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No answer Yahsho?
You are spamming federal agencies about CYDY, causing potential harm to CYDY long investors.
Because
(a) You are attracting the wrong kind of attention from these agencies. Some long investors seem to have had uncanny insider information in advance of press releases, and I have fought these frauders for a long time already. Take one long, for example you: you have made odd post at odd times, announcing a big news to come...right before a press release. Do you really want the SEC to zoom into your activity? I would love this but long investors might not appreciate, even if they are 100% clean, the free advertisement that would come with it
(b) This is giving a very poor image of the CYDY long community. Madness does not look good. I have had many conflicts with them, but I don't think anybody deserves this noise - long or short, rationality is better for everybody
I would be a long investor I would be furious to have someone like you gesticulating in front of the SEC. This already happened with the FDA (if anyone remembers Misiu), and this resulted in a public FDA intervention that nearly killed the company.
Also, your "vaults", or at least your posted screenshots I have seen, prove that you have zero IT knowledge. You don't know how the IP layer works, what the HTTP and TLS protocols transmit and do not transmit, how Python works, what ChatGPT does with you, and you use pseudo-technical keywords that, for a Unix developer, scream b*shit. This sounds like a bad movie script from 25 years ago.
Again, harm to investors.
their is something cooking and it is ready to pop.
A real look into the recent past FDA regarding CytoDyn and Amarex would make RFK Jr. adding to his list of who to fire. This must be done. Without accountability why have rules at all? Heads should roll and jail cells stuffed. FDA is liable. We all knew that from their contrived hit letter against leronlimab trial that led to trial freezes and kept some patients without leronlimab that was helping them greatly. What about this human loss? Sounds like a conspiracy case could result too.
Good work.
what are we waiting for lets get this higher.
Laughing at the CYDY delusion. So immature. Please, dear losing investor, take your screenshots, build your vaults, send letters everywhere. This is so scary LOL, kids are scared! At best, if you’re lucky, you’ll draw the authorities’ attention to the really odd behavior of some CYDY investors on message boards - you know those who magically always seem to know when a PR is about to fall - have they been informed? Are they leaking insider information? I remember the public FDA rebuke letter that killed CYDY, after a similar idiot had spammed the FDA with letters. Idiots never learn. LOL.
Has anyone been dosed yet, come on, let us know FF
lets make this a great year.
A week or so ago in Germany....Alles einsteigen!
And now in Spain...... ¡Todos a bordo!
Go $$$CYDY$$$
Here's the deal. Big Pharma is in revolt because they have been cut off at the knee caps. Look at all the mergers and partnerships and collaborations taking place. They are gobbling up innovative pharmas as a lot of their drugs are going off patent or being axed by new HHS leadership for being recklessly approved by prior Club arrangement. Go RFK Jr. Go. Toss em out.
I hope CytoDyn does not permit a buyout. I would rather hate to see some pig get leronlimab and keep it from seeing it's due.
However, we have lots of room for collaborations of different kinds due to the many indications which leronlimab will support. So let the numbnuts post all the same old garbage. They are just peanut mouthpieces for paid fake analysts who are paid by the shorting hedgefunds controlled by investment banks and Blackrock/Vanguard protecting their immense holdings. The ChggaLug is sweet music to my ears. Reminds me when I was a kid spending summers at my grandmothers who lived just a few meters from the train track. The chickens in the hen house would crow minutes before the train sped by, then the pigeons would fly.. like they will do here when that locomotive barrels down the track at break neck speed a la Casey Jones. https://techhistorian.com/fastest-steam-train-in-the-world/
Leronlimab...gathering speed.
Well it seems like some people on this board kind of like my Approach about a train chugga-lugging Chugga lugging Chugga lugging along. Picking up passengers on the way. They're not taking the ride for the practice, they're taking the ride into the town called success. And it's moving along faster and faster blowing its whistle and tooting its horn. Chugalug Chugalug chuck-a-lug and away we go. Steaming along over a hundred miles an hour. Woo woo woo woo I hear the clatter as we approach the town of success. Sure would be nice if the engineer wouldn't kick me off the train everyday. I've always got some long to pick me up and get me back on the train the following day. But I am tired of the interruptions. But they have to show their weight and boy can they be nasty with me. I don't know why to this day why. Hope everybody enjoys 4th of July. Cytodine and l e r o n l i m a b is certainly enjoying it in Spain. Boom boom boom as we take off. Up up and away we go.
he has already spoken and it is going higher.
Chug a lug is fine for me. I like to take it slowly. Gives me the opportunity to add more shares. News can hit at any time so I kick it in gear when the price is right. I am a silly long with big green bags.
Chugalug Chugalug Chugalug!
Just in the wrong direction!
AH AH AH AH
Well the train is steaming head gaining momentum and picking up passengers for the ride. I get to ride the train just one stop a day as I have an engineer that stops me and tells me to get off at every stop. I think he enjoys showing his superiority as an engineer. Or maybe it's the conductor. They sure are a pair to draw to. Whoever is in charge I sure wish that they let me take a longer train ride. Chugalug Chugalug Chugalug someday maybe I'll get to pull the whistle. Hang in there all you longs and keep bringing people aboard for the ride. Woo woo woo woo Chugalug Chugalug next stop here I come.
to the moon.
Word is spreading fast Doc. Does anyone read Yahoo Finance?? Notice who is listed first?
The report provides the total potential number of patients in the indications, such as PTCL, CTCL, Migraine, NASH, and others.
Leading GPCR-targeting therapies companies, such as CytoDyn, REMD Biotherapeutics, GPCR Therapeutics, Structure Therapeutics, and others, are developing novel GPCR-targeting therapies that can be available in the GPCR-targeting therapies market in the coming years.
Some of the key GPCR-targeting therapies in the pipeline include Leronlimab, Volagidemab, GPC-100, GSBR-1290, and others.
In July 2024, Radionetics Oncology entered into a strategic agreement with Eli Lilly and Company, providing Lilly access to Radionetics' proprietary GPCR targeting small molecule radiopharmaceuticals.
up 16.32% so far this morning. Thanks for the cheapies pigeons.
I couldn't have done it without you. The real market is speaking.
DATA and DEALS
$CYDY$ 2025
it only has one way and that is up.
LOL a badly hurt gullible investor escaping into his fantasy world in realtime
CYDY and it's -25% price destruction since you invested "massively" is the reality
Why are you asking someone how much they lost, didn’t you just mention childish and immature
Quite ironic that, contrary to your insinuations, the only real ongoing lawsuits are against Cytodyn
https://business.cch.com/srd/2025-06-26-03-46-10-143-297278_477_1.pdf
Interesting how you try to invert reality
Oh Ya I set this trap before they ever even knew there was one
These damned shirts!
The train has left the station but in the wrong direction it seems.
DISCLAIMER:
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:
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.
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
VANCOUVER, Washington, Dec. 17, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
As I look back on 2024, during which CytoDyn Inc. (“CytoDyn” or the “Company”) achieved multiple crucial milestones, and look forward to 2025 and the exciting developments that lie ahead, I remain truly grateful for your continued support. As described in detail below, we made important progress over the last year and I firmly believe the Company is poised for even more success in the year to come.
I am pleased to confirm that the Company has sufficient cash and drug supplies on hand to complete its clinical priorities in 2025. We also continue to make progress on the development of a long-acting formulation of leronlimab that should provide greater patient convenience and help secure additional patent protection for the Company.
Since my last update, we have also welcomed several new consultants to the Company, including three key members of our development team. In October, Dr. Melissa Palmer joined as Lead Consultant in Hepatology, leveraging her expertise to help guide the development of leronlimab in the treatment of MASH and liver fibrosis. We also welcomed Dr. Max Lataillade as Senior Vice President and Head of Clinical Development, capitalizing on his significant pharmaceutical experience and connections to help oversee the Company’s global research and development strategy, as well as to support our programs in inflammation and HIV. In November, Dr. Richard Pestell joined as Lead Consultant in Oncology to support our programs in colorectal cancer (CRC), triple-negative breast cancer (TNBC) and glioblastoma (GBM). The addition of this team of seasoned experts and top-tier consultants should enable CytoDyn to capitalize on our positive momentum, push our clinical development pipeline forward and make 2025 a pivotal year for the Company.
I believe our current strategy will result in significant value return to the Company and its shareholders and should give us the opportunity to do so on an abbreviated timeline. We are on good terms with the FDA, we have the funds required to pursue our key development objectives and we have the requisite expertise and associations to execute on our vision. Entering 2025, the Company is in control of its own destiny.
Shareholders are the lifeblood of the Company, and we remain committed to acting in your best interests. We will continue to take one thoughtful step at a time to hit our milestones and, in turn, drive value for our shareholders. It is my pleasure to provide a detailed update on some exciting new developments with this letter.
My dedication to CytoDyn continues to be grounded in my core belief that leronlimab has the potential to be a life-changing therapeutic. I remain fully committed to the mission of bringing value to our shareholders and to completing studies that will unequivocally demonstrate the impact of leronlimab in the clinic. Thank you again for your patience, support and trust. Best wishes to all for this holiday season. As we enter 2025, I am truly excited about the possibilities that lie just ahead.
With Gratitude,
Jacob Lalezari, MD
CEO
Oncology – December 2024 Update
The Company will be prioritizing oncology in 2025, as we believe this indication holds the potential for the highest value return to the Company in the form of a significant partnership and/or drug approval. As recently announced, CytoDyn has received FDA clearance to initiate a Phase II study of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (CRC). As noted in our prior release, we recently completed the kickoff meeting with Syneos Health, the CRO for the study, and enrollment efforts are set to begin in January.
I am also delighted to announce that Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance has agreed to be the lead Principal Investigator for the CRC study. As requested by the FDA, the first five patients enrolled in this study will receive 350 mg of leronlimab SQ once/week in combination with TAS-102 and Bevacizumab. After a preliminary safety review, subsequent patients will then be randomized to 350 or 700 mg of weekly leronlimab with the same background regimen. The Data and Safety Monitoring Board (DSMB) will perform a second safety review after the first 20 patients have completed at least 1 cycle of therapy. The DSMB can then recommend restricting further enrollment to a single dose level, should they identify a signal of superior activity in either one of the treatment arms.
For additional information, the CRC study protocol is posted on the NCI Clinical Trials website, and can be viewed here: (https://clinicaltrials.gov/study/NCT06699836?cond=colorectal%20cancer&intr=leronlimab&rank=1).
CytoDyn also remains focused on the possible role for leronlimab in TNBC. As previously announced, we are launching two preclinical studies in TNBC that will seek to further clarify the mechanism of action of leronlimab in oncology and identify potential treatment synergies to optimize the design of a follow-up clinical study.
Lastly, the Company remains focused on the possible use of leronlimab in the treatment of GBM. Preliminary results from a preclinical study performed at the Albert Einstein College of Medicine do not appear to show a difference in outcome with leronlimab compared to the control arm. The Company has committed to repeating the study based on unpublished observations by Dr. Pestell’s lab and will now employ a treatment sequence involving temozolomide and leronlimab. This follow-up study will start immediately and should help clarify the potential therapeutic benefit of leronlimab in the treatment of GBM. CytoDyn is also currently in discussions with a key opinion leader in neuro-oncology about the possibility of initiating a pilot study in patients with GBM based on Dr. Pestell’s unpublished work and the outcome of the follow-up preclinical study.
Inflammation – December 2024 Update
We continue to believe that treatment of inflammation with leronlimab remains a viable and important development pathway, and we are moving forward in three indications associated with chronic inflammation on a cost-efficient basis.
First, CytoDyn previously announced exciting results from an initial preclinical study with SMC Laboratories evaluating leronlimab in the treatment of a mouse model of MASH. The results from this preliminary study demonstrated that high dose leronlimab was significantly better at reversing liver fibrosis compared to an IgG 4 isotype control and demonstrated a trend toward better fibrosis reversal compared to Resmetirom. The final results from that study have now also demonstrated that leronlimab (both high and low dose) was significantly better than Resmetirom at reversal of fat deposition (steatosis) in the liver. These exciting findings have been submitted as a late breaker abstract to the MASH TAG conference and, if accepted, will be presented at the meeting in January. In September, CytoDyn launched two follow up studies to confirm and expand on these preliminary results. The first follow-up study seeks to confirm the observations of the original study with larger cohorts of mice (12 versus the original 8/group) and will compare leronlimab with a GLP-1 agonist (Semaglutide) in addition to confirming the comparisons with Resmetirom. The second follow-up study involves the administration of CCL4, a drug that directly causes liver fibrosis in mice. This study will clarify if the observed reversal of liver fibrosis is restricted to the MASH/fat deposition pathway or might occur independently of the etiology of fibrosis (e.g. alcohol, viral hepatitis, etc.). The results from both follow-up studies will become available in January. As a side note, we have been contacted by colleagues at a major academic institution who indicated that, if the liver fibrosis reversal results are confirmed in the follow-up studies, they would be interested in funding a pilot study of leronlimab in the treatment of patients with pulmonary fibrosis at their own center.
Second, in September, CytoDyn applied to the NIH/RECOVER-TLC group for the potential inclusion of leronlimab in their next round of Long Covid treatment studies. We expect to learn the group’s decision in the next several months. In the meantime, we have paused the launch of our previously announced pilot study in patients with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) since the two conditions (Long Covid and ME/CFS) essentially overlap. If the RECOVER-TLC team decides to move forward with leronlimab, we will formally suspend the ME/CFS study. If the RECOVER-TLC team declines to include leronlimab, we will resume the pursuit of a pilot study in patients with ME/CFS, for which we already have a draft protocol synopsis and lead investigator identified.
Third, we have finalized the protocol for a pilot study of leronlimab in the treatment of patients with mild to moderate Alzheimer’s disease. That study will take place at Cornell Medical Center in New York and will evaluate an objective neuroradiology primary endpoint that will provide a clear measure of leronlimab’s potential role in treating Alzheimer’s disease. I am pleased to announce the study is now fully funded by an outside foundation, and the protocol will soon be submitted to both the FDA and the Cornell IRB.
Other – December 2024 Update
As previously announced, CytoDyn is partnering with the American Foundation for AIDS Research (amfAR) to sponsor an HIV cure study called LATCH (Leronlimab in Allogenic stem cell Transplant to Cure HIV). The study will employ leronlimab to protect CCR5+ donor immune cells from HIV infection, while aiming for a cure in the setting of bone marrow transplant to an HIV+ recipient. We are confident in the likelihood of success of the LATCH program, given the announcement over the summer by investigators in Germany of a successful cure using donor cells from an individual who was heterozygous for the CCR5-delta 32 mutation. Indeed, those same investigators have asked CytoDyn if they too can run the LATCH study at their research center in Berlin. The LATCH protocol is scheduled to complete final updates at the end of December, and we look forward to the launch of this program in 2025.
CytoDyn has also continued to prioritize the publication of our existing clinical data. The CD10 manuscript describing the trial of patients with mild to moderate COVID-19 was recently published in Clinical Therapeutics. The manuscript for the CD02 Phase 3 study in patients with multi-drug-resistant HIV has also just been accepted for publication by the Journal of Acquired Immune Deficiency Syndromes (JAIDS).
The Company is pursuing publication of four additional manuscripts, including the CD12 manuscript (severe and critical COVID-19), twin papers on the TNBC study results, and the MASH manuscript. Those submissions were delayed by various obstacles but are now moving forward. In addition, CytoDyn is preparing a draft manuscript summarizing the integrated safety data from the almost 1,600 patients who have now been treated with leronlimab. The final draft of that manuscript will go out for author review in the coming weeks and will be submitted for peer review shortly thereafter.
February 6, 2025 CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories
VANCOUVER, Washington, Feb. 06, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today positive results from its preclinical studies with SMC Laboratories (“SMC”). The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). The first two studies, completed in late 2024, evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis in mice who received a single dose of Streptozocin at birth and were then fed a high fat diet from weeks four to twelve. The third study, concluded in January 2025, evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35. “The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,” said Melissa Palmer, MD FAASLD, the Company’s Lead Consultant in Hepatology. Dr. Jacob Lalezari, CEO of CytoDyn, added, “We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab’s core mechanism of action, binding to CCR5 receptors on cells, could translate into a variety of meaningful clinical benefits for patients across a number of medical conditions. As the Company continues to prioritize its oncology objectives for 2025, we look forward to establishing the right partnership to further the clinical development pathway for leronlimab in the treatment of fibrosis of the liver and potentially other organs, such as the lungs and heart.” CytoDyn is currently in discussions with several third parties regarding next steps in an effort to expand on these promising findings. The Company intends to explore a number of potential synergies and partnership opportunities in the coming months as it furthers its clinical development pipeline, including opportunities that might explore the potential widespread applications for leronlimab as a treatment path for fibrosis in other organs. About CytoDyn CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including infectious disease, oncology, and autoimmune conditions. About SMC Laboratories SMC Laboratories, Inc. is a CRO, with a focus on conducting the non-clinical research necessary for the drug development process. As a global consulting company that designs studies according to customer requests, it supports cutting-edge non-clinical pharmacological studies. The company owns a variety of mouse models for inflammation and fibrosis in various organs, centered on the innovative STAM™ mouse animal model of liver cancer derived from MASLD (metabolic dysfunction-associated steatotic liver disease). This patented mouse model was developed by SMC Laboratories as a worldwide-first model based on MASLD. We offer non-clinical pharmacological studies using the model mouse. Please check the company's website for further details.
February 24, 2025 CytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab
VANCOUVER, Washington, Feb. 24, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab. Although mTNBC typically has a poor prognosis, observed survival rates at 12, 24, and 36 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease. Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025. “We are encouraged by the longer-term survival data to pursue this potentially paradigmshifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology. “As a cancer therapeutic, leronlimab was well tolerated with remarkably infrequent treatment-related adverse events. These promising results suggest further studies with leronlimab are warranted to expand oncology treatment options and improve patient care.” Dr. Jacob Lalezari, CEO of CytoDyn, added: “These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors. I expect the Company’s oncology efforts to accelerate in the coming months, with further announcements in both mTNBC and colorectal cancer.” Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibodydrug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab). The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease. About CytoDyn CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including infectious disease, oncology, and autoimmune conditions. Note Regarding Forward-Looking Statements This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, 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 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 our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments. Media Contacts CytoDyn Inc. Riyaz Lalani Gagnier Communications CytoDyn@gagnierfc.com
March 18, 2025 March 2025 Letter to Shareholders
VANCOUVER, Washington, March 18, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders, As envisioned, 2025 is unfolding to be an exciting year for CytoDyn Inc. (“CytoDyn” or the “Company”). On February 24, 2025, the Company announced increased survival rates in patients with metastatic Triple-Negative Breast Cancer (“mTNBC”) who were treated with leronlimab in prior CytoDyn-sponsored studies. The impressive survival observations at 12, 24, and 36 months in patients who previously failed treatment in the metastatic or locally advanced setting indicate leronlimab could play a significant role as a paradigm-shifting therapeutic in oncology. Of particular interest, we identified a subgroup of these patients who remain alive and well today and currently identify as cancer-free. This is only the beginning of the Company’s 2025 oncology story. We are eager to provide updates in the coming months as they are available to share. There is still much work to be done, but I am encouraged by what is on the near horizon. I’d like to offer a word of deep gratitude to the CytoDyn team and the key opinion leaders (“KOLs”) who worked so diligently these last months to bring these data together. I would also like to reiterate my appreciation for you – the shareholders. Our business priorities are (i) getting leronlimab to patients in need; and (ii) generating value for our dedicated shareholders. As a long-time supporter of the company and now CEO, I believe investors deserve clear and direct updates as it relates to milestones, regulatory process, and finances. We will continue to incorporate this principle into our messaging as we move forward, presenting a clear picture of where we stand in the development pipeline and celebrating major milestones together. Looking ahead, we are excited to share more about the clarity forming around the putative mechanism of action of leronlimab in solid tumors, as well continued updates relating to the Colorectal Cancer (“CRC”) trial, as further described below. In terms of the regulatory process, I am confident that our collaborative relationship with the FDA has placed us on a positive trajectory. To accelerate progress in oncology where feasible, we’re establishing an oncology advisory board to ensure we are exploring the fastest and most responsible pathway(s) forward. We will continue to look for opportunities to solicit feedback regarding our development process from both KOLs and the FDA. Maintaining strong relationships and credibility with the FDA and industry partners remains a top priority as we chart our future course. The Company continues to be on track financially and we forecast sufficient cash and drug supply on hand to advance our clinical priorities in 2025. As we approach key milestones and announcements in the coming months, we’ll evaluate opportunities to raise additional funds at optimal times and through methods that best serve the Company and its shareholders. We believe leronlimab has already established the potential for tremendous value in the clinic, and in the coming months we look forward to sharing the basis for that conclusion. In sum, the developments in oncology have set the stage for 2025 to be a benchmark year for CytoDyn. This is no longer a platform drug in search of an indication; we now have compelling data to support a role for leronlimab in solid-tumor oncology and are executing on that vision. With Gratitude, Jacob Lalezari, MD CEO Oncology – March 2025 Update The Company continues to prioritize oncology in 2025, as we believe this indication holds the highest potential and shortest timeline for return on investment in the form of a partnership or drug approval. The exciting survival outcomes announced in February 2025 provide early clinical evidence of leronlimab’s potential impact across the field of solid-tumor oncology. As previously announced, we’ve submitted our findings as an abstract to the European Society for Medical Oncology meeting in Munich, Germany in May 2025. We are eager to share additional insights into the apparent mechanism behind the survival outcomes and will do so once appropriate and in compliance with pre-conference publication and announcement allowances. In the meantime, CytoDyn has initiated a follow-up protocol so we can continue to monitor the surviving patients into the future. The CytoDyn/Syneos study teams have now approved eight clinical sites and counting to participate in CytoDyn’s Phase II study of patients with CRC and refractory disease. These clinical sites will include a mix of both large community practices as well as academic centers which all have well-established track records of superior work and high enrollment. With our clinical trial agreements in place and study initiation visits about to start, we expect screening of patients into the CRC study to commence shortly. As previously mentioned, Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance will be the lead Principal Investigator for the CRC study. Per the FDA’s request, the first five patients enrolled will receive 350 mg of leronlimab SQ once/week in combination with TAS-102 and bevacizumab. After a preliminary safety review by the Data and Safety Monitoring Board (“DSMB”), subsequent patients will be randomized to 350 or 700 mg of weekly leronlimab along with the same background regimen. The DSMB will perform a second safety review after the first 20 patients have completed at least 1 cycle of therapy and can then recommend restricting further enrollment to a single dose level, if deemed appropriate. For additional information, the CRC study protocol is posted on the NCI Clinical Trials website, and can be viewed here. In concert with the observation of prolonged survival in patients with mTNBC described above, CytoDyn remains focused on expeditiously resuming our clinical development in this indication. Two previously announced preclinical studies in TNBC that will identify treatment strategies to optimize the design of future studies are now underway. A third study has begun to further examine the apparent mechanism behind the observed increase in survival as compared to existing treatment paths. In the meantime, we will continue discussions with KOLs about the possibility of initiating a follow-up study in patients with mTNBC on an abbreviated timeline, based on currently available data. The Company also continues to explore the possible use of leronlimab in the treatment of glioblastoma multiforme (“GBM”). A preclinical study at the Albert Einstein College of Medicine sequencing temozolomide and leronlimab is now underway. CytoDyn is also in discussions with several KOLs in neuro-oncology about the possibility of initiating a pilot study in patients with GBM, also based on currently available data. Inflammation – March 2025 Update As previously announced, CytoDyn applied to the NIH/RECOVER-TLC group for the inclusion of leronlimab in their next round of Long Covid treatment studies. The shifting policy landscape in the United States has created some uncertainty around governmentsponsored funding of research, but we have been informed by a member of the RECOVER team that their review process has resumed, and we expect a decision soon. In addition, the protocol for a pilot study of leronlimab in the treatment of patients with mild to moderate Alzheimer’s Disease (“AD”) is now finalized. The study will take place at Cornell Medical Center in New York and will evaluate a neuroradiology endpoint that should provide a clear signal of leronlimab’s potential role in treating AD. The study is fully funded, and our colleagues at Cornell are engaged to move the project forward through Cornell’s institutional review process and FDA submission. A new collaborator, Dr. Tom Carmichael, Professor and Chair of Neurology at the University of California, Los Angeles, has published important preclinical observations demonstrating how a small molecule CCR5 inhibitor can expedite recovery following a cerebrovascular accident (“CVA” or “stroke”). CytoDyn is working with Dr. Carmichael and Dr. Kate Schunke at the University of Hawaii to conduct a preclinical study of stroke in transgenic mice that express human CCR5. We are excited by this initiative, given our view that there is an unmet need for innovative and effective treatment paths for patients in this category, and our belief that the market for therapies to treat stroke and/or traumatic brain injury could grow significantly over the next several decades. Dr. Carmichael will also be advising on the pilot study of AD to be initiated at Cornell Medical Center in New York. As announced via press release on February 6, 2025, the final results from SMC Laboratories (“SMC”) indicated statistically significant reversal of liver fibrosis (p< 0.01) in all 3 studies conducted at SMC. Importantly, the reversal of fibrosis appears to be independent of the mechanism of liver insult, as the effect was seen in both metabolic-dysfunction associated steatohepatitis (“MASH”) and CCL4 models of liver injury. To call attention to a key point of clarification, the final results at SMC did not confirm a significant effect of leronlimab on fat accumulation in the liver in the MASH model. Given this observation, we will pause development efforts related to MASH in the near term. Instead, we are continuing discussions with potential partners who have expressed interest in funding studies of leronlimab in the treatment of patients with organ fibrosis to build on the promising findings listed above. Other – March 2025 Update As previously announced, CytoDyn is partnering with the American Foundation for AIDS Research (“amfAR”) to sponsor an HIV cure study called LATCH (Leronlimab in Allogenic stem cell Transplant to Cure HIV). The clinical teams at Oregon Health and Sciences University and the University of Washington remain confident in the chances of success of their LATCH protocol and we look forward to the launch of this program in 2025. CytoDyn continues to prioritize the publication of our clinical data. The exciting observation of improved survival in patients with mTNBC treated with leronlimab has naturally prompted us to reframe the focus of our oncology manuscripts. Submission of these oncology manuscripts for peer review is a top publication priority. Additional ongoing publication efforts include: The manuscript for our CD02 Phase 3 study in patients with multi-drug-resistant HIV was recently published by the Journal of Acquired Immune Deficiency Syndromesand has been posted to our website. The manuscripts for the CD12 Acute Covid and MASH clinical studies are in final preparation for submission. A manuscript summarizing the results of treatment with leronlimab on liver fibrosis from SMC is in preparation. As previously announced, CytoDyn is preparing a manuscript summarizing the integrated safety data from the almost 1,600 patients who have already received leronlimab. The final draft of that safety summary will be completed shortly. Note Regarding Forward-Looking Statements This letter contains forward-looking statements relating to, among other things, clinical drug development and research 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 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 our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements,” and in Part I, Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statements as a result of new information or future events or developments other than as required by law. Media Contacts CytoDyn Riyaz Lalani Gagnier Communications CytoDyn@gagnierfc.com
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