Rough notes from call
Special Meeting of Stockholders July 22, 2020 9:30 AM PDT
Preliminary voting results
1) Increase A/S to 800M
a. Approved by over 65%
2) Adjournment
a. Approved by over 67%
++++
NP:
CD10 (M2M)
Unblinded data
Announced yesterday re: data re: safety
Will be announcing efficacy as soon as all end-point analysis is completed
Re: Safety
If both drug and placebo have same SAEs, then you have a safe drug
There were almost 3x SAE’s in placebo vs. LERO arm
64% reduction of SAE when taking LERO vs. placebo
Only drug in world that can claim this
JL says this should be the efficacy in this trial
SK:
IL-6 inhibitors were worse than placebo
64% reduction in SAE’s is remarkable
Also think it bodes well for oncology indication
NP:
Will complete analysis within a few days
Will submit full package to FDA
Could be a few weeks away from approval
CD12
Process of approval could be even easier
FDA has agreed that study could lead to approval
DSMC – will look at 1st 100 pts
This is not an interim analysis; it is just a look at safety
Now have 153pts enrolled
Close to 195, which is the interim analysis milestone
3.1B in last 7mths, 930M shares have been traded this year
+++++
Cancer
Planning to meet with FDA in September for BTD
Believe will have enough data for BTD
For 23 different cancers
6 pts in basket trial
5 pts pending
15 enrolled in tNBC
12 pending
SK:
Safety in COVID will migrate to cancer trial as well
Describes MOA
+++++
HIV BLA submission
GSK, ViiV – spend $400M on injectables
IZ – had PDUFA date, then 6mths delay due to mfg, long list of items to correct
We don’t have issues with mfg
Believe we can resolve clinical issues
Requesting Type A meeting, hopefully next week
Then will update shareholders on new timeline
+++++
Advisory Board
SK:
Gero Kuter, 1st dr to functionally cure HIV, Timothy Brown
Hope Rugo, Prof. UCSF, Breast Cancer dept.
Luish, Cornell, Infectious Diseases, Al
MD Anderson, further indications in oncology
Dr. Sacha
Pulmonary and lung transplant
Dr. in NASH
Will announce the others in the coming weeks.
+++++
Blames former team (of which he was a key member) about past dilution
Have 18M A/S shares
8M are in escrow b/c of lawsuit from former BOD
Plan to use new A/S very carefully
Warrant exercise this year almost $48M
$50M worth of warrants out there, 78M warrant shares out there
+++++
Uplisting
MM:
Nasdaq
5-6 week process
Last week was week 1
Now in week 2
Next week expect to receive comment letter, CYDY will respond quickly
Week 5 is about mid August
Week 6 is third week in August
Filing 10k is due not later than 8/14 – goal is to file early
MM thinks we will get uplisted in 3-4 weeks.
+++++
Q&A
1,300 pts today online
Q: CD12 differences to CD10
A:
CD10 has many different EPs
Unmet medical need (particularly in a pandemic) can mean no need for P3
CD12 is P3 approval
Number of mortalities is PE
Many SAEs in this trial (= many deaths)
DSMC will see safety during safety analysis
Interim analysis will provide efficacy analysis
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