CD delivery. This pre-clinical drug candidate
comprises a novel, concentrated aqueous LD prodrug, and will
potentially be developed for treating Parkinson's disease motor
complications. Clinical development of ND0901 is anticipated to
start by early 2018.
Upcoming Milestones
The currently anticipated timelines for the
ongoing and upcoming clinical trials are as follows:
ND0612
U.S. Regulatory Pathway
- Initiation of two PK trials expected in the second half of
2017
EU Regulatory Pathway
- iNDiGO phase III efficacy trial (trial 007): trial completion
expected in parallel with BeyoND study
U.S. and EU Regulatory Pathway
- BeyoND long term safety trial (trial 012): expected to complete
in time to support 2018 submission of regulatory applications
ND0701
- Meeting with the EU regulatory authorities: first half of
2017
- Follow-on PK study for ND0701: initiation expected in 2017
Financial Results for the Quarter Ended
March 31, 2017
Research and development expenses were $10.1
million in the three months ended March 31, 2017 compared to $4.1
million in the same period in 2016. The increase was
primarily due to an increase in subcontractors and materials mainly
from ongoing clinical trials and pre-clinical studies, and due to
an increase in payroll and related expenses, including share-based
compensation expenses, as a result of an increase in the number of
employees.
General and administrative expenses were $3.3
million in the three months ended March 31, 2017 compared to $1.6
million in the same period in 2016. The increase was
primarily due to an increase in share-based compensation
expenses.
The company reported a net loss of $13.1 million
in the three months ended March 31, 2017 compared to $5.4 million
for the same period in 2016. The increase in net loss was
primarily due to the increase in research and development
expenses.
As of March 31, 2017, the company had cash and
cash equivalents and short-term bank deposits totaling $142.3
million.
NeuroDerm is a clinical-stage pharmaceutical
company with a limited operating history, has not yet generated
revenue from its operations and continues to incur significant
research and development and other expenses related to its ongoing
operations. Accordingly, there is no assurance that NeuroDerm’s
business will generate positive cash flow. As of March 31,
2017, NeuroDerm had an accumulated deficit of $193.8 million and
its activities have been funded through public and private
offerings of the company’s securities and issuance of convertible
loans and warrants.
Additional Information
NeuroDerm hosted its first Investor Day on April
21, 2017 and provided a thorough review of its product candidates
and timelines. Therefore, the company will not host a conference
call surrounding first quarter, 2017 financial results, but plans
to resume quarterly updates surrounding the release of second
quarter financial results. Individuals interested in listening to
the Investor Day presentation may do so by clicking here.
About NeuroDermNeuroDerm is a
clinical-stage pharmaceutical company developing central nervous
system (CNS) product candidates that are designed to overcome major
deficiencies of current treatments and achieve enhanced clinical
efficacy through continuous, controlled administration. The
company has three product candidates in different stages of
development which offer a solution for almost every Parkinson’s
disease patient from the moderate to the very severe stage of the
disease. The company has developed a line of levodopa and
carbidopa (LD/CD) product candidates administered through small
belt pumps that deliver a continuous, controlled dose of
LD/CD. The LD/CD product candidates are ND0612L and ND0612H,
which are used for treatment of moderate and advanced Parkinson’s
disease patients, respectively, and which are delivered
subcutaneously. In addition, NeuroDerm is developing ND0701,
a novel subcutaneously delivered apomorphine formulation for
patients who suffer from moderate to severe Parkinson’s disease and
who do not respond well to LD/CD. NeuroDerm is headquartered
in the Weizmann Science Park in Rehovot, Israel.
Forward-Looking StatementsThis
press release contains forward-looking statements, within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended that involve risks and uncertainties. Such
forward-looking statements may include projections regarding our
future performance and may be identified by words like
"anticipate," "assume," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict,"
"project," "future," "will," "seek" and similar terms or phrases.
The forward-looking statements contained in this press release are
based on management's current expectations and projections about
future events. There are important factors that could cause our
actual results, levels of activity, performance or achievements to
differ materially from the results, levels of activity, performance
or achievements expressed or implied by the forward-looking
statements. In particular, you should consider the risks provided
under "Risk Factors" in our annual report on Form 20-F for the year
ended December 31, 2016 filed with the Securities and Exchange
Commission. Any forward-looking statement made by us in this press
release speaks only as of the date hereof. Factors or events that
could cause our actual results to differ may emerge from time to
time, and it is not possible for us to predict all of them. We
undertake no obligation to publicly update any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
NEURODERM LTD. |
STATEMENTS OF FINANCIAL POSITION |
(Unaudited) |
(U.S. dollars in thousands, except share data) |
|
|
December 31, |
|
March 31, |
Assets: |
2016 |
|
2017 |
|
|
|
|
|
|
|
Current
Assets: |
|
|
Cash and
cash equivalents |
$ |
107,178 |
|
$ |
21,925 |
Short-
term bank deposits |
|
45,058 |
|
|
120,332 |
Prepaid
expenses and receivables |
|
2,666 |
|
|
2,956 |
|
|
154,902 |
|
|
145,213 |
Non-Current
Assets: |
|
|
Restricted bank deposit |
|
105 |
|
|
112 |
Long-term
prepaid expenses |
|
141 |
|
|
144 |
Property,
plant and equipment, net |
|
915 |
|
|
1,098 |
|
|
1,161 |
|
|
1,354 |
Total
Assets |
$ |
156,063 |
|
$ |
146,567 |
|
|
|
|
|
|
|
NEURODERM LTD. |
STATEMENTS OF FINANCIAL POSITION |
(Unaudited) |
(U.S. dollars in thousands, except share data) |
|
|
|
December 31, |
|
March 31, |
|
|
2016 |
|
2017 |
Liabilities and Shareholders’
Equity |
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
Current Liabilities: |
|
|
Accounts payable: |
|
|
Trade |
$ |
1,736 |
|
|
$ |
1,842 |
|
Other |
|
4,757 |
|
|
|
4,938 |
|
Total Liabilities |
|
6,493 |
|
|
|
6,780 |
|
Shareholders’ Equity: |
|
|
Share capital: |
|
|
Ordinary Shares, NIS 0.01 par value – authorized – 160,000,000
shares at December 31, 2016 and March 31,2017, issued and
outstanding – 26,335,098 and 26,338,198 shares at December 31, 2016
and March 31, 2017, respectively |
|
49 |
|
|
|
49 |
|
Additional paid-in capital |
|
320,339 |
|
|
|
320,343 |
|
Share-based compensation capital reserve |
|
11,956 |
|
|
|
15,220 |
|
Accumulated deficit |
|
(180,734 |
) |
|
|
(193,785 |
) |
Foreign currency translation differences |
|
(2,040 |
) |
|
|
(2,040 |
) |
Total Shareholders' Equity |
|
149,570 |
|
|
|
139,787 |
|
Total Liabilities And Shareholders'
Equity |
$ |
156,063 |
|
|
$ |
146,567 |
|
NEURODERM LTD. |
STATEMENTS OF COMPREHENSIVE LOSS |
(Unaudited) |
(U.S. dollars in thousands, except per share
data) |
|
|
|
|
Three months ended March 31, |
|
|
|
2016 |
|
2017 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
4,130 |
|
|
$ |
10,140 |
|
General and
administrative |
|
|
1,552 |
|
|
|
3,274 |
|
Operating
loss |
|
|
5,682 |
|
|
|
13,414 |
|
Financial income |
|
|
335 |
|
|
|
371 |
|
Financial expenses |
|
|
3 |
|
|
|
8 |
|
Financial income,
net |
|
|
(332 |
) |
|
|
(363 |
) |
Net
loss |
|
|
5,350 |
|
|
|
13,051 |
|
Basic and
diluted loss per ordinary share |
|
$ |
0.25 |
|
|
$ |
0.50 |
|
NEURODERM LTD. |
STATEMENTS OF CASH FLOWS |
(Unaudited) |
(U.S. dollars in thousands) |
|
|
Three months ended March 31, |
|
2016 |
|
2017 |
Cash Flows From
Operating Activities: |
|
|
|
|
|
|
|
|
Net
loss |
$ |
(5,350 |
) |
|
$ |
(13,051 |
) |
Adjustments in respect of: |
|
|
Depreciation |
|
11 |
|
|
|
43 |
|
Share-based compensation to employees and service providers |
|
795 |
|
|
|
3,264 |
|
Interest and exchange differences on bank deposits and restricted
bank deposits |
|
74 |
|
|
|
(283 |
) |
Exchange differences in respect of cash and cash equivalents |
|
(166 |
) |
|
|
(93 |
) |
|
|
(4,636 |
) |
|
|
(10,120 |
) |
Changes
in asset and liability items: |
|
|
|
|
|
|
|
|
Increase
in prepaid expenses and receivables (including non-current
portion) |
|
(480 |
) |
|
|
(290 |
) |
Increase
in accounts payable: |
|
|
Trade |
|
607 |
|
|
|
106 |
|
Other |
|
346 |
|
|
|
181 |
|
|
|
473 |
|
|
|
(3 |
) |
Net cash
used in operating activities |
|
(4,163 |
) |
|
|
(10,123 |
) |
Cash flows from
investing activities: |
|
|
|
|
|
|
|
|
Proceeds
from exercise of options granted to employees |
|
- |
|
|
|
3 |
|
Net cash
provided by financing activities |
|
- |
|
|
|
3 |
|
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
Purchase
of property, plant and equipment |
|
(37 |
) |
|
|
(226 |
) |
Investment in Short- term bank deposits |
|
(24,000 |
) |
|
|
(81,250 |
) |
Proceeds
from short-term bank deposits |
|
15,000 |
|
|
|
6,250 |
|
Net cash used in
investing activities |
|
(9,037 |
) |
|
|
(75,226 |
) |
Decrease in
cash and cash equivalents |
|
(13,200 |
) |
|
|
(85,346 |
) |
Balance of cash and cash equivalents at beginning of
year |
|
84,735 |
|
|
|
107,178 |
|
Exchange
differences in respect of cash and |
|
|
|
|
|
|
|
|
cash equivalents |
|
166 |
|
|
|
93 |
|
Balance of cash
and cash equivalents at end of period |
$ |
71,701 |
|
|
$ |
21,925 |
|
Supplementary
information: |
|
|
|
|
|
|
|
|
Interest received from cash and cash equivalents and bank
deposits |
$ |
230 |
|
|
$ |
36 |
|
NeuroDerm Contact:Oded S.
Lieberman, PhD, CEOoded@neuroderm.comTel.: +972-8-946 2729Cell:
+1-617-517 6077
U.S. Investor Contact:David
CareyLazar Partners Ltd.dcarey@lazarpartners.com+212-867-1762
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