Sunday post:
MGK_2
Game Changing
Loyal to Truth. This post was inspired by My69z.
Referencing this PR on July 9, 2024: CytoDyn Announces Amarex Settlement,
"The material terms of the settlement are as follows: (i) Amarex will pay $12,000,000 to CytoDyn, $10,000,000 was paid upon execution of the agreement and the remainder to be paid within the next 12 months; (ii) the surety bond, valued at $6,500,000, will be released to CytoDyn in full; (iii) all sums Amarex had claimed as due and payable, aggregating to approximately $14,000,000, will be eliminated, with no payment required from CytoDyn; and (iv) a mutual release of claims, resolving all legal claims between the parties."
Did we actually believe that CytoDyn only settled for just $12 million cash, the release of the $6.5 million surety bond and the elimination of all liability claims totaling $14 million to constitute the entirety of the settlement, when we knew full well that this was only a drop in the bucket of what the punitive and compensatory damages were actually worth? We all knew Amarex caused significant harm to CytoDyn and if justice got its way, was easily worth in excess of 10x this combined $32.5 million.
CytoDyn settled at this low figure, possibly because Amarex likely didn't have the more appropriate funds and their own insurance company also probably was tapped out and limited at $10 million. The $2 million probably came directly from Amarex, which is due by July 2025, together with the elimination of any liability claim and the release of the surety bond, is what was agreed to.
The claims against Amarex were severe and CytoDyn won the arbitration, so the judgement went in CytoDyn's direction. Even though the size of this settlement is paltry, it still represents a decimating blow to the loser. CytoDyn's case was very strong, and if they had the means to extract more, they would have. There just wasn't anything left on the table to take so as to justify an increase in the size of the settlement.
Truth was spoken that day, just not by the magnitude of the judgement. But CytoDyn seemed satisfied. Some expected CytoDyn to crumble under the sheer weight of the costs of litigation. But CytoDyn knew they were wronged and had the proof, and therefore, they proceeded with their claim.
From the most recent Press Release, CytoDyn Announces Promising Survival Observations In mTNBC, and since the entire PR pertains to this discussion, I'll repeat it here in its totality:
"VANCOUVER, Washington, Feb. 24, 2025 (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, today announced encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab. Although mTNBC typically has a poor prognosis, observed survival rates at 12, 24, and 36 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.
Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025.
“We are encouraged by the longer-term survival data to pursue this potentially paradigm-shifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology. “As a cancer therapeutic, leronlimab was well tolerated with remarkably infrequent treatment-related adverse events. These promising results suggest further studies with leronlimab are warranted to expand oncology treatment options and improve patient care.”
Dr. Jacob Lalezari, CEO of CytoDyn, added: “These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors. I expect the Company’s oncology efforts to accelerate in the coming months, with further announcements in both mTNBC and colorectal cancer.”
Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibody-drug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab). The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease."
With regard to mTNBC while discussing the Basket Trials, In the December 14, 2021 Conference Call, Nitya Ray spoke:
"27:60 Nitya Ray: The BTD application that is submitted is 28 patients from 3 different trials. And out of the 28, 6 had brain metastases. They are all mTNBC patients. So we have submitted all of the results, including all of the patients with brain metastases, now with the FDA and FDA is reviewing it and we are waiting for FDA to respond for BTD application and we expect to hear from them in about 2 weeks. 2-3 weeks. Our CTA application I believe was submitted on November 5. So by January 5, we should hear from FDA. and then we are going to discuss with FDA and see that forward with brain metastases. Now, these are not the only patients with brain metastases because these are mTNBC patients. But, we have other patients in the Basket Trial and not mTNBC, with brain metastases. And so we are very excited about what is happening with these patients. And so we are going to discuss this with the FDA and we do plan, after we receive the response from the FDA on the BTD application that is submitted, we are going to plan for perhaps another BTD just focusing on the brain metastases."
r/Livimmune - Game Changing
In expectation of the results of the mTNBC Clinical Trial, on September 5, 2022, I prepared the following: In Preparation For The Coming Results On mTNBC and wrote therein:
"Come 9/16/2022, we should be able to learn what the more refined PFS is for these 21 patients and what the more refined Overall Survivability is for these 21 patients. The study started 4/22/2019. By 7/19/21, the PFS was 8 months and the OS was 36 months. Since then, 13 months have passed. All in All, the patients were not very healthy. It was a combination of Compassionate Use, brain metastasis and patients had failed 2 other treatment protocols. Patients were treated differently, and may only have received up to 4 doses of leronlimab + carboplatin total while some other received much more, however, leronlimab may have been dosed even after PFS endpoint was reached and after the cancer had returned which may have extended OS. Hopefully, all of this is documented in the results of the trial. From the 7/19/21 PR, we currently had a PFS of 8 months and an OS of 36 months. Since November 2021, the PFS was recalculated to be 6.5 months and the OS became 12.5 months. 10 months have passed since then. Come 9/16/22, could the OS go to 20+ months?"
(How was CytoDyn able to put out in that PR a PFS of 8 months and an OS of 36 months if that period of time had not already passed? In short, they extrapolated.)
But the results of the mTNBC Clinical Trial were never released on the Estimated Study Completion of 9/16/2022. Why not? Knowing now what I didn't know then, I can say now that the data had to have been withheld. CytoDyn never said anything about why they didn't provide these crucial results, but that important data was due then, but it was never presented. Now, with the recent PR, it becomes clear that Amarex withheld the data, so CytoDyn had nothing with which to present. In fact, they had no presentation on 9/16/2022.
The settlement likely gave CytoDyn access to crucial clinical trial data which was previously unavailable to CytoDyn due to the dispute with Amarex. This is supported by the recent announcement of encouraging survival outcomes in metastatic triple-negative breast cancer (mTNBC) patients treated with leronlimab. Why would Amarex hide this data that was crucially important to all of humanity? In an effort to ruin CytoDyn's credibility? In an attempt to paint CytoDyn as duly incompetent? They no longer can claim that CytoDyn stopped payment, because they in fact lost the arbitration. Therefore, what is the truth here? Was there another reason they kept the information?
How much pressure was Amarex really under? Who were they in collusion with? Will this ever be uncovered and revealed? Could or Would the decision of the arbiter bring this information about? Yes, absolutely. What did Amarex need to do to avoid the decision of the arbiter? Settle.
Consider now the affected manuscripts. They probably do require tweaking. From the 12/14/2023 Webcast:
"00:33:19, Dr. Jacob Lalezari:
I've also recently reviewed the cancer data. And it is urgent that we get CD07 (mTNBC) published for that, again, provocative single benefit. So publications, are getting a protocol finalized, off hold, begin the process to implement, get these publications, including the NASH study, the long COVID study, submitted for peer review. I had talked to folks at NIH some years ago about our COVID data in the ICU population. They've been waiting to see the data in a peer reviewed format. And so that's a huge priority for me. And then at the same time, there's no reason why we cannot aggressively pursue partnerships to extend the research platform for leronlimab. And I will commit to that wherever that makes sense. So those are the significant events that, you know, I'll be looking for over the next, you know, two to six months."
r/Livimmune - Game Changing
From the 3/5/2024 Webcast:
"7:07: Turning now to the commitment to prioritize publications of our existing clinical data. I am pleased to announce that we are moving forward with the submission of (4) manuscripts in the coming weeks including (2) papers with 8 of 10 women with triple negative breast cancer. A paper in patients with multi-drug resistant HIV and a paper in patients with Mild to Moderate Covid-19.
7:40: The 1st publication will report on the observations that 8 of 10 women on the 3rd line therapies for triple negative breast cancer had either stable disease or a partial response after 6 months of combined treatment of leronlimab with a chemotherapy agent called carboplatin. This result compares favorably with historical controls.
8:09: The 2nd publication will report (2) further observations that suggests that leronlimab may have a role in the treatment of triple negative breast cancer. First, in the pooled analysis of 28 patients, there appeared to be a signal on the dose response. The patients on the higher 525mg dose of leronlimab, had a modestly increased progression free and overall survival compared to the 350mg dose.
Second, I think most provocatively, the pooled analysis showed that after receiving an initial dose of leronlimab, patients divided into one of two categories. About 25% of the patients had an increase in Circulating Tumor Cells, these are cells that are measured in the blood and can be referred to as CTCs. While about 75% of the patients had a decrease or absence of these CTCs in the weeks following the first dose of leronlimab.
9:17: That differentiation in CTC response in turn appeared to identify which patients subsequently responded to leronlimab with improved progression free and overall survival. Indeed, I believe the data on CTC response, is perhaps the most compelling part of the leronlimab story in triple negative breast cancer and could provide the basis for a screening test to identify which patients are most likely to respond from leronlimab in a follow up study.
I say all this to say, Why did Amarex keep data away from CytoDyn? Why was it part of the settlement to provide data to CytoDyn which had already been due them 3 years earlier? They claim they were withholding it because CytoDyn didn't pay, but since CytoDyn won the arbitration, their argument is null and void and that data rightfully belonged to CytoDyn all the while. Therefore, following the settlement, that data has been transferred to CytoDyn.
" In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.
Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025.
“We are encouraged by the longer-term survival data to pursue this potentially paradigm-shifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology."
The survival data for mTNBC patients is indeed remarkable. Some patients who had failed prior treatments for metastatic disease survived beyond 36 months, are currently alive, and show no evidence of active disease. This outcome is particularly significant given the aggressive nature of mTNBC and limited treatment options available.
Was there something behind that data they wanted to keep from CytoDyn? What did that data show? This is what I'm thinking. The fact that leronlimab eradicates metastatic disease to the brain? The fact that OS could not be definitively stated because patients were still alive? The fact that Circulating Tumor Cells essentially vanished after treatment with leronlimab?
What about the Basket Trial of various tumor types? Recall what Nitya Ray was saying. He wanted to gain BTD on metastatic Brain tumors. There were other tumors in that Basket Trial which could potentially reveal additional positive data. CytoDyn's access to the follow-up records of patients previously treated with leronlimab in oncology trials such as the Basket Trial could lead to even more discoveries across various cancer types
The mTNBC results I was looking for in September of 2022 should soon be revealed at ESMO in May of 2025. Shouldn't these all inclusive results also be incorporated in the (2) mTNBC manuscripts planned for publication as well?
Amarex agreed to provide this missing data which they sat on for years which they knew rightfully belonged to CytoDyn. But, they used the data similar to how hostages are used to negotiate with. As a means to augment the settlement agreement, which they knew fell far short of what it rightfully should have been, then they agreed to provide that data. But the value of this lost and forgotten data could become much more valuable than the one time payment. So that could be why CytoDyn agreed to the terms of the settlement agreement.
Certainly, this is not a fair resolution, but do CytoDyn shareholders have a choice? Not really. We hold and hope for the best. But, if what has been seen thus far holds true going forward, leronlimab becomes the treatment / cure for mTNBC plain and simple. 4 years of OS with no sign of ongoing disease = Cure.
At the time of settlement, they may not have realized that the return of the data which rightfully belonged to CytoDyn was worth far more than the $32.5 million in cash, eliminated liability and returned surety bond.
What else can we expect to come forth from this lost data? Actual OS of mTNBC patients to exceed even what was calculated through extrapolation? 36 months going on 48 months. Cure of mTNBC? The fact that leronlimab eradicates metastatic Brain tumors as Nitya Ray pointed out. How the addition of leronlimab augmented the beneficial effects of the chemotherapy carboplatin while attenuating its inflammatory side effects? Could the data show that there is a means by which we can know which patients respond to leronlimab and which patients will not? Abstract Changes In Circulating Tumor Cells
Is this why CytoDyn accepted the settlement agreement? Because the potential value of the data far exceeds the temporary monetary benefit? And why did Amarex agree to providing this data? Because they knew they could keep the monetary value of the settlement lower by providing the withheld (hostage) data and they didn't want this decision to go to the arbiter because they knew that if the decision was left to the arbiter, then their monetary payments would have put them into bankruptcy.
Why would Amarex withhold data on mTNBC? Life saving data, that could prolong the lives of patients suffering with the disease, and data that could cure patients of that disease? Why was it buried, left for dead? Would Amarex even have an answer? or would their finger be pointed at their Master? The arbiter would have been ruthless, CytoDyn remains cool and composed knowing that Truth is in its hands. CytoDyn has been in a war for so long, they knew the coming data would be well worth the compromised settlement. They knew the data had what it takes to get this mTNBC Clinical Trial back into ESMO, back in front of potential partners in the effort to cure this horrible disease.
This was a massive CytoDyn win against its own CRO parasite that shall be utilized to improve and preserve the lives of patients with mTNBC. CytoDyn finished those who directly attempted to play games with the truth, those who directly manipulated data to serve their own agenda, who attempted to silence them, by withholding their results. All of that has ended and their data shall be seen at ESMO in May. The first step to clearing sickness and disease is to eradicate the cause and that is what CytoDyn did in that settlement. It has cleared itself of its once CRO parasite which acted as a proxy of G.
CytoDyn has been on a Rampage ever since, clearing out its internal enemies and cleaning itself up for the work ahead which it is now in preparation and is undergoing. A Rampage that causes it to become the center of attention in that coming Bidding War. All of this means is that patience is required. That means, we are to live life. Have a really nice Sunday.
AI
