Theralase Technologies Inc. – The Greatest Story Never Told 1 comment
Jan 22, 2014 7:20 AM | about stocks: TLTFF
Last week I attended the inaugural Cantech Letter Conference in Toronto, and I have to report that there was a quite a buzz in the room - Canadian technology and biotechnology stocks are back in play. In September 2013, market momentum shifted and since then we've seen the amount of public and private offering in these markets dramatically increase. Lots of Bay Street firms were chatting up CEOs at their booths, and actively recruiting analysts. The retail investment community also appeared starved for growth names in these markets and flocked to every booth at one point or another.
The company that caught our eye in particular was Theralase Technologies Inc. (TSX-V: TLT, US-OTCBB: TLTFF). They design, develop, manufacture and market, patented, super-pulsed laser technology used in biostimulative and biodestructive clinical applications. The Theralase technology platform targets several health-care sectors: First, for non-invasive pain management and clinical therapy, used in neural muscular skeletal conditions, including arthritis and osteoarthritis; Second, wound care and healing (including non-healing fractures and bone fracture regeneration); And third, research and development into combining patented photodynamic compounds (PDCs) with patented, super-pulsed, biofeedback laser technology to attack specifically targeted cancers, bacteria and viruses.
The company is currently focused on the commercialization (production, marketing and distribution) of the TLC-2000 Superpulsed Laser Technology to healthcare practitioners, and commercialization of the patented TLC-3000 Photo Dynamic Compound Cancer Technology through pre-clinical research and clinical trials.
Key Investment Highlights:
Working on breakthrough bladder cancer destruction technology and has achieved tremendous success in pre-clinical trials
Proven clinical technology (TLC-1000) and commercial therapeutic laser business and brand developed over last 17 years, currently generating ~2M of revenue annually
Rollout of new TLC-2000 technology in 2014, along with a new recurring revenue business model
Strategic agreements in place with world renowned institutions to help advance research and mitigate expenses
Competitive technical advantages (Cellular pathways: iNOS, ATP, Na+ / K+)
Future technology (patented biofeedback technology and patented PDC cancer destruction)
IP protection (multiple issued patents)
Large addressable US markets ($ billions)
Positive cash flow / double digit growth
Lots of opportunity for short-term and long-term growth (revenue & profit)
Experienced management team (20+ years)
Clear vision and execution strategy
Technically speaking, Theralase is very bullish. Average volume has doubled this past month, and new 200-day highs have been reached. The MACD line is on the zero and signal lines, potentially setting up what I believe to be the next breakout. Short-term indicators appear bullish as well. The share price crossed the 21-day MA last week, and strong momentum moved the share price up to a new 52-week high.
ANTI-CANCER PLATFORM TECHNOLOGY
Theralase has patented anti-cancer drugs known as Photo Dynamic Compounds (PDCs) which localize the DNA of cancer cells and when irradiated, destroy the DNA resulting in apoptosis (natural cell death). While PDCs are used in Photodynamic Therapy (PDT) as a potential treatment regime for a number of conditions, Theralase has discovered that they hold particular promise as treatment to particular cancers. Theralase PDCs have proven successful in destroying breast, colon, brain and bladder cancer cells. Recent lab results have shown that Theralase was able to completely destroy subcutaneous bladder cancer tumors in mouse models. "The achievement of this important milestone signifies that Theralase's leading drug candidate is effective in the destruction of cancer in a live animal model and can prevent the cancer from recurring," commented Roger White of Theralase.
Key Market Statistics:
- US bladder cancer treatment annual spending was $3.9 billion in 2012
- 70,000 new cases, > 14,000 deaths in the US each year
- 386,000 new cases are diagnosed worldwide annually
- Standard treatment unchanged with no new drugs approved since 1998
- 5th most common cancer, 4th in men, 8th in women
- Most expensive cancer to treat with a recurrence rate up to 80%
- 70% of new bladder cancer cases are early stage disease and 90% of bladder cancers are Transitional Cell Carcinoma (TCC)
Theralase PDC Characteristics:
- Up to 100% cancer cell kill at very low concentrations (< 0.8μM)
(click to enlarge)
- More effective at killing cancer cells than FDA approved drugs
(668,000x ALA, 198x PHOTOFRIN)
- Survival of mice up to 20 months (50 human years) after one Theralase PDT treatment
(click to enlarge)
We are VERY IMPRESSED, and VERY EXCITED about these results! In 2012, annual spending for bladder cancer treatment in the US was $3.9 billion, and the current standard of care has been unchanged with no new drugs approved since 1998. Bladder cancer is the most expensive cancer to treat, and has a recurrence rate up to 80%. All of the mice which showed an initial response have remained cancer free, healed without scarring, and have developed normally after only one Theralase PDC treatment. Needless to say, the early results from Theralase look extremely positive. Imagine being able to not only provide treatment for bladder cancer, but to actually cure it, and stop it from coming back! The company is also working on developing further PDCs that can be used to treat a wide variety of other cancers (breast, colon, brain and lung), as well as bacteria and viruses.
- The general patent protects 1,000s of molecules - essentially a library of PDCs
- Virtually 0% toxicity at high concentrations (> 100μM) leading to ultra-high safety profile
- Activated by laser light providing excellent specificity and selectivity
- Able to treat solid core hypoxic tumors, such as: breast, prostate and lung
- Research outsourced to and performed at world renowned Princess Margaret Cancer Centre
- Patented under numerous US and International Patents:
- Issued USA Patents: 6,962,910, 7,612,057, 8,148,360, 8,445,475
- Pending USA Patent Applications: 61/801,674, 13/863,089, 13/36595
To help explain how the procedure works we sketched a diagram:
(click to enlarge)
- A catheter is inserted into the patient
- The PDC is injected and saturates within the patient's bladder, penetrating the cellular membrane (DNA localizing)
- Fiber optics cables are inserted up the catheter into the bladder
- Using laser technology, light is irradiated 360°
- The entire procedure takes about 2 - 3 hours
Theralase is currently completing the validation of the orthotopic rat model, a dose toxicity study, GMP drug manufacture, and FDA Investigational New Drug (IND) application. The next phase is to complete an FDA phase 1/2a human clinical study with FDA breakthrough status, and then to execute a strategic partnership agreement with big pharmaceutical (pharma) company (upfront payments, co-development funds, annual recurring revenue streams).
Read More: http://static.cdn-seekingalpha.com/instablog/19040961-e-vestorsgroup/2601761-theralase-technologies-inc-the-greatest-story-never-told W
atch Video: http://www.youtube.com/watch?v=dwzW-Gwj2sI#t=12