Theralase Technologies Inc. V.TLT

Tidbits from today's presentation

[Eoganacht]

3Q2021 - Commence Phase 1b clinical studies for GBM and NSCLC

4Q2021 - Enrol and treat 10 GBM and 10 NSCLC patients Canada

2021 - Breakthrough Designation from FDA for results of first 20 - 25 patients

Theralase has no affiliation with the study being conducted by Roswell Park and Dr. McFarland

FDA requirement for CR at 360 days is 360 days post the initial CR, not 360 days post the initial treatment. This has been done at the FDA's request and has lengthened the duration of the phase 2 study. Competing treatments such as Merck's Keytruda measured 360 day CR from the initial treatment which gives their results an advantage over Theralase as it represents a shorter duration.

[Hankerchief]

Thanks for the info.... Wonder why there has to be a wait until Q3 2021 to start phase 1 work on GBM/NSCLC? Would think they could hop on this now?

[tdon1229]

  No money now for another trial ... need to show some results in 1H2021, raise the SP and raise some cash in order to proceed in 3Q2021 ... salaries and overhead during the COVID shutdown apparently used up what they had set aside for additional trials, so those trials have been delayed ... options include grant money and also partnership/joint venture, but they're not in place yet.

[Hankerchief]

Sounds good.  Thanks!

[skys1]

He said their burn rate is now down to only $250,000 P/mo. It used to be more than double that. I had read that they had substantially reduced payroll etc because hospitals had pretty much shut treatments down due to the virus. At any rate, they can last a long time with that burn rate, as last time I checked I think they still had $9 million left from the $17 million raise.

[fredgoodwinson]

Thanks to Eog tdon & skys1. 

[StevenBirch]

Yes and I like the idea of results being good enough in the next couple/few months to bring the warrants into play to fund trials for GBM and NSCLC.

[newdaydawning]

That's highly re-assuring because even if they double the burn rate, upon activation of US trials, they still have about 18 months to get the 35-cent warrants delivering. Based on the recent appreciation in share price, I'd say that's entirely doable.

[tdon1229]

  As stated coming out of the COVID shutdown, all the money remaining was earmarked for the remainder of the NMIBC Phase II trials ... if they open sites in the US, then they pay each site up front for their participation costs ... after, of course, paying the FDA its fees and the costs for for FDA personnel to oversee and follow the trials ... oh, and RDW and his wife will continue to draw

[skys1]

No question it's true that the more participating hospitals and patients treated the more costs involved. However the shutdowns appears to be coming back, plus Roger & his wife as outrageous as it is, are already included in that quarter $million P/mo. Either way the theory that they will need to raise more money fairly soon "to keep the lights on", IMO is not valid.

[tamarindo1]

If senior management are so confident that they have a world beater in their PDC would it not be worthwhile for them to take a 50% compensation cut whilst covid19 lasts at its current level? After all coupled with some smart promotion would that not be an encouraging sign to potential investors. Besides I don't believe they are just in the middle echelon compensation wise for mini biotec

[Pandora]

Fits right in with the super long pause between Phase 1B and Phase 2 on the Bladder trial. How many months was that? and for what?

[skier59]

When I see the Market Cap's of many Bio's in the Market, with nothing that compares to what we have going, it really makes you wonder, if we have been suppressed by external entities ! That one below, really shows, what we all thought, long ago! Eventually, we will shine bright as the light !

[tamarindo1]

That sounds like preferential treament for Keytruda reference TLT.

[floatinketucky]

With our phase 2 under-dosing optimized and illistration of our CR based on the scientific results, it is  not going to matter. We will still dominate the data points and the safety profile. Our data points dominated with under-dosed patients and will continue to dominate with properly dosed patients. Its also looks like PH1 patients will be inculuded in the data poits needed for Accelrated

[skier59]

Ya float, I'm thinking the same. was extremely glad to read our burn rate at 250 per month, that was very positive, more than I think others realize. Well done Roger, that's what I wanted to see over the past 6 months ! Now the cash in the bank looks solid. Other 2 indications are not going to be rushed forward, as that would pull on the existing cash which is supposed to be directed at

[enriquesuave]

Yes 360 post initial CR  A harder condition than for competitors, probably because of potential for early BTD and Accelerated FDA approval  IMO.  We can possibly achieve AA with a small group of patients but durable response  may be extended by 1-3 months  if they can determine CR at 1 month post treatment, then maybe we can shorten timeframe by 2 months or so.  Imo