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Ahmm the greatest.
Massive green all over the market! Oh... Yeeaaahhhh, sorry CYDY, well at least you're up 0.1% LAUGHING
Way more long and way more knowledgeable. These short fools have run out of ammunition and are now trying to find some low hanging fruit.
I have never said Tanya is the greatest, but is part of the team that has put us back on track. Only shorts and paid bashers from some competing source dedicate themselves to attacking posters and a stock. Leronlimab poses a great threat to many a club member with big friends with tons tied
up in a lot of companies. Plain and simple that these types try to camouflage themselves as fake longs.
$$$CYDY$$$ 2024 Good job team!!
You don’t think we have pounded sand on this board?
You think we would like to hug that stupido BOD?
Where’ve you been lately..,
you've lost me. what does the number of chat board posts have to do with whether someone is long? I'd argue the opposite. You have clowns like fungderf who have admitted they have no stake - and they post 25 times a day. i think there are a good number of paid promoters or bashers on here - and the more daily posts, the more likely that's what they are.
my point is that if you've truly been long this stock - and lost most of your money - how can you not be frustrated and pushing for a greater sense of urgency from management and the board.
About Monroe: "Clearly has not been a long, or wouldn't be taking this "all is well" BS stance."
Can we use a little fact, BlueH? A couple of statistics.
Your stats are: joined iHub 6/2/2017 and frequent two boards and have amassed 729 posts.
Monroe's stats are: joined 5/30/2012, and frequents only one board (CYDY) and has amassed (drum roll, please) 29,716 posts. I believe he is more
long than you.
I like Kool-Aid so much, I bathe in it.
Not sure I missed??
Stated VERY clearly--she is there for privvy investors ONLY--FULL STOP
That is not retail--that is not the schlepps. Not that any retail EVER cares or they would have voted nodder out MANY years ago
So I doubt they will remove Tonya--if its a "vs: situation"-- it is retail shares vs: privvy shares and see how votes fall
She needs to go --what she allowed from/for weed/wine and the waste his salary/bonus for his antics--she should have been removed
you're right about that - the traders, the shorts, the lawyers, Paulson, and the board members (like Tanya and the other zombies who have done nothing) are the only ones who have made money here. And they've taken it straight out of the pockets of the common shareholders.
As for me, i'm voting against all of the board members going forward. That's about all a fed-up shareholder can do.
LOL....funny that you would read my post and interpret it that way. This isn't a question of work stoppage due to a fear of risk. This is a person hired with a knowledge to know how to reward insiders and stay within the guidelines.
Many of you seem to forget this is a penny stock with no actual marketable product. Money is being made, just not by the common shareholders.
Look at the trades this morning to push the share price up...A trade of 15000 shares is about $2k. Watch the trades at the end of the day.
09/17/24 10:00:46 AM 5 10300 0.1698
09/17/24 09:59:20 AM 5 2999 0.1699
09/17/24 09:59:13 AM 5 2000 0.1698
09/17/24 09:59:10 AM 5 5000 0.1698
09/17/24 09:59:09 AM 5 2000 0.1698
09/17/24 09:59:07 AM 5 8000 0.1664
09/17/24 09:59:07 AM 5 8000 0.1698
09/17/24 09:58:55 AM 5 3500 0.1664
09/17/24 09:56:21 AM 5 19500 0.1650
09/17/24 09:56:04 AM 5 2 0.1640 e
09/17/24 09:55:59 AM 5 300 0.1650
09/17/24 09:55:59 AM 5 500 0.1650
09/17/24 09:50:43 AM 5 15000 0.1650
09/17/24 09:49:05 AM 5 3000 0.1674
09/17/24 09:48:53 AM 5 15000 0.1650
09/17/24 09:48:47 AM 5 5000 0.1649
09/17/24 09:48:44 AM 5 31000 0.1650
09/17/24 09:48:19 AM 5 800 0.1639
09/17/24 09:48:14 AM 5 3900 0.1639
09/17/24 09:48:14 AM 5 20000 0.1639
I was there for his time also. However,you have missed facts about tayna. No scientific experience at all. No deals 2 years. Stock has sunk to new lows under her leadership. No clear path to any new deals or real trials. She has represented paulson more than shareholders. Under normal conditions she would have been fired a ways back.
yes, her bio is the key here. she is a financial / wealth advisor - as well as an attorney. a compliance person dealing with wealth advisors more specifically. I spent years in the financial space and know these types very well. the compliance lawyers are the most risk averse, anti-business people you will ever come across. They take weeks and months to do something that should take a day - because they are focused on the risk side of the equation, almost to the exclusion of all else.
the reality is, she came in to clean up the mess that Nader created - and at that point, it was 100% damage control. But that time has passed. We now have the ultimate "stick-in-the-mud" as our COB. She also has no clue about biotech or pharma, again because she has no experience in the industry. Time to get rid of her - because we can't afford to have the most powerful person in this company (in such a dynamic and fast-moving space) be a wealth management compliance officer, with zero industry expertise. It's an embarrassment, and you would never see something like that in a legitimate biotech company.
Maybe you missed the disgusting filth that was ceo for 10 years before her . Ran a kickback fraud scheme with his countryman khazem thru a CRO company. This duo is AKA khazempourhassan.
It resulted in hundreds of millions of $$ going into both their pockets , millions wasted defending losing lawsuits. Giving out massive awards and bonus' to all board members and all mngmt. For years. Phony "acquisitions"--phony divorce settlements--phony "fired for cause" scams. Phony BLA submissions--phony BTD submissions--years and years
Still defended by some--applauded by others
Now the company has SEC and DOJ investigations ongoing. The company cannot register/sale shares on open market. The company had hold placed on U S clinical trials. The company did not pay multiple suppliers. Did not pay multiple contractors.
All defended by many. Applauded by most
Tonya is just protecting the privvy investors--FULL STOP.
The nodder was just cheating and stealing from ALL--FULL STOP
I literally almost fell out of my chair! Are you considering changing your name to I_kinda_think_I_still_like_CYDY?
BTW, Tanya has done a decent job of what she was hired to do. She's not here to improve shareholder value, she's here with legal advice on how to work the rules to favor insiders.
Total Compensation
Period End Date 2023 2022
Currency USD USD
Salary
Bonus
Total Annual Compensation 100,389 35,661
Restricted Stock Awards 100,000 45,526
All Other Compensation
Fiscal Year Total Compensation 200,389 81,187
exactly. As Benjamin Franklin said "Blame-All and Praise-All are two blockheads". Monroe has zero credibility with me with his/her pie in the sky optimism. I maintain that Monroe is getting paid to promote the company. Clearly has not been a long, or wouldn't be taking this "all is well" BS stance.
At the end of the day, shareholder value is the name of the game here. Sure, we want to save lives, but anyone who says they're here just for that is full of it. This is an investment - and the scorecard for an investment is the share price, and if investors have made or lost money. Using that as our scorecard, current leadership gets an F. In fact, If there was anything lower than F, they'd get that - because I'm down over 80% in after-tax dollars. In the greatest bull market in history (with most investments doubling or tripling over the past 5 years), you can't find anything else that has crushed investors like this POS.
I've got nothing personal against Tanya - she's simply a wealth management lawyer and way out of her depth. It's not her fault that she's totally incompetent in this role - but as a shareholder, it's time we start demanding change and finding someone with a sense of urgency here.
I agree with you Big Bopper. It’s one thing to be positive but Monroe is drinking WAY TOO MUCH KOOLAID! How can ANYONE approve of the great job Tanya has done? She’s done a ‘great job’ damaging shareholder value for sure !
Are you another board member . Please,stock has crumbled under her leadership. Not one study going under her leadership. She represents paulson. She has zero scientific backround. She has got us zero deals. I think her and board should tells us if any deals proposed and let stockholders determine if deal is to our benefit. Its scrarry to think you believe she has done great job. Fyi, i am absolutely a long with a lot of stock.
TIK TOK.
I do love weekends especially the long ones when they come around.
CytoDyn undeniably has turned things around. Great minds continue to
be attracted to the science of leronlimab. It's not just the money. They want
to be associated with the next greatest thing in medicine so hence we are blessed to have
their continued association for the most part. Now that the old ceo has been replaced
we will see even greater longevity among those on our team. Thanks toDr. J especially.
What a masterful job he has done. So what happened to the dips? Ahhm hungry.
So who will that collaborator be? What day kicks off the next trial? 4th Q 2024 $$$CYDY$$$
Wondering how high the pps will jump?
I agree. all of the wounds of this company have been self-inflicted - Nader was an unmitigated disaster in every way, and the fallout has been massive. the conspiracy theories of this company being "targeted" by big pharma, the FDA, etc. - has always been a complete joke. CytoDyn under Nader was a very bad actor - submitting false data, Nader's fraudulent trading, partnership with Martin Shrekil "the pharma bro", etc. - and the shareholders have been paying the price for the fallout. The 13D group was spot on - again, their main point was the Nader would destroy the company - and here we are at a share price that is 90% lower from when they were saying that.
My point regarding Tanya is that while we have purged the worst elements (Nader and his buddies) we still have very weak links that would never be present at a real company. Tanya is former wealth management advisor and a lawyer - that's fine - but no way on earth she should be COB at a real company (and at a company where the COB should have some industry expertise). Again, if we were on a real exchange, with real investors - an activist would have come in and purged her years ago.
I'm still long (and somewhat exhausted). I still think there is some value in this drug - and at least we're not committing fraud, submitting incomplete information to the FDA, and bragging about $100 SP on random webcasts. But having an overly conservative, and totally inexperienced (in the biotech world) COB is troubling. And while i like him, Jay doesn't give me confidence that we'll see value at any point in the near or intermediate future. There is no "lack of urgency here" - and i think the investors who have suffered for years and watched their investment implode damn well deserve a sense of urgency to restore some value. What we really need is a deal-maker - someone focused on restoring value as quickly as possible.
Lets be real. Why would someone who is highly credible come to work for this company? They are either here for a big check for misleading shareholders or else they are a very poor judge of characters. Either way, why would you want them? Wouldn't your Dr Jay be able to get hired on to a successful and growing pharma company?
People really need to recognize already what a penny stock is and why it is.
You are correct about Tanya Urbach though and her purpose.
Your Dr Jay has just informed you that any product is still 5 years down the road.
Meanwhile, PFE is selling currently at a P/E of 11 and a 5.7% dividend, AND they raise the dividend annually.
I don't care where you waste your money, but it seems like you're starting to get it.
Even worse (if possible) someone that promoted weed/wine to a position beyond his abilities. Then rewarded/Awarded him --ONCE AGAIN WITH BOARD APPROVAL (can ANY be trusted??) Shareholder equity--OUR shareholder equity-- means ZERO toTonya and board
After ALL that he and his daddy mickey did to defraud shareholders--just disgusting
That is prob the best thing Dr J did --mandatory removal of weed/wineornodeal Lucille (tonya)
Used a lot of his leverage and now she has a grudge
No doubt the timeframe is the chasm. Maybe shellshock after years of fraud and millions (hundreds of millions??) lost eroded gone to fraud--up in smoke--handed out like candy
There is NOT 1 person I would trust beyond Dr J and possibly Cohen as it stands
Have seen a COB and 1 board member and 1 CEO complete destroy this company and product. Hired crook books and son weed/wine. Even after ALL that Tonya not only kept weed/wine she promoted and rewarded. Took a few years but shareholder equity gone. SEC and DOJ involved. FDA punishment and doghouse
If Recknor or Rahman or Patterson are needed by Dr J by all means. (after the screwjob when they did nothing wrong)
See IF Timmons and/or Patel would be willing to come back on board (literally) (after the screwjob when they did nothing wrong)
See if Dr Seethamraju would be amenable (after the screwjob when he did nothing wrong)
All believed in Leronlimab at some point. All were honest and a lot more interested in advancing LL than using it as a ATM.
If there is ANYONE at NIH or Drexel that is still in position--let Dr J talk (BEG) to those and apologize and see if any of that funding/grants can be restored for trials (after the screwjob)
Its hilarious to read how some are still upset at Pestell and the "acquisition". Asking where is that prostate test. Give us back those millions of shares. Yet they deny the SEC filing by CYDY that states there is NO PROSTATE TEST being acquired. They deny the endrun by nodder around the SEC to avoid a shareholder vote. They NEVER complain about the millions of shares nodder got from board/award for "acquisition"
defending someone who has presided during a period when shareholders have lost 85% of their investment value shows that you're likely a paid promoter for the company. you certainly don't speak for real shareholders who have lost their hard-earned money under the stewardship of Tanya and this board.
Tanya is doing an excellent job all the way around. More power to her. Naysayers dressed up like longs have many times revealed a lack of real due diligence and only seek to put downward pressure on the stock price by posting BS.
We get it. But wait, there's more....>>>>
Recently a tried and true long TOOK THE WORDS RIGHT OUT OF MY MOUTH.
How obvious the soft bashing and the innuendos.
Dr. J is doing such a good job he has to be beat over the head with a bunny rabbit!
The game is obvious. Not one person who cares at all for improving lives would bad mouth
this company in any way shape or form. The few who legitimately spoke out against the ex
CEO's pilfering are to be commended, but not those who just merely rode in on the coattail
to supplement their bashing. There is a great distinction to be make of this.
Be that as it was(is).... we still see some who can only dip into the past since we are off to a new
start making great strides in the pharma world. Nice to be on good terms with these agencies! Dr. J brings a whole lot to the table.
Say, how would anyone like to see a new head of the FDA, CDC, NIH etc giving leronlimab a real up and up evaluation?
I would venture to say the short stumpers would vanish and CYDY would get some timely approvals and maybe even a EUA or two!!
EXCELLENT JOB Tanya and CYTODYN TEAM. YOU ARE ALL TO BE CONGRATULATED FOR HANGING TOUGH. $CYDY$ 2024
this is spot on. she is terrible - her background has nothing to suggest that she can add any value to a company. she's a lawyer, who had a background at a wealth management firm. way too conservative - but beyond that, i don't think she has even basic business skill.
of course the problem has been that the company had no money to pay anyone good to come in - tough to attract talent with a stock at all time lows, and no cash in the bank. i had hoped the new infusion of capital would attract a new CEO, with a business focus. I would think that CEO (if good) would keep Jay at CMO, and then immediately demand competent board members - because we don't have any.
we'll see. I'm afraid we'll be stuck with her and the same zombie crew we've had for years. Doesn't mean the company will fail - just means we're many years from making any money here.
Tanya has been --is--absolute disaster for legit CYDY shareholders. She is--as you allude --here ONLY for paulson/privvy place qualified purchasers. Disaster for schlepps that buy open mkt shares--while Tonya and her minions get below mkt shares and free warrants
That is 1 thing that Dr Lalezare AND Cohen --really should ( NEED ) to explain to all--so all can see/understand; why there are not shares sold at mkt prices with registration thru SEC. Sorta like real cos operate--Have some shelf shares--can sell as needed at full price.
With the 100s of millions of shares that have been wasted on Pestell acquisition and nodder awards. 100s of millions of shares doled out to Welch/Naydenov /kelly --highest compensated board in the Northwest and for what?? ____________________??
Hundreds of millions wasted on PR firms. Wasted on khazempour kickback scheme. Wasted on lawsuits. Wasted on awards for lost lawsuits. Wasted on nodder divorce/not divorce fiasco. Wasted on disaster manuf costs. Wasted flying execs around to poster presentations and free trips. Wasted paying massive salaries while Clinical holds were in place to the very people that caused the clinical holds. Wasted rewarding weed/wine because tonya needs a BFF with benefits
We need to get some of the legit board members back. We need to get Dr Lalezare some help. He is OTJ training and trustworthy so --compared to past--compared to what might be drug up by the dogs and the cats wont drag off; For me he is great CEO all things considered
I have been a long for quite a few years. Under the leadership of tanya urbach and other board members who seem to be working for paulson rather than cydy,the stock has crumbled. Any other head would be fired,but its like paulson wants her there. We continue to go in circle never getting very far. We are at a burn rate of about million per month,but we were told enough for testing. This is very far fetched. I think jay trying to do his best but board members have him on very short leash. I think there are some opportunities but there is no great leader to bring us forward.
What can I say I love watching people lose money it tickles me
What an erudite rationale. Amazing that you associate with "garbage penny stocks."
Guy please
1st I know/remember who embraced the items/persons mentioned. And also those that attacked me a few years back because I spoke truth/linked SEC docs and been proven correct. Don't be mad at me for for your analysis/opinion that has been proven wrong
ANYONE--even you--can go back and see your posts/history from 2020-21-22
Don't embarrass yourself further.
There are 2 rules to holes.
#1 realize when you are in one
#2--stop digging
Companies only send letters to shareholders when they don't have any real updates but need to keep people from selling so they can keep their paychecks. I see it a lot with garbage penny stocks.
Funny you "forget" when you posted MANY times how nodder was doing a great job. That HIV approval was certain. That you had much experience in medical industry and knew how great the nodder/kelly/mulholland team was from your experience and"uplisting" was imminent.
Yet now --SOMEHOW--the company is "in the woods" and being led out????
Go back to your embrace of jimmy chuckles/blackops/nodder et al
Remember how you hated 13D because they stated there would need to be maybe 200 million shares of dilution to remove amawrecks and fund actual trials?? What was that 400 million shares ago??
There is still no trial being conducted nor has there been a trial conducted without amawrecks--CORRECT??
Tell us AGAIN what does "imminent" mean
Tell us again about minimal dilution
In all your communications with nodder--did he tell you about the "blips" in HIV treatment?? In all your communications with nodder did he
tell you khazempour was on CYDY committees??
Might reflect on how WRONG your/opinions have been over the years--100% WRONG
Might want to understand difference in bash and truth. Not hard if you try. Wonder what has done the most damage for years. The bashing or the embrace of fraudulent CEO and his pumper minions
Leronlimab deserves better
It's nice to get a letter - but how about a phone call for investors where we can ask questions?
As for the letter, it was well written and organized. But it adds to my conviction that we are likely years away from catalysts that will restore any real value to shareholders - by real value, i mean anything over .50. Much of the updates were "starting to enroll in 2025" - that means any meaningful data is 2-3 years out.
Part of the CEO's job is the communicate, and get investors excited (and maybe attract new investors). Sending out quarterly letters further makes me question whether Jay is the right man for the CEO role. I do like him - but he may be more of a CMO type.
The mCRC (MSS) trial was to begin in 2022--combo with Regorafenib
It was last updated in FEB 2023 then "withdrawn" a few weeks later
Notice the 2023 update still showing amawrecks
NCT05730673
link here--https://clinicaltrials.gov/study/NCT05730673?cond=colorectal%20cancer&intr=leronlimab&rank=1
Good post. This is what it is all about. We sit on a miracle drug that finally is getting off high center no thanks to Dr. Falsi whose HIV Pharma babies had his utmost devotion keeping all others at bay for many years. Well, this extended over into China Virus Syndrome too, unfortunately into many other indications that would lead one to believe the CCR5 was practically not more than hidden crook gone amuck. Plus now, it has been learned the immune system as well receives stimulation so we have a dual action going on.
Now years later, it has taken a herculean effort by some real champions to keep this God sent medicine into the realm of real science. So as truth never can be kept silent forever, we finally have a great board of directors and one of the world's best minds who has probably more knowledge about CCR5 than most.
God Bless Dr. Jay and the whole team that has given new life to leronlimab. We know it works, they know it works, so bring on the challenges and let's keep the good news out front. Remember. safety first...which by the way the miracle drug is safe, very safe.
Thanks for your posting Trding.
I haven’t been following closely lately here, but I am guessing it is because this is an area of need and one that matches previous research, with other ccr5 trials and papers. I am guessing they suspect that is the fastest way to approval, because with good results the time to approval can be greatly shortened compared to those cancers with good results already. Also they have a good way to show the drug is working with measuring crcs directly as direct evidence is needed for fast approval.
Example:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407580/
“CCR5 expression was found to increase with primary tumor size and peaks in T4 CRC tumors (metastatic colon cancer). In liver metastases, CCR5 intensity increased, compared to primary tumors, but the stain was detected in small isolated areas (patchy staining). Low CCR5 expression in metastases was found to characterize patients with prolonged disease-free survival and disease-specific survival. Patchy CCR5 expression in cancer cells is a signature of liver metastases, and maraviroc was still effective in patients with CCR5 “patchiness”.
The C-C chemokine receptor type 5 (CCR5) plays a role in colorectal cancer (CRC) progression and is associated with several factors, including:
Tumor size
CCR5 expression increases with tumor size, and peaks in T4 CRC tumors, which are metastatic colon cancer.
CCR5 expression increases in liver metastases compared to primary tumors, but is detected in small, isolated areas.
Disease-free survival
Low CCR5 expression in metastases is associated with prolonged disease-free survival and disease-specific survival.
Tumor microenvironment
CCR5 signaling increases the infiltration of regulatory T-cells and myeloid-derived suppressor cells into the tumor microenvironment. This can contribute to cancer survival and progression, and may make tumors resistant to immunotherapy.
Macrophage repolarization
CCR5 is a potent regulator of macrophage repolarization. It promotes a proinflammatory, prometastatic phenotype of tumor cells.
Mesenchymal stem cells (MSCs)
MSCs produce large quantities of CCR5, and the CCL3/4/5-CCR5 axis promotes tumor progression.
re. "relapsed/refractory micro-satellite stable colorectal cancer (“CRC")"
What is the prior research backing this clinical indication? Seems out of the blue to me.
How about this from one of your questions, which I think is the most relevant. "How much $$$ do they have to survive...?
CYDY has enough cash on hand to commence the contemplated clinical trials.
If any of the trials or other resources takes... no new shares will have to be issued....
You should probably read this. The entire article is important, but this should quash to 2025 talk.
Glad to see you are catching up. I bought more first thing this morning before it hit .16. I knew the PR was coming from the action last week.
We have a miracle drug. I am proud to be part of it as a shareholder.
"....As of today, the Company has a new and improved relationship with the FDA -- one that will remain a critical priority for the management team in the coming years. We believe the Company has sufficient cash on hand to commence the contemplated clinical trials and push our development initiatives forward into 2025..."
From September 2024 Letter to Shareholders
https://finance.yahoo.com/news/september-2024-letter-shareholders-123000229.html
Spend some time. Happy reading.
There is a shareholder letter with many updates that was released 10 minutes ago
Spend some time doing research. Happy reading.
For all jabbed and boosted and looking to take the next ones>>>> Here is some encouraging info.
https://rumble.com/v5dwc6l-500000-americans-have-been-killed-by-the-covid-vaccine-and-the-cdc-is-hidin.html?e9s=rel_v2_ep
So if the FDA could rubber stamp the jabs and hide evidence to the contrary, why could they not then
rubber stamp leronlimab that was far more tested and safer by huge ungodly amounts? We even had anecdotal evidence in abundance. Well, that chapter is behind us...wow, how time flies. Back at the ranch, Dr. Jay preparing for the new trial with the new CRO.
$CYDY$ 2024
Thank you, $5.95!
So, I guess Cytodyn only did the offer of 141M shares to sell in February 2024 and issued warrant tender offer in July 2024
How much $$$ do they have to survive before they will issue more shares?
Thanks upfront for the answer!
There has been no RS in the last two, there, four years.
Could anyone please tell me when the last dilution was? I think about 2 years ago was a reverse split, but I can't find any info on that.
Thanks, in advance!
My good buddy djjazzyjeff is here as he is a part of team Patterson. Keep in mind team Patterson hired Steven Gluk to help them work on advancing a CC5r platform. Anything dj can do to help eliminate support for P140 is his number one reason for being here.
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DISCLAIMER:
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn. The SEC has informed the Company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or securities trading activity.
In addition, the Company and certain of its executives have received subpoenas in connection with an investigation being conducted by the United States Department of Justice. The subpoenas seek testimony and/or records concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn.
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission (“SEC”) and the United States Department of Justice (“DOJ”) requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19, HIV, and triple-negative breast cancer, related communications with the FDA, investors, and others, litigation involving former employees, the Company’s retention of investor relations consultants, and trading in the Company’s securities. Certain Company executives have received subpoenas concerning similar issues and may be interviewed by the DOJ or SEC in the future. The SEC informed the Company that its inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or security.
The Company is cooperating fully with these non-public, fact-finding investigations, and as of the date of this filing, the Company is unable to predict the ultimate outcome and cannot reasonably estimate the potential possible loss or range of loss, if any.
VANCOUVER, Washington, March 30, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission.
The Company was not enrolling any new patients in the trials placed on hold in the United States. The partial clinical hold on the HIV program impacts patients currently enrolled in extension trials. These patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved. CytoDyn intends to work closely with the FDA to resolve the partial clinical hold as soon as possible. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved. The Company is not currently conducting any COVID-19 trials in the United States, as it is evaluating the most optimal programs on which to focus its resources and attention.
“CytoDyn is committed to FDA compliance,” said Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn. “We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA. We will provide an update when we have additional information.”
Up to 205,652,848 Shares of Common Stock
This prospectus supplement updates, amends and supplements the prospectus dated October 11, 2023, relating to our Registration Statement on Form S-1 (Registration No. 333-272815) (as supplemented or amended from time to time, the “Prospectus”). Capitalized terms used in this prospectus supplement and not otherwise defined herein have the meanings specified in the Prospectus.
This prospectus supplement is being filed to supplement the Prospectus with the following information:
The information in this prospectus supplement includes forward-looking statements relating to, among other things, future clinical trials and our business strategy. The reader is cautioned not to rely on these statements, which are based on our current expectations. Please see below for additional information about risks involving our securities.
This prospectus supplement is not complete without the Prospectus. This prospectus supplement should be read in conjunction with the Prospectus, which is to be delivered with this prospectus supplement, and is qualified by reference thereto, except to the extent that the information in this prospectus supplement updates or supersedes the information contained in the Prospectus. Please keep this prospectus supplement with your Prospectus for future reference. The Prospectus, together with this prospectus supplement, relates to the resale of up to 74,903,789 shares of our common stock, par value $0.001 per share (the “common stock”), and 130,749,059 shares of our common stock underlying certain warrants (collectively, the “Shares”), by the selling stockholders identified in the Prospectus under “Selling Stockholders”.
Our common stock is quoted on the OTCQB of OTC Markets Group, Inc. under the symbol “CYDY.” On February 29, 2024 the closing price of our common stock was $0.2575 per share.
Investing in our securities involves risk. You should carefully consider the risks that we have described under the section captioned “Risk Factors” in the Prospectus on page 8 and in Part II, Item 1A of the 2024 Second Quarter 10-Q before buying our securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if the Prospectus or this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is March 1, 2024.
November 3, 2023
November 2023 Letter to Shareholders
Dear Shareholders,
We write to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), and to thank you for your continued support of the Company.
Throughout our history, CytoDyn has made great strides in developing leronlimab from a single indication molecule into a platform molecule with the potential for multiple therapeutic indications. Through CytoDyn’s investment in clinical trials, we have generated valuable data demonstrating how leronlimab might be used in HIV, oncology, metabolic dysfunction-associated steatohepatitis (“MASH” formerly “NASH”), and metabolic dysfunction-associated steatotic liver disease (“MASLD”). We have also successfully transferred our manufacturing technology allowing us to manufacture leronlimab at scale in preparation for clinical trials and potential FDA approval.
Fiscal year 2023 proved to be a very difficult year for CytoDyn. We had planned to be off clinical hold and back to conducting clinical trials by now. Unfortunately, to date, we have been delayed in our efforts to satisfy the FDA with our clinical hold submission(s). We have embarked on a more comprehensive effort to resolve the FDA’s lingering questions. These efforts include the Company’s hosting of a number of advisory board meetings with key opinion leaders (KOLs). Adding to our delay was the unanticipated medical leave taken by our then President, Dr. Arman creating additional delays in our subsequent resubmission.
However, these unforeseen circumstances provided the time needed to help us gain new insights and understanding of leronlimab in the current HIV treatment environment. Further, we were able to receive and incorporate the perspectives of some of the top HIV KOLs worldwide as to how they believe leronlimab can play a significant role in helping HIV patients, notwithstanding other therapeutic options currently available to patients. As part of this process, the Company engaged various new clinical, regulatory, and medical consultants and advisors with relevant experience and expertise that we believe will continue to benefit the Company for years to come.
The Company has taken necessary actions to position us for near-term and long-term success. During the last fiscal year, the Company implemented significant reductions to its workforce, cash burn rate, and operating expenses, in order to conserve our resources and devote them to critical corporate priorities. In addition to our work in HIV, we have worked with top experts to develop a MASH clinical trial protocol and identify potential MASH pre-clinical combination therapy trial concepts, which trials we believe could be attractive to a partner and position the Company for a greater chance of success within the MASH space. We also began development of a longer-acting therapeutic with a partner who has a very strong and reputable artificial intelligence (“AI”) platform, which we believe may provide significant increases in shareholder value in the years to come. We also believe that the Company is positioned for success in the Amarex litigation. We fully funded Sidley Austin LLP – the preeminent law firm representing the Company in this matter, filed a more-detailed statement of claim, and scheduled a final hearing date (August 12, 2024) in the arbitration.
We understand that CytoDyn’s recent challenges may have tested your confidence. We want to assure you that we remain dedicated to developing important therapeutics that can make a difference in
patients' lives, and at the same time provide value for our shareholders. Again, we are grateful for your ongoing support and trust.
We will continue our efforts to prioritize and execute on goals that will enhance value for all shareholders. Our efforts are focused on successfully completing the resolution of the FDA’s partial clinical hold – having recently made a submission that we hope will be successful – and strengthening our leadership team. Additionally, the Company will be evaluating the various potential indications for leronlimab to maximize the effective and efficient use of our resources. We have always believed leronlimab holds great promise, and we are determined to explore all avenues by which patients and medical practitioners can benefit from its use. We believe that with the improvements we have made and continue to pursue, our company is positioned for long-term success.
We deeply value your investment in CytoDyn and are committed to acting in your best interests. We look forward to continuing to communicate as additional developments occur. We realize the updates above may not answer all the questions you have. We therefore include a November 2023 “Frequently Asked Questions” supplement with this letter. This FAQ supplement is something we intend to update from time to time and it will be posted on the Company’s website in the near future.
Finally, in advance of our upcoming Annual Meeting on November 9, 2023, we want to remind you to submit your votes, if you have not already done so. If you were a shareholder as of September 11, 2023, you are considered a shareholder of record. Notably, the Company has asked for the shareholders’ approval to amend the Company’s Certificate of Incorporation to increase the total number of authorized shares of common stock. This increased share allowance is critical to the ongoing viability of the Company, and we therefore encourage everyone to vote if you have not already done so. If you have any questions or require any assistance in voting your shares, please call the Company’s proxy solicitor, Alliance Advisors LLC, at (833) 814-9456.
Sincerely,
Tanya Durkee Urbach
Board Chair
Note Regarding Forward-Looking Statements
This letter and the accompanying Frequently Asked Questions supplement contain forward-looking statements relating to, among other things, future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and/or our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review the Annual Report on Form 10-K for the fiscal year ended May 31, 2023, including in the sections captioned “Forward Looking Statements” and “Item 1A. Risk Factors”, as later supplemented by our Form 10-Q for the quarter ended August 31, 2023, in the section captioned “Item 1A. Risk Factors”. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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