Theralase® Announces Settlement Agreement with Ontario Securities Commission
Toronto, Ontario – February 26, 2018
Theralase® Technologies Inc. (the “Company”) (TSXV: TLT) (OTCQX: TLTFF) announced today that the Company and Roger Dumoulin-White, former Chairman, President and Chief Executive Officer, have entered into a settlement agreement (“Agreement”) with Staff of the Ontario Securities Commission (“OSC”).
This Agreement resolves issues relating to the Company’s continuous disclosure between November 3, 2006 and August 29, 2017 (“Time Period”) and specifically resolves: (a) that the Company did not update or supplement certain disclosed forward‐looking information with additional mandated disclosure (including identification of assumptions, cautions and material risk factors) in connection with: (i) various statements in its public disclosure (including news releases and MD&As filed on the System for Electronic Document Analysis and Retrieval (“SEDAR”) and marketing materials posted on its website and elsewhere on the Internet), in which it rolled forward the launch date of the TLC-2000 therapeutic laser (“TLC-2000”) in 30-day to five quarter increments; (ii) revenue projections for TLC-2000 disclosed between 2006 and 2016; and (iii) five-year outlooks in its SEDAR filings; and (b) that certain of the Company’s disclosure may have conveyed that the regulatory approvals obtained with respect to the TLC-2000 extended to the biofeedback or Cell Sensing® technology.
This matter does not concern the accuracy of the Company’s financial reporting in its quarterly and annual financial statements filed with the Canadian Securities Administrators on SEDAR.
The Company will not face a financial penalty; however, Mr. Dumoulin-White has agreed to certain administrative penalties as detailed below.
The Company is committed to meeting corporate disclosure standards and regrets that it did not satisfy such standards during the Time Period. As a result of the inquiry by OSC Staff, the Company has already taken steps to correct the public disclosure record and improve its continuous disclosure. In particular, Theralase® previously issued two clarifying press releases (including a press release dated June 30, 2017). Theralase also introduced and updated certain policies and procedures relating to disclosure.
Under the terms of the Agreement, the Company will:
- Have the Company’s corporate governance framework reviewed by Peterson McVicar LLP (“Consultant”) and adopt all changes recommended by the Consultant that are accepted by OSC Staff;
- Effective as of the date hereof, appoint Arkady Mandel, the Company’s Chief Scientific Officer, to also act as its Interim Chief Executive Officer for a period of no more than one year;
- Use best efforts to recruit, as soon as practicable, an external Chief Executive Officer,
- Establish a Disclosure Committee to oversee and approve its disclosure;
- Cause each of its directors and officers to complete a corporate governance course on disclosure issues satisfactory to OSC Staff, the cost of which course will not exceed $2,500;
- Ensure that, for a period of five years, Mr. Dumoulin‐White complies with certain restrictions regarding his ability to engage in specified disclosure, investor relations and financing related activities, as further detailed below; and
- Cancel 4,000,000 stock options previously granted to Mr. Dumoulin-White for future services (which have exercise prices of $0.50, of which 1,000,000 expire on July 11, 2019 and 3,000,000 expire on May 28, 2020) (“Future Service Options”).
Under the terms of the Agreement, Mr. Dumoulin‐White will:
- Immediately resign any position that he holds as a director or officer of an issuer (including the Company);
- Not become or act as a director or officer of a reporting issuer or any related entity for a period of five years;
- Not become or act as a director or officer of any non-reporting issuer (other than a related entity of a reporting issuer with respect to which the five year prohibition applies) for a period of three years;
- Pay an administrative penalty in an amount equal to $250,000, less the costs of the Consultant (not to exceed $150,000) paid by him;
- For a period of five years, (i) not engage in specified disclosure activities; (ii) not engage, directly or indirectly, in any significant investor relations activities; and (iii) ensure that any of his activities for the raising of financing by, or the solicitation of investments in, the Company be supervised by its Chief Executive Officer or a member of the Disclosure Committee;
- Before engaging in any activities described immediately above, engage in a full day of one-on-one training with the Consultant regarding disclosure issues;
- Before becoming a director or officer of an issuer, complete an education program, satisfactory to OSC Staff, relating to the obligations of directors and officers;
- Not dispose of any of his securities of the Company until the day following the date the first management’s discussion and analysis is required to be filed by the Company following the completion of 12 months of the Consultant’s engagement; and
- Surrender for cancellation his Future Service Options.
Arkady Mandel, Ph.D., M.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer stated that, “The Company’s focus on an early resolution of these matters demonstrates the Company’s commitment to enhanced corporate governance and disclosure going forward. With these matters resolved and behind us, we can now direct all of our energy towards executing on the Company’s primary business strategy, the development and commercialization of our Anti-Cancer Technology. This strategy commences with the completion and Health Canada approval of our Phase I Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study in 2018, allowing the Company the ability to commence an adaptive, multi-center Phase II NMIBC clinical study. Mr. Dumoulin-White will be appointed Director of Business Development and I look forward to working with him in his new role.”
The Company also wishes to provide certain clarification about the status of the regulatory approvals with respect to its Cell Sensing® Technology. While the TLC-2000 received Health Canada and FDA regulatory approval in late 2015 for the treatment of knee pain, regulatory approval for “biofeedback” or “patented Cell Sensing® Technology” was not sought or obtained from Health Canada or the United States Food and Drug Administration (“FDA”) at that time. The Company initially applied for Health Canada and FDA approval of Cell Sensing® Technology in the first quarter of 2017. The review period for the initial applications has expired and new applications have been submitted with Health Canada and the FDA.
The Company also wishes to provide an update with respect to the redesign work on the TLC-2000 and the status of its regulatory approvals to expand the scope of the current TLC-2000 clearances beyond knee pain. As previously disclosed, in order to position itself to achieve a wider commercial distribution of the TLC-2000 and eventually grow its revenues beyond historical levels, the Company has, among other things:
- Commenced further redesign work on the TLC-2000 software, firmware and hardware.
- Made initial submissions to Health Canada and the FDA to expand the scope of the current clearances beyond knee pain.
The Company has made progress with respect to the redesign work on the TLC-2000. The current redesign work is targeted to be completed in 2018, subject to certain assumptions including: the Company having sufficient funding to complete the work, and the scope and parameters of the redesign work not being materially altered with reference to ongoing field testing, key opinion leader input or regulatory input.
The review period for the initial applications to expand the scope of the current clearances beyond knee pain has expired. Updated applications are targeted to be submitted with Health Canada and the FDA in 2018.
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations to safely and effectively destroy various cancers. The Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions.
This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s development and commercialization of the TLC-2000, including with respect to ongoing redesign work and regulatory clearance process for expanded claims and the Company’s development and commercialization strategy with respect to its Anti-Cancer Technology. Wherever possible, words such as “may“, “would“, “could“, “should”, “will“, “anticipate“, “believe“, “plan“, “expect“, “intend“, “estimate“, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to successfully complete the redesign work under the proposed timeframe and scope of work or at all, the availability of financing to advance the development of the TLC-2000, the ability of the Company to secure further regulatory clearances (including with respect to expanded claims) from Health Canada and/ or the FDA with respect to the TLC-2000 under the proposed timeframe and scope or at all, the ability of the Company to achieve wider commercial distribution of the TLC-2000, the ability of the Company to execute its strategy with respect to its Anti-Cancer Technology, the ability of the Company to secure further regulatory approvals from Health Canada and/ or the FDA for its NMBIC clinical studies and the ability of the Company to finalize development of, and successfully commercialize, its Anti-Cancer Technology. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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