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No, it's Nanostring, the company that might be interested in buying our prognostic test.
So, timeline for mono approval is roughly Q2 2021 IMO.
Protocol submission/FDA feedback: about 5 weeks from now.
Initiating trial and full enrolment: 3-4 months
48-week study
at least a month? for data analysis
sBLA filing: 1-2 months?
sBLA decision: 3 months
= about two years from now => Q2 2021.
To be fair, the thing with even good biotechs that ultimately succeed, is that you often don't know where the floor or inflection point is.
If you wait too long, you risk missing the run, and if there is a buyout you don't get anything. On the other hand, if you wait, you might be lucky and avoid a huge downfall while buying at the bottom before the stock turns around. There are some stocks that are loved by market (e.g. Tesla), while others are not. Despite excellent results which alone would justify a much higher SP and market cap, CYDY gets no love from investors.
Sure, those who have been invested here for a couple of years have had high opportunity costs, since almost any NASDAQ stock has doubled or tripled since 2013-2015.
Transcript of 07:00-07:29 (I can't make out everything due to the audio quality and I'm not a native English speaker myself).
"Prognostic test - the last but not the least. Again, I'd say we are very close to have a license agreement and we told (?) you we are pursuing this. Dr. Pestell has done an amazing job. I've been in meetings with him for this licensing agreement - it has been spectacular, it's an honour for me to be in the same room with him (???) and he will be adding very much value that we need, and he is continuing to do this."
Yeah, it's brutal. But since we now know that TNBC and NDA submission move long nicely, I can easily wait another couple of months. Might be that we drop a little bit more, but who knows. Any positive news on the financial side and we explode.
Yes, but finesand has better information and sources than NP himself (namely her own iHub and blog posts) that show that they won't be able to submit the NDA then.
Couldn't agree more. But we will get there. At least we will know where this is heading until end of this year at latest. What makes me more confident is that licensing and FILING of the prognostic test is now 1H. I refuse to believe they would have affirmed this if negotiations won't be closed till June.
Your point that (new) Paulson investors can minimise their risk while shareholders that have been on board much longer get to shoulder all the risk is very valid. If BOD or the CEO would care about this, they would find a way of having smaller or non-Paulson investors participate in the offerings. This clearly shows that they care little about current shareholders. For example, the Board Chair of Galectin, Richard Uihlein, has recently written a letter to shareholders of Galectin and offered everyone to participate in an offering that will be used to fund their PH3 in NASH. Unfortunately, I don't live in the US and don't have enough shares to make some impact on CYDY in person.
Also, it seems almost impossible that they didn't know that TNBC would take much longer than expected back then in February. They did this to pump the stock and try to lure new investors in. This is low-level management and verges on being unethical. My mistake was to build a full position without waiting for a PR and relying on Nader's words. But it isn't real till PR'ed. Rookie mistake, but now I will have to keep those shares anyway and add a small sum only AFTER they have a deal inked and PR'ed.
Yeah, it wouldn't have been necessary to do this interview. For what's it's worth: licensing of the prognostic test is now "very close", so we really might hear something very soon (in accordance with the timeline H1 Filing and Licensing). Note the wording: "We are very close to have a license agreement... We are pursuing this... Dr. Pestell has done an amazing job at these meetings...He has been spectacular". I'll have to relisten to the webcast, though.
Looking forward to see a deal inked now by end of H1. If they manage to do this, we can stop worrying on the financial side of the company and enjoy the science part.
Out of curiosity - is it possible to make the company disclose any potential offers that they rejected in the past? (provided that there are no legal obstacles preventing this - or are such offers always kept in secret and protected by signed contracts etc.)
Well, if I recall correctly, the majority here thought that a reverse split was a horrible idea, because the stock would suffer terribly. Turns out that it suffers all the same. No way that they will uplist organically any time soon.
Nah, till the shareholders meeting I'm trying to be optimistic. Although my realistic side tells me that they wouldn't do that conference tomorrow if they were close to close a deal as Nader told us in the latest videos and PR's. Also, they could have waited for the authorisation of the additional 100m stocks until they had announced a deal.
You might be right, but it seems that in 9/10 cases companies underestimate the costs and difficulties of a drug launch. But if we count 30m for a successful launch plus 2.5m every month til approval it'll get hard and TNBC and GvHD trials might be pushed back further. I think that we need 50m-60m altogether for the next 9-10 months.
I really do hope that something substantial materialises until the shareholders' meeting. Otherwise I don't know how this will play out. Even if we get 30 million through 100m additional shares and get combo approved, I don't think the SP will rise since we need a marketing and delivery force for commercialisation etc and the financial concerns will just reappear.
And if NP should repeat the usual phrases like "we pay our bills" "we have many opportunities for financing", I can't hear it anymore.
I have just re-listened to the ProActive-Investors video and some of the statements there are not easy to reconcile with each other:
"We like to have 100m which represents the maximum dilution we believe we will bring to the company before revenue, IF we were doing all-dilutive financing, which I don't believe we will be doing..."
"...But I hope the shareholders realise that getting the 100m authorised is just to have those shares in the case something profitable comes along the way that requires shares"
This means we need the shares if we go alone AND we will only use the shares to acquire? something profitable if the opportunity arises, which is somewhat illogical.
Well, Fortuno made a sensible argument: further dilution at .40 won't get us anywhere which changes the situation of the company fundamentally, since we will hardly get enough money for commercialisation with dilution at these levels.
This needs to be addressed differently than by saying "move on/stop bitching". Obviously, if a decent deal is closed till the SP meeting, we will be fine, but who knows? Personally, I expect that such a deal will be closed by then, but I'm not so sure anymore. After all, it hasn't been excluded by Nader that the 100m shares will be used in the near-term.
And again: the monotherapy protocol was promised for last week at the latest. Where is it? It is beyond my understanding why Nader would again miss a self-imposed deadline... From the CEO of a public company in a crucial stage of its development I expect a clear communication strategy:
TNBC "any day now" => If timeline has changed, explain why?
Monotherapy protocol "this week or next week" => If not, why?
You need to learn to read properly. I did not say that small raises are good. I'm not really interested in the company's financial failures in the past, but since partnership and licensing talks are underway and the situation changed significantly with the ProstaGene acquisition, I have initiated a full position in this stock. Until a deal is closed, the small raises are necessary evils, nothing more, nothing less.
What are you talking about? I didn't talk about picking 1 out of 1000 randomly, but identifying biotechs with great scientific results at depressed price levels. For me, this has worked extraordinarily well so far (CorMedix, Scynexis, Trevena, Axsome). All those are - even at this point - winners to be bought for a bargain a couple of months ago and which will most probably offset all possible losses with Cytodyn.
Your "arguments" have been debunked a hundred times already so I won't bother to do so once again in detail.
(1) Licensing and partnering interests only came up relatively recently after excellent mono data and the Prostagene acquisition (prognostic test, cancer potential).
(2) It is indeed a very profitable strategy to buy nano-caps when they are depressed without scientific reasons, even if you choose a loser. For instance, I bought 10000 shares of Scynexis at 0.36, and look where it is now. Same goes for CorMedix. Of course, with Achaogen etc. it wouldn't have worked, but in the world of small biotechs you can be wrong 8 out of 10 times if you choose 2 correctly.
I disagree with your agreement. Until licensing or partnership agreements are completed it is clear that the company will continue with small raises each month. Nano-cap biotech struggling with financing is not a unique feature of Cytodyn.
Suvorov, your knowledge of the history of music is fascinating and your talent to identify suitable similes is unparalleled!
You're welcome... I think we can now cross off a line at our CYDY bingo: We have a new video, Suvorov and Amateur appearing, finesand's new analysis and a reference to her blog etc.
The safety data for 700mg will be taken from the INVESTIGATIONAL mono trial, not the upcoming pivotal trial, as you are well aware, since this has been discussed /stated weeks ago. But nice try!
Thank you!!
But would it have been too much to ask to address the TNBC topic in a PR or video? Why don't say "the recruitment takes more time than expected" or whatever...
Mh, okay, must have slipped through then.
Also, I don't know why we have an IR if emails aren't answered. Eleven days ago I wrote an email with a question regarding TNBC:
"I have a question regarding CYDY's TNBC trial and I thought this would be a good opportunity for reaching out.
Given that everyone at CytoDyn was so excited about initiating the trial and injecting the first patient, I was wondering about the exact reasons for the delay, since it was stated by management in February/March that the trial will start "any day/week" now. So, my two questions are:
(1) Are the reasons for the delay of medical, financial, organisational or perhaps strategical nature? Since there is a lot of speculation going on SA, IHub etc. it would be most welcome if the exact reasons could be somewhat clarified.
(2) What is the approximate timeline for the first injection now? Can you confirm e.g. by end of April?
Many thanks in advance,
Best wishes,"
Sure, they could do this, if they want to entirely tank the SP. Get a licensing deal for Pc test and partnership done and dilute at higher levels. On the other hand, one might think that if a deal was close they would have waited for increasing AS until it was done. This company remains a mystery to me ^^
Do you think that they will use these shares at this price level? I mean, if they intended to, they would be crazy... At .40 with warrants 100m would bring us through for how long, 5 months? I think that it just is a formality since the 600m shares limit is approaching fast (or at least that is what I hope).
That argument is not really convincing. Combo might still be interesting for a BP trying to enter the HIV business or for an established player to crush competitors.
Doesn't matter :) I'm a "liberal ironist" and I don't take myself too seriously. I own 40,000 shares, a friend of mine 10,000 and my parents 20,000. If a deal is reached and cancer confirmed, the sky is the limit for this stock and I look forward to it. But the whole situation is just too comical to resist creating a satire about this.
Thanks. I had a good time composing it and that helps to deal with the depressing SP... Actually, I almost feel remorse, because the product is awesome and the company actually has achieved great things, but now is in a rather curious situation. But hey, I have tried to make fun of both the short and long side, so I guess it's okay after all.
Nah, now I feel challenged to post an extended version on the other place.
Seems like someone here has no sense of humour ^^
There are a couple of things I don't understand:
(1) If negotiations had already been in place about licensing the prognostic test before the Prostagene/CYDY merger (if I recall correctly), it shouldn't be too difficult "giving up" the test to an interested party for a larger upfront-payment with certain milestone-payments but low royalties, because we obviously need the funding now (i.e. taking a bad offer for this product rather than taking a bad one for PRO140).
(2) Similarly - why haven't we already negotiated a licensing deal for just one specific ex-US region (Europe or China) as soon as the splendid combo and mono-results were out. Verastem, for example, has done decent deals with Yakult in Japan and CPSC in China for quite a significant amount of upfront-payments.
(3) It was stated that TNBC trial will "start any week now". At the end of January it had already been stated that the trial will commence "any day now". This is a very creative interpretation of "any day now" - another instance of "overpromising". Also, Nader said that we will get interim results in Q3 - so does this mean we will only get the full results (i.e. after approximately 63 days, but not after 21, 42 days)?
The CC was mixed IMO; a couple of great things too, such as the potential manufacturing contract on favourable terms...
Emergcy is right, though. Not being able to raise non-dilutive funding during a time in which the market abounds in liquidity raises a lot of questions about Nader's financial and negotiation skills. The fact that CYDY trades on the OCD can only be a partial excuse. A lot of biotechs with much lesser potential have succeeded in securing more favourable funding. That is a fact. (And even if Nader will secure funding in a month or two (or whenever) his performance on the financial side will still be mediocre).
On the other hand, I am extremely grateful that I can buy shares of a company with such a potential and such a mind-blowing science at a bargain. If the problem of funding would have been solved long ago, the SP would have been much higher, obviously. However, I guess the worst thing that could happen is that CYDY is sold for a fraction of what it is actually worth. So, practically no downside and theoretically unlimited upside if the cancer story unfolds. Btw, Thank you for the productive discussions and scientific knowledge displayed on this board and good luck to all!
Recently, e.g. CorMedix sold tax credits to a third party as a way to raise money. Would that be a potential source of funding for CytoDyn too? (Sorry if that's a stupid question, I'm not familiar with this kind of stuff...)
Really frustrating that they struggle to raise capital on decent terms... Maybe they should create a crowdfunding campaign or find a generous billionaire :D