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Nailed it - they’ve said as much several times on calls or conferences. RP came to them and asked permission to study leronlimab, and we didn’t find out about it til his studies were complete and they were contemplating a merger or buyout. My guess is that this was known to the company as far back as maybe mid-2017. Well before mono had shown the efficacy necessary to make this an interesting acquisition target for any BP, and well before combo even hit PE for the pivotal P3.
Realistically, no deal was ever going to happen in that time frame, we just had no way of knowing it. Such is life. It allowed me to do a lot more DD, and buy a lot more shares for cheap. I suspect I’ll be perfectly happy with all of the Paulson funding that resulted when the book is finally written on this company.
Any personal opinions or trading strategies aside, if I were doing any negotiating on behalf of the company, I’d certainly be precluded from any open market trading.
Which is probably why you haven’t seen form 4’s for open market transactions from the principals or board members in at least two years.
Interesting information and context, thanks trding.
Nope. Pretty sure they’d rather see this go to $100.
It could happen I suppose, but it would be an expensive and dangerous game to play at this point with this ticker. I wouldn’t do it even if I were bearish on it. Too many shoes that could drop and blow up your short in a heartbeat. And if you’re thinking of more nefarious shorts, they’d be late to the game to influence the direction of the company, in my opinion. I just don’t see that being the case.
On the other hand, it makes a lot of sense for Paulson investors to short and cover with their own shares. I WOULD do that, were I so privileged. And then put my money right back into the next round, before I even had possession of the first round of shares.
That’s actually a pretty shocking about of short volume. Wouldn’t have suspected that. I guess it’s possible that some of the Paulson investors are shorting in anticipation of taking possession of shares. That would make more sense to me than actual heavy shorting at this point.
Excellent, I love a good application of Occam’s Razor. Here’s my application.
The people with the most information, including material non-public information about the company, the drug, the trials, the conversations with the FDA, and any conversations that may have occurred with potential partners and suitors...
...are so unconcerned about the need for additional money long-term that they haven’t bothered to ask for R/S authority or an authorization to raise the A/S. Those things take time, they don’t occur immediately. The simplest explanation is that the people with the most information are making rational decisions, and expect that future funding won’t be a problem.
As to your application, you ignore several things in your assumptions.
1) The company has raised quite a bit of money over the years from the selling of shares to accredited investors. Ostensibly, your smart investors. Some of those may well be family trusts, VC, or other institutions. You have no way of knowing who the holders are, or what positions they maintain. So the assumption that “smart” investors aren’t putting money in is just that - a big assumption.
2) The OTC, in addition to giving a stigma that many individual investors - even “smart” ones - won’t touch, also precludes the vast majority of mutual funds from making investments. This eliminates a massive portion of the “smart” demand curve that NYSE/NASDAQ listed stocks may enjoy. It also creates massive information inefficiencies and asymmetries since OTC companies get nearly zero coverage from credible analysts, simply because they are penny stocks.
3) No external source is going to provide funds on more favorable terms to the company than they could easily get by participating in the private placements through Paulson. That’s an economic irrationality, and will continue to remain in place until the expectation of future raises no longer exists. The one counterpoint I’ll accept is that there is currently no partnership, but I’ve addressed my logic for that in depth several times.
So, Occam’s Razor looks for the simplest solution. Whose application makes more assumptions?
Tell NP I’ll do it for warrants next time you talk to him.. ;)
Thanks, glad you enjoy the posts.
Waiting is tough right now. I think everyone is a little on edge. We’ll all know more soon, though never as soon as we’d all like.
I honestly haven’t bothered to put a price on cancer. If it works, the number may be unfathably big. It also likely would not be a buyout, but a partnership. BP, even if they could afford it via cash, stock, and financing, would be highly unlikely to place that large of a bet on one compound, no matter how great. I’m thinking Celgene money. Partnership is WAY safer for them. Value to us would jump significantly on the cash up front and the deal, then revenues would start to drive the value up. It would take a little while, but everyone involved would likely become very wealthy.
If cancer DOESN’T work, I’d suspect either a much lesser partnership, or maybe a buyout in that case. They’d get a significant portion of the value of mono, I believe. Realistically, maybe a $8b buyout give or take a bit. Neighborhood of $14-15/share. Just my guess at this point, no real modeling work done because since mono hit over 90% efficacy rates with a strong safety profile, I have zero doubt that in a worst case scenario the buyout would create value well above any share price this ticker has seen.
$8/share cash plus rights to royalties and they take it. Zero chance they take a BO offer tomorrow at $8/share straight up.
Maybe if cancer data bombs.
It’s a fair question, you just forgot to add the critical modifier “in cancer.”
Your answer? Leronlimab has not been used in human clinical trials for cancer to date. However, another CCR5 inhibitor, maraviroc, has. The results were fantastic. Unfortunately, maraviroc has toxic side effects. Even more unfortunately for Merck, they can’t commercialize it for cancer because CytoDyn’s IP prevents it until 2033.
The safety record for leronlimab is fantastic in all HIV trials to date, and the suspected mechanism at play for inhibiting cancer metastasis has shown results in humans with maraviroc. Leronlimab has significantly superior results in HIV (same mechanism...) to maraviroc, and has shown great promise in animal studies. Therefore, there’s very good reason to believe that the first cancer studies in humans with leronlimab will show both safety and efficacy in inhibiting cancer metastasis. Two caveats:
1) There’s no reason to believe that there would be adverse interactions with front line chemo - in fact, there’s reason to believe that it will be synergistic. However, anything is possible.
2) Efficacy in HIV trials has been dose dependent, due to the need to saturate CCR5 receptors. Higher doses work better. However, the first 18 cancer patients are a phase 1 dose escalation arm. The first information we get will be on the lowest dose. It’s reasonable to assume that it will be less effective in inhibiting metastasis at the lower dose than at higher doses.
Hope this is helpful. There’s a lot of noise and misinformation on the board, so folks can get defensive. Just ask specific questions, and you’ll get specific answers.
Since you asked... until very recently, the high water mark for market cap was in June of 2016 at around $150mm. The trend line was generally negative/flat until the last, say, six months, where the trend has generally been positive.
But market cap is a flawed measurement in some ways, it doesn't account for warrants, for example. Further, one could take that either way:
1) Look at the number of warrants out there! If the market cap is $A with X number of shares outstanding, if you add in all Y number of warrants, the share price would dilute down to [A x X/(X+Y)]!
2) If you consider that a rational person would view Y outstanding warrants essentially as issued shares - as would be the case if you expect the SP to rise and the warrants to be executed - then rational shareholders who are willing to hold shares at $A market cap must think that the true value of the company is at least [A x (X+Y)/X]
The bigger flaw in this scenario is that market cap is simply the product of outstanding shares and the current share price. If the share price isn't reflective of the value of the company due to illiquidity and access issues inherent to the OTC, or more unique circumstances such as a binary view of final valuations based on upcoming data, well...
The market cap really doesn't mean much.
To be fair, I agree that some of greedfear's recent posts were bordering on personal attacks or threats under the TOS. If I was a moderator I'd have removed them as well. Just like my AOC post, even if mine was a combination of a joke and a well-received olive branch.
My post about the Seeking Alpha blog being trash and bordering on libel? That's a different story, and I'm still annoyed that it was removed. I don't believe that it was a general iHub mod - you generally get a PM'd warning from them after they delete your posts, in my experience.
First, apologies for previously referring to you as "he". I simply assumed. You may not care, but apologies all the same.
Niceties aside, let's address business. To summarize your post, you acknowledge that you don't possess deep knowledge of the company, the product, the history of either, or of the biotechnology market in general. So, your entire thesis is based off of "two years ago, the stock was $1.20, why is it $0.50 now?"
Yet I'm the one missing the forest for the trees?
I've described at length in previous posts why funding has not improved, so I won't re-type it all here. You can do your homework and go back and find the details. In short, as long as there has been a viable product that threatened BP cash flows and would sufficiently entice them to action (mono efficacy), there has also been the possibility of a much larger market (cancer). BP isn't going to pay cancer money until it's proven to some degree, and CytoDyn isn't going to accept HIV money when they think it's worth cancer money. The sides have been too far apart. I maintain that splitting indications among BP is unlikely, just as I've maintained for months. If you remove the real possibility of a deal with BP until cancer plays out a bit, you're left with raising money through shares. No VC or IB is going to give the company money on better terms than they could get through the direct offerings, so that's off the table and always has been. Eventually, to tap the same well again and again for direct funding, the terms are likely to improve. This is self-reinforced by the warrant offerings which allow investors to sell shares into the market and keep exposure to the company. As such, I've long maintained that the share price won't significantly appreciate until the need for further dilutive funding is clearly past.
You should also examine your view of "desperately low on funds". If there's any veracity to my view that a transaction of some sort is likely to happen shortly after early cancer data, then "desperately low on funds" is a gross overstatement, and management should instead be applauded for raising only enough money to get to where they need to be.
Time will tell, I agree with you there. That's where the agreement ends. If you want to be taken seriously, you should support your thesis with something better than a trend line.
You're free to have that belief, but it's not dissimilar to saying that if I approach a curve in my car after I've been going straight for several miles, I'm inevitably going to drive straight through it. I've been driving straight for a while, so I'm clearly an incompetent driver and I'm not going to turn the wheel, right?
As I said, you're free to have the opinion that management is incompetent. However, the simpler explanation for why the fundraising has continued in the fashion it has been and yet there has been no ask regarding either a reverse split or additional authorized shares is simply that management doesn't expect to need to continue raising funds by selling shares. You haven't - and never have - provided any evidence to the contrary. On the other hand, I've at least advanced what I believe is a plausible theory:
The valuation of a transaction of any sort is nearly completely contingent on cancer efficacy due to the potential size of the market. Neither side is willing to make concessions prior to seeing early cancer data, particularly since generation of said data is possible in the very near term. Once cancer data is clear, a transaction on some level will most likely take place and alleviate funding needs. There's enough cash and shares to generate the cancer data, therefore there's no need to ask for authority for a reverse split or an increase in authorized shares.
Your turn.
I'm relatively certain that you and Suvarov know each other. Likely eetrog as well, but that isn't as easy to connect.
- You've acknowledged that you have a "group" that you work with.
- You have a tendency to support each other's points with very little factual support or pushback. Which is fine if you want to do that, but it's somewhat odd that Suvarov only tends to show up when you're in your more negative moods.
- You type in very similar syntax - very good English, but often improper or incomplete conjugations, for example. No offense meant whatsoever! Your English is far better than my Spanish, and FAR better than my Swiss/German/French. I'm just pointing out another similarity.
- Suvarov accidentally typed your name properly. Dead giveaway. And then felt the need to edit his post after being called out on it. It now says "thanks Fines" instead of "thanks feinsand", for those who missed the original.
- Your handles were established less than two weeks apart.
Yeah... there's some conjecture here, but I don't think I'm wrong. There's nothing wrong with being a flipper if that's what you want to do, but I don't like how you talk out of both sides of your mouth depending on whether you want to buy or sell, then act like you're some impartial analyst. I never have liked it.
It must be nice not to have a capital gains tax in Switzerland.
Well, finesand’s name is Sandra Fein. So either he mistakenly spelled her name correctly, or... well, you know where this goes.
I don’t feel the need to point out the obvious here.
Thanks tonysd57, appreciate the comments. I think your proposed timelines are pretty reasonable, though the BLA filing could be later. There's so much that goes into CMC, and they need to get that part right the first time for sure.
As to the mono trial, that's an interesting question right now no doubt. My guess - pure opinion - is that any deals being entertained at the moment are contingent on cancer data and they're simply full steam ahead on that, to the point of putting mono on the back burner for a moment. I say this because the investigational mono trial shows efficacy that should assure suitors that given whatever data the FDA requests from a new trial, the likelihood of approval for that label expansion is now very high. IF you're pursuing a deal, you've already demonstrated efficacy in mono (which I believe they have), and you have limited funds... you simply put those funds towards cancer and the BLA.
So I think that we'll hear about mono when we hear about mono, but I'm not going to be shocked if it doesn't start for a little bit here because I doubt that's the element of value that's currently a hypothetical sticking point in any negotiations. I also won't be surprised if the FDA accepts a relatively small (50-100 patient?) trial with a relatively short (24 week?) time frame. In that case, given a scenario where funding is secured from a partnership based on cancer results, the company has plenty of time to kick off that trial in May or June and still have the data ready nearly immediately for an sBLA after the (hypothetical) approval of the combo BLA. So... just no big rush. I could be way off on any of those assumptions about the trial though, and I still don't think it would change the strategy much. Cancer will most likely drive the details of a deal, not mono.
Last post for the day. Thankfully.
In response:
There are no additional details publicly available.
However, as part of the FDA approval process, a company has to be able to demonstrate the ability to effectively produce commercial quantities of the product at commercial grade. What NP was saying is that they're working on arrangements with commercial-scale producers whereby CYDY isn't going to pay for the product - at least in full - up front. The manufacturing company would take future payables as the drug is commercialized and sold.
So it would solve a big CMC issue for the BLA without spending a lot of money.
It's not lost on me that the only point that you responded to was the least relevant to understanding the situation at hand.
I disagree with just about everything that you said.
Yep, but for the fact benders around here...
The study WILL run until 2022 most likely. It's just that someone will have been marketing and selling leronlimab for TNBC for two years or so at that point, and the trial is only going to serve as confirmation of efficacy and safety, not a demonstration.
Again misiu, just adding to your point for those who are less educated on the trials/approval processes, and who are more likely to be misled by posters who may bend the truth to fit their narrative.
Oh I know, I'm agreeing with you! Just making sure that folks who are less informed on the clinical trial process and various approval pathways aren't misled by "true" statements that the trial won't finish until 2022, etc.
If the first cohorts come back strong, money isn't going to be an issue and Pestell will be able to advance any clinical trials he wants. Which will be great for literally everybody.
Oh the company will do the P2 one way or the other.
But if the first cohorts are good, the P2 portion will become an expanded PIIb/III post-marketing confirmation trial.
I'm considering offering my services to the company. I'm pretty sure that I could handle the role of Kobayashi from The Usual Suspects. You don't know me, I don't owe you anything, and my employee wants me to deliver the terms of this deal that you really shouldn't refuse if you value your future.
I'll do it for warrants. Hey NP/RP, DM me.
True. But we're talking about expiration, not exercise.
Yep, you could dig through every 8k and put together an exact timeline of when warrants were issued and on what terms, then put together a table for warrant expirations... but I don't really expect it to matter. I consider it an academic point.
I feel like trding put together some numbers a while back, but the reality is that all of the warrants have 5-year expirations and the vast majority were issued in the last year or so. I recall that the amount that would expire in 2019 would approach immateriality.
NP was very clear in the NobleCon presentation that they would be reviewing efficacy data in the dose escalation phase, and wouldn't hesitate to apply for BTD based on early positive data re: CTC reductions.
The rest is less a response to your question, and more a response to the claims that "maybe we'll get the trial finished in 2022" and whatnot.
Let's not forget that the FDA is not opposed to granting accelerated approval on the back of very limited data in cases of serious unmet medical needs. See: eteplirsen. Cliff's notes? Duchenne's drug, approved (though somewhat controversially) through AA on the strength of a P2 trial that was stopped after 12 patients. There were arguments over whether the trial even showed benefit to the surrogate endpoint. Very little safety data available. Granted, different condition, orphan disease... I get it. But there's a lot more data on leronlimab in general. Oh, and the FDA already likes CTC levels as a predictive surrogate endpoint in other metastatic cancer indications.
https://prostatecancerinfolink.net/2018/01/11/ctc-levels-as-a-surrogate-endpoint-for-clinical-trials-in-mcrpc/
TNBC is a death sentence and leronlimab has demonstrated safety in hundreds of patients over several years. They'll have to evaluate safety in combination with chemotherapy, but when the disease is a death sentence I'm betting the FDA will take its chances. This is why BP will move on early positive results.
Still have to bring it to market. The ideal is strong cancer data precipitating a very, very friendly partnership deal with BP. Which I think is the most likely outcome by far, despite my earlier questions about going it alone strategies.
But if I were CYDY's management right now... I'd be presenting Gilead with a take it or (permanently) leave it offer. Couple billion (maybe $3-5b) up front, they get the lion's share of HIV revenue (call it 70/30 for GILD), CYDY gets the lion's share of all other revenue (70/30 for CYDY). Tell them they have 48 hours, counterproposals or amendments will be considered outright rejections, and they'll never be negotiated with again after this offer. You're offering them the chance to save their HIV franchise - which they will otherwise lose the majority of - and likely get an all but free significant revenue stream on other indications (cancer, GvHD, maybe NASH?). Put their backs to the wall and soak them on the cancer revenue for better revenue split terms than the company would likely get elsewhere. They're over a barrel with the KITE acquisition falling apart and their late-stage NASH program failing. They'd have to pull the trigger. And even getting soaked on terms and with the up front money, it would be the best deal they've made in years. Plus, it would leave them cash to continue to pursue other pipeline options, rather than trying to buy CYDY outright and putting all of their eggs in one (damn good) basket.
GILD would hate it, but they'd take it, and the reality is that everyone would win.
Appreciate the response, finesand. I'll concede that the AOC posts were off-topic (who cares?), but firmly disagree with the assertion that my post regarding the claims made in the blog were off topic.
If it was IH Admins, so be it. I believe it would be best if they explained to the board why that was an inappropriate or off-topic post though.
Last post for the day either way.
I read this article when it came out a month ago, but somehow this line didn't catch my eye until just now.
“We actually tried to consummate some deals; they haven’t worked because we haven’t had a willing seller, or the asset was too robustly competitive because it was a late-stage asset,” Merck CEO Ken Frazier said at the conference.
That description neatly ties my current assessment of CYDY into a more succinct statement than I'm capable of making. Not willing to sell for the price offered at this late of a development stage. That's not to say he's talking about CYDY... but damn, that sounds pretty accurate to my ear.
Welcome. I was wondering if the HIV comments during the State of the Union would bring in some interested parties. Unfortunately, being on the OTC and trading at $0.50/share will keep many people from ever giving it a second thought, which is why, as you say, more people haven't found this incredibly exciting. That will turn out to be a costly mistake for them, because BP will not have that luxury when cancer data starts coming out.
Really, Gilead doesn't have that luxury now, what with the CAR-T write offs and the latest failures in late-stage NASH treatments. If somebody moves on this for the cancer indication, you better believe they'll be happy to steal GILD's HIV revenue stream as well. They should just pull the trigger before cancer data, if they even have the opportunity to do that at this point.
The only way that the article could be considered "thoughtful" is that it very carefully stayed on just the right side of a libel suit.
... a sophisticated crew would be better at what they do.
Don't feed the trolls, folks.
If they're actually short, you'll never convince them regardless, because they already know the score.
If they're actually stupid, they'll drag you down to their level and beat you with experience.