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I agree. As poorly written as the PR’s typically are, I don’t believe they’d leave that event up to word parsing. I expect we’ll hear something in the next week or so.
Sjacobs26 - I don’t have PM, but thanks for checking in. I haven’t gone anywhere, just been pretty busy with work and life. Plus, sometimes there’s just not a ton of new info to talk about, and it’s not always worth the (irrational?) stress of checking the board and responding every day. It’s worn on me after a few years, and I simply need to take breaks.
I actually don’t have any direct experience in licensing or partnership, and I apologize if I gave you or anyone else that impression. I’ve simply researched every biotech deal I can find for the last ten years or so to try to understand structures, norms, and expectations. I think that overall, the situation CYDY is currently in is in a class by itself - there’s no previous deal that you can really comp to their present position. As a result, I think that basically ANY sort of deal structure is potentially on the table, with up front money and revenue splits as levers to be manipulated to serve the strategies of CytoDyn and any potential partner. There’s so much strategy information that is non public that there’s really no way of guessing what direction it may take, in my opinion. With cancer being the bigger but by far, a deal for HIV may not end up being what we’d love and expect if the company prioritizes just having the cash to get through the next 12 months or so and not try to make a huge payday of it. To your point though, the revenue splits you mentioned tend to be reflective of deals that take place much sooner in the development process. In essence, the partner is shoulder the financial risk of development, and reaping the reward at the end. In this case, the risk/reward is quite different as combo is already past P3 endpoints. I know what that does to risk and deal structure in an efficient world. Who knows what it will do here? I think we’ll all end up happy though. I also agree with your speculations on price floors and expected value from combo, etc. Which makes the investment s no brainer, but it may take patience. C’est la vie.
We also tend to focus on HIV/GvHD for deal discussions, but they could easily be negotiating something on the diagnostic test as well. After all, they’ve mentioned that they’re in talks on “several fronts,” if I recall the quote correctly. Again, that knowledge may change what they’re willing to accept for any single asset in a license/partnership deal.
And to be clear, you’re actually a bit longer than I am, but a terrifyingly large portion of my position is on leverage. “Big” to one person may be “borderline irresponsibly concentrated” to another. For what that’s worth!
Ah, good call. Upon reading this, I checked Allergan's pipeline as well. Nothing about HIV at all. Pretty sure the other two TAK CCR5's are dead in the water. For ease of reference for others:
https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allergan-pdf-documents/rd/advancing-the-pipeline-q3-18.pdf
Also, I agree with BL that I think that you're right about this statement quoted below:
I did some quick DD on cenicriviroc the other day. The short story is that they never went past PII for HIV, and that was back in 2013. It was hitting best responder rates of around 70%. Moderate drop out rates due to adherence... you need the pill daily. Same old story, and doesn't pose any real threat to HIV at this point. Even if they did develop it further for HIV, leronlimab will beat it to the line. Then CVC will have to try to take market share against an extremely safe, once-a-week drug that in tests to date has also shown better efficacy. That's a tough sell. Probably why Takeda hasn't advanced that one further for HIV.
They've since focused on NASH for CVC, since CCR2 is expected to play some role in NASH therapy as well and CVC is a combined CCR2/5 inhibitor. I personally think that this is one reason CYDY hasn't gone fully down the NASH path yet - CCR5 may not be a magic bullet for that one. Worth pursuing down the road when money isn't an issue? Sure! Might be the safest, most effective CCR5 inhibitor out there, so it could have a place in a cocktail of drugs for NASH if current thinking is correct.
The paper you posted for TAK-220 is from 2005. Neither TAK-220 nor TAK-779 are listed in Takeda's current pipeline, nor is there a single clinical trial listed on clinicaltrials.gov. I'm not too worried about either of them, but can't hurt to learn more.
I guess you'll have to explain it to my inferior brain, since mine doesn't divine meaning.
Any chance that you'd like to restate that as a complete thought?
I'd like to (not very) patiently explain to you why you're not making any sense - again - but I have no idea what you're even trying to say with that post. Very effective.
Perhaps you should consider three things. These should already be clear to you, since you've followed this stock for so long:
1) Absolutely true that an outlier cured patient or two, based on semi-known mechanisms and somewhat available procedures, could lead to a cure. No doubt. And that would be a great thing! However, it's highly unlikely to happen on any measure of scale - if it happens at all - within 5-10 years. Remember the first "Berlin Patient" to be cured via stem cell transplant? That was 2008. Only 11 years later and we have a second successful case! So even if this DOES lead to a cure for HIV, it's unlikely to happen until leronlimab is staring marketing exclusivity mortality directly in the face anyway. Effect on current value? Roughly zero.
2) Remember how the article (that you may not have read) stated that the treatment is "dangerous and has failed in other patients"? Do you know why it's dangerous? It's a complication called Graft-versus-Host Disease (GvHD). Sometimes it's an annoyance, sometimes it kills you. Actually, in a more thorough AP article, it was mentioned that both the Berlin Patient and the London Patient experienced GvHD, though the article failed to mention it by name. If only there were a drug that was effective in combating GvHD in stem cell/bone marrow transplant scenarios...
3) Leronlimab's most valuable, though not most advanced, indication is clearly cancer. This article has zero bearing on that whatsoever, notwithstanding the remote odds that a "cure" therapy could advance fast enough to have significant impact on leronlimab's value as an HIV indication.
If you've been following this for years, I'd hate to see your hot take on something you've just looked at for the first time. But you're entitled to your opinion. Carry on...
Since your time is clearly too valuable to bother with reading an article prior to posting foolishness on a message board that you don't frequent (5 posts, including the two worthless ones today), I'll just leave this right here for you. It's a direct quote from the article.
The review cycle does not “typically” start. Is this PR implying that the FDA will actually begin reviewing portions of the BLA ahead of time? I don’t know. That would be beneficial though. Even if the official PDUFA clock doesn’t start until final acceptance of the full BLA, reviewing major portions of the work ahead of time could expedite things. The FDA has been known - recently - to approve drugs months ahead of PDUFA dates in select cases.
Regardless, I think that we can all agree that NP should hire Bored Lawyer to write the PR’s so words would have meanings again. I tire of parsing the company’s choice of words on every single thing thanks to careless or imprecise language.
I MAY be incorrect with my previous assertion, and it would be a good question for NP. As others have mentioned, FDA permission for a rolling submission was previously stated by the company. Either way, Rolling Review is not standard FDA practice any more than Fast Track - with which RR tends to be associated - or Breakthrough, ODD, etc. They’re all designations or privileges granted to specific drugs.
I disagree. Rolling submission and rolling review are two different things. Previously, the FDA had allowed CytoDyn to submit a BLA on a rolling basis, but would only review the complete final product. That’s basically worthless. Now, the FDA is planning to actually review pieces as they come in, expediting the overall time to approval granted that the last piece gets in when it always would have.
This is news, this is important, and it does signal FDA support in some manner.
I tend to think that enrollment isn’t an issue, but getting every last detail of the trial procedures is probably extremely important. Remember, Pestell seemed surprised at how quickly the FDA approved the IND. This needs to be done 100% correct the first time - I doubt the patients are the hang up.
Otherwise, you end up in the situation we’re in now where we need more data from mono patients for HIV to support the combo BLA, because they failed to do a proper dose escalation phase in combo from the start.
Maybe that’s semantics (enrollment vs. getting the details right), but it makes a difference to me after the difficulty enrolling the combo P3!
Edit to last post: my income numbers for accreditation may be a little off. The point still stands.
Yeah, I think that the key may be recognizing what counts as an accredited investor and comparing that to the minimum Paulson investments required. To be an accredited investor:
1) Be worth over $1mm, excluding primary residence, or:
2) Make over $250k for the last three years.
Neither of those necessarily and definitively put you in a place where a minimum investment of $50k in an OTC stock is a comfortable or easy thing to carry. However, if you can put in $50k, take out $52k, and keep warrants? That becomes very doable. I would guess that regardless if potential outcomes, the vast majority of individual accredited investors simply don’t want to carry $50k+ of exposure to an OTC stock if they can keep warrant exposure for free. Simply too large a portion of liquid net worth.
I’m with BL and finesand on this one. And if Paulson + OTC doesn’t fully explain the SP, I bet it explains 95% of it.
Correct. Trding can explain this better than I can if further detail is necessary. Still, seems to be a legitimate amount of short interest in the bi-monthly reports. I have to wonder if it’s not from Paulson customers whose brokers allow them to “short” knowing that they can deliver restricted shares not yet salable, etc. That would seem to make sense on all fronts, but I have no idea if brokers actually would/do allow that. I imagine they might allow it for good customers.
I hear where you’re coming from. I simply think the FDA would get BLASTED by the public if they require a whole new trial, because at this point that decision would likely come to light in full view of influential biotech analysts and would potentially hit mainstream news. As soon as a partnership is inked, whoever covers (insert BP here) will be all over any developments with CytoDyn’s pipeline and clinical program. Especially with our nation’s chief executive bringing HIV to the public forefront recently, that might be a very bad look for the FDA.
We’ll see how it plays out. I certainly agree that IF the current trial is granted pivotal status, it would be incredibly significant. I’m betting the company knows what the answer is - dependent on hitting certain data thresholds - because it would be very material to negotiating partnership opportunities.
This post generally agrees with my takeaways from the call with 24 hours of reflection. Nice summary, in my opinion.
The only point I would add is one that trding made a while back. The mono patients currently being injected under the investigational protocol to provide safety data for the combo BLA are very likely to give the FDA reason and opportunity to convert to a pivotal trial, therefore that isn’t necessarily wasted funding. I’m betting that’s part of the reason we haven’t heard too much noise of a pivotal protocol.
It’s a testament to what a disaster that call was that, for the most part, the fact that there are multiple offers in hand for partnership/licensing was completely lost in the mix.
Thank God for that bright spot. But it better be for a better up front than “multiple millions”.
I think you mistook my point, Lawman. I’m not going out on a limb making any predictions, but I’ll be very surprised if we don’t have very welcome news on Monday. Basically, if they don’t give us an update demonstrating that they’ve solved the financing issue, the raises granted will be tone deaf nearly beyond my capacity for belief. And they will get absolutely blasted on the conference call if that’s the case.
Anything is possible, I’m just not sure that I see that happening.
If I recall correctly, the company that became ABBV licensed the drug to Progenics, from whom CytoDyn then acquired it. They’re both owed some measure of royalties.
It’s in the 10-Q/K, but I don’t have that in front of me. I’m sure someone else can or will look it up before I get back to the notes on my computer on Tuesday.
All I’m saying is that I’m pretty sure I’ll be awake by 6am EST on Monday. Could be nothing, but there’s sure a whole lot of smoke.
Why would you give yourself a raise and announce it on Friday afternoon when the company is low on cash and you have to face angry shareholders on a call on Monday afternoon? Right after you announced that you’re expanding into additional cancer indications with money you don’t have? Right after you close the current share offering, which has been the way you’ve been raising cash for the company?
This isn’t a trick question.
Little do they know that ABBV is entitled to downstream royalties from leronlimab revenues.
Thanks chump, appreciate it. Will you be attending?
Interesting, thanks for the follow up. Any information you can share on the format of the invite-only event? Doesn’t sound like an investment conference to me, but it’s tough to tell.
I can’t find anything about this “conference” anyway, on the Edison site or otherwise. The last similar thing I could find was a charity ball held in 2015 (same organization, same room, etc.). There’s another breast cancer awareness gala in LA on the 28th, but not at that location.
All to say that I’m not even sure what this is, but it does truly sound more like awareness than fundraising. Not much like they’re pitching to a room of investors.
Chump, you mind my asking where you got your info from? The “invite only” portion may be keeping mortals like me from finding anything about it.
Mostly fatigue, with a healthy dose of “proximity anxiety” and a few shakes of occasionally transparent agendas.
No room at all for sexist remarks though, no doubt about that.
There’s still some good conversation and DD here. Better overall than most of the other boards I have or do watch, even if there is some chaff to sort out.
I sincerely appreciate your concern for my well being. Because believe me... if Mrs. BD ain’t happy, ain’t nobody happy.
Agreed. For any of the positive scenarios we've laid out recently to play out as expected, all outstanding balance sheet and current/future financing issues (within reason) would have to be definitively resolved by whatever deal is reached. I think the company's principals must know this - it's too (apparently) simple to overlook or misunderstand from their perspective.
Edit: I see a lawyer beat me to it. I should probably stay in my lane.
No need for CYDY to patent it for a new use. Patents, approvals, and marketing exclusivity are all separate concepts. It may come in handy, but really... someone would have to develop a more effective and/or safer CCR5 inhibitor than leronlimab for it to really matter from a patent standpoint, i.e. developing similar technology without infringing on FDA exclusivity protections. Good luck with that... The cancer patent means that it would likely be exceptionally difficult (patents are notoriously complicated) for Merck to commercialize maraviroc for cancer, which is incredibly helpful in terms of us being first to market. Interestingly, if you read Pestell's patent closely, I believe he needed CYDY more than the other way around from an IP perspective.
I don't believe that CYDY has bulletproof IP for CCR5 inhibition as an HIV therapy. I could be wrong about that, but I don't believe that they have something covering that so completely as Pestell's (now CytoDyn's) patent for CCR5 inhibition for treating cancer metastasis.
I don't think that TNBC data moves the needle in a vacuum. My speculation based on their latest communications - and it's just that... speculation - is that they have a plan/intent to reach some level of partnership or licensing deal for HIV/GvHD prior to TNBC data. Their language in PR's lately has been very clear lately in excluding cancer from any possible discussions or offers that may be in place. Plus, there's always still the prostate diagnostic that could be in play.
The hope would be that they're angling to clean up the balance sheet to a great degree with the HIV deal. This could solve the working capital issue and hopefully the financing issues for cancer trials, all while hopefully boosting the share price and getting significant press and analyst coverage, since analysts for whatever big boy signs on will need to know what their BP just purchased/partnered/licensed. With any luck, this would close off the idea of future raises through Paulson, theoretically shutting off a major supply of shares. With a ton of luck, the cash up front and the press could put the share price in a position for the company to uplist. That may be a stretch, but it depends to a large degree on how any potential deal may be structured, e.g. significantly more up front money for significantly less revenue share. Based on the numbers I've run, this would be a very sensible play if the company is truly confident on cancer results. If those things were to happen prior to positive results from TNBC, things could really be primed for liftoff.
Hopefully we'll hear more on Monday. And if nothing major happens? I'll just buy more shares I suppose.
Do some DD yourself, BL. The clinical results speak for themselves:
https://clinicaltrials.gov/ct2/results?cond=&term=snake+oil&cntry=&state=&city=&dist=
As I said, my words are worth exactly what you paid for them, though I'm shocked by how much you know about my model.
The only point was that if you take a few minutes to do any sort of research for yourself and put together a picture of what revenues may look like based on information that we have, the business strategy and the logic behind it becomes very clear. Oh, and also that I'm fully aware of exactly how rudimentary the model is, exactly what assumptions I'm making, and exactly what limitations are involved. No matter though. Emotion tends to win discussions, I suppose. You never did add value here, just yelled very loudly one way or another depending on your mood that day. Carry on...
You know, you're right.
A high school sophomore would be very unlikely to have the basic understanding of economics, finance, capital markets, or business strategy necessary to see or understand the obvious scenario that's kept the financing in Paulson's court to date. This has been discussed ad nauseam. There's nothing fishy, and honestly, it probably doesn't matter anymore. It's a simple waiting game at this point.
For fun, I put together a very simple cash flow model yesterday to estimate potential cancer revenues based on the eight cancers from the PR yesterday, then all cancers (CCR5+, of course) for US only cases, then worldwide cases of the same. I won't be sharing this model or the cash flows/market values it suggests due to its extremely rudimentary nature, but the results were "jarring", in the words of one of my colleagues. It's very, very easy to see why the company has been doing what it has been doing.
And before anyone jumps in to criticize a rudimentary model that they haven't seen and never will, I'll allow the board to know exactly one fact that could be considered personally identifying:
In my field, I'm literally considered an expert in balance sheet/revenue forecasting and in model risk management.
You can take any and all of that for what it's worth, and it's worth exactly what you paid for it.
... and any other CCR5+ cancers that show promising preclinical animal data from the 8 new studies announced. Since positive TNBC clinical data would prove a logical link between the effectiveness of the mechanism in animal data and in human data.
Legitimate question... Since at least mid-2017, there have been nonpublic preclinical trials and/or discussions going on with Pestell and Prostagene at a minimum. Do you think that Pourhassan, or any other member of the board or management, could actually buy on the open market while actively in possession of material nonpublic information, or even in active M&A discussions? I’m no securities lawyer and I certainly don’t know the answer, but I imagine the prohibitions would be strict.
If there wasn’t a Mrs. BD, there’s a good chance that a significant portion of my retirement funds would have found a way into this as well...
Yep... like I said, wasn’t necessarily responding to you there so much as addressing all audiences. Any public forum is going to have varying levels of sophistication amongst the readership. Everyone is responsible for themselves, but I’d rather not accidentally encourage someone to do something irresponsible. That’s all.
I personally wouldn’t have done it without Mrs. BD’s buy in. I had my reasons, and your mileage may vary. Time spent consensus building cost me the opportunity to buy nearly 25% more shares with the same money, but that was worth it to me.
Please don’t take this the wrong way, as it’s a general PSA and not necessarily intended for you. Please approach the use of leverage responsibly and with respect to potential outcomes. As bullish as I clearly am, our conversation centered primarily on “what does it look like if this investment goes to zero?” I believe that the odds of that outcome are approximately zero, but nobody knows what they don’t know.
As I’m sure chump would say about the ponies... don’t bet what you can’t afford to lose.
And for further transparency, my position, even levered, is still only about 25% of liquid and less liquid (retirement accounts) assets. It’s a much larger portion if you look at liquid only. Much larger.
How do you want to count leverage?
That should give you at least a basic idea of my level of commitment.