Monroe1
7 hours ago
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!
Blueheel1
1 day ago
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.
Blueheel1
2 days ago
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).
Blueheel1
3 days ago
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.
docj
3 days ago
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."
docj
3 days ago
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.
Blueheel1
3 days ago
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.
Monroe1
1 week ago
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. 🤠
Blueheel1
1 week ago
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.
Monroe1
1 week ago
"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.