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Theralase Technologies Inc. (TLTFF)

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Jan 22, 2014 7:20 AM | about stocks: TLTFF    

http://www.theralase.com/www/

 

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

(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)

  1. 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:

(click to enlarge)

(click to enlarge)

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:

Read More : http://static.cdn-seekingalpha.com/instablog/19040961-e-vestorsgroup/2601761-theralase-technologies-inc-the-greatest-story-never-told

Themes: Biotechnology, Micro Capitalization, Growth Opportunity, Pharmaceuticals, Cancer, Laser Technology, Photo Dynamic Compounds (PDCs) Stocks: TLTFF
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TLTFF News: Theralase Anti-Cancer Technology Picks Up Steam 01/06/2015 07:00:00 AM
TLTFF News: Theralase CEO to Be Interviewed Today on Clear Channel Business Talk Radio DFW 1190AM 03/12/2014 07:05:00 AM
TLTFF News: Theralase Achieves Commercialization Milestone For Its Bladder Cancer Therapy 03/14/2013 07:00:04 AM
PostSubject
#2413   Current average cost is 100 to 200 thous -3 01/16/17 09:19:58 AM
#2412   emailed them that ? . May phone later -3 01/16/17 06:47:46 AM
#2411   Don't know the answer to your question, but 123414 01/16/17 06:04:05 AM
#2410   Q... How much $$$ will it cost for CLINICIANS chakalalaBoom 01/16/17 12:00:15 AM
#2409   Q... How much $$$ will it cost for CLINICIANS chakalalaBoom 01/16/17 12:00:00 AM
#2408   I'm considering demand increase likely for TLC products 123414 01/15/17 07:30:22 AM
#2407   You're welcome. CUIN2 01/14/17 06:47:55 PM
#2406   Thats a really good write up about TLTFF..thanks The Rainmaker 01/14/17 06:08:28 PM
#2405   So back here the screening is probably the 123414 01/14/17 06:00:35 PM
#2404   “If you look at the Canadian and US 123414 01/14/17 02:21:12 PM
#2403   http://www.proactiveinvestors.com/companies/news/171615/laser-specialist-therala CUIN2 01/14/17 10:41:04 AM
#2402   Companys PR history indicates something coming. During the 123414 01/13/17 06:00:09 AM
#2401   I see biotech stocks announce progress on patient The Rainmaker 01/12/17 11:17:11 PM
#2400   Thats one of the ways we will know The Rainmaker 01/12/17 11:16:37 PM
#2399   The PI and/or Theralase would be the ones Geo2014 01/12/17 07:06:43 PM
#2398   What about peer review journals? Could anything get 123414 01/12/17 06:09:31 PM
#2397   I think they'll keep quiet until the first CUIN2 01/12/17 06:02:31 PM
#2396   It can be anyday but expecting news everyday 123414 01/12/17 04:56:33 PM
#2395   Thank you for that direct update. BIGKAHUNA57 01/12/17 02:51:54 PM
#2394   Thanks much appreciated IBjim 01/12/17 02:26:43 PM
#2393   Good info. Sets the right expectations. BIGKAHUNA57 01/12/17 02:03:36 PM
#2392   As I said last week, there is usually Geo2014 01/12/17 12:09:33 PM
#2391   Spoke to Roger this morning. No one has itsallgood11 01/12/17 10:59:55 AM
#2390   The treatment shows promise in cancers that current hubwolf1 01/12/17 12:36:44 AM
#2389   It's been a few. This is what we've been CUIN2 01/11/17 08:59:42 PM
#2388   Thanks Cuin. Man we have been on this 123414 01/11/17 08:53:19 PM
#2387   You are correct! Haven't seen that before. CUIN2 01/11/17 08:50:29 PM
#2386   100 percent all buys today. With sale prices 123414 01/11/17 08:49:23 PM
#2385   This could be the ONE that will find itsallgood11 01/11/17 08:09:53 PM
#2384   Last paragraph in particular is accurate. CUIN2 01/11/17 08:08:00 PM
#2383   Let's spread the word about this company . itsallgood11 01/11/17 08:05:42 PM
#2382   Cancer free for a large segment of cancer MasterSalix 01/11/17 08:05:21 PM
#2381   A cure aka cancer free for a large The Rainmaker 01/11/17 07:48:40 PM
#2380   This isn't a magic cure for all cancer MasterSalix 01/11/17 07:38:16 PM
#2379   What price tag do you put on the The Rainmaker 01/11/17 07:30:32 PM
#2378   To be honest I have no idea how MasterSalix 01/11/17 06:36:16 PM
#2377   "We're all set to go. We're just Signing 123414 01/11/17 06:27:03 PM
#2376   The simple answer is the lower the phase MasterSalix 01/11/17 06:01:37 PM
#2375   yep... yeah I was actually just thinking 123414 01/11/17 05:59:44 PM
#2374   I am new to Theralase but have a swimfli 01/11/17 05:46:10 PM
#2373   Fully is 165 or something right? Since the Gene_Simmons 01/11/17 02:03:18 PM
#2372   Hi 123, do you think the fully diluted bc2602 01/11/17 12:39:22 PM
#2371   I wonder if they have started testing, or Gene_Simmons 01/11/17 08:27:49 AM
#2370   MasterSalix can you explain the difference between the 123414 01/10/17 08:32:38 PM
#2369   Number of common shares outstanding 123414 01/10/17 06:40:24 PM
#2368   "three subjects at a low dose with a 123414 01/10/17 06:37:38 PM
#2367   "I do have a patient I have spoken 123414 01/10/17 06:24:19 PM
#2366   Preclinical company becoming Clinical company. 123414 01/10/17 05:44:37 PM
#2365   Interesting. Geo2014 01/10/17 10:26:32 AM
#2364   They told us the first patient they were The Rainmaker 01/10/17 10:13:19 AM
PostSubject