The Light Is Getting Brighter, But We're Still In the Tunnel

Let's try to shed a little light. Let's try to make the painted picture come alive. Let's see if we can figure it out. We're waiting and watching, seeing what is to happen, seeing how it all fits.

In September 2020, CytoDyn had this press release: https://www.globenewswire.com/news-release/2020/09/01/2086694/0/en/Global-Health-Leaders-Join-CytoDyn-s-Scientific-Advisory-Board.html

In it, CytoDyn "announced the formation and initial members of its Scientific Advisory Board today including leading HIV, NASH, Oncology, and Rheumatological clinical experts and researchers.

CytoDyn's Scientific Advisory Board members include Dr. Gero Hütter, German hematologist, best known for the bone marrow transplant resulting in the cure of the first HIV patient; Dr. Hope S. Rugo, Professor, Department of Medicine (Hematology/Oncology) and Director of the Breast Oncology Clinical Trials Education Program at University of California San Francisco; Dr. Richard T. Maziarz, Professor, Medical Director of the Adult Blood and Marrow Stem Cell Transplant and Cellular Therapy Program Knight Cancer Institute at Oregon Health & Science University (OHSU); Dr. Jonah B. Sacha, Professor, VGTI-Vaccine and Gene Therapy Institute at OHSU; Dr. Mazen Noureddin, a hepatologist and Director, Cedars-Sinai Liver Transplant Program in Los Angeles; Dr. Norman B. Gaylis, nationally and internationally recognized specialist in rheumatology and autoimmune diseases; Dr. Eric D. Mininberg, Oncology Specialist, Piedmont Cancer Institute, a member of the MD Anderson Cancer Network; and Dr. Lishomwa Ndhlovu, Assistant Professor, Immunology,  Department of Medicine, Division of Infectious Disease at Weill Cornell Medicine in New York."

---

Now, back at the beginning of the year 2022, everything seemed as if it were on track. We had NASH 350mg and we were soon expecting NASH 700mg. We were sending out our NASH 350mg data to a 1,000 recipients, world wide, to multiple pharmaceuticals and biotechs throughout the world. We were thinking a possible meta-analysis for CD20 in Covid Trial in Brazil. Having moved away from Amarex, with new trial experts added to the team, the HIV BLA was supposedly "on time", to be submitted the 1st quarter 2022; progress was being made in the monotherapy Phase 3 protocol; we were thinking possible BTD for NASH and Nader was very excited.

These were Nader's last words from a Proactive Interview with Christine Corrado in mid January, 2022:

"But people have to keep in mind also that right now, a partnership for our NASH looks very very solid. We can't wait to have a call with everybody which will be in about 10 days or so hopefully and lay out all the steps on what we are doing on each one of these indications and what are our milestones*.* NASH*, when are we expected to get the* BTD*? file and get the result.* Cancer*, the* same thing*, when we going to update the numbers so we can get that moving and the* BLA HIV and Covid 19*. With that plan for 2022 and all the* milestones laid out*, we will do a* fund raising based upon that and we believe it will be very successful and a very successful 2022. "

However, it all abruptly came to an end when Nader was unbelievably terminated. Everything, crashed in an instant, down to a stand still and CytoDyn went into stealth mode, and into a life support modus operandi.

Shareholders had to wait another 5 months, following Nader's leaving before both NASH 350 and 700mg data were seen.

HIV and Covid 19 clinical trials were put on HOLD in April, 2022 and continue to remain on clinical hold due to the aggregation of safety data.

Since April of 2022, the Amarex Audit of the data being performed by Chris Recknor and the CRO for Pharmaco-Vigilance to satisfy the FDA requirement for the Aggregation of the Safety Data so the Clinical Holds may be lifted and so the BLA for HIV may be submitted.

Cyrus Arman was brought on board as President of CytoDyn 6 months following Nader's departure, slated to become next CEO by December 2022.

---

Regarding these Pressing Problems which CytoDyn faces, the most recent conference call sheds some light:

18:05 Scott Kelly: Thank you Antonio. So, I would like to begin by addressing the partial clinical hold on our HIV program & clinical hold on our Covid 19 program*. To provide project management timelines for* submitting the necessary materials in September of this year*. Our initial time frame of 8-12 weeks, was dependent on us being provided data from former CRO according to industry standards. In the process of analyzing the data, in conjunction with our pharmacovigilance experts, we realized we needed to convert the data into industry standard format. To be clear,* We have the data. It is really a data conversion issue. Unforeseen data quality and other data related issues remain a risk that could impact the time line. AM, do you want to add some color on this?

18:50 Antonio Migliarese: Thanks Scott. One of the things we want to highlight is that addressing the clinical hold is our number one priority in the organization and this is an all hands on deck effort*. As we mentioned earlier, we have a* strong project team in place*, which is led internally, by our chief top performers, who have* vast industry experience including an internal project manager. This is led by our senior director of clinical operations, Joe Meidling and our vp of project management, Bernie Cunningham*. We've additionally engaged in CRO, clinical research organization that has deep experience in root sources in the areas of pharmacovigilance,* safety data based management analysis*. We also have the regulatory consulting firm that is assisting us with* the preparation and review of the various regulatory communication*, and lastly we have the data to work with an overall regulatory strategy advising group. This group is one of the* most reputable at being regulatory consulting firms led by former FDA regulators*.*

To provide a little more color on our project management, this team has a line by line detailed project plan with paths, timelines and milestones where its various team members are accountable. Our team holds a series of meetings designed to check in, discuss, progress for milestones, roadblocks and risks to the critical paths. These meetings occurs at various intervals throughout the week and the month. This allows us to identify issues as quickly as possible to trouble shoot and identify ways to overcome and impact on overall timeline. Furthermore, this allows us to identify opportunities to bring in additional resources and where if possible to expedite time.

20:33 Scott Kelly: Thanks Antonio. I will address the pausing for Covid19 Brazil trial*. In consideration to potentially un-blind the data. The* trials in Brazil were never put on clinical hold*. CytoDyn's clinical team decided to* pause the Covid 19 trials in Brazil, as the Data Safety Monitoring Board DSMV, had a scheduled predetermined date to evaluate safety within a few weeks. The DSMB evaluated the safety portion only of the trial, not the efficacy, but the recommendation was to continue the trial with ongoing monitoring, and in term analysis according to the trial protocol. We are currently awaiting to hear from ANVISA*. As we* wait for approval to proceed with the trial*, we will continue to analyze the dynamics of the Covid 19 landscape as it unfolds with a particular emphasis on the critical Covid 19 population. In regard to the potential to un-blinding of the data, we have had many people request the potential to un-blind the data early. We are considering all options and are working with our team, including our own statisticians, our Einstein clinical team in in Brazil, Einstein statisticians as well as our partner BIOMME.*

The updates on our clinical programs regarding HIV BLA*, there has been some concerns that we are abandoning the BLA for HIV and to be clear,* we are not abandoning the HIV BLA*.* We are currently working to achieve the deliverables required by the FDA to lift the clinical hold. We have requested a type c meeting with the FDA to gain further guidance with respect to completion of the BLA. Once we achieve the lift on clinical hold and receive further clarities from our type c meeting request from the FDA*, we will be in better position to provide an updated timeline analysis.*

---

Putting it together, re-assembling, I'm thinking that by now, it is possible, even likely, that Dr. Recknor along with the CRO for Pharmaco-Vigilance and the Group of former Regulatory FDA Regulators, have completed the Aggregated Safety Data Audit and that it could be presented in the delayed 10-K, or, if not, then in another communication shortly forthcoming. I believe it will be completed soon and discussed shortly or possibly in the Special Shareholders Meeting. It is also possible that the type "C" meeting also has been already executed and / or completed or it is currently scheduled. That is to say, that the lift of the clinical hold / or the resuming of the pause, remains imminent, and that the lift of the clinical hold would permit the submission of the BLA for HIV.

At this point, things are converging and by 9pm, Monday 8/15/22, the 10-K will be released disclosing many pertinent details which will lead into the Special Shareholders Meeting on 10/31/22. The Shareholders reading this have their eyes opened and shall witness first hand implications of the facts discussed in the coming10-K.

Seems to me, the cycle CytoDyn was in at the time Nader uttered the words above, abruptly was "paused" at the time Nader was let go, (in the same way the Covid 19 trials were "Paused"), but now, 7 months later, with Cyrus Arman on board, that same cycle will soon be resumed and many of Nader's prognostications for 2022 may still be realized following the coming 10-K and coming Special Shareholder's meeting on 8/31/22.

I'll repeat them Nader's words here: "But people have to keep in mind also that right now, a partnership for our NASH looks very very solid. We can't wait to have a call with everybody which will be in about 10 days or so hopefully and lay out all the steps on what we are doing on each one of these indications and what are our milestones*.* NASH*, when are we expected to get the* BTD*? file and get the result.* Cancer*, the* same thing*, when we going to update the numbers so we can get that moving and the* BLA HIV and Covid 19*. With that plan for 2022 and all the* milestones laid out*, we will do a* fund raising based upon that and we believe it will be very successful and a very successful 2022. "

---

This seems to be happening, even as confirmed by what is happening in the share price. I wouldn't underestimate the power of the shorts, but, recently, shareholders have been appreciating that the shorts have been losing their fire power. Their power is being quenched to some degree. They no longer appear to have the unlimited quantities of short shares available to them as they once seemed to have. They now are forced to pay tremendous sums of interest, (in the order of 50 - 130% annually), to borrow the shares to sell short to drive the share price down. Could Fintel have intervened? Because of their reduced capacity to dramatically affect the share price, this has resulted in the recent rise in share price. Because the rise in share price has been rather dramatic, many traders, who are not confident in CytoDyn, who had appreciated significant returns, they decided to take some gains. Therefore, these unstable traders, sold off and helped to knock the share price down a bit, off it's recent highs from $1.25 to the current $0.83. This drop off from the highs is mostly due to the unsteady hands of these traders selling off and less due to the short sellers who have limited numbers of shares to short, who also pay tremendously high interest on the shares they borrow to sell short, however, the short sellers did still contribute to the recent drop off from share price highs, but to a lesser degree than the unsteady hands of traders.

---

No doubt, all of this is quite confusing. But, I'll try to keep us informed and up to speed. The final destiny remains in the shadows, it remains hidden, it remains aloof. But, that destiny has a revelation date. A possible requirement for the revelation of the NDAs could be the lifting of the clinical hold. Another could be the acceptance of the Aggregated Safety Data by the FDA. A third could be the submission of the BLA for HIV. When the NDAs are revealed, CytoDyn share price stabilizes and levels out; it plateaus at the partnership proposed valuations. There could be two or three proposed partnerships with certain valuations each. Revelation of the NDA, stabilizes CYDY share price at higher ground.

This was Scott Kelly's closing statement in the last Conference Call:

48:15 Scott Kelly: I want to thank you all for your time this afternoon. We believe we've made significant progress on many fronts. Including search for CEO/President. Progress of Leronlimab. A lot of people asking questions regarding pursuing multiple opportunities for Leronlimab. I want people to understand our thinking behind this. I'll use 2 examples. If you look at Humira, it stands for human monoclonal antibody in rheumatoid arthritis. It is one of the best selling drugs of all time. What Abby did which was so brilliant*, was they took the target, TNF, tumor necrosis factor, and* that target is important across multiple indications*.* They have 14 global and 10 US approved indications, and we are trying to do exactly the same thing*. It is a very cost effective way to do drug development. Our target is the CCR5 receptor. If one looks at the literature, you will find that it has been implicated in many different indications, including HIV, NASH and oncology.* So we will be actively pursuing partnerships to realize the true potential of Leronlimab in these indications. Thank you again for your time.

​

I think we need to start taking Scott Kelly literally. He means what he said. Leronlimab will be the next Humira. There is no doubt that this will occur. There is no doubt that CytoDyn will partner. There is no doubt that Leronlimab will be developed for the purpose of that partnership. There is no doubt Leronlimab will be approved for that partnership and that it will help those patients for that indication. There is no doubt Leronlimab will be further developed on other indications and that other partnerships will be created with CytoDyn for Leronlimab to pursue those indications. There is no doubt that CytoDyn will combat opposition on all fronts as it progresses in its endeavors in each indication. CytoDyn won't give up. They will do what they are destined to do which is to progress Leronlimab. They have no way out. CytoDyn will be opposed. There is no way out of this, because as long as they advance Leronlimab, Leronlimab will advance CytoDyn, and if Leronlimab advances, opposition will be stirred up will rise. It is not a matter of "IF", but rather a matter of "WHEN". and like I said earlier, what Nader alluded to at the beginning of the year, "in the next 10 days", may be happening in the next 10 days from today or from the day of the Special Shareholder's Meeting. It was imminent then, it is imminent today. It can happen, it can happen any time. Scott was speaking to point the shareholders in a direction of thought. The 10-K tomorrow, is just a necessary part of being public. We are pre-revenue. But what else will be in there? Just because CytoDyn has debt doesn't mean CytoDyn cannot partner. I'll keep bringing you my line of sight.

Remain diligent. Stick with it. We will figure this out.