Transcription of part of 4-7 conference call posted by "Bridge" on YMB
Part 1 of 2. CD12 Results and Next Steps, from April 7 cc
In my efforts to make sense of the various analyses of CD12 results, I have transcribed part of the April 7th cc covering results and next steps. This is just a part of Nader’s opening remarks, no Q&A portion.
Minute 9:45
NP
Thank you, Dr. Kelly. Wow. This very sad news that you gave us, Dr. Kelly. With that explanation from Dr. Kelly, I believe I feel very safe on making this statement. In my humble opinion, there is no doubt that leronlimab will be part of the future of COVID-19 therapy. This opinion of mine is justified for me from the fact that:
-- with one trial in severe to critical population, we see data that indicated 82% 14-day survival benefit. Survival benefit was 82% with statistically significant p-value of .0233.
-- Change in clinical status for 14-days in the basis of ordinal scale: 400% better with a statistically significant p-value of .021.
-- 7% of these critically ill patients on leronlimab arm who were on invasive mechanical ventilator or ECMO walk out of the hospital within 14 days vs. zero in placebo arm. We could not evaluate a p-value for this scenario because since in the placebo arm zero patients walk out.
-- Hospital stay also shortened with, again, statistically significant p-value.
So these 4 strong items make me feel justified in my statement of saying in my humble opinion there is no doubt that leronlimab will be part of the future of COVID-19 therapy.
So this is 14-day results I am talking about.
-- So what happens to the patients in critically ill population in day 28, 21 days after the second injection of leronlimab? For 28-days results, our predefined primary endpoint or secondary endpoint, however you look at the data, leronlimab arm was better than placebo for all predefined primary endpoint and secondary endpoint. This is the basis of my excitement for future of leronlimab just in COVID-19. Other indications, I’ll get to it.
Now, there is an urgency that all of our shareholders have and that is why - that they want us to get EUA today. They want us to have EUA right now. However, no one is looking at how much product do we have. If we get EUA today, do we have enough product for one country? Just one country, any country. The answer is not if we are looking at a large country.
We only have 1.2 million vials, good for 300,000 treatments per patient -
600,000 doses which would treat 300,000 patients. As we have said in the past. We would like to dedicate more than half of this to Brazil if we are able to ensure EUA, and we already are talking about 100,000 vials perhaps dedicated to Philippines. We just announced that right after the market, so I’m sure everybody can see the press release. This is 100,000 vials for potential Compassionate Special Permit sales.
Meanwhile, we don’t have EUA anywhere in the world yet, even though we are very optimistic about getting an EUA with an additional small trial or maybe with our CD12 extra data that is coming in. So let’s talk about additional data, and how we are thinking about this task. [end of part 1]
CD12 Results and Next Steps, from April 7 cc, part 2
They won’t let me post this. I’ll try in sections before I give up
minute 14
We are currently exploring 3 paths to get the next study for COVID-19 completed and perhaps hit our primary endpoint like we did 3 years ago with a small HIV trial. The 3 options are this:
-- The first one: we can simply add more patients to the open-label of CD12 that we have, and recalculate the p-value until it is less than .05. Is this acceptable by regulatory agencies? I’m not sure. But we will be informing everyone about how this is shaping up. And so far, let me give you an update so you know how it is shaping up right now. Very good news today is we have 28-day mortality amongst our new 55 patients in open-arm data that is better in the whole mITT population and in the mITT population less than 65 or over 65 for our primary endpoint, 28-day mortality. And also the results so far in that is better in the 28-day mortality for critically ill population. And some of the results are MUCH better. For example, the mortality rate in the extension of CD12 right now in critically ill population is about 16.5, 16.7%, 16.7, about 17%. CD12, we had results of 28% in leronlimab, 37% in placebo. So the data is actually coming strong. That’s one option: get more data, recalculate, and see who likes the (inaudible).
Part 1 of 2. CD12 Results and Next Steps, from April 7 cc
In my efforts to make sense of the various analyses of CD12 results, I have transcribed part of the April 7th cc covering results and next steps. This is just a part of Nader’s opening remarks, no Q&A portion.
Minute 9:45
NP
Thank you, Dr. Kelly. Wow. This very sad news that you gave us, Dr. Kelly. With that explanation from Dr. Kelly, I believe I feel very safe on making this statement. In my humble opinion, there is no doubt that leronlimab will be part of the future of COVID-19 therapy. This opinion of mine is justified for me from the fact that:
-- with one trial in severe to critical population, we see data that indicated 82% 14-day survival benefit. Survival benefit was 82% with statistically significant p-value of .0233.
-- Change in clinical status for 14-days in the basis of ordinal scale: 400% better with a statistically significant p-value of .021.
-- 7% of these critically ill patients on leronlimab arm who were on invasive mechanical ventilator or ECMO walk out of the hospital within 14 days vs. zero in placebo arm. We could not evaluate a p-value for this scenario because since in the placebo arm zero patients walk out.
-- Hospital stay also shortened with, again, statistically significant p-value.
So these 4 strong items make me feel justified in my statement of saying in my humble opinion there is no doubt that leronlimab will be part of the future of COVID-19 therapy.
So this is 14-day results I am talking about.
-- So what happens to the patients in critically ill population in day 28, 21 days after the second injection of leronlimab? For 28-days results, our predefined primary endpoint or secondary endpoint, however you look at the data, leronlimab arm was better than placebo for all predefined primary endpoint and secondary endpoint. This is the basis of my excitement for future of leronlimab just in COVID-19. Other indications, I’ll get to it.
Now, there is an urgency that all of our shareholders have and that is why - that they want us to get EUA today. They want us to have EUA right now. However, no one is looking at how much product do we have. If we get EUA today, do we have enough product for one country? Just one country, any country. The answer is not if we are looking at a large country.
We only have 1.2 million vials, good for 300,000 treatments per patient -
600,000 doses which would treat 300,000 patients. As we have said in the past. We would like to dedicate more than half of this to Brazil if we are able to ensure EUA, and we already are talking about 100,000 vials perhaps dedicated to Philippines. We just announced that right after the market, so I’m sure everybody can see the press release. This is 100,000 vials for potential Compassionate Special Permit sales.
Meanwhile, we don’t have EUA anywhere in the world yet, even though we are very optimistic about getting an EUA with an additional small trial or maybe with our CD12 extra data that is coming in. So let’s talk about additional data, and how we are thinking about this task. [end of part 1]
CD12 Results and Next Steps, from April 7 cc, part 2
They won’t let me post this. I’ll try in sections before I give up
minute 14
We are currently exploring 3 paths to get the next study for COVID-19 completed and perhaps hit our primary endpoint like we did 3 years ago with a small HIV trial. The 3 options are this:
-- The first one: we can simply add more patients to the open-label of CD12 that we have, and recalculate the p-value until it is less than .05. Is this acceptable by regulatory agencies? I’m not sure. But we will be informing everyone about how this is shaping up. And so far, let me give you an update so you know how it is shaping up right now. Very good news today is we have 28-day mortality amongst our new 55 patients in open-arm data that is better in the whole mITT population and in the mITT population less than 65 or over 65 for our primary endpoint, 28-day mortality. And also the results so far in that is better in the 28-day mortality for critically ill population. And some of the results are MUCH better. For example, the mortality rate in the extension of CD12 right now in critically ill population is about 16.5, 16.7%, 16.7, about 17%. CD12, we had results of 28% in leronlimab, 37% in placebo. So the data is actually coming strong. That’s one option: get more data, recalculate, and see who likes the (inaudible).
5
