It Takes 2

It takes 2 to make a thing go right.

CytoDyn needs a partner and so does leronlimab.

Once a partner comes on board, CytoDyn stock becomes The Safe Haven.

Once leronlimab is partnered up with any PD-1 Inhibitor, cancer loses its ability to survive and if it is done properly, could achieve damn near 100% survival rate in the vast majority of all Tumors; that is at least 85% of all Tumors. Why do I say this? In the following Press Release:

CytoDyn Announced Data That Suggests Novel Mechanism of Action

"[CytoDyn] found that leronlimab treatment correlated with increased expression of an immune cell protein or “checkpoint inhibitor” known as programmed death-ligand 1 (“PD-L1”) on patient’s circulating tumor cells (“CTCs”). CytoDyn’s results indicate that 15/17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab. Increasing expression of PD-L1 can be likened to turning “cold” tumors “hot”, elevating PD-L1 levels to the level necessary for patients to potentially derive benefit from further treatment with a class of drugs known as immune checkpoint inhibitors (“ICIs”)."

As a result of these findings, CytoDyn partners up with the company offering the best deal for CytoDyn. Why? Because this partnership allows their PD-1 blocker the opportunity to be indicated in the treatment against the 85% majority of All Tumors which are MSS MicroSatellite Stable Type Tumors.

Which Tumors are the of the 85% MSS Type? These MSS Tumor Type are the Tumors which leronlimab already makes an impact upon. For example, mCRC is of this Tumor type and so is mTNBC. In the 12/7/22 R&D Update, Dr. Stefan Gluck discussed the varying types of tumors.

Overall Response Rate in Percent of All Tumors V.s PD-L1 Percent

Viewing the image above, you can appreciate that the cancers on the left are the tumors that are MSS Type Tumors while the tumors on the right are the MSI Type Tumors.

Let's look at the PD-L1 expression percentage of various tumors:

% PD-L1 Expression in Various Cancer Types

Starting with Tumors on the left of the R&D Update Graph and moving to the Tumors on the Right, from MSS to MSI, and incorporating the PD-L1 % expression, the Tumors are listed as follows:

1. Glioblastoma Multiforme, 10% PD-L1 expression, Non-Responder
2. Prostate, 3% PD-L1 expression, Non-Responder
3. Pancreatic, 5% PD-L1 expression, Non-Responder
4. MSS ColoRectal Cancer, 5%, PD-L1 expression, Non-Responder
5. Cervical Cancer, 21% PD-L1 expression, Non-Responder
6. Endometrial, 10% PD-L1 expression, Moderate Responder
7. Mesothelioma, 22% PD-L1 expression, Moderate Responder
8. Ovarian, 14% PD-L1 expression, Moderate Responder
9. Small Cell Lung Cancer, 8% PD-L1 expression, Moderate Responder
10. Hepatic Cell Carcinoma, 13% PD-L1 expression, Moderate Responder
11. Breast Cancer, 7% PD-L1 expression, Moderate Responder
12. Non-Small Cell Lung Cancer, 33% PD-L1 expression, Higher Responder
13. Head and Neck Cancers, 33% PD-L1 expression, Higher Responder
14. Renal Cell Carcinoma, 19% PD-L1 expression, Higher Responder
15. Bladder Cancer, 50% PD-L1 expression, Higher Responder
16. Esophageal, 18% PD-L1 expression, Higher Responder
17. Gastric, 10% PD-L1 expression, Higher Responder
18. Melanoma, 22% PD-L1 expression, Higher Responder

PD-1 Blockers primarily work on the Higher Responder type Tumors which are the "Hot" Type Tumors, The "MSI" or MicroSatellite Instability Type Tumors. Remember, these "Hot" Type Tumors only represent 15% of the Tumors out there while the Cold, MSS MicroSatellite Stable Tumors, the Non-Responder or Moderate-Responder Type Tumors represent 85% of the Tumors out there.

The Company believes:

"... this mechanism could be effective across a wide range of solid tumor types, and in particular benefit cancer patients with low levels of PD-L1 who were previously unresponsive to or ineligible for checkpoint inhibitors."

Dr. Lalezari points out:

"Leronlimab’s ability to induce an inflamed or “hot” tumor environment, that could then be treated with ICIs, would be a game changer in solid tumor oncology."

The following ESMO presented poster assembles the work that was done to arrive to these findings:

ESMO 5/15/25 mTNBC Poster

CytoDyn's reasoning regarding these findings makes so much sense. These findings form the basis and the foundation of CytoDyn's oncologic future. Scott Kelly was right when he said CytoDyn shall be an oncology company. This is why. Dr. Lalezari has already tweaked things going forward on account of these new fascinating realizations.

"Prospectively confirming these findings in patients with TNBC is a top priority. We have also amended our current colorectal cancer trial to ensure the prospective collection of PD-L1 data in a second type of solid tumor."

This new novel MOA, though it requires a joint venture, the combination of another drug, namely, a PD-1 Inhibitor, really sets forth a new path forward which CytoDyn MUST follow if it is to succeed. The path forward is leronlimab + PD-1 blockade for the CURE of the cold tumor oncologic processes listed above. The poster presentation has made it quite evident that this path absolutely MUST be taken.

Leronlimab causes the cold tumors to become hot tumors and then, the hot tumors may be treated by an Immune Checkpoint Inhibitor or PD-1 blocker. The two work together synergistically. Two mechanisms combine to make one synergistic mechanism which can transform a cold tumor into a hot one. Remember, 85% of them are originally cold. This combination transforms the vast 85% majority of them into the hot, treatable kind of tumor.

Does that mean CytoDyn partners with multiple PD-1 manufacturers or does CytoDyn only partner with one PD-1 manufacturer to treat all those tumor types? There are a few really good PD-1 blockers out there. For instance:

1. nivolumab, Opdivo, manufactured by BMS, has received FDA approval for a wide range of cancer treatments, including melanoma, non-small cell lung cancer, renal cell carcinoma, and Hodgkin's lymphoma, among others
2. pembrolizumab, Keytruda, manufactured by Merck, has been approved by the FDA for a wide range of cancer indications, including melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, and various other cancers like urothelial carcinoma, and gastric cancer
3. dostarlimab, Jemperli, manufactured by GSK, approved by the FDA for use in adult patients with primary advanced or recurrent endometrial cancer, and for solid tumors, specifically those that are mismatch repair deficient (dMMR).

Any one of these companies could partner up with CytoDyn to combine their PD-1 blocker with leronlimab in the treatment of the 85% majority, MSS Type, cold tumors which are currently untouchable, or they just may want to treat only one tumor type. CytoDyn understands that it absolutely must partner for this to become a success, because, CytoDyn does not own its own PD-1 blockade. For this Mechanism of Action to be used to CURE Cancer, leronlimab MUST be combined. Therefore, CytoDyn must partner and partner on good terms. It takes two to make things right; it takes two to Tango. BTW, This MOA rules out a partnership with G because they don't have a PD-1 blockade. This could explain the continued short attacks since this was announced.

What has been revealed is nothing short of astonishing. The combination of these 2 mechanisms puts in place a mechanism capable of curing cancer. Not only is this getting discussed by patients all around the world, but even more importantly, it is being discussed by the CEOs of companies who consider partnering with CytoDyn for this purpose, to CURE Cancer. Potential partnerships are being discussed right now since CytoDyn's entire leadership team has attended ESMO.

Possibly, Dr. Lalezari has received an offer, or possibly, he hasn't.