Some CYDY notes from the recent CC on April 7, 202
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Posted On: 04/08/2021 2:51:27 AM
Some CYDY notes from the recent CC on April 7, 2021
with approximate timings
NOT A TRANSCRIPT
listen to cc: https://www.cytodyn.com/investors/news-events...to-april-7
1. 4:38 USA- There are several other strains of Covid19 in circulation that can diminish the fighting capability of the 3 vaccines in the US.
2. 5:06 Canada- New variants are making younger people sicker and is sending more to the hospital. P1 variant is spreading rapidly in British Columbia and is causing what is thought to be the largest known outbreak of the virus outside of Brazil.
3. 5:34 Brazil- Just had its largest daily death count. More than 4000 in a single day. The more transmissible P1 variant is circulating uncontrollably. Hospitals are overwhelmed and 90% of ICU beds are full. Brazil now accounts for over 25% of the daily Covid19 worldwide deaths. 6000 Covid19 patients are waiting for ICU beds. The rise in ICU occupancy is across all age groups.
4. 6:22 India- 90,000 new cases daily
5. 7:08 France- Paris is in a new lockdown
6. 7:55 Hungary- Has one of the highest Covid19 mortality rates in the world
7. 8:10 Philippines- Daily record on April 2. 80% of ICU capacity in Manila is filled
8. 9:10 Longhaulers (PASC)- 20-60 million potential patients
9. 9:33 Chronic Fatigue Syndrome- Very excited to be in a position to potentially help these patients.
10. 13:00 We only have 1.2 million vials, 600,000 doses, good for 300,000 patients. We would like to dedicate more than half of this to Brazil if we are able to ensure an EUA , and we are already talking about 100,000 vials to perhaps be dedicated to the Philippines for CSP sales (Compassionate Special Permit) as indicated in the press release https://www.cytodyn.com/investors/news-events...spital-for
11. 13:40 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.
12. 14:00 We are currently exploring 3 paths to get the next study for Covid19 completed and perhaps hit our primary endpoint like we did three years ago with a small HIV trial. The three options are this:
13. 14:14 “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 data amongst our new 55 patients on 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. The mortality rate in the extension of CD12 right now in critically ill population is about 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.”
14. 15:44 “Second option: Study we can have for under 65 year old patients. CD12 P-value for this age group in the critically ill population indicated we could hit a primary endpoint with less than 75 patients. So we definitely will pursue, if different regulatory agencies are ok with this, we will have a 200 patient study, and perhaps do an interim analysis at 75 and see how things are. MHRA has told us they will accept interim data[/b ].”
15. 16:19 “ Third option is we want to do 4 doses. We do 3 arms. Placebo, 2-dose, 4-dose and then look at the data. We might do this, but whatever we do it will be heavily recruiting in overseas. Especially in countries that are having problems .”
16. 16:48 “Emergency Use timeline. Health Canada by April 15, eight more days, we will be submitting Interim Order packages, all the packages that we need to present to them, CMC, and so forth. We believe once we finish giving that Interim Order package, when it’s completed, and if we commit ourselves to do a trial over there, we can start selling this [garbled] of the product. That’s what we have seen through our people who are checking into the guidelines but we’ll find out.”
17. 17:21 “MHRA is coming up with new relaxed criteria’s. We’re working with them.”
18. 17:28 “With US we are definitely going to do the trial. We are working with them in regards to the trial.”
19. 17:34 “With Brazil and Philippines we are very very hopeful. If we have to do whatever we have to do, we will, and we will update everybody.”
20. 17:42 Cancer, Basket trial, 9 patients in basket trial, stage 4 going for about a year. Asking for a pre breakthrough meeting with FDA.
21. 18:30 Dr. Rahman is no longer with Cytodyn. His last day was April 5 (see 8k April 7)
22. 18:48 HIV BLA- “We already have in place resources to advance and accelerate the remaining work on our BLA re-submission. We have many good organization ready to go and as always AMAREX is working with us but we have brought extra resources and we will be working on that very carefully and update everybody on exact timeline. The timelines are not going to be very long in my opinion but I’d like to talk about that on the next call.”
23. 19:15 NASH & Longhaulers trial. We are officially finished the longhauler trial. We will put out a press release either tomorrow or the day after and let everyone know. This is getting very exciting and we are getting to very good places.
24. 19:33 We do have a lot of other activities that are happening which we will be updating you in the next two weeks in regards to all the organizations that are reaching out to us to do a study of leronlimab. People are realizing leronlimab is the real deal. That’s what I feel. The published data that has come out, the doctors that talk about us, these are very solid people and solid places to publish data. We have done that. We will not drop the ball and we will not stop pursuing approval, and once our first approval comes in any indication, any country, we believe back to back to back we will have many other approvals.
25. 21:57 A recent JAMA article suggests the median time to get a BLA submission back on track after a refusal to file letter was 189 days.
26. 23:00 The dose justification is the issue with the HIV BLA, in particular the receptor occupancy. It’s important to note that the prior assay was the thing that was in question which was the same thing that we saw in the CD10 trials. The receptor occupancy assay, the FDA had a lot of questions with it, so we are repeating that, with a solid assay. We have two different companies working with us on that. The dose justification alone from the standpoint of the viral load is very impressive. At the 700 dose it’s p-value is statistically significant at .006. We feel very confident just with the data we have, exclusive of the receptor occupancy, that we can make the argument. We are also doing receptor occupancy though in the extension patients that we have ongoing.
27. 26.04 Today’s FDA meeting with Dr. Nitya Ray. Good news that FDA said that if we submit our BLA, that they will not require 6-months stability from Samsung batch, 3- month will suffice and we have that now .
28. 26:50 No additional HIV trial needed.
29. 27:05 HIV filings- Canada hasn’t requested receptor occupancy. MHRA requires it. Will update in 2 weeks.
30. 27:40 HIV filings Canada & MHRA filing for 700mg, not 350mg.
31. 28:45 “Every 2-week updates”
32. 28:50 Brazil
33. 29:50 recent $25m raise- for manufacturing. “We have to get more product right now”
34. 31:00 Do you expect Brazil may require an EUA from another country before approval in Brazil? Maybe yes
35. 31:10 CD12
36. 34:30 half-life 10 days based on a study
37. 43:00 Dr. Recknor’s personal story of his Covid19 illness
38. 48:30 No current plan to look at interim results of Longhaulers study. It is a bio marker study.
39. 51:00 DSMC will review a CD16 critically ill Covid19 trial
40. 54:55 We believe that as the virus mutates that leronlimab will be effective as an immune modulator.
41. 56:22 The standard is that if your phase 2 is successful, they’re going to give you 15% of your total value and those numbers are going to go through the roof.
42. 57:41 A new trial in Brazil could take 4-6 weeks to start but if we open another center in Brazil for the open label CD12 it could be really quick. We are strategizing.
43. 59:00 Philippines- EUA may be possible there before anywhere else.
44. 1:00:00 Cancer basket trial is still open.
45. 1:07:35 “We did not say we do not have discussion with big pharma. We said we cannot comment.”
46. 1:13:20 big pharma- “Yes they have reached out to us but we can’t comment on active discussions”
47. 1:15:30 Philippines non-binding term sheet for 100,000 vials as CSP sales. Not signed yet
SOME RELATED LINKS
• March 30, 2021 data from 14-day endpoint.
Leronlimab Decreased Mortality in Critically Ill Covid19 patients by 82%
https://www.cytodyn.com/investors/news-events...14-days-by
• March 22, 2021 conference call notes (Not a transcript)
https://investorshangout.com/post/view?id=6093110
• March 8, 2021 SEC 8K with executive summary & graphs of CD12 trial data Covid19 critical cases. 28-day endpoints
https://www.sec.gov/Archives/edgar/data/11756...dex991.htm
• March 8, 2021 conference call notes (Not a transcript)
https://investorshangout.com/post/view?id=6080669
with approximate timings
NOT A TRANSCRIPT
listen to cc: https://www.cytodyn.com/investors/news-events...to-april-7
1. 4:38 USA- There are several other strains of Covid19 in circulation that can diminish the fighting capability of the 3 vaccines in the US.
2. 5:06 Canada- New variants are making younger people sicker and is sending more to the hospital. P1 variant is spreading rapidly in British Columbia and is causing what is thought to be the largest known outbreak of the virus outside of Brazil.
3. 5:34 Brazil- Just had its largest daily death count. More than 4000 in a single day. The more transmissible P1 variant is circulating uncontrollably. Hospitals are overwhelmed and 90% of ICU beds are full. Brazil now accounts for over 25% of the daily Covid19 worldwide deaths. 6000 Covid19 patients are waiting for ICU beds. The rise in ICU occupancy is across all age groups.
4. 6:22 India- 90,000 new cases daily
5. 7:08 France- Paris is in a new lockdown
6. 7:55 Hungary- Has one of the highest Covid19 mortality rates in the world
7. 8:10 Philippines- Daily record on April 2. 80% of ICU capacity in Manila is filled
8. 9:10 Longhaulers (PASC)- 20-60 million potential patients
9. 9:33 Chronic Fatigue Syndrome- Very excited to be in a position to potentially help these patients.
10. 13:00 We only have 1.2 million vials, 600,000 doses, good for 300,000 patients. We would like to dedicate more than half of this to Brazil if we are able to ensure an EUA , and we are already talking about 100,000 vials to perhaps be dedicated to the Philippines for CSP sales (Compassionate Special Permit) as indicated in the press release https://www.cytodyn.com/investors/news-events...spital-for
11. 13:40 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.
12. 14:00 We are currently exploring 3 paths to get the next study for Covid19 completed and perhaps hit our primary endpoint like we did three years ago with a small HIV trial. The three options are this:
13. 14:14 “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 data amongst our new 55 patients on 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. The mortality rate in the extension of CD12 right now in critically ill population is about 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.”
14. 15:44 “Second option: Study we can have for under 65 year old patients. CD12 P-value for this age group in the critically ill population indicated we could hit a primary endpoint with less than 75 patients. So we definitely will pursue, if different regulatory agencies are ok with this, we will have a 200 patient study, and perhaps do an interim analysis at 75 and see how things are. MHRA has told us they will accept interim data[/b ].”
15. 16:19 “ Third option is we want to do 4 doses. We do 3 arms. Placebo, 2-dose, 4-dose and then look at the data. We might do this, but whatever we do it will be heavily recruiting in overseas. Especially in countries that are having problems .”
16. 16:48 “Emergency Use timeline. Health Canada by April 15, eight more days, we will be submitting Interim Order packages, all the packages that we need to present to them, CMC, and so forth. We believe once we finish giving that Interim Order package, when it’s completed, and if we commit ourselves to do a trial over there, we can start selling this [garbled] of the product. That’s what we have seen through our people who are checking into the guidelines but we’ll find out.”
17. 17:21 “MHRA is coming up with new relaxed criteria’s. We’re working with them.”
18. 17:28 “With US we are definitely going to do the trial. We are working with them in regards to the trial.”
19. 17:34 “With Brazil and Philippines we are very very hopeful. If we have to do whatever we have to do, we will, and we will update everybody.”
20. 17:42 Cancer, Basket trial, 9 patients in basket trial, stage 4 going for about a year. Asking for a pre breakthrough meeting with FDA.
21. 18:30 Dr. Rahman is no longer with Cytodyn. His last day was April 5 (see 8k April 7)
22. 18:48 HIV BLA- “We already have in place resources to advance and accelerate the remaining work on our BLA re-submission. We have many good organization ready to go and as always AMAREX is working with us but we have brought extra resources and we will be working on that very carefully and update everybody on exact timeline. The timelines are not going to be very long in my opinion but I’d like to talk about that on the next call.”
23. 19:15 NASH & Longhaulers trial. We are officially finished the longhauler trial. We will put out a press release either tomorrow or the day after and let everyone know. This is getting very exciting and we are getting to very good places.
24. 19:33 We do have a lot of other activities that are happening which we will be updating you in the next two weeks in regards to all the organizations that are reaching out to us to do a study of leronlimab. People are realizing leronlimab is the real deal. That’s what I feel. The published data that has come out, the doctors that talk about us, these are very solid people and solid places to publish data. We have done that. We will not drop the ball and we will not stop pursuing approval, and once our first approval comes in any indication, any country, we believe back to back to back we will have many other approvals.
25. 21:57 A recent JAMA article suggests the median time to get a BLA submission back on track after a refusal to file letter was 189 days.
26. 23:00 The dose justification is the issue with the HIV BLA, in particular the receptor occupancy. It’s important to note that the prior assay was the thing that was in question which was the same thing that we saw in the CD10 trials. The receptor occupancy assay, the FDA had a lot of questions with it, so we are repeating that, with a solid assay. We have two different companies working with us on that. The dose justification alone from the standpoint of the viral load is very impressive. At the 700 dose it’s p-value is statistically significant at .006. We feel very confident just with the data we have, exclusive of the receptor occupancy, that we can make the argument. We are also doing receptor occupancy though in the extension patients that we have ongoing.
27. 26.04 Today’s FDA meeting with Dr. Nitya Ray. Good news that FDA said that if we submit our BLA, that they will not require 6-months stability from Samsung batch, 3- month will suffice and we have that now .
28. 26:50 No additional HIV trial needed.
29. 27:05 HIV filings- Canada hasn’t requested receptor occupancy. MHRA requires it. Will update in 2 weeks.
30. 27:40 HIV filings Canada & MHRA filing for 700mg, not 350mg.
31. 28:45 “Every 2-week updates”
32. 28:50 Brazil
33. 29:50 recent $25m raise- for manufacturing. “We have to get more product right now”
34. 31:00 Do you expect Brazil may require an EUA from another country before approval in Brazil? Maybe yes
35. 31:10 CD12
36. 34:30 half-life 10 days based on a study
37. 43:00 Dr. Recknor’s personal story of his Covid19 illness
38. 48:30 No current plan to look at interim results of Longhaulers study. It is a bio marker study.
39. 51:00 DSMC will review a CD16 critically ill Covid19 trial
40. 54:55 We believe that as the virus mutates that leronlimab will be effective as an immune modulator.
41. 56:22 The standard is that if your phase 2 is successful, they’re going to give you 15% of your total value and those numbers are going to go through the roof.
42. 57:41 A new trial in Brazil could take 4-6 weeks to start but if we open another center in Brazil for the open label CD12 it could be really quick. We are strategizing.
43. 59:00 Philippines- EUA may be possible there before anywhere else.
44. 1:00:00 Cancer basket trial is still open.
45. 1:07:35 “We did not say we do not have discussion with big pharma. We said we cannot comment.”
46. 1:13:20 big pharma- “Yes they have reached out to us but we can’t comment on active discussions”
47. 1:15:30 Philippines non-binding term sheet for 100,000 vials as CSP sales. Not signed yet
SOME RELATED LINKS
• March 30, 2021 data from 14-day endpoint.
Leronlimab Decreased Mortality in Critically Ill Covid19 patients by 82%
https://www.cytodyn.com/investors/news-events...14-days-by
• March 22, 2021 conference call notes (Not a transcript)
https://investorshangout.com/post/view?id=6093110
• March 8, 2021 SEC 8K with executive summary & graphs of CD12 trial data Covid19 critical cases. 28-day endpoints
https://www.sec.gov/Archives/edgar/data/11756...dex991.htm
• March 8, 2021 conference call notes (Not a transcript)
https://investorshangout.com/post/view?id=6080669
(35)
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