Rough notes from call:
07-30-2020 CYDY Investor Con Call
NP:
CD10, M2M
Difficult to show improvement of any drug
No one has received better than placebo results
SK:
Potential therapies in COVID-19
Believes therapeutics will be best for COVID until vaccine
M2M – NEJM 7/23/2020
Hydroxycloroquine +/- others did not improve
M2S – NEJM
REM shortened from 15 to 11 days
No clear effect on mortality or viral load
Sanofi & Regeneral
IL-6 – couldn’t help them
Roche
Actemera, IL-6 – failed to beat placebo
Dexamethadone
Shows so benefit, but is an immunosuppresent
M2M – may cause more harm than good
+++++
NP:
Results
CD10
Positive efficacy results in CD10
Data is still being evaluated
PE – clinical improvement scored in 4 categories
Seen improvement in D3 from D0 in LERO
SE – “news 2” national early warning score
Degree of illness of pt, will they need critical care intervention going forward or not
4 parameters
Seen good improvement in all Day 3, 7, 14
SE – pts who needed oxygen and ventilators
LERO beats placebo
Still evaluating data
There are 48 components in cytokine panel
Don’t want to rush
Hope to have top-line report within 10 days or so
SAE LERO 64% lower than placebo
Regeneron will be using SAE as their EP for their study
++++
JL:
Mixed results that SAEs (when published) engendered (presumably with stock price)
SAEs are the very events we want to see reduced
Appears to be a clinically significant reduction
Significant results at Day 3, very compatible with EIND program
EIND saw very rapid reductions at Day 3
Surprising result from CD10 – didn’t think it would work in early viral phase or early immunological phase, but expected good results in later immunological phase
CD10 are even early in the progression of the virus
CD10 – will be broadly effective early in the disease progression
Need to look at CD12 and see where we are
+++++
SK: Landscape of COVID
Need multiple therapeutics and vaccine
We are not worried if there are other therapeutics or vaccines
Antibodies might be transient
Pts will wait for safety data on vaccines
43% of respondents will take effective vaccine
50-70% effective vaccine = victory
Hope LERO will be part of the solution
++++
NP
CD12
DSMC – organized as of today, meeting is set
Monday, Aug 3rd
Results due sometime during the next week
CD10
Top line report should be ready within 10 days or so
They will give us better data next week
+++++
SK:
M2M
M2S
S2C
+++++
JL:
Encouraged since the outset, every piece of data is pointing more and more that this is going to work.
The sooner we get to CD12, the better.
+++++
NP:
BLA
Meeting A will be submitted to FDA Monday or Tuesday
Will be submitting all of MONO to FDA as well (hopefully that perhaps MONO will be evaluated as well)
+++++
SK:
MS, ALZ
Preparing protocols
NASH
Will make some minor changes to protocol re: enrollment
Advisory Board
11 commitments
More updates soon
+++++
NP:
Hope 1st pt injected in NASH in September
Financing:
Net $25M raise
Less than 3M shares “I believe”
NASDAQ:
MM:
Submision pckg under review
6 week process
Expect comment letter back next week
Next 2-3 week, other items for discussion
Review of 10k, which will be filed not later than 14th Aug
3rd week of Aug “to see where we are at that time”
“Fingers crossed” “prepared to do so”
++++++
Q&A
Ye Chen, HCW
Q: PR regarding EP’s
A: Absolutely
Results are very strong
Want to get all the efficacy data
All the drs who were involved in this study, they will be part of a publication
Q: Update on pts in CD12
A: more than 161, should be close to 165
Will be doing safety look
JL suggested if we can do interim analysis earlier if possible
Q: Interim at 50 vs. 195
A: Interim is not going to happen at 50.
+++++
Lori H, PI
Q:
+++++
Mark
Q: Lost his mother, father had heart attack from COVID. Brother has MS. Losing his ability to walk.
A: Hope to get approved for COVID soon.
Positive results in MS animal study
Definitely will start MS study this year. That is his intention.
+++++
Dr. Alex K.
Q: Tried to get it to some of his pts, who suffered from COVID. LL has much higher efficacy that any thing else, especially compared to e.g. REM. How did they get approved? Why is FDA blocking so much? What is the constraint to get knowledge / publicity / FDA support?
A:
2,000 drug companies say they have the ‘miracle drug’, FDA’s job is hard
FDA doesn’t have our data yet
Good news: LERO has excellent results
FDA is very clear. Do the studies.
+++++
Ernie Moody
Q: HIV pts taking LERO, none got COVID?
A: Not one single pt who is taking LERO has gotten COVID, as the SAE would have to be reported.
Has no merit for approval.
+++++
Roger M., PI
Q: MX trial?
A: They want to do a study in combo.
NP said to put on hold.
CD10 and CD12 – should be able to get info to FDA
MX was moving too slowly.
+++++
Laurie H., PI
Q: Federal funding?
A: We are working on those things.
NP told the team to not make an urgent matter
Team is small and trying to get bigger
NP believes when they get approval from FDA, all of those doors open immediately
+++++
Robert R., PI
Q: Good contact at FDA? Do you share some of the results before application is completed? Good repore at FDA?
A: FDA has rigid rules and regulations.
President and CEO of Amarex communicates with FDA
Every communication is e-mail format
Under their laws and regulations
+++++
Robert S., PI
Q: How rapidly pts in CD10 cleared virus in the bodies and vs. placebo?
A: Have only announced today
Score = indicator of improvement
SE, oxygen and ventilator report
Can’t say anything until they have legal and regulatory support
+++++
Barbara W.
Q: 8yr old T-Cell lymphoma, large tumor in chest
A: Screened several pts for lymphoma, but all so far have been CCR5 negative
Haven’t shown animal or other studies for children vis-à-vis cancer yet.
+++++
Donald P.
Q: Separate patents required for various indications?
A: Yes, we are working on those.
Also patent for composition for LERO
No one can use for any indication, LERO b/c of the “composition of materials” patent.
SK: All new indications, updating patent portfolio
++++++
Blake L.
Q: Regeneron PE related to SAE. Did change take place mid-trial or original EP?
A: NP we haven’t done P3, SE’s are just as important as PE’s. But we will make case for approval at this time
If “unmet medical need”, then could get approval
SK: We put in SAEs in our PR. Then found out about Regeneron.
Q: Production Samsung numbers. 5M vials, then down to 1.2M vials, now down to 1.1M vials and Samsung possibly being booked. Production we don’t know about? AGC production volume?
A:
NP changed the numbers as we get the numbers from them. Samsung got booked. WE couldn’t book them. Samsung has done the 1.1M vial production
500k vials this year
600k vials this year
Several billion in sales this year if approved.
AGC – has another facility they are starting, which is exciting.
As soon as CYDY gets approval from FDA, should get gov’t money
Might not get more than 100k vials from AGC this year. As of right now, 100k is good to go.
+++++
Robert Frist
Q: By day 14, decrease or eliminate the viral load?
A: Cannot answer at this time.
SK: What separates us is increase the CD8 population.
If P3 is required, what would it look like?
A: Don’t know, can’t guess.
Do pts who die from Flu, do they develop cytokine storm?
SK: Believe there might be the same component, but we don’t know yet.
Decrease tumor necrosis issue?
++++++
Chuck Grey
Q: No question
++++++
Jim Roberts
Q: 28.5M, are their conditions based on results in current trials.
A: No clinical or regulatory performance milestones / hurdles.
More details in upcoming 8k
Basically mirrors march 31 note
++++++
Deno Ramsey
Q: Positive results, magnitude of the effect?
A: Magnitude will be in topline results
“NEWS” – Very positive results in that regard” Day 3, 7, 14
NP thinks it will be much stronger than REM (mentioned 15 to 11 days)
++++++
???
Q: Trump, therapeutic, shot – referring to LERO
A:
SK – most are IV infusions, like REM
Certainly hope Pres is aware
We are only sub-Q
Q: 4-5 papers, Yang, Patterson … any updates?
A:
3 papers, hoping for update next week
Dr BP – no idea why it is taking so long
Not counting on this one (BP)
++++++
Mark Kramer
Q: PR reiterating info from today’s call
A:
Next week will report on CD12, safety
Hopefully have CD10 results announced AND published within 10 days
Most of Drs in our trials will be on the paper
+++++++
NP
COVID trials are going very well
Our M2M is better results than other companies have published so far
Cancer is still going forward
HIV having Type A meeting to discuss COMBO and MONO
Don’t have to pay back loan for at least 6 months, then due in full for 2 years
07-30-2020 CYDY Investor Con Call
NP:
CD10, M2M
Difficult to show improvement of any drug
No one has received better than placebo results
SK:
Potential therapies in COVID-19
Believes therapeutics will be best for COVID until vaccine
M2M – NEJM 7/23/2020
Hydroxycloroquine +/- others did not improve
M2S – NEJM
REM shortened from 15 to 11 days
No clear effect on mortality or viral load
Sanofi & Regeneral
IL-6 – couldn’t help them
Roche
Actemera, IL-6 – failed to beat placebo
Dexamethadone
Shows so benefit, but is an immunosuppresent
M2M – may cause more harm than good
+++++
NP:
Results
CD10
Positive efficacy results in CD10
Data is still being evaluated
PE – clinical improvement scored in 4 categories
Seen improvement in D3 from D0 in LERO
SE – “news 2” national early warning score
Degree of illness of pt, will they need critical care intervention going forward or not
4 parameters
Seen good improvement in all Day 3, 7, 14
SE – pts who needed oxygen and ventilators
LERO beats placebo
Still evaluating data
There are 48 components in cytokine panel
Don’t want to rush
Hope to have top-line report within 10 days or so
SAE LERO 64% lower than placebo
Regeneron will be using SAE as their EP for their study
++++
JL:
Mixed results that SAEs (when published) engendered (presumably with stock price)
SAEs are the very events we want to see reduced
Appears to be a clinically significant reduction
Significant results at Day 3, very compatible with EIND program
EIND saw very rapid reductions at Day 3
Surprising result from CD10 – didn’t think it would work in early viral phase or early immunological phase, but expected good results in later immunological phase
CD10 are even early in the progression of the virus
CD10 – will be broadly effective early in the disease progression
Need to look at CD12 and see where we are
+++++
SK: Landscape of COVID
Need multiple therapeutics and vaccine
We are not worried if there are other therapeutics or vaccines
Antibodies might be transient
Pts will wait for safety data on vaccines
43% of respondents will take effective vaccine
50-70% effective vaccine = victory
Hope LERO will be part of the solution
++++
NP
CD12
DSMC – organized as of today, meeting is set
Monday, Aug 3rd
Results due sometime during the next week
CD10
Top line report should be ready within 10 days or so
They will give us better data next week
+++++
SK:
M2M
M2S
S2C
+++++
JL:
Encouraged since the outset, every piece of data is pointing more and more that this is going to work.
The sooner we get to CD12, the better.
+++++
NP:
BLA
Meeting A will be submitted to FDA Monday or Tuesday
Will be submitting all of MONO to FDA as well (hopefully that perhaps MONO will be evaluated as well)
+++++
SK:
MS, ALZ
Preparing protocols
NASH
Will make some minor changes to protocol re: enrollment
Advisory Board
11 commitments
More updates soon
+++++
NP:
Hope 1st pt injected in NASH in September
Financing:
Net $25M raise
Less than 3M shares “I believe”
NASDAQ:
MM:
Submision pckg under review
6 week process
Expect comment letter back next week
Next 2-3 week, other items for discussion
Review of 10k, which will be filed not later than 14th Aug
3rd week of Aug “to see where we are at that time”
“Fingers crossed” “prepared to do so”
++++++
Q&A
Ye Chen, HCW
Q: PR regarding EP’s
A: Absolutely
Results are very strong
Want to get all the efficacy data
All the drs who were involved in this study, they will be part of a publication
Q: Update on pts in CD12
A: more than 161, should be close to 165
Will be doing safety look
JL suggested if we can do interim analysis earlier if possible
Q: Interim at 50 vs. 195
A: Interim is not going to happen at 50.
+++++
Lori H, PI
Q:
+++++
Mark
Q: Lost his mother, father had heart attack from COVID. Brother has MS. Losing his ability to walk.
A: Hope to get approved for COVID soon.
Positive results in MS animal study
Definitely will start MS study this year. That is his intention.
+++++
Dr. Alex K.
Q: Tried to get it to some of his pts, who suffered from COVID. LL has much higher efficacy that any thing else, especially compared to e.g. REM. How did they get approved? Why is FDA blocking so much? What is the constraint to get knowledge / publicity / FDA support?
A:
2,000 drug companies say they have the ‘miracle drug’, FDA’s job is hard
FDA doesn’t have our data yet
Good news: LERO has excellent results
FDA is very clear. Do the studies.
+++++
Ernie Moody
Q: HIV pts taking LERO, none got COVID?
A: Not one single pt who is taking LERO has gotten COVID, as the SAE would have to be reported.
Has no merit for approval.
+++++
Roger M., PI
Q: MX trial?
A: They want to do a study in combo.
NP said to put on hold.
CD10 and CD12 – should be able to get info to FDA
MX was moving too slowly.
+++++
Laurie H., PI
Q: Federal funding?
A: We are working on those things.
NP told the team to not make an urgent matter
Team is small and trying to get bigger
NP believes when they get approval from FDA, all of those doors open immediately
+++++
Robert R., PI
Q: Good contact at FDA? Do you share some of the results before application is completed? Good repore at FDA?
A: FDA has rigid rules and regulations.
President and CEO of Amarex communicates with FDA
Every communication is e-mail format
Under their laws and regulations
+++++
Robert S., PI
Q: How rapidly pts in CD10 cleared virus in the bodies and vs. placebo?
A: Have only announced today
Score = indicator of improvement
SE, oxygen and ventilator report
Can’t say anything until they have legal and regulatory support
+++++
Barbara W.
Q: 8yr old T-Cell lymphoma, large tumor in chest
A: Screened several pts for lymphoma, but all so far have been CCR5 negative
Haven’t shown animal or other studies for children vis-à-vis cancer yet.
+++++
Donald P.
Q: Separate patents required for various indications?
A: Yes, we are working on those.
Also patent for composition for LERO
No one can use for any indication, LERO b/c of the “composition of materials” patent.
SK: All new indications, updating patent portfolio
++++++
Blake L.
Q: Regeneron PE related to SAE. Did change take place mid-trial or original EP?
A: NP we haven’t done P3, SE’s are just as important as PE’s. But we will make case for approval at this time
If “unmet medical need”, then could get approval
SK: We put in SAEs in our PR. Then found out about Regeneron.
Q: Production Samsung numbers. 5M vials, then down to 1.2M vials, now down to 1.1M vials and Samsung possibly being booked. Production we don’t know about? AGC production volume?
A:
NP changed the numbers as we get the numbers from them. Samsung got booked. WE couldn’t book them. Samsung has done the 1.1M vial production
500k vials this year
600k vials this year
Several billion in sales this year if approved.
AGC – has another facility they are starting, which is exciting.
As soon as CYDY gets approval from FDA, should get gov’t money
Might not get more than 100k vials from AGC this year. As of right now, 100k is good to go.
+++++
Robert Frist
Q: By day 14, decrease or eliminate the viral load?
A: Cannot answer at this time.
SK: What separates us is increase the CD8 population.
If P3 is required, what would it look like?
A: Don’t know, can’t guess.
Do pts who die from Flu, do they develop cytokine storm?
SK: Believe there might be the same component, but we don’t know yet.
Decrease tumor necrosis issue?
++++++
Chuck Grey
Q: No question
++++++
Jim Roberts
Q: 28.5M, are their conditions based on results in current trials.
A: No clinical or regulatory performance milestones / hurdles.
More details in upcoming 8k
Basically mirrors march 31 note
++++++
Deno Ramsey
Q: Positive results, magnitude of the effect?
A: Magnitude will be in topline results
“NEWS” – Very positive results in that regard” Day 3, 7, 14
NP thinks it will be much stronger than REM (mentioned 15 to 11 days)
++++++
???
Q: Trump, therapeutic, shot – referring to LERO
A:
SK – most are IV infusions, like REM
Certainly hope Pres is aware
We are only sub-Q
Q: 4-5 papers, Yang, Patterson … any updates?
A:
3 papers, hoping for update next week
Dr BP – no idea why it is taking so long
Not counting on this one (BP)
++++++
Mark Kramer
Q: PR reiterating info from today’s call
A:
Next week will report on CD12, safety
Hopefully have CD10 results announced AND published within 10 days
Most of Drs in our trials will be on the paper
+++++++
NP
COVID trials are going very well
Our M2M is better results than other companies have published so far
Cancer is still going forward
HIV having Type A meeting to discuss COMBO and MONO
Don’t have to pay back loan for at least 6 months, then due in full for 2 years
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