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Link to FDA Fast Track Designation and Rolling Review information.
https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm
Last year CROI Poster Presentations took place in long aisles with limited space for Presenters and Attendees, so if it is the same in Seattle, a three person team of Presenters would be problematic. One of the benefits of Poster Presentations is the one on one opportunities to engage with Attendees. It is a very informal process, at least it was in 2018 in Atlanta, so those interested in asking questions can do so quite easily. When I met and observed NP and Kush last year, they did a great job representing and communicating CYDY's research and plans. I would expect they will do the same next week.
Yes, you are correct, a $3B BO would be hard for BP to "stomach", but I think it could happen, if the front end offering was handled properly. I am also ambivalent about a sale now for the same reason as yourself. RP influence, leadership, and the potential for Leronlimab to treat cancer have changed the "calculus" and licensing/partnership arrangements appear to be close.
What would the company bring, if it were put into play? If represented by a major or even Tier 2 Wall Street House, probably $5.00 plus or minus which is nothing to sneeze at, but I doubt enough shares would be secured at that price. Of course, if the offer price started to push $10, the result could be different. Its always nice to have a BO as a Plan B and the BOD understand this. At this point, Plan A is for CYDY to bring Leronlimab to market with the help of "partners", which is all well and good but,if Plan A stalls and the company is bought out, I don't think there will be too many complaints.
Bobby, you could be right, but I don't get the sense that many folks on the Board are in a selling frame of mind. It seems some of the really negative posts are coming from some who do not own shares. Maybe I'm wrong, we shall see in a few minutes.
What's done is done. Moving forward, the BODs must resolve to agree on a coherent strategy which addresses those shareholders who want to sell the company and those who want to develop it. I have no idea whether the majority of shareholders favor one or the other, but it seems from comments on the Board, that most would favor a leadership change and/or new role for NP. IMHO, as probably its largest shareholder, CMO, and Vice Chairman, RP is in the best position to address the changes which are needed. Leronlimab is an incredible product and story. I think the chapters to come will be exciting and rewarding.
Agree Marauder, I think they should have waited until they had a deal in hand before scheduling the Call. That said, unless I misunderstand, thankfully, no more raises with warrants from Paulson. Capital will have to come from upfront fees for future rights and perhaps sale of stock at higher prices once uplisting is achieved. IMO they are counting on milestones from TNBC study and other cancer studies to drive SP higher.
Tommyterrific, I understand your viewpoint. Nobody wants to see "RED" in an investment position, but the story is still being written and if you still are holding your position that "RED" can turn "GREEN". I guess success is a matter of perspective. True, SP has been a disappointing, but I do believe Management with the support of Directors have added tremendous enterprise value. Is the glass half full or empty? Hopefully, Monday will give us an answer we both like.
Thanks JPG77, PR after the call makes sense, but it sure would be nice to wake up Monday morning to some 6am "Good News". For folks who have followed CYDY for years, such as myself, it is hard to fathom, that while NP is still the CEO, RP and the BOD are now calling the shots. As a long time SH, I am grateful for NP's tenacity, commitment, and success keeping the "dream alive". For years NP was the driving force, even a "one man band", but now others new to CYDY, such as Drs. Pestell, Kelly, Welch and Mr. Michael Klump, will be leading and sharing the responsibility of bringing a potentially life changing and life saving treatment to those who need it. And yes, I invested in CYDY to profit, but what a blessing Leronlimab could be, if it meets expectations. Thanks and the best to all who are involved in making it happen.
Well the Compensation Committee thinks the raises are warranted and I hope they are right. That said, if news Monday is a rehash or without real substance than the decision is a "head scratcher". Since I believe the Compensation Committee and BOD, as a whole, know what they are doing, I trust we will not be disappointed on Monday.
Will Monday's News and/or Conference Call kick start a new positive era for"CYDY" Shareholders? I'm betting it will. The BOD and leadership team are not stupid. No way they show up empty handed Monday afternoon, that would be foolish and counter productive. Previous posters have said any significant news would need to be Press Released before the call. I don't know if that is the case, but it does make sense to get details out there with discussion to follow on the CC.
I think our BOD has a challenge to satisfy SHs who are ready to sell for $5 or $6 per share and those who are not. Given that RP is the largest SH and the key driver of the business, the odds favor a decision to hold on for the long term, which I guess he would favor. That said, the value of his shares would be north of $100MM, so I could be very wrong.
While on paper CYDY acquired Prostagene, in reality RP gained effective control of CYDY and to a large extent its future. Of course, we could hear Monday that a monetizing deal has been struck for the HIV segment and/or other diagnostic test, which most likely would push the SP to a more reasonable level. To a certain extent, that would satisfy SHs who are inclined to divest shares sooner than later.
IMHO, RP, with NP support, has done an amazing job executing his plan. I think NP deserves a lot of credit and respect for how he has handled the transition to new "ownership" and RP's leadership.
Scheduling a CC on Monday usually is done to announce and/or discuss very positive solid news, in CYDY's case specifics about a "capital" deal or significant Trial milestones and/or successful results. If I am not mistaken, most of CYDY's past CCs were mid or late week. I can't imagine NP and RP agreeing to a Monday call and just reiterating "plans and discussions blah blah blah" without announcing something definitive. Of course, I could be over thinking this, we shall see.
Video Interview with NP and RP regarding Pre-Clinical Trials at end of article.
https://www.proactiveinvestors.co.uk/companies/news/214963/cytodyns-flagship-leronlimab-product-reduces-by-more-than-98-human-breast-cancer-metastasis-in-mouse-xenografts-214963.html
Looks like there is a healthy appetite for buying CYDY today. Over 500K shares traded and still 35 minutes until close. As several have already said, I just couldn't resist buying more.
zi457 questions:
Leronlimab is safe, no reported Adverse Effects or Serious Side Effects in nearly 700 patients.
To my knowledge, international sales before FDA Approval has not been discussed by CYDY.
Thorough DD strongly supports investment in CYDY. Glad to see a new Poster, Welcome!
I have told many people about CYDY, most of whom are successful business leaders. After a brief introduction, I recommend that they do some DD. I don't hype it, just describe it. In every case, save one, they each bought in. In total, including myself, close to 500,000 shares. Moral of the story, if intelligent folks take the time to understand CYDY, they will buy and hold. While some SH with warrants will sell at these prices, anyone who did the DD work, will not.
Tipsy, welcome. You have chosen the perfect entry point and I wish you the best.
Finesand, glad you mentioned the $200MM of "anti-body inventory" (assume it is sale value at the $70K price point), which to my knowledge is not reflected in the Financials as an Asset. Paraphrasing Dr RP - buying at current share price was like getting the technology and development assets for free.
If I misunderstood his comments, please correct. Thanks.
Financing issues have little to do with Nader and mostly to do with what the debt / equity market will offer to a BioTech with zero revenue. CYDY's management team executes at the direction of the BOD. While I do not like the dilution, it is a necessary "evil". Let's not blame the messenger (Management). As long as we get to the "finish line", whether BO or JV or Licensing, etc. I'm good with it.
I have not read the entire filing, but looks to be a $1.5MM Loan @ 10% interest with a convertible feature.
Much speculation on BO, financing, and some combination thereof, but I wonder, who controls CYDY. As CEO, Nader will certainly influence the decision(s), but I think it is the BOD and major SHs(including of course Dr. Pestell) who will ultimately make the decision(s).
I first invested in CYDY in 2015 and believe Nader has done a fine job getting the company to this point. My respect for him is sincere, as is my appreciation for the many folks who post on this Board. Thanks to all who have and are contributing to getting the CYDY message out. I myself have introduced seven current SHs to CYDY. As was said in the Wall Street Reporter Interview, we are approaching an inflection point and I sense the anticipation on this Board.
Bored Lawyer, I would be surprised if there is another Paulson raise. IMO, if the source of new capital is anything other than an upfront payment for a "license deal", new debt financing is very likely to have a convertible option, which would be dilutive, if and when it was executed. Of course, if acceptable financing terms cannot be found, the best and maybe the only choice, will be to sell the company to the highest bidder.
Boils down to:
1. Licence Deal
2. Debt/Equity Financing
3. Sale of the company
Combination of #1 and #2 possible.
Gestalt, they will not be going back to Paulson. As pressure builds for more cash, they will have to decide on a better source of new capital. I expect some type of debt financing with a conversion feature.
IMO, there is no straight debt financing option until CYDY has revenue to pay it back, so the convertible option will be required.
It is interesting that two of the newest members of the B.O.D. are Atlanta area based. I do not know this for sure, but I think it is reasonable to infer that CYDY has a strong shareholder base in Georgia. As one of those Georgia shareholders, I welcome Dr. Kelly's Chairmanship, both from a business perspective, as well as from a medical one. IMO, the BOD is probably awash in consultants, shareholders, and bankers offering business advice, so I'm confident they've got the business component covered. As a long time shareholder, I'd like to see a SP which better represents the value I see in CYDY. That said, low prices have provided a wonderful entry point for new SHs and for existing SHs to add shares, as well.
In some ways, CYDY's value has tracked more like a limited liquidity "private equity investment" than a publicly traded company, which is most likely related to it not being on a major exchange and how it has had to raise capital. It has certainly not been an investment for the feint of heart.
Dr. Kelly is a respected and prominent physician in the Atlanta Metro Area, his election to Chairman of the Board will definitely benefit CYDY. For those of you not familiar with Resurgens Orthopedic Practice with over 100 Doctors, check it out. You will be impressed.
https://www.resurgens.com/.
Pro140, I am not sure what you mean, shareholders are free to sell to whomever they want. Certainly, Nader and Tony C. do not control the share price and logically would want it higher for lots of reasons.. Management and/or the BOD may or may not welcome an unsolicited tender, but that does not necessarily prevent such an offer from being made.
If an unsolicited $5/Sh tender offer was made directly to Shareholders, would it result in the majority of shareholders selling? Unless CYDY has something in place to block a takeover, it might be an approach that could work. Of course, it could stimulate higher competing bids and then those shareholders looking for a better price would be validated....
$10 a share works for me. Surprised there has not been an unsolicited offer to shareholders.
Nader takes direction from the BOD, as well as other major stakeholders. While, there was a time when he was truly leading/driving the company, almost a one man band, his new role is TBD, but IMO, it will be quite different than in the past. CYDY is now in hands of the "new" BOD, CMO, and their advisors. I too, give credit to Nader for getting the company this far, now it's up to the new generation of BODs, Dr. Pestell, and other influencers to monetize CYDY assets. I for one, think they will be successful and thousands of patients will benefit from their success.
Nader is but one vote on the BOD, he and the other Directors representing Shareholder interests will jointly make the decision whether or not to accept and/or present any offer(s). Granted Nader has been at the helm and calling the shots in the past, but IMO that is no longer the case, as Shareholders are now well represented on the BOD by Independent Directors.
Gestalt2 great post. You have summed up the situation perfectly.
Unconvinced that a Paulson raise is locked in, although many on this board say otherwise. Regarding cash burn, I think good through end of September, but I am not concerned because CYDY is a perfect candidate for convertible financing and IBs other than Paulson are aware of the opportunity.
Other sources of capital are available. If Paulson's offer was the best, so be it. CYDY will have the funds it needs and the dilution will be inconsequential in the end.
That would be sweet!
The last corporate acquisition I did took 5 1/2 months from the day the LOI was signed. The DD is crazy time consuming. I'm hoping a lot of the DD has already been done for the Prostagene deal and it can close in 60 days or less.
We will know who many shares he owns pretty soon I would be surprised if he did not already own millions of shares. As for the Paulson raise, I am confident the terms will be considerably better than those of the past, if in fact it is successful. It is possible another financial alternative may emerge.
Michael Klump has a sterling reputation in the Atlanta Investment Community. CYDY is very fortunate to have him as a Board Member and substantial investor.
My guess is that whoever wins the deal will structure it as a convertible note. Straight debt won't work (would require a very high interest rate to mitigate the risk/reward) and a pure stock sale would not be favorable to CYDY at current SP. That leaves the convertible note structure which gives the lender a great upside and the company the funds it needs without giving away too much equity on the front end.