Saturday, May 30, 2015 1:44:49 AM
In 2014 and early 2015, Theralase has made dramatic strides in both its Therapeutic Laser Therapy ("TLT") and Photo Dynamic Therapy ("PDT") anti-cancer divisions.
In the TLT division, Theralase has completed the design and initial manufacture of its next generation TLC-2000 therapeutic laser technology and is currently awaiting final Health Canada approval to launch in Canada. The TLC-2000, with patented Cell Sensing(TM) technology, is able to determine the precise location of injured tissue in a patient based upon their physical characteristics and automatically deliver an optimal dose of healing laser light energy safely and effectively to heal the damaged tissue faster and more effectively than any other laser system on the market.
In the PDT division, Theralase has significantly advanced its anti-cancer technology, focused initially on the treatment of Non-Muscle Invasive Bladder Cancer ("NMIBC"), and is gearing up for enrollment of patients in a Health Canada Phase Ib clinical study.
To meet this goal, Theralase has:
- Assembled an illustrious Medical and Scientific Advisory Board ("MSAB") in 4Q2014
- Presented its anti-cancer technology to Health Canada during a Clinical Trial Application ("CTA") meeting that occurred in 1Q2015
- Commenced the manufacturing process of its lead Photo Dynamic Compound ("PDC") TLD-1433 to Good Manufacturing Practice ("GMP") certification standards for completion of a Drug Master File ("DMF") slated for 3Q2015
- Commenced toxicology analysis of its lead drug, TLD-1433
- Commenced compiling the clinical protocol and investigator's brochure
Completion of these key objectives will result in submission of a CTA package to Health Canada in 3Q2015 and pending approval, enrolling patients that meet the inclusion / exclusion criteria into a Phase Ib clinical study for NMIBC in 4Q2015.
Total revenue for the three-month period ended March 31, 2015 increased 2% to $368,304 from $361,179 year over year.
The net loss for the three-month period ended March 31, 2015 was $933,643 (including $165,531 of net non-cash expenses) compared to a net loss of $344,074 in 2014 (including $15,897 of net non-cash expenses).
The net loss is a reflection of the ongoing commitment of Theralase to invest in the next generation of therapeutic laser technology and state-of-the-art anti-cancer treatment technology, partially funded from existing therapeutic laser sales.
Selling and marketing expenses increased 51% to $184,488 from $122,278 for the same period in 2014, primarily due to increased spending in associated marketing costs.
Administrative expenses increased 89% to $456,123 from $240,373 for the same period in 2014. The increase in administrative expenditures was due to increased spending on investor relations activities and medical advisory fees.
Research and development costs increased 276% to $545,645 from $197,792 for the same period in 2014. The increase was due to increased expenditures and investment into the commercialization of the TLC-2000 therapeutic laser technology and research and development of the TLC-3000 anti-cancer technology.
Roger Dumoulin-White, President and CEO of Theralase stated, "2015 will be a very strategic year for Theralase, as it launches the next generation TLC-2000 with Cell Sensing(TM) technology both in Canada and the United States and commences enrolling patients in a Health Canada Phase Ib clinical study for NMIBC."
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