SUMMARY OF SHAREHOLDERS MEETING:
CD-10 Phase II M/M Trial:
- Leron reduces SAEs in recipients by 64% (excellent results)
- No adverse effects attributable to Leron in those that received it
- Final results of this trial will take 6 weeks to complete from unblinding
- Results portend CytoDyn EUA in oncology use as well as COVID if Phase II
interim results are as good as expected. Huge!
CD-12 Phase III S/C Trial
- Complete data on 100 of current 153 patients available
- FDA can initiate a “safety review” of trial at any time to determine whether
to stop trial in order to save lives. I.E. Leron working so well, FDA does
not want to kill people given placebo in double blind test needlessly
- They would instead stop trial, give Leron EUA Authority and immediately
administer it to placebo patients
Cancer trials
- 23 different basket trials underway for Cancer.
- Many, including TNBC are showing excellent results in small enrollment
- CytoDyn will approach FDA for approval of several for EUA in September
pending previous approvals
- Trials are under independent analysis with no connection to CytoDyn
BLA for HIV
- CytoDyn has requested “Type A” meeting with FDA to resolve Refuse To File
problems (700mg dosage and inclusion of syringes in packaging)
- the meeting will occur “most likely next week” (Pourhassan speak)
- CytoDyn will report to shareholders the likely timeline of resolution after the
Type A meeting
New Hires to Scientific Advisory Board
- 4 new doctor hires in who are tops in their field regarding most promising
Cancer and HIV ongoing trials
- Hired to marshall/fine tune treatment in trials to maximize
potential for FDA approval of Leron in treatment of their specific disease
- New Hires include expertise in HIV bone marrow, breast cancer, pulmonary
lung transplant, blood cancers and NASH
- Not all have been hired just yet
Additional 100M Share Authorization (to total of 800M)
- Approved by 60+ % of shareholders
- Not yet necessary to use and would be used sparingly when done so
- have only used 15.7M shares this year thus far to fund operations
- 10M shares currently available for unforeseen needs outside of new shares
- $48M already raised this year through warrants (Nadar encouraged more)
to help fund ongoing endeavors
- $50 million more in warrants available at $5/share if they were exercised
NASDAQ UPLISTING
- 5-6 week process (we are completing week 2 on Friday)
- NASDAQ questions about filing ( if any) expected next week
- Week 5 or 6 most likely completion date (week 5 is mid-August)
- Nadar teased CFO Mike Mulholland about possibly completing filing
earlier. Chance it is done in 3-4 weeks
Final note - all timelines for major events are now in August and are not set in stone (good to prevent missed expectations and prevent short plays, imo). Very upbeat meeting, although presentation ranked up there with college frat house movie. Stock will drift along until we get further news and will likely face traditional daily day- trader fluctuations and occasional short attacks. I encourage all shareholders to hold the line as we longs enjoy the successes likely to come our way in August. There will be gut wrenching moments, but at the end of the day, DATA WINS! If you have any influence or skill you can bring to assist your fellow shareholders, now is the time to act. GLTA and anticipate much improved COMM going forward despite the charming and almost innocent nature of communications from CytoDyn to date.....
