Profound Medical Corp. ("Profound" or "Company") (TSXV:PRN), a
medical device company developing and commercializing a unique,
minimally invasive treatment to ablate the prostate gland in
prostate cancer patients, today reported financial results for the
three and nine months ended September 30, 2015. Amounts, unless
specified otherwise, are expressed in Canadian dollars.
"This quarter represents our first full quarter subsequent to
the completion of our financings, allowing us to execute on our
business strategy," said Steve Plymale, CEO of Profound. "We have
been building our team, progressing to commercialize in Europe, and
initiate the Pivotal Clinical Trial required for FDA approval."
Corporate Highlights
- On July 21, 2015, Royal Philips (NYSE:PHG) (AEX:PHIA) and
Profound announced that they signed a joint development agreement
to support Profound's proprietary technology designed to ablate
cancerous and non-cancerous tissue in prostate cancer patients on
Philips' Ingenia and Achieva 3T MRI systems.
- On October 15, 2015, Profound announced successful 12-month
Phase I outcomes at the European Symposium on Focused Ultrasound
Therapy, meeting primary endpoints. For further details, please
view the Phase 1 Clinical Trial Results Presentation located under
the Presentations and Papers section of the Investor Relations page
of our website, profoundmedical.com. The company will conduct a
Pivotal Trial to demonstrate the potential of this technology in a
larger prostate cancer patient population.
- On November 2, 2015, Profound announced that Hartmut Warnken
will join the company as Vice President, International Sales, to
lead our European Commercialization of TULSA-PRO™ in 2016. Mr.
Warnken has proven success in sales and marketing within the
medical device technology industry.
Summary Third Quarter 2015 Results
Profound incurred a net loss and comprehensive loss of
$2,957,179 (loss per share of $0.08) for the three months ended
September 30, 2015, compared to a net loss and comprehensive loss
of $1,528,125 (loss per share of $0.71) for the three months ended
September 30, 2014. For the three months ended September 30, 2015,
the net loss was attributed to the research and development
("R&D") expenses of $1,657,700, and the general and
administrative ("G&A") expenses of $1,099,798. For the
three months ended September 30, 2014, the net loss was primarily
attributed to the ongoing finance costs related to the preferred
shares and long-term debt of $668,730, the ongoing R&D expenses
of $453,669 and G&A expenses of $353,067.
R&D expenses were $1,657,700 for the three months ended
September 30, 2015 compared to $453,669 for the three months ended
September 30, 2014. The increase was primarily due to the
activities in preparing regulatory filings for marketing approval
of TULSA-PRO in Europe and Canada, preparation for the initiation
of the multi-jurisdictional Pivotal Trial, and preparation of the
12-month clinical outcomes from the 30 patient multi-jurisdictional
TULSA Phase 1 safety and feasibility trial. As a result material
costs increased by $831,406. The number of employees involved in
R&D also increased during this period to support these
activities resulting in salaries and benefits increasing by
$150,199.
For the three months ended September 30, 2015, G&A expenses
were $1,099,798 compared to $353,067 for the three months ended
September 30, 2014. This increase is primarily due to an increase
in the number of employees in G&A including the appointment of
a Chief Financial Officer, resulting in higher salaries and
benefits of $179,301 and share-based compensation of $241,436.
Professional and consulting fees in legal and accounting services
also increased $228,493 related to the private placement and the
June 4, 2015 qualifying transaction ("Transaction").
Liquidity and Outstanding Share Capital
As at September 30, 2015, Profound had cash, cash equivalents
and short-term investments of $23,279,079 compared to $406,495 as
at December 31, 2014. The increase is mainly a result of cash flows
provided by financing and investing activities which were partially
offset by cash flows used in operating activities. The cash flows
provided by financing activities related principally to the
issuance of common shares in connection with the private placement
for gross proceeds of $24,008,828, the $4,000,000 proceeds from the
Knight loan and the $1,500,000 proceeds from the issuance of
convertible notes, reduced by transaction costs and a bank loan
repayment. The cash flows provided by investing activities relate
to cash acquired from Profound as part of the Transaction.
As at November 4, 2015, Profound had an unlimited number of
authorized common shares with 39,473,327 common shares issued and
outstanding.
For complete financial results, please see our filings at
www.sedar.com and our website at www.profoundmedical.com.
Conference Call Details
Profound Medical is pleased to invite all interested parties to
participate in a conference call today, November 4, 2015 at 8:30
a.m. EST during which time the results will be discussed.
Live Call: |
1-877-407-9210 (Toll Free) |
|
1-201-689-8049 (International): |
Replay: |
1-877-660-6853 (Toll Free) |
|
1-201-612-7415 (International) |
|
|
Conf. ID #: |
13623015 |
|
|
About Profound Medical Corp.
Profound Medical is a Canadian medical device company that has
developed a unique and minimally invasive treatment to ablate the
prostate gland in prostate cancer patients. Profound's novel
technology combines real-time MR imaging with transurethral
therapeutic ultrasound and closed-loop thermal feedback control. It
provides a highly precise treatment tailored to patient-specific
anatomy and pathology. This method of prostate ablation offers
short treatment times and low morbidity, allowing for fast patient
recovery. The potential of this technology is currently being
demonstrated in clinical trials. For more information, visit
profoundmedical.com.
Notice regarding forward-looking statements:
This release includes forward-looking statements regarding
Profound and its business which may include, but is not limited to,
the expectations regarding the efficacy of Profound's technology in
the treatment of prostate cancer. Often, but not always,
forward-looking statements can be identified by the use of words
such as "plans", "is expected", "expects", "scheduled", "intends",
"contemplates", "anticipates", "believes", "proposes" or variations
(including negative variations) of such words and phrases, or state
that certain actions, events or results "may", "could", "would",
"might" or "will" be taken, occur or be achieved. Such statements
are based on the current expectations of the management of each
entity. The forward-looking events and circumstances discussed in
this release, may not occur by certain specified dates or at all
and could differ materially as a result of known and unknown risk
factors and uncertainties affecting the company, including risks
regarding the pharmaceutical industry, economic factors, the equity
markets generally and risks associated with growth and
competition. Although Profound has attempted to identify
important factors that could cause actual actions, events or
results to differ materially from those described in
forward-looking statements, there may be other factors that cause
actions, events or results to differ from those anticipated,
estimated or intended. No forward-looking statement can be
guaranteed. Except as required by applicable securities laws,
forward-looking statements speak only as of the date on which they
are made and Profound undertakes no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events, or otherwise, other than as required by
law.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
CONTACT: For investor or media inquiries, please contact:
Shameze Rampertab
CFO
Profound Medical Corp.
srampertab@profoundmedical.com
T: 647-476-1350, Ext. 424
Or
Rebecca von Goetz
Senior Marketing & Communications Specialist
Profound Medical Corp.
rvongoetz@profoundmedical.com
T: 647-476-1350, Ext. 426
C: 416.917.8650
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