2021-11-24 CYDY Annual Shareholders Meeting Rough
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Posted On: 11/24/2021 12:17:46 PM
2021-11-24 CYDY Annual Shareholders Meeting
Rough Notes
Live virtual webcast
Believe each company BOD nominees were elected
Warren Avert was approved
Comp was approved
200M shares was approved
Final vote count may vary
Concludes formal business of Annual Meeting
Business Update Presentation
“Year of Approval for LL”
Lot a lies every where
Slides
Never seen a BLA this poorly done
NR:
Clinical Section of BLA
Target is to submit CMC by next Tuesday
All sections are complete
Working with publisher for final formatting
Might take one or two additional days
Clinical working with partners
Getting ready to get documents to submit with module
Targeting end of Q1 2022
CR:
Extension pts
Pt safety
Making sure pts continue to get treatment
CD02, they were MDR, concerned with pts lives/well-being
Working with another CRO
Rolling over extension study into new study
NP:
File for expanded access “very quickly”
Also ask FDA to be able to charge pts
Already discussing with FDA
If granted BTD in cancer, FDA stated CYDY will need to file EAP within 15 days
Will file in a week or two
SK:
Targeting TME
No one been able to do that
Very encouraged by the responses
Will find out the exact MOA in the TME
NP:
MiL – is still alive today; trouble walking
Liver is clear of tumors
BZ trials have come to a halt
4 pts
23 pts
But continuing those trials
Believe there will be a spike
PH – team is working very hard
Having a hard time getting the shipments there quickly
Hoping to file for Critically Ill in USA
Protocol should go to the “hopefully soon”
LH
Hope to start 1st injection in Jan
CR:
1st trial able to implement biomarker lab
Multiple divisions within FDA are helping to refine protocol to help ultimately get approval
Trends in NASH/fibrosis might provide insight to LH trial
NASH & NAFLD
File FTD “right away”
Also working P3 [protocol]
Any other drug showing fibrosis dropping?
CR:
No approved FDA drugs for NASH
Msec is obtained from MRI scan
Very sensitive specific
In liver, iron needs to be removed to see
The CT1 changes we are seeing are significant a 40msec is significant
Not just stabilizing, but reducing
Part 1 looked at 700mg, not just 350mg
Reduction in pts with Advanced fibrosis, not just mild to moderate
Did Amarex cooperate with CR for the data?
A: Issues with Amarex are solved b/c working with another CRO
Will increase success
Dividing CRO work into what their specialties lie
Our prospects going forward are amplified
Re: Data – contract with MRi Lab, so have all that data
Clinical site have re populated the data
Last pt on Dec. 6th
SK:
Trial has only be 14 weeks, when most would say need to treat for over 1 year
Data might be more pronounced on biopsy vs. MRI
Biz Dev re: NASH & NAFLD
Can open up a lot of different partnership optys
Brought back Brendon Rae
Problem before was only animal data, now have human data
CR:
In LH say a dramatic improvement in OsteoArthritis
Seeing very similar signals from LHs to NASH
CCR5 signal AZ, Dementia, Stroke
350% improvement in Joint Pain, with stat sign p-value
Even pts in NASH trial that had joint pain are feeling better
HIV pts are also “feeling better”
++++
HIV BLA
Canada & UK
Will be filing with them “most likely”
+++++
SK:
Partnership potential
HIV domestically and int’l
Nitya Ray is now COO, CR is now SEVP of Clinical Operations
AM:
Cash position / financial update
Don’t report cash balances
Last report had $6.5M cash
Since Sept 21st
$28.7M
Through private placements and warrant inducements
$9.8m burn per month
$4.4M per month was for Samsung
$10.6M per month more recently
Retired more debt
Retired Nov Fife debt
Monday, Jan 10th, next quarterly filing
++++
Q&A:
Q: Enrollment
4 for critical
Q: EU / UK spiking COVID
A: Limited resources
Q: Second app for BTD for mTNBC
A: Forward looking statements
Will file, but will be delayed
Want to wait see what FDA says about original mTNBC
Q: Another portion for HIV BLA this months?
A: CMC this month
BLA is about 100k pages
Bernie Cunningham is doing great work
Q: LH trial
A:
Working with FDA
Protocol has not been approved yet
Q: Patent to treat LH? IncellDx just got one with M.
A:
Q: NASH BTD app filed?
A: Not likely to file BTD.
FDA probably wants placebo controlled trial
FTD by end of Dec.
Q: NASH trial released to the public?
A: End of Dec
CR: that is what we are trying to do
Q: Biomarkers
A:
CR: BM changes we can see when pts are having symptoms and then when get LL the BMs go down in both LH and NASH
NP:
In HIV, couldn’t figure out responders rates without higher doses
SK:
Trying to put together pieces of the puzzles for determining MOA
CR:
BM lab with Dr. Scott Hansen, has been crucial to make this happen
Dr. Sacha and Dr. Otto Yang have made big contributions
Q: Is CEO comp on par?
A: If I was getting $10M, I would be in Bahamas
Base is $650k
AM: $10M – not sure where that is being derived
Stock Options were issued
Rough Notes
Live virtual webcast
Believe each company BOD nominees were elected
Warren Avert was approved
Comp was approved
200M shares was approved
Final vote count may vary
Concludes formal business of Annual Meeting
Business Update Presentation
“Year of Approval for LL”
Lot a lies every where
Slides
Never seen a BLA this poorly done
NR:
Clinical Section of BLA
Target is to submit CMC by next Tuesday
All sections are complete
Working with publisher for final formatting
Might take one or two additional days
Clinical working with partners
Getting ready to get documents to submit with module
Targeting end of Q1 2022
CR:
Extension pts
Pt safety
Making sure pts continue to get treatment
CD02, they were MDR, concerned with pts lives/well-being
Working with another CRO
Rolling over extension study into new study
NP:
File for expanded access “very quickly”
Also ask FDA to be able to charge pts
Already discussing with FDA
If granted BTD in cancer, FDA stated CYDY will need to file EAP within 15 days
Will file in a week or two
SK:
Targeting TME
No one been able to do that
Very encouraged by the responses
Will find out the exact MOA in the TME
NP:
MiL – is still alive today; trouble walking
Liver is clear of tumors
BZ trials have come to a halt
4 pts
23 pts
But continuing those trials
Believe there will be a spike
PH – team is working very hard
Having a hard time getting the shipments there quickly
Hoping to file for Critically Ill in USA
Protocol should go to the “hopefully soon”
LH
Hope to start 1st injection in Jan
CR:
1st trial able to implement biomarker lab
Multiple divisions within FDA are helping to refine protocol to help ultimately get approval
Trends in NASH/fibrosis might provide insight to LH trial
NASH & NAFLD
File FTD “right away”
Also working P3 [protocol]
Any other drug showing fibrosis dropping?
CR:
No approved FDA drugs for NASH
Msec is obtained from MRI scan
Very sensitive specific
In liver, iron needs to be removed to see
The CT1 changes we are seeing are significant a 40msec is significant
Not just stabilizing, but reducing
Part 1 looked at 700mg, not just 350mg
Reduction in pts with Advanced fibrosis, not just mild to moderate
Did Amarex cooperate with CR for the data?
A: Issues with Amarex are solved b/c working with another CRO
Will increase success
Dividing CRO work into what their specialties lie
Our prospects going forward are amplified
Re: Data – contract with MRi Lab, so have all that data
Clinical site have re populated the data
Last pt on Dec. 6th
SK:
Trial has only be 14 weeks, when most would say need to treat for over 1 year
Data might be more pronounced on biopsy vs. MRI
Biz Dev re: NASH & NAFLD
Can open up a lot of different partnership optys
Brought back Brendon Rae
Problem before was only animal data, now have human data
CR:
In LH say a dramatic improvement in OsteoArthritis
Seeing very similar signals from LHs to NASH
CCR5 signal AZ, Dementia, Stroke
350% improvement in Joint Pain, with stat sign p-value
Even pts in NASH trial that had joint pain are feeling better
HIV pts are also “feeling better”
++++
HIV BLA
Canada & UK
Will be filing with them “most likely”
+++++
SK:
Partnership potential
HIV domestically and int’l
Nitya Ray is now COO, CR is now SEVP of Clinical Operations
AM:
Cash position / financial update
Don’t report cash balances
Last report had $6.5M cash
Since Sept 21st
$28.7M
Through private placements and warrant inducements
$9.8m burn per month
$4.4M per month was for Samsung
$10.6M per month more recently
Retired more debt
Retired Nov Fife debt
Monday, Jan 10th, next quarterly filing
++++
Q&A:
Q: Enrollment
4 for critical
Q: EU / UK spiking COVID
A: Limited resources
Q: Second app for BTD for mTNBC
A: Forward looking statements
Will file, but will be delayed
Want to wait see what FDA says about original mTNBC
Q: Another portion for HIV BLA this months?
A: CMC this month
BLA is about 100k pages
Bernie Cunningham is doing great work
Q: LH trial
A:
Working with FDA
Protocol has not been approved yet
Q: Patent to treat LH? IncellDx just got one with M.
A:
Q: NASH BTD app filed?
A: Not likely to file BTD.
FDA probably wants placebo controlled trial
FTD by end of Dec.
Q: NASH trial released to the public?
A: End of Dec
CR: that is what we are trying to do
Q: Biomarkers
A:
CR: BM changes we can see when pts are having symptoms and then when get LL the BMs go down in both LH and NASH
NP:
In HIV, couldn’t figure out responders rates without higher doses
SK:
Trying to put together pieces of the puzzles for determining MOA
CR:
BM lab with Dr. Scott Hansen, has been crucial to make this happen
Dr. Sacha and Dr. Otto Yang have made big contributions
Q: Is CEO comp on par?
A: If I was getting $10M, I would be in Bahamas
Base is $650k
AM: $10M – not sure where that is being derived
Stock Options were issued
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