2021-09-08 CYDY Investors CC
Rough Notes
No questions re: annual meeting or 13D
Slide 3
$1-2B cost to develop a drug
Slide 4
Slide 5
Slide 6
Slide 7
SK: population affected by COVID 19
Mutations are biggest threat
Delta
MU (could evade vaccines) less than .1% -- Ecuador 13%, Colombia high as well
All current mutations are occurring in the spike protein
LL is agnostic to spike protein
Other mAB neutralize spike protein
NP:
CD-16 Update
Was supposed to start by end of June, but were delayed
All comments from Anvisa are 100% satisfied
Got green light from Anvisa
However, this study was IV, 4 doses, not two (in CD12)
Anvisa had a problem re: stability via IV
Needed stability test
Final report going to Anvisa today (stability)
Have shipped the product already
It took 10 days in LA before product was shipped
Can inject the 1st pt next week
PE = Death or respiratory failure until day 28
700mg
IV every week
Power analysis – need 90 pts to hit PE (based on CD12 data)
Will do interim at 127pts
CR:
Very excited about studies
2 doses vs. 4 doses is what he is most excited about
Also breaking up CD12 trial into two groups
Severe group getting:
700mg SQ
3-doses at 350mg SQ
Instead of all cause mortality
Will be looking at how pts move in the ordinal scale of disease severity
NP:
CD16 (Critical)
4 doses IV, 700mg
CD17 (Severe)
612 pts
TOC had Absolute delta of only 1% and yet got approved
Screening right now
Will be announcing 1st pt injected any second now
++++
SK:
LH
Next tsunami in healthcare
More than 50% of young pts with COVID experience LH
45% of LHs working reduced hrs
22% are not working at all
As soon as get green light to proceed
NP:
Spoke to FDA
Asked for PE
Sum of all 24 symptoms
Drop in severity
-8 vs. -16 => 100% reduction
Should be
CR already sent protocol to FDA
Slide 8
Slide 9
CR
17 of 24 improved with LL
18 of 24 worsened in Placebo
Slide 10
In CD10 saw immune-supression
Placebo had 30% increased AE
In CD12 saw, within 14 days restoration of CD8 counts
Week 4: CD4 and B cell
Reactivation of viruses
Why is LL having these results?
Think it is related to CCR5
Interested in knowing CCR5, helps stabilize the cell surface
Low CCR5 on cells have higher risk of COVID
CCR5 are the wheels that allows the cells move
LL stabilizes the wheels
Studying how LL makes the cells work better
Maybe the adhesion is better
Slide 11
NP
Have patented all of these ideas
Slide 12
FDA letter did see critically ill pt potential
Eventually PI overcame FDA letter
Next PO arrived yesterday
PI is back on track
Now VIP people using LL
Now a campaign to get LL approved very quickly. It is back on track.
Slide 13
50pts will complete treatment on Sept 13
If only show fatty deposit drop, means have indication in NAFLD
SK:
NAFLD is 30-40% of the population
HIV pts have increased risk of NAFLD and NASH
NP
Believes broke the world record in enrolling this trial
CR:
From what we see in LH, fit with animal model in NASH
So, thinks this will apply to fibrosis as well
Slide 14
Application for BTD is ready to go
Awaiting “sequences” from new CRO
BTD:
1) Unmet medical need
2) Efficacy
a. Need at least 5 pts, we have 10 in the mTNBC trial + compassionate use trial
Basket trial
Most pts have passed 12 months
SK:
Some info has not been made public (animal studies)
They will put out data on CYDY website soon
Why CCR5 over expression?
CCR5 levels correlate with poor outcomes
Discusses same MOAs in cancer
Synergistic LL with other agents, such as:
a) DNA damaging agents
b) Can lower dose in chemo
c) Checkpoint inhibitors
a. Excited about this opty
b. Will be evaluating and will be signing a contract today regarding this
d) Antibody drug conjugates
LL 98% binding in human breast tissue to CCR5
Colon Cancer study at Cleveland Clinic
LL delayed tumor progression
Significantly delayed
Prolonged survival
Reduced 57%
Reduced 87% lung metastatic burden
Why were tumors not growing well when on LL
62% reduction in total vessel area
61% reduction in large vessels
82% reduction in small vessels
30pts with mTNBC (all trials)
12 month analysis
72% had decrease in CAMLs
Reduced CTC
Significantly better outcomes
NP:
Hopefully, SK will put in PowerPoint and on website soon
Slide 15
Highlighted 3 years. Leadership was changed and had to come clean-up.
Slide 16
Mfg “perfectly taken care of”
Rev value = ~$400M
Q&A:
Q: Status of LL in PH?
A: Latest PO is larger than 1st PO.
Q: BLA by Oct.
A: Delighted to see can fix problems
Most problems can resolved
Need more time from our CRO
New CRO will be able to dedicate more time
Cannot give timelines at this time
Once have timelines, will share with everyone
Q: LH submitted to FDA
A: Submitted yesterday (protocol)
Q: Long delay of trial in BZ
A: One already started
Didn’t have ROT in CD12
Could have changed PE
Q: Status of LL in India
A: Started “beautiful” project with them
Cases dropped
Didn’t have a CRO in India
Don’t need other trails in India now b/c of BZ
Other indications can be pursued in IN
Q: No open market purchases for NP of SK?
A:
Same history of what he did
NP is in possession of insider information and cannot buy
SK: certain times we can purchase
He has made significant open market purchase in the past as has his wife
Q: PO from PI
A: Will report those when get to a certain level.
Q: BLA with 350mg, clean data?
A:
Issue was needed a lot of safety, 500pts, for COMBO (if no MONO)
Avoided answering
Q: Latest clarification re: dose justification from FDA?
A:
Working on all these comment and timelines when ready
Q: LH P3 have placebo arm?
A:
CR:
Currently designed, there is a P arm
After the trial, the P arm will have access to LL
Q: Why not being used in PI?
A: Everything went right, we have revenue.
Moving forward with every project we have
Getting closer to fantastic finish line
Q: Plan for funding?
A:
Everyone says, I could raise you a billion easily.
Raised $400M for OTCB company, not NASDAQ company
Resume speaks for itself
Q: Financial health re: loan payment schedule?
A:
AM: Filed 8k yesterday
April Notes remain outstanding
Can reference SEC filings
10Q no later than Oct 12
Q: Role of S. getting BLA completed?
A: Every good thing comes via Nitya Rae
He found S.
He was hired for CMC part
He is helping to bring regulatory person for clinical part
Looking for in-house statistician as well
Q: MOA similar in NASH and LHs?
A:
CR: Yes, looking at biomarkers.
In tNBC like 700mg
In other conditions evaluating other doses
SK: Never seen the amount of progress re: MOA last several months. Credit goes to CR, Sacha, and others
Q: BZ trials designed to achieve the fastest results?
A: Yes
Q: Funds tight. Why spend $ fights proxy vote? Something to hide? Struggling to hold on to power?
A: SK’s fault, not NPs
SK has to follow the rules and regulations of the company
He has the obligation to follow the protocol
NP would have just let the shareholders vote
Will follow shareholders vote
Q: Exact status of HIV BLA? Oct 15 deadline?
A:
700k vials already dedicated to BZ
Will give exact timeline
Need contracts signed to get assays the FDA is requiring
COVID 19 is the fastest path to approval
Q: Child doses being looked at?
A:
SK: Not studying currently, but plan in the future
Q: LH full data? P3?
A:
NP is very happy with speed of progress
Submitted P3 protocol to FDA
Q: BTD for mTNBC submitted?
A:
Have application ready
NP is frustrated
Waiting for “sequence” from CRO, but no looking for other way to get “sequence”
Q: ROT vs. Tropism
A:
Tropism was put in place since 2007
Taken to ensure pure R5
ROT is whole different process
Q: Thoughts on LL as MONO for cancer? Or partnering?
A:
SK – speaking about pharma and Major Academic institution (to sign today, sitting on his desk, with academic inst.)
Looking at all different aspects of this
Q: Why have not replaced NP as CEO
A:
SK: Not a new concept
Leadership was changed in 2017 and 2018
Never made public before
Did call for CEO search 2019
Was not a reflection of NP’s performance
No guarantee any CEO could raise the funds
SK thinks NP has a proven track record in this regard (raising funds)
Not bring in new CEO unless NP agreed to a 1year transition
SK begged NP to stay if they brought in a new CEO, he agreed
New CEO wanted more equity than NP has received
Discussed NPs accomplishments
Said he would like to meet another CEO with similar accomplishments
++++
NP hoping to have interim results this year
Rough Notes
No questions re: annual meeting or 13D
Slide 3
$1-2B cost to develop a drug
Slide 4
Slide 5
Slide 6
Slide 7
SK: population affected by COVID 19
Mutations are biggest threat
Delta
MU (could evade vaccines) less than .1% -- Ecuador 13%, Colombia high as well
All current mutations are occurring in the spike protein
LL is agnostic to spike protein
Other mAB neutralize spike protein
NP:
CD-16 Update
Was supposed to start by end of June, but were delayed
All comments from Anvisa are 100% satisfied
Got green light from Anvisa
However, this study was IV, 4 doses, not two (in CD12)
Anvisa had a problem re: stability via IV
Needed stability test
Final report going to Anvisa today (stability)
Have shipped the product already
It took 10 days in LA before product was shipped
Can inject the 1st pt next week
PE = Death or respiratory failure until day 28
700mg
IV every week
Power analysis – need 90 pts to hit PE (based on CD12 data)
Will do interim at 127pts
CR:
Very excited about studies
2 doses vs. 4 doses is what he is most excited about
Also breaking up CD12 trial into two groups
Severe group getting:
700mg SQ
3-doses at 350mg SQ
Instead of all cause mortality
Will be looking at how pts move in the ordinal scale of disease severity
NP:
CD16 (Critical)
4 doses IV, 700mg
CD17 (Severe)
612 pts
TOC had Absolute delta of only 1% and yet got approved
Screening right now
Will be announcing 1st pt injected any second now
++++
SK:
LH
Next tsunami in healthcare
More than 50% of young pts with COVID experience LH
45% of LHs working reduced hrs
22% are not working at all
As soon as get green light to proceed
NP:
Spoke to FDA
Asked for PE
Sum of all 24 symptoms
Drop in severity
-8 vs. -16 => 100% reduction
Should be
CR already sent protocol to FDA
Slide 8
Slide 9
CR
17 of 24 improved with LL
18 of 24 worsened in Placebo
Slide 10
In CD10 saw immune-supression
Placebo had 30% increased AE
In CD12 saw, within 14 days restoration of CD8 counts
Week 4: CD4 and B cell
Reactivation of viruses
Why is LL having these results?
Think it is related to CCR5
Interested in knowing CCR5, helps stabilize the cell surface
Low CCR5 on cells have higher risk of COVID
CCR5 are the wheels that allows the cells move
LL stabilizes the wheels
Studying how LL makes the cells work better
Maybe the adhesion is better
Slide 11
NP
Have patented all of these ideas
Slide 12
FDA letter did see critically ill pt potential
Eventually PI overcame FDA letter
Next PO arrived yesterday
PI is back on track
Now VIP people using LL
Now a campaign to get LL approved very quickly. It is back on track.
Slide 13
50pts will complete treatment on Sept 13
If only show fatty deposit drop, means have indication in NAFLD
SK:
NAFLD is 30-40% of the population
HIV pts have increased risk of NAFLD and NASH
NP
Believes broke the world record in enrolling this trial
CR:
From what we see in LH, fit with animal model in NASH
So, thinks this will apply to fibrosis as well
Slide 14
Application for BTD is ready to go
Awaiting “sequences” from new CRO
BTD:
1) Unmet medical need
2) Efficacy
a. Need at least 5 pts, we have 10 in the mTNBC trial + compassionate use trial
Basket trial
Most pts have passed 12 months
SK:
Some info has not been made public (animal studies)
They will put out data on CYDY website soon
Why CCR5 over expression?
CCR5 levels correlate with poor outcomes
Discusses same MOAs in cancer
Synergistic LL with other agents, such as:
a) DNA damaging agents
b) Can lower dose in chemo
c) Checkpoint inhibitors
a. Excited about this opty
b. Will be evaluating and will be signing a contract today regarding this
d) Antibody drug conjugates
LL 98% binding in human breast tissue to CCR5
Colon Cancer study at Cleveland Clinic
LL delayed tumor progression
Significantly delayed
Prolonged survival
Reduced 57%
Reduced 87% lung metastatic burden
Why were tumors not growing well when on LL
62% reduction in total vessel area
61% reduction in large vessels
82% reduction in small vessels
30pts with mTNBC (all trials)
12 month analysis
72% had decrease in CAMLs
Reduced CTC
Significantly better outcomes
NP:
Hopefully, SK will put in PowerPoint and on website soon
Slide 15
Highlighted 3 years. Leadership was changed and had to come clean-up.
Slide 16
Mfg “perfectly taken care of”
Rev value = ~$400M
Q&A:
Q: Status of LL in PH?
A: Latest PO is larger than 1st PO.
Q: BLA by Oct.
A: Delighted to see can fix problems
Most problems can resolved
Need more time from our CRO
New CRO will be able to dedicate more time
Cannot give timelines at this time
Once have timelines, will share with everyone
Q: LH submitted to FDA
A: Submitted yesterday (protocol)
Q: Long delay of trial in BZ
A: One already started
Didn’t have ROT in CD12
Could have changed PE
Q: Status of LL in India
A: Started “beautiful” project with them
Cases dropped
Didn’t have a CRO in India
Don’t need other trails in India now b/c of BZ
Other indications can be pursued in IN
Q: No open market purchases for NP of SK?
A:
Same history of what he did
NP is in possession of insider information and cannot buy
SK: certain times we can purchase
He has made significant open market purchase in the past as has his wife
Q: PO from PI
A: Will report those when get to a certain level.
Q: BLA with 350mg, clean data?
A:
Issue was needed a lot of safety, 500pts, for COMBO (if no MONO)
Avoided answering
Q: Latest clarification re: dose justification from FDA?
A:
Working on all these comment and timelines when ready
Q: LH P3 have placebo arm?
A:
CR:
Currently designed, there is a P arm
After the trial, the P arm will have access to LL
Q: Why not being used in PI?
A: Everything went right, we have revenue.
Moving forward with every project we have
Getting closer to fantastic finish line
Q: Plan for funding?
A:
Everyone says, I could raise you a billion easily.
Raised $400M for OTCB company, not NASDAQ company
Resume speaks for itself
Q: Financial health re: loan payment schedule?
A:
AM: Filed 8k yesterday
April Notes remain outstanding
Can reference SEC filings
10Q no later than Oct 12
Q: Role of S. getting BLA completed?
A: Every good thing comes via Nitya Rae
He found S.
He was hired for CMC part
He is helping to bring regulatory person for clinical part
Looking for in-house statistician as well
Q: MOA similar in NASH and LHs?
A:
CR: Yes, looking at biomarkers.
In tNBC like 700mg
In other conditions evaluating other doses
SK: Never seen the amount of progress re: MOA last several months. Credit goes to CR, Sacha, and others
Q: BZ trials designed to achieve the fastest results?
A: Yes
Q: Funds tight. Why spend $ fights proxy vote? Something to hide? Struggling to hold on to power?
A: SK’s fault, not NPs
SK has to follow the rules and regulations of the company
He has the obligation to follow the protocol
NP would have just let the shareholders vote
Will follow shareholders vote
Q: Exact status of HIV BLA? Oct 15 deadline?
A:
700k vials already dedicated to BZ
Will give exact timeline
Need contracts signed to get assays the FDA is requiring
COVID 19 is the fastest path to approval
Q: Child doses being looked at?
A:
SK: Not studying currently, but plan in the future
Q: LH full data? P3?
A:
NP is very happy with speed of progress
Submitted P3 protocol to FDA
Q: BTD for mTNBC submitted?
A:
Have application ready
NP is frustrated
Waiting for “sequence” from CRO, but no looking for other way to get “sequence”
Q: ROT vs. Tropism
A:
Tropism was put in place since 2007
Taken to ensure pure R5
ROT is whole different process
Q: Thoughts on LL as MONO for cancer? Or partnering?
A:
SK – speaking about pharma and Major Academic institution (to sign today, sitting on his desk, with academic inst.)
Looking at all different aspects of this
Q: Why have not replaced NP as CEO
A:
SK: Not a new concept
Leadership was changed in 2017 and 2018
Never made public before
Did call for CEO search 2019
Was not a reflection of NP’s performance
No guarantee any CEO could raise the funds
SK thinks NP has a proven track record in this regard (raising funds)
Not bring in new CEO unless NP agreed to a 1year transition
SK begged NP to stay if they brought in a new CEO, he agreed
New CEO wanted more equity than NP has received
Discussed NPs accomplishments
Said he would like to meet another CEO with similar accomplishments
++++
NP hoping to have interim results this year
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