CytoDyn Inc (QB) (CYDY) Quote

I'm sure. But for humans so far--the FDA does not approve on mice and monkeys and test tube results.

They don't give BTD for airline partnerships or anecdotes. They seem to frown on hype and conjecture and hypothesis generating nonsense that gets stated as FACT. Shareholders should be leery by now of any AND all that nonsense.

Mice lie and monkeys exaggerate..

THX for posting the RCT--so at least you can find it from the trial number I have linked SEVERAL times. Must be aware that "Not Yet Recruiting" conflicts with your earlier conjecture of "already recruiting". But it is just now FEB and that is tentative start. And est finish is 2028.

You are NOT taking my word for filing info. I will play your game and you can ask Reuters, that was linked, OR the SEC

Leronlimab deserves better than conjecture

Even if CYDY went to a dollar on Monday longs would still have done better just sticking their money in an index fund for the last 4 years. Worst investors on the planet

They recruit anyone yet? They said they were recruiting in January. How's that going?

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.

Any idea how many times there will be a mouse study with LL in MASH/NASH??

Any idea why they are not running mTNBC trial to get real data with real CRO and submit for BTD?? Is there not enough $$ to run along w the MCRC trial since it has a 2028 results date--at least it "should" actually begin recruiting this month

As far as the "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." part of the "conjecture" piece:

That changed + 1 year ago--https://www.reuters.com/markets/us/us-sec-shortens-stock-disclosure-deadline-5-days-2023-10-10/.
It is now 5 days

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.

It's easy enough to do a search of the holdings of Sabby Management LLC, and see they have no connection whatsoever to this stock. Is it fair that hedge funds can naked short a stock as a market maker....yes and no. They must do it, but they can abuse the ability.
Either way, naked shorting a penny stock is pretty wasteful and the only reason it would make sense to do it is,
IF they knew the company was headed for the sewer
The company had way too many shares in existence.

Either way, to the poster who listed the hedge fund in his post, it was just done as a way to distract people from the facts of this particular stock.

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.

“The SEC alleges that Sabby and Mintz attempted to game the system and make an illegal profit,” said Carolyn Welshhans, Associate Director of the SEC’s Division of Enforcement. “When someone uses naked shorts or other manipulative practices to cheat the market and investors, the SEC will ensure that they are held accountable.”

SEC💹Catches🎅🏿+👽ArtificiallyDeflating Prices💹2Buy SharesCheaper

6, 12, 2023. —
SEC charged investment adviser Sabby Management LLC & managing partner,Hal D. Mintz,w/ fraud in connection w/ a long running scheme involving misrepresentations & violations of rules for short selling & order making, + other violative trading, that generated $2M + in illegal profits.


From at least March 2017-May 2019 Sabby|Mintz repeatedly circumvented trading rules to conduct unlawful trades in the stock of 10 PUBLIC COMPANIES. Sabby |Mintz engaged in illegal “naked short selling” by intentionally|improperly placing short sales when they knew or were reckless in not knowing that they had not borrowed or located the shares, & then failed to make timely delivery of the shares. The purpose was to earn profits they could not have gained by legal trading.
https://www.sec.gov/news/press-release/2023-107


Let's see how the new SEC reacts. Hopefully they will put some real teeth into this problem and not just occasionally make a showing for the public.
HOPE EVERYONE HAS A GOOD WEEKEND. $$$CYDY$$$ 2025

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

LOLOL that little Cytodyn pump is full of lies and undisclosed biases - the longs need gullible innocents to dump their shares on

Since you "believe" that shorts are to blame for stock price and there will be some massive "squeeze"--just curious how data like this fits into the "narrative" (conjecture) ??

https://www.marketbeat.com/stocks/OTCMKTS/CYDY/short-interest/

CytoDyn (CYDY) has a short interest of 21.27 million shares out of 1.2 BILLION + shares??
Percentage of Shares Shorted1.73%

"Artificial suppression" ??

January ending, recruiting yet? Lol

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

Any or ALL would be fantastic. Let us know when the Cydy company announces any and/or ALL.

NOT made up conjecture by day trade flippers pumpers FAKE PR nonsense. Not the decoder ring "hints" and "signs". Not the FAKE coverage page of some made up E F Hutton analyst that begins coverage. Not some fraud "chessmaster" or Lonsford/facebook or sheikh paid fraud articles.

Want a strategy to "trap the shorts"--perhaps stop the nonsense and let Dr J and team try and progress.MAYBE then 1 or more of your "strategy" would come to fruition.

Do you really believe the SEC is going to allow uplist with a ongoing investigation?? Dr J can address exactly the day that ends. There is some good news for a "trap"
They can also do a reverse and reduce float. There are over 1 BILLION shares to "squeeze"--lets get real--back to sane world--not conjecture

There is no new DATA to submit for ANY BTD. Lets get RCTs going and perhaps get some?? Maybe you remember--the last "attempt" was for mTNBC that used the wrong SOC for comparison. The SOC had changed 2 years earlier. Odd w all the Drs (Rey/Ray/Rugo/Kelly/etc) none were aware--odd huh??

As you can see--EACH or your "catalysts" are based on hopium and pump. Just like your # 6 alludes to. Hasn't there been ENOUGH of that?? Are you just flipping--fair enough/go for it. There are a few that would like to see LL get approval--the only way possible. There are a few that want a independent board. A legit CRO. A company run for progress--not for insider private placement profit and piggybank.

Hoping for change in security laws--surprises--regulatory pressure is not what any legit biopharm needs. Once AGAIN--there is no "blockbuster" trial results coming because there is NO--NONE trials being conducted in oncology or MASH/NASH. Believe what you want. Maybe understand your "conjecture" stuff from the real world FACT stuff. Its your choice as it is each investors'

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.

Thanks for the cheapies pigeons. Loaded those 17's and 18's and still Green oh so greeeeennnn thanks to those past 10's 11's 12's 13's.
Get ready to rumble!! I am!!

$$$CYDY$$$ 2025

ps. keep conjecturing, scratching, graveling

Longs fall for these pumps every time. And not only do they not get any benefits from them because they don't sell they actually buy more at the top. Worst investors on the planet

Since YOU are the person that always cuts/pastes this "conjecture"--don't you have ANY obligation for its lack of FACTS??

Is some "conjecture" more important to you than any credibility?? Or has the pump/conjecture become more important than actually getting Leronlimab approved by the only vehicle possible: FDA approved RCT and FDA approved data--collection-- analysis--submission all via a LEGIT CRO. You long for the old CEO days?? You long for the old amawrecks kickback fraud days??

As of today there is only 1 trial shown/approved on clinical trials.gov website: NCT06699836. A Phase 2 Study of Leronlimab in Combination with TAS-102 + Bevacizumab in Previously Treated Participants with MCRC. Last update was NOV 2024--NOT RECRUITING. Est completion JUN 2028

What YOU show as "upcoming trials" are STUDIES--mouse monkey etc. NO other trials shown with patients--FACT

There is NO FULLY FUNDED alzheimer clinical trial etc. There are NOT partners lined up as soon as the hold is lifted. There is NOT 100$$ million coming from amawrecks. The RCT is NOT recruiting yet. The SEC and DOJ investigations are NOT about 13D

Lets stop the decoder ring to decipher fake hints and signs of "institutional shares" and the "president and Bill Gates are talking Leronlimab" and Phillipine Airline partnerships and broken fax machines. Lets try acting like a LEGIT biopharm with a potential life saving product. Its NOT gamestop or bitcoin

LOL the price action is giving us a sour taste of what's coming - another wave (the 40th) of new shareholders being badly burned trusting this scam stock.

It's always funny with CYDY.

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

Thanks for the cheapies!!!!

Thats odd, because I'm not sure this will look right in the posting, but I'm seeing one mutual fund which dumped its shares and I'm seeing short interest going up

Investor Sentiment
Short Interest
Latest
21.27 M
Previous
20.12 M
% Change
5.71%
% Float Short
1.75%
DTC
8.27
Insider Summary
Period # Buyers $ Bought # Sellers $ Sold % Sold
1 Month 0 0.00 0 0.00 0.00%
2 Months 0 0.00 0 0.00 0.00%
3 Months 0 0.00 0 0.00 0.00%
6 Months 0 0.00 0 0.00 0.00%
1 Year 0 0.00 0 0.00 0.00%
2 Years 0 0.00 0 0.00 0.00%
Top FundsAll Funds
Fund Name Filing Date % Shrs Out Shrs Held Shrs Chg Value
Firsthand Technology Opportunities Fund
09/30/2023 0.00% 0.00 -222.73 K 0.00
Fund TransactionsMore Transactions
Fund Name Value Chg (6mo) Shares Chg (6mo)
Firsthand Technology Opportunities Fund
-41.30 K
-222.73 K

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 see institutional Ownership went up to 21.4% on Schwab. I'd love to see some filings to back this up.

Just as predicted. Time to grab some more. Thanks Pigeons. All bags green turning gold and happy happy happy.
$$$2025$$$ $$$CYDY$$$

Nice grab!! But oh, they skipped over another nice order. Must be time to go back up.

The bollinger bands are pinching!!!!

Bahhhahahhaha yeah he's so good at calling a pump after it runs lolllll

djjazzyjeff- Yes D0lph has published book on TA and is especially good with CYDY.
Chump

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!

Thank You Moderator MODERATORS for changing the amount of posts I can have. I sincerely appreciate it. MARCH 8TH I AM 84. IT'S BEEN A VERY LONG HAUL WITH ME WITH THIS STOCK. BUT I AM A BELIEVER. THANKS AGAIN NICK

D0lph- Glad your back with TA here. Always follow your comments, "what's possible", either way.
Chump

Much appreciated Dolph.

"It's possible it will go up if it goes up" - dolph genius TA analysis

D0lph- Glad your back with TA here. Always follow your comments, "what's possible", either way.
Chump

Testing monthly upper Bollinger band. If it can push through here, as it did in 2020, it would be extremely bullish at this overbought state.
CYDY | SharpCharts | StockCharts.com
https://stockcharts.com/sc3/ui/?s=CYDY&a=1891262156&p=M&yr=20&mn=11&dy=10&id=p10859208106

Gates or no Gates. No worry. The Gate is opening and the amazing leronlimab is being talked about among many circles.
I don't trust Gates. However, as a businessman he may recognize that this leronlimab is going to make history and he may as well be part of it.
Should he become involved on any level, the pps will surpass many analysts forecasts by a monstrous amount. New personnel at the FDA and other health agencies certainly will be amazed to read the history of leronlimab. Our time has come. The health sector as a whole has positively responded to the new changing of the guard.

So now, where have the naysayer pigeons flown to? The chirping and graveling have been greatly diminished.
We could be looking a .50 centavos real soon if this strong buying continues.

$$$CYDY$$$ 2025

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: )
*See the 3:00 mark and the 7:25 mark for his HIV-related comments

Also, for those who haven't seen it yet, this is worth watching re: possible HIV cure utilizing CYDY's drug, Leronlimab (Dr. Jonah Sacha is a member of CYDY's "Scientific Advisory Board" -- his presentation starts at the one minute mark and is about ten minutes long):
https://plus.iasociety.org/webcasts/planet-ap...mal-models

I remain... #BULLISH

above average volume for awhile now. next official update will be interesting.
flipper time... Monday after a run up?

Thanks for the history lesson which supports some analysts currently remarking about our CytoDyn;
Cytodyn Inc Stock (CYDY) Forecast
The Cytodyn Inc (CYDY) stock price forecast for the next 30 days is generally positive, with an average analyst price target of $0.9960, representing a +346.65% increase from the current price of $0.223. The highest analyst price target is $1.0583, and the lowest is $0.9338.

https://stockscan.io/stocks/CYDY/forecast

Long-term CYDY price forecast for 2025, 2030, 2035, 2040, 2045 and 2050

Based on our analysis about Cytodyn Inc financial reports and earnings history, Cytodyn Inc (CYDY) stock could reach $5.1574 by 2030, $15.38 by 2040 and $13.87 by 2050. See the projected annual prices until 2050 of the Cytodyn Inc stock below:

Cytodyn Inc (CYDY) is expected to reach an average price of $9.1981 in 2035, with a high prediction of $10.19 and a low estimate of $9.2096. This indicates an +4024.72% change from the last recorded price of $0.223.
Cytodyn Inc (CYDY) stock is projected to chart a bullish course in 2040, with an average price target of $14.50, representing an +6400.68% change from its current level. The forecast ranges from a conservative $14.51 to a sky-high $15.38.
Our analysts predict Cytodyn Inc (CYDY) to change +8934.14% by 2045, soaring from $9.2116 to an average price of $20.15, potentially reaching $21.18. While $9.2116 is the low estimate, the potential upside is significant.
Cytodyn Inc (CYDY) stock is expected to climb by 2050, reaching an average of $12.63, a +5564.26% change from its current level. However, a wide range of estimates exists, with high and low targets of $13.87 and $11.39, respectively, highlighting the market's uncertainty.

NOT FACTORED IN IS THE BUY OUT OR MERGER. IMO, THIS LONGTERM OUTLOOK IS FAR SHY EVEN WITH ONLY A PARTNER OR TWO. A BREAKTHROUGH WITH HIV AND FIBROSIS AND WE COULD BE AT THIS 2035 $10 PPS AVERAGE IN 2-3 YEARS WITH LICENSING AND PARTNERS THE FUTURE IS ANYTHING BUT PREDICTABLE EXCEPT WE ARE GOING UP. MY GRANDKIDS WILL REMEMBER THIS INVESTMENT.

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.

NO doubt that grabbed their attention. Should recent internal developments be taking place I expect an update will follow sometime fairly soon. Whether or not this next week is unimportant should they be putting together some type of new collaboration. Gates or no Gates, the gates are opening finally. Thanks for your postings. $$$CYDY$$$ 2025

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.

They recruiting yet? Jan is almost over.
Also how do these morans fall for the pump and dump every time?

We remember too that other players have been interested in leronlimab for quite some time. This new (or old) interest that has come about will only spur others to make a move to begin serious inquiries with CytoDyn. There is nothing quite like competition and to know that inaction and delay can lead to a lost opportunity. The same goes with stock trading. Good luck to all as we advance one way or the other. I can't see anything I don't like about the company at this stage of progress. So will Tanya and Max and our fab Dr. Jay soon to be seen as heroes? I think so. All in my well researched opinion of course. Sit on your ass all you want I am still buying but upset that the naysayer pigeons couldn't help me out at least one more time. Smile

$$$CYDY$$$ 2025

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.