No Questions Left On The Table

For the majority of our trials on HIV, CytoDyn relied on Amarex as CRO. After over 7 years of mishaps and unfortunate turns, the culmination of CytoDyn's work in HIV MDR came down to a crashing halt when the BLA was issued from the FDA a RTF for the trial. The raw data had produced a "p value" of 0.032 which was statistically significant and required the submission of that data in the form of a BLA for HIV MDR to the FDA. Amarex provided the document to the FDA who quickly turned it back around and slapped CytoDyn with a Refusal To File, RTF for that BLA.

The data Amarex provided was insufficient or it was corrupted and was not worthy of an acceptable BLA submission according to FDA Type Good Clinical Practice Guidelines. However, that was not the first time the FDA had warned CytoDyn about their CRO. Amarex had also been, prior to that, been warned by the FDA that their practices which they had followed did not comply with the FDA standards. These FDA warnings to Amarex were virtually ignored by NP and by the CytoDyn BOD at the time. More than likely, not a single CytoDyn board member or even employee had even ventured to assess Amarex on their data collecting, gathering, monitoring and recording methods, to ascertain, to assess and to judge the quality and quantity of the work Amarex was providing to CytoDyn.

The end result of this horrible data set on Leronlimab, likely caused by purposeful sabotage upon CytoDyn which employed a scheme to keep the important safety data away from the FDA, was ignored by CytoDyn, thought to be in good hand was left alone, unchecked and unvetted by CytoDyn which led to the eventual unsuccessful submission and resultant RTF on the BLA for HIV MDR.

Soon thereafter, the FDA wrote a warning letter on CytoDyn which discussed how Leronlimab was being misrepresented by the CytoDyn CEO.

Within 1 year of that time frame, Nader Pourhassan was terminated by the board whom he hired.

Following NP's resignation, the FDA issued another warning letter to CytoDyn on Nader's prior improper discussion of Leronlimab and quickly following that, there were 2 Serious Adverse Events in the Brazil trial for Covid 19. The 2 SAEs had to do with the heart, cardiovascular, maybe heart attacks, but who knows what it was. It was later determined that the side effects did not happen in the Leronlimab arm, but in the placebo arm, but nevertheless, a complete Hold of Leronlimab for Covid 19 was implemented and a partial hold of leronlimab for HIV was instated. Little did anyone know, these 2 events were just what the FDA was looking for to impart this hold. But, little did anyone know, that it would be exactly this clinical hold that would lead to CytoDyn's eventual restoration.

Essentially, with the imposing of the clinical hold, CytoDyn was shut down and it entered into a conservational, hibernation mode to survive.

What was the root cause of all this? The root cause of all this was that CytoDyn never proved to the FDA that Leronlimab was safe. CytoDyn knew anecdotally that Leronlimab was safe, but it never provided the data in the right format to the FDA so that the FDA could state that it was safe. Therefore, from the perspective of the FDA, Leronlimab was never safe, because it was never proved to be in their terms.

CytoDyn had the Effective part, CytoDyn has the data which proves Leronlimab as effective as it has been aggregated from the raw data, and that will be published soon in a Peer Reviewed Article as per Cyrus here: "1:33:35: We continue to contribute in medical meetings and peer-reviewed publications. Again, the CD02 trial data is in process for that right now*. We're going to continue to reshape our team and our capabilities in order to meet our goals. And at some point following the achievement of earlier metrics listed on the slide, we're starting a corporate rebranding as well.*"

But Amarex never provided CytoDyn with Safety Data in the FDA Good Clinical Practice format which was acceptable to the FDA, worthy enough for the FDA to give their blessing on Leronlimab that it was Safe. Four external FDA Type GCP Auditors went through the raw and aggregated data sets and determined that Amarex did not have a Quality QMS that would provide Quality data that would validate that Leronlimab was safe and therefore, the FDA would have failed the BLA, had they accepted it for review.

So when the FDA slapped CytoDyn with the RTF, the FDA essentially pulled the emergency brake and CytoDyn was set off into a tail spin. Eventually the spinning would stop when Nader was removed and the company was forced to re-configure.

Nader Pourhassan was terminated about January 25,2022, so that 1 year anniversary is coming up in about 1.5 months. From a company perspective, so much has taken place since NP has left, but share price has not improved. Nader got the drug out there, but it was being mis-handled right under his own nose. It is not clear if he was aware of the corruption, but he did nothing about the shoddy workmanship which he must have suspected at least. The board which he hired, fired him.

The company has been rebuilt from the ground up. And this time, they are doing it right. But that is taking time, but I feel, they are doing it faster than I would have expected and the fact that they are doing it at all, really is remarkable to me, but, the truth is that they are getting it done and what a team they have become.

The company is righting the wrongs of the prior leadership. All of the prior law suits, they have arranged to close. They have settled them. Their high debt load negotiated and worked out. Some of the board members take shares as payment. Website re-vamped. Videos deleted. Prior company statements deleted which violated FDA rules on discussing drugs safety and discussing drugs performance prior to the FDA declaring it as such.

Through $6.5 million bond, CytoDyn acquired Leronlimab's raw data from Amarex via injunction. That data compiled, that data aggregated. CytoDyn produced a data set format which the FDA would accept. CytoDyn hired 4 external FDA Type Good Clinical Practice Auditors to validate the aggregated data set to determine that Leronlimab was safe and effective after all. CytoDyn provided the necessary documentation the FDA is looking for in order to lift the current hold.

The time frame within which CytoDyn has accomplished the above really started when Nader Pourhassan was removed, on 1/25/22. So, it is coming upon 1 year. When it comes to share holders, and from a share price perspective, 2022 was a year from hell. But when it comes down to it, in 2022, the board did the right thing. In 2022, a new president to become CEO was hired and he orchestrated the biggest come back from the dead plays ever to have been witnessed. When Cyrus is done, CytoDyn will never enter into the mistakes committed by Nader again. CytoDyn will be a 100% FDA compliant bio-tech pharmaceutical.

Cyrus was given 6 months to deliver CytoDyn. The 5 documents the FDA requested, he is in the process of completing, but they will soon all be completed. Cyrus has read and understood what the overall gist was or what the meaning was that the FDA was trying to convey by leveling the clinical hold, and the value of the price CytoDyn paid and exactly what the valuable lesson is that CytoDyn is learning for not playing by the rules of the one governing the game.

Within the time frame of the clinical hold, nearly 1 year so far, Cyrus rebrands CytoDyn in the eyes of the FDA now as a compliant player, that CytoDyn has righted their wrongs, and that they have proved to the FDA that Leronlimab is both safe and effective. By sealing CytoDyn in the eyes of the FDA as compliant, Cyrus also seals himself as CEO of CytoDyn.

With the lifting of the clinical hold, essentially, the FDA anoints Cyrus as the head of CytoDyn. With the lifting of the clinical hold, essentially, the FDA says, yes, leronlimab is safe and had we had this information, the way it was presented to us, in the way we originally asked for it, given the way leronlimab performed, the FDA would have accepted and approved Leronlimab for HIV MDR. With the lifting of the clinical hold, the FDA provides the verdict in the Amarex arbitration.

With the lifting of the clinical hold, Cyrus says we will get funding. "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.**"

Following the lifting of the clinical hold, Cyrus is not expecting a partnership for NASH. However, Cyrus is expecting funding following the lifting of the clinical hold. In addition, Cyrus also expects Partnerships in Oncology either to follow the NASH funding or along side in tandem with NASH funding.

"1:32: 44: So what do we expect in 2023? So our largest priority is the removal of the clinical hold in HIV. This is essentially a gating step for us to be able to get back to normal operations as a company and do what biotech companies do, which is advanced therapeutics and try to bring them to market.

"1:33:10: Following the lift of the clinical hold, we expect financing to fund operations and to achieve this value inflection point that I've just alluded to. We intend on initiating a new NASH trial. We would like to commit to an investment in and advance longer-acting CCR5 molecules, as this is potentially the future of at least certainly HIV therapy, as Dr. Sacha presented. " Just take these words alone, "Following the lift of the clinical hold, we expect financing to fund operations*".* NASH will be funded through financing, not a partnership and from there, CytoDyn will build the unequivocal data set he is after.

"1:31: 40: So in terms of what potential time lines can look like, I think it's really important to highlight that: from a value-creation standpoint, and I've mentioned this before**, we truly do need to generate a large robust and** what I call unequivocal data set that will leave no questions left on the table, right? And that a strategic partner would find attractive and attractive enough to do a real value-accretive deal with the company. "

Cyrus' Vision and Plan:

"17:09: And we're also still committed to HIV, but we're really looking at it more through the lens of developing longer-acting agents. And Dr. Sacha will be talking about that at the end of our discussion today. 

17:21: So within oncology*, we're interested in studying what would be referred to as* immunologically colder tumors*. And Dr. Glück will present on what those -- what we mean by that later. But we think that* these are areas where more recent advancements from checkpoint inhibitors have yet to really have a large impact in those markets. And so we think that there's a unique opportunity based on the data we already have in some of these colder tumors to make an impact*.* 

17:51: Within NASH*, we're particularly excited about the data that we have there, and* NASH will be our primary focus going forward*. We'll also talk a little bit about a unique opportunity to study and* look for the treatment effect of leronlimab in people living with HIV who also have NASH*. And we think that we might be in a unique position to address that population.*"

"18:22: So going forward, we're focusing on NASH, oncology and earlier-line HIV indications through longer-acting agents that inhibit CCR5*. Again, we've already generated promising clinical signals in both NASH and oncology. And within NASH, we're exploring the opportunity to study a segment of patients of those NASH patients who are also living with HIV.*

18:50: Within oncology*, we want to pursue* colorectal cancer and breast cancer specifically. Within the colorectal cancer population, we want to focus on a micro-satellite stable group*, which represents* about 85% of all diagnosed colorectal cancers*. And within* breast cancer*, we want to* focus on the hormone receptor positive HER2-negative population, which is about 70% of all diagnosed breast cancers, and the TNBC population since we have data in that space. All of these are quite large markets."

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