Theralase Technologies Inc. V.TLT

9 more sites

[DJDawg]

When parsing that article of slighly new news I noticed that they talk about 9 more centres being added (hope to add). That is interesting update as I don't think I have heard that elsewhere. Correct?

No way to add 9 more centres with current cash on hand. But the fact that they are talking about it make me hope they have a plan.

[CancerSlayer]

Per the article: "We are approximately halfway through enrollment, with 11 clinical study sites currently enrolling patients and plans to add up to an additional nine clinical study sites in 2023 for a total of up to 20 clinical study sites in Canada and the United States,” according to Dr. Mandel. Good point Dawg....Having limited cash on hand & yet still planning to add "9"

[N0taP00p]

If they do get  AA, then I would think big pharma would be competing with each other much faster than the 12 month timeframe. But a year is a reasonable estimate. Let's hope for a quick approval in Q1. Icing would be if they get on the Frontrunner bandwagon for trying this treatment as a first line of defense, given the BCG shortage and safety profile in addition to efficacy. 

[enriquesuave]

A few years ago Endocyte got into a partnership with Novartis after good interim PH2 data.  Within 12 months they got bought out and MC went from $50 million gradually up until a $2.1 Billion USD buyout.  FDA approval only came about 2-3 years after buyout.  That is 42 time MC and SP appreciation over 12 months.  Anything is possible.  IMHO   

[StevenBirch]

That is interesting.

[ScienceFirst]

The example that EnriqueSuave is talking about was for the prostate indication but the example is useful as it once again shows that a drug candidate for FDA approval is always worth 1G$+.  This is just another of those examples that cross-validates this rule of thumb. When you read this article below, you can only think that PDT/PDC should be the future, whether with TLD-1433, Rutherrin or

[enriquesuave]

Nice details there SF.  TLD-1433 is so much more safe and versatile as well as easy to store and manufacture.  Not even comparable, but I pointed out that example just to show how quickly things can turn for the better once we hit BTD with great data  IMO   

[ScienceFirst]

Example of upfront payments that Endocytes obtained in 2012 with a first collaboration with a big pharma: Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate Vintafolide (EC145) - Merck.com  June 2012, Merck and Endocyte today announced that they have entered into an agreement to develop and commercialize Endocyte’s novel

[enriquesuave]

I just checked and see that Endocyte buyout happened in Oct. 2018 and the drug approval was 3.5 years later in March of 2022.  If we get AA, then a good chance we get bought out with an approved drug and while 3 PH1 trials are in place, GBM, NSCLC and COVID..  $2.1 Billion will be cheap. IMHO 

[CancerSlayer]

  Yep....& that drug approval was for only one indication.  As you inferred, our single drug/ACT has the realistic potential to cover multiple indications, which should add Billions to that $2.1 Billion price tag.  I also believe the market doesn't have a clue (including some Big Pharmas) as to the kind of ground-breaking potential TLT holds in its ACT/IP....an ACT that

[Infinity]

Logical to think we will have exposure and recognition as as we reach BTD.  We are almost there.  TLD1433 has almost endless potential based on it versatility, cost of treatment.  May even be used as a first line of treatment, eliminating BCG ??.  I think if we get BTD by June 2023, I will hang on to this stock till Jan 2025, or we get bought out before that.  It is going

[Donein25]

Infinity, your thoughts on first line treatment caught my attenetion. The additional 9 sites are also intriguing since we seem to have enough sites already. Perhaps the goal is to have a larger network in place with 20 sites ready to go for an eventual combo trial with a partner. Don't forget as well that FDA will want confirmatory trial in place for granting of AA. Either way, the 9 new sites

[CancerSlayer]

  Well stated & completely agree Donein.   The almost doubling in trial sites indicates to me that TLT is not only preparing for a more expedited post AA confirmatory trial, but is also very optimistic about having proper funding in place via a strong partnership, etc...imo.  With a successful completion of this NMIBC trial & under partnership, I see multiple indications

[Impalaman]

Cancerslayer----Including a combo trial----with our next guest----could that possibly be MERCK?.

[CancerSlayer]

Merck is in the driver's seat imo....Like skys1 said, Merck currently has the most to lose & others have the most to gain....this truly is the best case scenario for bidding up our price in any negotiations.  If Merck can only swallow a slightly bitter pill & if they play their cards right/early, they will be the next guest.  All imo...

[99942Apophis]

CancerSlayer your thoughts are gospel to me, I take it you also believe Theralase is in the driver's seat for negotiations with NMIBC only. I can't see Theralase giving away the apple cart but will negotiate each indication to the better experienced Pharmaceutical in that indication however if more than one with equal play in that indication then its a field day for Theralase. Yes reality

[CancerSlayer]

  Hi Apophis....thanks for your comments.  I am not a businessman by trade, but imo, the key to any successful negotiation (particularly with a big fish) is that a small biotech dearly/clearly protects its interests & that of its stakeholders.   Theralase has spent almost 2 decades perfecting its valuable asset/ACT, so it would be incumbent on the company to "clearly"

[DeathXray33]

I'll vote my 1m+ for $8. Fair for everyone...

[ramrodretired]

Add a 0  and im IN

[Oilminerdeluxe]

If all goes well, there will quite a few grotesquely rich people on this board in a year or two. I will remain in the category of "a little less poor" but I am fine with that. It would be cool to see some action in share price and in company related matters. An exciting year has started. As has been so nicely covered on the board, Big Pharma should be very interested in TLT's tech

[ramrodretired]

ROGER AND HAIR ?

[Legit62]

Im with you Ramrodretired on that one, $8 way too low IMO

[Infinity]

That would be roughly 1 for 1 in Merck shares in USD?

[ScienceFirst]

EnriqueSuave ... I concur.  NMIBC approval, plus Ph. 1b data on GBM and NSCLC and COVID-19 would clearly bring our market valuation much higher.  Easily.  10B$US+.   NSCLC is the #1 cancer in both US and Canada (and in many other countries).   NSCLC and GBM are extremely hard-to-beat cancers, so their extremely low survival rates.  Any life extension by

[Oilminerdeluxe]

Any thoughts on when we might start trials with a 2nd indication?

[99942Apophis]

Absolutely agree ScienceFirst especially on your $10B+US figure. Although GBM does have current treatments none of them can give a meaningful extension to life, if Theralase's treatment can do this i.e. by adding not only a few years but to show it can repeat treatment when necessary to assure an almost "normal life". This would at the same time indicate Theralase's treatment

[CAinPlap]

I have always thought that if we can prove it works in bladder cancer, it is just a matter of tweaking the PDT delivery mechanism and the laser activation for other indications. 

[Eoganacht]

I think the big tests after the bladder cancer treatment is approved, will be the systemic delivery of the photosensitizer, followed by low level X-Ray activation (X-PDT), the use of Rutherrin, and moving ahead with Dr. McFarland's more potent Osmium based photosensitizers which also work in low oxygen environments. And maybe the development of an Osmium enhanced version of transferrin

[CancerSlayer]

  Aside from the Wizardry of Os, the next biggest test imo will be finding that sorcery of light...the one that can unleash/activate this tech's full potential (i.e. a lower-dose & more targeted form of external radiation of which standard x-ray would be the simplest/least harmful).  The ability to treat a deep-seated tumor non-invasively with limited side effects would be the

[DeathXray33]

The LUNG & BRAIN cancer indications are interesting... Low powered X-RAYs are used safely everyday...

[Rumpl3StiltSkin]

Given AA is likey, soon. Meas 9 more TLT profit centers.. :-)

[ScienceFirst]

In communications (MD&A, news releases), TLT had hinted us about "up to 15", despite having 12 now.   Good thing that they plan to add 9 more in 2023, on top of the actual 12 ones as it will give us more visibility and we'll l'ose who is interested in on-boarding.  That could  be very telling.  For example, MD-Anderson (#1 in the US, Dr. Kamat), Dana