On March 31, 2024, there were 993,366 thousand shares outstanding of the registrant’s $0.001 par value common stock.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1175680/000155837024005134/cydy-20240229x10q.htm

On October 6, 2023, the Audit Committee engaged BF Borgers CPA PC (“BF Borgers”) and appointed the firm as the Company’s independent registered public accounting firm for the Company’s fiscal year ended May 31, 2024.
https://www.sec.gov/Archives/edgar/data/1175680/000155837023016328/cydy-20231006x8k.htm

Small Biotech Stock CytoDyn Soars on ‘Warp Speed’ Comment

By Michael Wursthorn
Updated Aug. 26, 2020 9:18 pm ET

The market for small biotechs working on coronavirus treatments is so hot that sometimes all it takes is a whisper to send a stock soaring.

So it was with CytoDyn Inc. , which climbed more than 20% after a former adviser told television host Dr. Drew Pinksy on Thursday that he thought the company would move forward with a federal-government program aimed at fast- tracking virus treatments.

CytoDyn isn't being considered for the program, known as Operation Warp Speed, according to a senior administration official.

Yet in the quick-punch world of retail investing, the video clip of the former adviser, Bruce Patterson , has already gone viral. Investors who closely follow the company shared it on social media and message boards, including Investors Hub, a forum popular with penny-stock traders. Shares of CytoDyn rallied 13% to $3.43 a share on Friday, notching the company's biggest daily gain in about a month, before rising another 12% on Monday.

CytoDyn Shares have plateaued since then, declining a more than 2% over the last two trading sessions.

Operation Warp Speed is a federal initiative to accelerate the development and manufacturing of drugs and vaccines for Covid-19, which has claimed more than 175,000 lives in the U.S. Through the program, the government has given funding to companies such as Moderna Inc. , Novavax Inc. and Regeneron Pharmaceuticals Inc.

The senior administration official said CytoDyn had only completed a preliminary qualification for being included in the initiative. The Vancouver, Wash ., company had submitted information through a so-called CoronaWatch, a program run by the Biomedical Advanced Research and Development Authority , or Barda, to assess the viability of drugs and therapeutics that might be effective against Covid-19, the official said. Technical experts reviewed the submission and opted not to proceed further at this time, the official added.

The team responsible for reviewing the materials makes clear to companies that submissions are for informational purposes only and don't lead to funding on their own, the official added. Companies must apply to specific grant programs to receive funding, the official said, which CytoDyn hasn't done at this time.

Dr. Patterson told The Wall Street Journal that he helped arrange an initial exchange of information between CytoDyn and Barda. He hadn't been involved in further discussions, he said.

CytoDyn declined to comment on the exchange or on any communication with Operation Warp Speed.

" CytoDyn received an email. I received an email from Operation Warp Speed. So yes they are aware of it," Dr. Patterson said in the video. "And I think we'll move forward with them."

The company hired Dr. Patterson as an adviser, in addition to hiring his company, IncellDx, to provide diagnostic services. CytoDyn and Dr. Patterson said his tenure as a consultant ended in May. CytoDyn also no longer uses Dr. Patterson's company for diagnostic services.

An April securities filing disclosed that Dr. Patterson was a CytoDyn shareholder.

In the interview with the Journal, Dr. Patterson said he never received paperwork regarding his ownership in CytoDyn . "I've gotten little to no paperwork regarding that," he said. "I don't think of it as real."

On the question of Dr. Patterson's share ownership, Arian Colachis , CytoDyn's general counsel, pointed to the April filing.

"The document speaks for itself, and we have no further comment," she said.

Write to Michael Wursthorn at Michael.Wursthorn@wsj.com

(END) Dow Jones Newswires
08-26-20 1145ET
Copyright (c) 2020 Dow Jones & Company, Inc.

1. We note statements in your proposed disclosure for Item 1 and Note 4 that you believe leronlimab is safe and effective, as well as language implying the existence of “clinical data that supports its safety and efficacy.” As safety and efficacy determinations are within the authority of the U.S. Food and Drug Administration and comparable regulatory bodies, please revise your proposed disclosure to remove language that states or implies that you believe leronlimab is safe and effective or that leronlimab is likely to be found safe and effective.

RESPONSE:

The Company will revise its proposed disclosure to remove language that states or implies that it believes leronlimab is safe and effective or that leronlimab is likely to be found safe and effective.
https://www.sec.gov/Archives/edgar/data/1175680/000119312521171425/filename1.htm

Leronlimab Anecdotes - A Patient's Perspective - Beating the System
BY CHESSMASTER
THURSDAY, AUG 12, 2021 - 22:03
CytoDyn, appears to be the only biotech company with a proven treatment in a large randomized controlled trial for severe and critical COVID-19. Proven means their drug reduced 14 day mortality by 82% in a phase 3 clinical trial. Proven doesn't mean the drug is approved by the FDA because they asked for more data. This is the rub because it's proven, but not approved and because of that the company has been under constant assault and criticism for how the management team has been handling the clinical trials. Their leading drug candidate is called leronlimab and is branded as Vyrologix and it has single handedly taken dying from COVID-19 off the table. Many of the critics of the Company are shareholders and in one special case a group of shareholders that called themselves Advancing Leronlimab and used what the Company described and illegal tactics to challenge the board of directors. Luckily for patients around the world their bid for greed and avarice failed.

When you put aside the greed and take a hard look at the company, their mission statement is to save lives and of course maximize shareholder value. This management team may be tiny in comparison to most biotechs, but enormous in terms of heart. This team actually cares for patients personally and at one time in the pandemic had the largest number of compassionate use approvals. The truth is that there’s only one reason for breaking a record for compassionate use and it has to do with the viability of the treatment. Many that have gotten either compassionate use or the rarely used Right to Try approvals have interfaced with top management as they worked tirelessly to get the approvals processed as quickly as possible.

Shareholders that have a hard time understanding how a drug with so much potential isn't approved by now don't understand how challenging the drug development process is, and they certainly don’t understand a management that seems to put patients’ lives first. At CytoDyn the CEO has gotten himself personally involved in pushing the process of many Emergency IND’s and compassionate use requests. This is not a normal thing that people are likely to see at any other biotech on the globe. The corporate culture really values human life and seems to do anything they can to preserve it.

Leronlimab has saved many lives. A very recent anecdotal report of another life saved by leronlimab underscores the importance of how truly revolutionary this drug could become. In order to preserve the privacy of the patient no identifying details will be used. Approximately 2 weeks ago a mother in the medical field was talking to her grown son who is also in the medical field and noticed over the phone that he sounded sick and nasally. The son indicated that he just had a bad cold and that something was going around because he thought since all people were all wearing masks for so long that their natural immunity was compromised and colds were on the rise. The mom was skeptical of the answer and made him take a home covid test from the pharmacy. Although he tested positive, the mom was well versed in treatment options and was prepared. She pumped him up with ivermectin, vitamins and eventually resorted to hydroxychloroquine. Nothing seemed to work, and after a couple of days his oxygen levels eventually dropped into the mid 70’s forcing him to call an ambulance. When he arrived he found himself in an unfortunate situation. The Floridian healthcare system was experiencing a surge and was overrun with patients. After many hours of waiting he was diagnosed via a chest X ray having double lobe pneumonia, no treatment was administered and the son found his way back home after picking up a canister of oxygen to use at home. During his wait in the Emergency room he was not provided water, or intravenous fluids, or a bed to lay down on. Despite his use of oxygen at home his oxygen levels continued to deteriorate to 74%. He could barely breathe or talk. This put him at severe risk of dying, he needed to get back to the hospital. The surrounding hospitals were all full capacity so the resourceful mom called around looking for open beds. Eventually he was admitted to another hospital with a compassionate doctor leading the treatment. The first treatment offered was Remdesivir and that was patently rejected by the mom who read the reports and understood it was not appropriate for her son's situation. This was a cytokine storm not a viral infection. She made it known that she wanted leronlimab to be used for her son. Instead of saying no, the doctor suggested they try one of the approved options like tocilizumab first and see if there was any change before they go the Right to Try route. After 3 days of seeing continued deterioration the Right to Try paperwork was signed by the doctor. The drug made it to the hospital the very next day. This was very A-typical because the mom was completely prepared and was on top of the communication.

Before taking leronlimab the patient was on high flow oxygen consuming between 6 – 10 liters. Since leronlimab is a subcutaneous shot it takes time to enter the bloodstream and she cautioned her son to remain patient. After administration it took two hours before there was a change in his status. The patient was able to talk better and had a more productive cough and the oxygen saturation levels started to increase. After 4-5 hours oxygen levels improves so much high flow oxygen was removed and reduced to the nasal cannula. The patient's strength was coming back and he felt like leaving the hospital, but there was also pressure for him to leave to make room for the sick that were in the hallways. The patient was ultimately discharged 26 hours after being injected with leronlimab, and went home with instructions to use oxygen as needed and report back if there was a worsening of conditions.

All these anecdotal patients that took leronlimab, which numbers over 100 understand one truth. The drug works and works extremely well and in most cases quickly. The last thing these patients care about is the greed involved in developing a drug and the he said she said minutia in the boardroom. They welcome a CEO and a company with a refreshing attitude that just wants to save lives. Critically ill patients have been abandoned by both the FDA with their draconian policies and politicians whom seem to be more concerned about mandating vaccines and masks. Team CytoDyn and Hero moms need to be celebrated whenever possible.

The measures to curb the pandemic failed with over 620,000 American in body bags. Initial estimates were 200,000. History will eventually reflect upon how many lives that could have been saved if leronlimab was approved sooner. There is still a long approval road ahead for leronlimab in the United States, but Brazil has their own pivotal trial starting imminently and may be the first beneficiary of a COVID drug that takes dying off the table and flattens the curve.

The situation in Florida with respect to available ICU beds is really bad and here sits a drug that saves the lives of almost everyone it touches. It also has the potential to seriously flatten the curve in hard hit areas because if all the people sitting in the hallways were given this very safe drug they might actually go home like this patient did. People need to know about this drug and the process required to get it. Right now it's only available via Right to Try since it doesn't have its EUA approval or any active clinical trial sites in the USA. Eventually the FDA will come around to approving this drug but in the meantime it's pointless to provoke the FDA and try to force an approval. That's been tried before and has failed. People just need to work within the system to get the drug for your loved ones should they need it. The hero mom in this story was well educated and prepared on what to do in case of this eventuality. Advanced preparedness seems to be partly responsible for the happy ending. So the lesson learned here is that there is no substitute for preparation. It's clear that this drug takes dying off the table and when politicians decide they've seen enough body bags then maybe this drug will see the light of day for use in COVID-19 in the United States.

Right to Try is the only way to access leronlimab and take dying off the table for severe to critical patients. The only hitch is that you have to ask for it and you have to get a doctor at the hospital willing to step up. These anecdotal reports are just whispers right now, but they will turn into a thunderous call to action as the pandemic worsens and news of the drugs success continues to spread.

—-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..

The Company has received subpoenas from the 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 former Company executives and directors have received subpoenas concerning similar issues and have been interviewed by the DOJ and SEC, including the Company’s former CEO, Nader Z. Pourhassan.
https://www.sec.gov/Archives/edgar/data/1175680/000155837024000305/cydy-20231130x10q.htm

3. Liquidation. Upon the dissolution, liquidation or winding up of the Company, after payment or provision for payment of the debts and other liabilities of the Company and subject to the rights, if any, of the holders of any outstanding series of Preferred Stock or any class or series of stock having a preference over or the right to participate with the Common Stock with respect to the distribution of assets of the Company upon such dissolution, liquidation or winding up of the Company, the holders of Common Stock shall be entitled to receive the remaining assets of the Company available for distribution to its stockholders ratably in proportion to the number of shares held by them.
https://www.sec.gov/edgar/search/?r=el#/q=winding&page=1&ciks=0001175680&entityName=CytoDyn%2520Inc.%2520%2520(CIK%25200001175680)&category=form-cat0&forms=-3%252C%2520-4%252C%2520-5&sort=desc

the relative ranking and preferences of the preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of the affairs of the Company; and
https://www.sec.gov/Archives/edgar/data/1175680/000155837024000836/cydy-20240130xs1.htm

December 31, 2023
(Date of Event Which Requires Filing of this Statement)
https://www.sec.gov/Archives/edgar/data/1175680/000119312524032312/d778219dsc13ga.htm