2021-09-08 13D Webinar Rough Notes PR: Paten
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Posted On: 09/08/2021 7:43:26 PM
2021-09-08 13D Webinar
Rough Notes
PR:
Patent issue
LH
BLA
Detailed plans that will be presented to all in the next few weeks
Not interest in aligning with BP
No communication with BP
Want to develop LL
None of the slate has ownership to IncellDx except Dr. P.
None, including Dr. P, want CYDY to buy IDX
None of proposed nominees have any discussion re: buying IDX
Bought shares in open market, just like “you”
Fed-up with mgmt and just want change.
Stock hit its highs due to Dr. P, including TedTalk
Tried to reunite CYDY and Dr. P
Dr. P had no participation in that endeavor
Sent 8 separate letters to BOD re: inconsistencies re: NP’s statements and SEC filings
No response from CYDY
13D to put CYDY on notice as to grievances
No response from the company
Attempted to avoid a proxy fight
Hoping “beyond hope” to avoid fight
No matter what you think of us
Think drug is fantastic, company is worth saving
Woke up every morning, thinking this is the day we will get approval
All in the same boat – want an approval
That is why they are here today
Shareholders, want the best for the company, want success
New something was wrong with the BLA submission
That mistake alone would cause for change in management
PR was CEO of a NASDAQ listed company
Employed over 1000 employees
Worked with Wall Street
Had independent BOD
Was not fired, replace or removed by the BOD
Left with support of BOD and management
Was paid $425K per year, while profitable
CEO should only be paid, rewarded when producing profits for shareholders
NP was 3rd highest paid CEO in Oregon, WA last year
Only chairman and CEO of Nike was paid more
Chairman of BOD reports to CEO as employee
No chance of NASDAQ approval with this BOD
Why not let shareholders vote?
That was SK’s decision
This proxy fight is about mgmt of CYDY
Is mgmt protecting your investment?
Are you satisfied with their performance?
Compare them to us and make a choice.
Dr. P.
CYDY was $0.26/share
After TedTalk was $10
Thinks he was a part of that SP movement
1st wants to dispel misinformation
Looking forward to his deposition
To say all he is going to say today under oath
Jan 10th, 2020
In Shanghai meeting with Longgen
Jan 27th, tried to get CYDY involved
Way before anyone in US was talking about pathogenesis of COVID
Then sent e-mail to CYDY
Reads e-mail
PR re: working on COVID with China partner
All the info was coming from Bruce
NP wrote e-mail to JL
It has something to do with macrophages
++++
Sign Assignment Agreement
If you invent, it is owned by the University or Employer
Consulting Agreement
If meant anything other than advising the company, it is absurd
It has nothing to do with where we are right now
++++
Went on to talk about dosing
e-mail that showed in a message in Feb
Discussion with Kush
Decided on four doses of LL covering 28 days
b/c of high doses of cytokines they were seeing in the lab
Montifiroe hadn’t even started yet
Other issue was ROT
Had one of the best ROT at IDX
He knew every pt on LL or on placebo
CCR5 expression on immune cells
Dosing is incredibly complex
Can’t throw a dose against wall
CCR5 changes on day-to-day basis
Monocytes, etc.
Level of CCR5 expression varies
The level has to be monitored
Why?
b/c T-regs are “bad” cells, they turn off the immune system, you want to block them 100%
Don’t want to occupy good cells
Can inhibit just the bad cells by appropriate dosing
++++
BLA
Internally, at CYDY there was confusion re: Tropism and ROT
Tropism is on viral side
ROT is on cell/receptor side
ROT has to be measured every day
Were getting confounding results on Tropism assay
CYDY thought ROT could substitute for Tropism
350mg dose is plenty of drug for CD02 b/c on HARRT
Which down-regulates CCR5
FDA wants to be educated, very interested in open dialog
All it required was a meeting with FDA, what are the issues
RTF -- Can guarantee it is not about ROT
Only had ROT on a portion of the MONO trial, which they were using for dose justification on the COMBO trial
Has spreadsheet with MONO
2/3rd of samples and time points didn’t have ROT
It was incomplete
Not that it was bad
IN CD10 and CD12, ROT was working very well
Knew ROT at every sample in COVID trials
Dr. P suggested the 4 doses over 28 days
What is plan for BLA?
Have expert meet with FDA, data in hand, 350mg might be appropriate dose
More is not necessarily better
Appropriate outcome measure should be CD4 count
LL is not an anti-viral
When someone gets flu or similar, their viral load would go up even though drug was working correctly, but that lead to a viral load failure
++++
LH
10,000 pts
Ivermectin is not their primary drug
Drugs are directed at vascular inflammation
Non-classical monocytes carry COVID remnants
Published data already
See 1000 pts a week
Could enroll very quickly
LL + statin is what they would use
Most potent, most successful treatment for LHs known in the world
Discussed outcomes with FDA that they are looking for in LHs
Have 50 clinical sites
Have people reaching out to fund the trial
Would rather do trial with LL than MV
Have some findings on LL that haven’t been released publically yet
Trial could be done very quick
Has no financial obligations to PZ
They (PZ) don’t even know about what he is doing with LHs
++++++
Cancer
LL is not a standalone for cancer
For therapy, must be in combo
Roche doesn’t have PD1
Discusses technical details of other drugs and LL
LL would be a very potent combination with other cancer drugs
+++++
COVID
Critical should be successful
And LHs
DoD is interested in funding trials related to LHs
++++
Showed cover letter
CYDY asked about acquiring IDX
Met with NP and SK
$150M value on cover letter
Only if the company was successful, then it would approach the numbers being thrown around
Didn’t hear even a response from CYDY
That was the beginning of the end
His hope is to get back working with the drug again
LL won’t get a BTD b/c it is in combo with other drugs
And there is no placebo
FDA will not believe the results
+++++
Melissa Yeager
25yrs in exec mgmt
US & int’l regulatory affairs
GILD
BD
Start-ups as well (early as well as late stage development efforts)
Dr. Errico
Long-time shareholder since 2017
Was a CYDY “junkie”
NYU – full tenured professor
Over 35 years in Clinical trials with FDA
Extensive patent experience, over 150 patents
Consultant to one large corp re patents
Founded company sold to Stryker for over $350M
Founded another company, sold around $2.3B
Served on BOD and Comp and Non-Gov committees on NASDAQ company
Chairman reports to CEO
Can’t go on NASDAQ without restructuring
Peter Staats
Founded pain med at JHU
Ran for 10 years
Sold private practice to PE
Cofounded ElectroCore
Was on BOD
Was CMO (left BOD when went as CMO)
Founded approved drug
Served on BOD both private and public
Consultant to FDA
CMO for both private and public companies
Works with wounded warrior
Survivor core as well
Survivor core would be interested in work with us
Investor in CYDY
Wants to lean-in
No history of previous BOD
Just wants to fix it and get stock back up
And most importantly get the drug out there for people who need it.
PR
Attorney
MI legislature
Specialize in insurance and banking law
Started own operation in M&A
Owned private chemical company
Chairman & CEO of NASDAQ company
Chairman of other boards
Chairman of Liquor Control Commission in OR with 800+ employees
TE
The thought that SK refuses to talk to this group – does that fit with his job as head of Biz Dev?
++++++
Q&A
Q: Who owns data for 10k pts? PZ?
A: IDX owns
It is IDX’s cohort
PZ does not own it
It is about partnerships
No one can do it alone
Let’s get the band back together and get this over the finish line
Q: Distinctions on discoveries IDX vs. CYDY?
A: CYDY needs to sign the appropriate agreements.
Master Services Agreement
Lays out who owns the data, samples, IP
There was never one of those agreements signed ever between CYDY and IDX
A consulting agreement is to give them advice
Industry standard contractual relationships – between pharma and other companies
Dr. Sacha was on the patent. That means that OSU owns part of the patent, and he was obligated to assign to INX.
PR:
Dr. P has patents, nationally and int’l that target CCR5
So, take out all the noise
Let’s talk about CYDY’s patent
CYDY has a patent
Usually, the issue is when someone was left off a patent
Dr. P was put on the patent, without his knowledge
They have proof of this, emails
And will put it on the record
He didn’t try to steal it, he was put on it without his knowledge
TE:
I’m going to wear my shareholder hat right now
Appalled that standard agreements were not signed
It is “bush league”
Q: Fife loans outstanding. Yesterday’s 8k filings. Please clarify if it was expected or unexpected conversions?
A:
AW:
Had issue sharing screen
Data is based on SEC reporting
There may be internal company data that would modify the results
8K yesterday was re: shares already on the shelf and being transferred
Potentially “non-diluting” has been used a lot
$10 conversion price was never used in settling the loan with Fife
Fife started in June, 2018
As of 8k yesterday, principal remaining is $57M
$85M paid off debt
$120M paid in cash to note holder (i.e. premium and profit)
$91M profited above the $34M profit above
Therefore, profited about $125M
Jan 19
The terms of the notes were disregarded (conversion and demands)
441% return before selling back into the market
June 29, 2020
Converted 22.5M on this note
4M shares converted
June 30, 2020
Reached all time high to $10
Created side agreements to settle the notes
July 2020 note
Disregarded the demand period
$25M principal
$10 conversion price did not apply at any time to settle the loans
Avg. conversion price was $2.69
S3 was issued to register stock for those loans
Only registered at $10/share
2.8M shares turned into 11.3M shares
S3
2.1M shares at 10 conversion
Same issue
Was asked to wrap it up in interest of time
Will be issuing over 50M shares to settle Fife loans
Could entrench management
Q: Taking company private?
A: No. No plans to take company private.
No connection to BP
Simply shareholders who have huge stake in the financial success of the company
Not taking it over for someone else
Yes, we do want revenue
Q: Why did you cover up past conflicts of interest? Why afraid of giving depositions?
A:
Not afraid of depositions
Just wanted a vote of existing mgmt of 13D group
Q: NP has committed fraud? Going to jail?
A: No idea. No comment. Will cooperate with any investigations.
Q: Why fighting so hard to not take depositions?
A: CYDY brought lawsuit in federal court based on preliminary proxy that we were filling out. Not even a final proxy. When went to court, said they wanted to depose everyone – who gave a penny. They only went to court on preliminary proxy. Bringing suit to make it go away. Spending millions of dollars to make it go away.
The SEC in effect gave approval to go solicit based on the proxies.
They are trying to bankrupt the 13D group.
To NP: Why spending all that money if you are going to win? SK’s decision.
Q: Why would 13D distribute BuyerStrike article?
A: JB has been very vocal against BS or Adam F. or “any of those low lifes”
This group is aligned with long shareholders
NP disclosed they employ 11 different PR firms
Large social media page run by gentleman, who is owner of PR firm paid by CYDY
++++
Wrap-up
Will do more calls
Won’t hear too much from us in the next week or so
Rough Notes
PR:
Patent issue
LH
BLA
Detailed plans that will be presented to all in the next few weeks
Not interest in aligning with BP
No communication with BP
Want to develop LL
None of the slate has ownership to IncellDx except Dr. P.
None, including Dr. P, want CYDY to buy IDX
None of proposed nominees have any discussion re: buying IDX
Bought shares in open market, just like “you”
Fed-up with mgmt and just want change.
Stock hit its highs due to Dr. P, including TedTalk
Tried to reunite CYDY and Dr. P
Dr. P had no participation in that endeavor
Sent 8 separate letters to BOD re: inconsistencies re: NP’s statements and SEC filings
No response from CYDY
13D to put CYDY on notice as to grievances
No response from the company
Attempted to avoid a proxy fight
Hoping “beyond hope” to avoid fight
No matter what you think of us
Think drug is fantastic, company is worth saving
Woke up every morning, thinking this is the day we will get approval
All in the same boat – want an approval
That is why they are here today
Shareholders, want the best for the company, want success
New something was wrong with the BLA submission
That mistake alone would cause for change in management
PR was CEO of a NASDAQ listed company
Employed over 1000 employees
Worked with Wall Street
Had independent BOD
Was not fired, replace or removed by the BOD
Left with support of BOD and management
Was paid $425K per year, while profitable
CEO should only be paid, rewarded when producing profits for shareholders
NP was 3rd highest paid CEO in Oregon, WA last year
Only chairman and CEO of Nike was paid more
Chairman of BOD reports to CEO as employee
No chance of NASDAQ approval with this BOD
Why not let shareholders vote?
That was SK’s decision
This proxy fight is about mgmt of CYDY
Is mgmt protecting your investment?
Are you satisfied with their performance?
Compare them to us and make a choice.
Dr. P.
CYDY was $0.26/share
After TedTalk was $10
Thinks he was a part of that SP movement
1st wants to dispel misinformation
Looking forward to his deposition
To say all he is going to say today under oath
Jan 10th, 2020
In Shanghai meeting with Longgen
Jan 27th, tried to get CYDY involved
Way before anyone in US was talking about pathogenesis of COVID
Then sent e-mail to CYDY
Reads e-mail
PR re: working on COVID with China partner
All the info was coming from Bruce
NP wrote e-mail to JL
It has something to do with macrophages
++++
Sign Assignment Agreement
If you invent, it is owned by the University or Employer
Consulting Agreement
If meant anything other than advising the company, it is absurd
It has nothing to do with where we are right now
++++
Went on to talk about dosing
e-mail that showed in a message in Feb
Discussion with Kush
Decided on four doses of LL covering 28 days
b/c of high doses of cytokines they were seeing in the lab
Montifiroe hadn’t even started yet
Other issue was ROT
Had one of the best ROT at IDX
He knew every pt on LL or on placebo
CCR5 expression on immune cells
Dosing is incredibly complex
Can’t throw a dose against wall
CCR5 changes on day-to-day basis
Monocytes, etc.
Level of CCR5 expression varies
The level has to be monitored
Why?
b/c T-regs are “bad” cells, they turn off the immune system, you want to block them 100%
Don’t want to occupy good cells
Can inhibit just the bad cells by appropriate dosing
++++
BLA
Internally, at CYDY there was confusion re: Tropism and ROT
Tropism is on viral side
ROT is on cell/receptor side
ROT has to be measured every day
Were getting confounding results on Tropism assay
CYDY thought ROT could substitute for Tropism
350mg dose is plenty of drug for CD02 b/c on HARRT
Which down-regulates CCR5
FDA wants to be educated, very interested in open dialog
All it required was a meeting with FDA, what are the issues
RTF -- Can guarantee it is not about ROT
Only had ROT on a portion of the MONO trial, which they were using for dose justification on the COMBO trial
Has spreadsheet with MONO
2/3rd of samples and time points didn’t have ROT
It was incomplete
Not that it was bad
IN CD10 and CD12, ROT was working very well
Knew ROT at every sample in COVID trials
Dr. P suggested the 4 doses over 28 days
What is plan for BLA?
Have expert meet with FDA, data in hand, 350mg might be appropriate dose
More is not necessarily better
Appropriate outcome measure should be CD4 count
LL is not an anti-viral
When someone gets flu or similar, their viral load would go up even though drug was working correctly, but that lead to a viral load failure
++++
LH
10,000 pts
Ivermectin is not their primary drug
Drugs are directed at vascular inflammation
Non-classical monocytes carry COVID remnants
Published data already
See 1000 pts a week
Could enroll very quickly
LL + statin is what they would use
Most potent, most successful treatment for LHs known in the world
Discussed outcomes with FDA that they are looking for in LHs
Have 50 clinical sites
Have people reaching out to fund the trial
Would rather do trial with LL than MV
Have some findings on LL that haven’t been released publically yet
Trial could be done very quick
Has no financial obligations to PZ
They (PZ) don’t even know about what he is doing with LHs
++++++
Cancer
LL is not a standalone for cancer
For therapy, must be in combo
Roche doesn’t have PD1
Discusses technical details of other drugs and LL
LL would be a very potent combination with other cancer drugs
+++++
COVID
Critical should be successful
And LHs
DoD is interested in funding trials related to LHs
++++
Showed cover letter
CYDY asked about acquiring IDX
Met with NP and SK
$150M value on cover letter
Only if the company was successful, then it would approach the numbers being thrown around
Didn’t hear even a response from CYDY
That was the beginning of the end
His hope is to get back working with the drug again
LL won’t get a BTD b/c it is in combo with other drugs
And there is no placebo
FDA will not believe the results
+++++
Melissa Yeager
25yrs in exec mgmt
US & int’l regulatory affairs
GILD
BD
Start-ups as well (early as well as late stage development efforts)
Dr. Errico
Long-time shareholder since 2017
Was a CYDY “junkie”
NYU – full tenured professor
Over 35 years in Clinical trials with FDA
Extensive patent experience, over 150 patents
Consultant to one large corp re patents
Founded company sold to Stryker for over $350M
Founded another company, sold around $2.3B
Served on BOD and Comp and Non-Gov committees on NASDAQ company
Chairman reports to CEO
Can’t go on NASDAQ without restructuring
Peter Staats
Founded pain med at JHU
Ran for 10 years
Sold private practice to PE
Cofounded ElectroCore
Was on BOD
Was CMO (left BOD when went as CMO)
Founded approved drug
Served on BOD both private and public
Consultant to FDA
CMO for both private and public companies
Works with wounded warrior
Survivor core as well
Survivor core would be interested in work with us
Investor in CYDY
Wants to lean-in
No history of previous BOD
Just wants to fix it and get stock back up
And most importantly get the drug out there for people who need it.
PR
Attorney
MI legislature
Specialize in insurance and banking law
Started own operation in M&A
Owned private chemical company
Chairman & CEO of NASDAQ company
Chairman of other boards
Chairman of Liquor Control Commission in OR with 800+ employees
TE
The thought that SK refuses to talk to this group – does that fit with his job as head of Biz Dev?
++++++
Q&A
Q: Who owns data for 10k pts? PZ?
A: IDX owns
It is IDX’s cohort
PZ does not own it
It is about partnerships
No one can do it alone
Let’s get the band back together and get this over the finish line
Q: Distinctions on discoveries IDX vs. CYDY?
A: CYDY needs to sign the appropriate agreements.
Master Services Agreement
Lays out who owns the data, samples, IP
There was never one of those agreements signed ever between CYDY and IDX
A consulting agreement is to give them advice
Industry standard contractual relationships – between pharma and other companies
Dr. Sacha was on the patent. That means that OSU owns part of the patent, and he was obligated to assign to INX.
PR:
Dr. P has patents, nationally and int’l that target CCR5
So, take out all the noise
Let’s talk about CYDY’s patent
CYDY has a patent
Usually, the issue is when someone was left off a patent
Dr. P was put on the patent, without his knowledge
They have proof of this, emails
And will put it on the record
He didn’t try to steal it, he was put on it without his knowledge
TE:
I’m going to wear my shareholder hat right now
Appalled that standard agreements were not signed
It is “bush league”
Q: Fife loans outstanding. Yesterday’s 8k filings. Please clarify if it was expected or unexpected conversions?
A:
AW:
Had issue sharing screen
Data is based on SEC reporting
There may be internal company data that would modify the results
8K yesterday was re: shares already on the shelf and being transferred
Potentially “non-diluting” has been used a lot
$10 conversion price was never used in settling the loan with Fife
Fife started in June, 2018
As of 8k yesterday, principal remaining is $57M
$85M paid off debt
$120M paid in cash to note holder (i.e. premium and profit)
$91M profited above the $34M profit above
Therefore, profited about $125M
Jan 19
The terms of the notes were disregarded (conversion and demands)
441% return before selling back into the market
June 29, 2020
Converted 22.5M on this note
4M shares converted
June 30, 2020
Reached all time high to $10
Created side agreements to settle the notes
July 2020 note
Disregarded the demand period
$25M principal
$10 conversion price did not apply at any time to settle the loans
Avg. conversion price was $2.69
S3 was issued to register stock for those loans
Only registered at $10/share
2.8M shares turned into 11.3M shares
S3
2.1M shares at 10 conversion
Same issue
Was asked to wrap it up in interest of time
Will be issuing over 50M shares to settle Fife loans
Could entrench management
Q: Taking company private?
A: No. No plans to take company private.
No connection to BP
Simply shareholders who have huge stake in the financial success of the company
Not taking it over for someone else
Yes, we do want revenue
Q: Why did you cover up past conflicts of interest? Why afraid of giving depositions?
A:
Not afraid of depositions
Just wanted a vote of existing mgmt of 13D group
Q: NP has committed fraud? Going to jail?
A: No idea. No comment. Will cooperate with any investigations.
Q: Why fighting so hard to not take depositions?
A: CYDY brought lawsuit in federal court based on preliminary proxy that we were filling out. Not even a final proxy. When went to court, said they wanted to depose everyone – who gave a penny. They only went to court on preliminary proxy. Bringing suit to make it go away. Spending millions of dollars to make it go away.
The SEC in effect gave approval to go solicit based on the proxies.
They are trying to bankrupt the 13D group.
To NP: Why spending all that money if you are going to win? SK’s decision.
Q: Why would 13D distribute BuyerStrike article?
A: JB has been very vocal against BS or Adam F. or “any of those low lifes”
This group is aligned with long shareholders
NP disclosed they employ 11 different PR firms
Large social media page run by gentleman, who is owner of PR firm paid by CYDY
++++
Wrap-up
Will do more calls
Won’t hear too much from us in the next week or so
(5)
(3)CytoDyn Inc (CYDY) Stock Research Links
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