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Read the letter. It's on CYDY's website.
I just love how you spin and spin. STFU means "short tool for you." Nice one. I will be here for at least a year. Get used to it.
Any plans to resume the original (held) trial which is no longer held?
LOL!
TD- keep up the good work! Take out all the “we plan”, “we expect”, “we believe” and then enjoy the word salad!
Jay needs this to pump the stock to get out on his $400k bill owed by Cytodyn! Take the bet!
You never show up here again if it TOUCHES $.10 by July 4! If it doesn’t, I’ll delete my account
Take it or STFU!
What ever happened with long lasting leronlamoob?
They running any trials yet or what
And now I challenge the Grip It sticky post! No chance of the sp hitting ten cents by July.
VANCOUVER, Washington, May 16, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
I write today to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), as we approach the end of our 2024 fiscal year (May 31, 2024), and to sincerely thank you for your unwavering support.
Fiscal year 2024 was a significant year for CytoDyn, and one that I believe will be remembered as the beginning of a turnaround. The Company achieved the lifting of the FDA’s clinical hold in late February 2024 and is now working to return to the clinic. Over the past several months, the Company has made significant internal progress on key initiatives which we believe will lead to marked external developments in the form of the commencement of clinical trials, the rollout of a number of pre-clinical research initiatives, and the continued publication of leronlimab data.
Shortly after my appointment as the Company’s CEO in November 2023, I hosted an investment update at which I committed to prioritizing the following: (i) getting off clinical hold, which required the submission of a revised trial protocol to the FDA; (ii) publishing clinical data that had not yet been released; and (iii) exploring how to extend leronlimab’s platform wherever it made sense. As I reflect on my first six months as CEO, I am pleased with the progress, but our work is not yet done.
Over the next six months, we expect to commence at least one, and potentially two clinical trials. The prospective clinical trials, in order of priority, are: (i) a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; and (ii) a Phase II study exploring leronlimab’s effects on inflammation. The Company’s priority will be the oncology trial which, if successful, will put us on track towards a commercial approval of leronlimab in that indication. The inflammation study is aimed at clarifying certain provocative observations related to leronlimab, and to help define the dose and underlying mechanism of anti-inflammatory action. It is imperative that the Company generate unassailable results in the clinic and I believe the above trials can accomplish this. Starting the oncology study and related fundraising is the top priority of the Company at this time, but our current hope is that we can initiate both studies before the end of this calendar year.
Research and development partnership opportunities are important to the Company as we search for cost-effective ways to further build out our product development portfolio. We have identified several such opportunities that we believe are intriguing, and anticipate finalizing agreements with these partners in the very near future. Such potential partnerships include an investigator-initiated pilot study of leronlimab in patients with Alzheimer’s Disease, and a project that will evaluate the use of leronlimab in patients living with HIV who are undergoing stem cell transplantation in a proof of cure study. Following lifting of the clinical hold, we have observed a significant increase in third parties that are interested in partnering with the Company. We will continue to review opportunities as they arise, given the potential for significant value return at little or no cost to the Company.
Finally, as promised, CytoDyn has submitted several leronlimab manuscripts for peer review and is in the process of completing final drafts of several others. The clinical endpoint data from the Long COVID trial (CD 15) was recently published in the Journal of Infection. All publications will be available on the Company’s website soon after publication.
I believe the Company is building for success and has made significant strides toward initiating a number of key pre-clinical and clinical leronlimab trials. I am also pleased to share that things are progressing well as to the development of a longer-acting therapeutic with our partner who utilizes its proprietary artificial intelligence platform.
As shareholders, you are the lifeblood of the Company and we remain committed to acting in your best interests. Your questions and feedback are always appreciated. Included herewith is a copy of the May 2024 “Frequently Asked Questions” supplement. This FAQ supplement is something that is also posted on the Company’s website and updated from time to time. You are always welcome to submit questions to the Company’s IR email account: ir@cytodyn.com.
I understand that the Company’s historical challenges may have tested your confidence, and I am grateful for your ongoing support and trust. My dedication to the Company is founded in my belief that leronlimab has the potential to be a life-changing therapeutic. As always, our commitment is to bring better healthcare to patients in need, and to maximize shareholder value.
Sincerely,
Dr. Jay Lalezari
CEO
What is the news you are expecting? The lifting of the hold produced nothing in terms of a catalyst. I think the only thing that would ever cause this stock to move is an approval and that is years away. They simply don't have the money for a proper trial, and they have a skeleton crew holding the fort down. They don't have many options at this point.
GOOOOOOOOOOOOOO CYDY GOOOOOOOOOOOOOO!!!!!!!!!!!!!!!!!!!! GOOOOOOOOOOOOO AMERICA!!!!!!!!!!!!!!!!!!!!!!
Go $CYDY !! You can do it !!
GLTA !!
Waiting patiently for $CYDY to come out of it's cocoon !!
GLTA !!!
Woooooooo!
"confidents"...pretty sure its exactly how CYDY likes 'em...
What have they accomplished since the hold was lifted
After checking all the negative posters against CytoDyn, CYDY, it confirmed my confidents in Leronlimab
and bought some more CYDY shares from my refund check on last Friday.
And the little fish will wisper and some will yell, "he/sh/it made do it!" and in time a few big catches get caught and skewered.
It's coming. Will take a while, but a price will be given.
Meanwhile, as mRNA covid variants keep popping up, the door was not shut completely as Dr. J mentioned.
Are there bigger fish to fry right now? Well, hopping on back to the HIV protocol I would say so. When studying the
covid mRNA history, it takes you back a couple or three decades and shows the footprints with HIV. So this was a long
planned plandemic for certain. So other than the recipients of 5.7 billion stabs and jabs and bun buster boosters, the world
can add to the count all the HIV victims to the lawsuits. Yes sir, it will shake and bake the whole health system and DoD.
We are talking 10 on the Richter scale. The earth tremors have begun.
And guess what? Leronlimab via CytoDyn with God knows who else trying to piggly wiggly their way in, will break out to the top of the pile into the sunshine while all those
pigeons and slop hogs will be put to where the sun doesn't shine. So what is the key? CCR5 and our sweet leronlimab.
$$$CYDY$$$$ Up 15% in the first few hours of the day. What gives? Someones doing some cookin in the CytoDyn kitchen? Looks to me 13D and related pigeons got wind of the cooking and decided it's time to skidattle.
Alas, Leronlimab is "out of the Covid Competition" as the VACs battle it out.
Another victim of the vacs wars -
americanmilitarynews.com/2024/05/covid-vaccine-causing-very-rare-and-dangerous-side-effect-pulled-worldwide/?mc_cid=66c7590758&mc_eid=1fbc7be438
In the meantime - how many folks now have to deal with a "new" serious problem thanks to this vaccine's side effects?
So my wife and I got both shots and a "booster" and I'm wondering what "other prizes are coming our way?
In retrospect, we both had significant "health changes" directly following the vaccinations.
"They'd never approve something that might 'mess us up', right?" Only later on did we begin to "relate" the timing of the vaccination and the resulting occurrences.
But nobody needs a vaccination if physicians have a potent treatment at their beck and call? Leronlimab.
But Leronlimab would "torpedo" this most excellent solution (think - lotsamoney for BP and potentially cyclical too [as the virus becomes a yearly event])
So we all (those "jabbed") await the eventual outcomes from those "JABations!"
"Oh golly, I'm so excited - what did I win?"
...And the deaths just keep on coming....and when will the numbers catch the eye of the DOJ?
You'd think >> Over a million dead. and how many could have been saved if certain "strategies" hadn't gone into play?
Like the organized obstruction of Leronlimab.
IMO
And a separate thought...a lot of "little fish" (usually the big fish slink away) will be caught and dealt with?
Lots!
LOL
(over a million 'slaughtered' and more given life-changing "alterations." Yeah, a lotta heads will "roll" (but not always the 'right' heads).
Again IMO
Reuters is a big part of the coverup. They are promoting Pfizer yesterday and today especially hard as the shorts are piling on. So we get the news of Pfizer/AZ investing a billion bucks in France for development and mgf. Gee tanks a lot Pfuzzy that really helps cure the problem.
All the FDA had to do was give EUA's to leronlimab, ivermectin, HCQ and others. So now, the mRNA makers are in a bit of a panic as these nano particles that they falsely call a vaccine are reaping havoc on the world's health. Sales have plummeted because the world is waking up to the big scam as the effects of the jabs are now mounting at an alarming rate. The real scientific community is coming together from all over the planet. The fallout from this assault on mankind is going to end up in court as these perpetrators of the big scamdemic are faced with the liability. So Sidley, pay close attention. Recall the emails and nasty chatter against leronlimab at FDA. They knew it worked, safe, and probably would become one of the medicines of choice. Hence, Nader et al. Yes, we are in the middle of it. One day we may be the next giant, the David that slew Goliath. Yes, they have no where to run but to try and force a new covid or worse on the world. Deflection though has been worn out as a strategy. A huge planetary revolt is forming. Watch what happens going forward. https://americanmilitarynews.com/2024/05/covid-vaccine-causing-very-rare-and-dangerous-side-effect-pulled-worldwide/?mc_cid=66c7590758&mc_eid=1fbc7be438
For those of us young enough we may recall the tobacco litigation. "In 2009, the Family Smoking Prevention and Tobacco Control Act gave the FDA the power to regulate tobacco products. State attorneys general have been active participants in helping the FDA shape its regulatory authority.
Also, because the contractual requirements of the MSA are in some ways broader than the authority granted to the FDA and are not subject to constitutional defenses, state attorneys general continue to step in where the FDA may be unable to act."
Total payout by tobacco companies thus far is $165 Billion, not including some states that sued individually before the Master Settlement.
Folks, THIS IS PEANUTS FOR WHAT IS COMING. Main Stream Media is also liable for actively promoting and collaborating in the big lie. So even now, they are not reporting the developments related to the Scamdemic. Watch it develop. The world demands relief and they will get it.
PS. I still get that feeling a PR is in the making. $$$CYDY$$$ 2024
Seriously, the (as per your link) Japanese rebuttal of MRNA drugs from the US and results are alarming, and I believe some of the Scandinavian Countries are doing likewise?
Meanwhile we're being encouraged to get jabbed?
Is there anybody keeping track in the US...and what kinds of results are we seeing?
And in the reference to "turbo-cancers" via the Japanese information ...
Seeing supportive evidence in the US ?
And will Leronlimab ameliorate such?
Questions that deserve a answer that will answer to mankind - when reviewed in the future.
It's only embarrassing because time is on your side, at the moment. There have been plenty of stocks that have plummeted into this penny range only to
soar.
"There is this real world called REALITY you know...with a stock called CYDY," and a poster who is the moderator of this board and calls Leronlimab
some derogatory term because he likes it. That is the REALITY of you.
Now, put a price on Leronlimab. You do remember it.
Short pigeons need to change their diapers too often. Of course they are following their leader and Pig Pharma which I am having so much fun shorting CytoDyn's competition. When you are over the target pigeons drop their bombs. Sadly they drink the poison water from the town's fountain and can't seem to get airborne anymore. This will become apparent fairly soon as we are getting closer everyday to some news breaking from the company. It will probably be about the studies and protocols they have been working on. Thanks again to the FDA for finally doing the right thing. Maybe they are trying to make good on their internal email writers. Sidley could be taking good notes on all this. Yep, bet she is having a field day .... and could be next month we get some updates on the AmarWreck front. Yes, I expect so. TIK TOK your time is short and shorts are going to get Tik Toked. So while you can, here is some relief from the Covid jab worms growing inside you via Dr. Jane Ruby ... ok, Jane take it away.... https://rumble.com/v4ue489-how-are-you-managing-your-parasites.html
There are ways to get rid of them it seems but you have to search and look hard because Pigs don't want you to get better no matter who you are. This is why they bend over backwards trying to keep CytoDyn's leronlimab from succeeding. How sad when competition breaks all the rules and gets away with it. But, the uncanny thing that the world witnesses time and time again is the interesting fact that truth has a way of escaping. Praise be to the light. $CYDY$ 2024 Get ready.
It is called tricking--- Nope, its called telling LIES on a Federal Communications Line to manipulate the market by saying one bought at 33 cents to induce confidence for others to join in and buy at the same price.
Look at the folks that actually bought at 33 cents by reading your lying recommendation and got whipsawed to the current 14 cents...that in itself is actionable.
And investigating WHAT shorting? Finra says theres only 4,643,720 compared to a previous 4,711,253 short shares---
https://otce.finra.org/otce/equityShortInterest
Hmmm, 4,643,720 out of a total of 993,366,000 shares outstanding is less than half of 1% ...so that DEBUNKS the investigating cytodyn shorting lie.
Are CYDY longs making threats again?? Tsk tsk losers we all know you deep the red and we laugh.
Read the court documents.
Let me help you with math!
Buy at $.33 and it’s $.15!
You’re under water and this shit stock is a scam! Call the SEC and give them this post it’s a FRAUD and will go to $0.00
It is called tricking...I get people to talk...investigating cytodyn shorting is bringing me many leads. 50 percent haircut? You have no hair to cut.
I love Cytodyn but why do a few posters dislike the stock? I invested at 33 cents so I'm very happy.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169568182
Looks like a 50%+ haircut to me kgro, just sayin...
We be LAUGHING.
Yes HB, that user has been yodeling for years about a miracle without one single solitary evidence of scientific confirmation from anyone on the entire planet.
Welcome to crazy world.
Has Nader given his deposition yet?
Please advise.
Dude are you drunk?
Yes, and now Europe holdouts are doing same as the world is taking notice of the real scam that pigeons are paid to protect.
They don't like to talk about the mechanism of action and the studies that show how CCR5 plays a leading role in HIV and how leronlimab both blocks and enhances the immune system. Pigs Pharma's who were given EUA (and not leronlimab or ivermectin or HCQ and a few others) are being poked with a cattle prod jolting them and their stock pps into a frozen comatose condition. ohhh but those dividends...dwindling? Yes.
Masanori Fukushima, talk about a heavy weight, is the real deal and not pulling any FDA-like punches or doing the Fausi Fauci two-step. . Matter of fact now most of Europe following the Scandinavian countries are or already have outlawed the junk JABS. But pigeons love it! Line on up and bend over pigeons. There are plenty of unsold jabs waiting just for you. Knock you lights out. https://www.brighteon.com/channels/hrreport
So let's get some overseas studies going like in India, Japan, Israel, Malaysia. USA FDA is prejudiced and said so in their emails....which by the way, Sidley is paying close attention all eyes and ears as next month some interesting news may leak out about WHO dangled the carrots in front of our Iranian CEO and his conspiracy CRO Amarwreck buddy? Going to be some fireworks? Or just more dodge and cover? What ever happened to that Ukranian-Russian cutey who helped run studies at AmarWreck? You know, the one who DOD got her the cush job. Oh brother, the WHO Flung Pooh could hit the wall before all said and done. Speaking of which... where did Flung_Dirt run off to?
$$CYDY$$ 2024 Watching and learning and leronlimab just keeps getting more attention for it's miracle type attributes so hated by the 5.95 clowns.
Laugh? I don't own shares. I was shown interest by an investigator private to assist into looking into cyber issues such as bashers and manipulation. It is what I do for several people. This one was easy.
Exactly...so-called doctor who doesn't understand basic scientific method, instead believes uncontrolled "test" of 1 coincidental , anecdotal "cure".
laughing over your rant, your bag seems ... heavy LOLOL
You embody perfectly the false logic of retail victims when they refuse to see that their "dream" stock was just a financial scam. Every alternative explanation for their losses will do it, but not the reality. That's exactly how a victim becomes a bagholder.
Enjoy your losses !
LOL. You .... "advised" them? LOL.
I have send all the twins posts to sec and doj regarding the lying failure of cytodyn . Advised them of also deleted posts on this message board. What is a warrant for information?
Is calling it a jab supposed to be cool or like woah this guy is clever or something? Just makes you sound like an idiot.
So you've "gotten the mRNA jab."
You might want to check out my former post #232305
(remember - my opinion)
And maybe you're lucky
OR
In reconsideration
You remember happenings shortly afterward but never considered a possible correlation.
between jab and whatever happened...
Going back " (My Take) "the presentation" suggests the mRNA seems to ineffectuate the immune system(s)...or does it only degrade it/them?
Either way ....
But I digress
Anyway, it would be GREAT if this was a "back to normal all gone" thing, but >>>It's -now-in- you"
Remember those nano-delivery particles employed...
Yeah, a lot of unknowns,
But society will reap what it has sown
Eeeeeek!
But fore-warned, which gives time to... your choice - it could all be BS.
And strictly my OPINION...not gospel
So do YOUR OWN RESEARCH!, please!
Monroe, Your second point:
". Japan says Sayonara: We need to do some trials in Japan! https://www.bitchute.com/video/9kRkv6T1NyCs/"
Caught my attention.
Loaded the site, watched and listened.
(There's always the concern of validity, but...)
The first 34 seconds says it all.
So went "hunting" - who is Masanori Fukushima?
Seems he IS a big deal in Japan
and
Dr. Fukushima doesn't "mince words!"
https://www.facebook.com/watch/?v=1313524522796668
( Part of the overview)
"Dr. Masanori Fukushima, Professor Emeritus at Kyoto University, warns about vaccine harms to the Japanese Ministry of Health:
"The people who have the disease right now are not the ones who haven't been vaccinated, but the ones who have been vaccina…"
Monroe >>> Seems this is real and has some serious implications
Including a good reason Leronlimab has been thwarted thus.
But your item #1 - suggests hope.
And for Many (including my wife and I) - it may be our best last chance.
So it appears if you've "had the jabs," the game is "on."
We NEED Leronlimab as "another arrow in our quiver."
especially since it (supposedly) can cross the BBB.
All my opinion But check out the findings of Dr. Masanori Fukushima
And if you had the mRNA...hmmmm.
Friendly reminder that CYDY longs are complete morons
Again, your interpretation of the events are way off base. What a pattern now you have of misinformation. Don't you know this is something
shorts specialize in... lying.
"I have a few other tickers who also reported the same predicament with Borgers. Here is one we all recognize.
https://www.msn.com/en-us/money/companies/the-sec-charges-trump-medias-newly-hired-auditing-firm-with-massive-fraud/ar-AA1o7cZx
TIK TOK
$CYDY$ 2024
1. Since Leronlimab crosses the BBB. Those suffering from too many jabs might get a real boost using leronlimab.https://www.theepochtimes.com/health/systematic-review-reveals-many-covid-19-vaccine-recipients-experienced-new-onset-psychosis-5643639?src_src=healthnoe_viewpromo&src_cmp=hview-2024-05-07&est=AAAAAAAAAAAAAAAAdbAmeh0exsTo9bIGsWoXCLt3DMv%2BeZd%2FEugtIdyHPONOLA%3D%3D
2. Japan says Sayonara: We need to do some trials in Japan! https://www.bitchute.com/video/9kRkv6T1NyCs/
3. OH boy, talk about a 180... are u feeling better jabbies? https://www.c-span.org/video/?c5008985/user-clip-dr-anthony-fauci-acknowledges-superiority-naturally-acquired-immunity-relative-vaccine-a
"I was never even INTERESTED in CYDY until YOU talked about me on this board."
Then, you won't mind if I mention you on other boards.
I find pretty telling the insistance of CYDY pumpers to water down through meaningless spam messages the bad news that has just been disclosed.
Reality is so painful they have retreated into some pink imaginary world.
Cytodyn was using a fraudulent accountant, is set to miss its 10Q deadline once again and is about to have 4 different accountants in only 2 years.
Yet here we are singing about trees growing in the sky, delusional partnerships and trying to conflate the SEC with the FDA with the DOJ etc…
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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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