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.
Gents,
The FDA attitude towards Leronlimab is something I have just not understood. I have seen myriad drugs being approved with SAE's just because show a hint of "superiority" over existing drugs themselves "poisonous" for lack of a better word.
Here we have a drug that has shown all treatment-related serious AE = 0 and, yes excellent primary efficacy (P=0.0032).
.
In a word much better to what is out there .. what do we get from them? I need more data for a higher dosage when 525mg was very good !!!
Either they still don't believe how good it is or … well has something to do with BP not wanting Leronlimab out there helping people.
Am I missing something?. I think FDA normally is doing its job but, frankly, am beginning to have my concerns about BP tainting it.
Does it mean that FDA has been fooled as well and they will mistakenly approve a "false" drug ???
Man, if this is the case CYDY is really good.
What would make you realize that it is not kool-aid? Shall I send you some links to scientific papers with lots of very smart doctors stating that apparently this is not Kool-Aid ??
Acquiring more than 5% of a publicly traded company
Section 13(d) of the 1934 Act and Regulation 13D thereunder require beneficial owners of more than 5% of a class of equity securities of a publicly traded company to file a report with the SEC. For purposes of calculating the percentage of shares held, a fund manager will generally be deemed the beneficial owner of the shares held by its clients, as well as of any shares held in its proprietary account.
The Section 13(d) reporting requirement is satisfied by filing Schedule 13D with the SEC. Schedule 13D must be filed within 10 days of crossing the 5% ownership threshold. Schedule 13D must be amended promptly to reflect any material changes in the information provided. “Promptly” is not defined in the 1934 Act but is generally interpreted to mean less than two business days.
Is a very risky strategy, GILD revenue is declining steadily, Truvada’s loss of exclusivity in Europe and, soon in USA, was the main driver for development of Descovy as the replacement for Truvada (TDF component was replaced with the TAF).
Several factors (convenience one of them) are resulting in having ViiV and GSK to steadily take market share from Gilead.
Leronlimab will pose a MAJOR challenge if approved, not only that, GILD is risking some other company acquiring Leronlimab and challenge Descovy either as a Combo or, worse, as Mono therapy.
I like the fact that he is "out there".
A lot to digest but long history short, "deal will be finished very soon (yes, you can smile if you want, I happen to believe) and we will be announcing it, revenue will be generated".
Bottom line, the deal is still ON (not MIA as somebody suggested). That is all I wanted to hear.
I will spare you the other details of the interview.
Will be cut in half $0.15
Ohm,
Yup. Average is actually 12.91X, as you point out 5X is a low end.
https://csimarket.com/Industry/industry_valuation_ttm.php?ps&ind=801
Ohm,
Well said, you are a little bit, just a little bit, below my model output for Mono. However, it does not matter as this depends on the amount of patients that will be injected an other model assumptions.
The bottom line is that, if you throw Oncology into te mix, we are way far away from the ultimate, fair SP.
I mean FAR away, if you know what I mean.
To all interested in NASH there is this excellent link. It has a wealth of information in NASH (don't forget to explore the drop down menus at the top where one can acces lists of drug candidates, market data, time to market and so on).
http://www.nashbiotechs.com/nash-biotech-analysis/nash-introduction/what-is-known-about-nash.html
The site is investor oriented for NASH (I happen to own GLMD and GALT)
Saltz,
Thank you for sharing your toughs apart from CYDY. Sorry to hear the loss of your parents. It is not easy.
In a small way, when all is said and done, we all have put our grain or sand to help the patients that will benefit from Leronlimab.
Of course, we did it for our own benefit but risked our capital knowing that there was science and future to it. CYDY has survived al this time because we investors have supported the SP buying.
I hope some day we will see the green and the smiles of the patients.
I Luv CYDY,
I agree with your post almost completely. I am for the long haul as well, however, I respectfully disagree with the message board meeting venue:
I happen to agree with you.
Volume is too high too "all of the sudden" (pardon my English).
There is something going on in the sub-surface. The oncology news had been released much before.
In any case, those buying are right. Buy Buy Buy
Your timing was exquisite … Congratulations (hope you bought a good bunch)
Price up 16% with very large volume ….
New buyers ??? Somebody knows something we yet don't know? (deal).
In any way … happy to see the gap printing ...
Agreed,
Price is not going up simply because there is not market exposure for CYDY. I am not going to lecture anybody with offer vs demand stuff.
We can't lift the price because we are very few and very poor (and some already overinvested in CYDY). I personally threw away all my long-held money-management principles and currently going through all the stages of remorse. I guess that when a dog is feed with bacon some kind of attachment can be forgiven.
Back to te subject. Once a deal is achieved and the data shows that the big boys need to smell the coffee the flood gates will open.
Now, IMHO the very first thing that management has to do (and should be planning already) is to up-list to either AMEX or NASDAQ. Any of the items you mentioned would shake the SP (or shall I say, eject?) to da moon (and please don't tell me I am being naïve) if we were listed.
This not to say that the SP will firm up considerably before.
There some reference to $5 dollars. Question: for what ?? Are we talking HIV only ?? If this is the case I might agree with you.
In any case, I share your view of the near future. Is up, up, up and away (as the cork of the well-deserved champagne).
????
ohm,
Yup. Agreed. And, might I add: better than anything in the market.
As the proverb goes: "we are living interesting times". GILD is desperate trying to re-capture the momentum it had in HIV. As you say, buying CYDY would had been a good move for them: from one of my a previous posts:
1. GILD is practically a company with few products (TAF-based) Bictarvy for HIV treatment, Truvada for PrEP, and Descovy-based drugs; somebody somewhat dismissably, said that is largely a one-product company (TAF-based combinations):
2. It has been underinvesting in HIV research and is facing very strong competition (GSK, ViiV). Apart from the TAF line (patent protection only until 2022 and earlier in the E.U.) all their other drugs are in phase I with exception of GS-9131 (a NRTI), in phase II for resistant patients
3. Its drugs are combos with three ingredients with sometimes serious secondary effects also, there is the resistance, compliance issues.
4. It recently failed a NASH candidate
5. It needs to return to “grow” as sales have been declining with HIV competition increasing (revenue peaked in 2016 and has been going steadily down ever since).
If Mono works it will have some very SERIOUS competition ( I don't want to list the litany of advantages of Leronlimab over their toxic combo) and very soon. I don't have any idea what the potential commercialization contract says, but GILD will have two options: swallow the bitter pill and BO/partner with CYDY or start a race/competition that is likely to hurt them one way or another as Lero will cannibalize present and future sales of whatever they produce down the road.
All of the above IF mono performs the way we are all expecting.
IMHO
Being right 1% of the time is all it takes … Once deal is announced, or BLA is approved, or NASH data shows very good results, or mTNBC idem or ...
Any time now … you are right … we are this close :) (no pun intended).
Ohm, StJacobs,
Agreed. Once the SP goes higher and the FDA approves CYDY will get out of dire-straits much easier.
My personal preference is simply a commercial loan (interest rates are very low), with the collateral of an approved drug with commercialization secured.
Many banks will readily jump in (not the case right now as they see CYDY as a risky investment.
Yes, there are several option:
The obvious way would be to get a commercial loan (much easier with a FDA-approved product and a commercialization deal in hand).
Private investment is another possibility. CYDY does not need a huge amount of money, the extra would be the required for the Mono trial.
The commercialization firm might be able to help (as somebody else mentioned, is to their advantage to get the Mono trial finalized expeditiously).
Last resort is to continue doing small stock-placement raises, hopefully by then the SP will be much healthier that it is today.
Whatever the venue, it will be much, much, easier with an approved drug and a commercialization partner in hand.
1% ? maybe … 2% ?. It is a rolling submission.
I am sure the "small upfront" will be enough to take us through the BLA; I am sure NP & BOD know that this is critical. Also, there will be some time where likely there will be the Mono trial ongoing before revenue from Combo comes our way.
However, with a BLA accepted raising capital either way will be much, much simpler as there will be confirmed "collateral".
Also, if (a big if at the moment) any of NASH or mTNBC studies shows exceptional results the moneys that could be generated rapidly there (partnership) could probably completely eclipse de HIV narrative.
Nope, I started much higher :). My assumed risk is 30% (0.3).
I am big time in the red right now.
Amatuer,
Right you are. There is not guarantee of success, which, again works in our advantage.
The lack of guarantee is called "risk", if there was no risk how much do you think the SP would be ??). It depends on the answer to the next question ? Risk (or lack of) for what? .
A good investment is one in which there is positive mathematical expectancy.
Mathematical expectancy = (1-risk) X dollars I win - risk * dollars I lose
In my case, I am modeling risk right now of 0.3 therefore:
Mathematical expectancy= 0.7 * dollars I win - 0.3 X dollars I lose
So, in general, if I invested, say 10000 dollars (that I can totally lose) if I expect to win more than $23333 dollars (or 2.33 times my original investment) I am doing a good investment (positive mathematical expectancy).
In the case of CYDY I think the potential is more than 2.33 times, when the FDA approves Lero the risk will go down meaning that pretty much any investment is a good investment.
1) FDA approves the Combo BLA
2) Our partner starts paying royalties for sales
3) The SP before (due to news and expectations) and afterwards starts to raise to "fair" valuation. Depending on sales this might well be $5 dollars (however, I suspect Combo alone will bring us half-way). Once Mono is a reality we will pass through $5 rapidly
4) Add up other indications and .. well .. up, up, up, and away we go !!
Bcgk,
I will try and explain to you, is very simple:
Without trying to patronize, the price of a stock depends on two factors: offer and demand.
Offer: CDY is an OTC stock and right now is broke, in order to finance its operations, it has to “print stock” very often selling it sometimes at very favorable conditions (sub-par value) to attract risk-takers. Apart from that some of this capital raises include provisions in which the buyers’ profits are not affected if the stock value is low, that is, when they sell their allowed periodic chunks of shares they don’t care if this puts downwards pressure on the SP.
Demand: Who buys CYDY ?, well, retail investors like you and me that, one way or another, found out about the company, liked it after due DD and invested from our savings/ salaries etc.
Nader mentioned 2000 in his last Investors Meeting, others say 860, whatever the case might be, this is a ridiculously low number. Also, most of us are already overinvested and are not buying any more shares. So, who is buying ?? Very few people.
So, how do other companies do?? They have INSTITUCIONAL investors (the big boys); FYI, CytoDyn has only 3 institutional investors and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of mere 575,200 shares (don’t you want to start crying ??) . Largest shareholders include InterOcean Capital, LLC, Diversified Trust Co, and Inverness Counsel Llc, also R Pestell has 22,494,631 of shares.
That’s it !!! Period.
Why don’t more big boys buy CYDY being such a wonderful company you were asking ?? Well .. because they can’t!!! Most funds have rules to which they adhere religiously (being part of their prospect) and would not touch CYDY with a 5-meter pole. These regulation include listing and stock price (5$ being a common level).
Guess what is the chance that an institutional investor come and buy an OTC-listed company trading at 30 cents ??? I think you know the answer already.
So … since offer > demand the SP goes south …. Which in my books is not a bad thing … why ?? Because I am not a big boy (economically speaking) and CAN buy companies like CYDY BEFORE they “discover” them. They buy at $5 whilst I bought at $0.3. Who is smarter ???
Answer: We are.
Newrunner,
Is a fair question, we are not far from finding out if Leronlimab has a therapeutic effect in mTNBC (and, likely in other types of cancer), some might argue that the fact that the emergency patient is still alive is an indication that good thinks are to come.
There is also ample literature in the subject depicting CCR5 importance in several types of cancer, and therefore the subsequent potential effect of inhibitors on its control.
Now, if you where seriously asking, some studies estimate the market size for the global 27 cancer blockbuster drugs to surpass US$ 120 billion by 2025. Now, let’s assume that Leronlimab can stop the metastasis of cancer. It will immediately enter the stage and displace some on the list below (trying to do exactly that).
Let’s be very conservative and assume that Leronlimab simply adds up to the list. We have, for example Ibrance which had 4.1 Billion in sales last year as a typical example ($120B/28=$4.28B as now there are 28 companies :)).
So, let’s assume $4.1 Billion of sales. 470 Million Shares for CYDY (376756444 stock plus 178591849 of Options + Warrants plus 7413000 Convertibles Preferred plus 7238707 “others”).
We have Sales/Share= $4.1 Billion/470 Million = $8.723
And the stock price would be: Sales/Share * Price/Sales term. Taking the mean of the biotech industry as 12.91 for the term: https://csimarket.com/Industry/industry_valuation_ttm.php?ps&ind=801)
We have:
Estimated Stock Price = 12.91*$8.723 = $112.61
Global Top 27 Cancer Blockbuster Drugs
Imbruvica (Ibrutinib)
Revlimid (Lenalidomide)
Pomalyst/Imnovid (Pomalidomide)
Keytruda (Pembrolizumab)
Herceptin (Trastuzumab)
Avastin (Bevacizumab)
MabThera/Rituxan (Rituximab)
Perjeta (Pertuzumab)
Opdivo (Nivolumab)
Sprycel (Dasatinib)
Ibrance (Palbociclib)
Zytiga (Abiraterone acetate)
Tagrisso (Osimertinib)
Darzalex (Daratumumab)
Xtandi (Enzalutamide)
Jakafi/Jakavi (Ruxolitinib Phosphate)
Yervoy (Ipilimumab)
Alimta (Pemetrexed)
Gleevec/Glivec (Imatinib Mesylate)
Velcade (Bortezomib)
Tasigna (Nilotinib)
Xgeva (Denosumab)
Afinitor/Votubia (Everolimus)
Neulasta (Pegfilgrastim)
Exjade Jadenu (Deferasirox)
Sandostatin (Octreotide Acetate)
Faslodex (Fulvestrant)
The above is just an exercise assuming that Leronlimab enters the stage as one of the Oncology blockbusters. It might get better as some of the drugs here will be replaced by Leronlimab. Also, something that can stop metastasis with no SAE's will likely enter into the Keytruda league (projected sales $22.2B by 2025) rather than in the Ibrance one.
But, please, don't book your tickets to Thailand/Vegas yet. We will probably get there but will take some time still ...
Finesand,
Part of the function of a good CEO is to instill optimism to his/her employees and to the investing community in general. He/she needs to see the glass half-full rather than half-empty.
Imagine that instead of saying:” the sky is the limit” or “we are the next Humira”, he would say: “the price will move a little after we get the FDA to approve Combo and Mono (by the way, we have a very favorable commercialization agreement on the works) and GvHD is approved and Leronlimab probes effective in mTNBC and we sign a licensing deal with BP for NASH and Lero shows therapeutic benefits in any (or all) of Colon, Prostate, Pancreatic, Liver, Lung or stomach cancers.”
I like his optimism providing he is truthful, and I don’t have any doubts that this is the case. He has make mistakes and he has admitted so, he could had done things differently, and he knows that, but, IMHO he is a honest hard-working person.
tonys57,
tonys57,
We all know (with exception the non-believers) a deal is coming. When is now open for speculation. Two, three weeks that is fine with me (I know, I know, this is not acceptable for some of you.)
What it is important in your communication is the fact that it will be a long-term deal for USA and for ALL HIV indications.
We were wondering before if this will include only Combo and not Mono. So is both.
So, let's sit and relax and wait for the upcoming good news (safety, NASH) before the big one comes.
To paraphrase you: the needle WILL move.
tonysd57,
Thanks for sharing the information. This are great news, however I think you don't understand the magnitude of the importance of the deal, less the meaning of a potential agreement.
The finalization of a commercialization agreement would mean that, once the BLA is submitted & approved and production is ramped up, CYDY will start receiving royalties.
CYDY needs some money to arrive to finance till BLA. a del would mean this s taken care of.
In the mean time there are lots of "golden eggs" to be laid soon , to use your terminology:
- Safety data for 700 mg
- Monotheraphy
- mTNBC resuts with patient(s)
- NASH animal results and possible partnership with BP
- PrEP (Thailand, US Army)
I don't know about you but, I have seen and own many OTC and otherwise companies trading at several multiples current valuation only in hope of one product making it to market (with only one product in the pipeline as well).
Maybe you where expecting a quick several Billion BO and take your money to the bank, however the more indications Leronlimab probes to be therapeutically beneficial the higher the price tag will be when BP comes begging to CYDY's door.
If they don't come … well, the SP then will give you a wide smile. Or so I hope.
Blue Baron,
Thanks for sharing the article, very instructive.
It WILL matter and it WILL make money. It is not when one wants, it is when it happens.
Just sit tight ...