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Posted On: 10/26/2021 2:14:52 PM
Post# of 154947
10-26-2021 Emerging Growth Call
Rough Notes
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Haven’t yet filed 1st BTD
Analyzing results from Basket Trial
Slide
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Ready to start LH trial
Slide
Slide
Slide
Going to submit MONO trial moving in US and BZ “perhaps”
CR:
Migrating data to
They are rebuilding the DB
Looking in good shape
Looking forward to get ready for BLA
Q: What was the problem with data at AMAREX?
A:
CR:
Been trying to work with A for a while
They didn’t have the experience to do the BLA
New staff now and making good progress
Data: proper procedures are adhered
At one pt maybe A did a good job
But now need to move faster and get the data submitted
Q: Did any HIV pts get COVID, Cancer, etc?
A:
NP – will be able to get this data going forward
Q: ROT, BLA?
NR:
Plan to submit nonclinical and CMC in Nov. On target.
Clinical module will be submitted Q1 2022
Area working on is ROT
Working with measured CRO on bioanalyisis
Need to validate the method before making submission
Q: Amarex moving away from them
A:
SK:
CR took over and stepped-up to make it so we can move from A to new CRO
Syvio ?? (HIV)
Also talking to PPD for other indications
Slide
Over 3000% better when taking out two pts
NR:
Will be submitted in the next few days, definitely next week if not this week
NP:
Some of these pts were on MONO cancer therapy
SK:
Some pts can’t tolerate chemo
One bladder cancer pt is an example
Slide
Slide
100% better outcome across 24 symptoms
CR:
Protocol complete
Building EDC with new CRO
Used everything learned from biomarkers and previous studies
500pt wait list
1:1:1 ratio
NP:
2 of 3 pts will get LL
SK:
Market size is overwhelming
Same info as always
Slide
Will start LH trial next week (CD18)
Slides
Data being put together for 39 and 17 pts
Slide
Don’t think will hit PE at interim for Severe
But do Think they will hit PE at interim for Critical
If there is a wave, then enrollment could happen very quickly
Slide
CR:
Already designing the 2b for biopsy
Can get ready end of this Q or next Q
Biomarker lab has been very handy
Thinks they have a solution for the NASH problem pts have
SK:
Immunized mice
3fold reduction in NAFLD
Once a week
Don’t expect drug-to-drug interaction
Addresses the formation of scarring via stellite cells
Slide
Next year run, will be for auditing the site for BLA
Previously were using AGC
Slide
Slide
SK:
200M shares put us in a position of strength
Comp is done by 3rd-independent party
Looking for pharma partners
Slide
6-7pts with mTNBC with Brain M.
Negotiate new cancer trial in BZ
Slide
Q&A:
Q: BLA resubmission status?
A:
Rolling review
Have to hear back from FDA
As soon as hear from FDA can submit per rolling review
NR:
Once we submit sections, they will start reviewing
Won’t get PDUFA date until after last section is submitted and accepted
NP:
NR was responsible for CMC
SK:
CMC & non-clinical are very impt for all other indications
CR:
Filed draft Dose J. with FDA
Asked for guidelines
Based on that correspondence, now in position to submit actual BLA
Q: Amarex is no longer
A:
Will have Symbio and other CRO companies they are talking to
Also hiring
NR is hiring top professionals from BP
NR:
Need own, internal team to work with CROs and help manage them
He built his own team for CMC and that why they have been successful
Just hired BioStatistician yesterday
Will be sending RFPs to multiple CROs
Select based on strengths in various indications
BioAnalytical will be joining in the next few weeks
Process of hiring clinical regulatory person and clinical project management
NP:
Will be overseeing everything the CROs do and make sure no issues going forward
Q: GvHD?
A:
Had humanized mice study
A couple of other products got approved, so couldn’t get BTD anymore
Small market
It is on hold and will not start GvHD at this time
Q: Filed patent app in BZ?
A:
In 57 countries
Over 80patents
Q: LH is mediated by fractiline pathway?
A:
SK: No
CR: Our biomarker lab is picking up some different things affecting these pts
Q: Likelihood to get EUA in 2022?
A:
Critical, think can hit PE at interim
Absolutely, could get approval in the next 6 months
NR:
mTNBC can see similar pathway to previously approved drug via BTD
Will take FDA about 60days to review BTD
Good chance will get BTD
FDA granted previous company accelerated pathway
Approved based on one single arm trial
Then completed P3 trial
Then got full approval
Think good chance to pursue same regulatory pathway
LL did substantially better than previously approved drug
Very optimistic
Side Effects from previously approved drug and has black box warning
Q: mTNBC is in combo with CHEMO how to know relative LL contribution?
A:
Historical data has over 12k pts that is used as comparative baseline
Q: HIV MONO possible with once per month injection?
A:
NP – I don’t think so
SK – could make a longer acting version of LL. This would be longer term, not short term
Would need to start P1 again if change the molecule
Could be once every 3 months after modification
Q: Why 225 pts for LH?
A:
CR:
Based on previous LH study and EP selecting for trial, it is calculated out
Interim at 90pts
NP: could potentially hit PE at interim based on previous study results
Q: Research collaboration?
A:
SK: In contact with multiple different academic institutions
Contacted by academic inst to do AI studies on MOA
Q: Samsung vials?
A:
NR:
6 years of commercial production and then can extend
There is a minimum number of batches per year
Already fulfilled for the first two years
Have mfg schedule for 2022 and 2023 and they are binding forecasts
Some of raw materials it takes 6-9months to fulfill
Samsung is expanding by more than 60%
Very good relationship with Samsung
Don’t foresee issue with mfg going forward
NP
Use 30-50M shares to ensure we have product
Q: No mention of Samsung in latest 10Q
A: Still using Samsung
Q: How come new hire hasn’t been introduced to investors?
A:
Dr. Sinew (?sp?)
Just the exec team comes to these meetings
He is working on CMC of BLA
Q: Merck COVID pill to receive EUA in PH after it receives EUA in US?
A:
Critical population could receive EUA after interim in BZ
Q: HIV partner with BP?
A:
HIV BLA has always been #1 priority
MONO 700mg created significant delays
1.5 years required for increasing dose
Q: LH CRO
A: Symbio
Q: LH regulatory pathway?
A:
Will be a P2
Will discuss with FDA to see if BTD or P3 required
Q: Tropism
A:
90% or more are R5
FDA required tropism
RO trying to add this data
Q: Comp in NASH space?
A:
SK – spoke very fast and hard to take notes on this one
Q: MD Anderson collaboration?
A:
SK – can’t talk about the specifics
Partnerships are continuing, unique things happening and will announce when appropriate
Q: Acq proposals rejected by CYDY?
A: Can’t talk about anything
Q: CD10 and CD12 manuscripts submitted?
A:
SK: Completed manuscripts
Multiple other manus as well
LH was submitted
CD02 is next one they are focused on
CD10 will not focus on that one
CD12 is a priority
Q: CR why choose to work for CYDY?
A:
CR – was very sick and got LL and felt so much better
In on Friday and discharged on Sun
Wants to provide this drug to others
NP:
CR invested in CYDY also right away
Q: Lab used for ROT that was not validated?
A:
Dr. BP, was not validated
Assay used previously was not validated
He never gave the validation to CYDY
Q: Lots of molecules for NASH, can compete?
A: Yes
Q: What obstacles importing data from BZ?
Q: 200M = 25% of AS?
A:
200M is 20% of 1B
[But it is 25% of the currently AS of 800M]
Have to have shares to raise funds
Summary
Rough Notes
Slide
Slide
Slide
Slide
Slide
Slide
Slide
Haven’t yet filed 1st BTD
Analyzing results from Basket Trial
Slide
Slide
Slide
Slide
Ready to start LH trial
Slide
Slide
Slide
Going to submit MONO trial moving in US and BZ “perhaps”
CR:
Migrating data to
They are rebuilding the DB
Looking in good shape
Looking forward to get ready for BLA
Q: What was the problem with data at AMAREX?
A:
CR:
Been trying to work with A for a while
They didn’t have the experience to do the BLA
New staff now and making good progress
Data: proper procedures are adhered
At one pt maybe A did a good job
But now need to move faster and get the data submitted
Q: Did any HIV pts get COVID, Cancer, etc?
A:
NP – will be able to get this data going forward
Q: ROT, BLA?
NR:
Plan to submit nonclinical and CMC in Nov. On target.
Clinical module will be submitted Q1 2022
Area working on is ROT
Working with measured CRO on bioanalyisis
Need to validate the method before making submission
Q: Amarex moving away from them
A:
SK:
CR took over and stepped-up to make it so we can move from A to new CRO
Syvio ?? (HIV)
Also talking to PPD for other indications
Slide
Over 3000% better when taking out two pts
NR:
Will be submitted in the next few days, definitely next week if not this week
NP:
Some of these pts were on MONO cancer therapy
SK:
Some pts can’t tolerate chemo
One bladder cancer pt is an example
Slide
Slide
100% better outcome across 24 symptoms
CR:
Protocol complete
Building EDC with new CRO
Used everything learned from biomarkers and previous studies
500pt wait list
1:1:1 ratio
NP:
2 of 3 pts will get LL
SK:
Market size is overwhelming
Same info as always
Slide
Will start LH trial next week (CD18)
Slides
Data being put together for 39 and 17 pts
Slide
Don’t think will hit PE at interim for Severe
But do Think they will hit PE at interim for Critical
If there is a wave, then enrollment could happen very quickly
Slide
CR:
Already designing the 2b for biopsy
Can get ready end of this Q or next Q
Biomarker lab has been very handy
Thinks they have a solution for the NASH problem pts have
SK:
Immunized mice
3fold reduction in NAFLD
Once a week
Don’t expect drug-to-drug interaction
Addresses the formation of scarring via stellite cells
Slide
Next year run, will be for auditing the site for BLA
Previously were using AGC
Slide
Slide
SK:
200M shares put us in a position of strength
Comp is done by 3rd-independent party
Looking for pharma partners
Slide
6-7pts with mTNBC with Brain M.
Negotiate new cancer trial in BZ
Slide
Q&A:
Q: BLA resubmission status?
A:
Rolling review
Have to hear back from FDA
As soon as hear from FDA can submit per rolling review
NR:
Once we submit sections, they will start reviewing
Won’t get PDUFA date until after last section is submitted and accepted
NP:
NR was responsible for CMC
SK:
CMC & non-clinical are very impt for all other indications
CR:
Filed draft Dose J. with FDA
Asked for guidelines
Based on that correspondence, now in position to submit actual BLA
Q: Amarex is no longer
A:
Will have Symbio and other CRO companies they are talking to
Also hiring
NR is hiring top professionals from BP
NR:
Need own, internal team to work with CROs and help manage them
He built his own team for CMC and that why they have been successful
Just hired BioStatistician yesterday
Will be sending RFPs to multiple CROs
Select based on strengths in various indications
BioAnalytical will be joining in the next few weeks
Process of hiring clinical regulatory person and clinical project management
NP:
Will be overseeing everything the CROs do and make sure no issues going forward
Q: GvHD?
A:
Had humanized mice study
A couple of other products got approved, so couldn’t get BTD anymore
Small market
It is on hold and will not start GvHD at this time
Q: Filed patent app in BZ?
A:
In 57 countries
Over 80patents
Q: LH is mediated by fractiline pathway?
A:
SK: No
CR: Our biomarker lab is picking up some different things affecting these pts
Q: Likelihood to get EUA in 2022?
A:
Critical, think can hit PE at interim
Absolutely, could get approval in the next 6 months
NR:
mTNBC can see similar pathway to previously approved drug via BTD
Will take FDA about 60days to review BTD
Good chance will get BTD
FDA granted previous company accelerated pathway
Approved based on one single arm trial
Then completed P3 trial
Then got full approval
Think good chance to pursue same regulatory pathway
LL did substantially better than previously approved drug
Very optimistic
Side Effects from previously approved drug and has black box warning
Q: mTNBC is in combo with CHEMO how to know relative LL contribution?
A:
Historical data has over 12k pts that is used as comparative baseline
Q: HIV MONO possible with once per month injection?
A:
NP – I don’t think so
SK – could make a longer acting version of LL. This would be longer term, not short term
Would need to start P1 again if change the molecule
Could be once every 3 months after modification
Q: Why 225 pts for LH?
A:
CR:
Based on previous LH study and EP selecting for trial, it is calculated out
Interim at 90pts
NP: could potentially hit PE at interim based on previous study results
Q: Research collaboration?
A:
SK: In contact with multiple different academic institutions
Contacted by academic inst to do AI studies on MOA
Q: Samsung vials?
A:
NR:
6 years of commercial production and then can extend
There is a minimum number of batches per year
Already fulfilled for the first two years
Have mfg schedule for 2022 and 2023 and they are binding forecasts
Some of raw materials it takes 6-9months to fulfill
Samsung is expanding by more than 60%
Very good relationship with Samsung
Don’t foresee issue with mfg going forward
NP
Use 30-50M shares to ensure we have product
Q: No mention of Samsung in latest 10Q
A: Still using Samsung
Q: How come new hire hasn’t been introduced to investors?
A:
Dr. Sinew (?sp?)
Just the exec team comes to these meetings
He is working on CMC of BLA
Q: Merck COVID pill to receive EUA in PH after it receives EUA in US?
A:
Critical population could receive EUA after interim in BZ
Q: HIV partner with BP?
A:
HIV BLA has always been #1 priority
MONO 700mg created significant delays
1.5 years required for increasing dose
Q: LH CRO
A: Symbio
Q: LH regulatory pathway?
A:
Will be a P2
Will discuss with FDA to see if BTD or P3 required
Q: Tropism
A:
90% or more are R5
FDA required tropism
RO trying to add this data
Q: Comp in NASH space?
A:
SK – spoke very fast and hard to take notes on this one
Q: MD Anderson collaboration?
A:
SK – can’t talk about the specifics
Partnerships are continuing, unique things happening and will announce when appropriate
Q: Acq proposals rejected by CYDY?
A: Can’t talk about anything
Q: CD10 and CD12 manuscripts submitted?
A:
SK: Completed manuscripts
Multiple other manus as well
LH was submitted
CD02 is next one they are focused on
CD10 will not focus on that one
CD12 is a priority
Q: CR why choose to work for CYDY?
A:
CR – was very sick and got LL and felt so much better
In on Friday and discharged on Sun
Wants to provide this drug to others
NP:
CR invested in CYDY also right away
Q: Lab used for ROT that was not validated?
A:
Dr. BP, was not validated
Assay used previously was not validated
He never gave the validation to CYDY
Q: Lots of molecules for NASH, can compete?
A: Yes
Q: What obstacles importing data from BZ?
Q: 200M = 25% of AS?
A:
200M is 20% of 1B
[But it is 25% of the currently AS of 800M]
Have to have shares to raise funds
Summary
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