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Take care of your twins since leronlimab damage them seriously per your many posts ,
I hope they feeling better ...
GLTA longs..!!!
I don't trade , I invest . And here I invested in a drug ..
And some of you coming making stupid comment not even knowing MOA ( mode of action ) of this drug ..is really almost a joke ..
This drug saved my son life in August of 2021 , with severe/critical Covid -Delta , when everything else failed,
and you all should be hoping it is approved , so ALL may benefit.
The worst is when some "EXPERTS " coming , not knowing anything about the drug , but bashing , I guess for different reasons , some for money , and others for whatever..
I am here since January of 2016 , and I never saw drug like this one , and without one serious side effect.
You ALL , including Janice Shell , should be fighting for approval of this drug , and not bashing.
But because of people as some of you , good drugs are not approved for us.
Great job , congratulation!!!!
All imo.
GLTA longs
" You would be , if you actually had to do that, But I jest : you'd be long dead "
You are right Janice , I rather be dead then do what you , and few others here doing..
Go leronlimab..!!!!!!!!
all imo.
GLTA longs.
" Beware when she show up "
What is your point .
Are you scarring us here ..??????
Janice Shell show up , you are done , you are saying ,
are you another of her associate who came here ?? Not the first one , I am sure it wont be the last..
Sorry . It is not that easy .
Yes , company itself going through a difficult times .
But the drug is like no other .
I will be happy to debate Janice here in public about our drug , but she said that she knows nothing about it , or something like that she said !!!
How easy you are impressed , if Janice who put over 300,000 posts since 2001 , attacking companies in trouble is impressing you
. But like in CYDY she has no idea about the products .
I don’t know if CYDY will succeed , but what I know for sure , leronlimab is a drug like no other .
And I don't need to bash day and night to make a living , I rather be starving !!
And you so impressed ???
So how she is good ???? When she is posting about a company with one drug , and she has no idea what this drug is representing .
Really very sad what people doing for money ..
All imo
GLTA longs
I do want to debate you , my problem is you are very aggressive and insulting , I never met people in my life like few of you here ..
Your accusation are really strong , not even sure if legally you can accuse people you don’t know of illegal transactions !!!!!!!! .
Is that your opinion , or is this a fact ????
And yes , I posted every drug one by one my son was on , and when he started to improve . And there is no question in anyone who watched my son what saved his life
It was leronlimab !!!!
So just stop attacking me ..go make your money some other way , maybe playing a clown ????
Thank you ..
Have a good day ..
All imo
GLTA longs
It is so sad what you said here ..
" Getting sweetheart deal on warrants"
Wow , they were offered to EVERY shareholder by the company , now Paulson is offering to everyone , why not to go with them , if you think they are extra deals , and maybe they are .., they are available to all .. go for it !!!
As for a drug for my dying at the time son,
Over 100 patients were treated by compassionate or RTT with leronlimab , not ONLY my son . , I still remember when you posted , you praying for my son !!!
What happened to your kind heart lately ??
And I did the article to show to people who didn’t know , we don’t need to die , just ask for leronlimab !!
All imo.
GLTA longs.
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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.
AI
