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Theralase Technologies Inc.: THE INVESTMENT CASE

TheraLase Technologies' TLD-1433 gaining traction as it journeys to clinical stage

Positive releases have centred around its photodynamic therapy technology
TheraLase Technologies' TLD-1433 gaining traction as it journeys to clinical stage
INVESTMENT OVERVIEW: TLT The Big Picture
The firm is moving from a pre-clinical to a clinical oncology organization.

A glance at the share chart of TheraLase Technologies Inc (CVE:TLT, OTCMKTS:TLTFF) shows a solid appreciation of the stock in recent months.

Since mid-March, shares have risen around 40% to where it stands now at 38 cents - a period, which has seen significant newsflow,  as the company continues to transition to a clinical firm - from a pre-clinical one.

Significantly, eye-catching positive releases have centred around its photodynamic therapy technology, which is being tried out on patients who have non-muscle invasive bladder cancer (NMIBC)

So what does the company do?

Theralase, which recently qualified to trade on the OTCQX Best Market in the US, has developed laser products to heal tissue and treat pain, although the long-term value in the group probably lies with an early-stage, light-activated treatment for cancer. 

Unlike many fledgling med-tech companies it is generating revenues and thinks there is scope to significantly increase turnover in the next few years. A market capitalization of  around $52mln suggests investors are yet to fully recognize the huge potential of this hybrid business.

Therapeutic Laser Technology

This is cold laser technology that uses light to penetrate tissue to promote cellular regeneration at the source of the injury. It effectively heals patients by eliminating pain, reducing inflammation and accelerating tissue healing.

WATCH: Here’s how it works

The equipment is used by doctors and other healthcare professionals and the company has around 600 TLC-1000 systems installed in Canada and 400 a further in the US and internationally. 

The TLC-2000 is its next- generation product backed by eight patents. Last year its kit, which is leased out, generated sales of $2mln. However, chief executive Roger Dumoulin-White had said he reckoned there was room for exponential revenue growth.  

But in a trading update last month, the firm revealed it was  to go back to the drawing board with the TLC-2000  after sales in the first quarter rose -  but not as quickly as expected.

The company said it did not expect to hit previously issued sales guidance of US$10mln in 2017 or the target of US$50mln within five years of launch. In response, it said it planned to optimize the TLC-2000 technology this year and next.

The company also plans to make regulatory submissions to Health Canada and the US Food and Drug Administration to expand the scope of the current clearances for use of the product beyond chronic knee pain.

The new clearances, if received, are not expected until next year.

Total revenues up in quarter...

In the first three months of the year, Theralase’s total revenue rose to C$507,428 from C$411,448 in the same period of 2016.

In Canada, revenue increased 79% to C$322,186 from C$180,069 but in the US, revenue decreased 7% to C$141,714 from C$152,375 while international revenue decreased 45% to C$43,528 from C$79,004.

The loss in the first quarter widened to C$1.47mln from C$1.15mln. It ended the period with cash of C$1.60mln, down from C$2.97mln at the end of 2016.

Photo Dynamic Therapy and TLD-1433

The company is developing light activated photo dynamic compounds (PDCs) to destroy cancer, where the compound is absorbed by the tumour and activated by light. 

It is making great strides with its lead compound TLD-1433.

Last month,  the firm revealed its phase Ib bladder cancer trial has gone well, with the primary and secondary objectives for the first part of the non-muscle invasive bladder cancer (NMIBC) clinical study successfully met.

The plan now is to sign-up another six patients for the second part of the study, in which they will be treated with a therapeutic dose of the photo dynamic compound (PDC) for NMIBC.

The company repeated that it had transformed from a "pre-clinical to a clinical oncology organization".

In pre-clinical work, presented recently at a Portugal conferenced focused on clinical treatment using light and photosensitizers, it was shown that TLD-1433 injected into a mouse model generated a greater than 90% cell kill in human glioblastoma multiforme (GBM) cancer treated preclinically with a low dose of X-ray.

Key takeaways of the benefits of  TLD-1433 are that it is able to destroy cancer cells predominantly through necrosis at 24 hours posttreatment, and provides noticeable damage to tumours when X-ray activated.

"This initial research will allow Theralase the ability to successfully complete a phase Ib GBM clinical study for this next generation PDT technology, demonstrating a primary outcome of safety and tolerability, and a secondary outcome of pharmacokinetics,"said Theralase.



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