Here’s the problem as I see it—there are something like 1.2 billion shares of Cytodyn out there, and THE BIG WALL STREET FIRMS DON”T OWN ANY OF THEM. Well, Paulson and hedge funds might own a chunk, but retail dominates. When they wake up the morning after the ESMO presentation and realize Cytodyn is sitting on a gold mine, they are going to be pissed. Pissed because the Lords of Wall Street are used to being in charge of these things, and they will be on the outside come late October. But they have the ways and means to make sure they get their piece of the pie… the whole damn thing if they can get it, with perhaps some crumbs left on the table for retail.
The long-term longs know the playbook better than I—naked shorting, fueled by innuendo and rumor, is just the start of it. I wouldn’t be surprised to see Adam F make a comeback, dredging up the past—clinical holds, Amerex and the Nader years, the 13D takeover attempt, and the recent lawsuit and settlement. Big Pharma analysts lowballing earnings estimates, and pious BioSpace and Stat journalist/enablers cautioning investors that the “trials are small, the evidence is promising, but will the results hold up?” Given Cytodyn’s history, they have a shit-ton to work with, and they will use every trick in the book. And if and when Cytodyn becomes eligible for options trading... well, that’s just another tool in the toolkit that Wall Street and the hedge funds use to pin the price of a stock, and keep it range-bound and under control so they can accumulate at a discount.
Ya really think Dr Lalezari and Hoffman haven’t seen this playbook before? Posters on this board and Livimmune have allowed as to Dr J being an able clinician and scientist who can run a clinical trial like nobody’s business… but he’s not a businessman. Where is the evidence for this? He has run Quest for a lot longer than some of the new pups on this board have been alive. He has run cutting-edge HIV and Hepatitis trials for decades, and gained the confidence of top-notch pharmaceutical companies (AI tells me these include Roche/Genentech, GSK/ViiV, Gilead (!), BMS, Merck, Pfizer, and Janssen, now J and J). And along the way, I suspect he has earned some institutional gravitas. Clout. Ya think he’s not going to use it at a time and place of his choosing… like call in some favors here, now, soon? Trust as an absolutely necessary component while negotiating the birth of a revolutionary—and incredibly disruptive—molecule into cancer wards and clinics across the world?
Lalezari outlined a path forward for the company that emphasized a science first approach, with a well-thought out, adaptive trial design for Clover. That has resulted in what appears to be the “unassailable” data he promised. What is under-appreciated is that science-first approach is a strategic business decision as well as rigorous science and clinical smarts. We are in a materially better place today then we were at the start of Clover. At that point, a year and a half ago, we were talking about prime and pair as the big leap forward. It certainly is the biggest leap forward! But by following the science, we now have multiple shots on goal in mCRC—the promise of a substantially improved Standard-of Care with Lonsurf and Avastin, as well as the ultimate promise of prime and pair. And the CHAMP trial in the wings, as well as the Alzheimer’s trial. And both are investigator-initiated trials, on someone else’s dime. Add the EAP program in TNBC. Not bad for a sub-optimal businessman who belongs in the clinic and not in the boardroom.
TechGuru wrote a really nice post a couple weeks back that summarized the early but strong data from Clover, and the implications that flow from this. (Post 164286). The importance of a dose-dependent effect, the significance of deep and rapid ctDNA declines, PD-L1 increases in the majority of cases. And more. Cytodyn can’t just come out and say “leronlimab works!” But that is what the early data is saying… and TechGuru laid out the case nicely. We’ll have more mature and thorough numbers by the end of the month and come January. The data embargo and perhaps NDAs are why we haven’t heard more from the company, in my humble opinion. But even under those restrictions Lalezari and Hoffman have provided a great deal of actionable intelligence, without waving three fingers and spilling the beans. Massaging the FDA and getting the rollover extension accepted into the trial, the strategic alliance with Natera…Under the circumstances I’d say they have threaded the needle pretty well, and TG elucidated the significance of their rather low-key disclosures.
Cytodyn has to get out of the pink sheets, and escape the predatory shorts and Market-Makers that regularly dick around with small-cap biotechs, and basically hold them hostage. I think the brain trust knows this, and will leverage the ESMO data release to negotiate a partnership that will provide a solid financial foundation for that process to play out. “Great Data,” by itself, might spike the price on a short-term basis… but don’t think for a moment that we are home-free without a solid foundation based on finances and the legitimacy provided by a respectable Big Pharma partner. I’ll be surprised if we are still on the OTC at some point in in 2027… likely sooner than later.
The most logical way forward leverages leronlimab as part of a new standard-of-care in mCRC, and leaves the larger ICI deal for later. Let’s say a couple hundred million up front, financing for Phase III, milestone money and 15% royalties on global sales. (Those numbers are just off the top of my head). That wouldn’t be as big a deal as prime and pair would require, of course. But it would provide a solid financial foundation, get us out of the pink sheets, allow the EAP and the Clover 12 data to mature, and show the world what we got. Roche would be the obvious candidate, because a new patent for this SOC would allow them to sell Avastin at a premium, on top of making money selling leronlimab. It will also provide Roche a great deal of incentive to study the triplet in first and second line CRC and expand the addressable market. Basically dominate the entire MSS mCRC market. This kind of arrangement with Roche would give Cytodyn what it really needs—legitimacy on top of the Benjamins. And plenty of time for Hoffman to do his thing and negotiate an entirely separate prime and pair arrangement. With Roche? There will be other suitors. Which could get very interesting. Roche could indeed lose a bidding war. But the triplet SOC would be a nice consolation prize… if you looked at it that way. Perhaps Cytodyn would provide them rights to the entire MSS CRC indication, including prime and pair… for the right price. As the consolation prize if the Big Behemoth in the room makes a move.
So who knows, Merck could come to it’s senses and swoop in at some point as this process unfolds, and make an offer we couldn’t refuse. Or Hoffman could get creative, and do a deal with Taiho, the owner of Lonsurf. Or some kind of royalty deal, or out-license the molecule to Japan and/or the Asian markets (Dr Reddy, anyone?). Non-dilutive financing, of course. Again, this would be exclusively for the triplet as a new SOC, reserving the LL/ICI doublet for a later deal… Unless Merck or Roche or whoever gives us what we are worth, on an expedited timeframe. Hopefully with lots of Contingent Value Rights built into the deal… And that deal will clearly be our Big Enchilada! If the data supports it, of course.
I think that is the most likely way forward—a smaller deal to get out of the OTC and let the data mature, and a much larger deal for the prime and pair MOA later. And this doesn’t happen if we don’t have a pretty sharp businessman as our CEO. I strongly disagree with those who think otherwise. We’ll see, and if I’m wrong, I’ll eat crow. But I expect to be eating that Big Enchilada sometime in 2027.
But we gotta get out of the pink sheets! That is really what I am looking for post-ESMO.
The long-term longs know the playbook better than I—naked shorting, fueled by innuendo and rumor, is just the start of it. I wouldn’t be surprised to see Adam F make a comeback, dredging up the past—clinical holds, Amerex and the Nader years, the 13D takeover attempt, and the recent lawsuit and settlement. Big Pharma analysts lowballing earnings estimates, and pious BioSpace and Stat journalist/enablers cautioning investors that the “trials are small, the evidence is promising, but will the results hold up?” Given Cytodyn’s history, they have a shit-ton to work with, and they will use every trick in the book. And if and when Cytodyn becomes eligible for options trading... well, that’s just another tool in the toolkit that Wall Street and the hedge funds use to pin the price of a stock, and keep it range-bound and under control so they can accumulate at a discount.
Ya really think Dr Lalezari and Hoffman haven’t seen this playbook before? Posters on this board and Livimmune have allowed as to Dr J being an able clinician and scientist who can run a clinical trial like nobody’s business… but he’s not a businessman. Where is the evidence for this? He has run Quest for a lot longer than some of the new pups on this board have been alive. He has run cutting-edge HIV and Hepatitis trials for decades, and gained the confidence of top-notch pharmaceutical companies (AI tells me these include Roche/Genentech, GSK/ViiV, Gilead (!), BMS, Merck, Pfizer, and Janssen, now J and J). And along the way, I suspect he has earned some institutional gravitas. Clout. Ya think he’s not going to use it at a time and place of his choosing… like call in some favors here, now, soon? Trust as an absolutely necessary component while negotiating the birth of a revolutionary—and incredibly disruptive—molecule into cancer wards and clinics across the world?
Lalezari outlined a path forward for the company that emphasized a science first approach, with a well-thought out, adaptive trial design for Clover. That has resulted in what appears to be the “unassailable” data he promised. What is under-appreciated is that science-first approach is a strategic business decision as well as rigorous science and clinical smarts. We are in a materially better place today then we were at the start of Clover. At that point, a year and a half ago, we were talking about prime and pair as the big leap forward. It certainly is the biggest leap forward! But by following the science, we now have multiple shots on goal in mCRC—the promise of a substantially improved Standard-of Care with Lonsurf and Avastin, as well as the ultimate promise of prime and pair. And the CHAMP trial in the wings, as well as the Alzheimer’s trial. And both are investigator-initiated trials, on someone else’s dime. Add the EAP program in TNBC. Not bad for a sub-optimal businessman who belongs in the clinic and not in the boardroom.
TechGuru wrote a really nice post a couple weeks back that summarized the early but strong data from Clover, and the implications that flow from this. (Post 164286). The importance of a dose-dependent effect, the significance of deep and rapid ctDNA declines, PD-L1 increases in the majority of cases. And more. Cytodyn can’t just come out and say “leronlimab works!” But that is what the early data is saying… and TechGuru laid out the case nicely. We’ll have more mature and thorough numbers by the end of the month and come January. The data embargo and perhaps NDAs are why we haven’t heard more from the company, in my humble opinion. But even under those restrictions Lalezari and Hoffman have provided a great deal of actionable intelligence, without waving three fingers and spilling the beans. Massaging the FDA and getting the rollover extension accepted into the trial, the strategic alliance with Natera…Under the circumstances I’d say they have threaded the needle pretty well, and TG elucidated the significance of their rather low-key disclosures.
Cytodyn has to get out of the pink sheets, and escape the predatory shorts and Market-Makers that regularly dick around with small-cap biotechs, and basically hold them hostage. I think the brain trust knows this, and will leverage the ESMO data release to negotiate a partnership that will provide a solid financial foundation for that process to play out. “Great Data,” by itself, might spike the price on a short-term basis… but don’t think for a moment that we are home-free without a solid foundation based on finances and the legitimacy provided by a respectable Big Pharma partner. I’ll be surprised if we are still on the OTC at some point in in 2027… likely sooner than later.
The most logical way forward leverages leronlimab as part of a new standard-of-care in mCRC, and leaves the larger ICI deal for later. Let’s say a couple hundred million up front, financing for Phase III, milestone money and 15% royalties on global sales. (Those numbers are just off the top of my head). That wouldn’t be as big a deal as prime and pair would require, of course. But it would provide a solid financial foundation, get us out of the pink sheets, allow the EAP and the Clover 12 data to mature, and show the world what we got. Roche would be the obvious candidate, because a new patent for this SOC would allow them to sell Avastin at a premium, on top of making money selling leronlimab. It will also provide Roche a great deal of incentive to study the triplet in first and second line CRC and expand the addressable market. Basically dominate the entire MSS mCRC market. This kind of arrangement with Roche would give Cytodyn what it really needs—legitimacy on top of the Benjamins. And plenty of time for Hoffman to do his thing and negotiate an entirely separate prime and pair arrangement. With Roche? There will be other suitors. Which could get very interesting. Roche could indeed lose a bidding war. But the triplet SOC would be a nice consolation prize… if you looked at it that way. Perhaps Cytodyn would provide them rights to the entire MSS CRC indication, including prime and pair… for the right price. As the consolation prize if the Big Behemoth in the room makes a move.
So who knows, Merck could come to it’s senses and swoop in at some point as this process unfolds, and make an offer we couldn’t refuse. Or Hoffman could get creative, and do a deal with Taiho, the owner of Lonsurf. Or some kind of royalty deal, or out-license the molecule to Japan and/or the Asian markets (Dr Reddy, anyone?). Non-dilutive financing, of course. Again, this would be exclusively for the triplet as a new SOC, reserving the LL/ICI doublet for a later deal… Unless Merck or Roche or whoever gives us what we are worth, on an expedited timeframe. Hopefully with lots of Contingent Value Rights built into the deal… And that deal will clearly be our Big Enchilada! If the data supports it, of course.
I think that is the most likely way forward—a smaller deal to get out of the OTC and let the data mature, and a much larger deal for the prime and pair MOA later. And this doesn’t happen if we don’t have a pretty sharp businessman as our CEO. I strongly disagree with those who think otherwise. We’ll see, and if I’m wrong, I’ll eat crow. But I expect to be eating that Big Enchilada sometime in 2027.
But we gotta get out of the pink sheets! That is really what I am looking for post-ESMO.
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