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)
No debt
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
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
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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).
Industry comparables:
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Deals with comparable big pharma companies have yielded anywhere from $466M to $1B plus royalties.
The thing is, by the time clinical trials have been completed (assuming they're successful), Theralase will be trading many multiples higher than today. Look how excited investors got when Theralase first released PDC breast cancer results during January 2010, the intraday high for TLT was $1.39/share:
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