News 
Market Data 
Discover
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
lol , you really trying with your lies and attack on people .
Yes this mother is in medical profession ,
Retired doctor is still a doctor … .
But you knew this .
Find yourself something more productive to do for living , This insulting people for money is sickening .
All imo
There is NEVER a crime to state the truth , but there is a crime when some trying to manipulate market posting for weeks that leronlimab damaged their twins ,
and this is a lie !!!!!!
Yes , I believe this is a crime..
All imo.
Excepted it shows Cytodyn was nowhere and has lied to its investors. What about that BLA data claimed publicly (PR!) by the CEO Nader to have been submitted to the FDA but that in fact was NOT submitted?
A corporate scam.
Yes very interesting I agree ,
Also many of them unprofessional , and all of them showing us work of FDA.
All IMO.
GLTU
I traveled for the last few days , opening mails this late afternoon/evening .
This came today from my friend , a great post from another message board..
https://www.reddit.com/r/Livimmune/comments/1c96auz/tomfoolery/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button
Yes , a very good post , showing us a little bigger window to FDA.
Sure they care for us all !!!
All IMO.
GLTA longs,
Leronlimab was proven being effective many times , much more effective , imo , then some of the toxic approved drugs , and in contrary without one serious side effect .
But then Dr Jeffrey Murray working at the time in FDA , didn’t talk in his emails about other companies i as he did about CYDY …
“ I hate them ..”
Another FDA employee posted in her email , it was Susan S ( I dont remember her last name )
So she said .
— you know this drug is an immunosuppressant ,
Wow , who they have working there .
No, it is not an immunosupressant , it is an immune modulator .
FDA , know what you are talking about !!!
Leronlimab has a great results in following studies ..
—-Phase 3 pivotal study for combo HIV , finished with 81% efficacy , and not one serious side effect. When at the time 2 other approved drugs were ,maraviroc with 45% , and Ibalizumab with 43%
—- CD12 study in critical Covid showed ,
82% mortality benefit ABOVE any drug in the world , when leronlimab was in the system ..
—-small study in cancers showed really positive results …
—-as also in Nash …
-—Long Covid study was a big success , it showed that some patients immune system is hyperactive , but many are immunosuppressed , leronlimab worked as a great immunemodulator in both ..
This study was peer reviewed and published by Dr Otto Yang from UCLA..
Yes , leronlimab seems to be a great drug , much better then many approved for us toxic , doing nothing , or minimum good drugs !!
All imo
GLTA longs
From your lips , to God ears ..
Go leronlimab !!!!!
GLTA longs
I am 90% with you here. In my mind there is no doubt about the bad tactics of the FDA et al which has been demonstrated repeatedly over the decades. This whole NP thing merely parallels the rampant corruption within the Administrative state in general. Is this Ukraine? This isn't Ukraine... they are being played just like the investors in CytoDyn and many others who thought we had at least an agency that cared for human life. The whole ivermectin and HCQ saga demonstrated this so vividly among so many other dirty tricks that have surfaced post covid...that MSM skips around. So NP and KareemD could see from the inside how the story was going to play out. Were they both disgusted or just buddies in the fox hole together trying to survive some nasty orders? Yes, NP was paid way too much. I believe he knew the outcome as a result of and after attempting EUA for Covid. Enter big brother. Look at all those who got shot down too. Many other non-club pharmas and university scientists who could see through the charade ... as emails have disclosed. So IMO it came down to the coup taking place with 13D. Support them and lose the whole enchilada or stay on board the ship and see where it sails? Had 13D some smarts they could have been successful, but they rallied the short bashers that no one likes... a big mistake and a costly one.
So I am more furious with the FDA than ever. Sure NP and buddy sold us down the river. So what is new? Just look at the state of affairs everywhere you find a large govt agency. Rules and regulations and mission statements are a joke for those who dangle the carrots. NP liked carrots better than the mercury found in tuna or the lead found in some skulls. The Iranian conspirators Pourhassan and Hassanpour, whatever his name is, will probably be left out to dry from all accounts unless they have some more Maji to leak out. Will Darius The Great rise again? This could get real interesting as things are quite sticky.
Consequently, I don't expect much but a lot of damage control. The sugar coated version is due out. Should make an exciting end to another great chapter in the leronlimab saga.
And to remember who let the light shine out of darkness? Thank goodness for Dr. Jay. who has penetrated this darkness with a ray of bright light.
Ready for the new chapter to continue lighting the path to success? I am. $$CYDY$$ 2024
Hmmmm the forbidden question longs refuse to ask: why was the Amarex "last hope" settlement postponed to November, hmmm???
CYDY is running on fumes and hiding information.
Today from another poster who was Ihub born in 2000. "There are some individuals on this platform who have made over 700 posts about a single company and all of them are negative. This speaks volumes in itself. To all the short bashers out there, bring it on! If your stock is being bashed, take it as the ultimate compliment. Don't waste your time, just report these traders who are trying to manipulate the market and keep them where they belong."
I would venture to say we have exceeded this with some short bashers here on CYDY.
Why is this? One simple word, leronlimab. So we got it, they want it and until they get it they will pay bashers to bash so they can try to buy up the company.
Secretly they are buying shares little by little just below the threshold of moving the stock up. Accumulation on the sly by those who know the value of leronlimab which is pretty much everyone. This is how the game is being played which is why I buy on any worthwhile dip especially now after the hold was lifted with assistance from the FDA on protocol development. So we know the company is going forward and in my opinion they are being extra cautious to insure an airtight HIV protocol along with continuing basically from where it was left off. Once a new trial gets started then is when I would start contemplating a collaborative effort with another pharma . Most likely I think for another indication perhaps in the wide arena of cancer. The company has definitely made good strides in 2023 revamping. 2024 is shaping up fine with the new CEO who masterfully assisted in the back and forth FDA negotiations to rectify to their arduous demands with ending the long slug of a year plus hold on trials. Patience will pay as the data will lead the way for very nice gains. A lot more of the medical science world now knows about leronlimab. We enter a new era much more grounded and savvy as to the obstacles. Don't forget the new possibilities even outside of the new longer acting leronlimab. You can add to that whatever else the contracted artificial intelligence company discovers. Things are going to get more exciting from here on. So for me, thanks basher pigeons for the cheapies. $$CYDY$$ 2024
Since when is some earned income a bad thing? Interesting, perhaps more on the way?!!
Not grim at all. However, here are some grim factors that have nothing to do with the basic fundamentals.
It is called a short attack by those who are threatened by the powerful potential of Leronlimab.
Date Close High Low Volume Short Volume % of Vol Shorted
Apr 15 NA NA NA 4,669,367 2,012,826 percent 43
Apr 17 NA NA NA 700,478 226,705 percent 32
Shorts come up price goes down
Shorts come down price goes up
Shorts come off, PPS skyrockets
$$CYDY$$ Home of leronlimab. We got it, they want it. That's what all the fuss is about. If it was justaSaline solution, it would be justaNada justaNofacts!!
I know .13 may seem cheap but the market cap of the company is huge guys. This is an expensive stock for the assets they have. They need to raise quite a bit of money to keep this scam going. You guys should take the money you guys have and move on.
I have trolled this msg board in the past with $4.20 price tgt when they filed the BLA which doesn’t seem like it is ever going to happen.
When investing focus on drugs with unmeet needs like KRYS. Here CCR5 mutation is filled with Selzentry. My .02 is move on.
HAVE YOU NOTICED THE WIDE SPREAD - THIS IS NOT GOOD NO LIQUIDITY ONLY VICTIMS HOLDING THE BAG
YOU ARE CORRECT IMO
|
Followers
|
813
|
Posters
|
|
|
Posts (Today)
|
0
|
Posts (Total)
|
233768
|
|
Created
|
11/18/05
|
Type
|
Free
|
| Moderators janice shell kgromax | |||
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.
AI
