Well Tada, I'd certainly welcome a more honest approach if Don is doing this on purpose!

If he's not trying to deceive us and things went awry, then he should tell us why that happened.

Things need to change...so tired of being strung along!!!

From Imtesty's great transcript...February 4, 2021, this is what was said:

Slide 16 – COVID-19 CLINICAL TRIAL LAUNCH IN Q1 – 2021

Now on Slide 16, hope you’re sitting down because I’m going to use the word “revenue”. We believe that because of the nature of this program and the desire globally to have a therapeutic solution, we have the potential to receive revenue in 2021. So, exciting for us no question about it.

We’re filing almost immediately within the next week or so for this program to commence. Patient enrollment should start as early as March. Maybe it will slip into April, but we will have patients enrolled in this very soon. We only need 100 patients and God knows there are way more than 100 patients available out there right now. We have set up with principal investigators already. This program will predominantly run in the United States. And the desired chemistry is not required to do this. The chemistry is in place, but we will still continue this chemistry program, because we believe that with positive results from this Phase II Trial, we should have data before mid-year, and quite possibly even sooner than that. The trial is only 28 days long and only has 100 patients.

And we’re expecting to see big things from this. If we see the positive results in Phase II, we will kick that chemistry program into full gear, right to commercial scale-up level. And we will do that with partners. We will do that in various sites around the world. Because just like the vaccines pre-selling their vaccine and pre-partnering so countries and payer groups are first-in-queue, that’s exactly what we have the opportunity to do here. And it is an exciting option, and it’s something we are going to pursue hard core.

We would be required to still do a Phase III. Some people would - some countries would proceed with administration of this drug without FDA approval or EMA in Europe. This is a very advanced drug. The safety profile time lengths etc. far exceed any of the vaccines that are in production. This particular program has thousands of man-years of treatment and safety profile in place, and breakthrough therapy designation from the FDA, so we will proceed at as fast a pace as we can. But emergency supply and manufacturing and partnership agreements could create a commercial opportunity for us in 2021. And long term potential for this program is also exceptionally strong. And that’s because this is not specific to SARS CoV-2 or COVID-19, this is specific to those viruses that use ACE 2 and the other terminals to enter the cell. So unlike the vaccines which some of them like Moderna are already starting a new vaccine for the mutations that have happened, this would not be in the same category. This is a therapeutic for this program.

So the trial would be four weeks. And we’re pretty excited about this as I’m sure you can tell. And again it’s a fairly cheap program. We can finance this internally, and we also have applications out to government bodies. We have received approval for a large funding from the Canadian government. However, they don’t quite understand the system here. They want to start with us going backwards and doing animal studies. So I think we’ll pass on that one. But anyway, the overall program for us is getting pretty exciting. And you will be hearing a lot about it in short order and regularly.

 Slide 17 – COVID-19 Treatment Study

So slide 17 is a description of this particular study. It will be an open label study. So we will be seeing what goes on as it goes on. Hospitalized patients must be over 18 years old and can go up to any age. The oxygen levels etc. are all standard.

What we’ve done is now that there’s a lot of activity out there, we’re working with a CRO who’s already done twenty different COVID programs. It took us forever to get into the cell labs where we could do our own cell studies. And finally we got outside of Canada we got into three of them that also paid for them. Which was a pleasure, and they studied the lung cells, the heart cells, and the kidney cells. So we have a ton of data to support this moving forward and believe that this will be a very successful program.

The primary endpoint will be to show evidence using the World Health Organization standards that we are reducing viral infection, we’re reducing time in hospital, costs to the systems etc. And for us there seems to be – any papers we’ve read, there’s nobody who is even close to a viable therapeutic that has Phase III safety data and the amount of programming behind it that this drug has. So we’re repurposing Apabetalone as an anti-viral and anti-inflammatory so that puts us in a very very unique light. Secondary endpoints will be going after the biomarkers like IL-6 IL-8, TNF-a, CRP - all areas that we have extensive data for Apabetalone and know we have a profound impact in these areas. So going forward it’s exciting times.

AND:

 Moderator:

Thank you. This is a second part also from John Vandermosten from Zack’s Small Cap research. What would need to happen to commercialize Apabetalone in patients who have COVID-19 who are experiencing cytokine storm and tissue damage? It seems patients need this now more than a vaccine which some are still hesitant to take. Would an accelerated pathway be used, such as EUA, and what might a timeline be?

 Don:

Yes. Good question. An accelerated path will be used. And we can initiate that path after we have these first hundred patients dosed. And as I mentioned earlier, the excitement there is that the turnout is only for 28 days and it’s only 100 patients. So we could have this data as early as May. And moving it forward from that point, yes it would receive an emergency clearance pretty much everywhere we put it. If this human data looks anything like the live human cell data, this is an amazing breakthrough for us. And it’s not just us looking at it. This is being picked up around the world as was highlighted in all those publications that are already out and that are coming out. The ones involving our own studies on heart cells and lung cells will be out shortly and that will also help in getting this to the emergency approval sections. In some countries as I’ve mentioned, we’ve talked before about the potential of named patient programs which could cover a cytokine storm patient. They can start taking it now in some cases. So we are pretty excited about where this is going to go. We do recommend - and keep this in mind, we do recommend that you take a vaccine if you can get one. Please. This isn’t a one shot solution to all the world’s problems, but it’s certainly going to be a help. The vaccines are important. Especially now while everything else is still in development. Going forward, you’re going to see a lot of people follow our path with this type of therapeutic approach. Thank you.

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