2021-09-29 Emerging Growth Conference Notes Rough
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Posted On: 09/29/2021 3:06:53 PM
2021-09-29 Emerging Growth Conference Notes
Rough Notes
Slide
Slide
Slide
What do we think about Biz Plan
“Or is it just fake”
Gave $6M back to NIH
Did Mono, to change HIV paradigm
That was our business plan that we went and executed
Biz Plan going forward
Cancer
We generated that result
Some people take 10yrs to generate those results
If we stop right now, minimum 400% better than SOC
People who analyze our data: ~“Don’t see how you don’t get BTD”
Had brain metastisis in 6 pts
Data was good for those pts as well
Unmet medical need + efficacy
Efficacy requires 5 pts in Clinical Trial; we have 10 pts now
Then try PDL inhibitors after getting BTD
Go small, unmet medical need, then go after other things
SK:
BTD—can reduce 2.5-3.5yrs
patient testimony
Pancreatic cancer
1st dose LL 7/27
8/3
8/19
8/26
9/9
Tumors shrunk 4.8 to 3.
…
2.5 to 2.2cm
Pancreas 4.6 to 1.5cm
NP:
Main primary tumor shrunk 25% in two weeks of being on LL
SK:
Thinks this is because of blocking angiogenesis
Slide
SK was one who said we should try LL in COVID
Heavy lifting was done by SH
If we had changed PE, would have had EUA by now
Did we drop the ball, CRO, … doesn’t matter now
Slide
Slide
If had 70pts, would have met PE (if this was PE)
Expect to get to interim this year (CD16)
Slide
Next indication that Biz Plan allowed us to have
NP was against LH
CR said he could enroll it this year
Then NP said, let’s do it
PE was not met, at p=0.05 (only 0.27) across 24 symptoms
SK: Post Viral syndromes
LH 233M COVID infections
20-60M for LHs
Perfect way to pivot into Post Viral Syndrome
Trying to crack the code in this arena
Some pts got out of wheelchairs on LL
Now want to get back on LL
Have protocol to FDA
FDA is giving guidelines
Hope to have protocol resolved in the next couple weeks
Slide
Orders are flowing in
$2-3M in sales without approval
Slide
New Biz Plan was created and executed in record time
Will get update on CD16 tomorrow
This is a world class CRO (not like previous CRO)
Slide
CR said he could enroll NASH trial in this year
Believe best enrollment ever
SK:
Over $21B market
NP:
Do we have enough product?
Spent $20M just transfer of technology
Slide
Need to raise money to secure mfg spot for next year
Slide
What is our biz plan?
Run it by experts and see if we are telling the truth or not
Plan for the future
Usually raise money from PIPE, RD, Loan
“Note is only way to raise funds without diluting completely”
Hoping for better day tomorrow
Screen shows 50M dilution for past two years
Group of shareholders doubt us
NP knows PR “very well”
Said we did a terrible job raising money
Didn’t PR tell you loan was great?
Slide
Slide
Slide
SK:
New slate
Immunologist
NIH obtaining grants
HIV expert
Interest in COVID
HIV cure – world leader
Dr. HS
Lung transplant
Went to FDA to get first two EINDS in COVID
Numerous clinical research trials
Well published
Tonya E.
Extensive corporate finance
Q&A:
Q: Independent BOD, SK has conflict?
A:
SK played an instrumental role when stock was going down
He stepped in and made the right decisions and rearranged the BOD
Saw eye-to-eye with us
NP asked SK to take over Biz Dev role
SK got involved with CYDY when following GILD
Thought CYDY would be one of those companies that could be acquired
SK:
Will have 4 independent directors
Partnerships, exploring Int’l partnerships
Now have data
NP:
Might not accept partnership
Shareholders will make the final decision
Q: Sequencing re: BTD for mTNBC?
A:
Pleaded to Amarex
They denied to give the sequencing
Reached out to FDA, got the sequencing
6 had metastases to brain and beat SOC and other drug that recently got approved
Sequence is the code to put in the computer to get data from computer system
Q: Why biz strategy better than activist group?
A: Strategy is to realize where the failures could happen
How to get point A to point B
And have the funds
Discusses trials
This is our biz plan – saving people’s lives
Talk to cancer pts – do they have good biz plan
SK:
A lot of times people promise things, really have to implement things and get things done
Q: Still collecting data from cancer trials?
A: Closing trials due to CRO
Putting pts in RTT
Going to FDA
Ask for approval right now for Cancer
Q: Activist group says problem is CEO
A:
His wife would like him to step down
He would love to step down as CEO anytime
I don’t want this job anymore if it wasn’t savings people’s lives
Has enough money in his accounts
Took oath to Jordan N. and a Paulson guy that he would not step down
Nitya Rae came back with condition that NP was CEO
If he is performing, then he should stay
SK:
Went through this before
Be careful what you wish for
Q: Agreement with ac. Institution
A: They have to approve the PR
Very interesting
Just one of many going forward
Q: 630M outstanding of 800M Authorized? Why 200M more?
A: Need to show we are strong, don’t go down
Q: How much raised via warrant exercises? Warrants generally?
A: Slowing down the fund raising in that regard
Perhaps PIPE with restricted shares
The plan was to double the price of warrants and give them double the shares
Q: Pts enrolled in BZ trials? Etc
A: most sites have both C and S
Going to reach 30-40 sites within 2-3 weeks
Q: Will initial small order lead to larger orders in PH?
A:
Yes
Don’t even have the money yet, due to contract terms
Q: Chiral still discussing EUA?
A: Yes, working on all those avenues
Perhaps could sell the drug w/o restriction of 500 vials per hospital
Changed original requirement which was much more strict
Q: Go forward plan funding?
A: Small fund raising
Q: NASH on track for
A: November, absolutely
Q: Partnerships
A: Can’t comment
Gets more exciting weekly
Q: Checkpoint inhibitors?
A: Can’t talk about it until announce the institution
Could be paired with many other drugs as well
Q: BLA filing?
A:
NP – due to discontinuation with Amarex
Managing to get all data in CYDY hands
Amarex is not cooperating
Biz Plan is to get EUA for COVID
Don’t have enough vials for HIV
Not avoiding HIV BLA
Number of indications
Will give new timelines
Q: BZ trial enrollment?
A:
Will update everyone, not shy about updating shareholders
Next couple of months will be very interesting
Q: S3 authorization
A:
Always have to renew authorization with SEC
You don’t have to use S3 to issue shares, can do PIPE
AM and MM are doing a fantastic job
Q: DOJ investigation?
A: Don’t have any update
Q: HIV study?
A: BLA 6-10 months
2-3 months for COVID
Not giving timelines for BLA now
Higher dose was at expense of BLA being “deragulated"
+++++
LH protocol to FDA
COVID trial protocol in USA
NASH results in next couple of weeks
Cancer BTD – might do two (one with M to brain, and one mTNBC)
Rough Notes
Slide
Slide
Slide
What do we think about Biz Plan
“Or is it just fake”
Gave $6M back to NIH
Did Mono, to change HIV paradigm
That was our business plan that we went and executed
Biz Plan going forward
Cancer
We generated that result
Some people take 10yrs to generate those results
If we stop right now, minimum 400% better than SOC
People who analyze our data: ~“Don’t see how you don’t get BTD”
Had brain metastisis in 6 pts
Data was good for those pts as well
Unmet medical need + efficacy
Efficacy requires 5 pts in Clinical Trial; we have 10 pts now
Then try PDL inhibitors after getting BTD
Go small, unmet medical need, then go after other things
SK:
BTD—can reduce 2.5-3.5yrs
patient testimony
Pancreatic cancer
1st dose LL 7/27
8/3
8/19
8/26
9/9
Tumors shrunk 4.8 to 3.
…
2.5 to 2.2cm
Pancreas 4.6 to 1.5cm
NP:
Main primary tumor shrunk 25% in two weeks of being on LL
SK:
Thinks this is because of blocking angiogenesis
Slide
SK was one who said we should try LL in COVID
Heavy lifting was done by SH
If we had changed PE, would have had EUA by now
Did we drop the ball, CRO, … doesn’t matter now
Slide
Slide
If had 70pts, would have met PE (if this was PE)
Expect to get to interim this year (CD16)
Slide
Next indication that Biz Plan allowed us to have
NP was against LH
CR said he could enroll it this year
Then NP said, let’s do it
PE was not met, at p=0.05 (only 0.27) across 24 symptoms
SK: Post Viral syndromes
LH 233M COVID infections
20-60M for LHs
Perfect way to pivot into Post Viral Syndrome
Trying to crack the code in this arena
Some pts got out of wheelchairs on LL
Now want to get back on LL
Have protocol to FDA
FDA is giving guidelines
Hope to have protocol resolved in the next couple weeks
Slide
Orders are flowing in
$2-3M in sales without approval
Slide
New Biz Plan was created and executed in record time
Will get update on CD16 tomorrow
This is a world class CRO (not like previous CRO)
Slide
CR said he could enroll NASH trial in this year
Believe best enrollment ever
SK:
Over $21B market
NP:
Do we have enough product?
Spent $20M just transfer of technology
Slide
Need to raise money to secure mfg spot for next year
Slide
What is our biz plan?
Run it by experts and see if we are telling the truth or not
Plan for the future
Usually raise money from PIPE, RD, Loan
“Note is only way to raise funds without diluting completely”
Hoping for better day tomorrow
Screen shows 50M dilution for past two years
Group of shareholders doubt us
NP knows PR “very well”
Said we did a terrible job raising money
Didn’t PR tell you loan was great?
Slide
Slide
Slide
SK:
New slate
Immunologist
NIH obtaining grants
HIV expert
Interest in COVID
HIV cure – world leader
Dr. HS
Lung transplant
Went to FDA to get first two EINDS in COVID
Numerous clinical research trials
Well published
Tonya E.
Extensive corporate finance
Q&A:
Q: Independent BOD, SK has conflict?
A:
SK played an instrumental role when stock was going down
He stepped in and made the right decisions and rearranged the BOD
Saw eye-to-eye with us
NP asked SK to take over Biz Dev role
SK got involved with CYDY when following GILD
Thought CYDY would be one of those companies that could be acquired
SK:
Will have 4 independent directors
Partnerships, exploring Int’l partnerships
Now have data
NP:
Might not accept partnership
Shareholders will make the final decision
Q: Sequencing re: BTD for mTNBC?
A:
Pleaded to Amarex
They denied to give the sequencing
Reached out to FDA, got the sequencing
6 had metastases to brain and beat SOC and other drug that recently got approved
Sequence is the code to put in the computer to get data from computer system
Q: Why biz strategy better than activist group?
A: Strategy is to realize where the failures could happen
How to get point A to point B
And have the funds
Discusses trials
This is our biz plan – saving people’s lives
Talk to cancer pts – do they have good biz plan
SK:
A lot of times people promise things, really have to implement things and get things done
Q: Still collecting data from cancer trials?
A: Closing trials due to CRO
Putting pts in RTT
Going to FDA
Ask for approval right now for Cancer
Q: Activist group says problem is CEO
A:
His wife would like him to step down
He would love to step down as CEO anytime
I don’t want this job anymore if it wasn’t savings people’s lives
Has enough money in his accounts
Took oath to Jordan N. and a Paulson guy that he would not step down
Nitya Rae came back with condition that NP was CEO
If he is performing, then he should stay
SK:
Went through this before
Be careful what you wish for
Q: Agreement with ac. Institution
A: They have to approve the PR
Very interesting
Just one of many going forward
Q: 630M outstanding of 800M Authorized? Why 200M more?
A: Need to show we are strong, don’t go down
Q: How much raised via warrant exercises? Warrants generally?
A: Slowing down the fund raising in that regard
Perhaps PIPE with restricted shares
The plan was to double the price of warrants and give them double the shares
Q: Pts enrolled in BZ trials? Etc
A: most sites have both C and S
Going to reach 30-40 sites within 2-3 weeks
Q: Will initial small order lead to larger orders in PH?
A:
Yes
Don’t even have the money yet, due to contract terms
Q: Chiral still discussing EUA?
A: Yes, working on all those avenues
Perhaps could sell the drug w/o restriction of 500 vials per hospital
Changed original requirement which was much more strict
Q: Go forward plan funding?
A: Small fund raising
Q: NASH on track for
A: November, absolutely
Q: Partnerships
A: Can’t comment
Gets more exciting weekly
Q: Checkpoint inhibitors?
A: Can’t talk about it until announce the institution
Could be paired with many other drugs as well
Q: BLA filing?
A:
NP – due to discontinuation with Amarex
Managing to get all data in CYDY hands
Amarex is not cooperating
Biz Plan is to get EUA for COVID
Don’t have enough vials for HIV
Not avoiding HIV BLA
Number of indications
Will give new timelines
Q: BZ trial enrollment?
A:
Will update everyone, not shy about updating shareholders
Next couple of months will be very interesting
Q: S3 authorization
A:
Always have to renew authorization with SEC
You don’t have to use S3 to issue shares, can do PIPE
AM and MM are doing a fantastic job
Q: DOJ investigation?
A: Don’t have any update
Q: HIV study?
A: BLA 6-10 months
2-3 months for COVID
Not giving timelines for BLA now
Higher dose was at expense of BLA being “deragulated"
+++++
LH protocol to FDA
COVID trial protocol in USA
NASH results in next couple of weeks
Cancer BTD – might do two (one with M to brain, and one mTNBC)
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