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I know they have a terrible track record of hitting their milestones, but given that we're more than a week into January and they're now saying they expect to complete enrollment this month, I suspect they must be very close or they wouldn't have said this month (i.e. within the next 1-3 weeks). Although the trial is blinded, I believe, and I may be wrong, that the CRO is evaluating the data throughout the enrollment period, and probably already have the PE data for the patients enrolled so far, so I don't expect it to take months after enrolling the last patient to determine the PE results. But again, I may be wrong, but I would be surprised.
They "hope" to have their 50 patients in January??
Really Fred? That's not what I read. My version says the Company "expects" to complete enrollment in January. Not early, not late, but sometime this month.
Funny, but you almost sound giddy Fred. Your post sounds like you want this to be seen as a negative Quarterly Report. Why is that Fred?
...and the number of Buys to Sells is approximately 2-to-1. We often see this just prior to a PR, however I'm not expecting one tomorrow since it's Friday. Perhaps Monday?? Just speculating...
I'm not suggesting they create risk out of thin air. In business, you ALWAYS pad your timelines to allow for the unknown. If the CRO is running the trials, and they are, then management has no control over the timelines they are given.
So what methodology would you suggest they use for determining and providing timelines?
Saltz - don't they need a specific amount of cash to qualify for the uplist? That leads me to believe they'll announce the combo PE before they announce the r/s.
You're correct when you say they have no idea how long things will take, however you missed the reason for that. The COR is running the trial and not mgmt, and it's the COR who gives them the timelines.
Grip - IMO, I believe they'll announce the RS in January, then move off the OTC, and then follow the upgrade with good news to prevent shorting. I believe Saltz recently said something similar to this timeline. This all makes sense when you look at their recent actions. They announced the reduction in the warrant exercise price with an end date of 12/22. This will help raise the required cash by January for the move up. And with today's announcement, they're basically saying that with 80% of the data in, no additional modifications are needed to achieve PE. To me, that's a significant reduction in risk for investors, and especially those who are on the fence with exercising their warrants. I was hoping for more interim detail, but in hindsight, I think it's more prudent on their part to hold this close to their chest so that when they lock the P3 combo trial, the PE announcement will give them much more bang-for-the-buck. Meeting the PE for a P3 trial is a BIG deal and the market won't treat it lightly. I also suspect this will be the announcement following the RS and upgrade. I also suspect that we may start seeing larger cash raises following today's positive announcement given that this should reduce the concerns of many potential investors.
You must be in the MT time zone, because I wake up at 6:00 and I'm ET. lol
I'm surprised that nobody's mentioned this, but I don't expect them to enroll just 10 more patients. As a reminder, they enrolled 40 patients when, according to the FDA, they only needed 30. The additional patients will provide a buffer in case any drop out before the end of the combo P3 trial. So, with that in mind, I assume they're enrolling 55+ patients. And I also assume they had already planned for this when they said it would take about 6-8 weeks to complete the P3 enrollment. It's funny how some on here like to remind us they only have 6 employees, but they forget the COR is doing the analysis, and the 6-8 week estimate probably came from the COR. I don't think mgmt would have given Dec 22 as the cut off date for the warrants if they weren't very close to the finish line.
IMO, when they release the interim PE data, the delay will quickly be forgotten. I can wait...
Yeah, I was hoping for and expecting it today, too. It may just be they want to get Thanksgiving firmly behind them since a lot of people are still traveling today. But regardless of the reason, in my opinion it's clear from Friday's PR that they're planning to release it any day now and it will be positive, so I can wait.
You may be right, but I suspect there will be 2-3 positive PRs between now and Dec 22, assuming we get the interim PE data this week, and then another update saying they've completed the combo enrollment, and one more PR with the completed combo PE results (they said this would be within 6-8 weeks from Oct 19, and we're in the 6th week). If the price hits $1 or more by Dec 22, and I'm not saying it will, I think it will be difficult for someone to not exercise their .75 warrants for .50 and make a 100%+ profit vs. a 33%+ profit. But just my opinion...
I'm not in front of my pc right now, but I believe they have until Dec 22.
Yes, I was agreeing with you, too. Thanks.
It's common sense that mgmt wants the warrant holders to exercise now. And why drop the exercise price to .50 if there wasn't good news on the horizon? Nobody is going to exercise their warrants if the sp drifts into the low .50's, and we're almost there now - mgmt is clearly expecting it to increase. Assuming we get a good PR next week, it will give the warrant holders additional incentive to exercise their warrants now rather than to wait, especially with the 30-day window to cash-in at this low price.
rab1 - you're absolutely correct! It's just common sense.
Spin?? Unlike others on this board, I don't have an agenda, so I don't need to put a spin (positive or negative) on my opinion. The next couple of weeks will tell who's right and who's wrong.
It tells me the odds of getting a positive PR update on Monday morning just went up. Time will tell.
I don't think it's desperation but rather getting their ducks in a row for next week's PR. Encouraging warrant holders to cash in is much better than selling new shares. The number of outstanding shares will increase, but the number of warrants will decrease proportionally, so it's basically a wash that generates cash. And what better way to shake loose the warrants than to reduce their conversion price just prior to a positive PR.
It appears that you "accidentally" left the following out of your post:
Side Effects include: "Severe skin and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment."
Interesting article just posted on Seeking Alpha by Terry Chrisomalis.
The highlights:
Summary
Upcoming phase 3 combination data of Pro-140 with optimized background therapy could change the landscape of HIV treatment.
Pro-140 has shown to be safe with fewer side effects, and has shown to suppress viral load in a lot of patients for over 2 years as a monotherapy.
Gilead has a combo regimen of its own for one pill per day, but still remains with a lot of side effects.
A new treatment option is desperately needed for patients on ART therapy, because of side effects.
CytoDyn may need to raise additional cash in the coming months to support its clinical development and potential BLA filing of Pro-140 pending positive phase 3 combination data.
This idea was discussed in more depth with members of my private investing community, Biotech Analysis Central.
CytoDyn (OTCQB:CYDY) is expected to release its interim phase 3 data in the coming weeks. That presents a good opportunity for those looking to invest in a highly promising biotechnology company. According to the company's conference call back on October 19th, the data would be forthcoming from 4 to 6 weeks from that date. That means that there should be an interim look into the efficacy of the phase 3 trial treating HIV patients using Pro-140 within the next few weeks.
Phase 3 Trial
The phase 3 trial is testing Pro-140 in combination with optimized background therapy in treatment-experienced HIV-1 patients. These patients must have the CCR5 tropic version of HIV. The trial is recruiting a total of 50 patients in which it will evaluate if the primary endpoint has been met. Enrollment is not complete, but the FDA stated that it would allow the company the opportunity to perform an interim analysis on the first 40 patients to determine if the primary endpoint has been met. That means that data from the other 10 patients will come a month or later thereafter. The most important item to consider now is whether or not the phase 3 primary endpoint is achieved. The primary endpoint is looking for a proportion of patients who achieve a ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of 1 week of treatment with Pro-140 in combination with background therapy. This trial is testing Pro-140 as a combination therapy. The hope is that such a combination treatment will reduce the need for a patient to remain on single ART therapy alone. I believe that Pro-140 has a good chance at success for reasons that I will describe below.
Prior Data
Why I think the phase 3 trial stands at a good chance for success is because of the progress of the patients in the phase 2b extension study. 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) and for > 2 years in 62.5% of patients (10 out of 16). Remember, this phase 2b extension study is for Pro-140 as a single agent therapy (no combination added). The phase 3 trial noted above is for Pro-140 in combination with optimized background therapy. That means that the combination therapy, in theory, should be substantially superior. Then again, the results from the phase 2b monotherapy of Pro-140 also support development for approval. That is why CytoDyn is also running another phase 3 study with Pro-140 being given as a monotherapy only. The downside is that the phase 3 monotherapy study has to recruit up to 300 patients. For now, the key is to see if Pro-140 in combination with optimized background therapy meets on the primary endpoint. The upcoming phase 3 results will be key to the success of CytoDyn.
New Treatment
The best part about Pro-140 is that it is given as a once a week self injectable treatment at home. Think of these HIV patients right now, that have to take pills everyday for the rest of their lives to keep their viral load suppressed. Even then, ART therapy has severe toxicity and side effects. That makes treatment with ART barely tolerable for patietns to take. On the other hand, Pro-140 has negligible toxicity, and no serious side effects/serious adverse events observed in over 200 patients treated across 7 different clinical trials.
Competitor
The current big competitor is Gilead (GILD). This company is working on combo therapies in order to improve the HIV treatment landscape itself. It has seen some amazing results in terms of efficacy, but it still has one major problem. The combo treatment has a lot of side effects. The combo treatment from this big pharma may not have serious adverse events, but it has a lot of side effects. For example, Bictegravir alone has nausea and diarrhea as side effects. When I looked up tenofovir alafenamide some side effects shown were: Diarrhea, upper respiratory tract infection, fatigue, nausea, and rash. Looking up Emtricitabine I found that some side effects include: Tiredness, trouble breathing, stomach pain with nausea and vomiting, dizziness and several others. This compares to Pro-140 which is a monoclonal antibody that has no side effects at all. I would think that a patient with HIV would prefer one injectable shot of Pro-140 per week as opposed to having to take a single pill everyday. In addition, I would be inclined to believe that a patient would prefer treatment that is free of the side effects I noted above.
Market Opportunity
CytoDyn has listed the combination therapy with Pro-140, which is set to report the phase 3 study in a few weeks, as being a $5 billion dollar market opportunity. That leaves the monotherapy potential of Pro-140 as an $11 billion market opportunity. I think that Pro-140 has a good chance at success. For starters, all the data shown to date has shown that the treatment reduces viral load below 40 copies/mL. There are at least 9 patients that have completed 2.5 years with Pro-140 as a monotherapy alone. This Pro-140 drug was acquired from Progenics (PGNX), therefore CytoDyn has to pay it a 5% royalty on net sales according to the agreement made should Pro-140 be approved by the FDA. If the phase 3 results are good and CytoDyn hits the primary endpoint then I am expecting Gilead Sciences to either partner with the company or buy it out. Gilead has been doing okay, but has had recent troubles with its Hepatitis C franchise. I doubt that Gilead will allow a small company like CytoDyn to enter its turf without doing something about it. It could leave the small-cap biotech alone, but if it does that will likely cripple sales for Gilead in its HIV franchise. Which is why I expect a high chance of a buyout of CytoDyn should it meet the primary endpoint of the phase 3 combination study.
Financials
The problem with CytoDyn is that it is a small-cap biotech stock that trades on the OTC. It has limited cash, and therefore is a huge risk of possible dilution occurring after positive phase 3 data (should the results be positive). According to the most recent 10-Q SEC filing, the company had ended August 31, 2017 with cash of $0.9 million. As I have stated if the results are good, then it is possible to expect some type of cash raise. Although, on the other hand with good data the company could also easily seek out a big pharma partner to foot the bill thereafter. The main point now is it highly depends on the upcoming phase 3 results on what will happen for the company in terms of its financials and its future.
Risks
Of course, the first risk is the dilution I noted above as CytoDyn is low on cash. The bigger risk would be whether or not the phase 3 data will succeed. I have high hopes that the trial will meet the primary endpoint of the study. The risk is that the prior trials were done with a small group of patients, therefore there is a chance that the phase 3 trial may not succeed. That is a risk to keep in mind. Still, I like the risk/reward scenario a lot because if it does succeed then the stock price will gap higher in the short-term. Another risk is that the company is thinking of enacting a reverse stock split to uplist to a higher stock exchange, and move away from the OTC. If that happens then it is possible for shares of investors to be reduced greatly.
Conclusion
I have high hopes that CytoDyn should succeed in its combination phase 3 study. If anything, patients need Pro-140 as a new treatment option. Not only is compliance with an injection better, one treatment per week, but it has less side effects. If this company succeeds then it will change the landscape for HIV treatment and I believe that's worth the risk/reward scenario. If the trial fails I expect the stock to tumble down to $0.25 to $30 cents per share. If it succeeds I can see it heading to $1.20 to $1.50 per share in the short-term.
Author's note: To get these types of premium articles on attractive biotech and pharma stocks as soon as they are published, just click here for my profile. Hit the big orange "Follow" button and choose the real-time alerts option thank you for taking the time to read my analysis.
Terry Chrisomalis runs the Biotech Analysis Central pharmaceutical investment research service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to my service, I'm currently offering a two-week free trial period for subscribers to take advantage of. Only the first 25 subscribers will get the lower legacy rate. If you want to secure your spot, please do so as soon as possible.
Disclosure: I am/we are long CYDY.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
I suspect they've completed the 50 patient enrollment by now and are holding off on announcing it while they get their ducks in a row. I'm hoping they'll announce the interim PE results, and then follow it with an announcement about completing the 50 patient enrollment, and then follow that with the PE data for all 50 patients. I'm willing to wait a little longer for an organized and systematic PR release.
IMO, given that these incremental raises continue to be very small, it tells me they like what they see in the PE data. Otherwise, I would expect a significant raise now knowing expectations will soon be dampened and thereby making it more difficult to raise the funds needed to continue the trials.
I hope he's right, too. I just picked up 40k more shares in the last 5 minutes, and all under .60.
Well said, Saltz, and exactly what I've seen while invested in stocks that went through a RS. Those that issued a RS to uplist experienced positive sp movement immediately following the uplist, and the sp increases were sustained.
Change of Ownership just filed:
https://ir.cytodyn.com/all-sec-filings/content/0000899243-17-025602/form4.html
8K just filed:
https://ir.cytodyn.com/all-sec-filings/content/0001193125-17-337321/d476087d8k.htm
You skipped the other scenario. BP sees the PE data and buys CYDY, which makes this all moot.
This is just my opinion, but I'm not so sure the FDA will make an immediate decision. I suspect they'll review the evidence that was provided today, and then go from there. I'm not expecting an immediate PR for that reason, but I'm sure some on this board will see that as a negative even though it's expected.
Imminent threat? The only thing that's "imminent" is the spreading of FUD. LOL
Announcing the completion of the enrollment for mono is the PR that I would expect to follow the r/s announcement. Then it's game on...