I think I know why Cytodyn surprised us all with an investors update right before ESMO.
The Madrid conference is going to be dominated by the Merck/Moderna cancer vaccine news. The establishment-responsive Big Parma press is already writing those headlines as we speak. So Cytodyn is going to get the jump with a conference call. Where it can have the spotlight to itself, so to speak...
This tells me that the data is going to be exemplary. But what gets me even more excited is the Natera exec on board. Reny Aniline, Senior Director of BioPharma Business Development. I do hope he talks more about the business arrangements rather than "just" the data... Would it be too much to hope for an equity investment... perhaps some funding for a Phase 3 trial that would include Signaterra as a companion diagnostic? Even if there is no breaking news about the collaboration, just having a Natera exec on the conference call is legitimizing.
The Merck/Moderna vaccine has the headline presentation at the "Presidential Symposium" on Oct 24th at ESMO. And there will no doubt be some news on sac-tmt, Merck's PD-L1/VEDGF ADC. They have something like 90+ abstracts dealing with 20 different tumor types to showcase in Madrid, as they work hard to keep up their oncology dominance even as they lose exclusivity on IV Keytruda. And for those interested in colorectal cancer, Agenus has three abstracts dealing with promising activity by the Bot/Bal combination. So this is a very smart move on Cytodyn's part--get ahead of the news and the noise, make sure the oncology networks and any potential partners know what's cooking, and exactly who's sharing the kitchen with them. Who says too many cooks spoil the broth! When you have Mr Aniline, and Drs. Kasi and Weinberg in the kitchen, your broth is in expert hands.
I have gone on record suggesting Dr Lalezari and the Cytodyn brain trust have expertly steered the company on the business side of the equation as well as the scientific, clinical and regulatory aspects. They have recognized that in the biotech world, great prospective data in clinical trials that address unmet needs and markets is the fundamental basis for consequential business development. Will this result in a reasonable bump in the stock price post-ESMO? I really can't answer that question, as it will take buy-in on the part of Wall St and the Big Pharma Press. (I think they are in bed with the Big Boys and Girls... because it seems that's the way the playing field is orchestrated to preserve existing capital arrangements in the high-stakes world of Pharmaceutical Development. But the biz of business journalism is to break stories, so something will have to give there... even if they are way way late to the game).
In case some might think I'm a mindless cheerleader for the company and the brain trust... Well, now that Cytodyn has the data, what are they gonna do with it? This pre-ESMO conference call is a brilliant move... but it needs to be followed up. Getting outta the pink sheets in certainly on the list, as is a BTD for SOC in 3rd-line mCRC as well. Some version of Accelerated Approval? Those are all near-term goals, and I have no problems with evaluating the business acumen of the brain trust on getting all three. Ideally before ASCO in January! Ultimately, of course, it's all about a partnership. Perhaps even an early partnership or royalty arrangement to keep the finances strong, based on adding leronlimab to the existing SOC... But the Ultimate Deal will be based on the prime-and-pair hypothesis. And that data still needs to mature.
By ASCO or early 2027 that data should be actionable. Gonna be an exciting few months! In the meantime, I think we could be in for a rollercoaster ride on the stock price, some ups and downs as the Adam Feuerstein's of the world start to become aware--or refamiliarize themselves--with the new-look Cytodyn. W[color=var(--text)]hat I'm trying to say is the brain trust is on the clock, with cut-throat competition and their lackeys out to get us and gut us... [/color]
[color=var(--text)]The brain trust hasn't had much of a hand to play thus far... but now they do. As part of this they've brought Drs Kasi and Weinberg on board, and most recently Natera. Bringing the Clover trial to a successful conclusion is just about the best business move I can imagine, and we'll be seeing that play out soon. Looks to me like we are going to have some serious cards to play. With options galore. Depending on further business-related moves, we may be doing the gutting, for a change. [/color]
[color=var(--text)]Fish fry anyone? I'd like to see Merck and Gilead served up, all lifeless and mouths agape, wondering what hit them... But that is pretty harsh, and doesn't account for all the retirees who have Big Pharma in their retirement accounts, and would take a big hit if a penny-stock biotech comes along with the keys to cancer. And takes out half-a-dozen or so Big Pharmas. So I'm actually thinking Lalezari and the brain trust--and perhaps the FDA, for that matter--will be more interested in integrating a revolutionary drug into mainstream medicine instead of gutting Merckfish and Gileafish (though both would deserve it). But if doing this means we shareholders do not receive fair value/reasonable value for our foresight in investing in Cytodyn... well, I would have a problem with that. Fair is fair! [/color]
[color=var(--text)]Gonna be a fascinating few months ahead. Haven't even mentioned that some people in this country won't be pleased if a European firm comes along and licenses The Cancer-Killer from an American firm (and Roche--because of the Avastin connection--is the most obvious company to do a near-term SOC deal. Isn't BioBerlin coming up soon?). Cytodyn is probably going to have to thread the needle pretty carefully in all this... especially if the Alzheimers trial turns out well. Good data means good options. Strike an oncology deal that will allow Cytodyn to a) continue to exist and b) develop leronlimab for inflammatory and auto-immune conditions? [/color]
[color=var(--text)]I'd like to see Merck and Gilead get a good poke in the eye while they wait around on what Cytodyn is going to do... And start bidding against each other! Serves them right for ignoring us all these years. I'd say that's all part of threading the needle, actually. I'd say the humanitarian thing to do would be to think about all those retirees with their 401ks... [/color]
[color=var(--text)]But that said, would Wall Street would let them? The champions of disruptive tech, suddenly faced with the biggest disruptor of all--a life and death cancer drug brought along by a West Coast biotech firm with a humanitarian at the helm? At pennies a share? And this time, Wall Street doesn't have what they are used to in the biotech world--dominance. Because retail has the huge majority of a billion plus shares. [/color]
[color=var(--text)]Grab yer popcorn... This is going to be fun to watch as the Big Boys and Girls squirm. And the share price should reset sometime soon, as this all plays out towards Act Two, at ASCO. And ESMO should be a pretty fine Act One. But always gotta keep 'em hanging for Act Two... [/color]
The Madrid conference is going to be dominated by the Merck/Moderna cancer vaccine news. The establishment-responsive Big Parma press is already writing those headlines as we speak. So Cytodyn is going to get the jump with a conference call. Where it can have the spotlight to itself, so to speak...
This tells me that the data is going to be exemplary. But what gets me even more excited is the Natera exec on board. Reny Aniline, Senior Director of BioPharma Business Development. I do hope he talks more about the business arrangements rather than "just" the data... Would it be too much to hope for an equity investment... perhaps some funding for a Phase 3 trial that would include Signaterra as a companion diagnostic? Even if there is no breaking news about the collaboration, just having a Natera exec on the conference call is legitimizing.
The Merck/Moderna vaccine has the headline presentation at the "Presidential Symposium" on Oct 24th at ESMO. And there will no doubt be some news on sac-tmt, Merck's PD-L1/VEDGF ADC. They have something like 90+ abstracts dealing with 20 different tumor types to showcase in Madrid, as they work hard to keep up their oncology dominance even as they lose exclusivity on IV Keytruda. And for those interested in colorectal cancer, Agenus has three abstracts dealing with promising activity by the Bot/Bal combination. So this is a very smart move on Cytodyn's part--get ahead of the news and the noise, make sure the oncology networks and any potential partners know what's cooking, and exactly who's sharing the kitchen with them. Who says too many cooks spoil the broth! When you have Mr Aniline, and Drs. Kasi and Weinberg in the kitchen, your broth is in expert hands.
I have gone on record suggesting Dr Lalezari and the Cytodyn brain trust have expertly steered the company on the business side of the equation as well as the scientific, clinical and regulatory aspects. They have recognized that in the biotech world, great prospective data in clinical trials that address unmet needs and markets is the fundamental basis for consequential business development. Will this result in a reasonable bump in the stock price post-ESMO? I really can't answer that question, as it will take buy-in on the part of Wall St and the Big Pharma Press. (I think they are in bed with the Big Boys and Girls... because it seems that's the way the playing field is orchestrated to preserve existing capital arrangements in the high-stakes world of Pharmaceutical Development. But the biz of business journalism is to break stories, so something will have to give there... even if they are way way late to the game).
In case some might think I'm a mindless cheerleader for the company and the brain trust... Well, now that Cytodyn has the data, what are they gonna do with it? This pre-ESMO conference call is a brilliant move... but it needs to be followed up. Getting outta the pink sheets in certainly on the list, as is a BTD for SOC in 3rd-line mCRC as well. Some version of Accelerated Approval? Those are all near-term goals, and I have no problems with evaluating the business acumen of the brain trust on getting all three. Ideally before ASCO in January! Ultimately, of course, it's all about a partnership. Perhaps even an early partnership or royalty arrangement to keep the finances strong, based on adding leronlimab to the existing SOC... But the Ultimate Deal will be based on the prime-and-pair hypothesis. And that data still needs to mature.
By ASCO or early 2027 that data should be actionable. Gonna be an exciting few months! In the meantime, I think we could be in for a rollercoaster ride on the stock price, some ups and downs as the Adam Feuerstein's of the world start to become aware--or refamiliarize themselves--with the new-look Cytodyn. W[color=var(--text)]hat I'm trying to say is the brain trust is on the clock, with cut-throat competition and their lackeys out to get us and gut us... [/color]
[color=var(--text)]The brain trust hasn't had much of a hand to play thus far... but now they do. As part of this they've brought Drs Kasi and Weinberg on board, and most recently Natera. Bringing the Clover trial to a successful conclusion is just about the best business move I can imagine, and we'll be seeing that play out soon. Looks to me like we are going to have some serious cards to play. With options galore. Depending on further business-related moves, we may be doing the gutting, for a change. [/color]
[color=var(--text)]Fish fry anyone? I'd like to see Merck and Gilead served up, all lifeless and mouths agape, wondering what hit them... But that is pretty harsh, and doesn't account for all the retirees who have Big Pharma in their retirement accounts, and would take a big hit if a penny-stock biotech comes along with the keys to cancer. And takes out half-a-dozen or so Big Pharmas. So I'm actually thinking Lalezari and the brain trust--and perhaps the FDA, for that matter--will be more interested in integrating a revolutionary drug into mainstream medicine instead of gutting Merckfish and Gileafish (though both would deserve it). But if doing this means we shareholders do not receive fair value/reasonable value for our foresight in investing in Cytodyn... well, I would have a problem with that. Fair is fair! [/color]
[color=var(--text)]Gonna be a fascinating few months ahead. Haven't even mentioned that some people in this country won't be pleased if a European firm comes along and licenses The Cancer-Killer from an American firm (and Roche--because of the Avastin connection--is the most obvious company to do a near-term SOC deal. Isn't BioBerlin coming up soon?). Cytodyn is probably going to have to thread the needle pretty carefully in all this... especially if the Alzheimers trial turns out well. Good data means good options. Strike an oncology deal that will allow Cytodyn to a) continue to exist and b) develop leronlimab for inflammatory and auto-immune conditions? [/color]
[color=var(--text)]I'd like to see Merck and Gilead get a good poke in the eye while they wait around on what Cytodyn is going to do... And start bidding against each other! Serves them right for ignoring us all these years. I'd say that's all part of threading the needle, actually. I'd say the humanitarian thing to do would be to think about all those retirees with their 401ks... [/color]
[color=var(--text)]But that said, would Wall Street would let them? The champions of disruptive tech, suddenly faced with the biggest disruptor of all--a life and death cancer drug brought along by a West Coast biotech firm with a humanitarian at the helm? At pennies a share? And this time, Wall Street doesn't have what they are used to in the biotech world--dominance. Because retail has the huge majority of a billion plus shares. [/color]
[color=var(--text)]Grab yer popcorn... This is going to be fun to watch as the Big Boys and Girls squirm. And the share price should reset sometime soon, as this all plays out towards Act Two, at ASCO. And ESMO should be a pretty fine Act One. But always gotta keep 'em hanging for Act Two... [/color]
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