Good post, Sherlock57. I wanted to give some thoughts around a few of your points because I see it a little differently.
"And hanging over any potential deal out there, for any of the indications, is the long-acting version under development. What Pharma Co would sign a deal for weekly leronlimab when a longer-acting version is just a few years away?"
I believe the main thing hanging over our heads was lack of robust data, along with, and stymied by, the remnants of what was once an active, well trafficked circus. The tent didn't come fully down until recently, and the bearded lady just finally stopped swinging by to shave in the executive bathroom. The cleanup has been a priority behind the scenes, and as we just witnessed with the mTNBC follow up we were all annoyed nobody seemed to think of doing, there's much more to the Leronlimab story that needs to be told. A guy in a top hat holding a CYDY coffee mug ultimately wasn't going to get the job done, well intentioned or not.
The original plan was to provide just enough compelling signals in a variety of indications to boost the buyout price. It actually came very close to working, but for those pesky kids*.
*the FDA, Amarex, Gilead-stocked DSMB decisions, and more!
The plan now is not much different, except that the data will be more of the unassailable variety and nobody is hawking peanuts or hot dogs. Not to mention the quantity of such data, which together will help dictate any current partnership and/or future buyout with more precision.
That's where the preclinicals are helping our cause. They're inexpensive, all things being equal, and fairly quick too. They help clarify Leronlimab's dosing and potential capabilities in each indication we're trying to grow. Which is necessary to bolster the often-muddied-but-always-compelling sparks of human data we have across all indications.
As for the worry that a long-acting LL being close to reality is dragging out the talks, I'd argue it's not going to get in the way of any current licensing or partnership deal. If anything, it just makes CYDY and LL more valuable. It'll allow whoever owns the drug to extend patent life and broaden LL's market.
The ways and conditions in which Leronlimab will be impactful will be worthy of infomercial-worthy ads. It slices, it dices, it juliennes!
There'll eventually be a variety of ways in which LL is dosed to ensure the right amount of Leron is humping (medical term) the appropriate number of CCR5 receptors for the correct amount of time, and no more or less. So basically, long acting is like, the 10th trick our little pony has in its future. By then, of course, it wont' be a pony any longer but the Secretariat of platform drugs.
Big pharma wants LL for Mash, fibrosis, and/or oncology right this second. The sooner they get it, the less it will cost them on both the front and back end. Because if they wait too long to lock in fibrosis, there's going to be advancements in crc and mtnbc initiatives. Alzheimer's capability will become clear. Glio potential starts to grow fast like, well, a glioblastoma tumor. The price to play goes up substantially every time new data advances one of our indications.
Which brings me to something I've been saying behind the scenes with people. It probably won't be a very long time from the start of a partnership to the offer of a buyout.
Because if you license an indication the traditional way, with the intent to see it through a phase 2 or 3, or through approval, at which point you intend to buy out Cytodyn, that's going to take at least a year on the very aggressive side of things. But more likely a few years. They need to get a trial or trials rolling, see them through, and spend months analyzing the data. By that time there's a possibility (just throwing out hypothetical and hopeful scenarios here) that maybe we learn that the DSMB in the crc trial recommends stopping the trial and giving everyone in it LL based on early success. Or LL helps cure an HIV paitent. The Bill and Melinda Gates Foundation collaborates on HIV and Alzheimer's and we get preliminary data in humans that shows LL slows or delays mental decline.
My point is that each of the fires Jay and the team have going are building in real time. Merck could come in and snag fibrosis and Mash with a killer licensing deal, but long before we get to the traditional buyout period for licensing deals (advancing the drug through phase 2/3 successfully, or winning approval) there's bound to be one or more fires for giant indications like oncology raging damn near out of control.
We're on the cusp of so many huge advances and how it all plays out is anyone's guess. Which puts us in control of our own destiny, just like Jay said. But I think he meant it in terms of having the leverage of multiple, major indications advancing successfully in real time. We don't have to go to anyone, they need to come to us.
So that's why I think we get a strong licensing deal very soon from a company capable of buying us out one day, and that "one day" comes quicker than what traditionally happens. Get in the catbird seat and be in position to buy Cytodyn while three huge indications are just potential versus later when one or two are mere steps from approval and you have to add a zero on the end of your offer to get it through.
You also wrote:
"Personally, I'd like to see Cytodyn partner with someone for one of the inflammation-related indications. (Pick one! Several to choose...). That, along with Gates Foundation money for the HIV cure, would give us enough cash to aggressively go after the cancer indications. And then hand off leronlimab to NP2 when the weekly version of leronlimab goes generic. And we keep the long-acting version for ourselves. And any gene-therapy applications too."
The problem with keeping something for our onesies, is that Cytodyn is not in a position to build out a proper go-to-market team. Nor do they seem to want to. You need a LOT of people to go from four employees and a slew of consultants to running your own regulatory, marketing, and sales teams. The vast majority of small biotech companies take the buyout for that reason. It's truly a job for the big boys, and we'll have a big boy already eyeballing the whole shebang.
But I like your thinking on the GF involvement, and I too think it will play out that way. We're going to have them involved for probably HIV and Alzheimer's (my best guess) and a big pharma partner for fibrosis/Mash. This combo allows us to get all of our initiatives advancing forward as fast and reliably as possible. Money won't be a problem.
But we differ in that I believe somewhere along the line the Merck/Gilead/GSK team is going to have to offer a truckload to buy the whole thing before it's so far along they literally can't afford it.
I don't see our eventual buyout floor being anything less than the $21 billion Gilead paid for Immunomedics, as long as things advance even partially like we all hope. It'll be super interesting to see how this all plays out, who gets in for how much "now", and what that means for the timing and price of a buyout offer down the road. But make no mistake, we're in the negotiating period for the partnerships right this second and could/should hear something at virtually any moment.
"And hanging over any potential deal out there, for any of the indications, is the long-acting version under development. What Pharma Co would sign a deal for weekly leronlimab when a longer-acting version is just a few years away?"
I believe the main thing hanging over our heads was lack of robust data, along with, and stymied by, the remnants of what was once an active, well trafficked circus. The tent didn't come fully down until recently, and the bearded lady just finally stopped swinging by to shave in the executive bathroom. The cleanup has been a priority behind the scenes, and as we just witnessed with the mTNBC follow up we were all annoyed nobody seemed to think of doing, there's much more to the Leronlimab story that needs to be told. A guy in a top hat holding a CYDY coffee mug ultimately wasn't going to get the job done, well intentioned or not.
The original plan was to provide just enough compelling signals in a variety of indications to boost the buyout price. It actually came very close to working, but for those pesky kids*.
*the FDA, Amarex, Gilead-stocked DSMB decisions, and more!
The plan now is not much different, except that the data will be more of the unassailable variety and nobody is hawking peanuts or hot dogs. Not to mention the quantity of such data, which together will help dictate any current partnership and/or future buyout with more precision.
That's where the preclinicals are helping our cause. They're inexpensive, all things being equal, and fairly quick too. They help clarify Leronlimab's dosing and potential capabilities in each indication we're trying to grow. Which is necessary to bolster the often-muddied-but-always-compelling sparks of human data we have across all indications.
As for the worry that a long-acting LL being close to reality is dragging out the talks, I'd argue it's not going to get in the way of any current licensing or partnership deal. If anything, it just makes CYDY and LL more valuable. It'll allow whoever owns the drug to extend patent life and broaden LL's market.
The ways and conditions in which Leronlimab will be impactful will be worthy of infomercial-worthy ads. It slices, it dices, it juliennes!
There'll eventually be a variety of ways in which LL is dosed to ensure the right amount of Leron is humping (medical term) the appropriate number of CCR5 receptors for the correct amount of time, and no more or less. So basically, long acting is like, the 10th trick our little pony has in its future. By then, of course, it wont' be a pony any longer but the Secretariat of platform drugs.
Big pharma wants LL for Mash, fibrosis, and/or oncology right this second. The sooner they get it, the less it will cost them on both the front and back end. Because if they wait too long to lock in fibrosis, there's going to be advancements in crc and mtnbc initiatives. Alzheimer's capability will become clear. Glio potential starts to grow fast like, well, a glioblastoma tumor. The price to play goes up substantially every time new data advances one of our indications.
Which brings me to something I've been saying behind the scenes with people. It probably won't be a very long time from the start of a partnership to the offer of a buyout.
Because if you license an indication the traditional way, with the intent to see it through a phase 2 or 3, or through approval, at which point you intend to buy out Cytodyn, that's going to take at least a year on the very aggressive side of things. But more likely a few years. They need to get a trial or trials rolling, see them through, and spend months analyzing the data. By that time there's a possibility (just throwing out hypothetical and hopeful scenarios here) that maybe we learn that the DSMB in the crc trial recommends stopping the trial and giving everyone in it LL based on early success. Or LL helps cure an HIV paitent. The Bill and Melinda Gates Foundation collaborates on HIV and Alzheimer's and we get preliminary data in humans that shows LL slows or delays mental decline.
My point is that each of the fires Jay and the team have going are building in real time. Merck could come in and snag fibrosis and Mash with a killer licensing deal, but long before we get to the traditional buyout period for licensing deals (advancing the drug through phase 2/3 successfully, or winning approval) there's bound to be one or more fires for giant indications like oncology raging damn near out of control.
We're on the cusp of so many huge advances and how it all plays out is anyone's guess. Which puts us in control of our own destiny, just like Jay said. But I think he meant it in terms of having the leverage of multiple, major indications advancing successfully in real time. We don't have to go to anyone, they need to come to us.
So that's why I think we get a strong licensing deal very soon from a company capable of buying us out one day, and that "one day" comes quicker than what traditionally happens. Get in the catbird seat and be in position to buy Cytodyn while three huge indications are just potential versus later when one or two are mere steps from approval and you have to add a zero on the end of your offer to get it through.
You also wrote:
"Personally, I'd like to see Cytodyn partner with someone for one of the inflammation-related indications. (Pick one! Several to choose...). That, along with Gates Foundation money for the HIV cure, would give us enough cash to aggressively go after the cancer indications. And then hand off leronlimab to NP2 when the weekly version of leronlimab goes generic. And we keep the long-acting version for ourselves. And any gene-therapy applications too."
The problem with keeping something for our onesies, is that Cytodyn is not in a position to build out a proper go-to-market team. Nor do they seem to want to. You need a LOT of people to go from four employees and a slew of consultants to running your own regulatory, marketing, and sales teams. The vast majority of small biotech companies take the buyout for that reason. It's truly a job for the big boys, and we'll have a big boy already eyeballing the whole shebang.
But I like your thinking on the GF involvement, and I too think it will play out that way. We're going to have them involved for probably HIV and Alzheimer's (my best guess) and a big pharma partner for fibrosis/Mash. This combo allows us to get all of our initiatives advancing forward as fast and reliably as possible. Money won't be a problem.
But we differ in that I believe somewhere along the line the Merck/Gilead/GSK team is going to have to offer a truckload to buy the whole thing before it's so far along they literally can't afford it.
I don't see our eventual buyout floor being anything less than the $21 billion Gilead paid for Immunomedics, as long as things advance even partially like we all hope. It'll be super interesting to see how this all plays out, who gets in for how much "now", and what that means for the timing and price of a buyout offer down the road. But make no mistake, we're in the negotiating period for the partnerships right this second and could/should hear something at virtually any moment.
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