My notes:
Majority of shares present at meeting
Quorm met
BOD
1) Scott Kelley
a. Joined BOD 2018
2) Nader
a. CEO since 2012
b. BOD since 2012
3) Michael Klump
a. BOD 2018
4) Jordan N
a. Semi-conductor industries
5) Dr. Welch
a. BOD 2019
b. Strategy adviser
Preliminary voting results
1) All directors re-elected 78+%
2) Accountant over 97+%
3) Exec comp approved by 58+%
4) Frequency of advisory vote, 1yr 84+%
Brief overview of business by NP
Close to 200 people on the call
David Callahan and Jordan N. – were the ones who supported NP to buy PRO-140.
830 pts on product
8/28 meeting with FDA
The mono trial and pts was why FDA granted P2 in cancer b/c they were sure there were no safety issues b/c there were no other products in their bodies
FDA Letter
Feb 28th
In their minutes
FDA stated:
Adamantly want to get approval for you for COMBO and MONO
Want Adquate data for dose selection
24 weeks of safety from 50 new participants at 700mg dose
NP: By the end of Oct, will have what FDA asked for
Mfg issues: Solved mfg issues.
Need stability for 6 months
FDA agreed to 3 months. By end of November, will be able to report to FDA.
If they get BTD from FDA, then they don’t have to wait the 3 months for stability data.
****
Signed NBA, “very solid agreement”
$90M in payments
$50M of which for launching product
50% of royalty from sales
TaiMed got 52%
Have 6 more weeks
This is US only
Also talking about licensing for 8 major markets
Deep talks re: non-HIV
Those people are in their data room right now
They said they will be giving an offer
NP: Thinking about uplisting by end of year (if SP supports it)
Have secured future funding (should be closed by end of next week) to get through the end of the year
****
1st mTNBC – for protocol, was injected last night
*****
GvHD – 1st patient expected to be injected this month
*****
Prognostic Test
8/28, sent e-mail questions to FDA. Waiting from FDA
In talks with major players for this test.
*****
Occupancy RT
“CCR5 is like the quarterback of the immune system”
IDX has already ordered 1st lot of product from CYDY
PRO-140 preserves the immune system
In cancer, CCR5 has been along for a long time
CCR5 on immune cells that control the tumor
After 3-6 months, current drugs stop working
T-reg cells are what stop the drugs from working
But PRO-140 blocks those cells from stopping the drugs
Also reprograms a cell called macrophage (like PacMan), they gobble up tumor cells. But when they are blocked, they can’t eat the tumor cell, but CCR5 prevents them being blocked by another immune system error
*****
Q&A:
Hoping for cancer data within 2-3 months
Q: Plan for uplisting?
A: Blamed Tony C.’s approach for depressed stock price while he was leader
They are going to shut-down the fundraising. One more, in the next week or so.
Who is selling, the people who are churning to buy into the next round
50-60 people are working on BLA
If the stock gets above $2, then they will uplist.
Q: Revenue in August? When do you project significant revenue to begin?
A: MONO trial will result in revenue. Got 1st revenue from IDX.
Planning on real revenue, 2nd QTR 2020, but might miss for a month or two.
