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Posted On: 07/23/2021 3:00:45 PM
Post# of 148870
CYDY notes from the July 22, 2021 cc with some approximate timings
NOT A TRANSCRIPT
Some points are highlighted, but all could be.
Cancer
1. mTNBC patients were mostly compassionate use. Will be talking with FDA about the path forward. This was trial closing data from P2. Hopefully Phase 3 or BTD to follow. Basket trial will follow same path.
2. Testimonials
3. MOA’s
4. 13:00- 16.44 One BTD (break through designation) for an indication in an annual $1B sales market can mean $8.3B. In other words, $8.3B for each cancer indication. It can also reduce time to approval by 2 ½ - 3 ½ years. There are at least 23 cancers that CYDY is looking at.
5. Right to try for the TNBC & cancer basket trials patients after the trial
6. 18:00 longest eIND patient
Longhaulers
(did not take notes in this segment)
Brazil
7. 33:40 2X a week (M & Th) we meet with the whole team at Albert Einstein research Group & Biomm
8. After almost 2 months of back and forth, gave them all the data they requested, we now have a solid CRO in Brazil for any study. Much more cost effective and with a good reputation. Just published in NEJM. All of the trial sites are ready to go, ready to inject.
9. Will be starting HIV prep study as well
10. 316 critical patients for Covid19 trial
11. 612 severe (“moderate” in Brazil defined terms) or Covid19 trial
12. Will look at Interim results at 40 patients
13. Will be a bonus to do patient enrollment in a very expedited way.
14. Have given ANVISA final comments and we are waiting any day for
greenlight
15. About 20 people or so on these team meetings
16. Scott Kelly- Biomm is a fantastic partner and we can get studies done more quickly with less expense.
17. Chris Recknor- They are outstanding and they have done 7 prior Covid studies.
18. 37:14 “A lot of the work we’ve done through this whole process in Brazil in terms of CMC and non-clinical has really put us in a fantastic position for submitting all throughout the world as well as all other indications. It’s really now we need to show efficacy in these indications and we have the ability to move forward very very quickly which most people do not have.”
19. 38:06 Philippines no news. No new PO yet. Covid is getting worse there.
20. 38:35 India cases went down but they are now asking about longhaulers
HIV BLA
21. 39:10 Wanted to work on biggest issue for FDA first, receptor occupancy assay.
22. 41:58 “Submitted on our draft to them, our plan for receptor occupancy, and they agreed, and we are proceeding. We’re thrilled. This is one huge obstacle that we now have overcome.”
23. 42:15 “We’ve always had the CMC portion dialed down, the issue has been the dose justification, and it’s complicated with the two different studies. Like you said the P value is significant, CD02 works, .032 significance. So really needed to get the dose justification in and we corresponded with the FDA. They wanted us to submit a draft dose justification and that’s what we’ve done, and we’re waiting for word back from them. This doesn’t change our October deadline. We have everything still in play for that. But I think getting the first hardest part that’s always been the stumbling block out of the way first , is the best thing, and we’re able to go forward. So we’re expecting to hear back from the FDA and when we get a greenlight on that, or we have to modify things will do so, but we’ll have the hardest part taken care of and behind us.”
24. Also, from later in the conference call
46.45 “We are going to put in the public domain what the FDA said about the previous receptor occupancy test that we submitted to them”
NASH
25. 43.35 NASH takes a long time to enroll, and many trials can take years. We believe this is the fastest NASH trial ever.
26. 60 current patients (700mg) have already completed the enrollment. Dr. Recknor wants 30 additional patients at 350mg. CEO is tempted to stop the trial at this current enrollment level and read data to ask FDA for P3. Some possibility with Brazil as well.
27. 46:05 “We should be getting a fill of the study of those 30 patients within the next 30 to 45 days and with that we will have more results of what 350mg looks like but also in combination with all these biomarkers that are immensely helping us.”
Biomarker Diagnostic Test Laboratory
28. 45:29 “We are developing a central repository for all of our biomarkers of which we can then learn from one indication to the next”
29. 46.37 Biomarker Diagnostic Test Laboratory & biomarker diagnostic test in development. It will make it easier for practitioners.
Patents
30. 49:00 Patent protection is growing rapidly. We are aware that patents were put on our products and we are pursuing that aggressively. We are patenting quite a bit of stuff.
31. 49:38 People working for the company may be on a patent, but it is assigned to the company. There are NDA’s in place where any work done for the company results in patent assignment to the company not worker or contractor.
Publishing & Presenting
32. TNBC P1b/2 data expected to be presented at conference by end of 2021
33. Longhaulers data needs to be published immediately
34. HIV BLA is clearer, so now is an opportune time for HIV publication, however the priority may be longhaulers, then HIV or CD10&12
Dosages
35. 57:35
dosages: 350mg 525mg, 700mg,
half life: IV 4 days, subQ injection 10 days
absorption: IV 1 hr, subQ injection 2 days
36. 59:00 Different indications may need different dosages. Biomarker attention is needed. Versatility in commercialization dosage is an advantage.
37. 1:01:05 concentrated leronlimab, every 3 months vs weekly. Encouraging work is ongoing.
Partners
38. 1:02:00 Have partners in Philippines, Brazil and India. Looking at potential partnerships in the USA and it’s getting even more interesting.
SOME RELATED LINKS
2021.07.22 CYDY Conference Call
https://www.cytodyn.com/newsroom/press-releas...sults-from
2021.07.22 Investor presentation
https://www.sec.gov/Archives/edgar/data/00011...dex992.htm
2021.07.19 Triple Negative Breast Cancer study preliminary results phase 1b portion of trial
https://www.cytodyn.com/newsroom/press-releas...m-30-mtnbc
2021.07.06 CCytoDyn Granted a Significant Patent by USPTO for Methods of Treating Coronavirus Infection with Leronlimab
https://www.cytodyn.com/newsroom/press-releas...or-methods
2021.06.21 CytoDyn Inc. Announces Positive Preliminary Results of Unblinded Data from Long-Haulers Trial Showing Greater Improvement in Leronlimab Group over Placebo in 18 of 24 Symptoms
https://www.cytodyn.com/newsroom/press-releas...results-of
NOT A TRANSCRIPT
Some points are highlighted, but all could be.
Cancer
1. mTNBC patients were mostly compassionate use. Will be talking with FDA about the path forward. This was trial closing data from P2. Hopefully Phase 3 or BTD to follow. Basket trial will follow same path.
2. Testimonials
3. MOA’s
4. 13:00- 16.44 One BTD (break through designation) for an indication in an annual $1B sales market can mean $8.3B. In other words, $8.3B for each cancer indication. It can also reduce time to approval by 2 ½ - 3 ½ years. There are at least 23 cancers that CYDY is looking at.
5. Right to try for the TNBC & cancer basket trials patients after the trial
6. 18:00 longest eIND patient
Longhaulers
(did not take notes in this segment)
Brazil
7. 33:40 2X a week (M & Th) we meet with the whole team at Albert Einstein research Group & Biomm
8. After almost 2 months of back and forth, gave them all the data they requested, we now have a solid CRO in Brazil for any study. Much more cost effective and with a good reputation. Just published in NEJM. All of the trial sites are ready to go, ready to inject.
9. Will be starting HIV prep study as well
10. 316 critical patients for Covid19 trial
11. 612 severe (“moderate” in Brazil defined terms) or Covid19 trial
12. Will look at Interim results at 40 patients
13. Will be a bonus to do patient enrollment in a very expedited way.
14. Have given ANVISA final comments and we are waiting any day for
greenlight
15. About 20 people or so on these team meetings
16. Scott Kelly- Biomm is a fantastic partner and we can get studies done more quickly with less expense.
17. Chris Recknor- They are outstanding and they have done 7 prior Covid studies.
18. 37:14 “A lot of the work we’ve done through this whole process in Brazil in terms of CMC and non-clinical has really put us in a fantastic position for submitting all throughout the world as well as all other indications. It’s really now we need to show efficacy in these indications and we have the ability to move forward very very quickly which most people do not have.”
19. 38:06 Philippines no news. No new PO yet. Covid is getting worse there.
20. 38:35 India cases went down but they are now asking about longhaulers
HIV BLA
21. 39:10 Wanted to work on biggest issue for FDA first, receptor occupancy assay.
22. 41:58 “Submitted on our draft to them, our plan for receptor occupancy, and they agreed, and we are proceeding. We’re thrilled. This is one huge obstacle that we now have overcome.”
23. 42:15 “We’ve always had the CMC portion dialed down, the issue has been the dose justification, and it’s complicated with the two different studies. Like you said the P value is significant, CD02 works, .032 significance. So really needed to get the dose justification in and we corresponded with the FDA. They wanted us to submit a draft dose justification and that’s what we’ve done, and we’re waiting for word back from them. This doesn’t change our October deadline. We have everything still in play for that. But I think getting the first hardest part that’s always been the stumbling block out of the way first , is the best thing, and we’re able to go forward. So we’re expecting to hear back from the FDA and when we get a greenlight on that, or we have to modify things will do so, but we’ll have the hardest part taken care of and behind us.”
24. Also, from later in the conference call
46.45 “We are going to put in the public domain what the FDA said about the previous receptor occupancy test that we submitted to them”
NASH
25. 43.35 NASH takes a long time to enroll, and many trials can take years. We believe this is the fastest NASH trial ever.
26. 60 current patients (700mg) have already completed the enrollment. Dr. Recknor wants 30 additional patients at 350mg. CEO is tempted to stop the trial at this current enrollment level and read data to ask FDA for P3. Some possibility with Brazil as well.
27. 46:05 “We should be getting a fill of the study of those 30 patients within the next 30 to 45 days and with that we will have more results of what 350mg looks like but also in combination with all these biomarkers that are immensely helping us.”
Biomarker Diagnostic Test Laboratory
28. 45:29 “We are developing a central repository for all of our biomarkers of which we can then learn from one indication to the next”
29. 46.37 Biomarker Diagnostic Test Laboratory & biomarker diagnostic test in development. It will make it easier for practitioners.
Patents
30. 49:00 Patent protection is growing rapidly. We are aware that patents were put on our products and we are pursuing that aggressively. We are patenting quite a bit of stuff.
31. 49:38 People working for the company may be on a patent, but it is assigned to the company. There are NDA’s in place where any work done for the company results in patent assignment to the company not worker or contractor.
Publishing & Presenting
32. TNBC P1b/2 data expected to be presented at conference by end of 2021
33. Longhaulers data needs to be published immediately
34. HIV BLA is clearer, so now is an opportune time for HIV publication, however the priority may be longhaulers, then HIV or CD10&12
Dosages
35. 57:35
dosages: 350mg 525mg, 700mg,
half life: IV 4 days, subQ injection 10 days
absorption: IV 1 hr, subQ injection 2 days
36. 59:00 Different indications may need different dosages. Biomarker attention is needed. Versatility in commercialization dosage is an advantage.
37. 1:01:05 concentrated leronlimab, every 3 months vs weekly. Encouraging work is ongoing.
Partners
38. 1:02:00 Have partners in Philippines, Brazil and India. Looking at potential partnerships in the USA and it’s getting even more interesting.
SOME RELATED LINKS
2021.07.22 CYDY Conference Call
https://www.cytodyn.com/newsroom/press-releas...sults-from
2021.07.22 Investor presentation
https://www.sec.gov/Archives/edgar/data/00011...dex992.htm
2021.07.19 Triple Negative Breast Cancer study preliminary results phase 1b portion of trial
https://www.cytodyn.com/newsroom/press-releas...m-30-mtnbc
2021.07.06 CCytoDyn Granted a Significant Patent by USPTO for Methods of Treating Coronavirus Infection with Leronlimab
https://www.cytodyn.com/newsroom/press-releas...or-methods
2021.06.21 CytoDyn Inc. Announces Positive Preliminary Results of Unblinded Data from Long-Haulers Trial Showing Greater Improvement in Leronlimab Group over Placebo in 18 of 24 Symptoms
https://www.cytodyn.com/newsroom/press-releas...results-of
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