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Agree, PR when enrollment complete is definitely warranted.
Yes, appreciate your interpretation of those sources/articles. My interpretation of the content leads me to a different conclusion(s). From what I gather, the difficulty in enrolling trial subjects is limited to the Combo Trial's criteria which will not be a factor in the Mono Trial or in adoption once approval is secured. That said, I can understand your viewpoint, but heartily disagree with it.
Thank you for sharing this information. Perhaps I am missing something, but what does it have to do with the role PRO 140 can have improving the quality of life for HIV patients, especially those whose HAART regimen is failing? All my DD has strongly supported the efficacy of PRO 140 without the toxicity associated with current treatments.
Agree, I think a capital raise is highly unlikely until Combo Trial is complete and at least some positive data announced, either at ASM or another communication soon thereafter. The SP must move significantly north for a another investment round to make sense.
I checked a sample list of Transplant Centers in the U.S. and it looks like there are at least a few thousand bone marrow transplants done every year. Would all the patients be candidates for PRO140 as a measure to reduce Gvhd? Some of the centers in California did almost 400 transplants in 2014 - 2015, so the patient population that could benefit from PRO140 appears to be significant. Is this correct?
I may be wrong, but I think Patients will relocate temporarily to trial site areas when it comes to a chance to dramatically improve their survival rate. Opinions welcome.
Thank you, that is excellent information and quite encouraging.
Enrollment could be quite fast for this Trial, as there are more good reasons for doctors and patients to opt-in. PRO140 has a good safety history and has a chance to save many GvHD patient lives, so why would patients and doctors not choose to add a preventive measure on the front end of these risky procedures. I know, based on my DD, if I were facing a transplant, I'd want to take PRO140. Early or interim reports of positive results should support ODD and Breakthrough designation. I would think that would push the SP higher and improve the capital fundraising proposition. Further, with about 4000 procedures being done per month, the patient population pool should be sufficient for a rapid enrollment.
Marty, appreciate your comments. Thank you!
Marty, I could be wrong, but I think the reasons Paulson may not take another bite involves reputation and credibility. After all, another round with at or near the current SP, even with warrants, isn't a compelling proposition to present to investors. Further, I don't think CYDY is in a position to secure debt capital, so, by default, management has limited options. That said, an attractive licensing deal is feasible and a reasonable solution for short term and long term capital challenges. Whatever path is taken, IMO, it must be a comprehensive solution to securing funds to finish the trials. A piecemeal approach has been okay and has gotten the company this far, but I don't think it's the best choice moving forward.
Agree, and that is why I don't think it will happen. IMHO Paulson will not go to its "investor well" again, unless something very positive occurs. I expect some type of a "deal" to be done this Summer, perhaps licensing in exchange for comprehensive Clinical Trial Funding by BP.
Given CYDY's current circumstances and history, a licensing deal makes sense for all parties.
Disclosure: I am a longtime investor in the company.
Current SP makes raising capital problematic to say the least, so that's the bad news. The good news is that the current SP because it makes raising capital problematic means that management will have to do cut a deal very soon or risk having to shut down the trials. Of course, deals made under duress never yield the return shareholders would like, but I for one, would be happy to settle for $3.00 - $4.00/share BO with the assurance that PRO 140 is made available to patients as quickly as possible.
The ASM presentation should include an update which enables shareholders to infer whether or not enrollment is on schedule for completion by the end of June or soon thereafter.
I think it has been quite awhile since they submitted the Abstract for consideration to ASM, so I expect the updated results to be presented in June will be based on a considerably larger sample of subjects/patients. Assuming, the results continue to be impressive, PRO 140 will have taken a giant step forward.
Here is a link to the PRO 140 Abstract on the ASM website.
http://www.abstractsonline.com/pp8/#!/4358/presentation/6520
For those only interested in the bottom line, go directly to the Conclusion. I don't know if this is new information or just restating what is already known, but nonetheless should be encouraging to prospective and/or new investors in CYDY.
Agree with you, it is all about the trial results and thus far they warrant investor confidence.
Reasons for share price rise could be risk/reward is obviously looking more favorable at current SP, increased confidence on part of investors who are familiar with CYDY, and/or shorts covering.
Tonysd57, I doubt Paulson will do another round at this point. IMHO bank debt is also highly unlikely ,so the pressure is on CYDY management to do a deal. As I've mentioned in a previous post, it probably won't be great for shareholders, but should be okay.
ASM could make a difference because it is a validation of late date clinical results at a time when CYDY is having to secure capital to complete the trials. Statistical significant results at this stage should drive investor confidence and SP which is essential to raising capital.
Understood, historical SP movement supports your viewpoint, but we're at a different stage of development and the market is nonlinear in its valuation of biotech stocks.
Not many comments about the upcoming ASM Presentation which I think is surprising for the following reasons:
1. The key to CYDYs success are the clinical results and the ability to
leverage those results to raise capital.
2 Management would not have accepted the invitation to present at ASM
unless they knew that the results were positive.
3. While ASM did not move the SP last year, it could certainly be a
catalyst this June and facilitate securing capital at better terms.
4. ASM coinciding with enrollment of 30 patients in the Combo Trial should
drive the SP upward and increase the potential for a BO or partnership
IMO.
I don't think CYDY can raise the necessary funds through debt, as the balance sheet is weak and revenues to pay interest and amortize the loan are not there. I know they don't want to give away the "farm", but sometimes you just have to bite the bullet and take the pain of a discounted price. Maybe I'm off base, but I would be happy to settle for a smaller profit than risk failure to achieve FDA approval and patients losing out on PRO 140 treatment because management was not realistic. I would be happy if management proves me wrong and they secure the required capital, whether the source be equity or debt.
Pears, the clinical data do not support your assertions regarding efficacy.
I do agree with you on the binary nature of CYDY, as it has always been an all or nothing play. If shareholders don't realize this, then they should not be in it.
Agree. BO in range I suggested could be bad "tasting" medicine to some, but should relieve the pain.
IMO, as long as Clinical Trial results remain good, worst case scenario is a BO at $2.50 - $4.00 per share. Of course, this is not full value, but without an extraordinary capital infusion to complete the trials, CYDY's value will be a heavily discounted by an acquiring company. Just the price of not raising sufficient capital on the front end, which is not a criticism of management, as alternatives were most likely limited early on.
Grip, I couldn't agree with you more. In a way, this is a bad news/good news situation. The bad, CYDY cannot raise $60MM with a stock sale at the current SP, The good, because CYDY cannot raise $60MM with a stock sale at the current SP, management will be forced to do a "deal" ASAP. Of course, the "deal" whatever form it takes, won't get shareholders all we hoped for, but will at least, assure that CYDY has the funds to get the trials to the finish line and also result in a decent, if not great, return for shareholders. Of course, as always, clinical trial results will drive the ultimate outcome.
Terrific post, thank you. My only concern regards the sale of stock given the SP. IMHO, CYDY must do a deal with BP or equivalent in the next 90 -120 days to fund the Clinical Trials. If the trial results continue to be steller, it will be a big winner for all parties. True, the consequences of an early deal will be giving away more of the company than one would like, but the benefits of insuring the funds to get to the finish line are overwhelming in favor of a sooner than later transaction. In fact, I do not think there is an alternative that will work, but of course, I could be wrong. The deal structure, could be any number of scenarios, but at its core must guarantee sufficient capital, no more partial stock sales leaving CYDY with near and intermediate term capital uncertainty.
Disclosure:I have been an investor in CYDY for two years and will continue to be, as long as trial results support my confidence.
I think this "legal action" is an example of throwing something against the wall and seeing if it sticks.IMO CYDY management has been candid and relatively transparent. I am a long time shareholder in CYDY and believe my investment will be well rewarded, hopefully soon, we shall see.
Thus far, PRO 140 has not been linked to toxicity as has many of the oral meds. I listened to the presentation, as well as the Q & A, and IMO Dr. Dhoudy presentation was spot on, as were his answers to the questions directed his way. I could not imagine a better introduction to the CROI audience.
I have no problem with current CYDY Management Team, as they have thus far guided PRO 140 through the trials and pitfalls of the FDA gauntlet reasonably well. Whether or not CYDY becomes a successful investment for shareholders will now depend on the Clinical Results of the Phase3 Trials. Based on earlier trial results and current reports, it appears the chances of success are excellent.
Agree that Nader would not apply for BTD unless it was a near certainty.
Excellent CC. I have been invested for about two years and have monitored CYDY development very closely. IMHO CYDY will achieve its clinical goals and with that will come a much higher share price. I do have a clinical background and have a great deal of confidence in managements ability to get to the finish line.
I could not agree more, very well said.
If you think and believe Pro 140 is going to be FDA approved, CYDY is an "investment" and deserves patience. Having said that, it is not an easy decision to hold on to a losing position. I feel your pain.
"Institutional investors" buying private placement is IMO a very strong positive for CYDY. As you say Chump, they did not invest to flip the stock for penny profits. It has been clear shares would have to be sold to fund development to market, so recent offering should not be a surprise or worry. The only thing that matters are the Trial Results and eventual FDA Approval. Perhaps, I have "drunk" the PRO 140 "cool aid", but I think not.
Excellent article, thanks for posting.
CYDY is one of those rare OTCBB stocks that is a buy and hold IMO. While there have been some bumps along the way, the trial results speak for themselves and suggest Cytodyn will be successful in bringing PRO 140 to market.
Reverse Split is absolutely the correct action. It is hard to understand the reluctance by the BOD to make the call. CYDY is positioned for a massive run and that's not hyperbole. It is a legitimate Biotech star in the making and a very appropriate investment for institutional buyers looking for a growth company with a well defined path to market success, both clinically and financially. Full disclosure, I am LONG since early 2015 and have added shares consistently and have never sold a single one.
CytoDyn's PRO 140: A Paradigm Shift in the $20 Billion HIV Market
NEW YORK, NY / ACCESSWIRE / June 13, 2016 / Rising Tide Equity Research, LLC announced today the release of its Initial Equity Report on CytoDyn (OTCQB: CYDY), a biotechnology company focused on the development of monoclonal antibodies for the treatment of human immunodeficiency virus (HIV) and Graph versus Host Disease (GvHD). The Company's lead clinical candidate, PRO 140, is currently in two Phase 3 trials evaluating its effectiveness as an adjunct therapy to current HIV treatment and as a monotherapy treatment for HIV.
Full article can be found on Accesswire.com
The submission approval rate for compassionate use is extremely high. There is an FDA graph representing all submissions from 2010 - 2014 on its website so one would expect CYDY's request be approved.