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Any chance Dr. J pivots the entire company to a veterinary focus to treat mice and monkeys? People love their pets and are willing to spend big $$ on them. No FDA to worry about is another bonus. The TAM must be around $500K a year, at least.
Well, ya see your problem there is that you come onto this board to defend her. When people point out to you that she has directly lied about us, well, you actually use the same tactic she did, which is calling us paid bashers. I know for 100% fact that no one is paying me for my thoughts, however when they don't align with what you all wish them to be, I must be a paid basher. Even when it is so much more logical that someone would be getting paid to promote the stock, not denigrate it. The company has denigrated itself.
And who would care to pay someone to say bad things about this bad stock? It is trading at SIXTEEN CENTS and got there all on its own merit.
BTW, she got herself kicked off the "island" (even though she really isn't). She posted people's personal info on more than one occasion.
You really should leave it to her to defend herself.
"But, as others have mentioned - i wondered why there was no update on the combination of our drug & Madrigal's. I actually thought that was the point of the study - but maybe i misunderstood."
The data analysis is not complete. This was a preliminary heads up, that the raw data looks very strong. Leronlimab should do everything the other drug can do. Therefore, there might be (most likely) no synergistic effect in combination. Additionally, it is very possible that Leronlimab might perform better in a well populated human, stage three trial. But, why risk a fight with a company that has an approved treatment, and why risk raising the hackles of the FDA. This was to let investors know that there are indications that may justify Leronlimab going into a phase three trial for this indication (something that is worth shopping around for a partnership). Madrigal might be interested in it as an option for intermediate to severe Mash. Who knows? We will have to wait until the data is fully processed and analyzed.
because even though it was a good deal, it required coming out of pocket with add'l cash to tender the warrants. i definitely thought about it - but i figure if this ends up working out, i'll make a lot of $ on the warrants anyway, which still have a few years to expiration.
# 1 On Breakout Board 2nd day! A lot of announcements to be made before end of year.
Come get with it shortie pies and brain dead leronsaline analysts. FEED ME AND FEED ME NOW.
$$$CYDY$$$ The tide has shifted. Leronlimab and leronlimab plus.... to rock the medical world with some big name collaborators. Significantly better than approved drug in recent study!
Must read...again and again until it sinks in.
GlobeNewswire
8:30 AM ET Sep-09-2024
VANCOUVER, Washington, Sept. 09, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
It continues to be a transformative year for CytoDyn Inc. (CYDY.NaE) (“CytoDyn” or the “Company”). A year in which we have made significant strides as a company, pursuing strategic initiatives to further our clinical development pipeline and charting the path forward in support of our mission. I sincerely thank you for your continued support and remain excited for what lies ahead.
As we enter the final stretch of 2024, let me first acknowledge that there is still a great deal of work ahead of us. The board of directors and the management team of the Company remain focused on advancing our clinical pipeline and opportunities to drive value for shareholders.
We are committed to being transparent with our shareholders and it is my pleasure to provide an update on some key developments described below.
CytoDyn (CYDY.NaE) has accomplished a number of milestones since the FDA lifted the clinical hold on leronlimab in March 2024, including: (i) the submission of two clinical trial protocols to the FDA, (ii) the negotiation of various agreements with vendors and creditors, and (iii) the settlement of litigation with Amarex resulting in an immediate $10 million cash influx into the Company, with an additional $2 million to be received in 2025. These important developments were necessary steps to prepare the way for CytoDyn (CYDY.NaE) to launch pivotal studies to address the potential role of leronlimab in the clinic.
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.
CytoDyn (CYDY.NaE) has made significant progress by initiating a variety of key pre-clinical and clinical leronlimab trials, to be funded by the Company and others.[color=red][/color] I am also pleased to share that we have observed considerable progress related to development of a longer-acting therapeutic with our partner, who utilizes a proprietary artificial intelligence platform to expedite the clinical development process.
As shareholders, you remain the lifeblood of the Company, and we remain committed to acting in your best interests. We are unwavering in our belief that by continuing to take the best next step, one after another, we will continue to hit key milestones in the coming year and, in the process, drive significant potential value for our shareholders.
My dedication to the Company is grounded in my belief that leronlimab has the potential to be a life-changing therapeutic. Our commitment is to drive value for you – the shareholders – and to bring better healthcare to patients in need.
Included below are updates on our top priorities. I am excited about CytoDyn’s prospects moving forward and will provide additional updates as warranted.
Sincerely,
Dr. Jacob Lalezari
“I'm still long shares (and warrants) that i've held onto…”
Blueheel - why do you still have warrants when CYDY had that tender offer recently where you could have exercised them for less than 8 cents a share (which included bonus shares)?
Take off your rose-colored glasses.
I thought it was a solid call and i was impressed with Jay - more so than at any point up to now.
The data on MASH seemed impressive. I took it to mean that the drug worked on it's own with statistical significance, and that it looked better than Madrigal's drug - but slightly missed statistical significance in that regard - so it may be better, but not beyond a shadow of a doubt. It also seemed to reverse fibrosis - which no other drug does right now - at least that was my sense.
Regardless, and even though its' pre-clinical, it's solid data. It also cleared up the 700mg vs. 350mg question that has been very confusing, at least to me. But, as others have mentioned - i wondered why there was no update on the combination of our drug & Madrigal's. I actually thought that was the point of the study - but maybe i misunderstood. Jay has stated that we can't attack MASH alone (too costly) - so isn't partnering the whole point? And if our drug didn't hit statistical significance relative to Madrigal's drug on it's own - how would it be approved as a competing drug?
The other updates (focus on cancer, functional cure for HIV, etc.) were things we generally knew about - so just updates generally.
On balance, I did think it was an excellent call, and Jay did a great job. I'm still long shares (and warrants) that i've held onto, despite concerns about the financial position / ability to prosecute real human trials without raising more capital. I remain of the opinion that we have a good drug, have re-booted from a disastrous path under Nader, and we're in the early innings of version 2.0 of the company. Those who have a long-term / muti-year horizon may make good money here, and i am holding all of my position as a "call option".
It was prob answered--it was just not given to the schlepps that buy shares at market price
They had a privvy call for the qualifieds--Dr J might have revealed more to them than the news??
But the data will be analyzed and what they want us to know (prob just the rosiest parts) will be released. Maybe there will be some writeup that gets published?? That would indicate there is something that other eyes should take a look at
NASH mish MASH is a fools errand except for the superwealthy. The trials--the biopsy stuff-- $$$$$$$$$$$$$$$
The real question is. If they are used together,will this increase their potency. This was not aswered
Your words are to live by.. newsletter has been right on!!
I remember some characters from before. Beating dead horses is not my thing especially when the horse is not in the stable to defend herself.
I will ignore any redundancy.
Simply put leronlimab is no better than the drug already approved. It's over.
No it means that when comparing the two drugs they are not statistically significantly different. Cydy longs are dumb.
What does it appeared mean. Its a word that is not 100 per cent certain. I would hope in a scientific trial,we would have more certain verbage
"I sure wish (well, maybe not) I knew what you were talking about."
All I have ever understood was that his posts are all negative. Therefore, I hardly ever read them (knowing that they are filled with the same, twisted to fit his narrative, crap day in and day out. If a guy reads too much crap like that, it can burn his brain cells out. I'm like you, I get tired of the constant negative posts. Those guys are just hired to influence the new investors with their negativity.
I interpret this to mean that
Best leave interpretation to others
But perhaps wait and see what the ACTUAL results (not preliminary review of results) might bring.
There might not be possible a real apples 2 apples comp at any point--but just in case here is some of the mouse study data from the drug that got approved
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10058113/
CYDY would be nuts to spend $$ trying to RCT for nashmash . If the mouse study should find some "partner" and they want to spend millions $$ forbiopsies etc--bring it on. Especially since some of you were not quiet correct in the "partners are lined up as soon as hold is lifted" and the "partners are waiting for conclusion to Samsung debt" nonsense.
MAYBE the mice will bring forth another "silent partner" if can get mice to agree to NDA like the monkeys did . C'mon murine miracle
I sure wish (well, maybe not) I knew what you were talking about.
I used to post here primarily to read Misiu's posts and would occasionally post some charts....backed off from that a few times because some thought charts were nonsense in otc but then did it again (by popular demand of one or two).
I either am not familiar or have chosen to forget the squabbles that went on. Like most IHUB boards there are the longs and the ?
(Not sure what the bashers are...paid bashers or someth8ng else). I really don't care.
I will repeat for the 5th or 10th time, I only know Misiu in my dealings with her. Honest, charitable, generous but passionate in her beliefs. Whatever your problems are with her that is between you and her. Well, guess not because she was kicked off the island.
As for Rockleo, yes I remember him, liked him and perhaps he left for the same reason I did. Got tired of the constant negative commentary here (not just this board).
I had liquidated most of my shares based on TA but O still own shares in another otc that I also do not post in that room because it is as toxic as here.
Glta longs.
Weird, that what is written is not what posts. I posted the second time, to see if the error would duplicate (it did).
Leronlimab showed statistical significance, in the reduction of fibrosis, p=0.01.
"Leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to an isotype IgG4 control arm (p<0.01);
Leronlimab monotherapy appeared to demonstrate dose-dependent antifibrotic activity, with leronlimab 700 mg performing better at reversing liver fibrosis compared to leronlimab 350 mg; and
Leronlimab monotherapy (700 mg) appears to have better anti-fibrotic activity compared to Resmetirom (p=0.057)."
There, I fixed it for you. I interpret this to mean that Leronlimab demonstrated statistical significance at reducing fibrosis at p<0.01.
Whereas, Resmetirom did not demonstrate statistical significance at p=0.057.
We don't know how many mice were involved in the study. Theoretically, the higher the population the greater the chances of statistical significance.
Perhaps, you should pay attention to what you read and make smart remarks about.
Ever seem odd to you that while you went down the "lifetime ban" road which was proven wrong.. Board ban yes--/ IHUB ban NO
That your friend / former poster here the Dr "rockleo"--that also runs the red thread (LLTimes) as "persianleo"--there are no posts there about Cytodyn or LL for 6+ months ?? Remember who posted there and made sure others got banned?? Certainly no "ban" nonsense from Dr Leo for the nodder advocates . No posts there by your buddies for MONTHS
How about the redthread "livimmune"--remember who all posted there and wanted certain posters banned ?? Wonder why they dont post there for months?? Certainly no "ban" nonsense given to any nodder pumper by waxonoff at his livimmune. Yet no posts by your buddies for MONTHS
Sure you want to downplay the witness list in upcoming trial as the reason for these disappearing "acts" by some of the more nefarious players in the khazempourhassan kickback fraud scheme and paid pumper PR firms
Sure you have never heard of those websites--never visited any EVER and just stay busy making sure countries get named or whatever the "raison detate" is for being-- blind in 1 eye and can't see out of the other
G L T U
"Leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to an isotype IgG4 control arm (p<0.01);
Leronlimab monotherapy appeared to demonstrate dose-dependent antifibrotic activity, with leronlimab 700 mg performing better at reversing liver fibrosis compared to leronlimab 350 mg; and
Leronlimab monotherapy (700 mg) appears to have better anti-fibrotic activity compared to Resmetirom (p=0.057)."
There, I fixed it for you. I interpret this to mean that Leronlimab demonstrated statistical significance at reducing fibrosis at p<0.01.
Whereas, Resmetirom did not demonstrate statistical significance at p=0.057.
We don't know how many mice were involved in the study. Theoretically, the higher the population the greater the chances of statistical significance.
Perhaps, you should pay attention to what you read and make smart remarks about.
To answer your question. Yes I have met her. Not her son. Believe what you wish..
Not so lucky. Bought half on the open and other half when it broke above the 200 day sma at .17. Glty.
I know and you think you know (regarding her son). Don't really care what you think.
Like I said several times, she has never lied to me but then I don't have an adversarial relationship with you. Glty. If you are Long you should be happy today, why so snitty?
What a complete crock! misiu has told so many lies about me. When cornered she claims "this is what I was told".....she never ever admits to her mistakes. Janice came over here when misiu started accusing me of working for Janice Shell. then wanted to know why Janice would come to this board.
There is nothing honest about her and I've looked and I see zero evidence of a sick son. And I've seen her family pics. She leaves a personal trail 10 miles long.
Have you met her son? Have you met her?
you have a knack for timing good trades, as i think you got back in around 10 or 11 cents. happy for you, and that has been the way to do it up to this point - simply being a long has not been a profitable approach.
Must have been an omen coming back to the room and defending Misiu yesterday. Today pps broke above the 200 day
CYDY | SharpCharts | StockCharts.com
https://stockcharts.com/sc3/ui/?s=CYDY&a=1766822630&p=D&yr=1&mn=3&dy=10&id=p89372959929
Not much money left. Hopefully something will stick soon
Partnership as a result of this new news in the works? Just wait until the other studies are in print.
Yes, $110 a share one day, not next year, but the company reformed and focused under Dr. J's guidance is on the way. Who is the mysterious Dr. J? Short stumpers should read about him before loose lips catch them wrong as usual. Wrong because they know leronlimab is powerful medicine and leronsaline is made up nonsense. Stick to science and not false postings about the product or about some very qualified doctors and others who support the research.
Every single bit of data gathered since the inception of leronlimab adds to the knowledge base. To say "starting over" is pure horse shit talk by lying incompetent
mommie boys who can't find a real job.
Want to read the fantastic. Go read the last Letter to Shareholders. Then ask yourself, is this starting over? Hello.
Leronlimab continues to march forward. Now we have some momentum growing after the Covid debacle and Nadar/FDA/Amarex problem.
How great savings in research are coming our way with partnerships and institutional collaborations. The future looks strong.
So shortie pies, and flipperfish, get with it. Give me some cheapies. And Hurry!
$CYDY$ 2024 Good job Tanya and Team, but you could do even better with cutting back on the salaries and buying some stock outright. The surgical knife cuts both ways. Hats off to Dr. J.
i do not believe this is a scam. I believe we have a molecule that has value, and i think Jay is a stand-up guy - he would be a great CMO.
My issue here is leadership. We have a chairman of the board who has no business being involved (at any level) here - she's a wealth management compliance officer. We have a CEO who is a good guy, but again, has never dealt with anything of this magnitude (this is a totally different ball of wax than Quest).
Can this team pull it off - a total re-boot of a biotech with limited financial resources? Maybe.
Would our chances (and our investment) be better off with a COB with biotech and deal experience - and with a CEO who has pulled off a turnaround like this before, with specific deal experience in the biotech space?
Those are the questions that need to be asked - at least if investors want this to succeed to the point of recovering some of their hard-earned investment dollars.
Yea, I must have missed that, can you show all of us here where you saw that, I want to see if I should believe you, or a doctor, clinic
Yeah huge news their preclinical trial is a bust! LAUGHING
"Leronlimab monotherapy (700 mg) appears to have better anti-fibrotic activity compared to Resmetirom (p=0.057)."
These guys sure love waving around results that are not statistically significant. What a joke lol. Terrible results for their pre clinical trial. Plus it's pre clinical!!!! Lolllllll
Fabulous news. So after they fired Nadar, they basically restart the company and the trials? $100 in a year or so?
I have not been on this board for many months. So I have no clue to what you refer. And since she is not here to defend herself she can not comment on those statements. I defend the person that I have known from first hand experience. And at the risk of redundancy, I will repeat that I have never known her to ORIGINATE a lie and I have personally witnessed her altruistic nature. I had a feeding ministry in the Philippines and she donated to help a child get an operation and donated on other occasions as well.
I can only attest to things to which I have had 1st hand knowledge.
Defending someone that YOU KNOW told lies about 13 D group (I suppose you heard the same lie AND have it recorded also)
Defending someone that YOU KNOW told lies about FDA was to blame for 2 shot vs 4 shot debacle (of course that is calling Dr Lalezare a liar because he specifically stated on video that nodder would not listen to him or Dr Patterson and meet FDA requirements)
Defending someone that YOU KNOW told lies about Dr Pestell and the "acquisition"--when SEC filed docs (linked here MANY times) state there was no prostate test being acquired. And you also know that the liar has said MANYtimes that Pestell should give his shares back--yet NEVER ONCE have you or others asked why/stated that nodder should return his ill gotten shares for the same acquisition
I won't get into the MANY lies about Tony C and Ken VanNess. The lies about Tony C being CEO or nodder purhasing Leronlimab made up nonsense (also proven by SEC docs)
So yes--defending someone that YOU KNOW told lies even AFTER FACTS proved they were 100% lies.That speaks volumes (IMHO)about you and your credibility
And now you come up with some "naming new countries" nonsense . Keep up the ruse
If defending my friend with truth about her honesty strips away my credibility, then by all means strip away. I stand by my comments. Since she is stripped of her rights to defend herself I consider it a privilege to do so for her.
As for the personal info, it is my understanding that a country was named after personal info was posted about Misiu. But I am stating info passed on from Misiu to me. Besides who would believe me, a person with no credibility.
Posting--doxxing with personal information is not "insensitive remark"
You and dolphin have lost all credibility with your nonsense today. But in your case you didn't ever really have any. But make sure and double down in case someone might still be giving you benefit of doubt--kudos for removing ALL credibilty
Well, I believed in Healthsouth and talked it up a lot. Had no idea the CEO was a freaking ********. And Enron - told my friends about it. Many others. It doesn’t matter how much one talks about a scam that is disguised as a bonafide stock does it? We all are snookered. I mean we on this board know beyond a reasonable doubt that Leronlimab has saved lives who were on their death bed. And yet others, here, say the opposite. Is it a scam?
Your opinion on another’s investment is just an opinion, thank heavens. But suppose you are incorrect? And now, today, your remark leaps the tallest building while she
Can’t even defend herself here.
Probably, in this instance, good because an admin would come along and kick her off for good all because of an insensitive remark.
i say we are years from revenue, and thus years from a much higher share price. unless mice start paying for drugs.
as such, i'll take .50 anytime this year. but you're right, you vote your way and i'll vote mine.
the other thing i will vote against, is every board member. they are a disaster from top to bottom - especially at the top.
Did not what? Didn't post a privacy violation about another poster?
Yes she did.
No. But I wonder if you wrote about them with as much conviction as she did.
I’ve been in a number of different scams over the years too. Does that make me a liar or one that is untrustworthy? I hope not.
I absolutely agree with you.
As she should be. Posting personal shareholder info--whether it is correct info or not is nonsense. Something a child would do and not understand why it is wrong
I have posted about some of the paid PR firms that the former CEO employed. That info was public data found on OTC Mkt disclosure page. At 1 time there were a dozen paid pump PR firms and however many fraud posters they employed pasting posting for a fraud coverup. EVERY one of those individuals--firms should be prosecuted for the out and out lies they stated as FACT. The fake author/chessmaster on zerohedge etc. Even the facebook website was/is run by a paid promoter--Chris Lonsford which FINALLY got exposed in a SEC filed doc during the 13 D "battle". I can post pages of lies that the CYDY "minions" posted about during that time. Miss Hooey/phooey/sooey was leading the charge of that nonsense. Not opinion--FACT
She even posted she heard--had audio tape recording of 13 D head saying they would buy Dr Patterson company IncellDX. Out and out lie. Then when called out for that LIE it is her go to the dodge/deflect/defer to start about Incell "investors" losing money and ANY defender of 13 D group was invested in IncellDX. Just rubbish
The reason the ban crap makes ZERO sense is miss hooey/sooey often posted on BIXT board (where mike sheikh is employed BTW) and a couple other IHUB boards. ANYONE can easily see she has not posted on those either. Click profile. Look at post history
Once again just made up nonsense.
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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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