New Additions To The Leadership Team

Are we in a Time of a Lull? Could this be the Quiet Before The Storm? Kind of. We can look at it this way.

Don't underestimate the sheer magnitude of what is going on here. In fact, a lot is happening.

Cyrus always had shareholders informed of his intentions. In the 12/29/22 Webcast, he spelled it out for us: " 9:25: We expect next year, 2023 to be catalyst driven in terms of growth and development for the company and we think that the table is set for a large number of significant developments to occur in early '23, including the submission of our complete response to the partial clinical hold for HIV, new additions to the leadership team*, a corporate rebranding, and then following those events, we plan on initiating a NASH trial as well as continuing the advancement of the long acting CCR 5 molecule.*"

In the Pharma Almanac article, Cyrus said, "CA: Steps have been taken to revitalize the leadership of the company*. The board has been made fully independent, with board members separate from the company and its day-to-day operations. The organization has also been* right-sized, with certain unnecessary leadership positioned eliminated. A couple of new people with specific expertise will be hired to backfill those roles."

The previously confidential information of who in fact would eventually replace Scott Kelly CMO was made public in this Press Release

yesterday when Melissa Palmer, MD was introduced as interim Chief Medical Officer. In addition, Dr. Salah Kivlighn joins CytoDyn as clinical and strategic advisor. Tanya Urbach Board Chair commented, "Dr. Palmer and Dr. Kivlighn each bring significant experience not only in the oncology and NASH spaces but also in leadership roles with clinical and drug development companies*. I believe these two individuals, coupled with* Antonio’s strong management abilities*, will allow us to not miss a beat during Cyrus’s absence.* "

Certainly, if CytoDyn was not mandated to release that Press Release, they would not have, because, that PR was slated for after the hold was lifted. But because Cyrus required a leave, it needed to be made within a few days, yet the hold was not lifted.
Therefore, they made the announcement and it is two fold. I see it as a warning to shorts, a threat to BP. Is this not a full declaration that CytoDyn is 100% confident in their submittal to the final deciding authority that the hold shall be removed? It is a full declaration that CytoDyn yet remains alive and is assuredly rising back up to life.

CytoDyn was previously withholding the news of these new hires to originally be announced following the lift of the hold. However, with the unfortunate circumstance of Cyrus Arman having need to take a medical leave of absence, it would not have been smart to make that mandatory Press Release by itself. It had to be combined with something positive to balance it off and so the announcements of the hires were included with the announcement of the Leave of absence.

CytoDyn is not ignoring the call to action. No, in fact, they are heeding it. There are a multitude of indications for Leronlimab, but certainly, CytoDyn's priority is in NASH.

Pharma Almanac: "Catching these (NASH) patients at the stage of early fibrosis and halting, attenuating, or potentially reversing it represents a tremendous unmet medical need*. Consequently, much clinical development in the NASH space focuses on halting the progression of early fibrotic development.* CytoDyn conducted a three-armed, placebo-controlled clinical trial that enrolled 75–80 patients, and the results were very encouraging. We were able to show that, with a 350-mg dose, both the level of fat in the liver and fibrosis are reduced*, as measured through surrogate imaging endpoints that are becoming increasingly more accepted by the medical community.* 

The NASH and oncology data sets form the basis of our forward-looking strategy for how CytoDyn will continue to pursue the molecule*. We are also developing a* longer-acting version of leronlimab with our partners at Oregon Health & Science University*. It has been tested in animal models, including rhesus monkeys, and has been shown to remain* active inside the body for up to 180 days*; treated monkeys are highly resistant to HIV infection, even after repeat challenges on a weekly basis for months. These data are really exciting, and there is no reason this* long-acting version cannot also be used for the treatment of solid tumors and NASH."

Dr. Melissa Palmer is a Hepatologist with vast experience in treating patients with Liver disease. Dr. Salah Kivlighn shall work with Dr. Palmer in getting the NASH trial underway en route for approval. Remember, NASH is the indication which Cyrus choose that CytoDyn would pursue ourselves, without a partner. However, with now our Merck born Dr. Salah Kivlighn making scientific advisements, some modifications to the original plan might even be planned. Possibly a partnership in NASH could or is in consideration may be in the planning stages.

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From 12/7/22 R&D Update Slide 23

NASH is a massive market and really, there is no definitive treatment for the disease. Merck is aware of the functionality of Leronlimab in NASH and they may very well be interested in helping CytoDyn get Leronlimab trialed properly for NASH. Melissa Palmer, MD, Hepatologist with extensive experience, has seen the NASH trial CytoDyn conducted and she agrees with Dr. Mazen Noureddin. She agrees with him so much so, she came to CytoDyn to become its CMO. Scientific Advisory Board

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"1:32:14: And so we've gone through and knocked out what the potential time lines are across each of the different areas that we presented on today. And as I mentioned before, NASH & Oncology are our priorities. However, because all of this is going to be funding dependent, we're going to focus on NASH initially and WORK WITH CO-DEVELOPMENT PARTNERS TO THE EXTENT THAT WE CAN TO DEVELOP IN ONCOLOGY.**"

This hits home the fact that CytoDyn is strongly in the running and is a contender in the race for NASH. The trial which Dr. Palmer, Dr. Kivlighn and Dr. Noureddin shall set up and run in NASH shall be extensive, well thought out, well run, well documented, well tracked and well documented. It will blow the doors off any other clinical trial in NASH. It won't even require all that many patients to be recruited as we found statistical significance in only 75 patients or so. Certainly, it will be more, but possibly only 150-200 which will definitively & unequivocally prove clinical significance as well as safety. It shall show that no other drug even comes close to the fat and fibrous tissue reduction, thereby making LL the treatment of choice for NASH.

Take this as a warning shorts, you would be wise to exit your short position now. Exit and go long. Take this as a warning BP, don't waste your money in clinical trials for NASH, because you won't become standard of care after CytoDyn's NASH trial is complete. Palmer, Kivlighn and Noureddin shall make the results of the coming NASH trial so robust, that the trial shall be even cut short as a result of overwhelming efficacy.

Pharma Almanac: "CA: We absolutely believe it has value in other indications. The reason why we’re starting in HIV is twofold: first, our academic collaborators are infectious disease specialists; so they can run those trials very readily and very easily. And two, there is a real demand in the HIV space for longer-acting injectables."

Scott Hansen & Jonah Sacha, MD are on top of HIV Prep & CURE and I see Merck wanting in here as well, but that undisclosed 3rd party. From the 4/11/23 Webcast:

"12:56: Additionally, we have also firmly established Dr. Scott Hansen as our Head of Research and Basic Science*. Dr. Hansen is currently an Associate Professor at OHSU. and within this newly formalized role, Dr. Hansen will support our clinical development activities, related to biomarker and assay development for future clinical trials, as well as supporting and leading some of our earlier staged efforts, geared towards* the development of longer acting molecules targeted to CCR5*.*

13:33: As a part of those efforts, we have also recently entered into a joint development agreement with a 3rd party Research and Development Bio-Tech company to develop long acting or more longer acting molecule CCR5 blocking*. So, in addition to potentially leading to a improved or modified therapeutic, that, we believe that has greater acceptance by those patients and physicians and this could help to yield extended intellectual property section that would increase the underlying value of our patent portfolio.*"

In oncology, Keytruda seems to be in the running to partner with (from the picture above), for what may be Colo-Rectal Cancer in the MicroSatellite Stable population as well as Breast Cancer in the HR+ and HER- and metastatic Triple Negative Breast Cancer subgroups. Cyrus threw share holders that bone in the BioSpace Article

MD Anderson study top line results to be announced. So all our bases are covered. "Leronlimab is currently being trialed in combination with Keytruda (pembrolizumab) in a breast cancer xenograft model in partnership with MD Anderson Cancer Center."

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Unfortunately, Cyrus had to go on this leave of absence, but before he left, he made the share holders feel safe. He has successfully backed himself up with a very experienced team of leaders that will take the horse by the reigns and get it over the finish line in record time.

I think CytoDyn's enemies have taken notice of how perfectly executed this temporary transition in power was performed. Certainly, Cyrus sought out these individuals, and he made their hire. He accomplished it.

Let's see what is going to unfold and what will happen next?