Toronto, Ontario (FSCwire) - Theralase Technologies Inc. (“Theralase®”
or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotech company focused on
the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds
(“PDCs”) to destroy cancer, announced today that for the three-month period ended March 31, 2017, total revenue
increased to $507,428 from $411,448 for the same period in 2016, a 23% increase.
In Canada, revenue increased 79% to $322,186 from $180,069 In the US, revenue decreased 7% to $141,714 from $152,375 and
international revenue decreased 45% to $43,528 from $79,004. The increase in Canadian revenue in 2017 and the corresponding
decrease in US and international revenue is attributable to the Company experiencing slower than expected sales growth of the
TLC-2000 in 2016 and 1Q2017, systematically building its sales and marketing teams in the Canadian and then the US market, the
learning curves associated with training and developing a new sales force in both jurisdictions and the ramp-up strategy of
successfully commercializing the TLC-2000 therapeutic laser system.
The Company has experienced slower than expected sales growth of the TLC-2000, has not achieved sales revenue guidance of $5 M
in 2016, is not expected to achieve sales revenue guidance of $10 M in 2017 or the forward looking target of $50 million
within 5 years of launch.
The Company plans on optimizing the TLC-2000 technology in 2017 and 2018 to increase the revenue opportunities afforded to the
technology through a “successful commercial launch of the TLC-2000” by:
1. Redesigning the TLC-2000 software, firmware and hardware to allow the implementation of
a “recurring revenue model” and large scale commercial distribution, not expected to be completed until
2018.
2. Submit regulatory submissions to Health Canada and the FDA to expand the scope of the
current clearances, beyond chronic knee pain, which if successful, is not expected to be completed until 2018.
Cost of sales for the three-month period ended March 31, 2017 was $207,237 (41% of revenue) resulting in a gross margin of
$300,191 or 59% of revenue, compared to a cost of sales of $131,764 (32% of revenue) in 2016, resulting in a gross margin of
$279,684 or 68% 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.
Cost of sales increased primarily by the retention of external engineering teams in order to optimize the TLC-2000 therapeutic
laser system software and firmware to support the Company’s mandate of successfully commercializing the TLC-2000.
Selling and marketing expenses for the three-month period ended March 31, 2017 were $410,979 representing 81% of
sales, compared with $316,254 or 77% of sales in 2016.
The increase is primarily due to increased spending in marketing and sales personnel, which should augment sales in future
financial quarters, potentially aiding in future sales of the TLC-2000. Selling expenses are expected to increase in the future
as the Company expands in Canada, the US and international markets. On-going investment in: sales personnel, marketing events and
advertising are necessary expenses to generate and potentially increase revenues in subsequent financial quarters.
Administrative expenses for the three-month period ended March 31, 2017 were $700,924 representing a 12% increase from
$623,314 in 2016.
Increases in administrative expenses are attributed to the following:
- Insurance expenses increased 27% due to increased product liability coverage
- General and administrative expenses increased by 65%, as a result of increased recruiting fees for sales personnel and
regulatory licensing fees.
- Administrative salaries increased by 15%, as a result of hiring clinical and educational staff.
Gross research and development expenses totaled $668,723 for the three-month period ended March 31, 2017 compared to $477,588
in 2016 (40% increase). The increase in research and development expenses is primarily a result of the ongoing Phase Ib clinical
trial for NMIBC, as well as investment into redesigning the TLC-2000 therapeutic laser system. Research and development expenses
represented 38% of the Company’s operating expenses for the year and represent direct investment into the research and
development expenses of the TLC-3000 anti-cancer technology and TLC-2000 therapeutic laser system.
The net loss for the three-month period ended March 31, 2017 was $1,472,184, which included $141,381 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 2016 of $1,145,739, which included $171,879 of net non-cash expenses.
The PDT division represented $697,207 of this loss (57%).
The increase in net loss is primarily due to increased investment in research and development of the TLC-3200 Medical Laser
and TLC-3400 Dosimetry Fibre Optic Cage (“DFOC”) related to the support of a Phase Ib clinical study for NMIBC
and sales, marketing and administrative personnel initiatives, related to achieving the successful commercialization of the next
generation TLC-2000 therapeutic medical laser system and the successful launch of its recurring revenue model.
The PDT division is focused on successfully completing a Phase Ib clinical trial for patients afflicted with NMIBC, utilizing
its novel next generation light-activated, anti-cancer drug, TLD-1433.
The Phase Ib clinical trial has been designed as follows:
Lead Institution:
Princess Margaret Cancer Centre, University Health Network (“UHN”)
Lead Clinical Principal Investigator:
Girish Kulkarni MD
Title:
A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients with Non-Muscle Invasive Bladder Cancer at High
Risk of Progression Who are Refractory to Therapy with Bacillus Calmette-Guerin (“BCG”) and Who are Medically
Unfit for or Refuse a Cystectomy
Objectives:
Primary: Evaluate the safety and tolerability of PDT employing TLD-1433 and controlled uniform
laser light (TLC-3200 System) in subjects with high risk, Ta/T1 or Tis NMIBC that are intolerant or refractory to BCG, and who
are not candidates or refuse radical cystectomy
Secondary: Evaluate the pharmacokinetics (“PK”) (movement and exit of drug within
tissue) of TLD-1433
Exploratory: Efficacy of PDT employing TLD-1433 and controlled uniform laser light (TLC-3200
System)
Methodology:
Phase Ib, open-label, single-arm, single-center study conducted in Canada. BCG intolerance or refractory disease
are defined as inability to tolerate or failure to achieve a tumour-free state after at least one induction (a minimum of 5
instillations) followed by either a second induction (a minimum of 5 instillations) or at least 2 maintenance instillations.
Subjects experiencing disease relapse within 12 months or less after finishing the second course of BCG therapy are also
considered refractory. 2 phases: In the first phase, 3 subjects will receive PDT (TLC-3200 System) employing 0.35
mg/cm2 (maximum recommended starting dose) TLD1433. If treatment with the maximum recommended starting dose does
not raise significant safety concerns, as determined by the safety monitoring committee, an additional 6 subjects will receive
PDT with 0.70 mg/cm2 (therapeutic dose) TLD1433
NMIBC PDT Treatment:
- Intravesically instill a sterile water based solution of TLD-1433 via catheter, through the urethra, into the bladder of a
patient inflicted with NMIBC, who has failed standard of care and who is not indicated or refuses to have their bladder
removed
- Allow the solution of TLD-1433 to absorb into any resident bladder cancer tumours for approximately sixty (60) minutes
- Void the bladder and flush the bladder with sterile water to remove any non-adhering TLD-1433 solution not absorbed by any
bladder tumours
- Admit the patient into the operating room and administer a general anesthetic
- Insert a rigid cystoscope through the urethra of the patient into the bladder
- Fill the bladder with sterile water to provide shape to the bladder
- Insert the TLC-3400 DFOC device into the bladder via the cystoscope’s working channel and connect it to the TLC-3200
Medical Laser System
- Deploy the DFOC in the bladder (like an umbrella) to strategically place optical detectors at approximately twelve (12)
predetermined locations along the bladder wall to monitor the laser light, intended to provide a uniform distribution of laser
light energy, in the correct dosage, to the bladder wall
- Activate PDC for approximately thirty (30) to one hundred and twenty (120) minutes
- Void bladder to remove sterile water
The TLC-3200 Medical Laser System delivers green laser light, at a wavelength of 525 nanometers (“nm”), while
the Dosimetry Fibre Optic Cage (“DFOC”) technology monitors the laser light to provide a uniform distribution of
the laser light energy, in the correct dosage, to the bladder wall.
The Phase Ib NMIBC clinical study protocol commenced by instilling a low dose of TLD-1433 PDC into the bladders of three (3)
patients with subsequent light activation using the TLC-3200 medical laser. These patients were treated on March 30, 2017, April
12, 2017 and April 18, 2017.
These three (3) patients were monitored for thirty (30) days post-procedure to ascertain achievement of the primary objective
of safety and tolerability and the secondary objective of pharmacokinetics. If no Significant Adverse Events
(“SAEs”) or severe Adverse Events (“AEs”) are reported, then an additional six (6) patients
would be enrolled at a therapeutic dose, followed by light activation and follow-up monitoring for six (6) months.
On May 26, 2017, Theralase announced that the independent Data and Safety Monitoring Board (“DSMB”)
unanimously decided that the primary and secondary objectives for the first part of the Phase Ib NMIBC clinical study
(“Study”) have successfully been met.
Princess Margaret Cancer Centre, University Health Network (“UHN”), in accordance with the DSMB’s decision,
is now recommended to enroll an additional six patients for the second part of the Study, treating them at a therapeutic dose of
the PDC (0.70 mg/kg) for NMIBC using its novel PDT technology.
The DSMB is comprised of three highly regarded, independent uro-oncologists; specifically: Dr. Laurence Klotz of Sunnybrook
Health Sciences Centre, Dr. Nathan Perlis of the University of Toronto and Dr. Alexandre Zlotta of Mount Sinai Hospital.
The clinical data on the first three patients was presented by Dr. Michael Jewett, Chair of the Medical and Scientific
Advisory Board (“MSAB”).
The DSMB members have unanimously recommended that the first three patients enrolled and treated in the Study successfully
achieved the primary and secondary endpoints of the Study and an additional six patients are now eligible to be enrolled into the
Study to be treated at a therapeutic dose of the PDC and monitored for 180 days, according to the endpoint criteria.
If safety and tolerability of the procedure is demonstrated in all nine (9) patients, the Phase Ib study results will support
Health Canada approval and a Phase II multi-center efficacy study for NMIBC will be commenced in Canada and the United
States.
Theralase’s anti-cancer technology pipeline includes numerous highly effective drug candidates, in various advanced stages of
preclinical development. Theralase will continue to validate its extensive data with additional cancer animal models and
toxicology analyses to bring these PDC drug candidates online for various cancer and bacterial applications.
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT)
(TLTFF: OTC) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures,
markets and distributes patented super-pulsed laser technology indicated for the treatment of chronic knee pain and in off-label
use the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle,
tendon, ligament, joint and wound conditions. Theralase’s Photo Dynamic Therapy (“PDT”) Division researches and
develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which are able to localize to
cancer cells and then when laser light activated, effectively destroy them.
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 the proposed use of proceeds. 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. 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 news 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:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com
To view this press release as a PDF file, click onto the following link:
public://news_release_pdf/theralase05302017.pdf
Source: Theralase Technologies Inc. (TSX Venture:TLT, OTC Pink:TLTFF)
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