TORONTO, Nov. 4, 2015 (GLOBE NEWSWIRE) — 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.”
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.
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)|
|Replay:||1-877-660-6853 (Toll Free)|
|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. firstname.lastname@example.org T: 647-476-1350, Ext. 424 Or Rebecca von Goetz Senior Marketing & Communications Specialist Profound Medical Corp. email@example.com T: 647-476-1350, Ext. 426 C: 416.917.8650