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Oh wowww, why isn’t your power still off???
Kobe is back for good???
Nice to see you…
In other news,,, I really enjoy this quote from the Pres Release.
“Importantly, the settlement ends the potential distraction and uncertainty associated with protracted litigation and allows the Company to immediately advance its clinical trials and research and development initiatives”
Sounds like it’s clearing Fear,,, Uncertainty,,, and Doubt…
This doesn’t feel as excite as the real housewives anymore,,,
I’ve been watching more movies lately,,,
Up In Smoke with cheech and chong???
I really miss Fung_derf,,,
But Cheech told me that Dave’s not here…
No one called Fung_derf bad names right???
Well that’s not allowed here anymore per Janice.
Anyone think we are in for a smooth 5 day sideway sailing ahead again?
5 day chart is trading at a sideway pattern,,, perhaps smooth sailing ahead???
Homie the Grip was wrong about his 10c prediction,,,
Heyyy JustDa,,,
Here is an excerpt from the 10Q that you didn’t fetch,,,you only fetched the 10K part that was a negative the company had overcame already…
“On February 27, 2024, the Company received confirmation from the FDA that its clinical hold on leronlimab has been lifted. The Company now intends to pursue its plan for the further development of leronlimab as a therapy that provides clinical benefit by modulating chronic inflammation. The Company believes its proposed inflammation study will allow the Company to further establish leronlimab'& mechanism of action in a cost-effective manner.”
Some bozos thought 200,000 promissory notes with other incels would take them to the moon,,, if CytoDyn bought them,,, but that didn’t happen either.
“To clarify the optimal dosing” sounds quite the comprehensible measure in this mouse study,,, considering the company believes its prior MASH study demonstrated a statistically significant benefit of leronlimab at a dosing level of 350 mg
I love to thrash my 1967 Chevrolet Corvette Stingray Big Block,,,Staci.
Looking to add more to my collection when CYDY goes where I want it to go.
I don’t know closet, the DOJ is not looking at CytoDyn and Nada as one unit.
G…Heck,, they’re not even prosecuting other executives when Nada was on the team trying to advance Leronlimab,, leronjimab…G,, that video on YouTube was hilarious…
Another thing to note is…they’re not prosecuting Scott Kelly who was arguably the boss of Nada…
However,, if Nada won,, and it showed moving of the goal posts for indications including,, but not limited to BLA and EUA process…
Than one could figure THAT would bold well for CytoDyn…and its shareholders…
And that’s one reason to be bullish imo. Very very bullish for CytoDyn !!
Happy Father’s Day Kgro!
Hope you have a maxed out day!
You were right all along. Please tell me more.
Mountainman is alive!!
Yes yes!!
Much better with shareholder letter communication!!
anticipate finalizing agreements with these partners in the very near future !!
significant increase in third parties that are interested in partnering with the Company !!
the potential for significant value return at little or no cost to the Company !!
Wowzers !!
Go $CYDY !! You can do it !!
GLTA !!
Waiting patiently for $CYDY to come out of it's cocoon !!
GLTA !!!
Woooooooo!
Look at them on stocktwits !!
happy because it’s green!
Now show us the hold was lifted in the 10Q lol
Why go fish for you when documents don’t matter unless it’s EDGAR.
So again, was the hold lifted in the 10Q?
Now what does the latest 10 >>> Q<<<
Say?
😂
Also, with all of DrJs experience and working with the drug/ HIV, he may already know of many patients that may want to enroll in the study.
So was the Hold Lifted in the 10K or does it need to be 8K’d?
How does he know that they ALWAYS present half of the facts if he also said this?
I say this without even looking at the data
Does the company have to 8K the FDA email for JustDa to consider it real?
Where is Janice? She was quite good at posting DOJ and SEC stuff before.
Ohhh myyy, hey @justdafactss
Did you see that it was on an 8K?
(Waits for boring response about other non 8Ks).
Haven’t seen Janice all day unless I missed a post?
FREQUENTLY ASKED QUESTIONS
Last updated February 2024
What operational and financial adjustments did the Company make in fiscal year 2023?
During FY23, the Company made significant reductions to its workforce, cash burn rate, and operating expenses, to preserve its resources and use them where they are most needed. This transformation consisted of reducing our force of full-time employees by approximately 70%, adding five part-time employees, and leveraging experienced consultants and advisors on a part-time basis. This, along with other expense reduction measures, led to significant improvements in the Company’s cash burn, G&A expense, and R&D expense run rates. Compared to the prior fiscal year, in FY23 we saw decreases in the Company’s cash used in operating activities of 68%, decreases in G&A expense of 61%, and decreases in R&D expense of 90%.
By restructuring our workforce and electing to retain specialized consultants where possible, we believe we have significantly enhanced our regulatory, clinical, and medical capabilities, and further assembled a team that places the Company in the best position to be successful. We are optimistic that the latest clinical hold submission to the FDA will result in the lifting of the clinical hold. If successful, our current team stands ready to implement the best strategies to maximize shareholder value in the near- and long-term.
What is the status of the clinical hold?
CytoDyn Announces FDA Has Lifted Clinical Hold (press release dated February 29, 2024)
What is the short-term development plan for leronlimab following the resolution of the clinical hold?
The Company has continually evaluated the various indications for leronlimab, and worked to strategically determine how to best focus and advance each indication – whether in-house and/or through strategic partnerships. This work did not cease during the clinical hold process.
Following the resolution of the clinical hold, we will continue to focus on a multiple therapeutic development approach to leronlimab. We have already been working toward eventual decisions as to the most opportunistic, least capital-intensive manner to develop and create value through various means for leronlimab, identifying strategies that are time- and cost-effective and create the opportunity for non-dilutive financing opportunities such as license agreements, co-development, partnerships, etc. For example, KOLs consulting with the Company identified a clinical trial in the HIV space they feel strongly about that will help patients and can be conducted in a time- and cost-effective manner. Further, we will continue to evaluate pre-clinical combination therapy trials in MASH and oncology. Positive developments in the foregoing initiatives could also result in more substantive interest from third parties by way of licensing and collaboration agreements, joint development initiatives, and other partnership opportunities.
What is the current status of the longer-acting therapeutic project?
Early in 2023, the Company entered into a partnership directed toward developing a long-acting therapeutic to bolster our existing IP portfolio and patent protection with the goals of attracting partnership opportunities, preserving and increasing the value of our patent portfolio, and creating additional shareholder value.
The partner company is an experienced drug development company and uses generative artificial intelligence (AI), among other technologies, in its development activities. If successful, such a modified therapeutic would require less frequent injections for patients on drug, furthering the convenience and overall marketability of the product. Working with a company with established AI-capabilities allows for an expedited and robust development path for this modified, longer-acting therapeutic for the Company.
How does the Company make decisions as it relates to executive compensation?
Each year, the Company’s Board of Directors reviews and appoints at least three independent members of the Board to serve on a compensation committee (the “Compensation Committee”). Among other duties, the Compensation Committee oversees incentive, equity-based and other compensatory plans for executive officers of the Company.
On an annual basis, the Compensation Committee evaluates the Company’s overall compensation philosophy and determines base salaries and other forms of compensation to be paid to executive officers, including cash incentive compensation and grants of stock options and other stock-based awards, which are all disclosed in the Company’s annual proxy statements. The Compensation Committee’s decisions are based on (annual) recommendations received from an independent executive compensation advisory firm retained by the Compensation Committee. The independent compensation consultant analyzes peer companies and other benchmarking and comparison data, and then makes recommendations as to the competitiveness of the Company’s executive compensation program, and a proposed mix of compensation elements. The above process ensures that the Company and Compensation Committee’s practices are in-line with industry standards, and companies of similar size and financial condition. This process also helps ensure that the Company is able to attract and retain talented key employees.
At the 2019 Annual Meeting of the Company, our stockholders approved the Board’s recommendation that an advisory vote on executive compensation be conducted annually. Accordingly, each fiscal year, the shareholders are asked to place an advisory vote as to the compensation of our executive officers.
Additional information as it relates to responsibilities and processes of the Compensation Committee is set forth in its charter and director and executive officer compensation policy, which are posted on our website under Governance Documents. Additional, more-detailed information in relation to the compensation paid to executive officers can be found in the Company’s required SEC filings, including the Company’s Definitive Proxy Statement filed on September 25, 2023.
What is the current status of the Amarex litigation effort?
In July 2023, the Company took the next step towards holding Amarex, its former clinical research organization (CRO), accountable for its numerous failures in relation to clinical trial management and regulatory services it was supposed to have provided to CytoDyn. The Company is seeking damages in excess of $100 million from Amarex in this action. We have fully funded the Company’s counsel, Sidley Austin LLP, for this litigation effort in advance, which allows them to take all steps necessary to maximize the Company’s recovery from Amarex. The final arbitration hearing is set to commence August 12, 2024. We would then expect the arbitrator to issue their final order sometime in the weeks following the conclusion of the final hearing, perhaps in late September 2024. We are confident in our case and have one of the preeminent litigation firms in the world representing the Company in this proceeding. We will continue to vigorously pursue this matter.
What is the status of the new communication strategy?
The Company is in the process of making a marked shift in its communications with stakeholders. These renewed engagement efforts will be clear, concise, measured, and compliant with pertinent regulatory requirements. We will continue to update shareholders as required with material information and developments via our SEC filings, but we also anticipate communicating more frequently with investors via direct communications. We will also communicate more frequently with the market at large, and we actively review and respond to investor inquiries.
You already may have noticed a change in our responsiveness with investors via the Company’s IR email account (ir@cytodyn.com) over the past several months. Additionally, we actively review all investor communications for recurring themes which helps better inform the Company on what is most important to current and potential investors. We are also in the process of setting up a FAQ section on the Company’s website where we intend to post and respond to the most important questions. This FAQ page will be updated on a regular basis.
Note Regarding Forward-Looking Statements
This Frequently Asked Questions supplement contains 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.
Friendly reminder, anything saying “leronsaline”
“Leronlimbag”
Is not considered to be on topic because CytoDyn does not recognize these as being on topic.
Same goes with the names of the individuals associated with or used to be associated with CytoDyn.
Use full and correct spelling words, so we can know you are on topic. If you read the 10Q it’s easy to copy and paste the names if you’re having trouble spelling.
Do you think that will be explained in the 3,345 documents or so?
(Oh, who’s counting)
They brought less and less because they’re strategy paying less people out.
You mean if the company goes bankrupt.
If, not when. If.
oh wow I'm just seeing this. awesome post, it makes you wonder why NP gets so much hate here...
"Well girls, it seems things are continuing to percolate in the saga of Nader Pourhassan and Kazem Kazempour. There may be a possibility that the Government represented to the grand jury that there were other known and unknown coconspirators who engaged in the alleged criminal scheme but never seemed to name them other than Executive 1, Executive 2, and Executive 3. So, if there was a conspiracy afoot at CytoDyn, why aren't these unnamed "Executive 1,2, and 3" being charged withe same crimes as Nader Pourhassan? Everyone remembers that toothy Georgian smile from Dr. Scott Kelly? Didn't he sell a bunch of stock around the same time as Nader Pourhassan - somewhere in the ballpark figure of 1,200,000 shares? Wouldn't Dr. Scott Kelly have, as a medical doctor, have intimate knowledge of the weak and incomplete BLA contents?
Did Nader Pourhassan finally get his bus drivers license and is going after Dr. Scott Kelly to run him down? Could it be possible that Dr. Scott Kelly is the one who originally threw Nader Pourhassan under the bus wheels of justice?
And girls, please don't giggle when you read this. We're going to hopefully hear from the following FDA employees: Murray, Birnkrant, Sheikh, Strayhorn, Akunne, Winestrock, Struble. Seems that by Apr 22, 2024 the government will be turning over 3,345 FDA documents to Nader Pourhassan and Kazem Kazempour. Don't we all wonder if someone from that list of FDA employees is going to top Suzanne's "real housewives" comment and actually say what they REALLY think about Nader Pourhassan and Kazem Kazempour in no uncertain non-politically correct terms? Everyone now has a month to butter up their popcorn and get ready the drama to play out in Maryland.
Now, now Katangolo. You may get your chance again if you play your cards right."
CytoDyn Announces FDA Has Lifted Clinical Hold
CytoDyn's CEO, Dr. Jacob Lalezari, stated, "We are excited that the clinical hold on leronlimab has been lifted by the FDA. CytoDyn is grateful for the FDA's guidance on our protocol and we are excited to open a new chapter in the development of leronlimab as a therapy that provides clinical benefit by modulating chronic inflammation."
https://www.cytodyn.com/investors/news-events/press-releases/detail/618/cytodyn-announces-fda-has-lifted-clinical-hold
2nd time applying for a moderator position.
Did so before Janice and doing so now again.
Do longs remember when it didn’t matter what the clinical trials.gov said and now we have came back full circle?
You look like a genuine moderator here.
You do know that too much iron can damage the brain and liver?
Create copper deficiency?
All because an article thinks it MAY help?
When it was already explained the iron is already being pushed into the organs?
I’m not sure what you’re getting here but not sure why someone can prop up an article based on “may help” but put down a “may help” of another drug that targets the actual problem
Inflammation.
So scam was what you wanted to put emphasis on even though there’s completely new management, FDA seen the data and cleared the protocol?
Fascinating
Did you just say CytoDyn was well managed?
DrJ is changing everyone’s minds!
Woooooooot!!
Do you remember yourself bickering in the past about an 8K all night, only for the company to file one before morning opening the next day?
Or even a day or so after because you thought it wasn’t the truth?
I remember, just like you can recite a 5 year old Nader smirk in a proactive video at 8:53:03am
By your count, how many days does this company have left to file an 8K?
Even Janice said this is a losing argument for you 🥶
Calling Professor DJJazzyJeff,
Is the hold lifted yet?
pseudonym
Like using Leronsaline?