Theralase Technologies Inc. V.TLT

Dr. Black article on Phase 2 Trial of Atezolizumab

[DJDawg]

In the discussion they have a nice summary of the other drugs in the immunotherapy category.

"The CR rate at 3 and 12 mo was 43% and 20% with atezolizumab,

41% and 19% with pembrolizumab (n = 96) [11],

53% and 24% with nadofaragene firadenovec (mandatory biopsy at 12 mo; n = 103) [12],

40% and 17% with oportuzumab monatox (n = 93) [13], and

55% and 40% withnogapendekin alfa inbakicept (N-803; n = 80) [14}"

Of interest, the only one that comes close to Ruvidar is the last one which is a combo drug with BCG. When they got a CRL recently, they indicated that the FDA asked for more data on long term follow up. I suspect that was because it is clear that you can get a good CR if you keep treating but at some point you stop and then see what happens. With N-803, the data published so far show that the patients keep gettin recurrences. From 24 to 27 months, they lose another 10% of responders. The 27 month CR is approx 20% whereas Ruvidar seems to be locked in after 365 from what I can see. The patients that have been CR every step from 90 to 365 stay that way for 450.

All in all, if you use above methology, Ruvidar is 60% and 36%. Very good.

It also shows that there is truly a limit to the results that you can get with immunotherapy agents. Ruvidar's approach on a different track altogether.

IMO

 

[Alamir1111]

 fda safety efficacy btd fast track guidelines ..24 pennies?

[Alamir1111]

Cmon Roche price is .90cents now

[enriquesuave]

Combo therapies should normally always yield better results, however they will probably be used only after a good single agent fails.  Simplicity first.  N- 803 was deemed futile when used alone and hence had v low efficacy.  Only when used in combination with BCG did CR hit about 42% at 12 months.  We are practically there as a stand alone.  Eventually Ruvidar can be used

[Eoganacht]

Right. I think the durable response rate of Ruvidar PDT will end up being as high or higher than this combo treatment. And there is no telling how well Ruvidar PDT might end up performing in combination with the right accompanying treatment.

[DJDawg]

Agreed! However, the feedback from the FDA wasn't a complete shoot down of their application so it seems like the FDA is not opposed to considering a double agent strategy once they fix their application and apply again. On the topic of Immunity Bio, when the got the CRL from FDA back in May, the market cap dropped over a billion dollars. Interesting as it give idea what market puts on value

[Oilminerdeluxe]

Sure hope the company will at least offer a few words on BTD next week. Mind boggling increase in value could be the outcome down the road. Just needs to happen. 

[DJDawg]

Agreed. Some specifics would be great! On that subject it would be nice if they could somehow indicate if PP in works or done. Would be nice if they indicate something like "we have working capital to fund through March 2024" or something so maybe people will believe there is not another 0.25 PP right around the corner.

[patience69]

Just a little question for the board. I just like you expect a large bump with BTD. My concern is our exchange. Does anyone know of any comparables that were on the venture. It is unfortunately much easier to see that pop if we were on the Nasdaq

[99942Apophis]

patience69,  many have made that comment however the only one in the states is TLTFF and in the not too distant future Theralase will move off of the venture to the senior board the TSX and I'm sure in the states they will go after a listing on the Nasdaq.  Be patient patience69 its not that far off now. Wonder which exchange they will be listed in Europe? 

[FGPstock]

  Roger has been talking about moving to the nasdaq for 7 years back before he was sanctioned at the agm. Nasdaq isn't going to list a penny stock, Tlt needs to come through on the btd promise they made a long time ago. 

[ScienceFirst]

FGP ... You doubt that TLT will not have applied for BREAKTHROUGH Therapy??? Not because you have no confirmation that it won't.  In fact, you're one of the few to requestion that. Why would they not apply, despite all you're raising?

[FGPstock]

  As you know, they said last year they were going to apply in q4  2022. It was a publicly announced NR  and it was their words not mine. 9 months have gone by and as of the agm they obviously hadn't applied as Roger said it was "days away". Again, his words, not mine. All I have asked for is some transparency which I feel we deserve. In November 2022 they stated

[Legit62]

Very valid point FGPstock, i believe every investor here would like to know why. Our only hope is the Data to this point and its the reason we all stay in on this stock. Im a little frustrated myself with these timelines that dont come true, i ran a business for 35 years and would never communicate false deadlines. With that said we are dealing with a different beast here relying on FDA to give us

[StevenBirch]

For those genuinely concerned why don't you contact the company? 

[Legit62]

Tried multiple times Steven, no response, but which doesnt surprise me. Hoping to hear some updates which hopefully comes next week. Probably dont have custom relation or investor relation  employee at this time IMO

[StevenBirch]

I just know in the past some have contacted them and got a response but we are due for an update, let's hope questions are answered.

[Sunvalley]

There is a possibility that the reason the company is lacking on giving out information and /or responding to queries is because those inquiring just might be competitors who are trying to take advantage of any information given. As there is so much at stake in the "Curing Cancer" sphere , perhaps TLT is keeping as secretive as possible as a policy. Who knows! I suppose we will find out

[eibbor44]

Same. Have tried. 

[99942Apophis]

You all know no public traded company can give out any material news to any individuals by rules of Securities Commission. To obey these rules they can only comment on previous information by News Releases or what has been made public by the media. Theralase is simply following the rules.  I too have had moments of anxiety thinking about a NR on BTD but as someone here said its in the hands

[riverrrow]

I wouldn't be surprised to learn that TLT has not even submitted their BTD application.

[Oilminerdeluxe]

I know I sound boring, but if they have not applied yet, there is probably a very good reason for that. They must have gotten advice which they follow on the matter. I admit, I can be very wrong, but it sounds logical to me. 

[DJDawg]

I agree wtih OMD. RDW and others are invested personally and financially so the BTD application would be timed based on advice from experts. My reading suggests that most companies gets a consultancy to review applications. Consultants who do nothing but help with FDA matters and know the ins and outs. Likely ex-FDA staffed.

[O12009]

Keep in mind we have been fast track designated and that allowed special Privileges so we could meet with the FDA making sure we were ready to apply for BTD 

[Eoganacht]

Hi Oilminerdeluxe. I agree. There have been times in the last 9 years when I have questioned the wisdom of some of the actions of Theralase management, but I have never questioned their good faith. I believe Theralase management is doing it's level best to advance the interests of the company and it's shareholders. If I didn't believe this I don't know how I could stay invested

[N0taP00p]

@Eoganacht:  I had mentioned a medical devices company that I had invested in that had the greatest design.and I always thought next month, next quarter, next year will be better in terms of execution to the FDA submission timeline. I also believed management would have a lot of vested interest in being successful. Big names on the SAB.   Well, that company has essentially folded

[BudFoxx2020]

Wow 15 years and then another 15 years with TLT.  You still haven't learned anything in 30 years in the markets.  This is why these promoters are here because they know there are suckers like you born every day in the markets.  Not trying to be mean but just giving you a reality check.  Watch as another deadline will pass and it will be 2024, the promoters will still be

[N0taP00p]

No offense taken, Budfoxx2020. I can't argue with your statement.  It's our own tolerance for risks I guess. 

[BudFoxx2020]

Kudos for not taking offense.  I am just calling it as it is.  This is not about TLT but it applies to any company or stock out there.  I am reading your post word for word.  You are pointing out the exact same mistakes you made in the past and you are going through the exact same thing again.   Dejavu.  The markets are all about learning from experience and

[Donein25]

Bud, you really are wiser than the rest of us. If you can't save the poor fools who believe in TLT, at least save yourself...move on...please! 

[BudFoxx2020]

This post has been removed in accordance with Community Policy

[N0taP00p]

Budfoxx .. You're looking for this company to fail. We're looking for this company to succeed, despite the hiccups and heartaches. That's the key difference. Time will tell. Next week you might be wishing you stayed invested. Best. 

[BudFoxx2020]

All I pointed out was your own mistakes.  That you clearly pointed out.  I even said it does not even have to be this company.  Too bad you still don't get it.  Next week, lol.  I have heard that for the last 15 years in this board.  Don't worry about next week, how about end of he year.  Lets just say, What if nothing happens.  Then what, you will

[Legit62]

Love you Budfox2020 for your insight

[Legit62]

Its all about the dream, lets roll

[Eoganacht]

It's always been 2 steps forward, one step back with Theralase. But that slow progress has got us a hair's breadth away from an FDA cancer treatment approval. To get here Theralase has been reduced to implementing a hiring freeze, a new initiative freeze, an employee cut back to a skeleton crew and they are now reliant on hand-to-mouth financing just to keep going. I believe Theralase is

[socksnblonds642]

Sounds like Titan Medical. If so I feel your pain on that one. Either way this is a completely different animal, Theralase has not sold the farm. I'm sure by now Roger has applied for BTD or at least sent in his exucutive letter and has had some sort of feedback. Just speculating based on timeline to prodcution etc. No way is this going to be a JV. I hope that's not even on the table. AA

[N0taP00p]

Great guess, socksnblonds .  Yes, I think this is a different animal too.  But same situation on funding and timeline pushes.  Looking forward to that BTD and AA approval and hopefully, additional approval as an adjuvant treatment like N-801.  And if we're really lucky, approval to use pre-BCG based on efficacy and safety.  I like what Enrique just posted on

[Eoganacht]

Nice post DJDawg. Yes, it looks like the results of N-803 plus BCG comes closest to Ruvidar PDT. As far as safety goes, ImmunityBio also claims there were no Serious Adverse Events related to their treatment. But I think Ruvidar PDT will do much better than their 27 month CR rate of 20%. My bet would be 40% - 50%. Our durable response rate is still going up as more patients are evaluated so it

[ScienceFirst]

DJDAWG ... Nice constructive post.  Thanks for providing the competition efficacy results.  It allows a global perspective on where we stand.  And confirms we're top of the class. I think one major efficacy data is missing though (the one from the recently approved (Dec. 2022 Ferring's gene therapy), so here it is: The complete response rate was 51%, the median

[Eoganacht]

I would just note that the Adstiladrin CR rate at 12 months was 23% (46% of the 51% of responding patients) As of May 30 the Ruvidar CR rate at 12 months was 36%

[thadeush]

And it's worth noting that as COVID, which attacks T-cells and is more and more being compared to HIV, runs in checked through the population there will be a LOT of people who are immunosupressed and immuno-compromised. https://time.com/6265510/covid-19-weaken-immune-system/ German Health Minister: "Anyone who gets infected with corona more often runs the risk of developing an incurable

[ScienceFirst]

Thadeush ... You are correct.  Good observation.   Even NHL's Blackwacks star Jonatan Toews got the COVID-19 long and missed one complete season and decided to take another one off struggling with immune system issues https://www.sportsnet.ca/nhl/blackhawks-jonathan-toews-reveals-battle-chronic-immune-response-syndrome/sn-amp/ https://abc7chicago.com/amp/jonathan-toews-long

[ScienceFirst]

At the time of the refusal in May, we learned that ImmunityBio had a big pharma agreement for a jv partnership.  We can assume Merck as N-893 was trialed with BCG. That partner reconfirmed it would keep the jv partnership.  But it's also possible that they change their mind later on if manufacturing issues raised by the FDA complicate. By the way, here's a very interesting

[ScienceFirst]

Good observation DJDAWG about the market shaving 1B$US to IMMUNITYBIO (IBRX) in May after the refusal/delay requested by the FDA.  It fits the usual valuation that we often see about a serious SOC candidate that are usually given a 1B$US valuation. Still, despite this shaving, IBRX is still being valued at 750M$US this morning (though they have multiple trials ongoing). https

[enriquesuave]

Adstiladrin 12 months CR is about 24%. We are beating them badly.  ( 46% of the 51% who are CR remain so at 12 months, so it's not 46% but 23.5%). . We may end up with double that, and much simpler manufacturing and less side effects, as well as less treatments. 

[ScienceFirst]

Thanks for the clarification Eoganacht and EnriqueSuave. There's absolutely no reason not to be granted breakthrough Therapy designation as even on Dec. 2022, the FDA was stating that BCG-Unresponsive patients have limited options, despite everything on the market, despite: - Ferring's Adstiladrin gene therapy, - ImmunityBio' N-803 combo with BCG, - Merck's Keytruda, - Roche

[N0taP00p]

Well, it's settled then. If I am one of the FDA experts that said TLT data is good enough to be fast-tracked and to come back and show me phase 2 data for 25 patients that is in the same vicinity - with emphasis on safety and efficacy- we should already be there?  What grounds would I have now to say NO?  Only unknown is if there were other things that came up that we have no