—Company announces anticipated timeline for DFU
Phase III clinical trial results—
—Company accelerates timelines for VLU Phase III
clinical trial results—
—Conference call and webcast scheduled for March
18, 2015 at 9:00 am Eastern Time—
Macrocure Ltd. ("Macrocure" or "the Company") (Nasdaq:MCUR), a
clinical-stage biotechnology company focused on developing a novel
therapeutic platform to address chronic and hard-to-heal wounds,
today provided a corporate update and reported financial results
for the fourth quarter and full year ended December 31, 2014.
Recent Highlights:
- Data from the Company's ongoing pivotal Phase III, randomized,
double-blind, sham controlled clinical trial in Diabetic Foot Ulcer
(DFU) is expected in October 2015. This timing is in line with the
previously disclosed milestone of reporting clinical trial results
in the second half of 2015.
- Due to strong recruitment rates from its ongoing Venous Leg
Ulcer (VLU), pivotal, Phase III, randomized, double-blind, placebo
controlled clinical trial, the Company intends to accelerate
timelines and report full clinical trial results in the first half
of 2016 versus the second half of 2016.
- Results from the Company's Mechanism of Action (MOA) study
presented in February 2015 demonstrated the presence of 55
cytokines and growth factors and a significant up-regulation and
amplification, by 2 to 100 fold from the baseline, of these
biochemical factors in the Company's lead product candidate,
CureXcell; the study is the first of its kind in the Wound Care
space.
- The MOA study suggests that the Company's science and
technology have additional clinical applications that present an
opportunity to expand the product pipeline to additional
indications outside of wound care.
- The Company intends to present two clinical abstracts at the
upcoming Symposium for Advanced Wound Care (SAWC) in April in San
Antonio, Texas.
- Total cash position as of December 31, 2014 is $47.4 million;
cash expected to be used for ongoing operating activities in 2015
is $21-$25 million.
Management Commentary
"We set far-reaching business objectives in 2014. We are proud
of our accomplishments, including the on-time achievement of each
of our milestones, which most notably includes consummating our
Initial Public Offering, completing and initiating patient
recruitment in our DFU and VLU trial, respectively, and commencing
and completing our Mechanism of Action study," stated Nissim
Mashiach, President and Chief Executive Officer of Macrocure.
"We reaffirm that 2015 is an important year for Macrocure. We
are on schedule to report DFU clinical trial data in an expeditious
manner and we are excited to report sooner-than-expected timelines
in our VLU trial. To these ends, in January 2015, we successfully
completed the sixth and final meeting with the Data Safety
Monitoring Board for our ongoing pivotal phase III DFU study. As
with prior meetings, we were advised to continue the clinical study
with no modifications after receiving confirmation that no safety
concerns have been observed throughout the duration of the study.
Furthermore, in December 2014, we successfully completed the first
DSMB meeting for the ongoing pivotal phase III VLU study. The DSMB
recommended the study continue with no modifications. As a result
of the accelerated timeline of our VLU study pursuant to which we
intend to report full clinical trial results in the first half of
2016 versus the second half of 2016, we will not report interim
trial results in second half of 2015. However, we intend to conduct
a futility analysis for our VLU clinical trial, which will include
quantitative results in the form of ranges of probability for
success. These results are expected in the third quarter of 2015,"
added Mr. Mashiach.
"Finally, we continue to build our team at Macrocure with the
additions of Mark Page (formerly with Credit Suisse Securities) as
Chief Financial Officer and Dr. Tharuvai Ramesh, Ph.D. (formerly of
Nuron Biotech, Pfizer and Wyeth) as VP Operations. These moves
strengthen our resources and expertise and further positions
Macrocure to realize our promise of transforming the advanced wound
care space," concluded Mr. Mashiach.
Financial Results for the Fourth Quarter Ended December
31, 2014
Research and development expenses for the fourth quarter of 2014
were $5.7 million, compared with $3.0 million for the fourth
quarter of 2013. This increase was primarily due to significant
increases in patient recruitment and enrollment, especially in our
VLU study.
General and administrative expenses for the fourth quarter of
2014 were $1.9 million, compared with $0.8 million for the fourth
quarter of 2013. This increase was primarily due to increased
professional expenses and other customary costs associated with
being a publicly-traded company.
For the fourth quarter of 2014, the Company posted a net loss of
$7.6 million, or $0.42 loss per share compared with a net loss of
$3.9 million, or $0.52 loss per share, in the fourth quarter of
2013.
Financial Results for the Year-Ended December 31,
2014
Research and development expenses for the twelve months ended
December 31, 2014 were $15.5 million, compared with $9.3 million
for the comparable period in 2013. This increase was primarily due
to the ongoing clinical development of CureXcell, including
increased expenditures associated with the continued and increased
patient recruitment in the DFU and VLU trials.
General and administrative expenses for the twelve months ended
December 31, 2014 were $5.4 million, compared with $4.6 million for
the comparable period in 2013. This increase was primarily due to
expenses incurred during the IPO, increased professional expenses
and other customary costs associated with being a publicly-traded
company.
Finance expenses, net for the twelve months ended December 31,
2014 were $4.5 million, compared with $4.3 million for the
comparable period in 2013. These items are both one-time, non-cash
expenses associated with a convertible credit line made available
to the Company in 2014 and a revaluation of warrants in 2013.
For the twelve months ended December 31, 2014, the Company
posted a net loss of $25.5 million, or $2.15 loss per share,
compared with a net loss of $18.3 million, or $2.46 loss per share,
for the comparable period in 2013.
Balance Sheet Highlights and Other Items
As of December 31, 2014, cash and cash equivalents, including
short-term and long-term deposits were $47.4 million, compared with
$19.0 million as of December 31, 2013. This increase was due to the
completion of the Company's Initial Public Offering on August 5,
2014, which resulted in the Company's receipt of approximately
$46.7 million in net proceeds.
As of February 28, 2015, the Company had 16,702,225 ordinary
shares outstanding. This figure excludes an additional 1,339,244
ordinary shares issuable upon exercise of warrants at an exercise
price of NIS 0.01 per share that were outstanding as of that
date.
Guidance
We expect cash used for ongoing operating activities in 2015
will be $21-$25 million, reflecting anticipated expenditures to
complete our current phase III clinical trials in process this
year. This range excludes approximately $4 million in potential
capital expenditures in 2015 primarily for our new U.S.
manufacturing facility; the exact timing of such capital
expenditures is yet to be determined.
Expected Corporate Milestones
- 3Q 15: Phase III futility analysis results for VLU
- October 2015: Phase III clinical trial results for DFU
- 1H 2016: Phase III results for VLU
- 2H 2016: Submit BLA to the FDA
Financial Results Conference Call and
Webcast
Macrocure's management will host a conference call to discuss
the financial results and provide a business update on Wednesday,
March 18, 2015 at 9:00 am EDT; 6:00 am PDT; 4:00 pm Israel time.
Shareholders and other interested parties may participate in the
call by dialing (877) 303-6496 (domestic/U.S.) or (315) 625-3080
(international) and provide Conference ID: 90068247. Alternatively,
to access a live audio webcast of the call please visit the
Investor Relations section of the Company's website at
http://investor.macrocure.com. The audio webcast will continue to
be available for 30 days.
About Macrocure Ltd.
Macrocure Ltd. is a clinical-stage biotechnology company focused
on developing a novel therapeutic platform to address chronic and
hard-to-heal wounds, such as diabetic foot ulcers and venous leg
ulcers. The Company's novel approach is to treat and close chronic
and other hard-to-heal wounds by injecting the human body's own
wound healing and regenerative components directly into the wound
itself.
Macrocure's lead product candidate, CureXcell, is a unique
combination of living human white blood cells that have been
activated to facilitate the healing process and stimulate wound
closure. CureXcell addresses each phase of healing in the impaired
wound, including the production of growth factors and other
biochemical factors involved in fibroblast activation, cell
migration and extracellular matrix production, stimulating the
body's natural healing process. CureXcell is currently in two
pivotal Phase III, double-blind clinical trials targeting a broad
indication for the treatment of all types of wounds below the knee.
For more information, please visit: www.macrocure.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of Section 27A of the U.S. Securities Act of 1933, as
amended, Section 21E of the US Securities Exchange Act of 1934, as
amended, and the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts, such as
statements regarding assumptions and results related to financial
results forecasts, commercial results, clinical trials and
regulatory authorizations. Forward-looking statements are based on
Macrocure's current knowledge and its present beliefs and
expectations regarding possible future events and are subject to
risks, uncertainties and assumptions. Actual results and the timing
of events could differ materially from those anticipated in these
forward-looking statements as a result of several factors
including, but not limited to, unexpected results of clinical
trials, delays or denial in regulatory approval process or
additional competition in the market, including those risks
discussed under the heading "Risk Factors" in Macrocure's
Registration Statement on Form F-1 filed with the Securities and
Exchange Commission. The forward-looking statements made herein
speak only as of the date of this announcement and Macrocure
undertakes no obligation to update publicly such forward-looking
statements to reflect subsequent events or circumstances, except as
otherwise required by law.
|
Audited Condensed Interim
Consolidated Statements of Financial Position as of |
|
|
|
U.S. dollars in
thousands |
As of
Dec-31 |
As of
Dec-31 |
|
2014 |
2013 |
|
|
|
Assets |
|
|
|
|
|
Current assets |
|
|
Cash and cash equivalents |
10,868 |
18,995 |
Short term deposits |
35,313 |
-- |
Accounts receivable |
536 |
569 |
Total current assets |
46,717 |
19,564 |
|
|
|
Non-current assets |
|
|
Property and equipment, net |
451 |
330 |
Intangible assets, net |
276 |
827 |
Deposits |
1,255 |
17 |
Total non-current assets |
1,982 |
1,174 |
|
|
|
Total assets |
48,699 |
20,738 |
|
|
|
Liabilities and Shareholders'
Equity |
|
|
|
|
|
Current liabilities |
|
|
Trade and other payables |
2,488 |
1,971 |
Total liabilities |
2,488 |
1,971 |
|
|
|
Shareholders' equity |
|
|
Ordinary shares of NIS 0.01 par value |
45 |
20 |
Series A preferred shares of NIS 0.01 par
value |
-- |
* |
Share premium |
95,941 |
48,158 |
Capital reserve |
6,167 |
5,117 |
Warrants held by shareholders |
12,256 |
8,219 |
Accumulated deficit |
(68,198) |
(42,747) |
Total shareholders' equity |
46,211 |
18,767 |
|
|
|
Total liabilities and shareholders'
equity |
48,699 |
20,738 |
|
|
|
* Represents an amount lower than $1. |
|
|
Audited Condensed Interim
Consolidated Statements of Loss |
|
|
|
|
|
|
Twelve
months |
Three
months |
|
ended |
ended |
U.S. dollars in thousands |
December 31, |
December
31, |
|
2014 |
2013 |
2014 |
2013 |
|
|
|
|
|
Research and development expenses, net |
15,542 |
9,303 |
5,679 |
3,020 |
General and administrative expenses |
5,374 |
4,567 |
1,862 |
835 |
Operating Loss |
(20,916) |
(13,870) |
(7,541) |
(3,855) |
|
|
|
|
|
Finance expenses, net |
(4,504) |
(4,305) |
(94) |
50 |
|
|
|
|
|
Loss before income tax |
(25,420) |
(18,175) |
(7,635) |
(3,805) |
Taxes on income |
(31) |
(149) |
47 |
(50) |
|
|
|
|
|
Loss for the period |
(25,451) |
(18,324) |
(7,588) |
(3,855) |
|
|
|
|
|
Other Comprehensive Loss that will be
transferred to profit or loss: |
|
|
|
|
|
|
|
|
|
Net change in fair value of available for
sale financial assets |
(26) |
-- |
(26) |
-- |
|
|
|
|
|
Total comprehensive loss for the
year |
(25,477) |
(18,324) |
(7,614) |
(3,855) |
|
|
|
|
|
Loss per share - basic and
diluted (in U.S. dollars) (*) |
(2.15) |
(2.46) |
(0.42) |
(0.52) |
|
|
Audited Condensed Interim
Consolidated Statements of Cash Flows |
|
|
|
|
|
U.S. dollars in
thousands |
|
|
|
|
|
|
Twelve months
ended |
Three months
ended |
|
December 31, |
December 31, |
|
2014 |
2013 |
2014 |
2013 |
|
|
|
|
|
Cash flows from operating
activities: |
|
|
|
|
Loss for the period |
(25,451) |
(18,324) |
(7,588) |
(3,855) |
|
|
|
|
|
Adjustments: |
|
|
|
|
Depreciation |
106 |
89 |
24 |
25 |
Amortization |
551 |
551 |
137 |
138 |
Financing expenses, net |
4,504 |
4,305 |
94 |
(50) |
Taxes on income |
31 |
149 |
(47) |
50 |
Share based compensation |
1,663 |
2,648 |
441 |
216 |
|
6,855 |
7,742 |
649 |
379 |
Changes in operating assets and liability
items: |
|
|
|
|
Decrease (increase) in accounts
receivable |
158 |
118 |
764 |
124 |
Increase (decrease) in trade and other
payables |
692 |
440 |
659 |
(471) |
|
850 |
558 |
1,423 |
(347) |
|
|
|
|
|
Income tax paid |
(303) |
-- |
(151) |
-- |
Interest received |
32 |
85 |
18 |
27 |
|
|
|
|
|
Net cash used in operating
activities |
(18,017) |
(9,939) |
(5,649) |
(3,796) |
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
Purchase of property and equipment |
(227) |
(116) |
(1) |
(46) |
Decrease (Increase) in long terms
deposits |
(1,238) |
2 |
(1,245) |
1 |
Investment in short term deposits |
(17,829) |
-- |
(10,329) |
-- |
Investment in Available for Sale financial
assets |
(17,563) |
-- |
(17,563) |
-- |
Repayment of available for sale financial
assets |
53 |
-- |
53 |
-- |
|
|
|
|
|
Net cash used in investing
activities |
(36,804) |
(114) |
(29,085) |
(45) |
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
Proceeds from issuance of shares and
warrants, net of issuance costs |
46,689 |
13,750 |
-- |
-- |
Exercise of warrants |
198 |
-- |
-- |
-- |
|
|
|
|
|
Net cash provided by financing
activities |
46,887 |
13,750 |
-- |
-- |
|
|
|
|
|
Net increase (decrease) in cash and
cash equivalents |
(7,934) |
3,697 |
(34,734) |
(3,841) |
|
|
|
|
|
Effect of exchange rate changes on
cash and cash equivalents |
(193) |
(24) |
(183) |
(13) |
|
|
|
|
|
Cash and cash equivalents at
beginning of the period |
18,995 |
15,322 |
45,785 |
22,849 |
|
|
|
|
|
Cash and cash equivalents at end of
the period |
10,868 |
18,995 |
10,868 |
18,995 |
CONTACT: Francesca DeMartino
Investor Relations & Corporate Communications
+1 (310) 739-6476
francesca@macrocure.com
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