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Had the FDA/CDC done their job correctly our competition for the jab would have never seen these great losses as people
wake up to the fraud. Pigeon posters can't turn that around as much as their bosses would like it to which in my opinion is
comprised of some our own 13D. Now is this sabotage legal? Go Sidley, there is much to discover if you haven't already.
The truth always has a way of being revealed. TIK TOK pigeons. $CYDY$ 2024 Leronlimab, the one that should have been granted EUA but for some pig pharma biased scoundrels at the FDA as we saw by their emails.... what else will legal eagle Sidley uncover as we pick apart AmarX??
BioNTech’s total revenue in the first quarter of 2024 nosedived to around $202 million, a sharp decline from nearly $1.38 billion during the same time period last year, the German biotech reported on Monday.
BioNTech suffered a net loss of almost $340 million during Q1, or $1.41 per share. Analysts had expected a $0.78 drop in earnings per share (EPS), according to stocks analysis firm Zacks Investment Research. By comparison, in Q1 of 2023, BioNTech reported a net profit of approximately $541 million, or $2.21 per share.
The company attributed the plunge in the latest quarter to “lower commercial revenues” from the sales of its COVID-19 vaccine worldwide, which it said was largely driven by the “endemic-level demand” for the shot.
Also contributing to the biotech’s net loss was a more aggressive investment strategy in research and development. BioNTech pumped around $546 million into its R&D activities, up from nearly $360 million during the same period last year. The increase in spending was due to progressing clinical studies and a larger workforce, resulting in greater wage, benefits and social security expenses.
Despite a steep drop in its Q1 revenue, CEO Ugur Sahin struck a positive note in the company’s statement on Monday, focusing instead on BioNTech’s pipeline and upcoming milestones.
“In the past weeks, we have reported positive preliminary data for both our individualized and off-the-shelf mRNA-based candidates,” which further demonstrate the strong potential of the biotech’s core technologies, Sahin said. For 2024, BioNTech plans to develop a variant-adapted COVID-19 vaccine, as well as advance its cancer programs, paying particular focus on its bispecific antibody and antibody-drug conjugate (ADC) assets.
Seeking to establish its footing in a post-COVID-19 world, BioNTech has upped its investments in oncology as a way to diversify its business. In October 2023, the biotech inked a potential $1 billion deal with Suzhou-based biotech MediLink Therapeutics to develop next-generation ADCs targeting the HER3 protein.
BioNTech in February 2024 also entered into a $250 million licensing and manufacturing agreement with Autolus Therapeutics to advance investigational CAR-T therapies for solid tumors.
Looking ahead to the rest of the year, BioNTech forecasts total group revenue of $2.69 billion to $3.34 billion. The company on Monday said that nearly all its expected 2024 revenues would come in at the end of the year. As of March 31, 2024, BioNTech had almost $18.25 billion in cash, cash equivalents and security investments.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
So Janice , if you know nothing about leronlimab , I will say learn ,
And then you will be posting as we shareholders do..
We trying to get a GREAT drug to the market , drug which may save our , or our love one lives ..
Please HELP here , yes company has problems , but not the drug ,
The drug we should ALL fight for !!!!!!
All IMO.
As I said before ..
" For No Money I Will Take Your Job "
Drug which could save millions , how does it feel ..???
Explain to me if you like to discuss , what is wrong with LL, ( I understand , there are problems with the company ) , but you should be fighting with us for the drug...
But you dont want to talk , you want to bash ..
I must say , you doing this little more gently then the ugly other bashers , at least you dont call me . and others , a different terrible names ....
I will give you that , you sound like more sophisticated basher ...
Still , how is it possible you " know " the drug and you post nonsense ..
Or you dont know the drug , and then you should not post at all !!!
My son life was saved by leronlimab.. If you EVER need it , please try !!!!
Go leronlimab ..
All imo..
GLTA longs
Learning , all great questions ..!!!!!!!
" ( Good Question >>> Why are )
Why are so many " grow-up ( maybe ) people " here daily to " nay-say" a penny stock ?
Duh , if it's worthless you walk away ..or ...are your days so " worthless " as to spend them here ?
UNLESS this is ...perhaps ...more then meets the eye "
I guess this is why I read on ST board how some bashers saying ...
I made so much of money on " SOUPQ and CYDY " boards ..
Yes , I am sure they did..they are working VERY hard , days and nights ..
But for NO MONEY I will take this job..
GLTA longs.
FACTS ABOUT
"Remind us when they started using Borgers?"
The appointment of BF Borgers followed the resignation of the Company’s former independent registered public accounting firm, Macias Gini & O’Connell LLP (“MGO”), as previously reported in the Company’s Form 8-K filed on September 25, 2023
CytoDyn Inc. (the "Company") received a letter from the Company's current independent registered public accounting firm, Warren Averett, LLC ("Warren Averett"), informing the Company that, effective April 13, 2022, Warren Averett was resigning as the Company's independent registered public accounting firm. The Company's Audit Committee had not recommended a change in the Company's accountant. On April 18, 2022, the Audit Committee appointed and engaged Macias Gini & O'Connell LLP ("MGO") as the Company's independent registered public accounting firm
LOTS OF RESTATEMENTS TO COME
Ouch that's so bad
THE SHORTS AND CRITICS ARE AFRAID THAT CYDY WILL TURN AROUND AND BITE OFF THEIR TORSOS.
I looked at that MB , and very interesting stuff about some bashers , hmmmmm ...
Hmmm, so some saying , they making a lot of money on CYDY board , yes I can see why ?
Wow.
Hopefully some positive news about leronlimab soon !!!!
GLTU.
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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
