Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I hope that your 200+ followers follow you for something more than your due diligence skills or your knowledge of capital markets.
That's a nonsensical question - what is the FDA supposed to be opining on?
Do some due diligence and people will be happy to answer clarifying questions. I'll start you with this readily available public information, available on the company's website.
https://content.equisolve.net/cytodyn/media/9bb625fefc4872db42ac65d15afea2ae.pdf
By the way folks, this is a new deck in the last day or two.
When I run my numbers I use a smaller multiplier to EBITDA to avoid sounding like a madman. I think $40/share is probably high for combo alone.
But if, at approval, it’s clear that mono and a platform cancer drug are also on the way, and whatever licensing or distribution agreements are in place at the time are reasonable... your multiplier could actually be low.
Per the recent webcast, protocol for TNBC is that the first 18 patients will do dose escalation through 350, 525, and 700. The remaining 30 will be on 700. They made a point of saying that they would be taking CTC readings from the lower dose cohorts as well, and wouldn’t hesitate to apply for BTD based on strong surrogate endpoint results in the early cohorts.
Assuming any efficacy and given the safety data we have from HIV, the cancer trials have all the makings of something the FDA would stop and grant AA on the condition that the trials are finished, etc. Not to count chickens, that’s just the facts as I see them and as they continue to be revealed.
Yep, by my loose count we’re probably getting near 500mm fully diluted. Appreciate the additional thoughts and context around the funding.
It’ll all work out in the end. A “diminished” return from continued dilution is still going to look pretty solid by my estimation. I run all my numbers assuming fill up 600mm shares anyways. Anything less is gravy!
Never ascribe to malice that which can be adequately explained by incompetence.
This isn’t MM games and never was. Nobody is building a wall to hold SP down. This is Paulson investors doing something many would see as economically rational - selling shares and holding warrants. Nobody has been real eager lately to sell below $0.50. People are just derisking and holding warrants. Most probably haven’t done the due diligence that many here have, since they can sell the shares and basically hold risk free exposure.
MM definitely can wreak havoc on OTC tickets, but this isn’t the MM. Ironically, due to a terrible capital structure and our home on the OTC, this is an incredible opportunity to buy a largely derisked investment (Pestell’s words...) at well below anything approaching a rationale valuation. And that may not change as soon as we’d like, but it will change.
You've got a better initial reason to be invested than I do, that's for sure. I found this because a drunk friend watched Charlie Sheen on a late night talk show. Somewhat bizarre that it will end up leading us to the same place.
I won't name names, because he walks amongst us occasionally...
Thanks, appreciate the education.
Thanks Tom. Functionally, what does it mean that the Bollinger bands are tightening?
Based on limited conversations with Paulson investors (I'm not one), they're not privileged to any material non-public information. However, regarding terms, the 8k this morning noted that the shares were priced at $0.50, with 50% warrant coverage at a $0.50 exercise price per warrant. The previous 8k announcing private placement financing (1/18, not the convertible note from yesterday) had the warrants exercisable at $0.30. So at least in a very minor way, the terms have improved slightly over the last two weeks. I'm not jumping around popping champagne corks over this development, but it is preferable to the trend moving the opposite direction.
I'll agree with you that it was interesting to hear Pourhassan note that they were "carefully crafting" a PR re: the meeting with the FDA. I'd think they'd be very careful about even hinting at negative non-public information though, so my guess is that they're working the timing of the PR as much as anything. Although I know that the current funding round is still open, they've raised about $10mm in the last two weeks. Good news (presumably) on the heels of fundraising will likely go over better than good news when we're dead broke and know that money will be needed imminently. I mean, $10mm at the burn rate implied by various statements from the company in the last few months would give the company almost three months of breathing room, not necessarily accounting for things like the BLA fee to the FDA, or the royalty payment to Progenics upon filing the BLA. Hopefully that's enough to make some positive progress before needing another chunk of cash.
Just my $0.12 cents or so.
I don't know the answers to any of the explicit or implicit questions here, but it's worth considering that the government shutdown likely impacted the ability of the FDA to review and approve new trial protocols. I suspect we'll hear something soon on the mono trial, though perhaps not as soon as we would expect without the shutdown. NP was pretty clear on the webcast that mono would require a pivotal trial, so I think the conversion ship has sailed. The company probably would have fought harder to get the investigational trial converted to pivotal if the plan wasn't to piggyback mono approval onto combo approval anyways via an expansion BLA, which both sets a best-case time frame for getting mono approved (whenever combo gets approved) and (likely) significantly shortens the approval process for mono post-pivotal trial relative to the time it would take through a standard BLA, even with a hypothetical BTD designation. Also, I think that they may consider a smaller pivotal trial than would usually be required, but I doubt there will be any true recycling of data. My guess is the protocol will be something like 100-150 patients with endpoints at 24 weeks, based on the previously noted and stated assumption of durability after more like 6-8 weeks. No real need to go a full 48. Lowers the burden and cost, and hopefully gets the trial done and data packaged right around the time they're looking for an approval on combo.
I think they currently care the most about getting this cancer trial started and generating data. If anything - aside from licensing/partnering/sale - is going to create pre-revenue movement in the share price, it's game-changing cancer data. Anyone who's paying attention already knows what the mono pivotal will end up looking like... the drug is safe and largely effective. Unfortunately, that story shockingly hasn't been enough to generate the volume we need to break the cycle we're in re: share price. Cancer is splashy. 60 Minutes, CNN, nightly news splashy. Hopefully blockbuster data there (fingers crossed) would get the job done.
I've got the rest of my life to WORK for money...
I feel like the rhetoric in the last few months has been more along the lines of "we are pursuing non-dilutive funding" or "exploring non-dilutive funding options such as...". It's been part of the conversation, just a little less direct and assured. Possibly just more careful choice of words.
The biggest disappointment for me on that front has been the change in tone regarding the diagnostic test. It seems that licensing that test has been more troublesome than they originally believed it would be. I hoped - and to a degree believed - that that was our ticket out of dilution a few months back.
Don't know, but it read like it was to one accredited investor. Wish it was me.
8k out. $5.7mm convertible note, two years, 10%. $5mm proceeds to the company. Convertible at $0.50 with 50% warrant coverage at $0.30.
Realistically, if they demonstrate an effective mechanism of action that impacts cancer treatment on that scale, you're talking about breakthrough designation and accelerated approval pathways post-P2, with required post-marketing follow up trials.
I was previously under the impression that I couldn't possibly think less of Network Newswire due to the incredible lack of content in the articles they produce.
Little did I know...
Amateur is fine. His (her?) posts are consistently conservative and perhaps more focused on past failings than future potential, but also freely give credit where credit is due. While I think Amateur's general stance may be too conservative/defensive at this point, there's not exactly a ton of empirical evidence to prove him wrong either. Pretty sure he's long either way, and his general attitude towards the investment and company is probably healthier than my nearly unabashed optimism.
I bet the cognitive dissonance (share price vs. my expected value) is leading me to (currently) drink more than Amateur, that's for sure.
To quote a dear friend...
They're all damn good.
Triple post... computers are awesome.
Double post.
Until the share price says champagne, I'll stick to the bourbon.
I agree that I'm going down in our family history as being the (second?) biggest fool ever or the (second biggest?) hero of the century.
Agree with you completely. I've told Mrs. BlackDoggie a number of times that if there were no Mrs. BlackDoggie, I'd seriously consider quitting my job and rolling my 401k and pension funds into a self-directed IRA to just bet on black here. Watching (and re-watching) the webcast has done nothing to dissuade that thought process. I believe that there will come a day when I'll be very sorry that I didn't sell everything that wasn't nailed down in order to buy more shares.
I need a drink as well. You pouring?
It couldn’t possibly be put better than that.
Not blaming you - I read it too and didn’t come to a different conclusion. That’s why I have a lawyer, to tell me when I don’t understand legal documents!
My lawyer agrees with greedfear. Which is why I keep him on retainer with cheap bourbon that I put in fancy bottles whenever he comes around.
It was fun for a minute though.
You sure your math is right? I got $1.2mm of warrants converted, and $1mm promissory note converted. That gives the company the $1.2, although it does alleviate a liability.
Still very good and I’m happy to see it, but not quite $5-6mm unless I’m missing something. Which is a distinct possibility.
No kidding...
But since were running with the football talk, I suppose we all may as well see the end of the game before we start talking about who won or lost.
Unless you’re Tony Romo. Then you already know what’s going to happen.
Agreed. I think all that we can really do is look at the data, and read the tea leaves based on what we know / when we know it. Sometimes that means changing an opinion on something (why haven’t we sold/partnered for HIV?) when we learn something new (we’re acquiring a cancer company and IP following promising preclinical work that has been going on for a year or two). Not everyone here is a fan of Pourhassan, clearly, and I’ve been critical of his presentation style in the past. But I don’t think he’s dumb, and I’d be surprised if he’s not making rational - not necessarily perfect - decisions with the company.
What I do know for sure is that if reality comes anything close to matching the current narrative I have for events of the past several years, then this will make a great B-school case study one day. And maybe a book.
I think the answer to that is relatively easy. For (at least) as long as the company has had compelling HIV data, they’ve also had Pestell studying cancer implications. We didn’t know that... but they did. I wouldn’t have sold the company for HIV money then, not without knowing more about the cancer work. I think that in hindsight (for us), not dealing in the past may be a rational decision and a reasonable, even good, outcome. I also think that prior to the compelling HIV data, most BP assumed Pro 140 would fail along the way. See: vicriviroc.
Why not just sell/license HIV then? I still don’t have an answer to my question of how you manage that from a logistical standpoint, since it’s the same drug and delivery system for multiple indications. If I was a partner, I’d want the whole show or nothing. Otherwise you can’t regulate off label use, etc. And when you’re talking about the prospective market sizes that are being thrown around... you want to make sure you’re getting what you pay for.
At this point, I think they’re close enough (relatively speaking) to the cancer data that they won’t do anything until they have it, save maybe licensing the diagnostic test. They may have a prayer of licensing the whole enchilada for ex-US use, as well. Could give someone a deal to distribute in Japan, get the company some cash, and wait for the data to negotiate for real money in bigger markets. Unless there’s a handshake deal in place already - which I doubt - that’s the direction I’d be trying to take it. Nobody is going to give us non-dilutive financing without a partnership or licensing deal at this point, and I’ve laid out my reasons for that in previous posts.
Also, as is often the case, the entirety of this post was not necessarily a response to you or your single post to which I “responded”.
The FDA has stated that it is not accepting new drug applications at this time due to the shut down.
...are you sure that’s not an issue for CytoDyn trying to submit a new drug application?
Fair point re: government shutdown and the .gov site. I don't know the answer, but it stands to reason that that's probably a non-essential function.
I don't think the study has been officially listed on the clinicaltrials.gov site yet. I'm not sure why that is, but the updates to that site aren't always particularly timely.
In my non-physician opinion, your comments on Keytruda combined with leronlimab missed the logical point of the combination. It's not that the mechanisms of action are necessarily thought to be synergistic - although misiu has some thoughts in that regard which may prove to the contrary, re: autoimmune AE's from Keytruda - it's simply that they do different things and would work well together. Complementary rather than synergistic, if you will.
- Keytruda, as I understand it, allows the immune system to more efficiently identify and attack cancer cells.
- Leronlimab (and other CCR5 inhibitors) supposedly inhibit the mechanism of cancer metastasis.
Keytruda, nor any other type of cancer-fighting treatment such as chemotherapy (e.g. carboplatin, which is the companion drug in CytoDyn's proposed P2 trial), will not give you outstanding long-term results if for every cancer cell you destroy, three more pop up. That's a losing battle, of course. But if leronlimab can keep the cells from spreading... you have a much better chance of destroying all existing cells. This is the theory that seems to be behind the current P1 trial (not directly sponsored by Merck, but I'm assuming they allowed use of the drugs for study) combining Keytruda and maraviroc.
https://clinicaltrials.gov/ct2/show/NCT03274804
Of course, we believe that we have IP protecting the commercialization of maraviroc (or vicriviroc for that matter, should that be revived by Pfizer) for this purpose.
I may be oversimplifying, but I believe that short of identifying adverse drug interferences, the CCR5 inhibition mechanism would be beneficial to combine with most any drug or treatment (radiation, resection...) that directly attacks cancer cells. That means that theoretically, any BP with an oncology program could and perhaps should be interested in our trial results. It would be a logical companion to any immunotherapy, CAR-T, standard chemo, etc... We've focused conversations lately on Merck (and Pfizer to a lesser degree) due to the preclinical work done with Pestell in 2012 and the fact that there's current research using Keytruda and maraviroc, but based on my current understanding of mechanisms, there's no reason that it would be limited in usefulness to a companion to Keytruda or a similar type of drug. However, as noted, Keytruda may find some additional use for leronlimab with regard to autoimmune side effects.
So in short, I agree with your thought that the focus should be on metastasis, because that proves leronlimab's mechanism of action. The rest will take care of itself, should that provide solid results.
Now THAT would be an interesting twist...
Yeah, it's interesting... I've been here a few years and never remember seeing the twitter rumor mill about CYDY. Hopefully there's something to that old adage about smoke and fire.
Got it. So although both drugs fall into a similar (and new) class of oncology drugs that work based on certain genetic markers, they have very different mechanisms of action. Sounds like leronlimab may be more complementary with Keytruda, as the CCR5 inhibitor would slow/halt metastasis while Keytruda allowed the immune system to attack the existing cancer cells.
And yeah... talk about side effects!
Appreciate the response and information, even though I think I'll probably have to read that between 5 and 10 times to grasp it to whatever degree my puny brain is able!
Your last comments get to the train of thought that I'm working through. Studies are currently being done using Keytruda and CCR5 inhibitors (maraviroc, in particular). Preclinical data from circa 2012 suggests that this is likely to be effective, but Merck doesn't have the IP to use maraviroc (commercially) to inhibit cancer metastasis. That makes Merck an obvious candidate for partnership, etc. However, Eli Lilly just bought LOXO (and Vitrakvi), and has indicated an interest in continuing to expand its oncology program but doesn't like the CAR-T approach. It apparently wants some diversity and broad usefulness in its assets. I'm wondering if CCR5 inhibitors would pair well with Vitrakvi, or other drugs in the LOXO pipeline, which would potentially make EL another player on our little stage.
https://www.reuters.com/article/us-lilly-cancer/lilly-eyes-more-cancer-deals-but-wary-of-car-t-gene-therapy-idUSKCN1P5294
https://www.msn.com/en-us/news/us/government-shutdown-fda-has-five-weeks-till-money-runs-out-for-approving-new-drugs/ar-BBSkmeT?li=BBnb7Kz
"The FDA cannot accept new fees or applications until the shutdown is over."
Yep, I'd say that has a chance at impacting us. Granted, I don't see the shutdown going until the end of Q1. At least the company isn't in a position to file the remaining elements of the BLA today, to the best of our knowledge.
Misiu and/or any other physicians on the board: Could you please do a quick comparison of pembrolizumab (Keytruda) and larotrectinib (Vitrakvi)? My basic understanding is that there may be some similarities, but I'm not smart enough to be a doctor.
Any information would be appreciated. Thanks in advance!