Some 3/8/2021 conference call notes with approximate timings. Some of these notes are highlighted but nearly all could be.
https://www.cytodyn.com/newsroom/press-releas...verview-of
(see also 3/8/2021 8K)
1. 4:00 Three regulatory agencies including the US FDA are working with us and have suggested the final path to approval for Leronlimab in Covid19.
2. 4:29 CD12 demonstrated that leronlimab works as an immuno-modulator which means we believe that leronlimab helps regulate one’s own immune system to fight disease.
3. 4:56 Statistical significance in secondary endpoint and demonstrates superiority to many other drugs used to fight Covid19.
4. 5:12 Covid is one of many diseases that we feel would benefit from the immune regulation that leronlimab provided.
5. 5:58 Grateful the FDA will allow extended trial to generate more data to show we can achieve statistically significant P-value and not only get EUA but also file BLA for full approval.
6. 6:59 – 11:48 Comparison of other drugs in the severe & critical Covid19 population:
o Remdesivir, approved, had unclear mortality benefit in this population
o Convalescent plasma EUA being scaled back to only early treatment
o Hydroxychloroquine failed
o Lopinavir/Ritonavir failed
o Azithromycin failed
o Colchicine trial was discontinued at “Recovery” trial
o Dexamethasone had 29% mortality vs 41% SOC mortality in this population
o IL6 drugs have no mortality benefit (7 previous trials) until “Recovery” trial.
o Tocilizumab (an IL6 drug) in “Recovery “ trial showed 29% mortality vs. 33% SOC mortality in this trial but the benefit was seen only when administered together with Dexamethasone. No benefit was seen by Tocilizumab on its own.
7. 11:51 Dr. Harish Seethamraju- In the critically ill population in a well-balanced age group, the outcome of using Leronlimab is phenomenally better than other medications including Dexamethasone.
8. 14:50 Dr. Mahboob Rahman- There is a benefit in the general population of the trial in all the endpoints. It was designed in April 2020 which was very early in the pandemic. Mortality was reduced 24% in the critically ill population, and there was a statistically significant reduction in the number of days in hospital.
9. 17:50 Drs. Mahboob Rahman Harish Seethamraju, Nicolas Agresti, Chris Recknor, Kush Dhody, Kazem Kazempour, believe the results are very strong to warrant conditional EUA while Cytodyn generates more data. We are working on all avenues for this immediate conditional EUA while we conduct a small 140 patient trial to support our data. That protocol for the 140 patients has been submitted and would be conducted at the same sites as the CD12 trial so things could go very quickly.
10. 18:45 An 8k is coming with CD12 data as an executive summary.
11. 19:05 Philippines FDA- Chiro Pharmaceuticals has said last night that a hospital is ready to file a (Philippines FDA) CSP to treat their patients. It could take 48 hours for clearance after the paper is filed. These would be sales for a small number of patients. If the results are good, an EUA could result after this.
12. 20:22 Brazil- Cytodyn is reaching out to the regulatory agency in Brazil
13. 21:55 UK- The MHRA has allowed an accelerated approval process and will take data from the trial extension.
14. 22:25 Canada- Cytodyn will file for an Interim Order. It is unknown if they can sell product there yet when Interim Order is active.
15. 23:01 Cancer- 10 patients surviving stage 4 and reaching 11 months
16. 23:33 Dr. Scott Kelly (Chief Medical Officer) and Dr. Mahboob Rahman (Chief Science Officer) both believe Cytodyn will eventually become an oncology company.
17. 24:24 The MOA is not specific to Covid19 and may be able to help many different cancers.
18. 25:00 NASH 30% filled and on target for results in Q4
19. 26:15 Long-hauler patients in the USA (11-35 million). Long haulers P2 trial started March 1 and is 50% filled already after only one week. Results in early Q3, June/July. Total of 8 doses. 4 weeks dosing, 4 weeks observation. This trial will listen to subjective complaints and correlate them to exploratory bio markers and may be able to extrapolate them to other post-viral syndromes.
20. 27:48 HIV - receptor occupancy test setback for BLA and had to generate more receptor occupancy data. Perhaps approval by end of year but not firm.
21. 30:11 Covid19 critical patients CD12- 24% improvement to survival rate, 166% improvement to the discharge alive rate, statistically significant improvement in the hospitalization length of stay. They are very confident about what the extended CD12 results will be.
22. 33:05 Nasdaq uplist points to remedy– Cytodyn believes revenues to be achievable in the near-term, they have a plan to cure the equity requirement of 5 million, seasoning of stock price above $4 dollars.
23. 37:01 mTNBC trial stopped due to covid travel issues. It will restart soon.
24. 38:30 Europe application for Covid19 is coming
25. 40:14 80 people died before day 28, & 8 or so afterwards
26. 40:27 OLE (open label extension) patient data is not usable for FDA review because they need double blinded study data. The new trial extension (CD16) will be 50% leronlimab vs 50% SOC.
27. 41:11 The Samsung CEO (manufacturer) told Cytodyn that they are ready to support whatever amount you guys need.
28. 42:15 If all vials are sold, still wants to give dividend if achieved by end of year.
29. 43:13 Nothing concrete, but hopeful about government support. After EUA approval will reach out.
30. 43:50 Discharge alive = alive and well enough to leave hospital. Mortality = dead. Regarding the Discharged Alive figures:
28% of leronlimab patients discharged alive by day 28 vs. 11% of SOC (standard of care patients).
31. 45:40 Five more critically ill patients enrolled in OLE
32. 46:00 IL6 blocker comparison (Tociluzumab)
Absolute delta 1% and relative 2% Tocilizumab (7 studies)
Absolute delta 9% and relative 24% Leronlimab
see also “Recovery” Trial
33. 48:15 Hospital dynamics in a pandemic:
ICU cost $25,000 per night
No ICU beds available at times
6 days earlier discharge equals more treated patients & more lives saved
34. 49:15 Extended trial timeline (CD16)
140 patients
4 to 6 weeks enrollment
plus 28 days observation
35. 50:40 American Regent (distribution) is ready and the contract issues are resolved. Labeling will be done by Dr. Nitya Ray and the company he controls.
36. 51:13 Philippine sales will be at the same price as the USA
37. 51:30 eIND will hopefully be closed so that the trial fills quickly, but maybe only closed at the sites where the trial will occur.
38. 52:15 Off label usage- no comment.
39. 52:26 Funding- “selling shares at $10”. Most of the approved shares are still available.
40. 53:00 Dr. Kelly is vaccinated and is visiting the scientific board.
41. 53:26 Steroids are not contra-indicated with Leronlimab and the safety of Leronlimab means that they can use it with a lot of other different agents and potentially enhance effectiveness.
42. 54:30 Samsung has worked with Cytodyn on payment. Cytodyn is hopeful to mention the plan soon.
43. 55:55 Laws, rules and regulations. Proud of the team. Best we can do. Doesn’t care if it takes a year and 3 months.
44. 56:48 Mortality overall population in over 65 ages is a 9% reduction with leronlimab. In the under 65’s it’s a 32% mortality reduction.
45. 57:42 The data in now out there. Interest on future trials and even offers of paying for trials where Cytodyn only supplies the product AND they are NOT asking for equity in Cytodyn.
46. 1:00:45 Do treated patients develop LH? They haven’t looked at it yet because it is too soon to tell, but will.
47. 1:01:40 Detailed cd12 trial data coming in 8k with executive summary.
48. 1:02:00 Solid tumor MOA’s. See video on website
CCR5 expression on tumor
M2/M1 macrophage conversion
tReg blocking
Endothelial cell migration
49. 1:03:45 Will do funding in a careful manner. Happy with fundraising so far.
50. 1:05:01 CD12 Trial design in February 2000 had a lack of information at the time.
51. 1:05:38 DSMB
52. 1:06:50 HIV will be a focus as well as Covid19
53. 1:07:48 OLE (open label extension to CD12) has had 46 treated which will not be included in the CD16 trial with 140 new patients.
54. 1:08:25 LH study is a proof of concept study looking at and correlating bio markers in an investigative trial. Still needs phase 3 study afterwards.
55. 1:09:22 Basket trial moving along well. TNBC trial not enrolled well due to travel during Covid.
56. 1:10:18 testimonials to Janet Woodcock FDA
57. 1:10:55 Yes, control of age in extended study CD16 with 140 patients
58. 1:11:20 Philippines estimates it will take their country 3 years to complete vaccination efforts
59. 1:12:25 Cytodyn will sell to anyone including China.
60. 1:12:45 RANTES
61. 1:13:05 Not a failed trial design according to CEO.
62. 1:13:45 The first approval is always difficult. Expansion labeling is easier.
63. 1:14:00 LA baby investor.
64. 1:14:35 Canada IO- Cytodyn is in the process of answering timeline questions. More coming very soon.
65. 1:15:30 The leronlimab MOA in covid is not affected by variants.
https://www.cytodyn.com/newsroom/press-releas...verview-of
(see also 3/8/2021 8K)
1. 4:00 Three regulatory agencies including the US FDA are working with us and have suggested the final path to approval for Leronlimab in Covid19.
2. 4:29 CD12 demonstrated that leronlimab works as an immuno-modulator which means we believe that leronlimab helps regulate one’s own immune system to fight disease.
3. 4:56 Statistical significance in secondary endpoint and demonstrates superiority to many other drugs used to fight Covid19.
4. 5:12 Covid is one of many diseases that we feel would benefit from the immune regulation that leronlimab provided.
5. 5:58 Grateful the FDA will allow extended trial to generate more data to show we can achieve statistically significant P-value and not only get EUA but also file BLA for full approval.
6. 6:59 – 11:48 Comparison of other drugs in the severe & critical Covid19 population:
o Remdesivir, approved, had unclear mortality benefit in this population
o Convalescent plasma EUA being scaled back to only early treatment
o Hydroxychloroquine failed
o Lopinavir/Ritonavir failed
o Azithromycin failed
o Colchicine trial was discontinued at “Recovery” trial
o Dexamethasone had 29% mortality vs 41% SOC mortality in this population
o IL6 drugs have no mortality benefit (7 previous trials) until “Recovery” trial.
o Tocilizumab (an IL6 drug) in “Recovery “ trial showed 29% mortality vs. 33% SOC mortality in this trial but the benefit was seen only when administered together with Dexamethasone. No benefit was seen by Tocilizumab on its own.
7. 11:51 Dr. Harish Seethamraju- In the critically ill population in a well-balanced age group, the outcome of using Leronlimab is phenomenally better than other medications including Dexamethasone.
8. 14:50 Dr. Mahboob Rahman- There is a benefit in the general population of the trial in all the endpoints. It was designed in April 2020 which was very early in the pandemic. Mortality was reduced 24% in the critically ill population, and there was a statistically significant reduction in the number of days in hospital.
9. 17:50 Drs. Mahboob Rahman Harish Seethamraju, Nicolas Agresti, Chris Recknor, Kush Dhody, Kazem Kazempour, believe the results are very strong to warrant conditional EUA while Cytodyn generates more data. We are working on all avenues for this immediate conditional EUA while we conduct a small 140 patient trial to support our data. That protocol for the 140 patients has been submitted and would be conducted at the same sites as the CD12 trial so things could go very quickly.
10. 18:45 An 8k is coming with CD12 data as an executive summary.
11. 19:05 Philippines FDA- Chiro Pharmaceuticals has said last night that a hospital is ready to file a (Philippines FDA) CSP to treat their patients. It could take 48 hours for clearance after the paper is filed. These would be sales for a small number of patients. If the results are good, an EUA could result after this.
12. 20:22 Brazil- Cytodyn is reaching out to the regulatory agency in Brazil
13. 21:55 UK- The MHRA has allowed an accelerated approval process and will take data from the trial extension.
14. 22:25 Canada- Cytodyn will file for an Interim Order. It is unknown if they can sell product there yet when Interim Order is active.
15. 23:01 Cancer- 10 patients surviving stage 4 and reaching 11 months
16. 23:33 Dr. Scott Kelly (Chief Medical Officer) and Dr. Mahboob Rahman (Chief Science Officer) both believe Cytodyn will eventually become an oncology company.
17. 24:24 The MOA is not specific to Covid19 and may be able to help many different cancers.
18. 25:00 NASH 30% filled and on target for results in Q4
19. 26:15 Long-hauler patients in the USA (11-35 million). Long haulers P2 trial started March 1 and is 50% filled already after only one week. Results in early Q3, June/July. Total of 8 doses. 4 weeks dosing, 4 weeks observation. This trial will listen to subjective complaints and correlate them to exploratory bio markers and may be able to extrapolate them to other post-viral syndromes.
20. 27:48 HIV - receptor occupancy test setback for BLA and had to generate more receptor occupancy data. Perhaps approval by end of year but not firm.
21. 30:11 Covid19 critical patients CD12- 24% improvement to survival rate, 166% improvement to the discharge alive rate, statistically significant improvement in the hospitalization length of stay. They are very confident about what the extended CD12 results will be.
22. 33:05 Nasdaq uplist points to remedy– Cytodyn believes revenues to be achievable in the near-term, they have a plan to cure the equity requirement of 5 million, seasoning of stock price above $4 dollars.
23. 37:01 mTNBC trial stopped due to covid travel issues. It will restart soon.
24. 38:30 Europe application for Covid19 is coming
25. 40:14 80 people died before day 28, & 8 or so afterwards
26. 40:27 OLE (open label extension) patient data is not usable for FDA review because they need double blinded study data. The new trial extension (CD16) will be 50% leronlimab vs 50% SOC.
27. 41:11 The Samsung CEO (manufacturer) told Cytodyn that they are ready to support whatever amount you guys need.
28. 42:15 If all vials are sold, still wants to give dividend if achieved by end of year.
29. 43:13 Nothing concrete, but hopeful about government support. After EUA approval will reach out.
30. 43:50 Discharge alive = alive and well enough to leave hospital. Mortality = dead. Regarding the Discharged Alive figures:
28% of leronlimab patients discharged alive by day 28 vs. 11% of SOC (standard of care patients).
31. 45:40 Five more critically ill patients enrolled in OLE
32. 46:00 IL6 blocker comparison (Tociluzumab)
Absolute delta 1% and relative 2% Tocilizumab (7 studies)
Absolute delta 9% and relative 24% Leronlimab
see also “Recovery” Trial
33. 48:15 Hospital dynamics in a pandemic:
ICU cost $25,000 per night
No ICU beds available at times
6 days earlier discharge equals more treated patients & more lives saved
34. 49:15 Extended trial timeline (CD16)
140 patients
4 to 6 weeks enrollment
plus 28 days observation
35. 50:40 American Regent (distribution) is ready and the contract issues are resolved. Labeling will be done by Dr. Nitya Ray and the company he controls.
36. 51:13 Philippine sales will be at the same price as the USA
37. 51:30 eIND will hopefully be closed so that the trial fills quickly, but maybe only closed at the sites where the trial will occur.
38. 52:15 Off label usage- no comment.
39. 52:26 Funding- “selling shares at $10”. Most of the approved shares are still available.
40. 53:00 Dr. Kelly is vaccinated and is visiting the scientific board.
41. 53:26 Steroids are not contra-indicated with Leronlimab and the safety of Leronlimab means that they can use it with a lot of other different agents and potentially enhance effectiveness.
42. 54:30 Samsung has worked with Cytodyn on payment. Cytodyn is hopeful to mention the plan soon.
43. 55:55 Laws, rules and regulations. Proud of the team. Best we can do. Doesn’t care if it takes a year and 3 months.
44. 56:48 Mortality overall population in over 65 ages is a 9% reduction with leronlimab. In the under 65’s it’s a 32% mortality reduction.
45. 57:42 The data in now out there. Interest on future trials and even offers of paying for trials where Cytodyn only supplies the product AND they are NOT asking for equity in Cytodyn.
46. 1:00:45 Do treated patients develop LH? They haven’t looked at it yet because it is too soon to tell, but will.
47. 1:01:40 Detailed cd12 trial data coming in 8k with executive summary.
48. 1:02:00 Solid tumor MOA’s. See video on website
CCR5 expression on tumor
M2/M1 macrophage conversion
tReg blocking
Endothelial cell migration
49. 1:03:45 Will do funding in a careful manner. Happy with fundraising so far.
50. 1:05:01 CD12 Trial design in February 2000 had a lack of information at the time.
51. 1:05:38 DSMB
52. 1:06:50 HIV will be a focus as well as Covid19
53. 1:07:48 OLE (open label extension to CD12) has had 46 treated which will not be included in the CD16 trial with 140 new patients.
54. 1:08:25 LH study is a proof of concept study looking at and correlating bio markers in an investigative trial. Still needs phase 3 study afterwards.
55. 1:09:22 Basket trial moving along well. TNBC trial not enrolled well due to travel during Covid.
56. 1:10:18 testimonials to Janet Woodcock FDA
57. 1:10:55 Yes, control of age in extended study CD16 with 140 patients
58. 1:11:20 Philippines estimates it will take their country 3 years to complete vaccination efforts
59. 1:12:25 Cytodyn will sell to anyone including China.
60. 1:12:45 RANTES
61. 1:13:05 Not a failed trial design according to CEO.
62. 1:13:45 The first approval is always difficult. Expansion labeling is easier.
63. 1:14:00 LA baby investor.
64. 1:14:35 Canada IO- Cytodyn is in the process of answering timeline questions. More coming very soon.
65. 1:15:30 The leronlimab MOA in covid is not affected by variants.
40
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