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Of course it does something for shareholder value - but just not now. It's good that they are working on several fronts, though we all know that only significant financing news (or extremely positive TNBC interim results) will move the needle here. With the amount of the TO they have at least bought 3-4 months time to show a solid deal.
CytoDyn Signs Groundbreaking Memorandum of Understanding with Thai Red Cross AIDS Research Centre to Study Pre-Exposure Prophylaxis Use of Leronlimab (PRO 140) in People at High Risk of Acquiring HIV
VANCOUVER, Washington, June 17, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a Memorandum of Understanding (“MOU”) with Thai Red Cross AIDS Research Centre (“TRCARC”) for the design and conduct of a pre-exposure prophylaxis (PrEP) clinical trial of leronlimab (PRO 140) in subjects at high risk of HIV infection. The trial is based on positive results in a pre-clinical study. CytoDyn’s financial contribution to this trial will be limited to supplying TRCARC with the necessary quantities of leronlimab. TRCARC will secure all necessary regulatory permissions, and ensure that the PrEP trial is conducted in a timely manner under mutually agreed upon clinical trial protocols. Results of the trial could potentially be used for label extension of leronlimab (PRO 140) in other jurisdictions, including potentially with the U.S. Food and Drug Administration (“FDA”).
“The rationale for the use of leronlimab as PrEP is grounded in the long-standing observation that individuals deficient for the CCR5 co-receptor are nearly completely resistant to sexual transmission of HIV,” said Dr. Jonah Sacha, Associate Professor of the Oregon Health & Science University. Dr. Sacha continued, “Given the difficulties many patients face with adherence to daily oral antiretroviral therapy drugs as PrEP, once-weekly leronlimab as PrEP could be transformative in slowing the epidemic.”
“I am thankful to Dr. Sacha for his investigational study of leronlimab that led to this opportunity for CytoDyn to collaborate with Thai Red Cross AIDS Research Centre,” stated Dr. Nader Pourhassan, President and CEO of CytoDyn. “We look forward to our collaboration with TRCARC to deliver quality, insightful, and timely clinical data that could further inform and validate the value of leronlimab,” he continued. “The only product currently in use for PrEP is Truvada, which was approved for HIV therapy in 2004, followed by a label expansion for PrEP a few years later. Truvada is a daily pill and has shown great results for use in PrEP. Thanks to Truvada, the number of new infected HIV patients in the U.S. in 2018 continued to decline. It is our understanding that Truvada has been used for PrEP by over 130,000 men and women in 2018. We believe that leronlimab, if approved as a combination therapy for highly treatment experienced people, could have multiple label expansion opportunities, including monotherapy and potentially PrEP. We are thankful for the opportunity to initiate this very important PrEP study now, so that if it is successful, we can move forward expeditiously in the event leronlimab is approved as a combination therapy. CytoDyn’s obligation under this agreement with TRCARC is to provide leronlimab without any other financial obligation,” concluded Dr. Pourhassan.
“We are excited to have the opportunity to partner with CytoDyn and their highly innovative and paradigm-shifting weekly self-injectable leronlimab,” stated Dr. Nittaya Phanuphak, Chief of PREVENTION and Chief of SEARCH (South East Asia Research Collaboration on HIV) at the Thai Red Cross AIDS Research Centre. “People who are at high-risk of getting HIV infection need various HIV prevention options that could fit different lifestyles and address barriers to consistent use. Leronlimab has high potential to be a very practical HIV prevention tool, both for clients and providers,” continued Dr. Phanuphak. “We look forward to moving forward to initiate this groundbreaking clinical trial,” concluded Dr. Phanuphak.
Yes, interesting result, much less than I had personally expected. Seems like the funds of the warrant holders are somewhat exhausted or they don't like more exposure in their portfolio. If I had warrants, I would have exercised them, but I can understand the situation...
Result of TO announced: 9.1M + 3M from May
CytoDyn Raises over $12 Million in New Capital from Private and Public Warrant Offers in the Last Five Weeks with Minimum Dilution
VANCOUVER, Washington, June 14, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications announced today that it raised approximately $9.1 million from its recently completed public warrant tender offer. Combined with $3 million raised from a private warrant exercise offer in May, new capital injected on a gross basis in the last five weeks now totals over $12 million with only about 15 million shares of dilution.
“When evaluating the advancement of leronlimab, we continue to be very excited on several fronts, including:
The completion of our first BLA submission in the third quarter of this year, as a combination therapy for HIV
The recent submission to the FDA of a protocol for a pivotal trial for a monotherapy indication as a label expansion after potential first approval
The evaluation of multiple potential indications for leronlimab in cancer, GvHD and NASH
These evolving prospects present many potential pathways to leverage the capabilities of leronlimab. The level of investor participation in the recent capital raises brings credence to our mission. The warrant tender offers present an efficient means to continue to engage our current shareholder base while minimizing the potentially dilutive impact of other sources of capital. This and other funding platforms (licensing/partnering opportunities) will continue to be explored by CytoDyn for the remainder of 2019,” added Dr. Nader Pourhassan, CytoDyn’s President and Chief Executive Officer.
“In addition to these developments, CytoDyn is about to enter the world of cancer therapeutics with the long-awaited first patient injection for TNBC approaching. We continue our product-readiness planning with Samsung BioLogics and look forward to preparing for our future with the objectives of benefiting patients and rewarding our shareholders,” concluded Dr. Nader Pourhassan.
Yes, this interpretation might be cortect, but don't tell me that the message was clear:
"...Right now, the first 10M, I will be able to tell everybody, we just saved you, the shareholders, 30M shares and we expect to get 30 or 40M hopefully, and if we do eventually get that much from tender offer, we will be saving 100M shares for shareholders."
To be fair, I think he has lost some credibility on the financial side and some timelines, otherwise he has done a great job in bringing leronlimab close to approval.
I mean, I understand, he has to make the stock attractive to investors, but why say (or quote) a totally unrealistic opinion, rather than saying something more general like "every additional indication like NASH will increase the company's value significantly".
Yes, but it is still a very unrealistic estimate... I agree that THEORETICALLY any additional indication should add a lot of value, but the market at this point doesn't simply reflect that value in the SP...
Yes, that's nonsense, or at least, let's say, quite optimistic, given that CYDY doesn't get any love from investors for even a completed Phase 3 study in combo and a completed investigational Phase 3 mono trial.
Galectin, which is about to start a Phase 3 trial in NASH, has a current market cap of about $180M.
Right, point taken. Ok, perhaps Finesand and Stockbroker42069 would like to mention one concrete number? Bets are open until the result is announced.
Yeah, you're right. I'm fully counting on the offer being successful so that the 8-12 or 9-15 M numbers won't have a chance of winning anyway ;)) I might put down 8-12 as 10 and 9-15 as 12...
Tender Offer Final Bet List
Chump............... $ 55+ M
Newrunner........... $ 50 M
iKnow777............ $ 43 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
Zi457............... $ 33.5 M
Ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
Skezan.............. $ 27.5 M
ShareRunner......... $ 27 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
I_luv_cydy.......... $ 25 M
Saltz............... $ 25 M
Penniestodimes...... $ 24.5 M
Zuess421............ $ 22.5 M
Lorbas.............. $ 22.3 M
TheBioTechG......... $ 22.1 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
IndexGuy............ $ 17.5 M
my2centz.............$ 17 M
EponymousKook....... $ 16 M
Bored Lawyer........ $ 15 M
FullTilt............ $ 14 M
Finesand............ $ 9-15 M (to be counted as 12M??)
Stockbroker42069.... $ 8-12 M (to be counted as 10M??)
Tender Offer Bet List
TO bet list
Chump............... $ 55+ M
Newrunner........... $ 50 M
iKnow777............ $ 43 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
Ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
Skezan.............. $ 27.5 M
ShareRunner......... $ 27 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
I_luv_cydy.......... $ 25 M
Saltz............... $ 25 M
Penniestodimes...... $ 24.5 M
Zuess421............ $ 22.5 M
Lorbas.............. $ 22.3 M
TheBioTechG......... $ 22.1 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
IndexGuy............ $ 17.5 M
my2centz.............$ 17 M
EponymousKook....... $ 16 M
Bored Lawyer........ $ 15 M
FullTilt............ $ 14 M
Finesand............ $ 9-15 M
Stockbroker42069.... $ 8-12 M
Um, not sure that we discussed this here. I didn't start the list, but just copied some in after I had seen their estimates. My estimate, for one, is based on the net proceeds, i.e. the amount of CYDY will effectively have in the bank after the offer.
50 billion, not million!! lol.
No, to be serious: We now might have enough estimates to calculate a reasonable amount, if we assume that some kind of "swarm intelligence" applies here.
Average is about 27.2 M as of now.
TO bet list
Chump............... $ 55+ M
Newrunner........... $ 50 M
iKnow777............ $ 43 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
Ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
ShareRunner......... $ 27 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
I_luv_cydy.......... $ 25 M
Saltz............... $ 25 M
Penniestodimes...... $ 24.5 M
Zuess421............ $ 22.5 M
Lorbas.............. $ 22.3 M
TheBioTechG......... $ 22.1 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
IndexGuy............ $ 17.5 M
my2centz.............$ 17 M
EponymousKook....... $ 16 M
Bored Lawyer........ $ 15 M
FullTilt............ $ 14 M
Finesand............ $ 9-15 M
TO bet list
Chump............... $ 55+ M
Newrunner........... $ 50 M
iKnow777............ $ 43 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
Ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
ShareRunner......... $ 27 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
I_luv_cydy.......... $ 25 M
Saltz............... $ 25 M
Penniestodimes...... $ 24.5 M
Zuess421............ $ 22.5 M
Lorbas.............. $ 22.3 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
IndexGuy............ $ 17.5 M
my2centz.............$ 17 M
EponymousKook....... $ 16 M
Bored Lawyer........ $ 15 M
FullTilt............ $ 14 M
Finesand............ $ 9-15 M
Well, at least we now have a professional who leads all on-going negotiations, and several shots on the goal, including a potential 25m China deal.
If the TO succeeds and brings in $20m+ this will surely take us towards any such deals and, more importantly, to approval. If not, well, then things might indeed get complicated until a substantial deal is closed and the up-front payment received - but even if we assume the worst and they only get, let's say, 10-12m this will suffice for about 4 months and give them more time to ink something definitive.
For what it's worth: The recent update at the CC regarding the prognostic test was that negotiations have progressed well and that they will be receiving a term sheet soon.
TO bet list
Chump............... $ 55+ M
Newrunner........... $ 50 M
iKnow777............ $ 43 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
Ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
ShareRunner......... $ 27 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
I_luv_cydy.......... $ 25 M
Saltz............... $ 25 M
Penniestodimes...... $ 24.5 M
Zuess421............ $ 22.5 M
Lorbas.............. $ 22.3 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
my2centz.............$ 17 M
EponymousKook....... $ 16 M
Bored Lawyer........ $ 15 M
FullTilt............ $ 14 M
Finesand............ $ 9-15 M
Yes, this is very sound reasoning. But as to AA there are obviously many unknown variables, and I often find that in biotech people are way too optimistic regarding time frames:
1. How many patients will the FDA require? Will the 50 patients we plan to enroll suffice?
2. How long need CTC levels and tumour shrinkage to be observed?
Given the huge unmet need, I think (1) won't be a problem, if results are very clear and impressive, but I think they will need all 50 patients. I also suppose that they will still be required to show reduced CTC numbers over a certain period of time to prove that the effect persists, for a couple of months at least (just guessing).
That puts us at 6? months after full enrollment, which at the current pace of enrollment might be more a year away, so I would guess 2H2020.
All in my totally unqualified opnionion.
TO bet list
Chump............... $ 55+ M
Newrunner........... $ 50 M
iKnow777............ $ 43 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
Ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
Saltz............... $ 25 M
Penniestodimes...... $ 24.5 M
Zuess421............ $ 22.5 M
Lorbas.............. $ 22.3 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
my2centz.............$ 17 M
EponymousKook....... $ 16 M
Bored Lawyer........ $ 15 M
Finesand............ $ 9-15 M
You're welcome. Probably those in between will be correct. I'm also pretty excited for the outcome.
Might be relatively quickly; as a comparison, Galectin, which recently did a rights offering, reported the results 5 days after the offer had closed.
Current list:
Chump............... $ 55 M
Newrunner........... $ 50 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
Ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
Saltz............... $ 25 M
Penniestodimes...... $ 24.5 M
Lorbas.............. $ 22.3 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
Bored Lawyer........ $ 15 M
Finesand............ $ 9-15 M
https://www.proactiveinvestors.com/companies/stocktube/13675/cytodyn-to-meet-with-fda-to-finalize-next-steps-on-leronlimab-drug-trial-for-hiv-13675.html
At about 3:50: "And we are just choosing the opportunities that we like to have. Another 25-30m we are at the end of the year, and our tender offer is going very well, so I am very excited to see where we get the next funding, but once we get that funding locked down, I don't think there is any doubt in anybody's mind what is going on in this company."
Of course, this must be seen in context with the different funding possibilities mentioned on the CC and the video (from about 02:00 to 03:00), which was curiously not mentioned by a certain poster here.
IMO, what he wants to say, although the passage I quoted is quite incoherent, is that they will be doing the tender offer plus any opportunities mentioned (direct investment form Samsung or Chinese company investment, or prognostic test licensing etc.) to resolve the cash issue for the foreseeable future. I mean, it is clear that not 100% of the warrant holders will convert.
No, it's not far away, except for the fact that your enrollment time line seems off based on the huge interest from patients and your patient number was not correct.
Your estimate might very well turn out to be right, depending on delays, but it was based on assumptions that are simply not true or pure speculation and on omitting relevant things, which I have pointed out.
Current list:
Chump............... $ 55 M
Newrunner........... $ 50 M
Ahab333............. $ 41.5 M
LongPennyPincher.... $ 37,000,001 M
Gestalt2............ $ 37 M
Fortuno............. $ 35 M
JPG77............... $ 35 M
Brman............... $ 34 M
ohm20............... $ 32 M
Evil Rabbit......... $ 30 M
SJacobs26........... $ 26.4 M
Blueheel............ $ 25 M
Saltz............... $ 25 M
Lorbas.............. $ 22.3 M
Z_Smith............. $ 20 M
Misiu143............ $ 20 M
Bored Lawyer........ $ 15 M
Finesand............ $ 9-15 M
I liked Nader's cocky smile when he said that Gilead/Truvada won't be a competitor in HIV prevention, if Leronlimab prevails there too.
Hahaha, good one!
Copy this and paste in in your post.
Fortuno $35 million.
Bored Lawyer $15M
sjacobs26 $26.4M
lorbas95 $22.3M
The quality of your DD is evident for everyone. E.g. Self-referenced (sticky) posts to support your opinion that safety data from mono pivotal would be required, against all sources provided here by the company and other posters.
Trding already provided exhausting and conclusive evidence for your manipulation games.
The thing with "DD" on CYDY is that the scientific and medical side is well known and explored - the potential is unlimited, while on the financial side we have hardly any insight at all, can only make more or less educated guesses, and thus anyone's guess is as good as anyone's else's. We don't know what the TO will bring nor when a deal is closed - though it is true that investors here have been too optimistic on the finance side.
In a recent video - I think it was last week - it was mentioned that they hadn't heard from FDA, but expect a decision soon.
Given that they didn't get ODD for HIV, since they aim for mobotheraoy too, to me it seems improbable that FDA changes their rationale and grants it now for TNBC since CYDY intends to tackle many more types of cancer, thus a much larger population.
Thank you. Yes, I agree that this is an excellent risk/reward play. I also agree that even with conservative assumptions as to dropouts and SOC survival a success is likely, although if Multikine is much more efficacious than 10% it will probably take another 3-4 months until the 298 events will have occurred.
Hi! I'm considering an investment, but was just wondering about the dropout rate. I read somewhere that it was 10%? in Ph2. Is this correct? If so, what is the reason for assuming that the rate will change significantly in Phase 3? Will they have a counter strategy to cope with this, e.g. following up patients against their will, by checking records etc.? If the dropout rate is anywhere near 10% it will obviously make a lot of difference in the models...
CYDY needs a Master of Coins and a Master of Whisperers, too. ^^
I'm not surprised actually. This stock is strange and does not go up on clinical results or other positive announcements.
I guess we won't move until the tender offering is closed and it becomes clear how much cash they got out of it. Given the "internal logic" of the stock, that's understandable since the 30m China offer is non-binding and can theoretically fall through at any time when the details are negotiated. Something definitive is needed here.
That implies that the tender offer succeeds, i.e. that they get enough cash out of it. That is not a given. If not, it will get really ugly (provided that no other, non-dilutive deal will be in place). Will be interesting to see...
Yeah, this is unreal. But although I am deep in red from .50, I do not worry too much, not anymore. I somehow love the "story" behind CYDY. I feel that this will be an Amazon or Tesla-like story; a small company, against all odds, against BP, with a breath-taking and disruptive product.
Will be interesting to see if the tender offer succeeds. I agree however that NP has little understanding of the right timing and the market in general. Be that as it may: Let's make history here soon.
Can someone here please stick either Trding's or Fortuno's explanation of the tender offer on top to balance finesand's "interpretation"?
As has already been posted by others here, finesand conveniently failed to mention e.g. the lock-up period for this offer.
"The Amended Warrants will also contain a lock-up provision that provides that neither the holder nor any of its affiliates will sell dispose or otherwise transfer, directly or indirectly, any of the shares of common stock issuable upon exercise of the Amended Warrants without our prior written consent for a period of six months after the Expiration Date (as defined below)."
The tendency to stick her own tendentious posts (and opinions before) on the top of this board is disturbing - that sticky post ought to be removed.