Toronto, Ontario (FSCwire) - (“Theralase®” or the
“Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company
dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their
associated drug formulations intended to safely and effectively destroy cancer released its 1Q2018 financial statements.
Total revenue for the three-month period ended March 31, 2018 decreased to $441,193 from $507,428 for the same period in 2017,
a 13% decrease. In Canada, revenue decreased 8% to $297,061 from $322,186. In the US, revenue decreased 36% to $90,354 from
$141,714 and international revenue increased 23% to $53,778 from $43,528. The increase in international revenue in 2018 and the
corresponding decrease in Canadian and US revenue is attributable to the Company focusing it’s sales and marketing efforts on the
Canadian and international markets.
Cost of sales for the three-month period ended March 31, 2018 was $242,857 (55% of revenue) resulting in a gross margin of
$198,336 or 45% of revenue, compared to a cost of sales of $207,237 (41% of revenue) in 2017, resulting in a gross margin of
$300,191 or 59% of revenue. Cost of sales is represented by the following costs: raw materials, subcontracting, direct and
indirect labour and the applicable share of manufacturing overhead.
The cost of sales versus revenue percentage increase, year over year, is attributed to discounted sales pricing for the
TLC-1000 product line, as this product line is near end of life.
For the three-month period ended March 31, 2018, selling and marketing expenses decreased to $280,874 or 64% of
sales, from $410,979 or 81% of sales in 2017, a 32% decrease.
The decrease is primarily due to the termination of certain sales and marketing personnel and decreased spending in
advertising.
Administrative expenses for the three-month period ended March 31, 2018 decreased to $555,086 from $700,924 in 2017,
representing a 21% decrease.
Decreases in administrative expenses are attributed to the following:
- Administrative salaries decreased by 16% due to the termination and/or resignation of certain administrative staff.
- Stock based compensation decreased 135% due to certain current employees forfeiting all non-vested and non-exercised
options totaling 4,300,000 and certain terminated or resigned employees forfeiting all non-vested and non-exercised options
totaling 130,000.
- General and administrative expenses decreased 65% due to decreased investment in investor relations and recruiting
expenses
Net research and development expenses for the three-month period ended March 31, 2018 decreased to $364,956 from $668,723 in
2017, a 45% decrease.
Research and development expenses decreased primarily due to decreased expenses for conducting the Phase Ib NMIBC clinical
study. Research and development expenses represented 30% of the Company’s operating expenses for the three-month period ended
March 31, 2018 and represent investment into the research and development of the Company’s anti-cancer technology.
The net loss for the three-month period ended March 31, 2018 was $1,004,068 which included $36,405 of net non-cash expenses
(i.e.: amortization, stock-based compensation expense, foreign exchange gain/loss and lease inducements). This compared to a net
loss for the same period in 2017 of $1,472,184, which included $141,380 of net non-cash expenses a reduction of 32%.
The PDT division represented $476,200 of this loss (47%) for the three-month period ended March 31, 2018.
The decrease in net loss is primarily due to three reasons:
1) decreased investment in research and development in the Phase Ib NMIBC clinical study.
2) decreased investment in external engineering resources to redesign the software, firmware and hardware of
the TLC-2000 therapeutic laser.
3) decreased sales, marketing and administrative costs.
Theralase Successfully Completed the Phase Ib Non-Muscle Invasive Bladder Cancer Clinical Study. Theralase’s Medical and
Scientific Advisory Board (“MSAB”) concluded that the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”)
clinical study (“Study”) has met its objectives and unanimously voted for the early termination of the Study based on
successfully achieving its primary and secondary endpoints after six patients.
On May 19, 2018, Theralase’s MSAB was convened to examine the clinical results obtained on the first six patients
enrolled and treated in the Study utilizing TLD-1433-based Photo Dynamic Therapy (“PDT”); specifically: the
primary endpoint of safety and tolerability, the secondary endpoint of pharmacokinetics (movement and exit of drug within tissue)
and the exploratory endpoint of efficacy primarily at 90 days.
The MSAB is comprised of world-renowned experts in bladder cancer and have been retained by the Company to provide
advice and strategic guidance on the research, development and commercialization of the TLD-1433-based PDT technology in the
treatment of patients inflicted with NMIBC.
After reviewing the clinical data presented by Girish Kulkarni, MD, PhD, FRCSC, an Associate Professor at the
University of Toronto, Department of Surgery and the Principal Investigator of the Study, the MSAB unanimously recommended the
early termination of the Study due to achievement of the primary and secondary endpoints. The MSAB also recommended that the
clinical data collected from the first three patients treated at the Maximum Recommended Starting Dose (“MRSD”)
(0.35 mg/cm2) and the three patients treated at the Therapeutic Dose (0.70 mg/cm2) were sufficient to
support the conclusion that the Study had successfully achieved the Study’s primary and secondary endpoints and had adequately
addressed the Study’s scientific, technical and clinical questions, as per the approved Study design and clinical protocol. The
MSAB recommendation to the Company was to terminate the Study based on the six patients treated to date and suggested that the
Company pursue a pivotal Phase II NMIBC clinical study approval with Health Canada and the FDA with efficacy as the primary
endpoint.
About the Study
The Study is being used to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and
tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of
efficacy.
Study Outcome Endpoints:
1) Primary: Evaluate safety and tolerability. (Measured by patients who
experience Adverse Events (“AEs”) Grade 4 or greater that do not resolve within thirty (30) days; whereby: Grade
1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death)
2) Secondary: Evaluate the pharmacokinetics. (Movement and exit of drug within
tissue) of TLD-1433 (Measured by TLD-1433 concentration levels in plasma and urine over 72 hours.)
3) Exploratory: Evaluate efficacy. (Measured by Recurrence Free Survival
(“RFS”), defined as the interval from Day 0 (Day of PDT treatment) to documented recurrence or death from any
cause, whichever occurs first. Recurrence is defined as any new tumour growth (i.e.: any biopsy-confirmed new or recurrent
tumour), evaluated at 90 days for the first three patients treated at the MRSD and primarily at 90 days for the last six patients
treated at the Therapeutic Dose and secondarily at 180 days post treatment.)
The Company is planning to meet with Health Canada and FDA, to discuss and finalize the design of a Health Canada
and FDA pivotal Phase II NMIBC clinical study, with a primary endpoint of efficacy.
About Theralase Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo
Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy cancer. 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.
Additional information is available at www.theralase.com and www.sedar.com.
This news release contains "forward-looking statements" which reflect the current expectations of
management of the Corporation’s future growth, results of operations, performance and business prospects and opportunities. Such
statements include, but are not limited to, statements regarding Theralase’s proposed development plans with respect to Photo
Dynamic Compounds and their drug formulations. 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 Theralase to: successfully fund and complete the
Phase Ib NMIBC clinical study, secure the requisite regulatory approvals to commence and fund a
Phase II NMIBC clinical study and implement its development plans. Many factors
could cause the Corporation’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 Corporation 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 press release are based upon what management currently believes to be reasonable
assumptions, the Corporation cannot assure prospective investors that actual results, performance or achievements will be
consistent with these forward-looking statements. The Corporation 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.
For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
info@theralase.com
www.theralase.com
To view the original release, please click here
Source: Theralase Technologies Inc. (TSX Venture:TLT, OTCQX:TLTFF, FWB:TTX)
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