Cytodyn Inc (CYDY)

[finesand]

Leronlimab PRO 140 HIV-1 Combo Status
======================================
Done

- Efficacy (and FDA likes it even at higher dosage w/o new trial)
- CMO (IMHO also about to be done, stability data done EOY latest)
- Rolling review, FDA check when delivered
and allows correction (hence stability data completion)

TODO

- Safety (coming up soon Nov'19)
- Stability data until EOY '19
- Certain payments (CMO, ..)
- BLA completion paperwork

Lots of the delays occurred due to the open process (rolling review) with FDA, i.e. safety and stability.
This is usually where other stocks dip hard.
(CLSD got their CRL finally, besides stability one addition data request)

If issues can be cured quickly, market may forgive (CLSD, CYDY, ..)

Commercialization Outlook
=========================

Having one licensing partner signed an NBA. Ratification of final contract expected next week until end of month.
This NBA says partner takes costs for commercialization and gives a good chunk of royalties (50% on net sales).

No further financing needed for commercialization.

https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/

+++

Other parties are interested and received access to the data room.

Financing
==========
Independent of licensing partnership, CYDY needs $10M - $15M to complete the BLA until EOY 2019.
Even in the worst case $15M/$0.20 = 75M shares this won't dent the economics, calculated with 1B shares partnership model or 2B shares going alone.

Risks
======
(as I perceive them, none of them is very likely)

- No $15M financing available all of a sudden (after having raised over $200M??)

- FDA doesn't approve - doesn't likes the data (all of a sudden).

- Interested licensing partner runs away (why?)

- ????

Bottom Line
===========
This is a late stage company by now.

All elements of bringing a compound to market has been already addressed.

The only perceived weakness is
- weak balance sheet
- company and drug not well presented in the market yet
- management style, especially NP's way of talking
- poor funding instruments until licensing partnership
- tired investors listening to NP and waiting and waiting and waiting (o8>

Strength
- Strong acting drug w/o serious side effects
- Proven on HIV-1 Combo
- Lately proven w/ 700mg on HIV-1 Mono, but needs refined pivotal trial
- Drug also works in many other indications, including metastatic cancer
Big potential for a suitor.