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"Good luck with $1.50 - that is 2.50 times from todays price -good luck with it"
Thanks A17 - obviously from your remarks you don't think we stand a snowballs chance in hell of getting to $1.50. Maybe we do maybe we don’t.
The SP was close to $1.50 in the summer of 2016 when we thought Combo PE was right around the corner. We are in a better position today as Combo PE news is on the way in weeks and Mono is over half enrolled with GvHD lurking.
I would say good luck to all of us.
For what it is worth here is my take on the near future of Pro-140. This is my opinion only.
Interim Combo PE will be announced the week after Thanksgiving. The results on the 40 patients will show that PE has been achieved and that N=50 PE has been statistically achieved because of the Interim results. IMO Combo PE is a done deal. As for the Combo safety data that will be 24 weeks after the N=50 PE data. Because Pro-140 is a monoclonal antibody and past studies have shown it to be safe it would seem that safety would be in the bag however the FDA wants to see the safety data when combined with ART Therapy.
While completing N= 50 patients enrolled and PR on final data on Combo PE will give closure it will be diminished substantially because of interim results already showing efficacy. Second half of January is where things get interesting with three events happening simultaneously.
1-Although Final Combo PE will be known in December they will save the PR to coincide with the two events below.
2-R/S with an uplist to the Nasdaq
3-Major Raise with what is hopefully a much higher SP based on Combo PE results. This will be needed to meet the Nasdaq cash requirement to uplist and obviously to keep the trials moving.
I would hope we could get to $1.50 so the R/S would be a 4:1 to get to $6. That allows for a cushion off the minimum Nasdaq SP of $4. I would bet the uplist SP is going to be $6 and whatever ratio of split is needed will be used.
The catalysts moving forward after the uplist are the ongoing results from the P3 Mono Trial which is not blinded and GvHD Trial which may be unblinded after evaluation of the first 10 patients if deemed appropriate by the FDA. It is quite possible that interim results with the P3 Mono will show high efficacy above the needed 70% success rate the FDA has set as the benchmark to continue to BLA without further trials. To further enhance hitting the 70% benchmark the company recently added the option for an increased dosage for any patients that experience a breakout. They can increase from the standard 350ml to 525-700ml dosage. Previous trials injecting the standard dosage of 350ml show Pro-140 exceeds 70% success as it was shown that weekly treatment with Pro 140 SC mg suppressed HIV-1 RNA levels below 40 copies/mL for > 40 weeks in 81.3% of patients (13 out of 16). The P3 Trial is much larger with N=300 so this increased dosage option at patient and doctor’s discretion is a very wise move. The interim ongoing results of the P3 Mono Trial will be a huge envelope pusher in terms of creating the tipping point for a buyout long before the trial is completed. If the writing is on the wall it would seem there are smart enough companies watching that will step up before completion to buy the molecule at a discount.
IMO it appears that the timing for these events is at hand and the value of this investment is going to transpire somewhere between Q2 and Q3 of 2018. P3 Mono and GvHD are huge wild cards that could fuel Pro-140 towards multiple offers. The first offer will trigger more. IMO Gilead will not move first it will only move when it is forced to.
Happy Thanksgiving to all and here’s to getting to the finish line in 2018.
Well that’s the million $ question. Hopefully with a buy out long before completion of trials.
The company is committed to completing both trials and there is enough value with Pro-140 to attract enough investment to get it done. IMO the company is figuring that this the least expensive way to get there. Hang in there we are going to get to the finish line. The only question is at what cost?
PE data is the derisker to attract new investors. Investors that are on the sidelines waiting for the proof. Banks and deeper pockets are not interested in what you think you have they want the meat. The meat is the FDA in our corner agreeing that PE has been achieved. As Tony has stated all along derisking Pro-140 by advancing both Combo and Mono P3’s is the primary focus not the SP. Obviously the cost of raising $ is tied to the SP so while it may not be the primary focus it is quite important none the less in terms of dilution and the ability to accelerate the trials with adequate funding.
So the strategy going forward is derisk through the advancement of trials and raise $ on the Combo PE news regardless of SP. Uplist through R/S and get the story out in front of the broader market.
They increased from 10:1 to 15:1 so they are able to uplist to the Nasdaq even if the SP dips to .40. Logic is worst case scenario they go 15:1 R/S at .40 for a $6 SP giving them a $2 cushion on the min $4 SP needed to stay listed on the Nasdaq. Best case scenario is the SP organically moves to $2 with blow out Combo PE and go for a 3:1 R/S. My opinion is the SP is going above $1 with good news and we will be on our way. It’s all about the upcoming results.
Correct me if I am wrong Gestalt. My understanding is with the shelf they have shares available to sell but they still have to have investors willing to buy to raise $.
Bobby, do you understand the BP players like Gilead that already control the HIV space would like to squash Pro-140 like a bug. Pro-140 doesn’t increase revenue for Gilead it protects it. At this point they would prefer to keep on keepin on without having to spend money on insurance. This story needs exposure and access to the broader investment community. It’s not going to happen on the OTC. You want to talk about diluting this investment - staying on the OTC and raising $ at these prices will do it. As Bucky stated public buying can’t possibly outpace warrant holder selling on the OTC. Writing is on the wall- R/S coming and that should be embraced not feared. The news to support the move is there. This is a way to increase our ROI not diminish it.
IMO the small incremental raises are small because they have been unable to attract enough interest to fill the offering. The current raise is for $15 M and they have filled a little over $1 M. $15 M Is not a huge offering but they obviously would like to raise 15 M. This is the second time around with very little interest. Seems Paulson has exhausted their investor base until there is fresh news.
There is no question in my mind that Tony is banking on strong Interim Combo PE and complete enrollment PE to increase SP and create some momentum for a major raise to see us through the summer of 2018 if need be.
If there is a current deal brewing that would awesome. My gut tells me Tony is gearing up for a big raise after Combo PE and a R/S and thinking he can cut a deal between those events and the middle of 2018.
Makes no sense. No trust or confidence in OTC. Only logical explanation other than OTC manipulation is many investors that control warrants are willing to unload their shares at a loss in favor of just holding warrants. This is like a treadmill and the cycle has to be broken. IMO need to R/S and uplist on Combo PE results so this story not only gets exposure but the restrictions are lifted allowing the broad market the ability to invest.
That would be great. I? hope so.
Broker, I? agree with many of your points. Yes, we need positive news to improve the SP and position for a big raise. I? think the company is well aware of this and obviously preparing the Interim Combo PE results to get the ball rolling. My only point is I have no information or reasoning for expecting a PR tomorrow more than any other day in the next two weeks. Obviously we are now just inside the 4-6 week window that was announced on the Oct. 19th CC for PR’ing Interim Data. I? hope your hunch is right. I? just find it odd to expect a PR tomorrow.
Definitely a possibility. Though I? wouldn’t count on it.
Welcome
Cold, your R/S hasn’t worked out. Sorry to hear that. There are no sure bets here. Simply making the point that when R/S splits are performed for the right reasons and with enough positive catalysts in the pipeline they not only make logical sense, they can be successful. Your bad lemon investment doesn’t represent the whole basket of fruit.
BTW, your snide derogatory comments would be better served left inside your head and off this board. I guess someone else here is if the same opinion.
Uplisting isn't automatic. After a company meets all of the requirements for an uplisting, including financial requirements, corporate governance requirements and share price, it is still up to Nasdaq to give final approval. Sometimes this happens almost immediately. Other times it can take a number of weeks. The conclusions are that timing on uplistings is uncertain, timing depends entirely on Nasdaq approval.
FYI-
Reverse splits are a sign of good things for companies on the way up, but a sign of bad things for companies on the way down.
In order to meet the minimum share price requirements for Nasdaq, many companies will conduct a reverse split. This is perfectly acceptable to the exchange, and the post-split share price will be evaluated accordingly.
Using a reverse split to raise the share price and obtain an uplisting is a very positive sign for a company and is much different than companies that use a reverse split to prevent being delisted. Once again, the confusion relates to delisting as opposed to uplisting. Many people who don't focus on uplistings only encounter reverse splits in the context of companies that are trying to stave off a delisting, so in many people's eyes a reverse split is a sign of a troubled company.
For the relative few of us focused on uplistings, a reverse split is typically the first catalyst that attracts attention to the potential uplisting and is considered a very good event.
It’s imperative that CYDY get off the OTC and uplisted to either the NYSE or NASDAQ to get this story in front of institutional investment and deeper pockets. Tony knows it, the company knows it, and anyone that has been around long enough knows it. I? don’t think there is any question that a R/S is coming with the catalysts in the pipeline; N=40 Interim Combo PE, N=50 Combo PE, potential GVHD partnership, completion of Mono enrollment, Mono Interim Data, a possible broader Combo label, and more ammunition in the bag that I? am missing. Point is it seems the time to make the move is fast approaching.
I would think the company is able to see data on 40 patients as they are working on interim PE. Correct me if I’m wrong but the company has always been able to see the data, but it was blinded meaning they didn’t know which patients were injected with Pro-140 or with placebo.
Thank you for your post Inoviorulez, I completely agree.
What is your opinion of CYDY from an investment perspective? Do you have a position, looking for an entry point, or simply making the point from the sidelines that often times management is not to blame for delays, but rather at the mercy of the FDA?
I was with you Pears until your last paragraph proclaiming doomsday if timelines are missed by even a couple of weeks. We can always count on you for the Murphy’s law absolute worst case nightmare. We certainly have balance on this board.
BD, I think it is reasonable to assume Tony and his team are thinking along these lines. To me the unknown is how serious is the dialogue regarding a GVHD partnership. Is there real interest this early in the trials? I heard rumors 6 months ago that GVHD could possibly have a partnership prior to the end of 2017. I found that odd at the time but with Dr. Berger’s comments on the last CC call it got my attention. If this was to come to fruition in a timely manner it would be game over. Your rationale and speculation is not far fetched - the tipping point may be closer than the current SP would lead investors to believe.
All good points BD. Having a strategy and the goods to build momentum is paramount.
Yes, 4-6 weeks from Oct. 19 CC is correct for interim Combo PE on the 40 patients.
Agreed. However t it is obvious that they are raising just enough to get to Combo PE data hoping for a bounce in the SP. Tony is showing confidence and IMO must be bullish on the results. The only thing I have been confused by is taking 4-6 weeks from the Oct. 19th CC to PR interim Combo PE on the 40 patients. That’s could be as long as 7 weeks from the Oct. 12th meeting with the FDA. It seems that time is critical in terms of positioning for a big raise. Why would they not have compiled data and disclosed in say within 3 weeks of the FDA meeting. I would assume they are really making sure they are in alignment with the interpretation of the data with the FDA. They certainly have no excuse to miss the 4-6 week cushion they gave themselves.
Maybe I do, maybe I don’t. It matters little as to what will transpire. Good luck to you Pears.
Pears, MCAP can increase rapidly as Pro-140 is de-risked. I understand your opinion and logic but it is flawed because it is tied to current valuation based on data up to this point.
You seem to think you know what the valuation will be even with stellar Combo PE results because you say Pro-140 is worth very little as a Combo therapy. Your basis for your opinion is the Combo Trial would have been enrolled long ago and patients would be beating the door down to get in the trial. Not with the initial protocol. These are patients that are so sick they have basically given up. That is not the profile of patient that will be treated with Pro-140. Yes there will be the adoption factor by the treating physician but your minimizing the value of Pro-140 as a powerful alternative in the Combo space is IMO quite flawed. That is where many here have a difference of opinion. Your attitude is that everybody needs to wake up because unless Pro-140 succeeds in the Mono space it is worthless. IMO once again not true.
As I have read your many posts I will say this you are knowledgeable and at times you make some valid points. You are however the epitome of Murphy’s Law. If something can go wrong it will definitely go wrong. You are not short CYDY like many believe. You are very worried this is going to be a bust and you at least want to be right about something if CYDY is a failure so you pound your negative perspective into the ground. Delays, incompetent management, and lukewarm sentiment about the science as your position in regards to the state of CYDY.
My belief is the data will determine our fate. Management is committed to completing the trials and revealing the data. Pears, I hope you stay in the game because you may get a very unexpected happy ending.
Agreed, it is all about the “Trial Results”.
IMO the SP is a reflection of a data drought - no new trial results in a very long time. This Combo Trial is going to be 9-10 months overdue and that has cost time and $. The delays are part of the FDA process but have weighed heavy on investor confidence that management can get the job done. The ball is in Tony’s hands to produce trial results so there is some real meat for BP to analyze and hopefully increase SP for a more favorable climate to raise $. At this point all we have is speculation about what we think we have from the past studies and obviously that is not nearly enough.
That’s a nice example of what is possible Tony. Is there room for one more? We certainly have the potential if Combo PE is met convincingly to start the ball rolling.
My thought is one event at a time. Let’s get a look at Combo interim data, that will have much impact on the next event. We are in dire need of nailing some positive milestones to give the R/S the momentum and meat needed to be a positive move.
Well said Gestalt. Your worst case scenario is about as bad as it can turn out IMO. Interesting, that matches Pears best case scenario.
I’m with you Bulldog. The FDA process is difficult however safe efficacious science will make it through the process. I am hopeful that Combo Interim PE will be out prior to the 4-6 weeks stated on the Oct. 19 CC.
Ok Marty, so if Tony converts he gets
1.388 million shares and access to 694k warrants at .75. Also it’s not like Tony could place a buy order for 1.5 million shares at .60 and get it filled, even by nibbling because at the time he made the decision it wasn’t available. He also gets a 6 month window of future progress to assess risk and make a decision. I don’t think your math makes sense especially when considering the flexibility and five year timeline on the warrants. Even if he BELIEVES with complete conviction in the future of Pro-140 he would not do it differently because it doesn’t make investment sense. So the question is; if Tony “really believed in the ultimate success of the product” why didn’t he just buy as many shares as he could at a million $’s? Because he had a better deal.
IMO what the company believes is the foundation of their strategy. So I have to disagree with your opinion that “what the company believes” is “repetitive and worthless”.
M, the company makes decisions based on what they believe will happen. If they believe if they do X then Y will happen and Y is a good thing, they do it. If saying the company believes pushes down other people’s opinions that is not my intent. If I don’t understand the company’s strategy based on what they believe and what supports that belief I have a hard time being invested. Your opinion is that anything that talks about what the company believes is useless information. Fair enough. You may want to place me on ignore.
Yes there are different levels of believing. One reason he would not buy at .60 is he would not receive 50% warrants on number of shares converted with his current deal.
I guess we will have your answer in terms of level of belief in January-February when Tony will make the decision to convert or not at .75.
Axe, that is the reality of the current SP and status of our investment. It’s going to be all about the news.
Some here believe the SP will drop even on good news because of the impending likelihood of a R/S. I do not share that opinion.
The company obviously believes strong Combo PE results significantly de-risks Pro-140 and will attract new investors and create a better circumstances for raising $. The company also believes the R/S is necessary so institutional investment can be attracted.
So we will all speculate as to the outcome as no one knows for sure how this will play out. I like our chances as the science up to this point is efficacious and safety has been a non factor.
The warrants are honored if the company is sold as long as they are not expired. My first chunk of warrants expire October 2018.
If the company has not been sold by then it will be interesting to see what the SP will need to be to entice the exercising of warrants. I believe the warrants are .65 so the SP would have to allow for enough cushion to make it safe. There is approximately a two week time frame between making the decision to exercise and gaining control of the shares so they can be sold. Much can happen to the SP in two weeks.
The safest play for the warrants is a buy out because you are guaranteed the price you will get when you exercise.
Fred, my posts are not an attempt to make the case that now or any other time is the correct entry point. I’m an investor not a trader. I built my position years ago.
The impact of raising funds to keep the science rolling is a given and dilution is a fundamental requirement of taking a drug from unproven to proven. At what cost, is yes important, which is your point. I’m not ignoring this as it’s already factored into the future valuation of Pro-140.
Your posts represent your agenda which is for the most part all about predicting the right time to buy and how long it is going to take to generate revenue. IMO the science will either be relevant or a bust and management has no intention of taking Pro-140 all the way to market. I don’t think you would be here if you didn’t believe in the science you just want a bargain- and who doesn’t. Personally I would not consider trying to time selling my position and buying in at a lower price. That would be gambling at a whole new level. In addition I think there is a greater chance that the SP will increase with the news that is ahead regardless of further dilution.
Your opinion is the SP is going lower and you are going to wait. You may be right and you may be wrong. We are all aware of dilution and the impact it can have on SP. So there is no blind spot.
Glad you remembered JPG. And this was Tony’s area of expertise at Gilead. VP Manufacturing.
Gestalt, Your statement below is why I believe it is only a matter of time. Much of the bearish opinions point to a bleak picture of how long it will take to be profitable. IMO there will be enough de-risking and value created long before profitability to attract a suitor.
“Pro 140 can only fail if there is bad results in the data, a safety concern or they run out of money. Not one of these has been a problem in many years of injecting patients of all types and there has not been a rumor that CYDY is having trouble getting money”.
Your welcome BH. I agree with your perspective also.
It is rare that a company on the OTC make it across the finish line, however this is a company with a very powerful molecule that will be bulldogged to the finish line if need be. Tony is up for the challenge and determined to make it happen because he knows what they have is legit and of value. He also clearly understands all that needs to be in place to open your data base up for audit from a suitor. These are really smart people that dig deep when the time comes. Tony has been there and done it.
Cold, did any of your penny stocks that were never bought out make it through P3 trials and FDA approval?
Rab, As you can see from the posts, some do not think there will be a buy out any time soon, if at all, and others believe differently. The truth is none of us know because we don’t have all the inside information that Tony and his team have. We are simply too far from the details and facts. So having said that, this is my opinion.
My understanding is the company wouldn’t take $4 a share at this moment. Reason being they believe the value of Combo approval alone is worth a minimum of $3-$4 a share and with strong Mono data there is a high probability for expanding the label increasing market size substantially beyond Combo. In addition GVHD adds value and could be a driver for a buy out or partner.
Regardless, my opinion in predicting a buy out target date and valuation is pure speculation. I am translating what I believe the companies strategy is.
Meeting Combo PE is the first milestone that must be accomplished to garner real attention. Then their are a number of milestones that could trigger a buy out or a partnership.
Results from first 10 patients enrolled GVHD.
Full enrollment Mono Trial.
Safety data from 300 patients.
Mono data.
Submission of Combo BLA.
It is quite possible somewhere in this de-risking process a buyer steps up. So to answer your question any time after Combo PE is PR’d a buy out is possible. I also believe a R/S is inevitable Q1 2018. It is imperative to get off the OTC and on the NASDAQ and it’s not going to happen organically.
Some of the forecasts on this board in terms of Combo Trial completion, Mono Trial completion, BLA submission, and FDA approval are well thought out and accurate in that they are forecasts that an change. A17 and Fred are smart people that understand the reality of BioTech and the FDA process. In addition Murphy’s law is always in play with the FDA as things rarely go as planned. When a buy out or partnership will take place in this process or if at all is an educated guess at best and we are all entitled to our opinion.
The question or debate is; how much de-risking, or more precisely how far will Pro-140 need to go down the FDA approval process to be bought out and how long will it take. The company believes well short of completing the P3 Mono Trial or FDA Approval. In my mind that translates to 2H 2018 so that is a more precise answer to your question.
From my perspective below is the conundrum we will find ourselves in as we start 2018 when de-risking gains real traction increasing the odds of a potential buy out.
It only takes one to force another’s hand. I was thinking last night it is similar to the popular Television singing program called “The Voice”. If your not familiar with the show there are four recording artists that make up the judges. They sit in big chairs that are turned away from the singer so they have to judge based on the contestants voice only, not their appearance. If they like what they hear and want an opportunity to have them on their team they push a button and their chair turns around. Generally what happens is the singer may sound good but the celebrities look at each other to see if anybody sees enough talent to push the button. Often times nobody pushes the button, however when one judge pushes the button most often others follow. All the judges that turned their chair compete for the contestant. It is very rare that just one chair turns because if one recording artist believes their is talent the perceived value increases and they don’t want to lose out on what may be a winner. Again the milllon $ question is what will it take to get that first serious suitor to pull the trigger for Pro-140? Obviously until somebody shows interest the crowd will hold out and watch. Consequently I think the first offer most likely will not come from those companies that already control the space. The bottom line is “fear of loss” has always been the most powerful motivator rather than the “anticipation of gain”.
Sorry for the long analogy but I do believe this is a chess game that is based on much more than just the scientific value of Pro-140 as an HIV solution. For example Gilead would like to see this science go away because they already control the space and Pro-140 doesn’t generate additional revenue for them, it cannibalizes the drugs they already have. So from Gilead’s perspective why would they pay for something that will not increase the bottom line. The answer is they won’t until they are forced to because of the fear of loss in the form of a competing company making a play that threatens their space.
The tipping point is what we are all patiently waiting for. Unfortunately it is impossible to predict. The chess game has to play out and we are all anxious spectators that have placed our betts eagerly awaiting the outcome.
GLTA.