Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
they have the $15m and can spend it
the effective s-3 allows buyers to sell. there will not be any issue with the s-3 / effect
in fact they have already spent a lot of it. they will be down to $7.5m cash in hand end of march.
if they pay welch they will be broke. if they don;t pay welch they can keep the lights on thru june.
march cc will ask for 500m new shares. warrant exercise agreements will get them thru the summer. they will need ANOTHER placement in the fall.
they have no money for trials and will not have any money for trials this year, UNLESS they have a significant catalyst to SUSTAIN a higher share price. the only possibility of that is MD Anderson, nothing else.
CYDY fails EVERY aspect of partnership DD
not that any BP has taken a look, because they haven't, but if they ever did, cytodyn might do ok per "the science". beyond that, cydy fails at EVERY turn.
x) they have no sustainable funding source and BP does not 100% fund the company
x) they have up to $100,000,000 subject to injunctive relief - which means if a BP gives them $100m it is GONE.. flushed down the toilet.
x) NO CYTODYN EMPLOYEE HAS EVER HAD A DIRECT ROLE IN ANY CLINICAL TRIAL aside from the biostats dude.
there is ZERO chance of any partnership for at least the next several years. ZERO.
sorry, but its NOT about the science. that's what gets your foot through the door, nothing more.
PARTNERSHIPS COMING! MULTIPLE!
ZERO chance. this is how partnerships in pharma work...
1) BP entity expresses interest via either a. their own knowledge of the competitive market or b. submitted inquiry from a biotech
2) BP requires biotech tom submit a prospectus - in their proprietary format - detailed EVERYTHING regarding the asset (the drug).
that's EVERY piece of data... in their format. AND... FULL FINANCIAL DISCLOSURE... AND... every detail regarding patents.
and... MORE. its a big deal
3) BP team starts digging. This team is dedicated to ONLY M&A research. that's all that they do.
4) BP DOES NOT focus only on "the science". they look at EVERYTHING. and they will dump you faster than the FDA.
x) BP needs the biotech to be financially stable. they need to know that the biotech can raise funds as needed BEYOND their monetary infusion.
x) BP needs to know that they are not dumping their money into a debt pit - that the money will not go to creditors.
x) BP will review the experience and background of all of the biotech executive and scientific employees.
BP WILL NOT PARTNER WITH A COMPANY THAT HAS NOT PROVEN TO BE VERY CAPABLE OF EXECUTING ROBUST TRIALS EFFECTIVELY.
If they partner with a pre-clinical entity, and this does happen, they will be looking very closely at the background / EXPERIENCE of the team.
case closed: Arman invested 100k in cytodyn
$458k salary, and made the 100k buy
i thought at one point that his compensation was all is equity not cash because i was seeing so much coming across in the Form $4s. but very shortly thereafter i looked further and found his cash salary detailed in an 8k.
https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/0001558370-22-010484/0001558370-22-010484.pdf
not open market because CYDY is banned - perhaps
SEC banned CYDY from open market transactions upon the start open investigation. that ban remains and MIGHT therefore Arman had to use some other method for his insider buy. and / or he was smart enough to reduce his risk and expand his potential reward by taking discounted shares and the warrant sweetener. .
Arman salary $458k, he has $100k to burn
he has never made so much money before. not even close, perhaps half that.
he also has a shot at a 40% annual bonus, and well over $1m in non cash compensation, much of which has been granted already
NOT an open market purchase, but a purchase
is was a direct buy from cytodyn, not open market. therefore they used A and a footnote so as not to be labeled liars by putting a P out there when the purchase was different than standard insider purchases that are exciting to investors of every company except cytodyn.
assumed purchase PRICE! 10000% purchase
its embarrassing to humanity that the PURCHASE by Arman is being disputed.
something "ASSUMED" in the finance world is something "calculated".
it is used in contractual language literally millions of times every single day.
the purchase price was ASSUMED because, as it already had stated in the 8k, the purchase PRICE was based upon the placement terms "above" - and those terms were spelled out for you... AND I ACTUALLY QUOTE: "The final purchase price per unit will be equal to 90% of (i) the intraday volume weighted average price of the common stock as of the first closing, which occurred on January 12, 2023, and (ii) the intraday volume weighted average price of the common stock on the date of the final closing in the Placement Agent Offering, whichever is lower;"
that which i quoted is the formula for which there is therefore an ASSUMED purchase price. the purchase price ASSUMES its value from the calculation.
thanks for the link
CYTODYN IS FLAT BROKE.
yes i am the voice of reason, now acknowledge the brutal financial mess that the company is in.
It was 1000% a purchase. end of story.
Fintel simply collects filing data. The filing said A. there are many possible explanations for that even tough there was 1000% a purchase and anyone that has learned how to read admits that. Two very good possibilities for the filing as an A are cytodyn incompetence and cytodyn being careful not to classify the purchase as if a standard open market insider buy had occurred.
to be fair his potential promotion to CEO is actually contingent on attaining certain milestones. i will say however, that anyone who has said that in here was just guessing or hoping. but it is also factual. his employment agreement is public. "The Executive shall serve in the capacity of President for an initial six (6) month term, with the opportunity for advancement to the position of Chief Executive Officer thereafter provided certain benchmarks established by the Board are met."
other stocks double on release of holds because they have TRIALS IN PROGRESS and/or REGULATORY APPROVAL FILINGS in progress and those things can then move forward again.
a flat broke company running no trials and having none planned won't get that bump. it'll get some bump, but nothing tremendous, and it will fade.
wth positive part3: there is a path forward
i think the drug works and the company is a mess. the finances may be too much to overcome, however....
they still ave 3 potential catalysts to save them.
1) amarex legalities
> the lawsuit was dropped, but arbitrators have wide ranging full powers to award all types of damages to whatever extent they choose, more or less. i personally don;t think anything excessive will be determined. but perhaps 10s of millions, which would be a big deal. imo the maximum award possible is perhaps $50m. Or... nothing. but i feel like amarex seems to have some culpability.
2) MD anderson preclinical mouse study leronlimab-keytruda
> unsure what's up with this. MD anderson keeps things quiet. i think they initiated. Arman said so via email inquiry. if they initiated, they are often pretty quick about things based on my research. tbh, publication of results is something that i feel could happen at any time. but again... did they initiate and who knows how long it will take to potentially wrap it up and to publish results. if results are very good and get published, that is a big deal
3) OHSU preclinical monkey studies, particularly HIV fucntional cure
> they are doing long acting agent studies, but there is a TON of competition there and many approved products already and several more coming.
> functional cure is a different story. the competitive science there is struggling. if there are good results from OHSU, then cytodyn would likely be in the lead. results may not come until 2026 though. hard to say. the grant is through 2025 and university labs prioritize self-preservation via grants and they are normally in no hurry and want to stick to the grant schedules. i'm thinking study completion 2025 and publication 2026. who knows?
> good preclinical results for hiv functional would be a BIG deal
4) the next trial:
> i don't see any significant catalyst coming from a trial for several years. all 3 catalysts above will occur or fizzle prior to any results being available from the "next trial" - if there ever is a next trial
something positive p2: arman and even old nader...
Arman seems ambitious, but also very very naive. obviously he is a bright guy and has a decent general background, but not for CEO at all. he is in wayyyyyyyyyyyyyyyyyyyyyyyyyyyyy over his head imo. heck he only has 8 years TOTAL pharma employment and only 5 of them of any value. and he is essentially running a small biotech??? all on his own??? a biotech that is in an exceedingly difficult position financially and legally??? he has ZERO experience in a lot of the matters he is dealing with. and he is dealing with all of it alone. that is a lot to ask of the guy. i deal with fairly deep depression daily. i could FEEL his struggles in both the october and december calls. i have also been a mid-range professional in over my head before and i can FEEL his struggles and sense his naivete there as well. Arman means well. He is trying very hard to succeed. He has talents that are valuable to any company. If i were important and ran a business, I would want the guy on board. But in his current position, he is in an almost impossible situation.
imo his reprioritization of indications was excellent.
imo the investor presentation was superb. well timed, very well prepared, long overdue.
imo his insider buy was a great strategic move.
imo the rebrand idea is very appropriate and another important strategic move.
imo his somewhat limited plans for moving forward are completely appropriate.
imo he is doing better than i would ever expect in his CEO role, given his lack overall and specific experience.
but, he has made several very questionable statements (this post isn't about that though and i can't say i blame him given the situation he is in and the inevitable stress of it all). i also think he expected the share price to respond better and the financing problem to sort of go away. his inexperience probably played a big part there.
the cytodyn advisory board is also very impressive.
i'll even give Nader some credit. he more or less did everything wrong, but he DID get a load of trials started and a bunch completed. he messed all of them up, but also managed to at least get some positive data signals out there, across many indications. i think he is a lying crook, but also think he absolutely wanted to get the drug approved. unfortunately he didn't understand how the game is played and his overconfidence was debilitating for cytodyn.
the board of directors is absolutely horrendous. couldn't be much worse imo. but this post is not about that so i'll not expound on it.
something positive? part 1: there isn't much positive to say about cytodyn (below though - i gave it my all on the positives). the positives are also buried by the astounding negatives. but, i'll indulge you. i have stated positive things many times. i do however post 999 times negatively for each 1 time positively. but here goes... as far as LERONLIMAB... NOT CYTODYN... not yet... and keep in mind you own stock in CYTODYN. you do not own stock in leronlimab...
i personally think the drug works and imo its very safe. i personally would request the drug if i were in bad shape with covid and it were available. imo its good enough for approval in various HIV indications. not sure on covid even though i'd try it. might also be good enough in other indications. it could be a very versatile important drug 20 years from now. or... it might be good at a lot of things but not great at more than 1 or 2. it may prove to be fascinating but completely unnecessary. even in HIV... its not needed. not until they work out the functional cure preclinical data. for MDR HIV lenacapivir is superior.
as far as CYTODYN? there are very few positives i can even spin never mind believe in. the former teams - nader's team and the predecessors were hands down atrocious. as far as the current team, well, there isn't a team. you have 3 execs (i didn't count the CFO) and a stats guy. the stats guy has nothing to do. cunningham and meidling have expertise mainly in project management and materials / supply chain; not the greatest fit for the current needs at cytodyn. i really don't think they have much to contribute, despite being bright people with deep pharma industry experience. they have no therapeutic development or regulatory filing experience at all. and they spent decades managing others, not DOING the work.
"This time the difference is there's a new management team at Cytodyn, silence means something totally different now"
silence doesn't pay the bills.
and the management "team" is a one man show. and he has EIGHT TOTAL YEARS of pharma employment, 3 of the 8 at startups where he did literally nothing. you have a guy with almost no pharma employment history and no experience even close to CEO, trying to save a broken and flat broke company. the silence is quite scary, if you face the reality.
science has moved 3 iterations beyond CRISPR already and those 3 are much safer, not requiring DSBs. cydy LOLngs love to say "but the science"... however, Mab ccr5 blocking isn;t the ONLY science out there. and gene editing isn't the only path to leronlimab becoming obsolete.
every gene editing platform under development will make leronlimab utterly worthless in 10 years, prior to any leronlimab approvals. there are more than 5. nuff said.
the financial conundrum is out of hand. consider...
they are essentially out of cash and almost out of shares. welch already has 45,000,000 warrants and 9,000,000 shares. they gave him 15m warrants 3 times now in lieu of the bond repayment. does he even want another 15m? sure, if they strike gold, he'll be rich, so the more the better. on the other hand, they can't strike gold if they go bankrupt. taking another 15m warrants from them at this critical juncture might be a bridge too far. but i guess its the same either way... if they pay him then that leaves them with ZERO DOLLARS right now. if he takes another 15m warrants instead, then they are down to less than 65m available shares, which they still use/require regularly for various other purposes - paying vendors, debt renegotiation, warrant exercise agreements, employee equity incentives (believe it or not!), etc. its a tough time for all involved over at cytodyn.
three things learned from the 8k 1) placement is STILL in progress. 2) they STILL hadn't paid welch by end of january - that's SEVEN missed bond deadlines. 3) clinical hold paperwork STILL was not submitted by end of january (or was rejected by the fda). tomorrow is day 31 since january 31st.
2022 lenacapivir mdr-hiv approved: > 87% efficacy
lenacapivir was better than 81%. 87.5% in phase 3.
it is the superior drug for treating mdr-hiv.
and it is approved. leronlimab will almost certainly NEVER gain approval for mdr-hiv.
its not being pursued. never will be. r5 tropic mdr-hiv combo third line therapy consists of less than 5% of all hiv patients.
its not much of a money maker. gilead went after it cuz they dominate hiv and they could afford to punch that out while simultaneously running trials for several other lenacapivir hiv indications that will generate much greater revs.
not a physician - i am more knowledgeable than any physician regarding the topics discussed here. professional day trader with a biotech slant. knowledge is money. 99.99% of physicians have never heard of any drug that has ever been mentioned in here, never mind know what went on in the development process or what the results look like or what the actual safety profile looks like. physicians learn the drugs sporadically - only once they become approved, and then become widely marketed. and then... they just read the label.
partners might actually ADD to the approval timeline
BP doesn't rush their trial process. they build their case meticulously. they run proper dose-finding trials for instance. cytodyn does not. and they make sure they have the right cohorts (lots of them) and create enough data along the way so they can present a winner to the FDA. they DO cut corners where they can but they are much more thorough than biotechs. they CAN help getting FINAL APPROVAL faster... because biotechs will end up getting an RTF or CRL instead of an approval. but they might take LONGER for the initial data submission to the FDA.
trial timelines please learn. ADD IT UP.
you literally only know the glossy edges of leronlimab science. you know nothing at all about therapeutic development timelines. i have spent hundreds of hours studying therapeutic development, including timelines. no one... no one anywhere ever finishes a robust p2 (a p2 that will allow yo to move on to p3) in less than 2 years for hiv, oncology, NASH or anything cytodyn has ever considered or will ever consider. go look at a couple dozen completed trials. 2.5 is FAST.
when i say 2.5 years p2 and 3.5 years p3... that is AGGRESSIVE. can easily be 5 years or even more for a robust p3.
every trial involves several time consuming elements. each of them takes several months. some elements take 1 or more years.
1. protocol design and approval. the design takes months. the approval can also take months.
2. site setup. this takes months, even as long as 6 months or more. each site has its own internal procedures. its not "oh we think it'll be swell to work with you, where do we sign?". its a process involving departments and meetings and resource allocation and tons of paperwork and signoffs and more.
3. enrollment. this can take multiple years for some p3 trials. always take many months, even up to a year or even more, for some p2 trials.
4. dosing and observation. bare minimum 6 months for a robust p2 (a p2 that will be adequate to then move on to a p3), but usually longer than 6 months for the full results set, all endpoints. 12 months always preferable for leronlimab indications. for p3 it can be 24 months or longer. they need to report on DURABILITY vs disease progression.
5. dataset lock. this is always more time consuming than anyone expects. several months. for large trials, like a NASH p3, it could even take a year (that's a bit long but it happens), depending on the trial design.
6. top line analysis and presentation. again... several to many months, can even stretch for a year or even more for some large complex trials.
tbh we don't KNOW whether leron is best or not...
that's the most important fact. after 20 years all we know is that its effective for MDR-HIV.
but it isn;t needed there and is not being pursued.
for covid there was some good data. but it still failed and is not being pursued.
for all other indications the evidence is thin and will take many years to prove.
patents, MOA, positive signals, uniqueness, broad potential applicability, etc etc etc DO NOT MATTER if the company can not gain approvals. and they DO NOT MATTER until efficacy is PROVEN. it has not been proven outside of MDR-HIV. you think it'll work elsewhere. heck, so do i. but it doesn't mater at all because they need 10 years to get a 1st approval and the competition increases every year in every indication. leronlimab can be the best drug ever discovered and still not be necessary at all.
lenacapivir same efficacy/safety broader impact better delivery for MDR-HIV
more than 80% patients undetectable viral load same as leron
minor safety events, very similar to leron - I HAVE LOOKED AT THEIR SAFETY RESULTS SIDE BY SIDE MORE THAN ONCE. you have not.
leronlimab treats ONLY R5 TROPIC
lenacapivir treats BOTH R5 AND R4 TROPIC.
leronlimab is WEEKLY. was only trialed and approval sought for weekly subq.
lenacapivir is LONG ACTING just 2x annual injection....
leronlimab subq ONLY.
lenacapivir subq OR ORAL administration.
you keep proving me right.
i agree that FDA prefers BP. and for that reason leronlimab may never be approved. even after 10 years
i agree that NIH will favor BP. and for that reason cytodyn will likely never get future NIH funding. even if the drug is great
the drug works. that doesn;t matter. this is an investment board. you own stock in cytodyn. cytodyn is a terrible investment because it is nearly impossible for biotechs to get approvals on their own and cytodyn is in an almost impossible position to ever gain a partner. they are in a deep financial morass. they aren't running trials. they need 10 years of pinpoint accurate execution to perhaps gain any approval. share price could languish most of that time. potential catalysts are few. you have MD Anderson preclinical results (unknown time frame) and functional cure preclinical results (2026) as top notch potential catalysts. anything else is minor and/or extremely unlikely.
CYDY is likely TEN YEARS from any approval. timeline provided
"the science" doesn't matter if you don';t get approved.
there is competition in all cancers, and NASH, and HIV, including long acting HIV solutions.
meanwhile, leronlimab needs to start in phase 2 for ALL PIPELINE and ALL OTHER indications.
1 year to even think about starting a trial due to lack of funding,
2.5 years from protocol thru phase 2 top line,
3.5 years from protocol thru phase 3 top line,
1.5 years for any approval process.
total of 8.5 years and that's THE BARE MINIMUM. that is WITH NO DELAYS. there are always delays.
tnbc an awesome example. they designed the trial fine. there was no SOC. but when they were further along, there WAS SOC. trial now need to be started all over again, new protocol and all. and that happens A LOT in pharma. and its more and more likely all the time as so many profound advances are being made every year at an accelerating pace.
lronlimab is at least 8 YEARS AWAY from any approval.
and in that time frame, competition grows and grows.
the scientific advances happening are mind blowing and by the time cytodyn completes a phase 3 for anything, leronlimab will likely be just an "also ran".
the central flaw in CYDY LOLngs is that they have NO IDEA regarding COMPETITION.
you have to be better than the rest to have a shot at decent revs
competition exists for ALL INDICATIONS.
it doesn't matter if leronlimab does A B C and X Y Z and 1000 things pretty good or very good or great.
if in each indication something else is better, then leronlimab is NOT NEEDED.
talking about MOA or "we think it might be great for X" is also useless.
to get approval, to create shareholder value, to collect revenue, to help patients...
you need to EXECUTE ROBUST TRIALS AND GAIN APPROVALS.
lenacapivir beats leronlimab for mdr-hiv. end of story
NIH does a background check, cytodyn would fail.
the application process is insane. time consuming, voluminous, tricky, exhaustive.
and they look at EVERYTHING. a company cannot be facing insolvency or have past due debt.
cytodyn can not get NIH funding. you also don;t just apply for the heck of it. your application needs to be in response to a pre-existing FOA. what that means is if you want money for NASH, then the NIH needs to already have created an FOA that calls for applicants that plan to run specific types of NASH trials. all their programs are pre-funded and itemized. its the government.
Lenacapivir is approved and superior to leronimab for HIV.
an earlier post failed to mention these relevant facts.
Leronlimab BLA was for MDR-HIV combo.
Lenacapivir approved december 22 for MDR-HIV combo.
same efficacy impact, similar safety profile,
1) dosed less often 2) both oral and subq 3) works for both r5 and r4 tropic.
patients and doctors will always prefer lenacapivir.
i agree FDA likely will need more info regarding the hold, once the paperwork is submitted. that is common and i completely expect that to happen. cytodyn has 4 exec team members and a biostatistician, none of which have any regulatory experience at all. the hold could remain in place for quite some time. but its hard to say imo. hold could come off next month, could still be in place a year from now, or anywhere in between.
cytodyn has only $5m cash AFTER the private placement.
had $2.6m 11-30, added 800k in december via warrant inducement agreement.
placement adds $15m net, you hope
between $5.5m and $6.5m cash went to welch.
quarterly burn is $7.5m - quarter ends tomorrow.
3.4 + 15 - 5.5 -7.5 = $5.4m
$5m gets them thru april
570m shares burned in 15 months, only 80m available shares remain.
$80,000,000 past due, $20,000,000 needed for basic burn rate thru to end of the year
total $100,000,000 needed and just $5m cash in hand. they are short $95,000,000 AFTER the placement completes.
Facts are facts regardless of who posts them.
$80,000,000 past due debt and only $5m cash in hand.
Those are documented facts from SEC filings. Some math is involved - don't mean to alarm you.
So if I am Bugs Bunny are those still facts?
If I am Adam Feuerstein are those still facts?
If I am paid to post are those still facts?
If I am the CEO of Gilead are those still facts?
If I wake up every day trying to think of ways to thwart CYDY are those still facts?
If I am just the a guy who once owned shares, no longer does, but despises pumpers are those still facts?
whether I post once daily for 10 years or 500 times today only are those still facts?
if there is no PR by 8pm friday, then the clinical hold response was not submitted by end of January... or Arman is hiding a negative reply from the FDA. friday is 31st day after january 31st.
99% of the actionable DD comes from "bashers". LOLngs have no idea what is going on with the company. Its amazing to me. And then when LOLngs are presented with 100% documented facts, even sometimes WITH THE SOURCES... they argue against documented facts??? its bizarre and actually a bit scary. When i leave the house I'm sharing the roads with these people?