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The stock is not on the investment community's radar at all
The stock is gathering no institutional investment and even among the biotech-aware people...I've seen multiple articles on SeekingAlpha recently by authors who specialize in biotech and when those authors were asked about Cytodyn in the comments section, they said they knew basically nothing about the company.
The Proactive videos and the like are only getting viewed by a very tiny group of people. This is good news because there is a massive pool of people to get excited about the stock but for that to happen there needs to be a major catalyst. I think the best chance for that catalyst is great preliminary cancer or NASH results. That will likely increase the SP towards the level needed for uplisting.
Hofstadter's law says
It always takes longer than you expect, even when you take into account Hofstadter's Law.
Hofstadter's law is a self-referential adage coined by Douglas Hofstadter to describe the widely experienced difficulty of accurately estimating the time it will take to complete tasks of substantial complexity.
Nader did the same thing with the Samsung deal
Teased it before the official announcement was made. He's the eternal hype man.
So who is the Chief Science Office?
I asked this on the other board and I'll ask it here because maybe someone has some additional insight...
Pestell's suit says the board voted 4-3 to appoint Dr. Kelly to the "newly-created" positon of Chief Science Officer, which SEC filiings from last month confirm, while the first slide from the presentation yesterday lists Dr Burger as being back in his former position of CSO, which he resigned in July of last year. It's confusing.
Is Dr Burger the permanent CSO or just temporary and why does Dr Kelly not still hold the position? I don't think they just used an old slide with outdated info because NASH is listed. Hopefully Dr Burger can get things done but something doesn't seem quite right here.
Only the first forecast to Samsung is due 3/31
So it seems like the payments are contingent on date of FDA approval, which makes sense. From the 10K:
The first forecast will be delivered to Samsung by March 31, 2020. Thereafter, we must provide Samsung with a rolling quarterly forecast setting forth the total quantity of commercial grade leronlimab that we expect to require in the following years.
We estimate that initial ramp-up costs to manufacture commercial grade leronlimab at scale could total approximately $60 million, with approximately $30 million payable over the course of calendar 2020, and approximately $30 million payable in the first quarter of 2021. Thereafter, we will pay Samsung per 15,000L batch according to the pricing terms specified in the Samsung Agreement.
edit: I see you posted this as well, ohm
We'll see a bump on approval but
I doubt it will be a massive one and some pharmas even decline after the approval bump. Approval is nice but generating revenue is what is really important. Obviously some type of partnership with a larger company will help the situation.
The real igniter would be the reporting of major cancer or NASH results. That could 10x the stock.
I disagree, even though finesand may often be wrong
I think it's not necessarily a bad thing to have a militantly skeptical voice. With a big chunk of my money in the stock I want to hear all possibilities.
Public notification of a patent transfer is not crucial
I just talked to a very helpful lady at the Assignments Recordation Branch of the patent office. All a change in the US Patent Office database does is let the public know there has been a patent transfer, it's not necessary. It carries no legal weight.
The signed contracts transferring the patents are what are important, and it still seems obvious after reading Pestell's lawsuit filing and the SEC filings from earlier this year that Cytodyn has signed contracts and thus owns the patents.
If patent ownership were an issue
it would be in Pestell's filing. It's not. So it seems obvious that the patents were transferred. The 10Q filed 2/28 shows that the patents are Cytodyn's:
The aggregate purchase price paid for the ProstaGene acquisition was $11,558,000 based on the issuance of 20,278,000 shares of common stock of CytoDyn at $0.57 per share, including 1,620,000 shares earned, but not yet issued, by the investment bank for advisory services. In connection with the purchase, the Company entered into a Stock Restriction Agreement (“Agreement”), restricting the transfer of 8,342,000 shares of common stock payable to Dr. Pestell for a three-year period from the closing date of the transaction. In the event Dr. Pestell’s employment with the Company is terminated, as defined in the employment agreement, the Company will have an option to repurchase such Restricted Shares from Dr. Pestell at a purchase price of $0.001 per shares. The Restricted Shares will vest and be released from the Agreement in three equal annual installments commencing one year after the closing date of the acquisition of ProstaGene.
Assets acquired from ProstaGene include (1) patents issued in the United States and Australia related to “Prostate Cancer Cell Lines, Gene Signatures and Uses Thereof” and “Use of Modulators of CCR5 in the Treatment of Cancer and Cancer Metastasis,” (2) an algorithm used to identify a 14-gene signature to predict the likelihood and severity of cancer diagnoses, and (3) a noncompetition agreement in connection with an employment agreement with Dr. Pestell as Chief Medical Officer of the Company.
Looks like the bottom line from filing
"the CEO made a series of spurious
accusations regarding Dr. Pestell' s conduct, including, inter alia, that Dr. Pestell was
uncooperative and had misrepresented information regarding programs and patents."
"At least one Board member, Carl Dockery, pushed back on this
improper attempt to fire Dr. Pestell, highlighting the imprudence of hastily firing "our public
face of the cancer program, our largest shareholder, a fellow board member, and our only claim to
expertise in cancer" without first conducting an appropriate investigation."
There are multiple allegations of Nader dropping the ball but, without going through them individually, some seem like they are not borne out by recent events. It's obvious that Richard had his plan and it's not exactly one shared by Nader.
Comment about Pestell was just boiler plate platitude
because Nader was likely expecting litigation
Is it possible to download Pestell's filing?
Since it's in federal court?
Viral load testing
When first diagnosed with HIV; 2 to 8 weeks after the start of therapy or therapy changes, then every 4 to 8 weeks until the viral load is not detectable; then every 3 to 4 months if you are on stable therapy and the virus remains suppressed; after two years of this, viral load testing frequency may be decreased to every 6 months.
It's an important announcement
Only having to go to a doctor 6 times a year for injections would be fantastic for patients. Plus it further minimizes issues with injection site reactions. Like misiu said, it's not for patients with hepatitis, there are resistance issues and longer-acting substances mean longer-acting side effects, but the cabotegravir plus rilpivirine combo will definitely exert market forces on leronlimab and it will be very well marketed by GSK.
.30 can still happen
We are hanging around 10-year SP lows now and the sentiment has been undeniably downward for years. Prelim cancer results could ignite momentum but I'm not sure BLA submission will have a lasting effect. I think that's all about financing and sentiment around cancer possibilities.
Thanks for the replies sjacobs26 and everyone
I firmly believe in being constantly skeptical about my investments, I hold 145,000 CYDY, and being conservative in future projections. I think it's always better to be prepared for the lesser scenario and to try to keep emotion out as much as possible, which is obviously not always easy.
He specifically says
that the stock has been beat down so right now he's trying to keep from harming the price, but then he says when they "see that big jump in the stock and then we can think, more funding".
That to me means selling shares when the price goes up.
The 15 million to get to the end of the year is the likely nondilutive funding but after then I think he's definitely talking about capitalizing on an increased share price with dilutive fundraising. I'm just trying to be realistic here.
Dilution when SP rises
In the Wall Street Reporter question section, Nader says (@ about 1:20):
He needs 15 million to get to end of year
Plans to raise more money when SP jumps later this year or maybe early next. Seems to mean significant dilution. Right now it sounds like the plan is to use Syneos or another type deal for commercialization, he mentions two other offers he has, and raise funds through stock sales when the SP rises to hopefully get to the point where a comfortable revenue stream is generated.
It's important to remember that the first payment to Samsung will be due at some point next year. I hoped to ask him about the terms of that payment but I missed the webcast so I hope he will speak about it some time in the future. There is also the possible Hercules loan.
At this point I think it's a great bet that we will make money on CYDY in the next year but there are financial drags that may keep us from optimistic projections of SP. I expect less than a dollar, maybe 60 to 70 cents, a year from now. The wildcard is cancer results, which could generate momentum but I'm not figuring that in until it happens.
Start at a high price to recoup costs
That makes sense.
Nader has met multiple major milestones this year.
Manufacturing deal, BLA submission, first TNBC injection (after Pestell left). With more to come.
Nader has done a good job keeping his promises this year and I see no reason that won't continue.
I just question how leronlimab will fare against very well-funded competition, something micro-biotechs have to seriously worry about.
Just trying to get people's opinions
I've never ranted at anyone, but it's important to play devil's advocate with money on the line. Nothing wrong with always questioning any investments. Keep your mind on your money and your money on your mind.
I understand but resistance takes time to develop
Cytodyn will have to make that first payment to Samsung, which I believe will be due at the end of 2020, and obviously they need the money to continue business. I'm just concerned that cabotegravir approval will seriously eclipse leronlimab.
You and I and those close to Cytodyn can see benefits of leronlimab but I don't think the benefits are nearly extreme enough to make a difference against GSK's sales and marketing onslaught.
94% of the 308 participants reported satisfaction
that received the long-acting cabotegravir + rilpivirine injectable in the ATLAS trial.
In the FLAIR trail, 283 received the long-acting cabotegravir + rilpivirine injectable. At week 48, 91% of these participants reported a preference to stay on the injectable.
86% of participants in the cabotegravir + rilpivirine group reported that the pain associated with the injection was either “totally” or “very” acceptable.
https://www.infectiousdiseaseadvisor.com/home/topics/hiv-aids/long-acting-injectable-art-noninferior-to-oral-and-preferred-by-many-patients/
Playing devil's advocate here because I'm heavily invested in Cytodyn, just questioning if the cabotegravir + rilpivirine combo will be a significant hindrance to leronlimab revenue. A once a month trip to the hospital for an injection is something many patients will find very attractive.
What effect will cabotegravir approval have on sales
of leronlimab?
In late April Viiv healthcare submitted their NDA for a once a month IM injection of cabotegravir plus rilpivirine to replace standard of care HIV therapy. Approval should happen around the same time next year as leronlimab if not earlier.
With GlaxoSmithKline behind Viiv, they are going to swamp the market and make it very hard for leronlimab to get attention. Yes, you can say that leronlimab offers advantages when it comes to side effects and perhaps eventually resistance but that won't matter nest year and it will be very hard for leronlimab to get noticed enough to generate early revenue.
Sounds like they are not going it alone
Nader talked about a commercialization deal with Syneos Health for outsourcing promotion and sales. The good is that Syneos is an established company, its commercial solutions segment did over $310 million in revenue in the first quarter, so they can provide the ready-made salesforce.
The bad may be that, if you look at some of the Glassdoor reviews, their salespeople are pushed to the limit and incentives may be on the low end of contract work so the quality of the work may suffer some, but it's definitely much, much better than Cytodyn creating their own sales and marketing dept from scratch.
Partnership w/Syneos Health looks important
Nader mentioned that they are partnering with Syneos Health to commercialize leronlimab and that there will be a commercialization plan posted on the Cytodyn website in the next few weeks. Syneos offers outsourced sales and promotion:
https://www.syneoshealth.com/solutions/commercialization/promotional-field-teams-and-support
Here is the video where he talks about TNBC failure
RP's email addresses
If someone wants to try to contact him. I doubt he'll say anything informative, probably won't even respond, but here are the email addresses listed for him:
rgp102@jefferson.edu (Thomas Jefferson University email)
richard.pestell@bblumberg.org (listed on 2017 paper)
Richard.pestell@gmail.com (listed on The American Society for Clinical Investigation website)
Could be a bombshell
trding on hangout posted that Pestell's wife was making accusations on Youtube against him last year of "Epstein kind" of behavior.
Where is the talk of reverse split coming from?
Did Nader say something?