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Brazil Trials are back on
Keep your head on a swivel
Don’t Blink
CYDY held up better than expected today guess the short game didn’t work today GLTA longs
Or buyout. Yep, looks like Cytodyn is gearing up for a buyout or merger.
A lot of people are leaning that way- market sees it no?
No product = no business = cease operations or bankruptcy.
Agreed dolphin.....I incorrectly expected a bloodbath with the SP this morning...."oh ye of little Faith"......only I do have faith....GLTAL
There is no strategy behind filing a 10K. It is a requirement by SEC rules. The data in it must be accurate or lawsuits and penalties will follow. That's it.
Today was the perfect opportunity , again, for shorts to kill the pps but it is resilient. I am more certain then ever that something big is cooking.
they posted the same on ST referring to an article from PA from 2019
https://www.proactiveinvestors.com/companies/news/907367/cytodyn-s-lead-drug-leronlimab-inhibits-colon-carcinoma-metastases-to-liver-and-lung-in-preclinical-studies-907367.html
Since they are not doing anything in Brazil and havent all year...I would say nothing is happening in relation to Covid19.
I would also emphatically state that the highly touted recent article speaking to VERU, CYDY and TOMDF was also worthless as there is no movement in 2 years on the COVID front by Cytodyn. Much touting by Cytodyn and yet nothing accomplished. I mean who seriously signs up more Hospitals than patients.
Cytodyn needs a new tag line, I have one for them. We Shoot Ourselves in the Foot Better Than Any Other Pharmas.
If you can't drive it, sell it.
jmo
10K update was excellent. Many don't see the strategery....
Cyrus only signing for 6 months trial.
He is either the right man or not. So what is this trial biz all about?
To me, they/Paulson used him to raise money around. Can show "investors" see, we are making moves and have someone lined up. Wording in contract allows him the out.
More smoke and mirrors.
Doesn't matter the daily price antics until the impending news we will bobble around. It actually ended when the Nada stepped down and the new CEO came aboard all the while NIH grants were given. The market PPS spoke loud and clear as it started it's climb. The new trend was established and it is up up and away.
Yahoo Finance reiterates buy. 186,000 views and climbing. Technical indicators strong buy. This all despite the problems. OTC forward thinking thank goodness as we whiplash around trending higher and higher. Watch out for the backwash upon full throttle. It is coming. Market has spoken. Investors are accumulating and holding while the predictive behaviour upside is far greater than downside for any given trading day during this uptrend. 20 Day up 99%, 50 Day 143%, 200 Day 77% on increasing volume for the past 45 days plus.
How leronlimab was treated by FDA when remdesivir was a known killer is worse than criminal. Time has passed and it is obvious that Dr. Patterson was right on when he said, "Anecdotes don't come off of life support". Our day in the sun is fast approaching. Will the first partnership come domestically or from S. Korea, Canada, UK, or Brazil? $CYDY$
The fact that they wrote off the raw materials show they know Samsung deal is over and getting ahead of it.
Anyone know why Nader termination date was January 2022 yet his separation agreement is signed March?
https://www.sec.gov/Archives/edgar/data/1175680/000155837022005291/cydy-20220228xex10d2.htm
Also, so kinf od him to return 30,000 shares he got in "error". What an honest man.
“It doesn’t look like they ever restarted the Brazil COVID trials”.
It appears they may never restart the Brazil COVID trials given their comment in yesterdays 10k (“strategic alternatives”) and the fact that CYDY has had the DSMCs recommendation for an extended period of time.
“The Company is in the process of considering strategic alternatives prior to commencing the enrollment of new patients in the Brazilian trials.” - page 40.
STRONG AND LONG!!!!!!! THREE DIGIT SHARE PRICE AND DIVIDENDS 2028!!!!!!!!!! (BIONTECH IN 2 YEARS WITH SUPPORT FROM PFIZER)
THE 10K iS VERY POSITIVE AND HOPEFUL!!!!!!!!! ITS VERY EXCITING NOW!!!!!!
It doesn't look like they ever restarted the Brazil Trials.
Claims about the treatment of COVID19 related ARDS without supporting Trial Results is what caused the SEC to refuse to certify any S-3 from the company.
They threw the opportunity to prove their claims away. So we have basically been in stasis for 4 years doing nothing more than paying millions in legal fees
Yep...these guys just get better all the time.
Jmo
Absolutely. Although anyone who has been around this stock for awhile knew the play days ago. I smell desperation creeping on the short side. Nothing has changed.
We slipped below middle Bollinger band. Next support is the 200 day sma at .64.
https://stockcharts.com/h-sc/ui?s=CYDY&p=D&yr=3&mn=3&dy=10&id=p91229630300&a=1223550895&listNum=1
WISH EVERYONE A HAPPY BLESSED DAY!!!!!!!!!!
BIONTECH = PFIZER = AMERICA!!!!!! CYDY = AMERICA!!!!!!! VERY INTERESTING THE ARTICLE IN FINANCIAL INSIDER!!!!!!!!
COULD CYDY BE THE NEXT BIONTECH ($ 390 - 8/2021)!!!!!!!!?????? - „FINANCIALINSIDER“
10K IS MUCH BETTER AS EXPECTED!!!!!!!!! GOOOOOOO CYDY GOOOOOOO AMERICA!!!!!!!!
HIV, NASH, CANCER, COVID AND MORE INDICATIONS = LERONLIMAB = CYTODYN = AMERICA!!!!!!!!!
I am impressed with the action so far today. Sellers jumped on the open and we are higher. Shares being accumulated.
Pure hopium! Now bad news is good news? Cyrus is there because he is getting paid. He is not working for free. As long as the 350MM shares are approved his gravy train keeps rolling.
There are always irresponsible guys or guys with particular agendas that create hypes, and then people get the setback to reality. We haven't had to expect great news coming out with this recent 10Q. We know all the good and bad matters about our current situation. Nothing has changed.
We are inching daily with the new management to the deserved success of the great drug Leronlimab. We have known the roadblock for many months. Nader was one and got removed. The several battles with bad guys we won (e.g. Pestell, 13D Group). In Amarex's case, we will win - maybe it will take another 4 to 6 months. FDA will once stop to block us as the data are just overwhelming significant. BLA will be once managed, poorly done in the past; it will take another few months. SEC and DOJ will disappear with nothing. Our trial results in the pipeline will blow many people's minds away. BP know it and is therefore fighting against us, but some will join us, and with 350 Mio shares more, we will be ready as well.
I don't expect, with this many roadblocks, a fast solution, but we will grind up, and the near-term partnerships will make us take off like a rocket.
Don't worry, be patient. Maybe our time is September, October, but not later than November 22.
Misiu 143… I thought the 10 k was excellent. So was the guidance..!!! We’ve laid it out there ..for all to see..!!!
To take a loss for inventory that may still be used..is brilliant to say the least..!!!
The FDA did us a huge favor by insisting on the expedited Safety Data..This would have caught up with us..Sooner or later..!!! Now is just fine..!!!
With Cyrus in charge… I feel extremely confident of getting Leronlimab approved for multiple indications..!!!
IMHO..!!!
$ 1 TODAY!!!!!! FULL CYDY POWER!!!!!!!
Misiu, dont you think the corrupt FDA would drop the hold in 2 seconds if suddenly one of its favored big pharma outfits was involved with our drug? This government doesnt even try to cover up how corrupt it is anymore, its just blatant.
It is going to take monumental amounts of time and money to undo what nada did with shoddy sloppy half baked FDA communication.
The holds remain in place.
<<On March 31, 2022, the Company announced that the FDA had placed a full clinical hold on its COVID-19 program and a partial clinical hold on its HIV program in the United States. Under each of these clinical holds, no new clinical studies may be initiated until the clinical hold is resolved. The partial clinical hold on the HIV program allowed patients who were enrolled in the extension trials to transition to other available therapeutics. 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 previously notified the FDA that it was pausing its COVID-19 trials in Brazil. We voluntarily withdrew the Investigational New Drug Application (“IND”) for COVID-19 in the United States. >>
VERY INFORMATIVE 10K WITH A LOT OF OPTIMISM!!!!!!!!!!!! GOOOOOOOOO CYDY GOOOOOOOO AMERICA!!!!!!!!!
No Cytodyn fact in that entire statement, which points only to rumors, assumptions and opinions.
It’s important to understand the difference between Cytodyn facts and Cytodyn rumors because that’s how Cytodyn has defrauded so many mon & pop investors.
The partnership rumor is a good example to do so. It comes exclusively from 2 sources:
- “Spokane” Mike, an illegal stock promoter paid by the company to sell its stock (its true”product”) - he writes fake “articles” which conveniently hide all the company legal, financial and clinical failures. He is paid by the company to write these.
- “Dr D”, a Yahoo message board resident who has been constantly wrong with every prediction yet loves to move the goalposts each time. After April which was supposed to be THE big reveal, it became May. Then June. Then July, a sure bet at the London NASH conference. Then mid august with the 10K. Now it’s end of August. I am sure it will soon move to September etc… she sounds very confident each time yet magically never comments past failures. As if she had just arrived, every time. Amnesty or amnesia.
All the facts about this company are negative. This is the sad Reality.
Thanks Misiu for your perspective....today will test long's resolve....yet again....going to be a bumpy ride...
I was thinking about our 10K .
It is not looking good , but then we are pre earning small biotech , they all look terrible to me ..
But it must be a reason Dr Arman just joined Cydy ,
and he look like a very proper person for us .
With his scientific and financial background , that what we need ..
Why will he be here if we we will be close to the end , no , not possible .
And who was buying millions and millions of shares for 1-1.20 couple of weeks ago ..
Yes , imo something is coming , personally I believe the strong rumors we hearing about partnership , must be it ..
I am not sure , but I think for partnership to finalize they need to remove hold first , but I am not 100% sure about it .
After reading this 10K even I understood it is bad , but after evaluating all I know going on in cydy , and most important how excellent is Leronlimab , I am again relaxed ..
CCR5 inhibitors became suddenly very important in medicine , many MOA , , very important MOA discovered in the last 10 years for many different indications ,
And what best 2 CCR5 inhibitors there are ,
Maraviroc which sometimes people becoming resistant to , and with Black Box warning for toxicity , and
Leronlimab , without one serious side effect and no resistance , and better clinical responses to ..
Yes , no possibility that most of BP have no interest in it ..
Let’s see what will happen after hold is gone , or sooner , this could be an excellent trap for shorts .,
I will love it ..
I am expecting some partnerships , as doctor Kelly said in March conference ,
We have few NDAs with some very BP ,
There is a reason for it ..
GLTA longs
And all imo
It is odd, that's because its a scam
It’s all over now. The price is high enough to short back down to 0.2 and make decent gains. No catalysts on the horizon to make this do anything but drop. Shower sellers dream.
Colon cancer trial? Did I miss something?
Nope this is post-failure fraud. Toxic loans. FDA, SEC and DOJ issues. No escape. A pre-revenue biotech? LOL
Wrong. The deadline was missed.
One of the consequences is that they are forbidden from obtaining S-3s from the SEC for at least 12 months. That’s a big issue.
YESSSSSSSS - TRIAL ON COLON CANCER!!!!!!!!!!!!!
CYDY's accounting firm states "In our opinion, the Company did not maintain, in all material respects, effective internal control over financial reporting as of May 31, 2022, based on the COSO criteria." p.58
They are patting themselves on the back for submitting the easy parts of the BLA nearly 1 year ago. No progress on that pesky final portion that is difficult.
Can CYDY be even trusted to keep its own word?
By action taken on February 21, 2022, and May 23, 2022, the Board released 15.0 million and 7.0 million shares of common stock, respectively, from reservation under the 2012 Plan to permit their use for general purposes,
https://www.sec.gov/Archives/edgar/data/1175680/000155837022013680/cydy-20220531x10k.htm
The Corporation, during the term of the Plan and outstanding Awards, will at all times reserve and keep available such number of Shares as shall be sufficient to satisfy the requirements of the Plan.
no amendment may be made without shareholder approval
https://www.sec.gov/Archives/edgar/data/1175680/000119312512506383/d456568dex101.htm
Pathetic, desperate and potentially unlawful.
YESSSSSSSS - CYDY STAYS AMERICAN!!!!!!!! GOOOOOOOOO CYDY GOOOOOOOO AMERICA!!!!!!!!
YESSSSSSSS - VERY POSITIVE 10K - GREAT FUTURE FOR ALL PEOPLE THEY NEED LERONLIMAB!!!!!!!!!!!! GOOOOOOOOO CYDY GOOOOOOOO LERONLIMAB!!!!!!!!!
Ahhhh, so Arian Colachis was fired eh?
No wonder CYDY swept that required 8K under the rug.
During the fiscal year ended May 31, 2022, the Board terminated the employment of our CEO and General Counsel.
Interesting. Motivation for AC to spill her guts to the Feds?
Why the F would I ask the question if the dollar amount was already posted in the filing?
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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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