Theralase Technologies Inc. V.TLT

"impressive, paradigm shifting, photodynamic therapy"

[Eoganacht]

Research Capital sees Theralase’s Ruvidar NMIBC potential better than Keytruda

Michelle Carr    February 23, 2023

 

Research Capital likes the potential chances of Theralase Technologies’ (TSXV:TLT) Ruvidar photodynamic therapy being better than Merck’s Keytruda for treating Bacillus Calmette-Gurin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC).

 

In a new research report, analyst Andre Uddin, Ph.D., writes that Theralase recently presented more positive data at the 2023 GU ASCO conference that continues to highlight their “impressive, paradigm shifting, photodynamic therapy” for treating BCG-unresponsive NMIBC.

 

“Based on the data presented (while we are somewhat comparing apples to oranges and the sample size is smaller) – new Kaplan-Meier curves and swimmer plots showed a complete response duration that has the potential to be better than Merck’s Keytruda for treating NMIBC,” Dr. Uddin said.

 

He said the data generated to date shows that Ruvidar’s efficacy is strong and durable, with a clean safety profile for this patient population.

 

“If this trend continues, we believe Theralase’s Ruvidar (TLD-1433) has the potential to be better than Merck’s Keytruda and expect Ruvidar to launch in 2026,” he added.

 

Dr. Uddin rates Theralase as a “speculative buy” with a price target of 80 cents. The stock closed at 39 cents on Feb. 22.

[riverrrow]

My personal price target is $1 before year end.  GLTA.

[chry200030]

Very conservative. Me thinks we will be above $3 unless things are not happening.

[CAinPlap]

I find it hard to reconcile a "better than Keytruda" with only an .80 price target. Seems overly conservative. Underpromise, over deliver?

[judgesmails]

I like the tone of this article.  Gonna start keeping an eye on the website its from: biotuesdays.  Also like the introduction of a brand name.  Ruvidar.   If feels like things might finally be starting to click. Cheers, judgesmails

[Irishjimmy]

I feel that we will be getting more and more attention as the weeks go by. Building towards the next conference. I hope all the short sellers get what they deserve , I don't think their games will be effective any longer.

[CancerSlayer]

  Per Dr. Uddin... "If this trend continues, we believe Theralase’s Ruvidar (TLD-1433) has the potential to be better than Merck’s Keytruda and expect Ruvidar to launch in 2026"   It seems Dr. Uddin believes Theralase is headed towards a more traditional approval (i.e. data on 100-125 treated patients).  He has mentioned "2026" on more than one occasion.

[Rumpl3StiltSkin]

Well Slayer , We've been looking at this for many years now as a pivitol Phase 2. So Maybe Dr. Uddin is thinking a phase 3 will have to happen? I doubt it will take TLT another 3 years to treat ~50-60 more patients at 20 sites? I do think the criteria is still 20-25 CR data to apply for AA and that can happen with merely a FTD.  BTD would just speed the process up. Perhaps Dr. Uddin isn

[CancerSlayer]

No Ph 3 needed....just a more extended Ph 2 is how I interpret Dr. Uddin' s stance.  I agree though...2025 is a realistic timeframe if you accept his premise.

[Rumpl3StiltSkin]

I wonder when the last time Dr. Uddin looked at the AA criteria? Has that changed from 20-25 to 100-125? Since we all last looked? I think TLT has been very conservative that in their PRs they use 2024 a lot.   It might be that long but likely due to FDA delays and delays at the clinic. The patients needed have already been treated, IMO.  If what your thinking is correct though

[Eoganacht]

If we don't get accelerated approval I think Dr. Uddin's timeline is reasonable. It all depends on how many patients are treated every month. If we (optimistically) treat 5 patients a month we might be finished all the primary treatments by the end of 2023. It will take another 450 days to do all the evaluations which brings us to April 2025. Another 3 months to compile and submit the

[chry200030]

June 2026, that's a long time. The share price better respond.

[Eoganacht]

I'm hoping for accelerated approval. I think it's more than justified in our case.

[Rumpl3StiltSkin]

Ok Arrgghh, I think Dr. Uddins remarks make sense under this scenario, he isn't taking into account AA. Which TLT has been talking about applying for at least 8 years. :-) I personally think they have all required criteria to achieve AA approval. Which is provisional comercialization.

[Donein25]

Lets keep in mind AA criteria have changed recently. Now most all applicants must show that they have confirmatory trial in place, and in some instances even patinet enrollment. My mind keeps coming back to these new 9 sites. What is their purpose? Perhaps this senario: BTD for 25 patients at 450 in coming weeks/months; AA by end of year after submission of additional 450 data, (say an additional

[CancerSlayer]

  The timeframe to a traditional approval shouldn't change significantly, whether it comes via an AA that is later converted to a traditional approval (that is...post obtaining successful confirmatory data from the remaining 50+ patients) or comes via a more complete Ph 2 study (I.e. after a total of 100+ patients treated).  The advantage provided by the AA comes in the form of

[CancerSlayer]

  An interesting article published in Regulatory Focus (8/10/2022) reported that 50% of AAs converted to traditional approvals, & the conversion rate has increased significantly in the past decade....30.5% of AAs over the last decade converted to traditional approvals at a median of 2.3 years, which compares quite favorably to a median of 3.2 years over the entire timeframe studied

[ScienceFirst]

Donein25 ... That's exactly what I have in mind.  9 new sites to satisfy Accelerated Approval new criteria. On the other side, because we're halfway into this pivotal trial, adding 9 newxx ce sites after Breakthrough designation could also be a legitimate decision from management to accelerate the pace of enrollment in order to complete this trial asap.   But my flair tells

[Rumpl3StiltSkin]

I believe TLT is meeting these criteria as well. The new 9 sites are part of that for sure. Also, If AA is achieved in 2023-2024, those additional 9 sites will, as you say, allow TLT to further complete this trial. Also, those sites all become additional profit centers, since TLT will have provisional approval and commercialization through AA.

[Irishjimmy]

Im hoping it's one of those "under promise , over deliver' situations. Many things can change ( joint venture , FDA approvals) in the next year or so.

[Irishjimmy]

Im hoping it@s one of those @under promise , over deliver@ situations. Many things can change ( joint venture , FDA approvals) in the next year or so.