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Posted On: 10/13/2021 2:53:48 PM
Post# of 148863
2021-10-13 Emerging Growth Conference
Rough Notes
1445 pts
Slide
Investment to date = $400M+
Inventory
Could support potential sales of $400M (conservative number)
Could be close to $1B if price like MDR HIV
Slide
“I’m here to tell you the truth and the whole truth” – re: BLA
2019 Market value = $1B in 2019
Two independent orgs, did their market sizing
BioVid and Syneos
MDR = less than 5% of HIV pts
GILD and ViiV: Take over the HIV market
Talked to BP, HIV
COMBO is very small market, not interested
MONO if get 90% in then they would be interested
Slide
Why is BLA taking so long
CR took control
Found amazing stuff: sites, monitoring
Now made job NR to fix BLA
Reads CR’s bio
PI for 100+ clinical trials
Clinical trial recruitment and management (software company)
CR looked at all EDC
He recognized we could do a lot better
NR
Knows the molecule better than anyone in the world
Reads NR’s bio
COO, CTO – CYDY
SVP at Progenics, 14yrs, mfg , process, analytics, and process control
30yrs of experience
PhD in biochemical engineering from Rutgers
NR:
Will start submitting next month
CMC, nonclinical
Still working on Clinical module
Working with bioAnaytic lab
And Johna Sacha
Trying to resolve RO challenge they had/have
Expect BLA to be ready in Q1 2022
Anti-drug antibodies that the FDA had comments on
CR enrolled 90pts in NASH already
He knows how to enroll pts
CR:
1st Protocol
Inclusion & exclusion criteria
Strategic development
PE
How does the flow of operations and data work btw sites and data capture and CROs
2 step process
Automated query
System has to be monitored
Need to oversee the data
Iterative process
Transferring extension study pts to a new CRO
Some pts nearly 7yrs on MONO
Found that binding (CCR5) is an immunomodulator
CCR5 is the transmission system of our immune system
A lot of this has to do with leakiness of vessels
Seeing this in NASH, LH, stroke … perhaps Diabetic pts
BioMarker initiative
Helps us select which pts will respond
Also helping to understand the MOA
Upcoming LH trial
Spent a lot of time vis-à-vis markers
Just started with the biomarkers
SK:
Why wait a virus to infect a cell vs. prevent it from infecting the cell
Stellate cells are what produce the scars in the liver
NP:
NR Submitted CMC and have very little comments
Filing MONO trial in US and potentially BZ
Doesn’t make sense to have just COMBO and not have MONO option as well
COVID
Slide
CD16
Have not injected 1st pt
Hospitals need to be comfortable using IV
NR solved all the questions Anvisa had
Should be getting update re: BZ tomorrow
CD17
By OCT 18 or so, ARO told us, should have 20 sites or more on each CD16 and CD17
COVID is coming down in BZ
Our expectation of timeline
CD16 – interim analysis this year
PH
Orders are getting larger and faster
Work being done with regulatory dept
Should have update within 2-3 weeks, should be exciting for us
Hoping for some type of approval better than CSP
Orders are going up
NASH
Slide
60pts, 700mg
30pts open label 350mg
If the results are good, perhaps could file for BTD
Results are still blinded
CR is working with lab to figure out MOA
Expect to happen this year
CR:
Revamped NASH protocol
Using MRI scans
Fat and Fibrosis
Included pts with high Fibrosis and expect them to progress
Cleaning data, getting everything right
Expect to do this trial the “right way”
Hope to get really good info this year
BASKET TRIAL
Slide
NR is going to do BTD app
NR:
Have data on 30pts
Using Creative MircoTech lab
Seeing encouraging results
Comparing vs. SOC and drug approved last year (antidrug conjugate, they had FT then BTD)
FDA granted them accelerated review while still in P1/P2
Received complete response from FDA had CMC related issues
Last year it was approved
At that time they were doing P3, randomized trail
Completed the trial and FDA granted full approval this year
Sees similar regulatory pathway (except Complete Response)
BTD would be hopefully ready next week and definitely this month
Pts at 525mg or 700mg better response than 350mg
73% CTC going down and significantly better than current gold standard for mTNBC
Believe results could support a BTD
Could potentially get an approval before completion of the P3 like the previous drug
NP:
A week or two weeks later, will file BTD with breast cancer with metastasis to brain
Have 7pts all together right now
Previous drug could remove brain metastasis and did in their protocol
60days after BTD application, should get the results from the FDA
Slide
Not presented/shown
CR:
Working with FDA on trial for LH
Larger number of pts
Think picked the endpoints very well
Don’t think there will be a problem filling the trial
SK:
Should be able to enroll quickly
NASH
End of NOV hoping for results
Top Line report end of DEC
BTD
Both filed this month
Cancer trial in BZ
Q&A:
Q: Why SP is languishing?
A: The stock will take care of itself as long as the fundamentals are there
Q: How is LL better than the COVID antivirals
A:
SK:
Other products are Directed to spike protein
They will have challenges due to mutations
Q: 1M vials => how much revenue?
A:
IZ (HIV MDR) selling for $117k per pt per year
$1B in revenue
If sell at ½ that price, then => $500M
But he is being more conservative => $400M
As soon as get EUA in BZ => 700M vials to BZ
Q: BTD for NASH?
A:
Need to see the results 1st
Q: Problem with AMAREX?
A:
Very difficult to move CROs
Went to CRO’s office, sat there and pleaded with them, no indication they would provide the data
P2 MONO protocol was very fast with Amarex
Did “fantastic things” with that CRO
But when performance goes down, need to solve the problem
Q: How to fulfill order if get EUA?
A: There will be multiple choices of who we want to distribute
It will not be a problem
Q: NASH was going to get 1st 50pt data
A:
Amarex locked us out of the data, so delayed us
Good news is that CR got access to the data from the hospitals
CR:
All our data was in our possession for MRIs which was good
Working with the sites, they are helping us reenter the data
Results end of NOV
CR did not respond to NP’s “putting him on the spot”
Q: mTNBC BTD ready? Why not submitted?
A:
NR found more data that is positive
Don’t want to rush
Want it to be rock-solid
Hopefully next week, but definitely this month
Q: Why struggling to get BLA
A: already addressed
Q: Cash position, burn, capital requirements
A:
Over $6M in cash in recent filing
Will raise money “when less dilution”
Option of PIPE, Notes, quite a bit of options
Will select option that will dilute the company the least
Q: Samsung next batches?
A:
Next Feb
NR:
Samsung is producing bulk
Have now more than 700k vials in our inventory
Making additional batches from bulk into vials
That will get us the 1.1 to 1.2M vials
Have next batches that making next year in bulk
Might not “finish” and put into vials
Bulk remains frozen and stable for up to 4 years
Met with FDA early this year
Last year had AGC and Agimoto
New submission, adding Samsung into it
NP:
When first purchased Pro140
Ex GILD lady, who was very good at CMC
Said will need 100 people to help with CMC package
NR:
If BTD, Clinical typically moves very fast, but CMC cannot keep up
CMC mfg process if fully ready to go, so should move much faster
NP:
HGEN
Hit PE many months ago, but don’t have the mfg
Q: CYDY partner for NASH and PASC?
A: No, no partner needed
Q: NASDAQ uplisting
A: SE +5M
SP over 3 or $4
Will have iBank to raise more funds after uplisting
Q: Price per vial?
A: Don’t disclose
Q: interim results NASH
A: Pushing for end of Nov
EOY for sure
Q: BZ enrollment to date
A: Very slow, numbers going down in BZ
Total confidence in team in BZ to get to finish line
Q: MS, ALS?
A:
MS on map
Dementia
Stroke
Need more funding, more people
CR:
Getting synopsis ready for Dementia
Given results from LH, then Dementia is a logical extension
RO of over 75% in the Brain
CCR5 is upregulated post stroke
Should have a protocol early next year
SK:
Looked at ALS previously
CCR5 antagonism is rich in this area
Q: New HIV trial for BLA?
A: No
Q: HIV pts who got COVID?
A:
Didn’t get this info from Amarex
Expect to be able to get this type of data with our new CRO
SK:
A lot of HIV pts have comorbidities
NASH can be as high as 65% in HIV population
Can make a backbone of a regiment
Q: Staff changes in past 12mths with all new indications?
A:
New lab that CR is working with
Strong team under NR
CR:
Strong clinical development dept
Biomarkers is the key for everything we are doing
NP:
AM takes care of finances and lawsuits
Has 10-15 people working for him
Need regulatory person
Need bioanalytic and biostatistician
Will be adding to the team
Q: Meeting date with PH group?
A:
Chiral said meeting 2-3 weeks from today, but not a sure deal. I will update when have more info
Now selling in PH in CSP
Q: Assuming 1 FDA approval, barrier to 2nd indication or off label?
A:
Can’t use off-label, that is a no no
CMC is the hardest part
Q: CYDY not longer using RTT
A:
Raising money to have people to do all the tasks
CR
Demand has been overwhelming for RTT
Demand for the product is there
Q: Future fund raising?
A:
Where is the toxicity in the Fife loan
John Fife is a fantastic person
He is the reason we could save peoples’ lives
It is a fantastic program Fife has
Products get completely stopped with no fundraising
Don’t believe everything people said
Q: Why tropism has to be redone?
A: Tropism was done with Covance and LabCorp before that
No problem with tropism
The Ultra Tropism is 99% accurate for DNA vs. RNA
Q: Assays needed before BLA submission?
A:
ROT
NR:
Had issue with ROT on original submission
FDA was very specific on what needed to
1st method was not validated at all
Need validated method to get approval
Working with University and Lab
Some challenges
Johnas Sacha, KOL in RO
Lab has also done many RO
Not only method needs to be validated
But method needs to be robust as well
Will do everything that can be done
Will do everything they can and if can’t solve the problem, then tell the FDA and work with them
Thinks on the right path with RO
Things Q1 2022 will be ready and send to FDA
Q: Is LL still available EAP in US?
A: No
Q: Rank following indications?
A:
1) COVID critically ill
a. Will be filing same protocol, modified, with US soon
b. Might ask for Compassionate use for a fee in US and BZ
2) Cancer
3) LH
a. CR working with FDA to develop a path / protocol to go forward
b. Protocol has been submitted
4) HIV
5) HIV
6) NASH
Q: How many doses does a vial represent
2.34mL per vial
2 vials => 700mg
Q: Two new BOD directors
A:
Samir Patel
Allen Timmins (forgot his name)
A lot of regulatory work was dumped on them
They worked very hard to get this cleaned-up
The two that are coming in
HS
Lish N. (forgot last name)
Just had dinner with them a few weeks ago in NY
Lish is top KOL in HIV
HS had vision for LL in COVID
Also have a “lady” we are nominating
Tanya (forgot last name)
SK
Worked with Lish for a long time
Served on SAB
Q: Enough funds to get through trials in BZ?
A:
Raise money as need funds
Have paid the BZ folks very quickly
Pay immediately
Raised $420M to date
Q: How is NP’s MIL doing?
A:
Not doing very well, can talk very little
18 lesions to brain before LL
Expected to live 3mths
Now alive almost 2 years (2yrs next month)
Rock star pt for brain metastisis
Q: How will finance the trials?
A:
Finance through shareholders have relationship in the past
Some shareholders work out to CYDY to invest
Perhaps PIPE
Q: Total projected trial sites in BZ trials?
A:
Solved IV challenges with Anvisa
20-25 sites by Oct 18th ready to go for each trial
20-25 pts ? or sites ? for CD17
They have a group of Drs that go to every site to help enrollment
Amarex was not doing that here in the US
Q: Additional optys vs completing COMBO BLA?
A:
60-80pts saved lives in COVID
MONO revealed higher dose was critical for us
Q: Study size for LH? BTD?
A:
Cannot ask for BTD, need p-value stat sig.
Now have to do a trial
CR submitted protocol to FDA
CR:
W/ FDA guidance submitted protocol to FDA
Confounders that might interfere with study were pulled out
Also have 350 vs. 700mg dose
225 pts in the protocol
Can enroll the pts very quickly
Have about 500pts on lists in different states
NR taking care of assay development helps free up CRs time
Q: COMBO dose justification
A:
1M LL per one cell
<I did not understand the answer>
Q: IV, particulates?
A:
No problem, there was just a concern of a potential problem
NR:
SQ formulation into IV bag
Contracted to CRO to test the application
On the particulate test, a light imaging test
Sometimes cannot distinguish bubbles from particulate
Went to another lab, imaging and microscope and verified there was no particulate issue
ANVISA approved the results
Q: Whey SEC not authorized last S3 filings?
A: CFO says that they have authorized
S3 is registered shares, that they can sell right away
Prefer to lock the shares for 6months
And don’t need S3 for these locked shares
Q: Chemo + LL
A:
SK:
Thinks synergistic effect of Chemo with LL
Don’t think there are any negative effects of chemo on LL
Haven’t seen drug-drug interaction
NP:
How do you know chemo is working or LL is working?
Use historical data that is well documented
Carboplatin can’t use for 6mths typically, but appear to be able to use with LL
Q: Efficacy data needed for LH’s
A:
If hit PE on P2 with two hundred pts, then can file for BTD
Q: Any further trial inquiries IN or PH?
A: No
Q: Update on CD16 CD17 enrollment
A:
CD16=0
CD17 = 20-25pts
Adding sites and enrollment should pick up
Q: Age issue in CD12 resolved in BZ trial
A: Yes
Q: Post stroke depression? PHE is trialing this.
A:
Love it when MV does well
Gives us a chance to go straight to P2
MV has black box liver toxicity
SK:
A lot of different things to look at in stroke (symptoms)
CR:
Can focus in on symptoms for given pts
Q: Dividends?
A:
Once we have sales and cash flow is great and SP is at dream level
Q: Compassionate Use in USA?
A:
Critically ill is USA and CU
Q: Chemo providing clinical benefit?
A: already answered
Q: Advancements with addition of new board members
A:
Lish can bring more visibility for HIV
HS believes product has expanded application, tests he wants CYDY to do to prove to the scientific world
SK:
Very careful in who chose
Top immunologist in the world
Q: Does LL require special handling?
A: 4yrs stability of the vials
Bulk has even more
Handling refrigerated
NR:
Long history of stability since early 2000
Current formulation up to 4yrs in vials
Frozen stable for “years”, used after 8years
Stability data at room temperature – up to 6 months, then drug quality deteriorates
Don’t suggest drug is stored at room temp
Suggest stored refrigerated
Q: Warrant conversion incentive
A:
Will let shareholders know
Q: Using leading PR firm
A: Using one
Q: When are proxies going to be mailed?
A: Just received SEC clearance to file definite proxy and will file today
Q: USA sites impact BZ trial
A: No, it will not impact BZ
Q: Biggest concern?
A:
Keep himself aligned with the Lord god.
Rough Notes
1445 pts
Slide
Investment to date = $400M+
Inventory
Could support potential sales of $400M (conservative number)
Could be close to $1B if price like MDR HIV
Slide
“I’m here to tell you the truth and the whole truth” – re: BLA
2019 Market value = $1B in 2019
Two independent orgs, did their market sizing
BioVid and Syneos
MDR = less than 5% of HIV pts
GILD and ViiV: Take over the HIV market
Talked to BP, HIV
COMBO is very small market, not interested
MONO if get 90% in then they would be interested
Slide
Why is BLA taking so long
CR took control
Found amazing stuff: sites, monitoring
Now made job NR to fix BLA
Reads CR’s bio
PI for 100+ clinical trials
Clinical trial recruitment and management (software company)
CR looked at all EDC
He recognized we could do a lot better
NR
Knows the molecule better than anyone in the world
Reads NR’s bio
COO, CTO – CYDY
SVP at Progenics, 14yrs, mfg , process, analytics, and process control
30yrs of experience
PhD in biochemical engineering from Rutgers
NR:
Will start submitting next month
CMC, nonclinical
Still working on Clinical module
Working with bioAnaytic lab
And Johna Sacha
Trying to resolve RO challenge they had/have
Expect BLA to be ready in Q1 2022
Anti-drug antibodies that the FDA had comments on
CR enrolled 90pts in NASH already
He knows how to enroll pts
CR:
1st Protocol
Inclusion & exclusion criteria
Strategic development
PE
How does the flow of operations and data work btw sites and data capture and CROs
2 step process
Automated query
System has to be monitored
Need to oversee the data
Iterative process
Transferring extension study pts to a new CRO
Some pts nearly 7yrs on MONO
Found that binding (CCR5) is an immunomodulator
CCR5 is the transmission system of our immune system
A lot of this has to do with leakiness of vessels
Seeing this in NASH, LH, stroke … perhaps Diabetic pts
BioMarker initiative
Helps us select which pts will respond
Also helping to understand the MOA
Upcoming LH trial
Spent a lot of time vis-à-vis markers
Just started with the biomarkers
SK:
Why wait a virus to infect a cell vs. prevent it from infecting the cell
Stellate cells are what produce the scars in the liver
NP:
NR Submitted CMC and have very little comments
Filing MONO trial in US and potentially BZ
Doesn’t make sense to have just COMBO and not have MONO option as well
COVID
Slide
CD16
Have not injected 1st pt
Hospitals need to be comfortable using IV
NR solved all the questions Anvisa had
Should be getting update re: BZ tomorrow
CD17
By OCT 18 or so, ARO told us, should have 20 sites or more on each CD16 and CD17
COVID is coming down in BZ
Our expectation of timeline
CD16 – interim analysis this year
PH
Orders are getting larger and faster
Work being done with regulatory dept
Should have update within 2-3 weeks, should be exciting for us
Hoping for some type of approval better than CSP
Orders are going up
NASH
Slide
60pts, 700mg
30pts open label 350mg
If the results are good, perhaps could file for BTD
Results are still blinded
CR is working with lab to figure out MOA
Expect to happen this year
CR:
Revamped NASH protocol
Using MRI scans
Fat and Fibrosis
Included pts with high Fibrosis and expect them to progress
Cleaning data, getting everything right
Expect to do this trial the “right way”
Hope to get really good info this year
BASKET TRIAL
Slide
NR is going to do BTD app
NR:
Have data on 30pts
Using Creative MircoTech lab
Seeing encouraging results
Comparing vs. SOC and drug approved last year (antidrug conjugate, they had FT then BTD)
FDA granted them accelerated review while still in P1/P2
Received complete response from FDA had CMC related issues
Last year it was approved
At that time they were doing P3, randomized trail
Completed the trial and FDA granted full approval this year
Sees similar regulatory pathway (except Complete Response)
BTD would be hopefully ready next week and definitely this month
Pts at 525mg or 700mg better response than 350mg
73% CTC going down and significantly better than current gold standard for mTNBC
Believe results could support a BTD
Could potentially get an approval before completion of the P3 like the previous drug
NP:
A week or two weeks later, will file BTD with breast cancer with metastasis to brain
Have 7pts all together right now
Previous drug could remove brain metastasis and did in their protocol
60days after BTD application, should get the results from the FDA
Slide
Not presented/shown
CR:
Working with FDA on trial for LH
Larger number of pts
Think picked the endpoints very well
Don’t think there will be a problem filling the trial
SK:
Should be able to enroll quickly
NASH
End of NOV hoping for results
Top Line report end of DEC
BTD
Both filed this month
Cancer trial in BZ
Q&A:
Q: Why SP is languishing?
A: The stock will take care of itself as long as the fundamentals are there
Q: How is LL better than the COVID antivirals
A:
SK:
Other products are Directed to spike protein
They will have challenges due to mutations
Q: 1M vials => how much revenue?
A:
IZ (HIV MDR) selling for $117k per pt per year
$1B in revenue
If sell at ½ that price, then => $500M
But he is being more conservative => $400M
As soon as get EUA in BZ => 700M vials to BZ
Q: BTD for NASH?
A:
Need to see the results 1st
Q: Problem with AMAREX?
A:
Very difficult to move CROs
Went to CRO’s office, sat there and pleaded with them, no indication they would provide the data
P2 MONO protocol was very fast with Amarex
Did “fantastic things” with that CRO
But when performance goes down, need to solve the problem
Q: How to fulfill order if get EUA?
A: There will be multiple choices of who we want to distribute
It will not be a problem
Q: NASH was going to get 1st 50pt data
A:
Amarex locked us out of the data, so delayed us
Good news is that CR got access to the data from the hospitals
CR:
All our data was in our possession for MRIs which was good
Working with the sites, they are helping us reenter the data
Results end of NOV
CR did not respond to NP’s “putting him on the spot”
Q: mTNBC BTD ready? Why not submitted?
A:
NR found more data that is positive
Don’t want to rush
Want it to be rock-solid
Hopefully next week, but definitely this month
Q: Why struggling to get BLA
A: already addressed
Q: Cash position, burn, capital requirements
A:
Over $6M in cash in recent filing
Will raise money “when less dilution”
Option of PIPE, Notes, quite a bit of options
Will select option that will dilute the company the least
Q: Samsung next batches?
A:
Next Feb
NR:
Samsung is producing bulk
Have now more than 700k vials in our inventory
Making additional batches from bulk into vials
That will get us the 1.1 to 1.2M vials
Have next batches that making next year in bulk
Might not “finish” and put into vials
Bulk remains frozen and stable for up to 4 years
Met with FDA early this year
Last year had AGC and Agimoto
New submission, adding Samsung into it
NP:
When first purchased Pro140
Ex GILD lady, who was very good at CMC
Said will need 100 people to help with CMC package
NR:
If BTD, Clinical typically moves very fast, but CMC cannot keep up
CMC mfg process if fully ready to go, so should move much faster
NP:
HGEN
Hit PE many months ago, but don’t have the mfg
Q: CYDY partner for NASH and PASC?
A: No, no partner needed
Q: NASDAQ uplisting
A: SE +5M
SP over 3 or $4
Will have iBank to raise more funds after uplisting
Q: Price per vial?
A: Don’t disclose
Q: interim results NASH
A: Pushing for end of Nov
EOY for sure
Q: BZ enrollment to date
A: Very slow, numbers going down in BZ
Total confidence in team in BZ to get to finish line
Q: MS, ALS?
A:
MS on map
Dementia
Stroke
Need more funding, more people
CR:
Getting synopsis ready for Dementia
Given results from LH, then Dementia is a logical extension
RO of over 75% in the Brain
CCR5 is upregulated post stroke
Should have a protocol early next year
SK:
Looked at ALS previously
CCR5 antagonism is rich in this area
Q: New HIV trial for BLA?
A: No
Q: HIV pts who got COVID?
A:
Didn’t get this info from Amarex
Expect to be able to get this type of data with our new CRO
SK:
A lot of HIV pts have comorbidities
NASH can be as high as 65% in HIV population
Can make a backbone of a regiment
Q: Staff changes in past 12mths with all new indications?
A:
New lab that CR is working with
Strong team under NR
CR:
Strong clinical development dept
Biomarkers is the key for everything we are doing
NP:
AM takes care of finances and lawsuits
Has 10-15 people working for him
Need regulatory person
Need bioanalytic and biostatistician
Will be adding to the team
Q: Meeting date with PH group?
A:
Chiral said meeting 2-3 weeks from today, but not a sure deal. I will update when have more info
Now selling in PH in CSP
Q: Assuming 1 FDA approval, barrier to 2nd indication or off label?
A:
Can’t use off-label, that is a no no
CMC is the hardest part
Q: CYDY not longer using RTT
A:
Raising money to have people to do all the tasks
CR
Demand has been overwhelming for RTT
Demand for the product is there
Q: Future fund raising?
A:
Where is the toxicity in the Fife loan
John Fife is a fantastic person
He is the reason we could save peoples’ lives
It is a fantastic program Fife has
Products get completely stopped with no fundraising
Don’t believe everything people said
Q: Why tropism has to be redone?
A: Tropism was done with Covance and LabCorp before that
No problem with tropism
The Ultra Tropism is 99% accurate for DNA vs. RNA
Q: Assays needed before BLA submission?
A:
ROT
NR:
Had issue with ROT on original submission
FDA was very specific on what needed to
1st method was not validated at all
Need validated method to get approval
Working with University and Lab
Some challenges
Johnas Sacha, KOL in RO
Lab has also done many RO
Not only method needs to be validated
But method needs to be robust as well
Will do everything that can be done
Will do everything they can and if can’t solve the problem, then tell the FDA and work with them
Thinks on the right path with RO
Things Q1 2022 will be ready and send to FDA
Q: Is LL still available EAP in US?
A: No
Q: Rank following indications?
A:
1) COVID critically ill
a. Will be filing same protocol, modified, with US soon
b. Might ask for Compassionate use for a fee in US and BZ
2) Cancer
3) LH
a. CR working with FDA to develop a path / protocol to go forward
b. Protocol has been submitted
4) HIV
5) HIV
6) NASH
Q: How many doses does a vial represent
2.34mL per vial
2 vials => 700mg
Q: Two new BOD directors
A:
Samir Patel
Allen Timmins (forgot his name)
A lot of regulatory work was dumped on them
They worked very hard to get this cleaned-up
The two that are coming in
HS
Lish N. (forgot last name)
Just had dinner with them a few weeks ago in NY
Lish is top KOL in HIV
HS had vision for LL in COVID
Also have a “lady” we are nominating
Tanya (forgot last name)
SK
Worked with Lish for a long time
Served on SAB
Q: Enough funds to get through trials in BZ?
A:
Raise money as need funds
Have paid the BZ folks very quickly
Pay immediately
Raised $420M to date
Q: How is NP’s MIL doing?
A:
Not doing very well, can talk very little
18 lesions to brain before LL
Expected to live 3mths
Now alive almost 2 years (2yrs next month)
Rock star pt for brain metastisis
Q: How will finance the trials?
A:
Finance through shareholders have relationship in the past
Some shareholders work out to CYDY to invest
Perhaps PIPE
Q: Total projected trial sites in BZ trials?
A:
Solved IV challenges with Anvisa
20-25 sites by Oct 18th ready to go for each trial
20-25 pts ? or sites ? for CD17
They have a group of Drs that go to every site to help enrollment
Amarex was not doing that here in the US
Q: Additional optys vs completing COMBO BLA?
A:
60-80pts saved lives in COVID
MONO revealed higher dose was critical for us
Q: Study size for LH? BTD?
A:
Cannot ask for BTD, need p-value stat sig.
Now have to do a trial
CR submitted protocol to FDA
CR:
W/ FDA guidance submitted protocol to FDA
Confounders that might interfere with study were pulled out
Also have 350 vs. 700mg dose
225 pts in the protocol
Can enroll the pts very quickly
Have about 500pts on lists in different states
NR taking care of assay development helps free up CRs time
Q: COMBO dose justification
A:
1M LL per one cell
<I did not understand the answer>
Q: IV, particulates?
A:
No problem, there was just a concern of a potential problem
NR:
SQ formulation into IV bag
Contracted to CRO to test the application
On the particulate test, a light imaging test
Sometimes cannot distinguish bubbles from particulate
Went to another lab, imaging and microscope and verified there was no particulate issue
ANVISA approved the results
Q: Whey SEC not authorized last S3 filings?
A: CFO says that they have authorized
S3 is registered shares, that they can sell right away
Prefer to lock the shares for 6months
And don’t need S3 for these locked shares
Q: Chemo + LL
A:
SK:
Thinks synergistic effect of Chemo with LL
Don’t think there are any negative effects of chemo on LL
Haven’t seen drug-drug interaction
NP:
How do you know chemo is working or LL is working?
Use historical data that is well documented
Carboplatin can’t use for 6mths typically, but appear to be able to use with LL
Q: Efficacy data needed for LH’s
A:
If hit PE on P2 with two hundred pts, then can file for BTD
Q: Any further trial inquiries IN or PH?
A: No
Q: Update on CD16 CD17 enrollment
A:
CD16=0
CD17 = 20-25pts
Adding sites and enrollment should pick up
Q: Age issue in CD12 resolved in BZ trial
A: Yes
Q: Post stroke depression? PHE is trialing this.
A:
Love it when MV does well
Gives us a chance to go straight to P2
MV has black box liver toxicity
SK:
A lot of different things to look at in stroke (symptoms)
CR:
Can focus in on symptoms for given pts
Q: Dividends?
A:
Once we have sales and cash flow is great and SP is at dream level
Q: Compassionate Use in USA?
A:
Critically ill is USA and CU
Q: Chemo providing clinical benefit?
A: already answered
Q: Advancements with addition of new board members
A:
Lish can bring more visibility for HIV
HS believes product has expanded application, tests he wants CYDY to do to prove to the scientific world
SK:
Very careful in who chose
Top immunologist in the world
Q: Does LL require special handling?
A: 4yrs stability of the vials
Bulk has even more
Handling refrigerated
NR:
Long history of stability since early 2000
Current formulation up to 4yrs in vials
Frozen stable for “years”, used after 8years
Stability data at room temperature – up to 6 months, then drug quality deteriorates
Don’t suggest drug is stored at room temp
Suggest stored refrigerated
Q: Warrant conversion incentive
A:
Will let shareholders know
Q: Using leading PR firm
A: Using one
Q: When are proxies going to be mailed?
A: Just received SEC clearance to file definite proxy and will file today
Q: USA sites impact BZ trial
A: No, it will not impact BZ
Q: Biggest concern?
A:
Keep himself aligned with the Lord god.
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