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ILIAD RESEARCH AND TRADING, L.P. is the Investor. Looks like a reasonably good deal for both them and CYDY.
Yes, you are correct. Very good news IMO.
Tommyterrific you beat me to it, was thinking green at the close, as well.
Volume is actually very modest. While the SP is down, I am not getting the sense that long term SHs are dumping the stock. I think if you have been following this company, it is clear that it is a very suitable strategic acquisition for a mid market pharmaceutical company. At current SP, not much to lose and very attractive upside. As many have said before, it is a binary investment with much of the downside mitigated by the demonstrated efficacy and safety of PRO 140.
Agree with everything in your post, but IMO MONO enrollment is higher than you estimated.
Approval in mid to late 2019 for Combo seems a long way off, but in the world of getting drugs approved, its not. IMO, at the current SP, CYDY is a very favorable asymmetrical Risk vs. Reward investment, heavily favoring the Reward.
Yes, $500MM is the number I heard, as well. That said, as another poster said, CYDY would grow that because it would support decision to do more transplants.
Correct.
Thanks for posting the two articles. Each article should be featured and/or referenced in the Offering Memorandum which is distributed to prospective buyers, as they represent independent perspectives on PRO 140.
Agree, FDA meeting could be next week or at least by month's end. MONO Study could very well be converted to Pivotal Trial and BLA accepted. That said, the company will need experienced Sell-Side Marketing and Transactional support to find the right buyer and get a deal done. The latter can be fairly painstaking and a lengthy process.
Yes, it all seems to be coming together. Hopefully, the FDA meeting will be in the next 30 days or so and we get an update on the MONO study during that period, as well.
Understand, appreciate your input and concerns.
The ASM Release is consistent with the Poster Presentation, but includes specific information I did not find on the Poster and vice versa. As I said in a prior post, I hope the company posts the complete Poster Presentation on the website. Here are a few more points mentioned in the Poster Presentation:
Anti-PRO 140 antibodies were not detected
Favorable PRO-140 PK profile that allows once-weekly dosing
No change in co-receptor tropism at virologic rebound
Safety Summary -
Generally well tolerated
No discontinuation due to AEs
No pattern of toxicity
Administration-site reactions were infrequent, mild
transient and self-resolving( in less than 10% of subjects)
No dose-limiting toxicity in preclinical or clinical studies.
0.5log is correct.
Yes, 35 subjects have entered the extension study. The primary efficacy endpoint for this study was pegged to 0.05log or greater reduction in
HIV-1 RNA viral load from baseline at the end of the 1 week double blind treatment period. I did not find any reference to another viral reduction value.
Misiu, agree the fact that so many of the Physicians recommended that their Patients enter the Extension Study is hugely important and IMO should be emphasized in future PRs. It is hard data personalized by treating Physicians opinion. What more can we ask?
Gestalt, here is something new from the ASM Poster - "A roll-over study, PRO 140 CD02-Extension, was designed to extend a subject's access to PRO 140 treatment when, in the opinion of the treating physician, PRO 140 was required to form a viable suppressive regimen."
Of critical significance is that...."To date, 35 subjects have entered the extension study."
p=0.0032 was value reported on the ASM Poster Presentation. The PR did not include the supportive data and analysis. I would hope that a copy of the Poster Presentation will be posted on CYDY website.
The p=0.0032 reported by the Poster Presentation is an extremely high level of statistical significance. About 3x the number of Subjects treated with PRO140 vs. the Placebo Group experienced 0.5log or Greater Reduction in HIV-1 RNA viral load from baseline in the end of one week double blind treatment period. IMO, since the Combo Trial Subjects posed a greater treatment challenge than those in the MONO Trial, one would expect the results to be even better for the MONO Subjects.
Finesand, based on the quality and depth of your research, you should make yourself available to CYDY. IMO, they will be needing your help with prospective buyers. I am serious, send your information to them, you never know. Best and thanks for your hard work on our investment.
Tommyterrific, you are correct on your analysis, except regarding Paulson. IMHO, without Paulson, the company would never have made it this far. Of course, I can't prove a negative, so maybe there were other better sources of capital...tough call IMO.
Finesand, based on what I learned today, I think you have realistic expectations as to what should occur in the next few months. Whether or not the FDA is supportive and CYDY's financial situation improves are significant factors that will need to fall in line. That said, from a clinical prospective, I see no impediments.
GvHD was not discussed.
ASM Poster Presentations are spread over a very large public area next to the Exhibit Floor. One or a few Attendees viewed the Posters at a time in a narrow aisle and spoke privately with representatives, so I could not judge their reactions, questions, and interest. Drs. Pourhassan and Dhody were present to answer questions of those stopping to review the Presentation. The attendees were, not surprisingly, microbiologists and related professionals from other specialties. I didn't get the impression that BP folks were trolling the Poster area, but obviously, can't say for sure. Both Pourhassan and Dhody were very personable and answered all my questions satisfactorily. I came away quite impressed.
The results reported in the ASM Poster Presentation met my expectation that PRO140 will eventually be part of the SOC for all appropriate HIV patients. While I am not able to post a copy, I expect that the Poster and supportive commentary should be released in its entirety on or before Monday. As many have posted here before, the next 30 - 60 days should be quite eventful for CYDY.
Heading down to ASM Conference in a few minutes. Not sure how much new information will be available, but will post anything of significance ASAP.
Misiu, you are 100% correct in your assessment.
All true!
We do our best DD and place our "bets". We can only analyze information available to us outside SHs. The alternative is to get "inside the enterprise wall". The trade off to being an "insider" is that buying and selling shares are restricted/regulated. Insiders that have knowledge of positive information may sleep better than outside SHs, but the downside is that their investment is locked down until full disclosure is made to the public. At least, that is how it is supposed to work.
Buckysherm, based on my recent M&A experience, NDAs are requested/required just to open preliminary conversations of minimal substance. I was not implying that they were in the midst of a BO Deal, just that folks, who are knowledgeable as to the why and why not of decisions being made, cannot disclose information to those who have not signed an NDA. I do not know the equity threshold or criteria regarding who they will allow inside the information inner circle, but I'm certain NDAs would be required and restrictions consistent with SEC rules.
The people who know what is going on are obviously locked down by NDAs. That said, if you think it through, there are only two paths. First, either a strategic buyer, such as Gilead, buys the company or second, sufficient financing is secured to take PRO140 to market. Pulling the RS suggests management and their advisors determined that the first path is more likely than the second, so, if the path leads to a BO, why take the risk of a short attack and spend significant capital on up listing. The up listing would benefit nobody. IMO clearer heads prevailed and to their credit, in the end, management made the right decision. The next key decision, will be to select a financial firm to help the company achieve its objectives and there are many to choose from.
Once conditions are right to move forward, it takes time to identify the best Buyer and make a BO happen. I have executed and managed acquisitions on both the Buy and Sell sides. Six months from signing the LOI to Closing is not unusual. Of course, all parties will be under NDA. I would not expect to hear anything about a BO until it is very far along.
The RS was not in the interest of SHs and management in the end realized that. Because the Combo Trial efficacy has been established, capital will be available on better terms than in the past. How soon a BO or JV deal happens is pure speculation, but it will occur IMHO.
Tony,sometimes things are not what they seem. CYDY has a bankable and/or saleable product in PRO140. Of course, patience is understandably in short supply, given the long wait SH have endured. IMO, those who hold will be rewarded, but I certainly understand your frustration and disappointment.
It's a tie.
Yes, I took the comment about MONO Results to reflect very positive efficacy. I can't imagine Dr. P. would make such a forward looking statement unless he had the "goods" to back it up.
Agree, silence from management is bullish sign. Weak "hands" talk, strong ones don't give meaningless CC and/or PRs.
Annual Revenue.
Impressive presentation and timeline, even better than I had hoped.
Great Post gestalt, agree with you 100%.