Toronto, Ontario – November 29, 2016, 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 nine-month period ended September 30, 2016, total revenue increased from $1,061,608 to $1,206,726 from the same period in 2015, a 14% increase.
In Canada, revenue decreased 18% to $728,277 from $885,562. In the US, revenue increased 193% to $399,445 from $136,382 and international revenue increased 99% to $79,004 from $39,665. The decrease in Canadian revenue in 3Q2016 and the corresponding increase in US and international revenue is attributable to the Company systematically building its sales and marketing teams in the Canadian and US market and the learning curves associated with training and developing a new sales force.
In December 2015, the next generation TLC-2000 laser technology received FDA 510(k) clearance and Health Canada approval, allowing Theralase the opportunity to commence recruiting a high performance sales and marketing team in Canada and the US, with the mandate of dramatically increasing sales of the TLC-2000 across Canada and the United States, in 4Q2016 and 2017. Once these strategic markets have been established and running independently, Theralase will focus on growing its international revenues through exclusive international distribution agreements.
Cost of sales for the nine-month period ended September 30, 2016 was $414,794 (34% of revenue) resulting in a gross margin of $791,392 (66% of revenue), compared to a cost of sales of $357,750 (34% of revenue) in 2015, resulting in a gross margin of $703,858 (66% 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. As revenues increase, volume purchasing should reduce the cost of goods sold.
Selling and marketing expenses for the nine-month period ended September 30, 2016 were $1,114,180 representing 92% of sales, compared with $750,098 or 71% of sales in 2015. The increase is primarily due to increased spending in marketing and sales personnel, which will augment sales of the TLC-2000 in future financial quarters. Selling expenses are expected to continue to increase in future quarters, as the Company expands in Canada, the US and international markets. On-going investment in sales personnel, marketing events and advertising are required to generate and increase revenues in subsequent financial quarters. As revenues increase, selling and marketing expenses should decrease as a percentage of revenue.
Administrative expenses for the nine-month period ended September 30, 2016 were $1,993,897 representing a 23% increase from $1,619,120 in 2015. Increases in administrative expenses are attributed to the following:
- General and administrative expenses increased 15% due to increased spending on investor relations and research scientist activities
- Stock based compensation increased by 56%, as a result of vesting of stock options to certain employees, directors and officers of the Company in 2Q2016
- Administrative salaries increased by 33%, as a result of hiring clinical and educational staff.
Gross research and development expenses totaled $1,598,175 for the nine-month period ended September 30, 2016 compared to $2,629,163 in 2015 (39% decrease). Research and development expenses represented 34% of the Company’s operating expenses for the period and represent direct investment into the research and development of the TLC-3000 anti-cancer technology.
The net loss for the nine-month period ended September 30, 2016 was $3,918,320, which included $573,592 of net non-cash expenses (amortization, stock-based compensation expense, foreign exchange gain/loss and lease inducements). This compared to a net loss for the same period in 2015 of $4,253,079, which included $438,539 of net non-cash expenses. The PDT division represented $2,367,893 of this loss (60%). The decrease in net loss is due to decreased investment in research and development of the next generation TLC-2000 therapeutic laser technology, while maintaining investment in research and development of the TLC-3200 Medical Laser and TLC-3400 Dosimetry Fibre Optic Cage related to the commencement of a Phase Ib clinical study for NMIBC and sales, marketing and administrative personnel initiatives, related to the commercialization of the next generation TLC-2000 therapeutic medical laser system.
Theralase has been very successful in executing on its strategic objectives by completing:
- Health Canada Medical Device Licence (Class III) approval of its next generation TLC-2000 Therapeutic Medical Laser System
- US Food and Drug Administration (“FDA”) 510(k) clearance of the TLC-2000
- Health Canada Clinical Trial Application (“CTA”) approval of the lead PDC, TLD-1433
- Princess Margaret Cancer Centre, University Health Network (“UHN”) Research Ethics Board (“REB”) approval
- Demonstrated 6 month accelerated stability and 9 month long term stability of it lead anti-cancer PDC TLD-1433
- Signed a Clinical Research Agreement (“CRA”) with UHN to conduct a Phase Ib clinical study for the indication of Non-Muscle Invasive Bladder Cancer (“NMIBC”)
- Health Canada Investigational Testing Authorization (“ITA”) approval of the TLC-3200 medical laser and TLC-3400 Dosimetry Fibre Optic Cage (“DFOC”) technology
The primary outcome measures of a Phase Ib NMIBC clinical study will be safety and tolerability, with a secondary outcome measure of pharmacokinetics (where the drug accumulates in tissue and how it exits the body) and an exploratory outcome measure of efficacy.
The Phase Ib NMIBC clinical study protocol will commence by instilling a low dose of TLD-1433 drug into the bladders of three (3) patients with subsequent light activation using the TLC-3200 / TLC-3400 medical laser technology. These three (3) patients will then be monitored for thirty (30) days to ensure safety and tolerability of the procedure. If no adverse events are reported, then an additional six (6) patients will be enrolled at a high dose, followed by light activation and follow-up monitoring for six (6) months.
If safety and tolerability of the procedure is demonstrated in these 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, the United States and Europe.
Mr. Dumoulin-White concluded that, “The Company looks forward to commencing a Phase Ib clinical study for NMIBC in 4Q2016. This will allow the Company to dramatically increase shareholder value by demonstrating the safety, tolerability and as an exploratory outcome measure efficacy of its next generation anti-cancer technology.”
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 and joint 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.
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For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225