A string of fascinating messages and replies you might enjoy:
: Katangolo
Dr. J and the Team have been keeping their cards close to the vest. This started before he came on board when we were handcuffed with the FDA hold. We had proactiv videos, YouTube interviews, etc; it all looked like a circus roadshow.
The powers that be didn’t like this for obvious reasons and the pendulum swung back viciously, giving us almost no communication during the Hold. CA Comes in and tells us the pendulum is swinging back and the team tells us we will be pleased with their new approach to communication with shareholders. So we then get quarterly calls and press releases.
Jay comes in with his quarterly letter to shareholders. Not much in terms of conference calls, and Q&A session sessions that we were used to for years. Basically we are told you can submit questions, but nothing’s really ever answered, and there are no direct communications with shareholders outside of the shareholder letters and press releases.
This is frustrating to many out there, but I’m OK with it because I think they have an endgame in mind. Our new PR firm seems to me to be brilliantly, rolling things out in a cadence that leads to the endgame and those with diamond hands, a steel gut and patience can manage this without the fret that other shareholders are experiencing right now.
The approach I see the company taking is - give us a few hints at the direction they are going and they don’t tell us when they begin the studies or the endeavors that they are hinting at but instead let the results happen first, and then inform us. They did this with glioblastoma, they did this with the mash trials, they did this with SMC labs., and they’re doing this with the work that Max, Richard, and Melissa are doing.
Do we think they are not working? Absolutely not. We’re getting breadcrumbs about what they are doing and we are, like I’ve said for a while, putting pieces of a puzzle together. Collecting the breadcrumbs. The real problem, which is actually a gift, are the NDA’s, which are in place. We’ve been told since the times of Scott Kelly that multiple NDA’s are in place. And subsequent levels of leadership have also told us NDA’s are in place.
I believe we are in a silent period now because of those NDA’s. If the suppositions above that I am positing are true, the company can’t say anything to begin with and their m.o. has them with a results first, then inform (shareholders) later, approach.
So back to the question about what is actually going on right now. This has me thinking that the trials with Trodelvy and Keytruda are underway if not finished. Glioblastoma as well. The same possibilities strongly lead me to believe this is the case with fibromyalgia, Alzheimer’s, pulmonary fibrosis possibly HIV and inflammation although my gut says this has been shelved, CRC & mTNBC. Jonah is working hard on an HIV cure and we are getting strong clues that BMGF is involved in probably making moves behind the scenes.
So yes, this is frustrating from a shareholder perspective (or is it?) because we want to know what’s going on and we would like to share price to go up. Come back to the concept of the NDA‘s, which hamstrings the company from telling us anything but allows them to be sitting at a table negotiating with all of the big Pharma, who are salivating over the very real possibility that, through a negotiation, they can get access to controlling and developing this molecule for the indications they are interested in. Hopefully one company wins it all and doesn’t piecemeal the indications but we don’t lose at all if for example, BMFG gets HIV and someone else gets fibrosis, etc.
These negotiations take time. We have a lot of evidence that negotiations are going on right now. Silence is certainly a big clue. So Jay drops a few press releases to keep us happy and let us know what they have been working on and shareholder letters give us clues as to what they actually are working on.
It’s an honor for me to be a part of this group of people; these Internet sleuths, made up of lawyers, researchers, lay people who are investors, doctors, engineers, and beyond. Collectively, we put our pieces out there for each other to digest and synthesize a story that’s becoming more beautiful each day. It helps filling the gaps of the silence we sit with.
But that silence is leading us to what I believe will be the promised land. Patience leads to Patients.
All IMHO and certainly not financial advice. Just hope.
GLTAL
sherlock57
Re: Katangolo #150780
Kat--Appreciate your post on the "radio silence." Like you, I think our patience will be amply rewarded. But I suspect the extended nature of the negotiations probably have a lot to do with the uniqueness of the mab itself--the various indications it can address, the difference in price-point for life-saving drugs (think cancer) versus more maintenance kind of uses (say HIV or AD). 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 also don't think Jacob Lalezari is a "normal" CEO--in other words, he's not just in it for the money. So I think "the vision thing" should be part of the discussion--how does Dr Lalezari want to develop the drug? I don't know how it plays out, but he is the current Vice President of the Board and founding member of NP2, a non-profit Pharma Co whose mission is to reduce the price of generic cancer drugs whose prices have skyrocketed in recent years. I don't think he is going to let his role at NP2 interfere with his fiduciary responsibility to shareholders--I hope not! But I think his humanity will guide--is guiding--some of the decisions that lie ahead.
I can't think of any other drug out there, when it is approved, that can be used for multiple life-saving indications as well as multiple chronic indications. How does one go about pricing leronlimab for a cancer cure--as the recent press release on mTNBC suggests--when it will also be used weekly for inflammation-related indications? Can you price the same drug differently for different indications? If it's priced like a cancer drug, any off-label use would be prohibitive. So I suspect any Big Pharma out there would have to consider these kind of issues when negotiating with Cytodyn. And that's why I'm fine being patient. And I love all this preclinical work and the upcoming clinical trials--we need more hard evidence about leronlimab's MOA and utility in various indications. Even if it takes longer than we might hope.
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.
Hey, I'm not a medical professional, or a lawyer or a Wall Street guy. I did go to art school, though, and I'm well-trained to think big, and think creatively. Kat's post was quite thoughtful and detailed, and inspired me to riff off on the above-related concerns, which have been rambling around in my noggin a while now. I'd love to hear any responses from doctors and lawyers and people in the business. And one final thought--when I think about Dr Lalezari, the old saw about TR comes to mind--Speak softly but carry a big stick. To any Cytodyn stockholder, I'd say Lalezari should "Speak softly, and carry a laptop full of unimpeachable data." Not quite as poetic, but appropriate to our situation.
At the risk of sounding like Colombo--you know, "Just one more thing"... I'd like to express my gratitude to the Board and the mods. I feel like I could sit down with any of you here and have a good, reasonable conversation. And remain civil throughout. Can't say that about any other stock message board! Thanks everyone.
Respert24
Re: sherlock57 #150813
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.
AI
