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Grip,
I wish I could buy more as well. The truth is I am "up to my neck" with a large (perhaps too large) part of my portfolio in CYDY.
I envy you .
Good luck to all.
Amatuer, you forget the "price of opportunity". Ideally we all would like to buy an stock right before the LAST cash rising exercise and right before the price jumps (for whatever reason).
If we knew this consistently we will be all millionaires (with little time to post in message boards).
Of course, we all bought thinking this was going to happen after we bought (price go up). It didn't, and most of us are holding bags (BIG one in my case ).
But, again. recognizing that we were wrong does not mean we WILL be wrong all the time. I am not a day trader and, after recognizing my limitations, consider that rather than selling at .40 if I where to analyze the company now (without accounting for past "timing" mistakes) I would be buying rather than selling, which in turn, tells me not to sell what I have.
The price might go down in the future presenting a better opportunity to buy, but again, it might go up (and rapidly) presenting a lost opportunity to buy. As nobody knows when and for how much we need to do any of three things: buy, sell or hold.
I am in the last camp and wish my money-management criteria would allow me to actively be part of the first.
If your current DD tells you the price is going down just short the stock if you can. Or, better, look for other opportunities out there (they exist).
Good luck with your decision making.
From CYDY posting (relevant, complementary info. to yesterday's CC):
To date, over 830 HIV patients have participated in clinical trials with leronlimab (PRO140), including over 600 patients in ongoing and previous monotherapy trials. There have been no drug related serious adverse events (“SAEs”) reported in any of the HIV patients treated with leronlimab.
In addition, the response rate for the first 10 weeks of leronlimab monotherapy in HIV patients has approximated 95% with the 525 mg dosage. Identifying the patients who can respond to leronlimab monotherapy at the screening is critical for therapeutic success. As such, the development of the Receptor Occupancy Test is a significant milestone that may further increase the monotherapy response rate.
“The development of the Receptor Occupancy Test is an important milestone for CytoDyn because it may allow more precise screening for leronlimab monotherapy,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “Over 600 HIV patients that have taken leronlimab as a single agent over the years have had no drug related SAEs,” continued Dr. Pourhassan. “The potential for leronlimab to be a safe and effective treatment for HIV with highly accurate dosing is an important driver of continued excitement and support from key opinion leaders within the medical community,” Dr. Pourhassan concluded.
Significantly, CytoDyn has been granted an in-person meeting with the U.S. FDA to discuss its pivotal monotherapy protocol that could lead to label expansion approval should leronlimab have its first approval as a combination therapy.
To date, 110 patients have reached approximately one year of monotherapy trial with six patients in the extended portion reaching almost three years. Four patients in the extension arm of a previously reported Phase 2 monotherapy trial have continued on leronlimab monotherapy for nearly five years with no drug related SAEs and no viral breakthroughs.
Maybe I am talking from my pocket but the best will be to get the combo approved and shout: "hey you BP, if you don't buy us there will be serious competition down the road !!".
They have the resources to bring Combo and/or Mono to market quick (sales force included).
Thanks Grip.
CC yesterday was interesting. Sharing here some of the known and some of new info/clarification(s) for me.
NP did not do most of the talking (Sacha, Lalezari). Some important takeaways for me (please correct/elaborate as I am working out of my bad memory), again, the quotes are what I remember was said:
1) Colon cancer research is more advanced that I thought. "Very exiting animal data", going to new phase.
2) August 28 meeting with FDA regarding prognostic test
3) End of September for BLA approval possible (some IF's)
4) Face to face meeting for Monotherapy in September to discuss monotherapy protocol should Leronlimab have approval as a combination therapy
5) TNBC delay due to difficulty to get patients. New protocol will be tried as it is preferred to have Naïve patents, however Non-naïve will be injected (I think 5 patients) and then "go to the FDA".
6) Commercialization plan will be posted within couple of weeks in web site.
7) Back and forth for a license agreement has been ongoing for some time, we where "far away from each other" but "we believe we are very close to an agreement".
8) Exploring the Prev. properties of Leronlimab (work in Thailand), this can produce another revenue venue. Sacha thinks this is the best way to stop the HIV epidemic, that is, Prev(ention) and Cure.
9) CCR5 does not work in everybody, trying to understand why. CCR5 come in two forms and is highly regulated so it si important to know how much is expressed in the cells on a patient-by-patient basis.
10) The occupancy test are critical to "personalize" the dosage by optimizing treatment suites in an individual fashion.
11) There is another cancer mechanism that is being investigated (apart from the one from Dr. R. Pestell work).
12) Main investigator on monotherapy Dr. Jacob Lalezari says: "once-a-week will be a killer drug" and "life-changing".
13) The Receptor Occupancy Test is important because it will help with precise screening for Leronlimab monotherapy. Will tell when all the receptors are blocked.
14) Some patients are taking Leronlimab for more than 5 years now with no with no drug related SAEs Lalezari says "benefit without toxicity".
15) First TNBC patient injection is imminent (patient identified).
NP did not say why RP was fired (had some brief good words for him), also, no much time to answer questions which was disappointing.
In general got some takeaways from meeting and it seems there will be some milestones in the next few months. If only one of these work out the price should go north.
I liked Nader comment: "we are at a crucial position and too many people worked too hard and many shareholders have risked everything they had to fund us and we need to be very careful. Need to very honest, very transparent and clear about our goal and potential.". Well … I agree, so he is thinking on us bag-holders (finally, some would say).
Ladies & Gents: A kind reminder of numbers for yor valuation estimates:
GILD with Biktarvy (a triplet) saw growth in its HIV product revenue, which rose to $3.7 billion on the back of Biktarvy sales, nearly 20% above consensus forecasts.
GSK is selling LOTS of Juluca (a single pill two-drug combo, dolutegravir/rilpivirine) and is estimated that peak sales will approach 5 Billion.
The problem is always that that doublets could invite treatment-emergent resistance compared to standard triplets, and, more to the point, that a monotherapy will be riskier. Fortunately, Leronlimab apparently has not shown any symptoms of resistance so far a HUGE plus.
The market is there with more than 1.4 Million patients in US alone living with HIV (around 40 Million worldwide according to UNAIDS). The global market around 30 Billion.
Now, with these figures, how much is the valuation of a Non-adverse effects drug with a potential market of, say, $3.7B+$5B * 0.3= $2.6B (I am here being EXTREMELLY conservative with a market penetration of only 30% and CURRENT sales of competition.
Well. If am correct the price of CYDY should be at least X10 times what it is now. Now, lets be again conservative, my target is $3-$4 dollars with COMBO alone. Again, these are very low estimates.
Monotherapy is another ball-park all together.
Waiting anxiously on the CC ...
Correct. I meant to say RP. Thanks for clarifying.
Gents,
First I have to state from the onset that I am invested (very long) only because of the HIV indication (combo and possibly monotherapy). On this basis alone, I think the SP should be in the $3-$4 range.
The Cancer pipeline is a pleasant plus and reinforced my positive view on the future of the company.
Now, Dr. Prestell demise might be due to several reasons (this is pure speculation of my part with NO knowledge at all of the circumstances):
1) He miss-represented his findings meaning his Oncology research results where silver-lined, a fact that came to light afterwards.
2) He demanded more priority to oncology as opposed to HIV and clashed with NP in the allotment of the limited funds pushing RP to some smoke-filled-room dealing with other companies/investors.
3) NP and RP disagreed on the action to take under an external event (for example a partnership or B.O. proposal) and NP went "solo" without authorization from the board.
4) NP indulged in some 'hanky-panky' or similar business on the premises.
The truth might be of different nature however RP dismissal is not good news for the TNBC pipeline of the company and, for the company itself. However, as far as I am concerned CYDY should finalize the combo license and then focus on mono and other indications. In the same vein I would be happy if the company is BO as patients and investors will get their rewards sooner.
Will be listening in tomorrow. NP has to address RP firing without mincing words. We investors deserve the truth unvarnished.
Bored Lawyer,
Agree. As I have mentioned before, my reasoning for investing in CYDY was that the combo HIV drug was (and is going to be) a blockbuster. NO ADVERSE EFFECTS (or perhaps, much less than other similar dugs). This is huge on its own and should be easy to understand (thankfully not everybody does otherwise one could not buy CYDY for the current price).
The rest is a nice plus for me. However, Dr. Pestel leaving is not good news in general. I hope there will be some clarity regarding the circumstances.
Management needs to act and communicate.
Good news about the agreement. Bad news about Pestell. Lots of questions for the next conference call.
Next question is if the Cancer line of research continues or goes with him.
As mentioned before, I invested in CYDY in basis of the HIV combo alone, however these are not good news years down the road if the cancer indication is still being pursued.
Hope this is clearly addressed by NP soon.
A kind reminder of facts:
https://aidsinfo.nih.gov/drugs/423/leronlimab/0/patient
PRO140_CD 01 (NCT02175680) and PRO 140_CD 01-Extension (NCT02355184):
There were no drug-related serious side effects and no participants dropped out of the study because of a side effect. All of the reported side effects that were definitely or probably related to leronlimab were local injection site reactions of mild or moderate severity.9,10,14
Researchers presented an update on the ongoing CD 01-Extension study in February 2017. At the time of the update, 10 participants were still receiving leronlimab, with nine participants close to completing 2 years of treatment. Leronlimab continued to be generally well tolerated, with no drug-related side effects. No participants have dropped out of the study due to a treatment-related side effect.
PRO 140_CD 02 (NCT02483078); PRO 140_CD 02 Extension (NCT02990858):
A June 2018 safety analysis looked at data from the CD 02 study. None of the participants dropped out of the study due to side effects and there were no drug-related serious side effects. Injection site reactions, which were described as infrequent and mild, occurred in less than 10% of study participants. These reactions were temporary and went away on their own. So far, the CD 02 Extension study has enrolled 35 participants.
I agree. If we don't build opinion with facts we all lose.
I don't mind contrarian opinions, they rather help me to make better decisions, but I do mind contrarians without facts in hand (both, long and short).
Call me a fool, but I invested in CYDY after doing DD only on the COMBO market potential. My main takeaway was the lack of adverse events. For me that is huge and, if this holds, can't think on anybody not switching to PRO-140.
In the interview SP skillfully stressed this point: long term consequences of the other drugs vs Leronlimab (yeahhh!!) . If I had HIV, taking a drug daily cognizant of the cumulative secondary effects and somebody comes and says: "this one does not have any", I would switch in a heartbeat. Wouldn't you ????
There is of course, the added advantage of compliance (once a week) and future treatment-emergent resistance with doublets and triplets; if approved as mono the latter issue will be gone.
My point is that the other indications are simply pluses for me. Get the combo approved, the price will certainly will go North considerably and there will be resources and time to tackle the mono and the cancer, the latter with humongous potential.
In the interview NP should had mentioned the compliance issue as well, but generally speaking, a good interview.
Chump,
Thanks for sharing the link.
Interesting.
Agreed. Once of the reasons why I heavily over-weighted CYDY on my portafolio was the fact that is practically de-risked.
I can't think of any other company with such a large risk-reward ratio (they might exist but haven't found it.)
GILD and GSK control about 90% of the HIV market.
GILD with Biktarvy (a triplet) is trying to enter the market and, are doing well as it saw growth in its HIV product revenue, which rose to $3.7 Billion.
GSK is selling LOTS of Juluca (a single pill, two-drug combo, dolutegravir/rilpivirine) and is estimated that peak sales will approach 5 Billion.
Worldwide market is around 30 Billion 1.4 million Americans have AIDS.
Doublets could have treatment-emergent resistance compared to standard triplets, and, more to the point, a monotherapy could be riskier.
Here, repeating myself: PRO-140 seems to be a great drug provided it can be successfully incorporated into a combo, or, even better as a monotherapy. WITHOUT ADVERSE EVENTS, IMPROVING COMPLIANCE AND WITH NO EMERGENT RESISTANCE (some of these points have been already been proved).
But, in my opinion, CYDY should not try to fight BP, should integrate itself into it. Either GILD, GSK or J&J should get the point that, if they don't have Leronlimab, they will be facing serious (survival) competition from whomever gets it.
Imagine, for instance that GSK can incorporate into "Juluca" Leronlimab and reduce adverse effects and improve compliance (taken less often). Or GILD decides to go "mono" and launches PRO-140 as such. Or J&J decides to "go to war" with GILD and GSK by using Leronlimab with Symtuza (a combo) intead of GILD's drugs (that are currently being combined with Prezista, its product) obtaining a much better product …
You get the point. The road, in my opinion, if CYDY wants to make a positive medical impact with Leronlimab , is to join the "sumo wrestlers" not try to tumble them.
So, I still hope there will be a BO offer once CYDY can probe that PRO-140 works … hope GILD, GSK or J&J will, at some point, wise up .
Interesting commentaries. I like to hear the optimist and the pessimists. All add value. Myself I do my own DD and don't blame anybody for the bad investments and congratulate myself for the good ones.
My mantra is that any company real value is what the SP exhibits. CYDY is worth $0.469 per share, period.
The questions is always: why? or, better, why investors in general don't think is worth more ?. Why isn't everybody buying like crazy ???
I dare to answer that question by saying that the majority of the investing community does not consider that what the company has (or will have) merits a higher valuation.
I invested in CYDY because I think they are all wrong.
The thing is we can say that Leronlimab is the panacea with multiple indications and advantages and zero adverse effects and … and …. but the point is that we have to PROBE it (at least with one indication). And is there where the whole thing falls apart.
My opinion is that CYDY should focus in one indication (HIV will be a good place to start) and get it approved; the money, the credibility and the investors will come like Hemmings afterwards. However, if we continue playing piñata with whatever condition we can find in the illnesses medical dictionary, well, the price will be $0.469 per share or whereabouts simply because nothing has been probed and hence nothing deserves attention.
A penny stock has to probe it can deliver something before the large amount of readily available investing money out there thinks that is worth a look. Unless, of course, somebody in management thinks is better to play piñata for as long as possible (as long as his/her fat salary gets paid punctually by us investors.)
The Prostagene Test should generate some revenue if it is licensed. I believe that the company should FOCUS and get a product through the FDA goalpost.
I personally bought the stock under the assumption that the combinational potential for HIV treatment was large (the point is it helps with compliance and it lacks (so far) the adverse effects that other cocktails have).
Monotheraphy, Prostagene, oncology applications, where not my motivators and are positive additions.
So, why did I invest in CYDY?, well I thought that in this cut-throat environment GILD (or GSK or J&J) would pay anything to “have a look” and incorporate PRO-140 in their combination drug research to make a potential drug with higher adherence rate and less side effects. Be this a combination or a monotherapy.
Obviously I have been wrong all this time as BP has not been nosing around (not yet). However with a market with more than 1.4 Million patients in US alone (around 40 Million worldwide according to UNAIDS) and a global market of around $30 Billion I am prepared to be patient. Once Leronlimab is approved in combination the dam will brake (or so I hope).
Time will tell, in the meantime I think my money is in a good place.
Interesting... talks with “very strong partner”. IT would be a good way of financing to get the pro-140 through the goal post.
Great post, very informative. thanks.
Thanks Pravachol, useful information.
Ladies, Gents, I am in the same boat will you all, owing a large quantity of shares at an average price of $0.78 (won't mention how many so you all can sleep weel).
The risk we have is to provide each other with positive feedback leading all to the precipice like Hemmings. So far so good, this is a factual and objective board. What will lead us to an early (comfortaby) retirement is objectivity and science. Still believe CYDY has the latter an the board has the former.
Hopefully the Co. will execute and we can all join, down the road, for some beers (or beverage of your choice) in Thailand (if you need suggestions as of where just let me know) to celebrate.
Good luck to you all and have a good week-end !!!
MrGuru.
I like this board as most of the postings (bullish or bearish) are informative. I do my own DD and any information is welcomed. Thank you.
Just wanted to share with you why I am still long CDYD, in spite of buying a substantial amount of shares at an average price of $0.78 (47% unrealized loss of a large investment so far).
My idea (and still is) is that the HIV drug can be competitive for two main reasons: it helps with compliance and it lacks (so far) adverse effects. Only one of these, on its own, is huge. However, there is always competition and poor executing: GILD with Biktarvy (a triplet) is trying to enter the market and, apparently they are doing well as it saw growth in its HIV product revenue, which rose to $3.7 billion on the back of Biktarvy sales, nearly 20% above consensus forecasts. Also, they announced in March a new prophylactic HIV drug similar to Truvada. GSK is selling LOTS of Juluca (a single pill two-drug combo, dolutegravir/rilpivirine) and is estimated that peak sales will approach 5 Billion (sold almost $130 Million in 1998). These two companies control about 90% of the market. The thing is GSK I working in a once-a-month injectable combo. And there is J&J’s Symtuza (darunavir) approved mid-last year that uses the company’s drug Prezista in combination with GILD’s drugs, for a strong viral suppression.
The problem is always that that doublets could invite treatment-emergent resistance compared to standard triplets, and, more to the point, that a monotherapy will be riskier. Fortunately, Leronlimab apparently has not shown any symptoms of resistance so far a HUGE plus.
The market is there with more than 1.4 Million patients in US alone living with HIV (around 40 Million worldwide according to UNAIDS). The global market around $30 Billion.
Now, if CYDY is to succeed it needs to tap the non-compliance market (a large percentage of patients don’t take medication because is difficult) and do it quickly. The holy grail is a no side effects drug that helps with compliance.
PRO-140 seems to be that drug provided it can be successfully incorporated into a combo, or even better, c as a monotherapy.
So, back to why did I invest in CYDY?, well I thought that in this cut-throat environment GILD (or GSK or J&J) would pay anything to “have a look” and incorporate PRO-140 in their combination drug research to make a potential drug with higher adherence rate and less side effects (hell, with total HIV-related sales of Billions I would buy CYDY in a second, more-so when multi-class combination drugs are projected to be the top market growth in the HIV space).
My biggest worry is that CYDY management have not seen the need to speed up and, either launch the drug as a combo, or simply sell the company to whomever can incorporate it quickly and effectively. If NP treats CYDY as a good milk-cow for future assured salaries time will catch up and all of the sudden the competitive advantage will be eroded (say J&J succeeds in a once-a-month injection with a combo that does not include PRO-140). BP with myriads of researchers and capital are not just sitting there waiting for CYDY to obtain results or “share” what it has. If this is delayed PRO-140 advantage might well disappear (and our investment with it).
I am very optimistic about the drug (actually, I believe is almost de-risked), but don’t like what I see in management. The obvious course of action is to sell the company to the best bidder, PRO-140 as a combination ingredient is worth a LOT of money. If RP wants to continue doing research or NP wants to launch another company and pursue TNBC and GvHD is good and well (believe me, there will be plenty of money for that), but FIRST need to take home PRO-140 before is too late. I honestly don’t like this going about the bushes with this and that, at the end we will be all left holding bags.
In essence, I bought CYDY thinking that the company was going to be BO. Still think, the moment my original motivation is proven wrong I will re-evaluate and probably take my losses.
Good luck to you all longs.
Thanks Amatuer17, I will be listening not only for he "meat" but aso for the "tone".
It will be interesting to hear what they say (if any) abut the how the financing is going.
"today announced the hiring of Brendan Rae, Ph.D., J.D., as Senior Vice President of Business Development and George Bitar as Executive Director - Head of Quality. The addition of these senior positions aligns with CytoDyn’s pursuit of strategic partnership agreements and efforts to attain its first FDA approval.
Dr. Rae will lead CytoDyn’s business development initiatives, including all potential partnering and licensing opportunities for leronlimab. Dr. Rae is an accomplished licensing and business development executive with a proven track record of deal-making. Dr. Rae comes to CytoDyn from Serina Therapeutics where he was Chief Business Officer, responsible for partnering, out licensing and overall company strategy. Previously, Dr. Rae was the Executive Director of NPS Pharmaceuticals and Head of GI and Endocrinology Business Development until the acquisition by Shire Pharmaceuticals for $5.2 billion in 2015.
Seems that they are going to have somebody looking full time for licensing/BO's.
More importantly for the time being the combo. I think this will be used before the mono. If the company is not BO that is.
Fortuno: Spot on. NP interviews nd the depiction in GILD coincide. Now GILD is "thinking" in subcutaneous with long duration with two parts. What would it be ?? Hint: is white, chicken lay it and one can eat it in an omelet".
If Leronimab is not what GILD needs to reach the depiction above (when talking about acquisitions) what is it?
In any case, I have my money where my mouth is.
Thanks for pointing to GILD conference comments. Very valuable (both literarily and otherwise).
Exerpt from the video:
“Dr. Prestell has proven them wrong with the in vitro and preclinical studies so for how we going to be able to show to the world what we are do in human data. When they say stock is low, we will say the same thing: we are close to major milestones, make no mistake, these are milestone that the FDA has allowed us to take and, going forward, in fundraising we will pleasantly surprise everybody very soon about what we are going to do”
Index Guy. I agree, the company has a big potencial but none of this will come to fruition if financing and focusing is not done.
Just bring the first ball to the goal and THEN look back.
The 700 mg had more response rate that the 350 mg: from February 2019: "This was the first follow-up meeting since its June 2018 pre-BLA meeting regarding the Company’s planned submission of its BLA and the positive interim data of its 700 mg monotherapy trial. The FDA recognized that the higher dosage of 700 mg in the monotherapy trial had a much higher response rate than the 350 mg dose used in the combination therapy trial. In order to avoid a long delay in the BLA filing, the FDA agreed to accept safety data from 100 patients in the monotherapy trial with the 700 mg dose, which enables the BLA submission for the combination therapy to use 700 mg instead of the original 350 mg dose."
Evil Rabbit, you forgot the MOST important one (the one I am betting will happen): BO.
CytoDyn’s Monotherapy Trial with Leronlimab (PRO 140) Reaches its Ultimate Goals
New data shows 525 mg dose achieves 95% response rate after the first 10 weeks of monotherapy with leronlimab.
Over 110 patients have reached almost one year of suppressed viral load with monotherapy on original dose of 350 mg or higher dosages.
Half-life of leronlimab is now confirmed at approximately 10 days versus the previous understanding of approximately 3 days.
These are very good news. I am not really thinking on monotherapy approval. Once Leronlimab is proven there will be a race for BO; any company in this field (including GILD) would love to have a drug without SAEs with weekly dosage.
I agree, that is exactly what I thought. For some reason there is something about Gilead on Nader's head when he talks about Big Pharma. He has been very likely talking to them …
The most important words for me in the interview to the CEO (he was referring to Big Pharma) where that they said: "give me statistical significan data so we can decide what to do with your company".
What do you think this means? Honestly I did not know he was taking to big pharma .. I am VERY long CYDY (average $0.58).
That would be great so we can load up
Thanks BugStocks, interesting article, mainly because it depicts other companies and approaches as well.
I needs to be remembered that GALT failed Phase 2a (NASH-FX) in 30 NASH patients with advanced fibrosis. For this short trial the results where analyzed with magnetic resonance imaging for inflammation and fibrosis and end-points where not achieved. The only finding was that GR-MD-02 was safe and well tolerated.
Even though this trial (NASH-CX) is of longer duration, has more patients and is looking for different endpoints (HVPG being one of them) is important, I am really not worrying too much about its results one way or another. The real possibility exist in the performance of GR-MD-02 as a combinational drug. If it potentiates Pembrolizumab (as 1b trial over 2 years on 9 refractory patients seems to suggest), or any other NASH drug, the potential is humongous. This trial was carried out with sub-optimal dosage, only 3 patients received 2 mg/kg (minimum dosage stablished in mice for the drug to have ANY effect) and ALL have either parcial responses (2) or total response (1) in 4 months !!!. Two patients from cohort-1 receiving less than the minimum dosage had responses (one total response).
I guess what I am trying to say is that if the current trial (with higher dosage of GR-MD-02) in combination with Pembrolizumab shows ANY improvement (over Pembrolizumab alone) the sky is the limit. This irrespective of GALT's own NASH-CX trial as really the future of NASH treatment will be a combinational approach and GALT will be taking a ride in the shoulders (or the stomach, if you know what I mean) of MERK or whomever wants to potentiate its drug with GR-MD-02.
So, let's wait and cross fingers on that the combination works …
I am VERY long GALT
The price went up due to both, sympathy with GLMD and more importantly, because there is a predator out there (BMY) with a big pocket ($9 Billion cash) looking for any promising NASH player. If it does not but Madrigal CNAT is one of the contenders for "beauty queen".
So is not surprising that buyers are jumping on the possible BO wagon.
Truly yours included.
Same here, however the negotiation can bring good news. I hope the addition of this new technology can bring value. What I am afraid of is that when the stock is posted again those that want to trade (at last) will start selling indiscriminately.
I will wait until the dust settles down to see if the new structure is better that before. Have a good amount of money (long) at stake.
Crossing fingers ....