2021-09-15 Emerging Growth Conference Presentation
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Posted On: 09/15/2021 4:34:26 PM
2021-09-15 Emerging Growth Conference Presentation
Rough notes
7years on MONO
No other product has done that
COVID
Person who “really needs to get credit”
Dr. SH
Read papers that SK provided to him
CR single handled started LH trial
SK: re CURE
London pt, Berlin pt
Devoid of CCR5
Working with AMFAR on this project
BTD application was immediately prepared by us
Separating from CRO (AMAREX)
Not getting sequence from CRO
Need to get it from another CRO
SK:
MOA
In order grow beyond 2mm, need it own blood supply
Need 100 to 150 pts to hit p-value of 0.05
SK:
23-69M pts without treatment options
50% of young people with COVID are experiencing LH
Could turn into over 100M people who don’t have treatment options
PH – looking for 3rd PO soon; 2nd PO product has already been used
CD16 – expect 1st pt any day
Will be getting weekly updates on pt enrollment and will update shareholders
SK:
Same stats re NAFLD and NASH
Anthony C.’s leadership, with NP as CEO
Stopped cancer study
Stopped gVHD
Just wanted to focus on COMBO
Hospitals were not paid
Leadership was given back to SK and NP
Don’t think could find any company that has achieved amount raised and dilution in 2020.
SK:
Testimonials
1st
S4 prostate cancer
Miracle cancer drug has arrived
Beyond chemo or radiation
6-1yr to live by 3 different hospitals
Sept 1st, once per week
October, pancreas, liver, lungs
… now end of July (report) one in Feb, on in May
No new growth and no new movement
Study is ending end of month
Live in RTT state
He can inject himself
No side effects
Still on LL today
2nd
S4 Bladder cancer
Not able to take chemo
Used RTT in OH
37 injections
No metastasis
Not live past Dec 2020
Doing well
Works 60+hrs per week
No other treatment other than LL
Will get visual of bladder wall soon
No new metastasis
Q&A:
Q: Academic collaboration?
A: Signed agreement with major academic institution
Waiting for approval for PR
Checkpoint inhibitor
Q: Critical trial in BZ?
A:
ANVISA has given approval based on stability in IV bag
Did study and sent results to ANVISA
Should get cleared asap
Should get 1st pt injected soon
Q: DOJ investigation
A:
RE: DOJ – not supposed to put in filing
It is a fact finding procedure
No new updates
SEC
Have been looking into it for the last year or so
Nothing to report
Q: PH FDA to release data
A:
Can’t disclose confidential details
Q: BLA OCT 15th
A:
Wait, want to talk to FDA
What dates they will submit each package
Q: EUA in BZ impact on FDA
A:
BIOMM pharma
700k vials to BIOMM
If EUA in BZ, then those 700k vials go to BZ and not USA
AE feels very strong on hitting PE at interim analysis
US FDA was excited about our CD12 results
SK: Excited about trials in BZ
Concerned about variants
LL should not be affected by variants; not spike protein dependent
Q: Rev potential in BZ
A: very, very high
Q: Funding until end of year? Burn rate?
A:
Can’t incorporate revenue from BZ into plans b/c don’t have it
Payment is due 90-days after shipment to PH
Hoping shareholders have comfort in how CYDY raised $400M
They are very proud of the fundraising
Now we are in good share
Thinks leadership can raise any amount they want
Q: Preclinical data support use in cirrhosis?
A:
SK – not studied yet
Really rich literature re: cirrhosis
NP –
$420M shareholder money raised
$400M value of inventory today
SK:
In Miami last night meeting with dr. re: rheumatoid arthritis
Q: HIV market size
A:
3 class resistance market is very small
Negotiated with FDA with e.g. Paul Maddon
2 class resistance with limited treatment options
Market is about $1B for COMBO
$6-7B for MONO
Now with right CRO in BZ
And PREP is on top of that
Q: Pt in GvHD? CURE trial?
A:
Leadership change
GvHD was doing wrong population
Corrected it, but now so much more on their plate
Something got approved for GvHD
CRO didn’t have capacity to move as fast as they wanted
So, put on hold
SK:
Originally, myol
Reduced intensity population
COVID pt who had organ transplant was doing poorly before LL then good on LL and then bad after going off LL
Q: LH
A:
Working on PE with FDA and CR
Hoping to get to P2 and adaptive to P3
Working with FDA
If approval comes Q1, 2022, then not enough vials to
Need to pay SAMSUNG now to get product next year
BP puts $350M down payment to Samsung
SK:
LH opens up the adjacent markets
Q: Milestones in the near future?
A:
SK is working with BP
PH
BZ
22 cancer
mTNBC BTD
LH next trial
NASH trial results hopefully in Oct
SK:
Need data to talk to BP
Now have oncology data to show BP
Ultimately CYDY will be a cancer company
Ideally wouldn’t sell the company and would continue building
Q: Share buyback plan
A: No
Working to get drug developed
Q: Plans to partner with BP?
A:
SK – a lot of ways to structure a deal
On multiple fronts now
Q: Will CYDY need partner to fund LH or other trials?
A: Let BP come to CYDY
CYDY does not go to BP
Q: EU or RTT in CA?
A: Pause on EIND and RTT and open clinical trial
Working with agencies on other ways to get the product
Q: Former CRO withholding data?
A: Could be lawsuits
Will defend the shareholders’ value
Q: Contract on desk w/ academic institution?
A: Already signed
Q: Milestone based comp for exec team?
A: Very awkward answer
They now have an independent compensation consultant and compensation committee
Q: Funding trials?
A: Raise funds, pay cash
Q: Capital requirements for 12-24 months?
A: Planning on getting EUA
Will result in $400M in revenue
1B shares to get $200M in funds if have to raise again
Q: Staffing
A: Will bring top leaders in the field
If they do well, then they stay; if not, they will go
Praised Nitya Rae again
Q: Patents on indications presented today
A:
SK – extensive patent portfolio
Q: Price per vial?
A: Don’t disclose
Q: Teaming with CASSAVA for AZ trial?
A:
SK: No, but doing work with INt’l group out of London
Done animal studies for ROT in brain
Very eager to pursue
Q: BTD what issue prevented sending
A:
Own the sequences for each indication, but CRO kept it from them
They will go to court if they have to
Asking FDA to give the sequences from website the FDA has
Takes 3-4 weeks to get from FDA
Q: EAP
A: No longer available
The US and Int’l requests are overwhelming
Couldn’t process all the people asking for the drug
Q: How will fill orders if EUA is given?
A: Have a process
Q: OLE status update?
A: Still have OLE in HIV
But closing it b/c moving away from old CRO
Still haven’t chosen new CRO
Q: Length of time remaining on critical patents?
A: FDA => 12 year exclusivity
Q: Meeting date with PH group?
A:
PH group requested the meeting and it will happen tomorrow night.
Rough notes
7years on MONO
No other product has done that
COVID
Person who “really needs to get credit”
Dr. SH
Read papers that SK provided to him
CR single handled started LH trial
SK: re CURE
London pt, Berlin pt
Devoid of CCR5
Working with AMFAR on this project
BTD application was immediately prepared by us
Separating from CRO (AMAREX)
Not getting sequence from CRO
Need to get it from another CRO
SK:
MOA
In order grow beyond 2mm, need it own blood supply
Need 100 to 150 pts to hit p-value of 0.05
SK:
23-69M pts without treatment options
50% of young people with COVID are experiencing LH
Could turn into over 100M people who don’t have treatment options
PH – looking for 3rd PO soon; 2nd PO product has already been used
CD16 – expect 1st pt any day
Will be getting weekly updates on pt enrollment and will update shareholders
SK:
Same stats re NAFLD and NASH
Anthony C.’s leadership, with NP as CEO
Stopped cancer study
Stopped gVHD
Just wanted to focus on COMBO
Hospitals were not paid
Leadership was given back to SK and NP
Don’t think could find any company that has achieved amount raised and dilution in 2020.
SK:
Testimonials
1st
S4 prostate cancer
Miracle cancer drug has arrived
Beyond chemo or radiation
6-1yr to live by 3 different hospitals
Sept 1st, once per week
October, pancreas, liver, lungs
… now end of July (report) one in Feb, on in May
No new growth and no new movement
Study is ending end of month
Live in RTT state
He can inject himself
No side effects
Still on LL today
2nd
S4 Bladder cancer
Not able to take chemo
Used RTT in OH
37 injections
No metastasis
Not live past Dec 2020
Doing well
Works 60+hrs per week
No other treatment other than LL
Will get visual of bladder wall soon
No new metastasis
Q&A:
Q: Academic collaboration?
A: Signed agreement with major academic institution
Waiting for approval for PR
Checkpoint inhibitor
Q: Critical trial in BZ?
A:
ANVISA has given approval based on stability in IV bag
Did study and sent results to ANVISA
Should get cleared asap
Should get 1st pt injected soon
Q: DOJ investigation
A:
RE: DOJ – not supposed to put in filing
It is a fact finding procedure
No new updates
SEC
Have been looking into it for the last year or so
Nothing to report
Q: PH FDA to release data
A:
Can’t disclose confidential details
Q: BLA OCT 15th
A:
Wait, want to talk to FDA
What dates they will submit each package
Q: EUA in BZ impact on FDA
A:
BIOMM pharma
700k vials to BIOMM
If EUA in BZ, then those 700k vials go to BZ and not USA
AE feels very strong on hitting PE at interim analysis
US FDA was excited about our CD12 results
SK: Excited about trials in BZ
Concerned about variants
LL should not be affected by variants; not spike protein dependent
Q: Rev potential in BZ
A: very, very high
Q: Funding until end of year? Burn rate?
A:
Can’t incorporate revenue from BZ into plans b/c don’t have it
Payment is due 90-days after shipment to PH
Hoping shareholders have comfort in how CYDY raised $400M
They are very proud of the fundraising
Now we are in good share
Thinks leadership can raise any amount they want
Q: Preclinical data support use in cirrhosis?
A:
SK – not studied yet
Really rich literature re: cirrhosis
NP –
$420M shareholder money raised
$400M value of inventory today
SK:
In Miami last night meeting with dr. re: rheumatoid arthritis
Q: HIV market size
A:
3 class resistance market is very small
Negotiated with FDA with e.g. Paul Maddon
2 class resistance with limited treatment options
Market is about $1B for COMBO
$6-7B for MONO
Now with right CRO in BZ
And PREP is on top of that
Q: Pt in GvHD? CURE trial?
A:
Leadership change
GvHD was doing wrong population
Corrected it, but now so much more on their plate
Something got approved for GvHD
CRO didn’t have capacity to move as fast as they wanted
So, put on hold
SK:
Originally, myol
Reduced intensity population
COVID pt who had organ transplant was doing poorly before LL then good on LL and then bad after going off LL
Q: LH
A:
Working on PE with FDA and CR
Hoping to get to P2 and adaptive to P3
Working with FDA
If approval comes Q1, 2022, then not enough vials to
Need to pay SAMSUNG now to get product next year
BP puts $350M down payment to Samsung
SK:
LH opens up the adjacent markets
Q: Milestones in the near future?
A:
SK is working with BP
PH
BZ
22 cancer
mTNBC BTD
LH next trial
NASH trial results hopefully in Oct
SK:
Need data to talk to BP
Now have oncology data to show BP
Ultimately CYDY will be a cancer company
Ideally wouldn’t sell the company and would continue building
Q: Share buyback plan
A: No
Working to get drug developed
Q: Plans to partner with BP?
A:
SK – a lot of ways to structure a deal
On multiple fronts now
Q: Will CYDY need partner to fund LH or other trials?
A: Let BP come to CYDY
CYDY does not go to BP
Q: EU or RTT in CA?
A: Pause on EIND and RTT and open clinical trial
Working with agencies on other ways to get the product
Q: Former CRO withholding data?
A: Could be lawsuits
Will defend the shareholders’ value
Q: Contract on desk w/ academic institution?
A: Already signed
Q: Milestone based comp for exec team?
A: Very awkward answer
They now have an independent compensation consultant and compensation committee
Q: Funding trials?
A: Raise funds, pay cash
Q: Capital requirements for 12-24 months?
A: Planning on getting EUA
Will result in $400M in revenue
1B shares to get $200M in funds if have to raise again
Q: Staffing
A: Will bring top leaders in the field
If they do well, then they stay; if not, they will go
Praised Nitya Rae again
Q: Patents on indications presented today
A:
SK – extensive patent portfolio
Q: Price per vial?
A: Don’t disclose
Q: Teaming with CASSAVA for AZ trial?
A:
SK: No, but doing work with INt’l group out of London
Done animal studies for ROT in brain
Very eager to pursue
Q: BTD what issue prevented sending
A:
Own the sequences for each indication, but CRO kept it from them
They will go to court if they have to
Asking FDA to give the sequences from website the FDA has
Takes 3-4 weeks to get from FDA
Q: EAP
A: No longer available
The US and Int’l requests are overwhelming
Couldn’t process all the people asking for the drug
Q: How will fill orders if EUA is given?
A: Have a process
Q: OLE status update?
A: Still have OLE in HIV
But closing it b/c moving away from old CRO
Still haven’t chosen new CRO
Q: Length of time remaining on critical patents?
A: FDA => 12 year exclusivity
Q: Meeting date with PH group?
A:
PH group requested the meeting and it will happen tomorrow night.
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