What Can Be Expected to Follow Murine Studies?

Greetings Friends,

Don't have much today, but this is what I've been thinking about.

Let's revisit the 15 elements of the plan:

More recently, that is in the past 6 months, CytoDyn has been working on the plan, on how best to exit out from the depths of the hole that the hold sunk the company into. The 15 points discussed in "Dad, Are We There Yet?" represents the output which constitutes their plan. They can be summarized here:

1. Resolution of the Samsung Debt (now to be paid back only when CytoDyn receives income)
2. Sidley Austin and CytoDyn focus on Litigation in Amarex yet remain open to settlement offers. Completed with realization of $18.5 million and $14 million erased debt off company's balance sheet. "Importantly, the settlement ends the potential distraction and uncertainty associated with protracted litigation"... "The terms of the settlement provide an immediate influx of non-dilutive cash and eliminates $14 million of accounts payable."
3. CytoDyn's IP is safe & sound. Updates & developments are made routinely. (Livimmune trademark should be realized within a few weeks.)
4. Prospective Trial #1: A phase II study of leronlimab in patients, with relapsed refractory, MicroSatelliteStable, Colorectal cancer. Basically, third line colon cancer.
5. Prospective Trial #2: A phase II study exploring leronlimab's effect on Inflammation.
   1. For #4 and #5: "... The settlement allows the Company to immediately advance its clinical trials and research and development initiatives*, said Dr. Jacob Lalezari, CEO.*"
6. American Foundation for AIDS research to partner and co-sponsor a study called LATCH, led by investigators at Oregon Health Sciences University and the University of Washington. LATCH stands for Leronlimab and Allogeneic stem cell Transplant to Cure HIV. The proposed study evaluates the use of leronlimab to facilitate an HIV Cure in the HIV positive subjects, undergoing stem cell transplantation. 
7. CytoDyn is collaborating on an exploratory investigator-initiated pilot study of leronlimab in patients with Alzheimer's disease.
8. We have contracted with a lab to perform a pre-clinical mouse study, evaluating both 350 and 700, milligram dose levels alone, and in combination with Resmetirom, a drug recently approved by the FDA for the treatment of MASH.
9. CytoDyn is working with a local generative AI company to design and create not only a longer lasting leronlimab, but possibly a more potent molecule that can be used in pre-exposure prophylaxis or PREP. 
10. The clinical endpoint data from the CD15 Long COVID trial was recently published in the Journal of Infection. That study enrolled. 56 patients, with Long COVID who were treated for eight weeks with either leronlimab or Placebo and the study results showed clinical improvement in 19 of the 24 endpoints that were evaluated. That data is now posted on our website and has been brought to the attention of colleagues at the RECOVER program at NIH, overseeing studies in long COVID.
11. Two manuscripts from our studies of patients with triple negative breast cancer has been submitted for publication and currently undergoing peer-review.
12. A manuscript from our study of HIV positive patients with multi-drug resistant virus has been submitted for publication and currently undergoing peer-review.
13. A manuscript from our study of patients with mild to moderate COVID-19 that has been submitted for publication and is currently undergoing peer review.
14. In addition, a manuscript detailing results from both our pre-clinical and clinical studies of leronlimab in MASH is undergoing final internal review and will be submitted shortly.
15. Lastly, after some unavoidable delays, the pre-clinical study of leronlimab and a mouse model of GlioBlastoma at my father's lab at Einstein Montefiore Medical Center in New York, is now underway and we look forward to reviewing those results by the end of the year.

What are the possibilities now?

I have described in The Outline of This Platform Molecule, the multi-modal capacities of leronlimab. Also, within this same document, I describe a few of the reasons why leronlimab was chosen to be tested in these Murine Studies in combination with resmetirom from Madrigal.

Results of the murine studies should be out by mid-Fall / early Winter of 2024.

"VANCOUVER, Washington, June 27, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that its preclinical MASH study with SMC Laboratories, Inc. (“SMC”) has commenced, with results expected in the fall of 2024*."*

What are some likely outcomes? Because of the known history of this molecule, we already know what to expect for results and my expectations are high on all the fronts.

When Madrigal realizes that the results completely benefit them when resmetirom is combined with leronlimab, what do I expect? An announcement of a collaboration agreement.

Madrigal is sitting on $1.1 billion in cash. They raised it all in the past year. Madrigal is a one-trick pony: resmetirom for MASH. To have access to the plethora of indications which leronlimab offers, Madrigal must either buy out CytoDyn or partner for every indication desired.

$1.1 billion can't buy CytoDyn, but it certainly can partner in a few indications if it wanted to go that route to gain access to other indications in the MASH space like HIV with MASH.

However, looking again at the buyout alternative, Madrigal's market cap is $6 billion. For many CytoDyn shareholders, a stock deal might be acceptable. If following the results of the murine studies, Madrigal and its shareholders are convinced, management there may approach Mitch Cohen and find a way to work out a deal with CytoDyn.

Given what CytoDyn already accepted as a settlement in Amarex arbitration and given Dr. Lalezari's desire to get leronlimab in the hands that could get the drug approved, if a buy-out of CytoDyn by Madrigal could be worked out for $5 billion with $1 billion in cash and $4 billion in Madrigal stock, I think many CytoDyn shareholders would accept it. I for one certainly would prefer Madrigal management. I don't know how many Madrigal shareholders would accept such a deal though. I believe this kind of deal would have to dilute the Madrigal shareholders considerably in order to generate the necessary number of new Madrigal shares to be authorized to give to CytoDyn shareholders. Consider it this way, for every share you own in CytoDyn, you would receive $1 cash, but also receive 4 times that total dollar amount in Madrigal Stock value.

The whole thing might be pie in the sky thinking, but the advantages afforded to Madrigal shareholders of accepting such a deal would allow Madrigal to own a Platform Drug and to do anything/everything CytoDyn was doing with regards to all the trials that are yet unfinished, they could finish them all and have access to all of these new indications. Dr. Lalezari would be assured the drug is in the right hands to get the drug approved. After all, Madrigal was successful in getting their one-trick pony authorized so they know what they are doing.

So far, CytoDyn is not hiring anybody, so as far as I can tell, management at CytoDyn are not acting as if they are intending on running things once the Murine studies are over. So far, at least to me, it appears as if CytoDyn is expecting some sort of partnership or buyout offer based on expected stellar performance of leronlimab in these Murine studies.