Theralase Technologies Inc. V.TLT

TLT and Competition

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Just thought I'd summarize where TLT sits among their competition in the NMIBC market. Please respond with any corrections or updates as this wasn't a deep dive. In 2017 the NMIBC market was $1.45B and it was estimated to grow about 8% each year which makes it about $2B in 2021 (in the 7 major markets of the world). https://www.delveinsight.com/report-store/non-muscle-invasive-bladder-cancer-market TLT competitors: Keytruda, the only FDA approved competitor right now aside from BCG. Administered every 3 weeks for I don't know how long. 41% complete response (I assume after 3 months). 46% of those, so 18.9% overall, had CR at 12 months. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer Also, "The list price for each indicated dose of KEYTRUDA when given every 3 weeks is $9,869.94. The list price for each indicated dose of KEYTRUDA when given every 6 weeks is $19,739.88.*" https://www.keytruda.com/financial-support/ N-803. They were acquired about a month after getting Fast Track approval in 2017 for $290M. They do a combo of immunotherapy with BCG. So BCG might be a bottleneck for them. Their results were really good though. About 80% CR at 6 months (sample size of about 20 at the time). Last year they were given breakthrough status. https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.4561 Adstiladrin. Did a phase 3 trial. 53% CR at 3 months. 24% CR at 12 months. https://www.google.com/amp/s/www.urotoday.com/conference-highlights/suo-2019/suo-2019-bladder-cancer/117556-suo-2019-the-suo-ctc-phase-iii-adsiladrin-trial-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer.amp.html Valribicin. Is approved and has been for a while but they terminated a phase 3b trial and I can't find why. Also can find new info for it so maybe it's been phased out? https://en.m.wikipedia.org/wiki/Valrubicin https://clinicaltrials.gov/ct2/show/NCT01310803 Vicinium. Completed a phase 3 trial. FOR CIS patients 40% CR at 3 months. About 20% at 12 months. For papillary patients 71% 3 month CR and 37%12 month CR. About 2.5% had severe adverse events. https://www.google.com/amp/s/www.urotoday.com/conference-highlights/aua-2020/aua-2020-bladder-cancer/122653-aua-2020-phase-3-results-of-vicinium-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer.amp.html CG0070. Interim phase 2 results from 2018 show 47% CR at 6 months. 30% at 12 months. There's probably a more updated report somewhere. https://www.google.com/amp/s/www.urotoday.com/conference-highlights/aua-2018/aua-2018-bladder-cancer/104383-aua-2018-cg0070-an-oncolytic-adenovirus-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer-12-month-interim-results-from-a-multicenter-phase-ii-trial.amp.html A little bit on TLTs trial: Regarding the 4 TLT patients who were removed from the study. All did not show any response after the first treatment and were then removed from the study (this criteria has been changed and these patients would now be eligible for a second treatment). Also, they under-treated all 12 patients in a range from approximately 30-150%. Even so, as of July 2020, 7 of them responded and 3 of those responded completely. The 1 remaining patient had negative cytology and "suspicious cystoscopy". As of Sept 2020, 3 patients with CR and 3 with Partial response. One of the patients must have gone from partial to no response or something. Anyways. If N-803 went for $290M and it was only half of the treatment, maybe TLT could be valued in that range with improved phase 2 results. $290M would be about $1.50/share or so. But if the other studies (GBM and NSCLC, vaccine) show promise, maybe its worth more. Thinking about investment risk The TLT CR is around 25% at 6 months with poor execution. By quickly estimating, Keytruda would have been about 33%, Adstiladrin 40%, Vicinium %32, CG0070 47%, and then N-803 at 80% (but needs BCG). So even without proper execution, TLT isnt very far off from most of the competition (with most data based off a single treatment). And I doubt the CR% will go down once we have more numbers with better optimization. So I dont feel like there is a ton of risk, even though the stock price is super unpredictable. Of course there is always risk with a trial and it could end suddenly, but I think theres a better chance of the CR being equal to or better than the competition. Although one big problem is TLT is looking like itll be the last to market. Buuut if the optimization bumps CR to something like 50% at 6 months wed be doing better than all except for N-803. I think the risk is acceptable for the potential success.

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[Antidote]

Trying to fix formatting... Just thought I'd summarize where TLT sits among their competition in the NMIBC market. Please respond with any corrections or updates as this wasn't a deep dive. In 2017 the NMIBC market was $1.45B and it was estimated to grow about 8% each year which makes it about $2B in 2021 (in the 7 major markets of the world). https://www.delveinsight.com/report-store

[Rumpl3StiltSkin]

Well, I thought I remember discussion here about a year ago of a vaccine for NMIBC coming out of Britian soon? Or was it Scotland? Anyway it seemed to be a drop in replacement for BCG. Bummed me out becuz it looked like it could limit TLTs upside to ~ 50% of the total NMIBC/MIBC market. I mean getting a shot that will work half the time might appeal to many people. Or behind door 2 is 1433, that

[Antidote]

Do you have any more info on this. I'd like to read about it.

[Rumpl3StiltSkin]

I'm not 100% sure that it isn't one of the ones you've covered. There are a couple there that have 50% CR. I just remember that it was a vaccine and from Europe/UK. I think it was a year or two out before it would be approved, so 1433 might be to market first, would likely compete with it. Since 1433 is being looked at seriously for Skin, Lung, GBM, Covid 19. Which will all likely

[enriquesuave]

I'm not sure of the status of Radachlorin, but it may be approved elsewhere.  However it is IV infused and they used red light which is not as safe and more side effects overall compared to TLD-1433 which is instilled and uses green light.  If they both achieve similar efficacy then TLD-1433 will triumph as it will be most effective and safe controlled procedure.  Can't wait

[enriquesuave]

Quite accurate but N-803 in combo with BCG was 82% CR at 3 months and 64% at 6 months out of 11 patients (23 CIS were treated but we only were given data on 11) . 9 out of 11 at 3 months and 7 at 6 months were CR and for Vicinium it is 17% at 12 months  What counts for the FDA is CR at 3 months, but mostly they want to see a durable response or 12 months data.   Keytruda 12 months CR

[Antidote]

Thanks for the clarification Enriquesuave. I see that Photofrin gave patients issues with stenosis due to collagen deposition and so it's not really used for NMIBC anymore. I can't find much recent info on Radachlorin. Do you know if it was discontinued? Or maybe they're just sticking with Russia for now? Thanks