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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: Small Company Offering and Sale of Securities Without Registration (d) 05/29/2018 05:28:56 PM
TLTFF News: Theralase Demonstrates 18 Month Stability of Lead Anti-Cancer Drug 03/15/2017 07:02:00 AM
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
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#3385   Ann Oct 5 2016: 123414 09/10/18 10:35:45 PM
#3384   Health Canada Approves Commencement of Phase II Clinical Study 123414 09/10/18 07:06:32 AM
#3383   Anticipation for mice survival rates 123414 09/02/18 12:41:02 PM
#3382   10m bucks gets them to interim results where JMoriarty 08/28/18 07:39:09 PM
#3381   Funding shouldn't be required for approval. 123414 08/28/18 07:11:42 PM
#3380   Theralase Announces Proposed Non-Brokered Private Placement of up CUIN2 08/28/18 05:29:46 PM
#3379   UK Nixes Gilead Gene Therapy Citing Cost, Casting 123414 08/28/18 03:24:34 PM
#3378   Well there's complete and theres pps appreciation at JMoriarty 08/28/18 08:28:21 AM
#3377   If they have as many as 25 places -3 08/28/18 05:03:22 AM
#3376   Part of the reason for slow enrollment was -3 08/28/18 04:42:39 AM
#3375   Agreed CUIN2 08/27/18 10:12:07 PM
#3374   Look how long it took to enroll the MasterSalix 08/27/18 10:08:54 PM
#3373   “The enrollment, treatment and follow-up of these 100 CUIN2 08/27/18 09:02:06 PM
#3372   In light of the statement in this PR Anesthesia 2007 08/27/18 10:30:52 AM
#3371   Theralase® Provides Corporate Update Theralase® Provides Update on Anesthesia 2007 08/27/18 10:23:36 AM
#3370   geo...i wonder about that. yes, still early but citoyen 08/21/18 03:14:38 PM
#3369   Maybe it's time to start treating GBM off Hank Kerchief 08/20/18 01:03:26 PM
#3368   Theralase Submits Phase II Bladder Cancer Clinical Study 123414 08/20/18 08:56:02 AM
#3367   Theralase Submits Phase II Bladder Cancer Clinical Study Anesthesia 2007 08/20/18 08:31:55 AM
#3366   Perhaps now is the time for accumulation. 123414 08/16/18 07:31:02 AM
#3365   Our dosimetry software now ready for the GBM 123414 08/16/18 07:18:29 AM
#3364   Still too early. Geo2014 08/15/18 11:29:35 AM
#3363   I know! It’s infuriating! I guess we’ll have Anesthesia 2007 08/13/18 06:25:58 PM
#3362   It seems this stock can never get any traction. Why? CUIN2 08/13/18 06:08:46 PM
#3361   No Clinical Evidence of NMIBC at 180 Day 123414 08/13/18 06:02:31 PM
#3360   Very exciting times! Looking forward to commencement of Anesthesia 2007 08/13/18 07:49:54 AM
#3359   Theralase Achieves Exploratory Efficacy Endpoint in Phase Ib CUIN2 08/13/18 07:29:53 AM
#3358   Agreed 100% JMoriarty 07/26/18 04:41:31 PM
#3357   Funding shouldn't be required for approval. 123414 07/26/18 04:14:40 PM
#3356   Commercial on BTV IBjim 07/22/18 08:09:57 AM
#3355   Patient six results not reported yet. 123414 07/16/18 05:09:49 PM
#3354   Patient Five Demonstrates No Clinical Evidence of NMIBC 123414 07/16/18 04:45:40 PM
#3353   Well could be the 30m that needs to JMoriarty 07/16/18 01:38:33 PM
#3352   Na, FUSZ is more than fine IMO. Theralase has CUIN2 07/16/18 12:49:31 PM
#3351   Maybe because FUSZ stagnates at 0,58 $ lol suerte88 07/16/18 12:41:58 PM
#3350   Still don’t understand why this isn’t getting more CUIN2 07/16/18 12:24:18 PM
#3349   Nice news - moving right along... MasterSalix 07/16/18 09:33:47 AM
#3348   Theralase Demonstrates Anti-Cancer Technology Prevents Recurrence of Bladder Van Beethoven 07/16/18 09:27:09 AM
#3347   So they slapped about a third of todays 123414 07/13/18 06:11:07 PM
#3346   Looks like some slappers moved in at the EOD. 123414 07/13/18 05:53:07 PM
#3345   Theralase Releases AGM Videos 123414 07/05/18 06:10:33 AM
#3344   Grant was for researchers and Theralase holds all 123414 06/28/18 04:34:57 PM
#3343   Strong PH1 NMIBC Completed trial results commanded attention. 123414 06/28/18 04:30:19 PM
#3342   Can the government make any claims on the CUIN2 06/28/18 04:09:50 PM
#3341   Well deserved! So is this $4.5 million we Anesthesia 2007 06/28/18 12:19:18 PM
#3340   Theralase Researchers Receive Government Grant 123414 06/28/18 12:04:06 PM
#3339   TLTFF GBM RG2 cells were pre-treated in 123414 06/27/18 05:55:20 PM
#3338   You’re right. Hoping the phase 2 trial Hank Kerchief 06/25/18 07:34:59 AM
#3337   The tech is showing initial promise. No CUIN2 06/24/18 11:21:13 AM
#3336   Why? Hank Kerchief 06/24/18 05:26:21 AM
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