Theralase Technologies Inc. V.TLT

Various thoughts

[DJDawg]

The PP success or lack of success
- this was a shot in the foot moment of TLT
- price was 0.25, then announced LIFE offering, which triggered big selling. Selling may have been by those who wanted cash for the LIFE offering but more likely was a lot of selling by people who were afraid of the price falling because of people selling (vicious loop here)
- LIFE was not successful, likely because newbies are not going to jump onto a new stock that has dropped from 0.25 to 0.17 (32% !!) in days AND is on the sketchy TSX venture exchange. I have a friend who works for an institutional investor and they avoid TSH venture stocks like the plague. So less institutional buy in as well.
- so LIFE triggered big sell off but then LIFE not filled due to big sell off (IMO)
- next they convert to a private placement but now all the usual investors are saying "WTF, we participated in the last few PP's and just keep losing". Keep in mind that the last few PP's were at 0.25 and they are looking at 32% drop and yet being asked to pay a 0.22 entry point for a stock currently at 0.17. I can see why they would sit out that round.
- so that makes PP underwhelming at 1.17 million.
- another entertaining example of TLT's ups and down (mostly downs though)

Cash situation
- people who can read financials better than me indicate that we now have a runway of 4-5 months. That may help the stock price a bit. Who knows.

Clinical trial data
- one reason that the clinical trial data is not a huge change is that THEY JUST DID A TRIAL UPDATE Oct 16. Not enough time has passed for the data to change much. I have updated my powerpoint screenshot. As Eog pointed out there is a nice wave of green moving from left to right :)

https://i.postimg.cc/9X6hZycL/Nov-29-observations-on-clinical-trial-data-TLT.jpg

BTD situation
- I have spend hours reading the BTD process to understand it. It is confusing, partly because they actually give the FDA reviewing staff LOTS of latitude. From what I can tell from reading various experiences is that you don't really submit a pre-BTD application in the formal sense. They don't seem to call it that but I'm guessing TLT calls it that to make it less confusing. You mostly meet with a reviewer and show them the data to get feedback on whether you are ready for BTD application. They often say that you have a better chance if you add in a,b and c. You then get a, b and c and check back in as to whether you look good to go.
- as such, I'm guessing that they did this first step, were told that the application would be stronger with 18m data as well. I'm guessing that they were told that a central pathology review was a good idea. The FDA has never seen a NMIBC treatment protocol like this so perhaps the random reviewer suggested the central pathology review as a way of being really certain.
- I do feel strongly that the BTD will happen but that the delays are because of data points that TLT has to chase down or wait on. Still really lousy.

Stock price going forward
- who knows? Maybe all the sellers who got out with the LIFE announcement will gradually swing back in now that a small pool of money on board and the clinical data is solid. Or maybe they have no faith in management and won't come back. My own hunch is that most who would sell, have sold and the rest of us are holding long.

Other things
- I like the website that popped up Oct 28 showing Dana-Farber (Harvard) oncology being a trial site in the future. They could use the Harvard reference for a tiny pr boost.

So that is my longwinded opinion. Love the science, not impressed by the management. Have a great day.

[Longholder99]

Where, beyond your own personal opinion are you getting the 18 month requirement from the FDA?  It's a change from the initial trial protocol which would be material and should have been reported in this last Q.  Do you have a source or are you just adding 6mos to the plan on speculation? 

[DJDawg]

I'm guessing. Take with a grain of salt.

[Longholder99]

Dawg you seem adamant in many of your posts in bringing up this 6mos extension to the BTD timeline which is not in the company narrative, has not been  mentioned by the FDA.... nor is it based in any real facts.  With a company doing its best to work on a short leash for time and money.  Do you not see where some would suspect this determination in suggesting a half year longer

[greaterfoolFred]

Come on guys, read the Oct 23 release; "Theralase® is collecting the survival data for all patients, with central pathology laboratory validation, who have been previously enrolled and provided the primary Study II Treatment and who have demonstrated a CR or IR at any point in time, with duration of that CR or IR at 450 days, for submission to the FDA in support of a pre-Break Through

[enriquesuave]

From MD&A. "In 2016, Kamat et al. stated in the Journal of Clinical Oncology that the International Bladder Cancer Group (“IBCG”) recommended that, “Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50% at 6 months, 30% at

[Dumbeldorfwhite]

They literally announced the protocol change..... 

[Benedictus]

Dawg, good oberservations.  I'll chime in and offer my take on the failed LIFE offering.   Between Oct 15 to 31st, short interest spiked from 68K to 1.14M. The sp collapse orchestrated by the shorts appears to have contributed to undermining the LIFE offering.  With no lock up period and a known .22 ceiling, those looking to participate in the LIFE offering, intending to dump

[Sunvalley]

Good morning Benedictus. Your take on the possible happenings during the last short while is right on the button in my view. Thank you for sharing your thoughts on this matter. The "Venture " exchange is really the "Vulture " exchange in my long held view. It seems to be the "Wild West" exchange in every sense of the word. I,m sure that TLT management realize this

[DJDawg]

So teach me. Given the spike in shorts that you noted, does that mean some people out there may need to by up a moderate size group of shares to cover the short? So if the number of shares on the ask are not huge, then that could trigger a price spike?

[Longholder99]

Theoretically if they get caught with a bunch of those borrowed shares going out the door and the asks keep getting filled it could cause them to panic and cover.  Losing money in the process if/when the SP comes up in the process.  PAYING a higher price to cover ya.....would be some poetic justice for the under rock dwellers who would short an oncology company that is keeping people at

[Benedictus]

Well I'm certainly not schooled enough on Bay Street shenanigans to consider myself a teacher...I'm merely throwing out my 2c worth of speculation based on the reported short activity and sp action. The latest shorts out are at 870k as of Nov 15th, so 273K were already covered and my guess is when we get the Nov 30th update, shorts outstanding will likely be under 500K.  But back to

[Rumpl3StiltSkin]

Yes, anything Dr LBiati can do to get a handshake deal done, contengent on TLT getting BTD? Would be perfect. So after they get BTD approval the next announcment is a JV deal. Would be pretty awesome! It is in Her best interest to do so with those stock options. Also, TLT management can't be too excited about this last round of financing. They also have incentive to get past this situation

[DJDawg]

Interesting observations. I don't know much about shorting but the whole situation did feel manipulated in some ways. It seems that the ONLY way to avoid TSX venture type situations like this is to get cash from an outside party (JV, licensing deal...) rather than PP's and LIFE offerings.

[Oilminerdeluxe]

Those j/v's take time to get done. Hopefully, something will happen to break the shackles. Not so sure what will happen if they need to raise again in a few months at these prices. Who will participate if not much has happened by then. 

[Rumpl3StiltSkin]

I hope they have a JV already in the works? If not this could take a while into 2024 to see this Share Price stabilize somewhat higher. BTD might be enough of a catalyst to get SP to move up. If investors notice that could snowball. We haven't seen that happen yet. so no guarantee but BTD has moved stocks before.... BTD should happen before they need more $$$. What do they have? 5 months

[O12009]

If the stock price was much higher and they offered the same amount of shares as before, yes it would be a much higher pp.glta

[Benedictus]

Agreed. Dr Lbiati was hired in early June and in the same NR, the CoB stated: "Based on this latest interim clinical data, the Company is commencing to actively explore international partnering, licensing and distribution opportunities for our cancer targeting PDC, Ruvidar™." So, theoretically they are 5 months into this process. With the cash runway probably ending somewhere in the