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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) 10/19/2018 04:24:41 PM
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
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#3550   $TLTFF 3 months chart $Pistol Pete$ 05/21/19 02:07:37 PM
#3549   Feels like more news this week Gene_Simmons 05/21/19 05:05:44 AM
#3548   Prospectus Withdrawn on May 16, 2019 123414 05/21/19 02:14:46 AM
#3547   Goes way beyond JMoriarty 05/20/19 11:07:30 PM
#3546   Cancer cells do not have a chance against robwilly 05/20/19 10:31:18 PM
#3545   Hey, these guys must be getting serious robwilly 05/20/19 10:22:39 PM
#3544   $TLTFF Theralase Granted Notice of Acceptance for PhotoDynamic $Pistol Pete$ 05/20/19 05:50:07 PM
#3543   Very close to phase 2 patient Enrollment/treatment news. 123414 05/20/19 10:21:46 AM
#3542   Theralase Granted Notice of Acceptance for PhotoDynamic Compounds 123414 05/20/19 08:05:25 AM
#3540   Good, im glad they're focused on opening new JMoriarty 05/16/19 10:33:18 AM
#3539   REB approval had a deadline of beginning of 123414 05/15/19 11:21:22 PM
#3538   I just look at the Phase 1.. they JMoriarty 05/15/19 10:44:11 AM
#3537   Arkady Mandel, M.D., Ph.D., D.Sc. Interim Chief Executive 123414 05/14/19 12:44:27 PM
#3536   Maybe all Candian patients will be treated in 123414 05/14/19 12:37:16 PM
#3535   News: $TLTFF Theralase's 5th Annual Medical and Scientific whytestocks 05/13/19 09:31:00 AM
#3534   Theralase’s 5th Annual Medical and Scientific Advisory Board 123414 05/13/19 08:57:08 AM
#3533   The way you look at the numbers is 123414 05/12/19 11:56:38 PM
#3532   My math stinks 6.59*.3 is $1.97 JMoriarty 05/12/19 11:29:16 PM
#3531   I like your breakdown, very accurate. JMoriarty 05/12/19 10:59:32 PM
#3530   2.6 Million required for initial treatmentof Canadian patients 123414 05/12/19 05:54:59 AM
#3529   by Phoenix Thera-Lase Systems 123414 05/11/19 09:46:21 PM
#3528   Evaluating Different Low-level Laser Therapies to Treat Neck scoobey-do 05/11/19 09:14:57 AM
#3527   Chinese Patent Office Issues Notice of Acceptance for scoobey-do 05/11/19 08:20:05 AM
#3526   Transaction History 123414 05/11/19 02:48:53 AM
#3525   Thanks for the heads up. Interesting that TLT citoyen 05/10/19 12:38:51 PM
#3524   Recruiting!! Recruitment Status : Recruiting 123414 05/10/19 08:52:46 AM
#3523   China patent update NEWS citoyen 05/07/19 05:44:21 PM
#3522   $TLTFF Phase1b NMIBC Clinical presented@ American Urological Association 123414 05/06/19 07:57:26 AM
#3521   $TLTFF "clinical study for a new cancer indication.” 123414 05/01/19 09:46:04 AM
#3520   Been that way for awhile. If you were MasterSalix 04/26/19 12:06:29 PM
#3519   Your welcome to your opinion. 123414 04/26/19 10:15:04 AM
#3518   Volume obviously important however why is the SHORT Lakersrback 04/26/19 10:13:52 AM
#3517   Enroll, Treat 2Q2019 - Company guidelines holding strong. 123414 04/26/19 05:23:54 AM
#3516   About 6300 bucks worth of stock shorted onthe24th. 123414 04/25/19 11:22:19 PM
#3515   thanks lrb. will check it, but of late citoyen 04/25/19 10:55:07 PM
#3514   OTC short report bud. If youre not Lakersrback 04/25/19 08:44:08 PM
#3513   link please citoyen 04/25/19 05:56:13 PM
#3512   HEAVY shorting here in the US. Can Lakersrback 04/25/19 03:03:47 PM
#3511   Again my thanks. I saw company guidance in citoyen 04/25/19 02:51:05 PM
#3510   The company guidance is for q2 patient treatment. 123414 04/25/19 02:29:47 PM
#3509   Thanks for posting 1234. TLT's news does not citoyen 04/25/19 02:15:53 PM
#3508   News: $TLTFF Theralase Commences Phase II NMIBC Clinical Study whytestocks 04/25/19 11:30:39 AM
#3507   $TLTFF-Theralase Commences Phase II NMIBC Clinical Study 123414 04/25/19 07:32:25 AM
#3506   6 month chart looking great, Excellent consolidation! Next-leg-up-soon! 123414 04/25/19 02:35:38 AM
#3505   My thanks for posting this again. Things do citoyen 04/24/19 03:36:23 PM
#3504   this all reminds me of in the 1950's heavymetal 04/24/19 09:02:54 AM
#3503   Hello, Thanks for the kind words. I'd 123414 04/24/19 02:02:50 AM
#3502   thanks for the response staine. i remember what citoyen 04/23/19 02:54:50 PM
#3501   As I understand it, Phase 1 required that stainedone 04/23/19 02:28:12 PM
#3500   123414.... mostly thanks for your informative posts. and citoyen 04/23/19 01:29:13 PM
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