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Over the years I have accumulated 100's of thousands of shares, every once and awhile i'll buy 5k more but i'm mostly tapped out. I have never sold any shares and since the SP is close to all time lows there really is know one that is averaged down to the current SP. I don't believe in averaging down on lottery tickets, for bigger slow growth investments maybe but that has more to do with options trading to hedge etc.. this is not that kind of investment. I don't think to many here buy at $.60 and sell at $.70 and call it a day. Also the transaction costs at these price levels really cut the opportunity given the price movement. It's a $1 today investment that someday might be above $5 and don't think about it too much. I have not ever participated in a direct offering, I was given the opportunity once but at that time the mgmt team (Van Ness) did not make me feel confident to put it mildly. At that point i felt the investment was a write-off loss. When Nader showed up the sizzle was on the steak, even though it has taken way longer than i thought. I have no warrants, totally just a retail trader. It would be great to just find this now and not to have wasted all these years waiting but many bios do get bought before p2 trials.
I also have to say that I primarily trade options on futures so i get a huge amount of leverage. If i was a more traditional investor where i need a good amount of capital to hold positions to make a reasonable amount off of then the size of a CYDY position would need to be much smaller. It's just basic risk management, nothing to do with not believing in pro 140.
That question was asked in a past CC and the answer was that the profit margins are huge in the US, the rest of the world not so much. Other countries have somewhat control over the cost of drugs, the US is crazy town when it comes to that.
admittedly mgmt has not given much confidence in any timeline. However, we know they don't have much control of the fda or the rate of enrollment - this has shown to delay things but it can also mean that things get done sooner. I absolutely did not invest based on mgmt being able to nail it on creating a timeline, I invested based on this product being worth far more than my investment as it is being developed. You must see that right now patients are being injected and data is being collected, at some point it will be known what we have here. it's about creating value, not judging weather a timeline is met.
It is a little confusing, in other slides it shows P3 mono trial as getting a data readout in 2018 and as you posted it also shows on the investment highlights that they expect the trial to be done in 2018. Since it is a 48 week trial I would guess they have really close to the 300 patients now, which is also good for the safety part of the combo trial. In theory this could mean there is a typo and they expect a PE readout in 2018. either way, looks like we will be getting tons of data soon.
Not to be a debbie downer, but why have they not been doing this all along? One of the problems with this company is very few know about it, they keep presenting to investment firms for raising money and to the biotech industry about the science but not so much to the general public and HIV charity organizations. Social media is relatively free and to not do it is insane.
Thanks for asking, I am having a good saturday. Cleaned the condo with my girlfriend, the weather is sunny and getting warmer here in Chicago. I am planning on spending the afternoon working on my auto restoration project. As for the trials, I am not worried about the science and the data, Im just worried about the financials and the fatigue if the investors. We just have to wait for the data and see what the response is from there, and no, i'm not JK.
I don't understand the connection between enrolling patients and the efficacy of pro 140, they are 2 unrelated issues. Its not like HIV individuals look at the enrollment rate and decide to not bother because pro 140 obviously can't work. Whether or not a trial applicant meets the criteria agreed upon with the FDA depends on the patients tropism and history. Patients that are approved to be in the trial get injected with pro 140 and data is generated. The criteria to qualify for the trial, as we know, is very strict and the specifics of loosening the criteria is unknown. We also don't know how many patients cytodyn is trying to enroll, it could be they had 50 weeks ago and they are enrolling extras (i would bet this is a certainty) to have a safety margin in case the FDA questions some to the individual trial participant's data.
A suiter would really be only interested in if pro 140 works, if it stands a good chance of getting approved and what it will cost to not buy vs to buy the product or company. Cytodyn is and has been doing everything they can to accommodate the FDA so they have the best chance of getting approval. Past trials have shown that pro 140 does do something positive so the first criteria is likely met. Once these 2 steps are solidified with the PE combo data i think the cost to not buy vs the cost to buy for BP will become much clearer as well.
Correlation does not equal causation - remember?
PE is for primary endpoint. This is the data from the trial patients 1 week after being injected, it shows if the drug does anything with just one dose.
I agree, your right that mgmt could have/should have given more about how they created the timeline and gave some info of what they control and don't control. I think the climate of the posts here would be different if we knew months ago that the timeline is just a guidance and not set in stone "we have facts that make this good as gold" timeline. I think mgmt assumed investors would know there is not a lot they control in trials but it really only takes 1-2 sentences to set the tone. I do not feel that enrollment is a linear process that we can extrapolate a rate of enrollment based on past #s. They might have one day where they get 12 patients and they might have a month of no patients. In the mono trial with 300 patients there might be a little better rate of enrollment # but with only 50 for the combo, enrollment is sporadic. Either way, I have very little interest in the speed of enrollment or mgmt's communication skills, patients are being injected right now and have been for months - we will get data someday and that is all that matters. There is no way the dilution will outrun the potential. mgmt gave us an estimate of $60mil to do the trials and the market is billions.
I'm as upset as anyone about the delays, however I know mgmt does not have control over when and how many candidates walk into a testing clinic. They also have very little control over the FDA. Those here who chime in with the "captain obvious" remarks seem to not ever have a plan for what they would do differently. So, what would you do to enroll the trials months ago, raise cash at higher SP and take charge of the FDA?
I asked Jody the same thing and she gave me the impression that the full enrollment would be announced this month. I asked if there was some FDA review required before PR'ing the PE results in 4-6 weeks (my estimate) and she did not want to answer what the process is. I found it odd and I also feel that they really are not taking anything for granted. I think the extrapolation of the dates and achievements is getting out of hand and mgmt is really trying to avoid some commitment slip up. It seems the sequence of events is very crucial and mgmt is trying to control things so news is not wasted on unfavorable market conditions or assumed but not real future capital raises. My guess is that releasing any data requires FDA approval and that will take time to make sure the FDA is ok with what is PR'd.
I just had a theory, is it possible the high volume sell-off today might be warrant holders selling off stock (again) to free up the cash to exercise their warrants? isn't the deadline 1/26 for the $.50 discount?
LOL, the problem is that the past trials were only N=50 so the hat causation could be placebo or another "me too" baldness disease. ;)
correlation does not equal causation. People who wear hats might have a higher incidence of hair loss but that that does not mean hats cause hair loss.
What would you do differently? Tell the FDA to shove there combo trial protocal? Drop the GvHD trial? Sell pro 140 for what ever they can get? Fire everyone and replace with millenials?
Pro140 has been injected in enough patients over many years to show it does something. The trials are largely dictated by the FDA who don't give a crap about the cost and difficulties to conduct trials. Raising funds for a high risk OTC biotech when the stock market is red hot is not easy. Does this mean you just throw in the towel and give up all trials and move on?
If this is a scam, then that would mean pro140 has some problem that the world does not know about, or there is no trials going on, or the company is actually broke and everything is stopped,or some other possibility that mgmt is keeping a secret illegally. If you feel this is a strong possibility then what is the evidence? If a patient in the trial suffers some major problem from being on pro 140 that would need to be reported, the IDMC report seems to show there is no problems with the trial so that is unlikely. The company is certainly raising cash at a low SP and is raising in small increments, so that could show that there is a funding problem. But there is too many deep pockets in this and they generally don't let things slip away from a funding problem. I would really like to know what scam you think is going on? Keep in mind, getting a drug through clinical trials with a small biotech company is not easy, but not a scam
Thanks for being a 20/20 hindsight expert, what would you have posted if the SP was much higher and you missed it? I realize I might be drinking the cool aid but you are trading a penny stock and most here are investing for a long term goal.
good to point that out - thanks! I'm still 50/50 on the R/S uplist issue. I feel the effort to do this tells us mgmt thinks we are in this for awhile, or the groundwork might be an effort to look like there is no desire to sell soon for a low price. who knows!
I posted this example in an effort to find a situation that might explain the low SP and OTC trading. Everytime I do a little research on the market, pro 140 and other buyout deals i'm left wondering why this still feels like we are in a high risk biotech that might have a failure drug and no assets. I read the articles on OCAT and saw many details that suggested that they were in very bad financial state and did not have any real big institution support. It felt like having 80% of the shares owned by individual retail traders was not a good situation. One of the other buyout examples showed that once good data was PR'd, one of the large hedge funds that owned a chunk of shares went all in and bought a huge chunk which greatly supported the SP until the buyout. I hope that doing a RS and getting uplisted after a data PR is purely meant to create this situation for CYDY.
I don't think you will ever find a direct apples to apples example because these buyout deals are full of unique details. What I think is important is to see how the articles are written in review of these deals. If it is a buyout of a company that has more than one product, is generating revenue and is of a decent size - the value of the deal is referenced as what % over the prior SP. When the company has a single product, no revenue and is in the process of developing the product - the buyout is referenced in multiples of the projected annual market size. This is why using the CYDY SP for any estimate of a buyout # does not apply. In a few past posts I showed the 12 largest drugs in the HIV market, the smallest was $670mil/yr and the largest is $3.3B. Pro 140 as a combo drug would take one of those spots, even if it is the $670m spot it is a 7x multiple. If the data from the mono trial looks compelling enough, pro 140 can take 2-3 of the existing drugs revenue which is greater than a billion a year easily. The fact that these buyouts occur before and during p3 and are a multiple over the annual revenue tells me we are in the window of a multi billion buyout. I can't understand how our current SP is so low considering this. Even factoring in the risk of a bad data PR, FDA protocol change or some massive cash raise deal it seems the potential should be reflected in a higher SP. Keep in mind, many of these other buyout deals involve drugs that don't have stellar data, aren't yet in P3 or in a growing market.
It is odd, I’ve noticed this also. It’s not just a lack of update conf. calls, it is a lack of any news from anywhere. I am very hesitant from posting this, but in a cc earlier in the year a caller asked tony in the chance that there is a buyout offer, how would that information reach us. Tony’s answer was that the offer would be reviewed by the board, agreed on and then after the deal is done announced. I absolutely don’t intend to insinuate that something is going on but the silence is just odd. It could also be that their timelines estimates are worthless so mgmt decided no info is the solution to wrong info.
After reading that I’m glad our SP is so low so that the shorts don’t jump in. I really hope mgmt know what they are doing, this really should not turn into a tragic failure from made up social media, fake lawsuits and made up bad PR. (It also shows the motivations behind some posters here that show up every once and awhile!)
Totally, this is where an experienced mgmt needs to be very careful. After reading it it made me feel forget uplisting! It seems to me focusing on establishing the market potential for pro140 through trial data will do far more towards a buyout than a manipulated stock price on the nasdaq.
Idenix was bought by Merck for $3.85 billion in 2014 for it's Hep C drugs. SP went from $7.23 to $24.50. Why? because GILD estimated there Hep C market at 7-12 billion and Merck decided they wanted a part of that - possibly sounds familiar?
Aquinox SP jumped 2000% (from $1.84 to $17.44) in 2015 because of favorable test results for a bladder pain drug, not data from a clinical trial or a buy out, just favorable test results.
Pharmacyclics got bought by Abbvie for $21B, for its blood cancer drug which has an estimated revenue of $1bil/yr
Salix was bought by Valeant for $10.1B For a $1b/yr revenue drug.
Baxalta was bought for $32b by Shire, the revenue from Baxalta was $6b/yr at the time.
So, The HIV market is about $17B, Pro 140 is for only the CCR5 tropism which is estimated at 70% of the population, so that is a potential $12B market. The above examples range from a .3x to a 30x multiple of the 1 year revenue, so that gives a $3.6B buyout at the low end.
I found an interesting example of how things can go wrong, Ocata. It got bought out at a 79% premium back in 2014 which the share holders were super pissed about. Looks like the company did a 1-100 stock split to get listed on the nasdaq (or stay on the nasdaq) and got shorted heavily. Sounds like there stem cell drug was in early pre phase 2 trials. basically the share holders (80% small retail) were hoping for more development and a big buyout and got a much smaller buyout based on the heavily shorted SP rather than it's high SP. my rough calculations are that it was a $80 million company before buyout and sold for $379 million.
https://www.bizjournals.com/boston/blog/bioflash/2015/11/ocatas-379m-acquisition-leaves-many-small.html
https://seekingalpha.com/article/3832246-ocata-shareholder-majority-rejects-astellas-offer-woefully-inadequate
Using overall generalizations does not help when finding exceptional opportunities. If pro 140 was a de-risked product, capable of billions a year in revenue, then the company owning it would not be a $100mil company. If you have a product that has not published data in a p3 trial showing that it will likely make it through the trial and be a on market trial someday it has risk and the value will be close to 0. This is why many here consider this a lottery ticket, an investment that is worth $1 up until the drawing at which point it is worth way more than the $1 or zero. What you are talking about is a generalization across all industries and size deals, which show that if you invest $1, it has a high probability of being worth $1.20 or $.80 at some point in the future. It just does not apply to this or any other similar situation. Many biotechs have other products, some with revenue, CYDY has one product and no revenue, a lottery ticket. The investment is based on the belief from past trial data that the science works and there is a huge market beyond the current value. Why you don't comprehend this even though it has been explained many times is hard to fathom. I have pointed out that you don't accept anyone's replies to your posts with any respect and you repeatedly re-posting the same post information is just insulting. I don't need to give you examples to prove anything, You need to give evidence to support how pro 140 is as worthless as you apparently think it is. There is no investor that looks at CYDY as a good dividend stock, as a 10-20% growth stock or as a shorting opportunity, we all know the risk and the possibility. We don't need your "educating us" attitude.
Sounds like somebody that works hard to accomplish more than what is expected. It is clear that Nader is an optimistic person that faces challenges with confidence. Keep in mind, in 2012 CYDY was broke and about to disappear for good, Nader got the protocols approved for the trials and got the funding to get us to this point. It would be nice if there was a history of insider buying from him but that is about the only bad thing i can come up with.
The BO price in all situations is what someone is willing to pay. Many here have explained why your premium % over the SP does not really apply here. Most BO follow this rule but this is not a typical situation. As long as there is an unknown risk of success in the trials, the price will price in a huge risk. Once the risk is lifted, the true value based on the market size (billions) will be realized.
If you worked for any BP in their MA department, part of your job is to know what drugs are in phase 3 trials with the FDA. BP knows about pro 140 and are watching it. The point at which the BP that wants to get into the HIV space, wants to take market share from the other BP and/or wants to protect their own market share will occur. To think that pro140 has no value or that BP does not want it at all at any future point in it's development is just ridiculous. Even if the trial is some level of failure and its back to the drawing board, pro 140 does do something and is worth something, more than the $100mil value of CYDY for sure.
I really don’t think comparing this to some generic startup really applies. If a startup has some product or service that has this level of burn rate for this long then your right, the future does not look good. However in a small biotech, the cost in time and money to get through trials is significant and well known. The market for pro140 is also very well known from existing drugs. I don’t think scaling the market size and value of the product just because of the time and investment exceeds the original plan. We are talking about many multiples here so even a doubling in time and money to get there does not change the ultimate value, as long as that value is proven with data.
In my opinion, your sequence makes perfect sense. However the problem I worry about is if the SP does go up after PE/mono/ partnership happens. I would assume it would but in the past warrant holders have used any move up in the SP to sell there stock and hold the warrants with very little risk. Also, if everyone agrees that a big raise is in the future, why buy now? These 2 problems are why we need to be off the otc so new investors can jump in. Unfortunately that won’t happen until the good news is out. There has been good PR in the past that was wasted on this otc market situation. I really hope these upcoming PR’s do work to push the SP out of this purgatory.
Thanks Saltz, it really helps to have an actual warrant holder's viewpoint instead of speculating what the warrant holder's motivations are. I do wonder why a large raise is needed, They did say it will take $60mil to get through these trials but they don't need it all at once and the longer it takes the less per month the burn rate is, to some degree. No doubt everyone including mgmt thought money would be raised at a much higher SP than it is by now and I'm sure this greatly affects the amount of dilution. Being on the OTC is one chicken/egg problem but the how much to raise at this SP and how to get investors to drive the SP higher even though they know there will be more capital raises is the other chicken/egg problem.
It sounds to me that many warrant holders are not exercising either because the risk is still in the potential results of the data and the timeline. If they pr the data and it is good, then exercise the warrants before the stock is up listed seems to be the logical sequence. If this does happen, then I think the major raise may not be very major or even happen at all. They have only been raising what they need and with PE data out, money will be much easier to raise as they need it.
What would you do differently? Stand outside trial sites and grab people off the street? Bribe the FDA? In my experience, you get what you pay for. We don’t know yet but someday we will.
Does this mean you are finally throwing in the towel Pears? Don't want to wait? I will really miss your balanced posts.
Why? Don't you think at some point they do fully enroll each of the trials and generate the PE data? I agree there have been significant delays but patients are enrolling and being injected. There is no guarantee of when and what PR we get but just because you're negative towards everything does not mean progress stops.
Bucky, I don't argue with the missed timelines - they are a guarantee rather than an occasional occurrence. However, simply multiplying or adding an arbitrary amount of time to every date given does not take into consideration why the timelines have been pushed back. Before the trials started, the delays were getting the protocol finalized with the FDA, we don't really need to worry about that now. The other delay is the enrollment rate, once they do fully enroll the trials we don't have to worry about that either. We are 1-2 months, possibly a few weeks away from full enrollment in both trials, once that is done we might see timelines that are beaten rather than missed. Ignoring the factors in the timelines makes me feel you are more interested in judging mgmt on calender success over actual accomplishments.
Awhile back in post #17301, I did a simple estimate of where cytodyn is relative to the annual market revenue for the existing HIV combo drugs. I think I was very reasonable in my estimate of the worst case scenario of a 7x multiple, just for a combo drug. The money raised to pay for these trials is significant in the dilution of this company as it sits now, however that is tiny in comparison to the market size. If we go with $95mil value for CYDY now, raise $15mil over the next 6 months, we have a 15% dilution in the value of our stock. This seems bad, however if during the 6 months we get data to show that pro 140 is effective and safe as a combo drug and estimate we get potential revenue per year as a combo drug at a low of $670 mil to $3.3 billion high. This is a 7x to 34x multiple in the value of the company. In my googling, it seems that buyouts generally are for 1-1.4 times the annual revenue potential for a p3 drug, that means the buyout is anywhere from $700 million to $4.6 billion. This is just for the combo trial.
The fact that they are in a mono trial - which no other drugs are, means this trial will threaten not just the revenue of one combo drug but multiple combo drug revenue. This is very important, not just because it might be a much better option for HIV individuals, but because the threat of lost revenue is billions to any of the top 3 pharmas. Because the Mono trial is open, I would assume the data read outs will be available soon after full enrollment. Any BP will see the damage this drug can do and will spend the money.
If anyone is worried about the data from the trials, many have already been injected and the data shows efficacy, safety and a lack of side effects beyond currently available p3 approved drugs. Pro 140 does not have to be 100%, many other drugs have failures, side effects, rebounds and resistance in their data and are approved.
If anyone is worried about funding, the company has always been raising money as they need it. The plan has never been to raise all in one chunk. The reason is to have the ability to get the best deal possible as they need it. I'm sure the access to funds has been tough at times and I'm sure raising funds at these prices sucks for everyone but if someone told me I could invest $60 million and get 1-6 billion in return, it might be worth it! That's $10 - $60/share, I agree $60 is quite optimistic but it is possible.
They are injecting 40+ in the combo trial and 150+ in the mono trial right now, both trials will be fully enrolled soon, less than 6 months from now. There is nothing to say the data will be bad, which means the risk could very well evaporate very soon.
Also, do you think mgmt is holding up the development so they can dilute more? That would not make much sense, not sure why you can’t accept the possibility that FDA phase 3 trials take lots of money and time to complete. I’m not sure you understand this, you keep complaining about dilution and insisting that some partner should just crack open their wallet and pay for everything. I don’t think that comes with no strings attached.
They bought pro140 from progenics and there was already a grant tied to it, cytodyn did not get the grant. Mgmt was asked about this and they said the process takes very long, there is no certainty of if you get anything or how much. This is very unreliable source of funds and would greatly hold up the process. As for Charlie, why don’t you email him? Or you could try calling the company and asking them, have you ever even tried to call Jody?
! ? really, you need an exclamation point? Do you know how they could get funds without dilution? they could stop the trials, does that sound like a good idea? You can't have your cake and eat it too, It takes money to pay for trials and they are only raising barely enough to keep going at these low stock prices. Investors are not feeling that this is a sure bet yet so some won't exercise warrants yet and a partner is not jumping in yet. In the 10K they outline what happens when they are not able to raise funds, they cut the speed and even delay the trials. They have not done that so my guess is they can get the funds to keep going as fast as they can. Everyone would like to have the data months ago, everyone would like a buyout now and everyone would like the SP to jump to the value of a company with a multi-billion product. But, We have to wait for that to happen and listen to whiners who aren't happy until everything is handed to them.