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Top of the day to you Monroe one. You are especially the greatest member we have on this board. You're extremely well read and reflect yourself accordingly. It is an honor to read what you so diligently provide to this board with your in-depth research. I thank you very much.
CytoDyn Inc., a clinical-stage biotechnology company, engages in the development of treatments for multiple therapeutic indications.
The company is involved in the clinical development of leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 receptor in the areas of COVID-19, human immunodeficiency virus (HIV), Metabolic dysfunction-associated steatohepatitis (MASH), and solid tumors in oncology, such as metastatic triple-negative breast cancer.
Its leronlimab is currently under phase 2 development for the treatment of NASH, HIV- NASH, and solid tumors, as well as under pre-clinical development for the treatment of HIV-PrEP and HIV-Cure.
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The sad part of all this during Covid is that NADA didn't go about it correctly. Too bad Dr. Jay was not at the helm. However, due to the state of chaos back then, anybody with common sense would have at a minimum allowed the continuation of leronlimab under Compassionate Use. At least Erap ex President of Philippines was saved and handfuls of others who Nader helped with the process of Right To Try. Shame goes to the FDA for pushing the experimental jabs onto the trusting world public. All IMO. Leronlimab will rise again! $$$CYDY$$$ 2024 Year of the turn around, year of the AmarX settlement, year of lifted hold, TRIALS! and more... what company is ready to partner?
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The present FDA hierarchy in power is under scrutiny like never before chiefly because of their role in EUA's for Covid "vaccines". The President of Costa Rica recently entered into "Nurenberg" approved court con Dr. Yeadon y al.https://interestofjustice.substack.com/p/nuremberg-hearing-costa-rica-update
The higher court is literally ORDERING the lower court to hear testimony of scientific experts Sasha Latypova, Dr.Yeadon, Dr.Janci Lindsay, Professor Norman Fenton, & Dr. Ana Mihalcea,etc. Yay!
Then tell CYDY to state the drug is "safe and effective" on its website.
Wake up. If that were the case then fda would have never lifted the hold!!! Nor helped with the new protocols!! Hello.
$CYDY$ 2024
Ready for the trials and partnerships? I am. However, give me some cheapies if you aren't too panicky. TIK TOK Any time now.
Way back when Allen D Allen started this endeavor, the company produced a newsletter to keep us apprised of research. Very informative at that time.
Blue is correct--and you are also.
The difference here is how many hundreds of millions of shareholder equity were wasted by lies--by gift--by graft--fraud
Difference here is how many years have been wasted by sham board of skelly--naydenov--nodder for years being 3 fifths of each and every board vote
And willing or incentivized posters defending that graft/fraud/corruption every step of the way with out and out lies
Just 1 example of wasted years--published yesterday NEJM--No participants receiving twice-yearly lenacapavir acquired HIV infection.
https://www.nejm.org/doi/full/10.1056/NEJMoa2407001
While some like you ?? continue to rave about multi partners on hold lift(nonsense)--multi partners on amawrecks 100 million $$ award(nonsense)--rave about super secret AI partners--stealth hints from removing 2 SAB members from website
Meanwhile the COB mudfence tonya gives millions to her boytoy weed/wine --the COB is only there for Paulson. She should be removed ASAP
I agree regarding the communication with shareholders and its frequency. They should commit to communicate at least once every 3 weeks minimum to allow for updates and progress. That would put many of our concerns to rest hopefully.
Many may say this is unrealistic however we all endured terrible management for several years and the COB needs to recognize the frustration that exists and put plans in place to keep the “true Owners” of the company updated. Otherwise maybe we need to board members to to move us forward.
No Leronlimab does not "work". The FDA made Cytodyn take down all statements on its website that it was "safe and effective".
you're right about that - pre-revenue biotech is a gamble. this one seemed like a layup in 2016 with the strong HIV data, no safety signal, etc. But, one takeaway from this has been that leadership has to be just as good as whatever the product is, and that was my big mistake, and the rest is history. once burned, twice learned as they say.
hopefully you're right and they get this across the finish line. My only point is that we need more communication, and a dedicated plan to create value fast. And until we see that, i'm not sitting back and waiting for animal trials that will take years.
I want to hear from Jay (or whoever) the exact timeline for translating the science into shareholder value. The time to sit back and be patient is long past.
Seems to me Blueheel 1 you may have committed funds that you need and there by committed the mistake of over investing. Never commit funds you are not prepared to lose entirely, especially in the OTC pharmaceutical market place. It really does not help your investment by bringing up negatives about the company and their current situation. When I invested in this stock I only used funds that do not impact my day to day lifestyle. If we get traction at some point, great! If not I’m prepared to take the tax loss. I still have faith that the current team will get us approved, merged or partnered so we can celebrate our investment. IMO only
Still no trials. Still no partnerships. What are they waiting for?? Everything pumpers told me was holding them back has been resolved. What gives???????
no doubt, we have lost many great posters. I thought SALTZ was the best - always a well reasoned, rational and highly educated approach. I think he finally had enough of Nader, and sold in the $3 range - smart man. And while Grip and I disagreed at times, don't forget - he called this trainwreck years ago - even though no one wants to admit that. I wish i had listened and sold every share i had back then.
With regard to the 13D group, they have been attacked repeatedly by the leadership at Investors Hangout. But again, remember, the 13D's core point was that Nader was going to destroy the company - that was it. So....they were dead on accurate, and may have saved this company from 2 years of a clinical hold, and a continued black eye in the biotech and pharma community as we are the company whose CEO was indicted for fraud. It's like you had a group who wanted to remove Bernie Madoff because they knew he was a fraud, but you "defeated" that group and left Bernie in place. That's a victory?!?
Yes, i'm long and I'm complaining. What i can't understand is, how more longs aren't pissed off at this point - and demanding something be done to restore shareholder value? It's like the twilight zone - you've lost 85% of your money, and you're not upset about that? you don't want accountability?
As for me, i want to see change at the top - whether that be Jay, Tanya, etc., because for all the "progress", the SP is at all time lows. Jay seems like a good guy, but isn't a business guy. And Tanya has been COB during a period when value has fallen by 75%. In any legitimate business, she would have been tarred and feathered by now.
Laslty, i want to see some creative ideas on boosting the SP. That could include finding an aggressive buyer who would take a shot on our molecule and selling the entire company for $.50 (just a random idea - but one i would vote all of my shares for).
Well I have blocked several of the name callers so I don't see a lot of that.
I might be guilty on occasion of some when I get the "short" nonsense. No board is better when you lose folks that know the history--the original OGs investors----aware some of the behind the scenes activity
There were a few folks here that had been assoc for years. Not the blackops jimmy chuckles crowd with made up stories/crap but like 3X ?? that actually knew Ken VanNess. And some others. Some moved on. Sure some passed. Others really got discouraged during the whole 13D project--as they saw that as their only hope to get rid of nodder and his kickback fraud with amawrecks. Fair chance to salvage their many years investments and see LL in legit trial/legit CRO/legit chance of FDA approval
Ever notice how NONE--ZERO--of the anti 13D crowd EVER talk about the waste of the BTD in mTNBC andnodder/ray using the wrong SOC?? Ever notice how none ever comment on the Pestell fiasco--where nodder presented ZERO evidence of "cause". Again wasting months/years and millions in shareholder equity. Ever notice that NONE ever comment on using amawrecks for NASH even AFTER all the findings/allegations/fraud had already emerged from the BLA debacle. Not trading--or dolphin--or 595--or mgkmoonrow--or misshooeyfooeysooey or persianleofraud.
Ever notice that each of those posters that were screaming about patents being stolen--that a couple years later they were bragging about the IP protection of the CYDY patent portfolio. Just frauds that can't even keep their stories straight.
Place has lot a lot thru time. Mostly the good folk. The nonsense crew remains here and thangout with their fraud mods. But Dr Lalezare is still trying.
You have to realize there are some that want to push a "narrative"
If you read that redthread post the other day that went thru the "history" of cydy and nodder and Tony C etc. There was so much wrong, bad, out and out lie in that--yet stated as fact; how nodder stepped down as CEO etc. Just absolute nonsense.
Yet even after being aware that is false--the author continues to state and repeat multiple lies. Why?? Sure many of the "defenders" would say what difference does it make--its all in the past. But if it makes no difference--why not tell the truth?? Yet for some reason (incentivized$$??) the fraudsters continue. For sure they never mention Tony C and his winning lawsuit against nodder
Sadly Leronlimab has been held back for years (as you mention) by this fraud collection of posters and mods at various locales.
You did forget to mention the great progress in the monkeybutts to go along with the mouse studies. But yea the super secret decoder ring "partners" are the best. I forget how many partners were lined up for the removal of "the hold" on trials and then there were some partners that were just waiting for the amawrecks legal snafu to end.
I feel for Dr Lalezare and what these frauds and mngmt/board frauds have piled on top of Leronlimab to dig out of
Sell and be gone. Easy enough. I will continue to support and to buy, buying on dips and selling a few on decent rises.
In case you haven't noticed we won the fairy tale suit with AmarX. We won the hold lift battle with fda.
Nader screw up has at long last led to a better relationship with fda...and exposed their corrupt bias. In this regard expect
a bit better treatment going forward as we have already seen. Expect a partnership or two. Expect more publishing and trials.
All of this brings more attention to the drug leronlimab which you have even endorsed. So go ahead. Take your loss. You have
had a chance to average down and to flip so don't blame anyone but yourself for any losses. Yes, it has been a rough go and
having shorts pile on from Big Pharma and hedge funds have slammed the stock price. I love it after all this experienced as it
has been an eye opener to corruption and allowed me the opportunity to fill my bags cheaply. I anticipate much better days thanks
to the vision of our present directors and for recognizing the brilliance of Dr. Jay. Anyway, best of luck to you whatever you decide to do.
Leronlimab works and works well safely. This reality will be appreciated and brought into the world to help relieve a lot of suffering.
That's my story and I am sticking to it.
I understand all of what you're saying. but at some point, given that human life expectancy of the average investor is only about 80 years (shorter if you've lived through owning CYDY) we need to see some sign of a financial profit in this company Punch in the 10-year graph on your iPhone stocks app - that's a loss of -85.4% over a 10 year period. I couldn't even find another stock that has erased that much investor money over the same period. You know why? - because they've all gone out of business.
the whole "the science is world changing", "it's right around the corner, etc." is the same song & dance i have been hearing for 8 years in this stock - we've always been "one quarter away", "in discussions with a partner behind closed doors", "nearing a buyout", etc. All of it has been pure fiction - never a shred of reality to any of it, and during that time the S&P 500 has tripled, and CytoDyn investors have lost nearly all of their money.
I look at this very simply - over 8 years i have lost 85.4% of my hard-earned, after-tax dollars. All the time i've heard fairy tale after fairy tale. So forgive me if right now (as we sit at $0.14) i want to hear more than just "we're starting mouse trials, we're publishing white papers, etc.".
I want a real leader to step up and tell me when shareholder value will be restored.
All well and good if one chooses to not see the expected positive effects of announcing a partnership and new trial. We all know we have the money now and have more than a few others interested in partnering. So the timing of this may well coincide with any warrant conversions and selling. Personally I like the idea of converting and selling only after a nice price rise which will dampen some rising ...all depending on the clout of the partner. I expect Jay is timing this as good as he can. Should it ever go to .08 we won't be there long before climbing back. I doubt we make it that low but should that be the case it will be more loading as usual. This is a long term investment that many feel will not only be successful but well noted in the medical world.
Hey Swordman. I did not even look at home many warrants were redeemed out of a possible total of how many. So I can’t answer honestly whether I was surprised or not.
AAV research 2022 press release, plus 2024 pre-clinical poster abstract
Here's the July 2022 press release announcing the NIH grant for the AAV research with Leronlimab.
https://www.cytodyn.com/newsroom/press-releas...ional-cure
"The grant will fund the development and preclinical research of a single-injection gene therapy that codes for the leronlimab protein sequence and which will be delivered via an adeno-associated virus (AAV) vector. The study will examine if this gene-therapy approach could provide the potential for “functional cure,” i.e., sustained viral suppression to people with HIV without requiring them to take medications for the rest of their lives."
Here's the July 2024 poster abstract at
https://programme.aids2024.org/Abstract/Abstr...actid=3857
"In two of the RMs, SHIV viremia declined and reached undetectable levels between 10-40 weeks post-AAV, and those levels have remained undetectable through 70 weeks post-AAV. The remaining two RMs developed ADAs within 5-15 weeks post-AAV resulting in complete clearance of Leronlimab from plasma as well as a rapid decline in CCR5 RO. Spontaneous reemergence of CCR5 RO by Leronlimab was observed approximately 1 year post-AAV. One of the two animals has had full and sustained CCR5 RO, detectable plasma Leronlimab, and undetectable SHIV RNA in plasma for over 1 year post-reexpression. The second re-expressing animal has achieved and maintained 100% CCR5 RO for about 10 weeks, has detectable plasma Leronlimab, and has declined plasma viremia."
abstract released today
https://programme.aids2024.org/Abstract/Abstr...actid=3857
excerpts
Title
Delivery and long-term expression of CCR5-blocking monoclonal antibody Leronlimab with AAV for ART-free remission from SHIV viremia
BACKGROUND: CCR5 blockade represents a scalable non-transplantation approach for long-term ART-free HIV remission. Here, we tested if AAV vectors could induce long-term expression of CCR5-blocking monoclonal antibody Leronlimab in a SHIV-infected rhesus macaques (RMs).
METHODS: Four SHIV-infected RMs received AAV9 encoding macaque Fc Leronlimab with stabilizing, silencing, and half-life extending mutations (AAV9-MacLSLeron). Animals were monitored longitudinally for CCR5 receptor occupancy (RO), plasma Leronlimab concentrations, antidrug antibodies (ADAs), and SHIV plasma viral loads.
RESULTS: All four AAV9-MacLSLeron-treated RMs reached 100% CCR5 RO on blood CD4+ T cells within 1 week and plasma Leronlimab was detected (>1ug/ml) within 2 weeks of AAV administration. In two of the RMs, SHIV viremia declined and reached undetectable levels between 10-40 weeks post-AAV, and those levels have remained undetectable through 70 weeks post-AAV. The remaining two RMs developed ADAs within 5-15 weeks post-AAV resulting in complete clearance of Leronlimab from plasma as well as a rapid decline in CCR5 RO. Spontaneous reemergence of CCR5 RO by Leronlimab was observed approximately 1 year post-AAV. One of the two animals has had full and sustained CCR5 RO, detectable plasma Leronlimab, and undetectable SHIV RNA in plasma for over 1 year post-reexpression. The second re-expressing animal has achieved and maintained 100% CCR5 RO for about 10 weeks, has detectable plasma Leronlimab, and has declined plasma viremia.
CONCLUSIONS: While further investigation is needed to develop AAV vectors and/or regimens that reduce the incidence of ADAs, the transgene reexpression phenomenon we have observed highlights the need to further investigate the interplay between AAV establishment and the development of ADAs. Overall, these data demonstrate the potential of AAV vectors for sustained antibody-based CCR5 blockade as a gene therapy approach for long-term ART-free HIV remission.
correct. the warrant offering closed last Thurs night at midnight. But those shares won't be registered immediately, so the investors who exercised won't have those shares available to sell for a few weeks i believe.
It may indeed be the case that once those shares are available to sell, we see major downward pressure on the SP - because the equivalent cost basis of those warrant conversions is in the .08 cent range (factoring in the free extra 20% shares that were given to those who exercised). So, the smart trade would be to sell down current shares until the SP hit's about .09 - free, easy and fast profit for those who converted their warrants.
Put another way, any way you slice it, the company has effectively set the market at .08 - that's the effective price of this warrant conversion, and is the only reference point for how the company is to be valued. No different than a big public company doing a follow-on offering, or debt issue - they set the price for their stock via those offerings.
In reality, the only money that has ever been made in this stock, has been made in these types of warrant schemes, driven by Paulson investors. And it has driven a continual downward spiral in the SP to .14, and has also driven an incredibly bloated share count of well over a billion shares outstanding. So you have a small number of players making money, with the long-only investors footing the bill and getting murdered. It's like Buffet's quote "if you're sitting around the poker table wondering who the patsy is, it's you".
The SP may well recover, but getting back to $1 is likely years away, at least in my opinion.
Were you surprised by the # of redemptions/conversions of warrants to shares?? To the low or to the high side??
You are not wrong. And technically the warrants were ‘exercised’ by shareholders into shares - the warrants were not sold. The shareholders have not yet received their shares from this recent warrant conversion and thus have not been able to sell any of the newly acquired shares yet. Perhaps CYDY may have some news soon before all these new shares end up in the accredited investors’ accounts ?
That’s the way it read to me as well.
I may be wrong, but the warrants sold during the offering haven’t hit the market yet.
well, so much for that theory of the warrant exchange suppressing the price. not the first (or last) time i've been wrong about this company and stock.
on the plan B. Jay, time to man up and speak with shareholders - because despite what seems to be good news, we're not a penny richer for it. And i for one, am ready to hear something positive (cause I'm not getting that warm & fuzzy feeling from the 80% loss on my brokerage statement)....
The show must go on! Are there any real housewives left in America? They used to be glued to the boob tube watching "As The World Turns".
Personally, I am hoping for a novella called "Leronlimab Ladies Live And Well" starring the Pour Brothers. Maybe the "Adventures of CytoDyn" would increase
the chance for returning seasons. Murray, Birnkrant, Sheikh, Strayhorn, Akunne, Winestrock, Struble et al, still looking for actors to play their juicy parts.
Surely stands a chance to beat out All My Children anyway.
Dr. Kildaire or Make Us Welby, MD actors could fit right in, but I vote for Katangolo. What say? This could be a real cash cow providing the big bucks for more trials... medical that is, hopefully not legal thanks to Dr. Jay in the lead role now.
Yippers, $CYDY$ 2024 The New Beginning is unfolding right on cue. Lights, camera, action. 🤠
ok, thanks for that clarification. that would further bolster the economic case of that offering serving as a lid on the SP.
Ideally next week, post-transaction, we get either (i) a jump in the SP, or (ii) CC announcement from Jay. Actually, i'll take both !
Achhhuallly CYDY hasnt run a trial in years
Hey loooongs how's it going? Sticking it to the shorts eh?
RE: FDA Communications
Anyone recall the two fda bureaucrats that bad mouthed CytoDyn? Are they on the list.
Also note..."with the understanding we are not limiting our list by doing so".
I also wonder who is the redacted person in the heading?
Interesting the pps is up 8% this past week or so. Where are the 13D shorts?
Are some of them buying warrants or covering short positions or both?
Could be they finally see the light that Dr. Jay turned on.
Actually, the EXACT price of the warrant conversion is $.09387 per warrant to get 1 share plus a 20% bonus share bringing the cost down to $.078225 per share. And yes I believe the deal closes by this Friday.
The warrant exchange deal closes Friday, at least that's my understanding. My theory has been that this has put pressure on the SP, as people sold shares at .14 to buy (exercise warrants) at .09. But, i could be wrong and we'll find out next week if there is anything to that theory.
Aside from that, what we really need is to hear from Jay. A lot has happened since the last call in terms of new trials / protocols, etc. - and obviously cash in the bank from the Amarex settlement and this warrant exchange.
Jay should address shareholders and frame these events - I would think he'd be chomping at the bit, as these are all positive developments (especially the cash in the bank). He should also give projections on the timetables as to when all of these trials could begin to deliver data, which ones could lead to a partnership, etc.
Personally, I think we need some explanation as to why the stock remains at all time lows here - and when we we might expect to see some recovery.
Interesting that you seem to know what I'm doing or not doing. Or that you even care. I need to spend money and sign up so I can see the day by day activity of the NP/KK case so I can do what, exactly? How does that have anything to do with CYDY? I'll just stick to looking for the things that matter for the trajectory of the company now in the present. Seems more productive to me.
Interesting that you still will not get off your **** and look for facts.
Um, ok. Don't know what all that's about. What a smartass. Thank you, oh great one for gracing us with this information. I'll gladly sit in the cheap seats since I'm not paying for access to Pacer or anything else like that. It's not pertinent to anything that I do. Interesting that it's that old and was just posted.
Many understand your frustration for instant gratification.
These PACER posting were made on 2024/07/15, so I guess you'll have to take that up with the US Court's reporting system.
Or better yet, why not contact Judge Xinis directly and ask her to provide you with free and prompt reporting of court documents. I'm sure she'd understand your frustrations and indulge you.
Withstanding that, I guess you'll have to just sit with everyone else in the cheap seats watching the show.
#3 and #17--probably would pay to be called as a witness
#2 and # 6--might do the same, just as eager to testify against DR pourhassan
#14 and # 22--probably could not find any persons less credible unless lonsford
Yes, and that was from March going into April. Any new news? It's now July.
"leronlimab could be paired with checkpoint inhibitors like Merck & Co.’s Keytruda, Bristol Myers Squibb’s Opdivo or Roche’s Tecentriq. The plan likens leronlimab to Bristol Myers’ Yervoy, which is often paired with Opdivo. The Big Pharma collects about $1.5 billion a year from the therapy’s combination approvals.
These partner therapies, called immune control point (ICI) inhibitors, act when the tumor begins to resist the main treatment, reactivating the immune system to extend the anti-tumor response.
CytoDyn could capitalize on the popularity of combination treatment trials, which are all the rage in oncology at the moment. They suggest that leronlimab would perform the same duty as an ICI, basing their argument on data from previous COVID-19 and HIV trials that suggest the drug can reverse T-cell exhaustion.
“Leronlimab has an opportunity to be a major replacement option for ICI’s due to toxicity concerns,”
The therapy avoids major side effects associated with this type of treatment such as pituitary disorders and organ dysfunction, according to the plan. Leronlimab may have opportunity in lung, breast, pancreatic, urothelial and colorectal cancers.
Wonder if this....." suggests that CytoDyn seek out partnerships with Bristol Myers, Roche, AstraZeneca, Pfizer and Regeneron to negotiate potential clinical trial combinations.
“These companies should be amenable to clinical investigation into leronlimab combination once leronlimab proves its efficacy as a CCR5 inhibitor,”
From a couple of years ago. Would any of this is being presently contemplated since we have official word that partnerships are in the hopper. Go Dr. Jay and Team CytoDyn.
ONE other note... would so love to hear about the Pour Brothers trial. I used to love sitting in on trials hearing first hand testimony. Will those derelicts from the fda that spouted out their hate for CytoDyn be testifying? Hopefully they will be dragged through the mud no matter the trial outcome. Transparency matters. EUA should have been granted or at a minimum Expanded Use/Compassionate Use should have been maintained. At least Erap ex president Philippines was saved.
"Expanded access, or compassionate use, is an individual patient use of an investigational new drug outside of a clinical trial. Expanded access is sometimes possible when the investigational new drug is needed to treat a serious or life-threatening condition and there is some clinical evidence suggesting that it might be effective in that condition." So so many ways the official health agencies conspired to harm the public. Sad sad sad.
Yawn dead stock for zombie company is boring now. Bring back Nader.
Is that short for Delivery Boy? Well, whatever!
All have a blessed weekend.
TICK TICK TICK ..... money in the bank and trials in the works together with some new pharma company raring to go.
Okay, Del, we hear you, loud and clear. Check out who Del is?
Would guess weed wine is selling as fast as possible--now he doesn't have to report as insider. IF CYDY is not paying nodder legal--same for that disgusting filth
Selling shares at 13-14 cents then getting shares in the 8-9 cent range and maybe selling those also??
Dr Jay was left with crap hand of cards. From years and years of shareholders/mngmt/pumpers posting lies/voting and allowing fraud to proliferate
How confusing is it the dilution hasn't stopped look at the float. And they are a clinical stage biotech not running any trials. I'm actually shocked they've managed to keep it this high.
I am truly perplexed by the SP action here. The fact that we're trading lower than before the hold was lifted, and before the Amarex settlement makes no sense to me. Because those were the 2 big unknowns (inability to run trials and solvency) clouding the future of the company - they've now been resolved, and the SP is.......lower? It's like the Twilight Zone.
My only explanation is that people are selling long shares to raise cash to exercise their warrants at the 9 cent range. And I can imagine that's driving the SP, because volume is so low there's clearly not any buying of size on the other side of the table.
Still, It's pretty damn frustrating I have to say.
BlackOps is not dead. I spoke to him recently and is enjoying his retirement.
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DISCLAIMER:
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn. The SEC has informed the Company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or securities trading activity.
In addition, the Company and certain of its executives have received subpoenas in connection with an investigation being conducted by the United States Department of Justice. The subpoenas seek testimony and/or records concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19 and related communications with the FDA, investors, and others, and trading in the securities of CytoDyn.
Securities and Exchange Commission and Department of Justice Investigations
The Company has received subpoenas from the United States Securities and Exchange Commission (“SEC”) and the United States Department of Justice (“DOJ”) requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19, HIV, and triple-negative breast cancer, related communications with the FDA, investors, and others, litigation involving former employees, the Company’s retention of investor relations consultants, and trading in the Company’s securities. Certain Company executives have received subpoenas concerning similar issues and may be interviewed by the DOJ or SEC in the future. The SEC informed the Company that its inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or security.
The Company is cooperating fully with these non-public, fact-finding investigations, and as of the date of this filing, the Company is unable to predict the ultimate outcome and cannot reasonably estimate the potential possible loss or range of loss, if any.
VANCOUVER, Washington, March 30, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission.
The Company was not enrolling any new patients in the trials placed on hold in the United States. The partial clinical hold on the HIV program impacts patients currently enrolled in extension trials. These patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved. CytoDyn intends to work closely with the FDA to resolve the partial clinical hold as soon as possible. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved. The Company is not currently conducting any COVID-19 trials in the United States, as it is evaluating the most optimal programs on which to focus its resources and attention.
“CytoDyn is committed to FDA compliance,” said Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn. “We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA. We will provide an update when we have additional information.”
Up to 205,652,848 Shares of Common Stock
This prospectus supplement updates, amends and supplements the prospectus dated October 11, 2023, relating to our Registration Statement on Form S-1 (Registration No. 333-272815) (as supplemented or amended from time to time, the “Prospectus”). Capitalized terms used in this prospectus supplement and not otherwise defined herein have the meanings specified in the Prospectus.
This prospectus supplement is being filed to supplement the Prospectus with the following information:
The information in this prospectus supplement includes forward-looking statements relating to, among other things, future clinical trials and our business strategy. The reader is cautioned not to rely on these statements, which are based on our current expectations. Please see below for additional information about risks involving our securities.
This prospectus supplement is not complete without the Prospectus. This prospectus supplement should be read in conjunction with the Prospectus, which is to be delivered with this prospectus supplement, and is qualified by reference thereto, except to the extent that the information in this prospectus supplement updates or supersedes the information contained in the Prospectus. Please keep this prospectus supplement with your Prospectus for future reference. The Prospectus, together with this prospectus supplement, relates to the resale of up to 74,903,789 shares of our common stock, par value $0.001 per share (the “common stock”), and 130,749,059 shares of our common stock underlying certain warrants (collectively, the “Shares”), by the selling stockholders identified in the Prospectus under “Selling Stockholders”.
Our common stock is quoted on the OTCQB of OTC Markets Group, Inc. under the symbol “CYDY.” On February 29, 2024 the closing price of our common stock was $0.2575 per share.
Investing in our securities involves risk. You should carefully consider the risks that we have described under the section captioned “Risk Factors” in the Prospectus on page 8 and in Part II, Item 1A of the 2024 Second Quarter 10-Q before buying our securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if the Prospectus or this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is March 1, 2024.
November 3, 2023
November 2023 Letter to Shareholders
Dear Shareholders,
We write to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), and to thank you for your continued support of the Company.
Throughout our history, CytoDyn has made great strides in developing leronlimab from a single indication molecule into a platform molecule with the potential for multiple therapeutic indications. Through CytoDyn’s investment in clinical trials, we have generated valuable data demonstrating how leronlimab might be used in HIV, oncology, metabolic dysfunction-associated steatohepatitis (“MASH” formerly “NASH”), and metabolic dysfunction-associated steatotic liver disease (“MASLD”). We have also successfully transferred our manufacturing technology allowing us to manufacture leronlimab at scale in preparation for clinical trials and potential FDA approval.
Fiscal year 2023 proved to be a very difficult year for CytoDyn. We had planned to be off clinical hold and back to conducting clinical trials by now. Unfortunately, to date, we have been delayed in our efforts to satisfy the FDA with our clinical hold submission(s). We have embarked on a more comprehensive effort to resolve the FDA’s lingering questions. These efforts include the Company’s hosting of a number of advisory board meetings with key opinion leaders (KOLs). Adding to our delay was the unanticipated medical leave taken by our then President, Dr. Arman creating additional delays in our subsequent resubmission.
However, these unforeseen circumstances provided the time needed to help us gain new insights and understanding of leronlimab in the current HIV treatment environment. Further, we were able to receive and incorporate the perspectives of some of the top HIV KOLs worldwide as to how they believe leronlimab can play a significant role in helping HIV patients, notwithstanding other therapeutic options currently available to patients. As part of this process, the Company engaged various new clinical, regulatory, and medical consultants and advisors with relevant experience and expertise that we believe will continue to benefit the Company for years to come.
The Company has taken necessary actions to position us for near-term and long-term success. During the last fiscal year, the Company implemented significant reductions to its workforce, cash burn rate, and operating expenses, in order to conserve our resources and devote them to critical corporate priorities. In addition to our work in HIV, we have worked with top experts to develop a MASH clinical trial protocol and identify potential MASH pre-clinical combination therapy trial concepts, which trials we believe could be attractive to a partner and position the Company for a greater chance of success within the MASH space. We also began development of a longer-acting therapeutic with a partner who has a very strong and reputable artificial intelligence (“AI”) platform, which we believe may provide significant increases in shareholder value in the years to come. We also believe that the Company is positioned for success in the Amarex litigation. We fully funded Sidley Austin LLP – the preeminent law firm representing the Company in this matter, filed a more-detailed statement of claim, and scheduled a final hearing date (August 12, 2024) in the arbitration.
We understand that CytoDyn’s recent challenges may have tested your confidence. We want to assure you that we remain dedicated to developing important therapeutics that can make a difference in
patients' lives, and at the same time provide value for our shareholders. Again, we are grateful for your ongoing support and trust.
We will continue our efforts to prioritize and execute on goals that will enhance value for all shareholders. Our efforts are focused on successfully completing the resolution of the FDA’s partial clinical hold – having recently made a submission that we hope will be successful – and strengthening our leadership team. Additionally, the Company will be evaluating the various potential indications for leronlimab to maximize the effective and efficient use of our resources. We have always believed leronlimab holds great promise, and we are determined to explore all avenues by which patients and medical practitioners can benefit from its use. We believe that with the improvements we have made and continue to pursue, our company is positioned for long-term success.
We deeply value your investment in CytoDyn and are committed to acting in your best interests. We look forward to continuing to communicate as additional developments occur. We realize the updates above may not answer all the questions you have. We therefore include a November 2023 “Frequently Asked Questions” supplement with this letter. This FAQ supplement is something we intend to update from time to time and it will be posted on the Company’s website in the near future.
Finally, in advance of our upcoming Annual Meeting on November 9, 2023, we want to remind you to submit your votes, if you have not already done so. If you were a shareholder as of September 11, 2023, you are considered a shareholder of record. Notably, the Company has asked for the shareholders’ approval to amend the Company’s Certificate of Incorporation to increase the total number of authorized shares of common stock. This increased share allowance is critical to the ongoing viability of the Company, and we therefore encourage everyone to vote if you have not already done so. If you have any questions or require any assistance in voting your shares, please call the Company’s proxy solicitor, Alliance Advisors LLC, at (833) 814-9456.
Sincerely,
Tanya Durkee Urbach
Board Chair
Note Regarding Forward-Looking Statements
This letter and the accompanying Frequently Asked Questions supplement contain forward-looking statements relating to, among other things, future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and/or our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review the Annual Report on Form 10-K for the fiscal year ended May 31, 2023, including in the sections captioned “Forward Looking Statements” and “Item 1A. Risk Factors”, as later supplemented by our Form 10-Q for the quarter ended August 31, 2023, in the section captioned “Item 1A. Risk Factors”. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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