I can't say how realistic this is but the poster has a ton of experience in the field. Enjoyable speculation at the very least:


Upwithstock

My Valuation of CYDY
Dear Longs,

My apologies for posting again; but my time is limited in the next few weeks and I wanted to get this off my chest. If there is a buyout, how will CYDY be evaluated?

As I mentioned in the past, I have not been in the board room while these negotiations took place. However, I supplied market information to help our side in the talks. I was fortunate enough to get some of the details after some of the meetings, or I had to wait to hear the details after the official announcement. Nonetheless, I received great insights on how some of the numbers were bantered about.

Priorities on the valuation:, no particular order!

Market Potential in the indications that are most probable for the drug to receive FDA approval in the next 5 years.

potential market penetration into each indication. Or Market share in years 1 thru 5

How competitive that indication is currently and what is known to be upcoming competition in those various indications.

What phase of development the drug is currently in. Pre-clinical, Phase 1, Phase 2 or 3

How efficacious it is to date in those early trials, what spend will it take to go to the next phases, including the pivotal phase 3 trials.

How much does it cost to take it to market?

Current Debt

Comparable buyouts. Not stock price but overall payouts, including debt. Stock price is not talked about. Every company has different outstanding share counts. What matters is the billions that will be exchanged for the assets.

Current revenue (None for CYDY)

Current FDA approvals (None for CYDY, yet)

How much does the buying company discount for no revenue, and no FDA approval. They run all of these market numbers, penetration, competition and other factors; then the buying company suddenly says we will offer 75% less because we have to finish the potential. It is a discount to the valuation because it won't be realized for 1 - 5 years, depending.

There is a ton of other factors that influence the valuation and I will not be able to cover even 10% of all of those. But, I wanted to give you all a taste of what will go down when it starts to get exciting during the negotiations.

Personally, I want CYDY to maximize our valuation as much as possible but balance that out with the risks that exist. The days of three fingers are over unless we go with a partner for so many years and that is without encountering any risks to the markets we participate in.

I'll list three risks that I had given to response to another post sometime ago:

There are also risks down the road, nothing is ever guaranteed. Many times I have seen other companies that should have sold earlier hold out for something better and several things happened:

the market conditions changed - In the Pharma space Medicare sets the standard on reimbursement and other private insurance use that as a standard for their own reimbursement policies. But, as the Baby Boomer generation continues to move almost completely into the 65 years and older category it is draining the heck out of the Medicare Funds. In 2025 Medicare will officially be operating in a deficit. It is very possible that Medicare and our wonderful Congressional policy leaders will put huge restrictions on drug pricing and pricing increasing to help keep Medicare solvent. The pharmaceutical world and their associated stock prices will be negatively affected and so will the value of an up and coming pharma company like CYDY. This is a HIGH RISK area and I hope it does not kick in, but you never know.

Today, there is high hope for Long Acting LL. No matter what, I hope that it works like we all hope it will. But, I can not tell you how many times I have seen the BIG HOPE project that will take our company over the top FAIL. BackwardsK in a response to another post said: In the biotech world there is a OLD saying; " Monkeys Lie and Mice exaggerate". Every biotech has had the experience of animal studies going well, and showing tremendous promise. Then when the human phases start it does not make it across the finish line. Should've sold when it was considered promising.

Every Pharma company is using AI to accelerate development. As freaking good as LL is, there might be a better formula out there eventually. Some AI just might develop a better drug for all of the indications we are going after.

All I am saying with just three above examples (there are more) is you take a risk waiting for a better offer and rolling the dice that everything in the future is going to be smooth sailing. If we do not get what I think is a fair offer, I am all for trying to increase the value of CYDY, by partnering and hitting milestones that carry more value. In the end, I am aware of some of the risks ahead, but its the risks you don't see coming are the ones that really hurt the most.

Let's TAKE A LOOK AT CYDY's POTENTIAL VALUE:

I think that CYDY Leadership and the BoD of CytoDyn can and should be confident that Leronlimab has the potential to be bigger than Humira and Keytruda combined. But, it would take at least 12 - 15+ years to achieve as many indications as those two drugs have. Both of those drugs are roughly $20 billion each annually. And both drugs are under attack. They are losing patent protection and biosimilars are biting at their ankles and will soon be biting off their legs. I can almost guarantee that the buying BP company is not going to value anything past five years.

Great that CYDY leadership will hold out for a fair offer but what is a fair offer when one side is high and the other is low? That is when they start to look at comparables:

Information on Merck's acquisition activities:

Merck was in discussions with a company called Seagen. They actually were in discussions to buy Seagen out for $40 Billion dollars, mainly for a drug called 'LV" that was supposed to treat breast cancer. Merck spent about $1.6 billion prior in partnership payments only to back out because Merck stated; "a new emerging treatment has come to light with better outcomes." But Merck was ready to pay $40 Billion for Seagen. Pfizer ended up buying Seagen for $43 billion. This is the article: https://www.fiercebiotech.com/biotech/seagan-puts-16b-merck-partnered-adc-back-burner

The other recent buyout discussions that took place with Merck is with Prometheus. In December 2022, Prometheus announced positive results for MK-7240 from ARTEMIS-UC, a Phase 2, placebo-controlled study evaluating safety and efficacy in patients with moderate-to-severely active UC and APOLLO-CD, and a Phase 2A, open-label study evaluating safety and efficacy in patients with moderate-to-severe CD. Merck bought Prometheus for $10.8 Billion after a phase 2 trial and phase 2A trial. Link to article: https://www.biospace.com/article/merck-leans-into-immunology-with-10-8b-prometheus-buy/

The THE ULCERATIVE COLITIS MARKET SIZE WAS VALUED AT USD 7.24 BILLION IN 2021 AND IS EXPECTED TO REACH USD 12 BILLION BY 2027, GROWING AT A CAGR OF 8.77% DURING 2022-2027

The global Crohn's disease treatment market size is $11.68 Billion by end of 2023. The market is expected to grow at a CAGR of 4.3% until 2033 and be valued at $17.8 billion. (Future market insights

Between the two possible indications UC & CD) using the most recent valuations, the combined market size is $18.92 Billion. Merck paid $10.8 Billion for Prometheus. That's roughly 57% of the potential market size.

Let's look at Leronlimab and market potential: This was a market size analysis done by Synthesis 1

HIV market just in America is $14 Billion: The Global HIV Drugs Market was valued at USD 31.3 Billion in 2021 and is projected to reach a value of USD 40.3 Billion by 2028 at a CAGR (Compound Annual Growth Rate) of 3.7% over the forecast period.

Cancers: Melanoma Full market value $8.19 billion 2019, Brain glioblastoma $2.83 billion 2021, Throat $1.48 Billion 2019, Lung $17.9 billion 2018, Stomach $2.6 billion 2018, Colon $15.3 billion 2020, Breast 21.58 2019 , Ovarian $2.9 Billion 2022, Pancreas $2.41 B 2020 The total listed here and I left a few off the tally: $75.19 Billion total but I am going to use just Breast and Colon: $36.88

NASH $84 Billion 2029 from Madrigal's press release

Market size for Leronlimab: Taking just HIV, NASH, and Breast/Colon cancer, we get: 152.18 Billion dollar market size, and that was all data that is a year or older. Not including any growth rates. If I use the 57% purchase price of the market size from Prometheus and use it on the $152.18 Market size of Leronlimab, we get an offer of $86.74 billion buyout. Is that the formula for this buyout?

What I am suggesting to the BoD is: whoever is trying to buy us out needs to understand from CytoDyn how we value the company's number one asset, 'Leronlimab'. The potential is enormous and Merck clearly showed that they are willing to pay for potential with Prometheus. If AI is being used to help with the discovery of value, then I am underestimating the potential of Leronliamb in my example. There is a plethora of articles citing CCR5 as a major contributor to many disease states and Ohm20 created a list of 90 possible indications that a CCR5 inhibitor could potentially treat. I only broke it down to 3 main indications. Plus, I don't have the time to break this down into market penetration and associated revenue for years 1 thru 5.

The below spreadsheet should help people understand why CYDY is not going to get three digits if CYDY gets Bought out in the 4-24 months. I am fairly confident that most of these buyouts all involve companies that had significant revenue when they got Bought. The buying companies all want to recoup their investments in a reasonable amount of time (5-8 years). If the first five years are trying to get FDA approval before revenue is initiated, then the buying company is going to discount that.

Below is a list of the Largest mergers and acquisitions:

Year Purchaser Target [1]Transaction type Value — with debt(in billions USD) Value — with debt(adjusted for inflation) Ref
1999 Pfizer Warner-Lambert Acquisition 111.8 204 [2]
2000 Glaxo Wellcome plc SmithKline Beecham (formed GlaxoSmithKline)Merger 76.0 134
2019 Bristol-Myers Squibb Celgene Acquisition 74.0 — 95.0 88 — 113 [3]
2004 Sanofi Aventis Acquisition 73.5 104
2015 Actavis Allergan, Inc Acquisition 70.5 91 [4][5][6]
2009 Pfizer Wyeth Acquisition 68.0 97
2002 Pfizer Pharmacia Acquisition 64.3 109 [7]
2018 Takeda Pharmaceutical Shire Acquisition 62.0 75 [8]
2016 Bayer Monsanto Acquisition 54.5 — 63.5 69 — 81
2009 Merck & Co. Schering-Plough Acquisition 47.1 67 [9]
2009 Roche Genentech Acquisition 44.0 62
2014 Medtronic Covidien Acquisition 42.3 54
2015 Teva Pharmaceutical Industries Actavis Business Unit 40.5 52
2010 Novartis Alcon Acquisition 39.3 55
2016 Shire Baxalta Acquisition Unit 32.0 — 35.0 41 — 44
2016 Abbott Laboratories St Jude Medical Acquisition 30.5 39
1998 Astra AB Zeneca (formed AstraZeneca)Merger 30.4 57
2017 Johnson & Johnson Actelion Acquisition 30.0 37
1996 Ciba-Geigy Sandoz (formed Novartis)Merger 29.0 56
2006 Boston Scientific Abbott Laboratories Guidant Acquisition 27.2 41
1999 Pharmacia & Upjohn Monsanto Merger 25.2 46
2016 Abbott Laboratories St Jude Medical Acquisition 25.0 — 30.5 32 — 39
2015 AbbVie Pharmacyclics Acquisition 21.0 27
2014 Actavis Forest Laboratories Acquisition 20.7 27
2011 Sanofi Genzyme Corporation Acquisition 20.1 27
2012 Johnson & Johnson Synthes Acquisition 19.7 26
2006 Bayer Schering Acquisition 18.4 28
2016 Quintiles IMS Health (formed QuintilesIMS)Merger 17.6 22
2015 Pfizer Hospira Acquisition 17.0 22
2014 Merck Group Sigma-Aldrich Acquisition 17.0 22
2001 Amgen Immunex Acquisition 16.8 29
2006 Johnson & Johnson Pfizer Consumer Health Business Unit 16.6 25
2014 Novartis GlaxoSmithKline Oncology Business Unit 16.0 21
2015 Valeant Salix Pharmaceuticals Acquisition 15.8 20
2007 AstraZeneca MedImmune Acquisition 14.7 22
2007 Schering Plough Organon International Acquisition 14.5 21
1995 Glaxo Wellcome Acquisition 14.2 28
2014 Bayer Merck & Co Consumer Health Business Unit 14.2 18
2014 Zimmer Inc. Biomet Inc. Acquisition 13.4 17
2019 Amgen Otezla (drug programme) Acquisition 13.4 16
2006 Merck Group Serono Acquisition 13.2 20
2018 GlaxoSmithKline GlaxoSmithKline–Novartis Consumer Healthcare Acquisition 13.0 16
2016 Boehringer Ingelheim Sanofi MerialAnimal Health ( ) Business Unit 12.4 16
2017 Gilead Sciences Kite Pharma Acquisition 11.9 15
2018 Sanofi Bioverativ Acquisition 11.6 14
2011 Gilead Sciences Pharmasset Acquisition 11.2 15
2013 Amgen Onyx Pharmaceuticals Acquisition 10.4 14
2020 AbbVie Allergan Acquisition 63.0 74
2024 Novo Holdings A/S Catalent Acquisition 16.5 17
When GSK finally buys CYDY, they will be buying whatever debt that CYDY has at that time. That's why I like the spreadsheet above because it shows how much debt was at play during the buyout. Most of the time, the debt is paid off immediately or gets absorbed and is paid back in roughly the same manner/terms that existed before the buyout. In other words, the debt transfers with the new owners.

For the Crowd that believes that CYDY should hold out for $100 per share or as high as $999 per share. Let's see how that LOOKS TO THE BIG BOY purchases above.

$100 x 1.23 Billion shares outstanding = $123 Billion for CYDY, with no revenue. That would be the LARGEST buyout in the HISTORY of pharmaceuticals.

Do I want to get $100 per share? Of course, but I know the risks and how long that would take. I am hoping a buyout happens before the end of 2025. My best comparable is Prometheus. I shared the Prometheus stats above. No doubt that LL, and Long Lasting LL has way more value and 3X to 4X over the $10.8 billion buyout price is what I think CYDY can fairly argue and negotiate. That 3X to 4X translates to: $32.4 Billion to $43.2 billion. which translates to $26.34 per share or $35.12 per share.

Have a SUPER SUNDAY and Go CYDY!

I'd appreciate your not replying to my posts in such a way as to confuse me with the posters you recall.

I'm not part of the I hate Pestell club. Mostly I've read good things about his expertise in cancer research. That is all I care about. If JL and company believe he can help, who am I to argue otherwise.

I usually skip over hatred posts about Gates and most others. I know he his giving away billions to try and help the world. Bless him if he decides to use leronlimab to assist in that endeavor. I'd say it is a long shot but there is an incredibly strong connection between the GF and Cytodyn, His name is Dr Max Lataillade.

Have a good weekend.

You should do better being an intelligent person not to mention being a moderator.

https://www.psychologytoday.com/us/blog/the-full-picture/202408/the-psychology-behind-name-calling-in-politics-and-beyond#:~:text=What%27s%20at%20the%20Root%20of,by%20tearing%20down%20innocent%20others.

What’s at the Root of Name-Calling?
Calling others names they do not deserve stems from insecurities, displaced aggression, or the need to dominate and/or control a partner/friend/coworker/etc.

Those who do not have much ego strength build themselves up by tearing down innocent others. It’s a maladaptive pattern that could stem from learned behavior—that is, witnessing others do this in childhood. It may also arise from unresolved emotional issues.

Timing means a lot in investing. Whether it be CYDY or otherwise. You are enjoying looking backwards when almost everything appears to be heading in a positve direction.Not being able to change one's opinion, even in the face of new evidence or compelling arguments, can be a sign of stubbornness, dogmatism, or a strong adherence to ideology.

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.

I agree with the resistance level. That is just a day/swing trader spot on the chart. Long term holders would be looking to get above there and have it stay there a bit. We could say the same about 40 cents. There is room above there. I am disappointed it hasn't done more the last couple of days but I'm hearing private placement holders are raising money.

Hard to say what can happen given the right circumstances. Patience is required by the long term investors.

Have a great weekend!

Looking forward to hearing directly from Drs Pestell, Lataillade and Palmer. Perhaps we will have a shareholders call over the next month or so as things come together. I'd also like to get Dr Arman's perspective on everything that has happened since he came aboard and especially since Dr Lalezari took over.

One wonders if CYDY/GSK are in talks:

From doit4dale on Stocktwits. Look at what Emma just said:

Chief Executive Officer (CEO) Emma Walmsley said the company lifted its 2031 estimate as the company is "increasing and prioritizing R&D investment to promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV.”

From Katangolo over on ,,,,

Cardio and pulmonary fibrosis opens up a whole new ball game. The mention of statistically significant reversal in fibrosis in three different studies is massive And shouldn’t be taken lightly. In fact, if I am a company looking at MASH or fibrosis in any organ system then I am picking up the phone and calling CYDY and saying hey, can we sit down and talk about what you’ve got?

It sounds like there are multiple parties sitting at the table and they haven’t decided on which one yet and because of that they put out a PR to make The shareholders happy. But this also puts the news out to the public and to other big Pharma companies Saying hey, we can reverse fibrosis and we believe we can across multiple organ systems and we are open to discussions about how to move forward with a partnership or partnerships.

No mention of Ozempic is interesting. In the first mouse study, they mentioned Resmiterom (MDGL) And the fact that LL was trending Towards a reversal in fibrosis And now we have statistically significant proof. And the prospectus from last fall said that there was a threefold decrease in fat deposits in the liver . This is also very significant news .

So I am assuming that because they did not mention that they were better than Ozempic there could be a synergistic effect With Ozempic and LL. And that makes me think Novo is still sitting at the table, but CYDY put the data out there to tempt others into a Partnership discussion. Hello Eli Lilly and anyone else looking at fibrosis in other organs!

Partnership/licensing agreements take more time than most people want, and that dreaded anticipation word has to be acknowledged.

This last paragraph reads quite nicely when you think about a partnership:

“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.”

So they are acknowledging that partnerships take time, and I believe that there are several seats at the table that are filled, and there are more companies wanting to sit down and talk. After this press release, there should be more interest and I’m OK waiting As they entertain discussions and sort through the offers.

Sounds like Jay knows this thing is going to explode and he just telegraphed that to us. (bolding mine)

Patience then Patients.

ValueInflection
6m
$CYDY LL should be given fast track status, break through therapy designation, whatever the FDA can give, to allow LL to be used to treat MASH ASAP.

CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories
Download as PDFFebruary 06, 2025 8:30am EST
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.

I've been hearing similar, plus reading some interesting ideas about the talks CYDY is having.

Reminds me of something related. I asked my wife the other day why our after hours activity had slowed. She responded with "after 30 years of marriage, we have entered the we are talking phase."

I hope CYDY and the new partner get their crap together. I'd like an update.

Yeah, those cute little lab mice must hate seeing the leronlimab injection coming to get rid of so much fat and fibrosis, thus extending their lives quite a bit compared to the current available treatment.

I suggest you check with Drs Pestell and Lalezari regarding cancer priorities or wait until the next update to see if anything has changed.. Here is what we know:

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.


I'm no securities rule expert. I'll take your word for the filing info. If, or more likely when, Cytodyn has a partner or investor, once the paperwork is finalized we will be informed.

Upwithstock

MASH Results? and Ohhhhh baby part 2
Dear Longs,

It is Friday night and it has been a long week, but it has been a long four + years for a lot of investors.

I posted a couple of topics just recently: One about the MASH Poster being pulled last minute from a MASH TAG conference. Plus, I posted about Refinitive data that is on several trading platforms and on YF.

I have to thank RESPERT from Investor Hangout for the inspiration for this post and for some other posts complaining about not having the MASH mice data by today.

As most of you know, I am voicing my opinion. It is speculation on my part.

I am asking Longs to review with me now the MASH part of the Shareholder letter dated 12-17-24:

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.

I have been at these Cardiology conferences for 33 years and in the last 20 years, they started doing these "Late-Breaking" abstracts at these conferences. To qualify for a "late-breaking" abstract, the content has to be pretty special.

Sometime after the Shareholder Letter was issued on 12-17-24, we found out that CYDY did indeed submit their abstract/Poster and it was accepted. The conference link: https://www.mashtag.org/ was held January 9-11th in Park City, UT. A couple of days before the start of the MASH TAG conference, it was reported by Long investors that CYDY pulled the abstract/Poster from that meeting, and Melissa Palmer would not attend.

Key POINT #1: You do not submit an abstract for late-breaking announcement at a conference if you got crappy data. It must've been GREAT data to be considered for "Late-Breaking" status.

So, for whatever reason, they pulled the accepted abstract/poster from the conference, it is the same reason not to disclose that information from the investor community and the general public at the end of January. To be fair, Dr. JL never said he would disclose the data to the general public. Nonetheless, What could that reason be???

I pointed this out in my OHHHHH Baby post but will reiterate briefly here: IMO the reason that CYDY pulled the MASH abstract/poster from the MASH TAG conference is because they were told to by their future partner in MASH. Why do I think that?

We longs have been reading for a couple of years, since Cyrus laid out his first plan in 2022, about how MASH studies would result in partnership in MASH. When Dr. JL first came on in his official CEO role, I remember a comment about CYDY being told to perform certain pre-clinical studies to obtain a partner.

Here we are, with no announced partnership! If CYDY was not in talks of any kind; CYDY would have been at the MASH TAG conference waving the LATE-BREAKING ABSTRACT POSTER in the FACES of every BP who attended that conference. But, we pulled out; because in my opinion, we were told to. Whoever, the partner is wants to keep a low profile on two things:

LL is freaking GREAT drug especially in MASH, and why let the competition know. In the competitive world we live in, you try to keep intelligence out of the competitors' hands as long as possible.

Until the MASH partnership with CYDY is locked up, the partner probably does not want another BP to jump into the mix. My God!!

Lastly, whats up with the Refinitiv data?? I have read a lot of posts saying the ten days is up on a 13D filing. But, in my other post regarding Refinitiv; I stated the following:

From SEC website:

What Is Schedule 13D? Schedule 13D is a form that must be filed with the U.S. Securities and Exchange Commission (SEC) when a person or group acquires more than 5% of a voting class of a company's equity shares. Schedule 13D must be filed within 10 days of the filer reaching a 5% stake.

Additional information:

What is the rule 13D 60 days?
Rights to acquire beneficial ownership: Under Rule 13d-3(d)(1), a person is deemed a beneficial owner of an equity security if the person (1) has a right to acquire beneficial ownership of the equity security within 60 days or (2) acquires the right to acquire beneficial ownership of the equity security with the ...Oct 27, 2023

NOW THAT IS INTERESTING. This entity/institution/person is deemed a beneficial owner of an equity with the rights to ACQUIRE beneficial ownership of equity within 60 days. Basically, this entity has to ACQUIRE their plus 5% ownership within 60 days!

Is that why Refinitiv data is ahead of the 13 D filing? I hope so!

More from Bogelhead20 on ST:

Refinitiv, previously owned by Thompson Reuters and Blackstone, had extensive access to financial data networks, which allowed it to track market activities like private placements and institutional ownership BEFORE the SEC filings were made public.

END of post from a few days ago.

You can see that from the SEC, you may have a situation of some entity with "rights" to acquire more than 5%. This entity has 60 days to acquire the amount of shares that exceed a minimum of 5%. Isn't Refinitiv reporting 21.4%?? Could this be the potential partner?

The MASH partnership is where my thoughts are leaning. I have waited 4+ years, what's another 60 days?

Have a great weekend!

NikNak1, please review the rules IH has regarding posting. I believe posts regarding deletions are not about CYDY and therefore considered off topic.
I look forward to reading more of your posts in the future.

Naked shorting is certainly happening and I suspect stocks like CYDY being on the OTC are more susceptible to this activity. Looking forward to hearing from the company next week with an update of what has happened since the last shareholders letter was released.

PSA:

IH Geek [Dave]

Member Level
Re: None

Tuesday, January 28, 2025 4:22:58 PM

Post#
218985
of 219011
Early heads up.. the last and most complex part of migrating our systems to a cloud-based infrastructure will start on Saturday morning. There will be extended periods when the site is down completely and inevitably other times when various parts of the site are not working properly. We'll have plenty to do so there won't be a lot of interaction here until most of the obvious dust, debris and boulders have settled

Guess who gets a mention? Thanks brentie!

Submission received: 18 December 2024 / Revised: 18 January 2025 / Accepted: 27 January 2025 / Published: 30 January 2025

3.1. Mononclonal Antibodies

"Leronlimab is currently in phase III clinical trials for preventing HIV infection [308], but has previously shown promise in treating breast cancer. In triple negative breast cancer lines, Leronlimab was shown to reduce migration, calcium signalling, as well as enhance the effect of doxorubicin in killing breast cancer cells. Furthermore, in xenograft mice models it was able to reduce tumour burden of > 95% after 6 weeks of treatments [309].
Leronlimab has also shown success in early clinical trials; a phase I trial showed that it was well-tolerated in combination with carboplatin and showed early signs of anti-tumour activity [310]. In a basket study of advanced and metastatic solid tumours, Leronlimuab showed a median progression free survival of 6 months in greater than 75% of patients, along with a reduction in circulating tumour associated cells [311]."

https://www.mdpi.com/2673-6284/14/1/7

Here is one just for you:

Designer_Anteater_18

"Strategy" to trap the shorts
The best way for CytoDyn (CYDY) to trap short sellers—especially those who may be artificially suppressing the stock price—would be to execute a short squeeze strategy by releasing catalysts that force shorts to cover at higher prices. Here’s how they could do it:

1. Surprise Positive News Catalyst
Shorts profit when a stock declines, but they get trapped when unexpected good news forces a sharp rally. CYDY could trigger a squeeze with:

Partnership Announcements – If CYDY announces a major partnership (e.g., with GSK, Madrigal, Merck, or the Gates Foundation), short sellers would scramble to cover.

FDA Approvals or Breakthrough Designation – A regulatory green light (e.g., Fast Track designation or Phase II/III clearance) would send shares soaring.

Clinical Data Release – If CYDY releases blockbuster oncology or NASH trial results, it could force shorts to exit.

2. Strategic Uplisting to NASDAQ
Many institutional investors can't buy OTC stocks, so an uplisting would invite new big money buyers and put pressure on shorts.

Uplisting requires a higher share price, which could be achieved via a reverse split (if necessary) and strategic news flow.

3. Buyout or Licensing Deals
If CYDY secures a licensing agreement or buyout offer, shorts could be forced to cover instantly, causing a rapid price spike.

A big pharma company like GSK, Merck, or Madrigal partnering for oncology or NASH would be a nightmare for shorts.

4. Restrict Share Availability (Float Reduction)
CYDY could reduce the float by having insiders, long-term investors, or institutions buy up available shares, making it harder for shorts to cover.

A share buyback program (if financially viable) would also shrink supply and squeeze shorts.

5. Legal or Regulatory Pressure on Naked Short Selling
If there is evidence of naked shorting or manipulation, CYDY could file complaints with the SEC and FINRA to force accountability.

Some biotech stocks have fought back by exposing Failure to Deliver (FTD) reports or hiring forensic analysts to uncover manipulation.

6. Strategic Press Releases and Media Blitz
CYDY should control the narrative and highlight its pipeline value, forcing analysts and media to cover it fairly.

A well-timed CEO interview or industry conference presentation could attract new buyers and disrupt short strategies.

7. Force Short Sellers to Pay Higher Borrowing Costs
If demand for shares increases, the cost to borrow (interest shorts pay to hold their positions) will rise.

A combination of higher volume, news flow, and insider buying could increase the short borrow rate, making it too expensive to maintain large short positions.

Final Thoughts
If CYDY executes multiple catalysts back-to-back, shorts will have no choice but to cover at higher prices, triggering a massive squeeze. A perfect storm would be a major partnership, breakthrough clinical data, and NASDAQ uplisting all within weeks of each other. If management plays this right, a squeeze could send CYDY to new highs quickly.

You have a point about CYDY's past history of ups and downs. I'm very patient and am happy to wait.

Sad that someone finds humor in other's misfortune. I can't imagine why a fellow investor would be that way.

I'm sure you are really hoping for CYDY to be successful in the coming years so investors can benefit and Cytodyn can help a lot of patients along the way.

A short summary of what is ahead by BGT:

BuildGoodThings

Making sense, then dollars
Awareness percolates at different speeds through institutions and individuals. Additional investors in 2025 will shape a different share price. This post is not investment advice. For entertainment, people might consider:

Why now?
The activity in clinical trials has increased. 2025 Leronlimab clinical trials are expected in a number of diseases: Colorectal Cancer, Alzheimer's, and HIV.

It has been mentioned in press releases in 2024 that licensing or partnerships in some diseases may be considered.

Phase 2 or Phase 3 data already exists from studies in MASH, HIV, Breast Cancer (TNBC), and Covid.

What has recently made CytoDyn (CYDY) more compelling?
There is financial support coming from 3rd parties for upcoming clinical trials in Alzheimer's (2025), HIV LATCH (2025). Perhaps also in Pulmonary Fibrosis.

The company did not request to increase the number of authorized common shares at the annual meeting in November 2024.

The recently appointed Cytodyn Senior Vice President and Head of Clinical Development was also recently appointed to be Head of HIV Drug Development at the Bill & Melinda Gates Foundation.

In addition to Phase 3 HIV monotherapy data, there is recent & compelling preclinical data in primates of 3 approaches to an HIV cure or functional cure.

The recent MASH & Oncology consulting appointments in October and November 2024 have distinguished backgrounds & networks.

Leronlimab crosses the blood-brain barrier as well as the placenta.

Additional clinical studies might be considered in Breast Cancer (TNBC), Chronic Fatigue Syndrome, Chronic Inflammation, COVID PASC (longhaulers), Glioblastoma, HIV, MASH, Pulmonary Fibrosis, or others. 4 of these already have phase 2 data.

A manuscript about the safety profile of Leronlimab using data from multiple previously completed clinical trials is being developed for publication.

CytoDyn said in the December 17, 2024 press release that:
We "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."

"the Company has sufficient cash and drug supplies on hand to complete its clinical priorities in 2025"

The Alzheimer's clinical trial "is now fully funded by an outside foundation"

"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)."

More information can be found at sources including:
CytoDyn 2024 press releases https://www.cytodyn.com/newsroom/press-releases?year=2024

10/23/24 pre-clinical oral abstract: 2024-NHP-AIDS(New Orleans) "AAV Delivery of the CCR5-blocking monoclonal antibody Leronlimab yields long-term expression and ART-free remission from SHIV viremia" 4 of 8 complete CCR5 RO for >1.5years post-AAV, 3 of the remaining 4 return of CCR5 RO approximately 1 year post-AAV. https://tulane.app.box.com/s/85cwf9gyyp1ghy2jb8x1ypo81dvktrqm

Crossing placenta https://www.tandfonline.com/doi/full/10.1080/19420862.2024.2406788

Video of SHIV Triple therapy research presentation https://plus.iasociety.org/webcasts/planet-apes-learning-immunogenicity-animal-models

Reposting as a reminder of what is anticipated now that we are ending January:

December 2024 Letter to Shareholders
Download as PDFDecember 17, 2024 8:30am EST
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.

Hope it is true but it is possible it's a mistake or possibly the way Paulson investors shares are being accounted for. We'll see before too long. Thanks for posting. It is great to see old posters returning and contributing.

I hope CYDY has a small part in helping you to have a wonderful birthday. I think many of us are hoping for news between this week and next. Best of luck to you and Cytodyn!

Thanks mighty cydy:

Posted By: mightycydy
New Bill Gates quote re: HIV Cure "on its way"

'‘I believe in HIV medicines, where the US is keeping tens of millions of people alive. If you cut those off, not only would they die when we have a cure on its way , the negative feelings you’d have say in Africa would be worse than never having done that thing at all.'
(Source:

Anything can happen even for CYDY being on the OTC market. Partial credit to Biostocktraderbyday for this info:

Several biotech companies that initially started as over-the-counter (OTC) stocks or smaller companies have gone on to become major players in the pharmaceutical and biotech industries. These companies often gained success by developing breakthrough treatments and seeing their stock prices soar. Here’s a list of some noteworthy companies that began in OTC markets but eventually became more prominent:

1. Amgen (AMGN)
OTC Origins: Originally started in 1980 as a small biotech company, trading under various names before going public.
Success: Amgen is one of the largest biotechnology firms in the world. Their blockbuster drugs, such as Enbrel (for autoimmune diseases) and Neulasta (for cancer patients), have driven immense financial success.
Stock Price Performance: Over the years, Amgen’s stock price has risen significantly, becoming a staple of biotech investing.
2. Gilead Sciences (GILD)
OTC Origins: Gilead started as a small biotech company and traded on the OTC market in its early days in the 1990s.
Success: Gilead revolutionized the treatment of HIV and hepatitis C with drugs like Sovaldi and Harvoni. Later, its acquisition of Kite Pharma helped establish it in the CAR-T cancer therapy space.
Stock Price Performance: After gaining approval for key drugs, Gilead’s stock price surged, and it became one of the most valuable biotech companies.
3. Regeneron Pharmaceuticals (REGN)
OTC Origins: Founded in 1988 and initially traded as a smaller entity.
Success: Regeneron has had huge successes with drugs like Eylea (for eye diseases) and Dupixent (for asthma, eczema, and other inflammatory conditions).
Stock Price Performance: Regeneron’s stock has performed exceptionally well, particularly since 2014, when its revenue started to skyrocket from Eylea and Dupixent sales.
4. Vertex Pharmaceuticals (VRTX)
OTC Origins: Vertex started out in the late 1980s, and its early stock performance was often on the lower end of the spectrum.
Success: Vertex revolutionized cystic fibrosis treatment with its highly effective CFTR modulator drugs, such as Kalydeco and Trikafta.
Stock Price Performance: Vertex saw substantial stock price growth as its cystic fibrosis drugs generated billions in sales.
5. Biogen (BIIB)
OTC Origins: Biogen was founded in 1978 and, while it wasn’t initially traded as an OTC company, it did have humble beginnings before going public in the 1980s.
Success: Biogen became a leader in multiple sclerosis (MS) treatment, with drugs like Avonex and Tecfidera. More recently, its Alzheimer's treatment Aduhelm (despite controversy) has put Biogen in the spotlight.
Stock Price Performance: Over time, Biogen’s stock price surged, especially with the success of its MS therapies.
6. Moderna (MRNA)
OTC Origins: Moderna was founded in 2010 and initially had a less visible presence in the market before it went public in 2018.
Success: Moderna’s development of one of the most widely used COVID-19 vaccines, based on its mRNA technology, brought it global recognition.
Stock Price Performance: Moderna’s stock saw a meteoric rise during the pandemic, as the company’s vaccine became a cornerstone of global vaccine distribution.
7. Illumina (ILMN)
OTC Origins: Illumina started as a small, specialized company in the early 2000s in the genomic sequencing space and had early trading at relatively low prices.
Success: Illumina became a leader in genomic sequencing technology, crucial for various fields including diagnostics and personalized medicine.
Stock Price Performance: Illumina has seen dramatic growth in stock price as the genomic sequencing market has expanded, becoming one of the most significant biotech companies in the world.
8. NantKwest (NK)
OTC Origins: A smaller biotech firm originally focused on immunotherapy and oncology treatments, trading in OTC markets before eventually going public.
Success: While not as established as others on the list, NantKwest’s focus on immunotherapy and the promise of its NK cell-based cancer therapies led to notable stock performance, especially post-IPO.
Stock Price Performance: Though volatile, the company’s potential has intrigued investors, and its stock price surged after its IPO, although it’s had more ups and downs compared to the larger players.
9. Exelixis (EXEL)
OTC Origins: Exelixis was founded in the early 1990s and initially had a low profile before it became more prominent in the cancer treatment space.
Success: Exelixis gained attention with its cancer drugs like Cabometyx (for kidney cancer) and Cometriq (for thyroid cancer).
Stock Price Performance: Exelixis’ stock has seen significant increases as it advanced its cancer treatments, making it a leader in oncology.
10. Sarepta Therapeutics (SRPT)
OTC Origins: Sarepta started out in the 1990s, trading in smaller markets before it became more widely recognized.
Success: Sarepta is a leader in developing treatments for rare genetic diseases, especially Duchenne muscular dystrophy, with drugs like Exondys 51 and Vyondys 53.
Stock Price Performance: Sarepta's stock price has fluctuated significantly but rose sharply after its success with Duchenne treatments, making it a favorite for investors in the rare disease space.

These companies demonstrate how biotech firms, even if starting in less prominent markets or as smaller OTC stocks, can achieve significant success with breakthrough therapies. Their growth is often driven by scientific innovation, regulatory approval of high-demand treatments, and expanding market opportunities.

Build Good Things is usually a nice read:
Go to Livimmune
r/Livimmune
•
2 hr. ago
BuildGoodThings

Listen to J. Sacha present the HIV Triple Therapy research. 10 min.
10/9/2024 Audio with slides https://plus.iasociety.org/webcasts/planet-apes-learning-immunogenicity-animal-models

slides only https://plus.iasociety.org/sites/default/files/2024-11/presentation-slides_313.pptx

Well maybe it's just my opinion but I think this data in early October 2024 shook some things up. The Cytodyn appointment of Max Lataillade was announced the same week. Then a short time after that we see Max update his LinkedIn to show both Cytodyn and Gates Foundation as current.

IMO there are a few big time quotes in the presentation that attendees heard 3 months ago starting at the 1 minute mark.

Here are some paraphrased sections from that October 9th presentation by Sacha.

Why this is important is because it reveals a previously unknown synergy between HIV Broadly Neutralizing Antibodies and CCR5 blockade, and because all of these are in clinical development, it is a real clinical option that we can take forward.

All of this is in very stark contrast to the triple therapy group where not a single animal rebounded with plasma viremia and this data is now through 7 1/2 months off of ART.

re. DNA copies per million- In the triple therapy group, we never see any evidence. We didn’t have a single positive at any point in any of the eight animals, suggesting that perhaps the viral reservoir had been cleared.

At week 56 we took a blood draw and lymph node biopsy and we assayed it for virus specific T cells. The triple therapy group there is no evidence of a T cell response in peripheral blood or lymph nodes.

We looked at isolated CD4 T cells with a higher sensitivity assay. We didn’t have a single positive hit in any of the triple therapy animals. Again suggesting that the virus Reservoir had potentially been cleared.

So finally at week 60 we initiated a gold standard CD depletion and you can see here that in the triple therapy animals all of the CD8 T cells are removed from the blood. We don’t see any rebound of virus in any of the CD8 depleted infants that receive triple therapy, so cumulatively this data suggests that the virus reservoir was indeed actually cleared in these animals.

The latest from MGK_2:


Evolving Course
Maybe we should try to prepare everybody. There is an endgame in town, and that game is to get this drug into play on the world stage. Big players seem to have come that they may take the reigns. Jay, Max, Gates, Trump. CytoDyn is about to embark on amazing transformations which could only come as a results of the honorable and dutiful effort of bringing forth this multifaceted molecule.

Here, I don't give dates as to when precisely, but do offer approximate time frames. I discuss more and look at various and different angles. I offer a little more in the way of reasoned thought than those who are just looking for information on the timing of things. Here, I try to look a bit forward, I try to see what is happening at the moment and try to make connections or alignments that make sense for the future.

Of late, I have made mention of various reasons for discussions between CytoDyn and potential collaboration efforts. At the very last minute, and in 180 degree polar opposite opposition to what it originally claimed it was intending on doing, CytoDyn stealthily pulled out of its presentation of its initial murine study in MASH at the MASH-TAG conference. I offered up a few reasoned possibilities for why that may have occurred. In addition, we have learned of a 3-hour long conversation which took place between Bill Gates and President Trump regarding the cure of HIV. Most recently, there are now statements coming from Schwab and other reputable trading institutions that there is now 19.86% Institutional Ownership in CytoDyn when just a week or two prior, there was almost none.

No doubt, CytoDyn has been hard at work in all of its endeavors to advance this molecule. As I've listed in Almost There, the clinical indications which are most paramount are only briefly described there in so as not to make the post too lengthy or arduous. All of those indications are CytoDyn's hot spots, while there are certainly more that could have been listed, I did not want that post to go on and on, nor did I want it to be too inclusive of every little bit, but rather, wanted it to be more sort of an introduction to much of what is happening here at CytoDyn. CytoDyn has taken great effort on multiple fronts to confront each and every one of those listed indications and the gaps are certainly closing as can be appreciated in that post.

Dr. Lalezari spoke in December, that CytoDyn share holders may expect the results of CytoDyn's confirmatory murine study in MASH in January, 2025.

"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. "

At the time of the writing of this post, there are only 5 trading days left in January and Dr. Lalezari is a man of his word.

CytoDyn has excellent intentions, but speaks softly. They do carry a big stick though. Phase 1 is over and done. CytoDyn got over the clinical hold and have made tremendous headway towards the point they are at right now. Signs now point to some sort of partnership being established which should be announced in the very proximal future. Combine that with CytoDyn pulling out of MASH-TAG and Gate's recent conversation with Trump. 20% institution ownership has just been uncovered in the past week, when prior to that there was none? Yeah, with the assortment of all of these notes into a medley, I'd say this is the beginning of Phase 2. Ownership of stock marks the start date.

We can begin to ask some questions. What is the agreement and with who? Which Institution bought 20% CYDY? Will there be board seats which must be created for this investment? What are their interests? Is it with an institution with only one goal in mind such as the Gate's Foundation for an HIV Cure or like Madrigal for MASH, or could it be with an institution that has a broad spectrum of goals in mind, like GSK? With whoever it is with, they have had over a minimum of 6 weeks to discuss their plans, possibly even 3-4 months. The Shareholder meeting was on 12/17 and CytoDyn's intention was to present. However, by Christmas, those plans were shot down. Something happened and today, CytoDyn has 20% Institutional Ownership without any details surrounding that claim. That information has to come out within 10 days of that claim, so therefore, it's coming.

The deal though doesn't appear to be a licensing deal which we have so far discussed. It seems more to be an investment into CytoDyn itself, which seems to be somewhere around $40 million for about 250 million shares at about $0.15/share. These are just approximate figures and really, I'm only surmising. There is no documentation on any of this, but hopefully, there will be soon. This is not a typical partnership either and certainly, nor is it a buy out. It seems to be an investment into CytoDyn. But it exceeds 5%, so, if you might remember, that 5% is what 13D needed to exceed to be able to overthrow the CEO. Maybe, the terms of this agreement that were agreed to might have eliminated that possibility.

Most companies do not follow such a path to gain partnership. This investment at a very low and special price, at a volume in excess of 5% seems to be more along the lines of a Foundational Investment. Something more along the lines of what the Gate's Foundation would venture into. It does not seem to be something another company like Madrigal or GSK would enter into because there would be too much political influence for another Pharmaceutical to own 20% of another pharmaceutical.

What would CytoDyn gain from such investment by the GF? I would understand that CytoDyn would gain the optimization and fast tracking of all of their current indications with the help and experience of the Gate's Foundation. Certainly, the GF's primary concern is HIV Cure, but if they're 20% invested in CYDY, then, they would want all of CytoDyn's indications to succeed. By gaining the support of the GF, CytoDyn becomes well equipped to take on the challenges they face in getting HIV Cured, in proving out leronlimab in MSS mCRC and all the rest of their challenges. Those obstacles no longer become road blocks. The experience of both Max and those at the GF, dismantle these rocks in the road, driving around pot holes or filling them in with asphalt as they arise and surmount these problems with far more ease than had CytoDyn been alone. So this is where I think this is headed.

So Phase 2 has already begun, because there is 20% Institutional Investment, but we just don't know it yet, because it hasn't been announced. How many Phases are there? 3? 4? What could Phase 3 be, $400 million? CytoDyn would need more shares, but let's not consider that right now. That stage has not yet been agreed upon, but this Phase 2 has been. The details of Phase 2 should be coming out in near future. Nothing else has changed. The license deal I mentioned with Novo Nordisk might still be in play. But, in addition, I do suspect an investment by the GF and then it is back to business as usual, now however, with the assistance of the GF in overcoming obstacles in the effort to reach shared goals.

Now, with this in place, when G attacks CytoDyn, they would also be attacking the GF. Remember, the GF also has Trump and his minions backing their efforts, or is that Phase 3? Lalezari remains CEO, at the helm and is on the offensive. Now, with this substantial investment and backing, he is only that much more powerful. As the obstacles arise and present themselves to him, he brings them up to his collaborating partners for their analysis and their strategy to overcome this persistent resistance.

So, I believe that the GF wants very much to be a massive part of the HIV Cure. I also believe that Trump wants very much to be a significant contributor to the HIV Cure. Currently, and still only hypothetically, they own only 20% of CYDY and that 20%, my suspicion shall not be sufficient for purposes of their ego. But, at this early point, they are not yet quite ready to go for it all. They need more proof. So once the proof is made, then Phase 3 goes into action. Could that be when Trump enters? Regardless, that's where the real money comes in.

How hard does CytoDyn run towards their end goals? What changes does this Phase 2 investment bring? How great a resistance is made against any progression towards these goals? Remember, any time in the past that CytoDyn met resistance, it has always overcome it and has come out on top. That doesn't change. Lalezari remains in control, that is at least until shareholders own less than 50%, and Jay shall see it through to completion. There shall be a hefty price to pay for 100% of the shares, but that might be Phase 4 or 5, but, he won't let it be completely bought out until he knows the drug shall obtain approval.

Provided this investment into CytoDyn takes root and does begin to grow, as in progress made towards an HIV Cure, then Phase 3 assuredly, is down the road. But if no headway is made and failure in the goal near term is met, then the GF might want to pull out if they are not that interested in the other indications. But, who then would be interested in the other indications? I think then, it could go back to GSK who for many reasons, share the same ideology as CytoDyn and who has a great familiarity with Max Lataillade.

But if there is progress and it does come to Phase 3, that would be to the point where an HIV Cure is just about definite, does the GF settle for only 49%? I don't believe CytoDyn can let go of 51% or more and be left with 49% or less, because CytoDyn needs to have control. But would only 49% be satisfactory for the GF? They may just have to make an offer for 100% at that point when the destiny of the other indications is better understood. It seems to me that considering the vast number of indications that leronlimab can handle, it becomes harder and harder to understand why Lalezari could choose to give up CytoDyn's right to control the rest of them.

None of this was understood on the day of the Shareholder's letter, 12/17/24. But, today, we are beginning to understand, that there appears to be collaborative efforts which are materializing in such a way as to result in the cure of HIV and the establishment of leronlimab as an approved medication in the fight against cancer, MASH and many more inflammatory diseases, provided that these efforts do progress to their next interval step which does require the success of the preceding phasic effort.

Provided the collaboration is successful, it won't be long before there is an approved HIV Cure. Could be as soon as mid 2027 if everything goes right. That would be 3 years ahead of Trump's HIV-2030 goal and Trump would eat that notoriety up, that HIV was cured under his watch and under his investment. The massive investment made by the GF would also not go unnoticed. So, that is the end game, which is just beginning now, which is the signing off of Phase 2, the beginning of a collaboration to get serious about an actual HIV Cure. The next few years to get there, are like a new era of time. The work is yet to begin and the work shall begin. How long? Everything like this takes time, but with the help of the GF, the Trump assistance and Max's experience, it takes a lot less time than it would have otherwise without them.

The direction is changing Folks, from what it has been. This is where, to me at least, it seems to be going, but as I see it, this seems to be an evolving new course.

Understood. A beneficial ownership form would be expected within 10 days of whenever it took place if it happened.

Thanks to Cycl2R for this nugget:

Re Gates and us

The quote below from an overall critical piece about the Gates Foundation might be of interest in case it's them who have taken almost 20% of our company.

"The foundation has put $500 million into its own nonprofit pharmaceutical enterprise, the Gates Medical Research Institute, according to Schwab, and it makes hundreds of millions of dollars in charitable gifts directly to for-profit pharmaceutical companies “in which the foundation’s endowment reported holding stocks and bonds, like Merck, Pfizer, and Novartis. This means the foundation is sometimes positioned to benefit financially from its charitable partnerships.”

Through its grant contracts and ownership stakes in pharmaceutical companies big and small, the elite foundation aggressively, and coercively, acquires useful knowledge about the intellectual property underlying all of the pharmaceutical products whose development it finances. In the education of policymakers and the public, it steadfastly defends the patent-system structure in which intellectual-property rights are exercised and monetized by it and Big Pharma, if those are even separate. It protects and defends specific patents in always implicitly threatened or occasionally actual lawsuits, as well.”

Don't know what you are talking about. What is my "pseudo"?

I wouldn't want to speak for another person. Why don't you go on that board and ask him/'her to explain?

What a statement:

"There is nothing different between this stock and every other penny stock board"

Apparently this poster doesn't realize the place Cytodyn holds in the message board community. CYDY consistently ranks as one of the highest, if not the highest, most active stock board, active boards as far as posts go for stocks, has the most viewed posts regularly, has been a leader in amount of money traded off and on, has active boards on virtually every single platform, has amongst the highest number of individual owners of any OTC stock, etc.

I too have been an investor and trader going back to !988 plus or minus. I trained using candlesticks originally and I've seen everything along the way with indicators and the like. I have a first edition of Steve Nison.s charting technique book signed by the man himself. I spent a couple years training with Greg Capra and Oliver Velez in the mid 1990's. Big deal. Who cares? Charts have their place for traders for sure and perhaps even investors if they are looking for an entry or exit point.

The bottom line is CYDY has a fascinating future ahead as it works through the clinical plan that I posted earlier MGK_2 was kind enough to put together..

Let's stay on topic and keep posts regarding CYDY. There are people who are still negative about Cytodyn for whatever reasons and want to see the company fail. For the most part their arguments are older and don't typically apply anymore. I'm looking forward to a major PR soon and look forward to discussions revolving around CYDY's future even as I keep the events of the past in mind.

Another summary from MGK_2:

Almost There
Almost There, Aren't We? This post really is meant to bring new investors up to speed as to the various avenues of interest that CytoDyn is currently pursuing.

All of that which we expect as CYDY shareholders is simply that which leronlimab is capable of, and we hope and believe that those laboring souls at CytoDyn do their absolute best to make each of these expectations a reality. The feeling of positivity emanates as many of us are expecting good news in the proximal future.

We are aware that there are plenty of temporary treatments out there for HIV, but there are zero cures. Those treatments work for a certain period of time, but if you stop or fail to take the next dose, HIV returns back to the body and would lead to AIDS unless the medication is taken again. That is because the medications are not a cure. There is a massive interest to insure that the disease itself doesn't go away, that HIV is never cured. If HIV is cured, then tens to hundreds of billions of dollars would be lost in recurrent annual revenue, therefore, there is immense pressure to insure that HIV doesn't go anywhere. Treatments for the disease do abound, but there exists not one cure.

CytoDyn however, is the one and only company actually working towards and getting extremely close to establishing a viable cure for HIV.

Jonah Sacha, Ph.D., who is a professor at OHSU's Oregon National Primate Research Center, and who also sits on CytoDyn's Scientific Advisory Board, is currently working on several projects aimed at curing HIV:

Reverse-engineering stem cell transplant cure: Sacha studies the molecular mechanisms and immune responses behind the five known cases of HIV cure via stem cell transplant. This research aims to develop HIV-specific immunotherapies that could lead to a widespread cure.

Gene therapy using leronlimab: Sacha leads a preclinical study funded by a $5 million NIH grant to develop a single-injection gene therapy based on leronlimab. This approach aims to provide a "functional cure" for HIV, allowing sustained viral suppression without lifelong medication.

Nonhuman primate studies: Sacha has successfully cured two nonhuman primates of the monkey form of HIV using stem cell transplants. This research provides valuable insights into the mechanisms of HIV cure and informs efforts to make the cure applicable to more people.

AAV vector-based gene therapy: Sacha is involved in research to develop novel AAV vectors for gene therapy to cure HIV. This work aims to establish long-term antibody-based competitive CCR5 inhibition as a potential cure mechanism.

Sacha is involved in a study investigating the transplacental transfer of leronlimab. The study aims to test the hypothesis that FcRn-enhancing mutations can lead to increased and prolonged levels of antibodies crossing the placenta. This research is part of Sacha's broader work on developing HIV cures and treatments. While not explicitly stated as an HIV cure, this study explores a potential method for preventing HIV transmission from mother to child during pregnancy. The use of LS mutations (likely referring to FcRn-enhancing mutations) is being investigated to improve the efficacy of leronlimab in crossing the placental barrier.

Sacha is involved in a groundbreaking study that combines early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab to potentially achieve sustained viral control in HIV infection. This study was presented at the 5th annual HIV Research for Prevention Conference in October 2024. Key aspects of the study include:

Objective: To assess whether the combination of early ART initiation with bNAbs and leronlimab could provide sustained viral control in infant rhesus macaques, potentially reducing or eliminating the need for lifelong daily medication. This research represents a significant step forward in the quest for an HIV cure, combining multiple therapeutic approaches to achieve sustained viral control without the need for continuous ART.

Methodology: Eighteen infant rhesus macaques were infected with Simian Human Immunodeficiency Virus (SHIV) and then treated with various combinations of ART, bNAbs, and leronlimab. The study evaluated the efficacy of these treatments over a 27-week period, followed by a treatment interruption to monitor virus rebound.

Results: The combination of ART, bNAbs, and leronlimab showed promising outcomes, with no virus rebound observed in any of the treated animals. This suggests a potential for durable viral control and a significant advancement towards minimizing or eliminating the need for ongoing ART.

Significance: Dr. Sacha noted that the results demonstrate a previously unappreciated synergy between CCR5 blockade (via leronlimab) and antibody neutralization, opening the door to a new approach for an HIV cure.

Collaboration: The study was funded by an NIH grant awarded to Oregon Health & Science University (OHSU) and led by Dr. Nancy Haigwood, Dr. Sacha, and their collaborators.

Together, these projects collectively represent a multi-faceted approach to developing an HIV cure, ranging from basic science to translational research and clinical applications. Their efforts towards this end are proving successful as they now have multiple monkeys with eradicated SHIV vius and not taking ART therapy in excess of 1 year.

During his first term as president, Donald Trump launched a program aimed at ending the HIV epidemic in the United States by 2030. This initiative, called "Ending the HIV Epidemic: A Plan for America" (EHE), was announced in 2019. The EHE plan had four main pillars: diagnose, treat, prevent, and respond. It focused on providing additional resources and funding to areas most affected by HIV, including 48 counties, Washington D.C., San Juan, Puerto Rico, and seven states with high rural HIV rates. Key aspects of Trump's HIV/AIDS program included:

Increased funding: The administration awarded grants to strengthen efforts in combating HIV, including $1 million in Ryan White HIV/AIDS Program grants.

Focus on prevention: The plan promoted expansion of pre-exposure prophylaxis (PrEP) and secured a donation of HIV preventive medication for eligible patients.

Global efforts: Trump continued support for PEPFAR (President's Emergency Plan for AIDS Relief), signing the PEPFAR Extension Act in 2018.

While the program aimed to end the HIV epidemic rather than specifically "cure" AIDS, it represented a significant commitment to addressing HIV/AIDS in the United States. COVID came along in 2020 and put a real damper on this initiative, but the plan remains underway.

As of late, Bill Gates recently had a three-hour dinner meeting with President Donald Trump, during which they discussed several global health issues, including efforts to develop a cure for HIV. Gates shared that he spoke extensively about HIV and the work his foundation is doing to find a cure. He emphasized that the Bill and Melinda Gates Foundation is "literally working on a cure for that," although they are still in the early stages of this research. During their conversation, Gates drew a parallel between the accelerated vaccine development during the COVID-19 pandemic under Trump's administration and the potential for similar progress in HIV research. He asked Trump if a similar approach could be applied to HIV cure efforts, stating, "So I was asking him if maybe the same kind of thing could be done here". Gates reported that both he and Trump became excited about the possibility of accelerating HIV cure research. He noted that Trump showed genuine interest in the topics discussed and appeared energized about driving innovation in this area. The Microsoft co-founder expressed that he was "frankly impressed" with how well Trump demonstrated interest in the issues he brought up, including the potential for advancing HIV cure research.

Given that Max Lataillade, SVP is simultaneously the Head of Clinical Development at CytoDyn while also the Head of HIV Drug Development at the Gate's Foundation, it is also given that Max had likely informed Bill of all the accomplishments Jonah Sacha, PhD has achieved in regards to an HIV cure. My understanding would permit me to believe that Gate's understanding from Max allowed him to communicate to Trump that an HIV cure utilizing leronlimab could become an FDA approved reality by ~early-mid of 2027 provided proper funding is obtained now. If the proper amount of investment and provisions were made, such a possibility would then place Trump's HIV-2030 plan way ahead of schedule. Trump was more than responsive.

So, this could have been the topic of this 3-hour long discussion that has taken place, and I suspect that we can expect more like it. What might be the fruit of these discussions? A collaboration between CytoDyn, the Gate's Foundation and the Federal Government for an HIV cure that could be approved by mid-2027. That is 30 months from now.

//LATCH

In HIV, CytoDyn is also advancing its LATCH (Leronlimab in Allogenic stem cell Transplant to Cure HIV) program, which aims to use leronlimab in an innovative approach to potentially cure HIV. The company has two notable developments in this area:

Primary LATCH Study: CytoDyn is partnering with the American Foundation for AIDS Research (amfAR) to sponsor the main LATCH study. This trial will:

Use leronlimab to protect CCR5+ donor immune cells from HIV infection

Aim for a HIV cure in the setting of bone marrow transplant to an HIV positive recipient

Complete final protocol updates were completed by the end of December 2024

Launch in 2025

Berlin LATCH Study: Following a successful HIV cure announcement by German investigators using donor cells heterozygous for the CCR5-delta 32 mutation, CytoDyn has been approached to expand the LATCH program:

The same German investigators have requested to run a similar LATCH study at their research center in Berlin

CytoDyn is makeing this opportunity a reality

The company is optimistic about the LATCH program's potential success, given the recent breakthrough in Germany. This dual-track approach with studies in multiple locations could accelerate research and potentially lead to groundbreaking advancements in HIV cure strategies.

What else does CytoDyn have going on?

//MSS mCRC

The MSS mCRC clinical trial has begun. This trial is the only clinical trial that CytoDyn is actually currently funding, the remainder are being sponsored by 3rd parties. CytoDyn's Phase II clinical trial for leronlimab in colorectal cancer has begun patient enrollment in January, 2025. The company has received FDA clearance for the trial, which evaluates the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer. A trial kickoff meeting was completed late November 2024, and patient screening is expected to start in early 2025. The trial is conducted in partnership with Syneos Health, which CytoDyn has engaged as the contract research organization (CRO) for this study. This Phase II oncology trial represents an important step for CytoDyn in advancing leronlimab's potential as a treatment for colorectal cancer, with the company's CEO emphasizing that investigating leronlimab in oncology remains their top priority.

//MASH

CytoDyn has probably already received the MASH murine results of its second confirmatory MASH murine study. CytoDyn has commissioned two follow-up studies following preliminary study with SMC Laboratories to confirm and extend the observation of fibrosis reversal seen in their initial preclinical study concluded in September 2024. These follow-up studies are likely complete, with results expected in January, 2025. These follow-up, confirmatory studies were initiated after promising initial results from the September 2024 study, which showed that leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to a control group. One of the current studies is using the STAM mouse model again. Dr. Melissa Palmer, an internationally renowned hepatologist, has been appointed as the lead consultant in hepatology to oversee these follow-up studies with SMC Laboratories. The studies compare leronlimab alone and in combination with other therapies, building on the findings from the previous research. Given the current date, it's likely that these studies are in their final stages, with results anticipated to be released soon.

//Pulmonary Fibrosis

CytoDyn's potential involvement in a pulmonary fibrosis pilot trial is contingent on the positive outcomes of their ongoing studies, particularly in the area of fibrosis reversal. While there is no direct mention of a pulmonary fibrosis trial for CytoDyn, the company's recent findings in liver fibrosis studies suggest promising applications for leronlimab in fibrotic conditions. The preliminary results from CytoDyn's study with SMC Laboratories showed that leronlimab demonstrated significant fibrosis reversal in a liver model:

Leronlimab monotherapy (700 mg) showed statistically significant fibrosis reversal compared to a control group (p<0.01).

The drug exhibited dose-dependent antifibrotic activity, with the 700 mg dose performing better than the 350 mg dose in reversing liver fibrosis.

Leronlimab (700 mg) appeared to have better anti-fibrotic activity compared to Resmetirom, an approved therapy for MASH (p=0.057).

Given these encouraging results in liver fibrosis, it's plausible that CytoDyn might consider expanding their research into other fibrotic conditions, including pulmonary fibrosis. The company's CEO, Dr. Jacob Lalezari, stated that these results "confirm our belief that leronlimab has the potential to be materially beneficial for patients suffering from a number of medical concerns".

If CytoDyn decides to pursue a pulmonary fibrosis pilot trial, it would likely follow a similar structure to other pilot studies in this field:

The trial would likely be small-scale, possibly involving around 20-30 patients, similar to other pilot studies in pulmonary fibrosis.

The primary endpoint might focus on changes in lung function, such as forced vital capacity (FVC), which is a common measure in pulmonary fibrosis trials.

Secondary endpoints could include measures like diffusing capacity for carbon monoxide, 6-minute walk test distance, and quality of life assessments.

However, it's important to note that initiating a pulmonary fibrosis trial would be a significant new direction for CytoDyn, as their current focus appears to be on liver conditions like MASH, as well as other areas such as HIV, oncology, and potentially Alzheimer's disease. Any decision to expand into pulmonary fibrosis would likely depend on further positive results from their ongoing studies and strategic considerations by the company's leadership.

//GlioBlastoma Multiforme

CytoDyn has initiated a pre-clinical trial for glioblastoma multiforme (GBM) in partnership with Albert Einstein College of Medicine and Montefiore Medical Center in New York. This study, which began in December 2023, aims to evaluate the efficacy of leronlimab in treating GBM using a humanized mouse model. The trial design includes three groups of humanized mice:

A control group

A group receiving only leronlimab

A group receiving a combination of leronlimab and temozolomide

The primary objective of this study is to assess leronlimab's effect on primary tumor growth and the occurrence of metastases in both CCR5+ and CCR5- cells in humanized mice. This pre-clinical trial is significant as GBM is a common and often untreatable form of primary brain cancer, and CytoDyn aims to evaluate leronlimab's potential in this challenging disease setting. Dr. Jacob Lalezari, CEO of CytoDyn, expressed excitement about starting this pre-clinical trial, emphasizing the opportunity to evaluate leronlimab's potential effects in a pre-clinical model of this deadly cancer.

//Metastatic Breast Cancer

CytoDyn is conducting murine studies in metastatic breast cancer to evaluate the potential efficacy of leronlimab in this challenging disease. These preclinical studies are an important step in the drug development process, potentially paving the way for future clinical trials in humans. Here's an elaboration on CytoDyn's efforts in metastatic breast cancer research:

Preclinical investigation: The murine studies allow researchers to assess leronlimab's effects on breast cancer metastasis in a controlled laboratory setting.

Mechanism of action: Leronlimab, as a CCR5 antagonist, may inhibit the migration and invasion of cancer cells, potentially reducing metastasis.

Previous results: CytoDyn has reported promising results from earlier studies, showing that leronlimab reduced breast cancer metastasis in humanized mouse models.

Combination therapy potential: The murine studies may also explore leronlimab's efficacy in combination with standard breast cancer treatments, such as chemotherapy or immunotherapy.

Biomarker identification: These studies could help identify potential biomarkers that predict response to leronlimab in breast cancer patients.

Dosing optimization: Murine studies allow researchers to experiment with different dosing regimens to determine the most effective approach for future clinical trials.

Safety profile: While leronlimab has shown a favorable safety profile in other indications, these studies will provide additional data on its safety in the context of breast cancer treatment.

If the murine studies yield positive results, CytoDyn may proceed to:

Design and propose human clinical trials for metastatic breast cancer

Seek regulatory approval for initiating these trials

Potentially expand their oncology pipeline to include breast cancer as a key indication for leronlimab

These murine studies represent an important step in CytoDyn's efforts to develop leronlimab as a potential treatment for metastatic breast cancer, a disease that still has significant unmet medical needs despite recent advances in therapy.

//Alzheimer's Disease

CytoDyn has finalized the protocol for a pilot study of leronlimab in the treatment of patients with mild to moderate Alzheimer's disease. Here are the key details of this upcoming trial:

Location: The study will take place at Cornell Medical Center in New York.

Funding: The study is now fully funded by an outside foundation that wishes to remain anonymous.

Primary Endpoint: The trial will evaluate an objective neuroradiology primary endpoint, which will provide a clear measure of leronlimab's potential role in treating Alzheimer's disease.

Status: As of the current date (January 22, 2025), the protocol is set to be submitted to both the FDA and the Cornell IRB soon.

Significance: This study aims to assess leronlimab's efficacy in treating Alzheimer's disease, focusing on its potential to modulate inflammation and amyloid in the brain.

The initiation of this Alzheimer's trial represents an important step in CytoDyn's efforts to expand the potential therapeutic applications of leronlimab beyond its initial focus on HIV and oncology.

//Long COVID

CytoDyn has submitted a protocol to the National Institutes of Health (NIH) for a clinical trial to evaluate leronlimab in treating Long COVID, also known as Post-Acute Sequelae of SARS-CoV-2 (PASC) or Long Haulers syndrome. This submission represents a significant step in CytoDyn's efforts to address the ongoing health challenges posed by the COVID-19 pandemic. Key points about CytoDyn's submission for Long Haulers:

The company has submitted a Phase 2 clinical trial protocol to the NIH for the treatment of Long COVID using leronlimab.

This submission follows CytoDyn's previous interactions with the FDA regarding the use of leronlimab for various COVID-19 related indications.

The proposed trial aims to evaluate leronlimab's efficacy in alleviating symptoms associated with Long COVID, which can persist for months after the initial SARS-CoV-2 infection.

Leronlimab, as a CCR5 antagonist, is believed to have potential in modulating the immune response and reducing inflammation, which are key factors in Long COVID symptoms.

If approved, this trial could provide valuable data on leronlimab's effectiveness in treating a condition that affects millions of people worldwide and currently lacks standardized treatment options.

The submission to the NIH is a strategic move by CytoDyn, as it could potentially lead to:

Collaboration with NIH researchers and access to additional resources

Increased credibility for the study design and potential outcomes

Faster patient recruitment and trial initiation if approved

It's important to note that while the submission is a positive step, it does not guarantee approval or immediate commencement of the trial. The NIH will review the protocol, and CytoDyn may need to address any feedback or concerns before the trial can proceed. If approved and successful, this trial could position leronlimab as a potential treatment option for Long COVID, addressing a significant unmet medical need and potentially opening up a large market opportunity for CytoDyn.

//Chronic Fatigue Syndrome

CytoDyn has strategically positioned itself to pursue multiple avenues for investigating leronlimab's potential in treating conditions related to chronic fatigue. If the NIH does not grant approval for the Long COVID trial, CytoDyn has a backup plan in place with a contract for a Chronic Fatigue Syndrome (CFS) trial. This approach demonstrates the company's commitment to exploring leronlimab's therapeutic potential in related conditions. Key points about CytoDyn's CFS trial contract:

Contingency plan: The CFS trial contract serves as a fallback option, ensuring that CytoDyn can continue its research even if the Long COVID trial is not approved by the NIH.

Similarities in conditions: Both Long COVID and CFS share overlapping symptoms, particularly persistent fatigue and cognitive issues, making leronlimab a potentially relevant treatment for both conditions.

Expanded market potential: By pursuing trials in both Long COVID and CFS, CytoDyn is targeting a broader patient population, potentially increasing the drug's market reach if successful.

Scientific rationale: Leronlimab's mechanism of action as a CCR5 antagonist may be relevant to CFS, as immune dysfunction and inflammation are thought to play roles in both CFS and Long COVID.

Regulatory strategy: Having multiple trial options may strengthen CytoDyn's position with regulatory bodies, demonstrating the company's commitment to thoroughly investigating leronlimab's potential applications.

The existence of this CFS trial contract highlights CytoDyn's proactive approach to drug development and its confidence in leronlimab's potential therapeutic benefits. It also provides the company with flexibility in its clinical development program, allowing for continued progress even if one avenue faces setbacks. If CytoDyn proceeds with the CFS trial, it could:

Generate valuable data on leronlimab's efficacy in treating fatigue-related disorders

Potentially lead to a new treatment option for CFS, a condition with limited effective therapies

Provide insights that could be applicable to other fatigue-related conditions, including Long COVID

This dual-track approach underscores CytoDyn's commitment to exploring leronlimab's potential in addressing significant unmet medical needs in the realm of chronic fatigue-related disorders.

If all of the above is not a Multipronged Approach, I don't know what is.

Thanks for posting!

Welcome back. I was mentioning elsewhere it would be great to see more ol the knowledgeable posters return.

Thanks! Appreciate the post.

Interesting. Schwab and Yahoo Finance both have institutional ownership at nearly 20%. Weird.

You may recognize the authors names of this paper being connected closely to Cytodyn:

https://journals.lww.com/co-hivandaids/abstract/2025/01000/stem_cell_transplantation_and_allogeneic_immunity_.14.aspx

Stem cell transplantation and allogeneic immunity: post treatment control or HIV cure?
Cleary, Megana; Ndhlovu, Lishomwa C.b; Sacha, Jonah B.a,c
Author Information
Current Opinion in HIV and AIDS 20(1):p 86-91, January 2025. | DOI: 10.1097/COH.0000000000000892
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Metrics
Abstract
Purpose of review
Long-lasting HIV remission has been reported in a small group of people with HIV (PWH) following allogenic hematopoietic stem cell transplants (HSCT) for the treatment of hematologic malignancies. While the mechanisms of HIV remission following release from antiretroviral therapy (ART) were not initially known, subsequent findings from clinical cases and preclinical nonhuman primate studies have implicated mechanisms of clearance. Here, we review the six currently published human cases of long-term ART-free HIV remission.

Recent findings
Since the first report of ART-free HIV remission following HSCT, five subsequent cases of HSCT-induced sustained HIV remission have been published. While the pre- and posttransplant treatment conditions vary greatly, all but one received cells from donors homozygous for a 32 bp deletion in the gene that encodes CCR5 (ccr5?32), the major HIV coreceptor. Studies in nonhuman primates and the newest published individual suggest that while CCR5 deficiency can protect donor cells from infection early posttransplant, it is not required for long term remission, as ablation of the viral reservoir is likely due to allogeneic immunity mediating a graft-versus-reservoir response.

Summary
Studies of HSCT in PLWH and simian immunodeficiency virus (SIV)-infected monkeys show that those with durable remission are likely cured, demonstrated by complete ablation of the replication-competent HIV reservoir, gradual loss of anti-HIV immunity, and greater than 5 years of aviremia.

He follows with:

MGK2
Yesterday 4:34 PM

Funded by BMGF, a human trial that determines if CURING HIV through Triple Therapy is statistically clinically significant, then pushing for FDA approval. BMGF, through Max, gets access to long-acting leronlimab, PrEP as well. They get access to AAV-CURE. They get access to Scott Hansen's work with the 3rd party AI development collaborator. Human Trials are coming folks, but the main one that I'm looking at right now is the one I discussed here in this post. Triple Therapy for CURE. That BMGF sponsored Human Trial gets CytoDyn through the next few years until the completion of the MSS mCRC clinical trial and everything else that it is slated to do in the next few years.

Another nugget to ponder from MGK2:

MGK2
Yesterday 4:32 PM

$CYDY
reddit.com/r/Livimmune/comm...

BMGF helps secure their own leadership towards an HIV Cure by bringing in Max Lataillade, DO funding his vision which aims to Cure HIV. Max left ViiV to come to CytoDyn because of leronlimab. Max knew that an HIV Cure was imbedded into leronlimab which blocks the CCR5 doorway that HIV uses to enter CD4 T Cells. He knew he needed to be planted at the company who owned the molecule. The GF hears and considers this molecule with Max at the head of the initiative.

Max knew, he could not eradicate HIV without leronlimab. He also knew that BMGF could not eradicate HIV without leronlimab. Somehow, Max brought the plan to BMGF and it has been codified. Now the thinking is how much is coming? Hundreds of millions is my answer. Nobody has cured HIV. Nobody that is until STEM Cell transfer. AAV is also coming close, but work yet has to be done on that initiative. However, Triple Therapy has done it and now BMGF and Max Lataillade start the human trial.