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.
Misiu,
Great summary. Only one of the "things" that will happen would send any normal stock to a high valuation (being very restricted here).
Soon this will be the case.
Bobbyinvest:
I am using:
50% royalties paid to CYDY (as per latest NP number)
CYDY pays 10.5% of these to third parties (Progenics & AbbView)
30% discount for valuation rNPV
Operating expenses of 60M (from May’s CYDY 10-K + 5M) to calculate Net Income and FCF.
Using a total of (rounded) 570M shares (376756444 stock plus 178591849 of Options + Warrants plus 7413000 Convertibles Preferred plus 7238707 “others”).
For FCF projection I used 30K patients @ $35K
All of the above only my assumptions. I used a relatively "pessimistic" value whenever the value was not available.
Ohm,
Repeating it once more, I invested in CYDY just for Combo indication. My DD showed me that, if approved, it was going to impose itself for the reason of the absence of SAE's (apart from other advantages such as resistance and compliance). This fact is critical.
Using a 30% discount for valuation (risk-adjusted Net present value rNPV) calculation gives $3.15 for combo only (of course, greatly depends on several factors such as number of patients treated). As time goes by this factor is increasing (de-risking).
It was a pleasant surprise for me to see the Mono advancing and, now, I believe it will be a fact. Going into more "shaky" parameters, the price should be in-between $10-$15 once this is approved, however, I cannot possible think in an scenario where BP will not see the writing in the wall and "negotiate" with CYDY before is too late.
Now. If you throw in Oncology and are willing to bid your time, I completely agree with your quote: "Given the other potential indications $50 a share is low".
It would be low indeed …
I put an order for 30K @ 0.29 but got filled partially.
Agreed, LOTS of catalyzers coming soon our way:
Deal or no deal, mTNBC data in few days, the large animal data for NASH and the FDA Safety data.
If this stock was listed in NASDAQ only one of them will move the SP like an earthquake, only that upwards, not sideways.
If one believes NP deal hadn't fallen through yesterday.
I personally prefer a CEO that sees the glass half full and not half empty.
Optimism is an indispensable quality for a CEO. If he had not been an optimist Lero would be sitting in a drawer.
So, here we are ….
Blueheel,
I agree. NP is not a liar, being the CEO of a company he will have legal jeopardy if he did lie. I believe he is an optimist and sometimes he communicates more than he should, but personally I like that.
He has missed deadlines, sometimes he has taken the wrong decisions and he has made plain mistakes. But I think he is a hard-working honest man that is fighting to get the product he rescued from a shelve to the market.
And apparently a very good product.
I believe the company is de-risked and the potential huge. I hope those that don't share my opinion on NP do not miss out in a very good opportunity simply because they took the wrong turn.
Of course, I might be wrong. I will then pay a hefty price for it (literally) as I am VERY long. So be it.
Good luck to you all.
Amatuer, If SP's had relation to fundamentals please tell us why some stocks jump all of the sudden?, sometimes several times. Fundamentals are suddenly discovered ???. No, they where undervalued and when news reach the disinformed everybody runs for the, shall I say, entry ??
In one thing you are right: OTC bag holder. I have lost some won some. Which is the name of the game. No shame in that. This will be a winner.
Please see above for the market perception of the fundamentals. Well, the way I look at it, if the market had a good grasp of the fundamentals investing would be a very boring (and perhaps unprofitable game) as the price would change very little from day to day. The opposite is true.
BTW, what is an "intelligent investor" like you doing here then ??? Are you staying away by participating ?? Or, as I suspect, you are invested and not happy ?? I suggest you sell what you have and go and make "good money" somewhere else, is easy and will not have to worry about NP anymore.
Good luck with whatever decision you reach.
Bobbyinvest,
Thank you for the very valuable information you have shared in the last few posts.
Appreciate the effort and research you have done.
Hopefully we will "cross the line" soon.
Misiu,
There is hope. He has finally seen the light; I hope is not that his position calls for his current posture. The numbers don't lie and FS is too smart to fight against hard truths
Finesand: welcome to the world of realism where the current SP does not bear relation to fundamentals. Even-though my stock valuation is somewhat different from yours, we have something in common: the current price is way undervalued and can only be explained by market inefficiencies, noteholders and (pardon me) the delusion of the masses.
Shall we all live long and retire early.
The fact is $0.3 … until is not the fact any more.
If any of you where expecting an up-trending SP since the second you bought CYDY I am afraid you don't know what investing in Biotech looks like (less in an OTC stock).
The R/R here is huge. But the numerator of the equation is risk, you better learn to handle it or go and invest in something more suitable for your sleep patterns.
I am happy with the risk and taking any opportunity to average down. Right now have large amount @ $0.466 (calmly taking a 35% loss on my investment).
Keep cool until is time to be happy.
One is right until, well, one is wrong. Something I have learned:
1) Is very difficult to time an investment (sometimes it goes up, sometimes down sometimes does not change). If I am long I will be wrong for the time is below my buy price. Sounds logical doesn’t is?. But, there will be times when I am right.
2) If there is an efficient market (that is, the generalized information on the company is reflected in the stock price) there will not be any opportunities for investing. The only way to make money is to profit from the relative ignorance of others (who are not valuating the company properly).
So, yes, here we are. The question is: where will we be ?? . If one is “listening” to the market for indications one will be another hemming going to the edge …
I once has a couple of stocks that did RS. Both times I lost a big chunk of my equity just on the RS. The price just went south right after the "new price".
Nowadays before I do my DD in a company that is ether not listed or is below the listing requirements for a while I simply treat it with extreme caution. If there is already a RS "rumor" I prefer not to invest.
Just my experience. I wish CYDY would wait until the SP raises on its own.
It will
From last PR:
"The FDA has given written guidance that prior study AP-003-A qualifies as a pivotal trial, and that successfully passing the current study, AP-013, would support the filing of our BLA."
"In fact, the combined results of the prior single-injection trials indicate that the AP-013 KL 4 patients could report a difference of Ampion over saline that is 50% less than observed in the prior trials, and the clinical benefit of Ampion in both pain and function would still be statistically significant (p-value < 0.05)."
This sounds good. I hope that the difference does not reduce but statistically things are looking good.
Waiting anxiously for results. It they are good the price will go to da moon !!!
Up listing is in NP list of things to do. He mentioned it in the last meeting.
I don't think reverse split will be a good move, they normally make the market cap to go down. For example, price is $0.5 and there is a 1:8 RS next day price starts at $4 and falls rapidly to, say, $3.
Don't ask me why but tat is the way that it goes the majority of times (it is maybe a psychological effect) .
We will get to listing price easily when the BLA is approved and then NP will execute (if he does what he said it was going to do) the up-listing.
LaundryMoney,
I followed like a hemming this morning purchasing more shares. I guess I will enjoy the "fall" if it comes, but will not enjoy watching from outside all the action.
All in and ready for the ride ….
Bump??, My friend, if this is what you are expecting I would rather sell and invest somewhere else.
Unless, of course, our definitions of "bump" are different.
Any NASH or Oncology indication will send the stock to the moon. But, let's remain on earth as all these are way far apart (if).
Combination Therapy on its own, will seriously move the stock several X.
New presentation in CYDY site.
https://content.equisolve.net/_7274c023b329df091fa73c2d0d340d84/cytodyn/db/193/2912/pdf/CytoDyn+-+Investor+presentation+-+Aug+-+26.pdf
Very interesting, mainly pages 9 and 10 where very conservative numbers for market potential are presented (with only $35K per treatment).
Initial approval Combination Therapy = ~$1.7 to $3.4 billion
Label Expansion Switch to Monotherapy Maintenance ~ $6 to $11 billion
Needles to say, just take the lowest estimate here (just Combination Therapy and forget the rest, and that is a very LARGE chunk to forget), with $1.7 Billion, what should the SP be ???
Any suggestions ??? .
I estimate more than 8 times current SP using a conservative valuation model.
Yup, well said . Thanks ohm.
He is ONLY suing for $1.3M , Pestell has many CYDY shares and doesn't want to "shoot himself in the foot".
Not by any means the end of the world, he wants to "resign from the Company for Good Reason" and get paid salary till November 2021 and any bonuses he would have obtained.
That's it.
Thanks Ohm !!. How do you know this ???
Yup, the question is what are the reasons. The good thing is that we will be able to learn more what happened (in due time).
In general not good news as the litigation mean extra expenses down the road.
which one in 12 month approved? HIV Combo?
If lucky then, HIV Combo
Yes, combo but there is not luck on it, please read on …
- BLA completion & ready for review clock: EOY '19 (Probably 1Q20)
According to N.P: “Our goal firmly remains to complete in September 2019 the BLA filing with the FDA for leronlimab as a combination therapy with HAART for HIV-infected patients and hopefully initiate our first monotherapy pivotal trial for label expansion soon after our in-person meeting with the FDA.” MAybe it will take longer, so be it, I am willing to wait .
- BLA approval min +6 month: end of 2Q20 (Probably within 2H20)
Probably right about the duration. At this point (after BLA submission) I expect the price to firm up quite a bit. However, remember that this has “fast track designation”.
- Revenue to build up allowing to drop the dilution: 1 year?
Revenue should start shortly after approval, the drug is there (Samsung biologics) and the commercialization company as well.
That is a possibility. Give 3-6 month or take off 3 month (best).
The drug is available and as per other posts can be sold rapidly.
Mono is very far on the horizon, ph3 protocol still in limbo and didn't even start yet.
What do you mean by “very far?” As with any other company, a protocol has to be decided and Ph3 carried out, whatever it takes (every company has to go through this). With the combo approved and the drug proven to have few SAEs, this will go at the sped it needs to go (by the way, several patients already being treated on Monotherapy. The rate of viral load suppression post-10 weeks of monotherapy was 68%, 94%, and 85% with 350 mg, 525 mg, and 700 mg, respectively), also, the receptor occupancy test will potentially raise the success rate in the monotherapy program,”
One HIV related GILD vs ViiV article on SA, not even mentioning CYDY.
ViiV seemingly wears the crown .. outperforming GILD.
SA article, if anything, is positive for CYDY (even though does not mention it). Excerpts from the article: “at this point, GILD is largely a one-product line company, namely TAF-based combination products (plus TAF itself: Vemlidy for hepatitis B).”
Let me remind you of the possible side effects of their drug Biktarvy (a combo of 3 drugs):
Worsening of hepatitis B (HBV) infection.
Changes in your immune system.
Kidney problems, including kidney failure.
Too much lactic acid in your blood (lactic acidosis),
Severe liver problems,
diarrhea (6%), nausea (6%), and headache (5%)
Same goes for their other drugs, ATRIPLA, COMPLERA
Another good statement from SA article: “GILD may have under-invested in HIV research aside from developing its TAF-based line of products.”.
Well, what about making an offer for B.O of CYDY ???
Now, let’s turn to ViiV: Dovato (a two-drug combination of dolutegravir and lamivudine) approved on April, 2019 and later on in Europe:
Hypersensitivity reactions have been reported with the use of dolutegravir, a component of DOVATO, and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. These events were reported in <1% of subjects receiving dolutegravir in Phase 3 clinical trials
Hepatic adverse events have been reported in patients receiving a dolutegravir-containing regimen. Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ (abacavir, dolutegravir, and lamivudine). Monitoring for hepatotoxicity is recommended.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine (a component of DOVATO).
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including DOVATO.
As Misiu correctly states (#45069) in of these have many drug interactions warnings.
$15M fundraiser anybody?
In last Investment Community Conference call (minute 32:20) NP mentions that there has been an back and forth with other group and an agreement, with the help of Dr. Ray, for the first $250 Million of sales will be founded by a capital group with significant money upfront. He mentions that does not want to make and agreement with yet another company as they where "far apart".
No, the potential biologics exclusivity period from the FDA is surely not a sure thing and automatic.
Whoever thinks that must be out of their mind.
There is a possibility CYDY gets more IP protection beyond patent expiration, but it is a risk for whoever cares.
We mentioned this FDA mechanism a long time ago,
no reason to even use this as an instrument to discredit.
This is incorrect, please see ohm20’s post #45053, I am quoting here: “A biological product submitted for licensure under section 351(a) of the PHS Act (a 351(a) application) may be eligible for a period of exclusivity that commences on the date of its licensure unless its date of licensure is not considered a date of first licensure because it falls within an exclusion under 351(k)(7)(C). In most instances, the date of first licensure will be the initial date the particular product at issue was licensed in the United States.”.
Leronlimab has not been licensed so it will start on licensure.
But .. all of that is purely academic now.
Shares are being dumped constantly and spiking lower.
40c support will break soon IMHO.
No, I am not only expecting 30c, I do seriously expect 20c'ish to be reached - matching the poor last offerings.
Guess that is all of my daily notes here.
Well, it is not academic, this is only your opinion.
The HIV field is now in the hands of GILD who is running out of options, ViiV (GSK) which launched Dovato and J&J with Juluca a combo with a drug from ViiV (Doluteragravir) and Rilpivirine (J&J), and MRK (Doravirine+Istatravir) who is probably partnering with either of ViiV or J&J ALL of them with AEs some serious.
CYDY should have a great niche there. IMHO N.P. should look seriously on partnering with any of these (ideally GILD) to launch Leronlimab soon to market.
Finesand,
As you well know, there is nothing certain about investing. Much less doing it in a penny stock.
If you want "will be" and "will happen" and so on … this is NOT the place to invest (shall I suggest Treasuries ?).
Everything is uncertain here stock price being one of them.
Of course, you might be right and price will go down, I take it that you are short CYDY as are not swinging and are not long. Good luck. For every share sold there are two opposing opinions. This makes the market.
I am very long as I believe that the risk/reward ratio is compelling (don't agree in that the current SP is very high, which, on itself, is another large discussion), the science is there and a successful CYDY will help many people.
But again, I respect opposing views, at the end, I am putting my money where my mouth is, as, I hope, you are as well.
Good luck to you all longs.
Thanks for sharing. Interesting paper. The evidence seem to indicate that indeed CCR5 is involved in the presence and propagation of many types of cancer.
Agreed, regarding the stock price the problem is the lack of Institucional ownership (Currently only 575,200 shares owned.) This is what normally projects the price upwards rapidly. CYDY currently lacks this and is running "under the radar", a couple of large institutions investing would move the price up.
Why ??, well, not listed in NASDAQ and not approved drugs. However, this will change soon and when the company is "noticed" things might change rapidly...
Below the list of Institucional ownership.
InterOcean Capital, LLC 334,700
INVERNESS COUNSEL LLC /NY/ 15,000
Diversified Trust Co 225,500
Finesand:
You are incorrect, CYDY has several patents:
8821877: METHODS FOR INHIBITING HIV-1 REPLICATION INVOLVING THE ADMINISTRATION OF AN ANTI-CCR5 RECEPTOR MONOCLONAL ANTIBODY AND SMALL MOLECULE CCR5 RECEPTOR ANTAGONIST.
with 25 properties.
9499621 and 5424066 are not very relevant to current work.
Pestell had 9453836 : "Use of modulators of CCR5 in the treatment of Cancer and cancer metastasis." This I believe is now property of CYDY as was assigned to Prostagene.
Need to be careful when you state something that can be easily checked.
Interesting, I was not aware that the Protocol for pivotal Phase 3 trial of Monotherapy had been filed.
Marauder, Cancer does not have cure. Success is simply surviving longer with a relative good quality life.
As far as the drug goes, they will measure CTC (Circulating Tumor Cells) with periodic tests (maybe daily).
A reduction and/or stabilization will mean a longer life and drug is successfully (the measure will depend on the actual numbers vs time). If CTC is unaffected will mean drug is not efective.
What NP mentioned in his last interview is that, if there was a change in CTCs, they will go to FDA and get permission for 5 naïve patients (that is what they wanted originally) and fast track designation for Leronlimab in treatment of TNBC.
The data from the next few days (weeks) will determine this. The good thing for the patient is that this can be monitored very closely giving a quick indication if the treatment is working or not and guidance as far as what the right dosage is.
These are good news. However, we should not put too much into it as is a VERY long shot.
The advantage of the test is that the CTC will be monitored, quantified and critical data will be gathered.
Now, lets asume that CTC progression "suddenly" goes to a halt. Well, as NP said, this will be a different company (and several people will be very rich).
However, most probable scenario CTC count is affected somewhat (reduction in progression, reduction on acceleration), the question is how much ? for how long? how significant ? adverse effects ? and so on and so on.
Regardless of what, first of all, lets hope it works for the patient and her family; it would be GREAT if her survival is significantly extended or illness stopped, or quality of life improved.
The stakes are high (in regards to the science) but, for CYDY, is a very long shot and a very long road ahead … However, is worth taking it for the thousands of patients with TNBC with little hope.
Lets keep our fingers crossed …
Ladies & Gents,
Fist of all, we all have the same motivation here: to obtain information to do DD and, make money and contribute by investing in a company that will hopefully help many people.
Now, there are many ways of making money, one can go long or short, invest for few minutes or few years. What applies for one does not apply to other.
The expectations and motivations are different. That is why sometimes we are talking pass each other. The only thing we need is to keep strictly to the facts and argue them respectfully.
For example, I am basically interested on the HIV future of the company (invested in basis of the Combo potential, which on itself should provide a great risk/reward setup), for me, is very "nice" to hear about Mono, and "nice" to hear about TNBC, and "nice" to hear about colon cancer.
I respect that, for some of you, this might not be the case.
The point here being that SP projections are a fool's errand to start with. SP based on what? combo? combo + mono, combo + mono + tnbc, combo + mono+ tnbc + colon and so on and so on.
And, when ? after BLA approval ? 6 months ? one year? after combo BLA approval? after sales start ? After mono works and TNBC doesn't or vise versa ? Once news get released ?? When, When ? When ??
Projections are valid, I don't invest if I don't think I know when I would sell but, it is necessary to state when and in what conditions if we want to keep our board sane.
is $4 SP crazy ??? Nope. Is then $40 crazy ? Nope.
Good luck to you all, one way or another. Let's keep the facts and forget the rest.
I am very curious to understand if, for example, a company can use Receptor Occupancy to quantify the pivotal monotherapy dosage during the trial?
Or, put it in another way, can a company tell the FDA: we will conduct the test injecting the patients with and optimized dosage (tuned-in with help of occupancy tests) to achieve maximum viral suppression?
And, what would the label looks like? "this to be used concurrently with receptor occupancy follow up" ?.
My "feeling" from listening no NP is that they might go that way, improving
as a consequence virologic suppression, and greatly reducing virologic failure and AE's in general (even-though these are currently very small.)
My question is: does anybody know how such as test would go?, or the FDA simply approves drugs with XXX mg to be taken weekly or whatever?
FDA meeting will be key. I believe the patients are enrolled (well, depending on how many will the FDA require) and the protocol proposal I would think is ready from CYDY's side.
If FDA decides that this needs "fast track" treatment (rather than designation )I don't see why the study cannot start relatively soon.
Again, a reminder from February 2019: CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.
Good point Sjacobs, actually I had not taken into account the fact that a lower dosage could have a better profit ratio once commercialized, and, accounting for the inventory this might be a significan amount of money.
Let's hope FDA "plays ball" one way or another.
This is from February 1, 2019:
"CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose."
Therefore 74 patients where at hand in February plus upgrades. Therefore the required 100 are surely pretty much available by now. In case FDA demands 700mg, however 525 mg was found to have excellent results.
One way or another, BLA for Combo and Mono are on sight. I am willing to wait calmly (the same way I will wait by a Thai beach latter on when the price goes north ).
Some comments here:
The efficacy of 700 mg is better than that of 525mg. And, perhaps 875 mg will be better. As you well know, the FDA would like Cytodyn to keep on improving efficacy while monitoring SAE's.
The question is: when do we (CYDY) stop ??. Every new dosage brings expenses (paid by us) and time. In normal conditions an equilibrium between SAE's and dosage (for efficacy) provides the answer (well, and, of course, cost), however, it seems than with Leronlimab no sizable/significant SAE's have surfaced so, to put it in some way, a blessing might be a curse.
From CYDY perspective the best is to get approved a dosage and, then, continue with a higher one to cement safety and efficacy data. Then ask FDA for permission to sell higher dosage.
The response rate for the first 10 weeks of leronlimab monotherapy in HIV patients has approximated 95% with 525 mg ; I am sure FDA will agree that this is good response and the drug belongs in the market.
Now, come 700mg or whatever dosage a potential Receptor Occupancy Tests for individual patients say the dosage must be, the results are bound to improve in both, response rate and efficacy. By then safety data will be extensive and FDA would approve optimized (personal) dosages, or, simply higher ones.
What I am trying to say is: approve 525 mg or whatever FDA thinks is approvable and then continue fine-tuning while simultaneously acquiring data. To an extent, it seems that this is precisely what is being done (apart from optimizing dosage with occupancy studies).
Link to CYDY communication for your perusal:
https://www.cytodyn.com/newsroom/press-releases/detail/346/cytodyn-sponsored-researchreaffirms-the-role-of-ccr5-in
Lorbas, Thank you for the posting, is very informative and important for one reason: apparently Leronlimab affects the spread of colon cancer (in animals). Honestly, cancer is a very complex condition and hoping for a one-works-for-all is a bit optimistic, however if the results obtained by Dr.Lindner at the Cleveland Clinic are indeed positive is VERY good news as it probes that there is an effect (can suppress colon carcinoma growth in both low, and high CCR5 expression) on the disease.
If the receptor Occupancy Test can help as well with fine-tuning the dosage (in animals and latter humans) we have in our hands a POTENTIAL gold-mine, and patients life-saving relief.
Good news indeed, I personally would like to see the actual "numbers" (data) on this initial tests, but, if it is what it says … well …