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Post by mango on May 1, 2024 11:42:15 GMT -5
MannKind | The Rise of Technosphere
Heretofore Technosphere has been disregarded and overlooked by Wall Street, Big Pharma and investors—plagued by a series of unfortunate events from years past, MannKind and Technosphere have been thought of as a struggling biopharma company with a struggling inhaled insulin product. With the recent FDA approval of Tyvaso DPI, which is now United Therapeutics best selling drug, MannKind has still struggled to gain the attention and respect of investors, The Street and its competition alike.
Until now. Enter Nintedanib DPI.
Idiopathic pulmonary fibrosis (IPF) is a chronic fibrotic lung disease characterized by dry cough, fatigue, and progressive exertional dyspnea. Lung parenchyma and architecture is destroyed, compliance is lost, and gas exchange is compromised in this debilitating condition that leads inexorably to respiratory failure and death within 3–5 years of diagnosis.
MannKind is harnessing their proprietary, one of a kind inhalation delivery platform (Technosphere and dry powder inhaler) once again to tackle an incredibly terrifying disease with no cure and few treatment options. The only intervention known to increase life expectancy is lung transplants.
MannKind is in an incredible situation. With a perfect, 100% FDA approval success rate for two drugs using Technosphere, MannKind is poised to make an unbelievable name for itself with Nintedanib DPI. Only around 12% of drugs ever make it to FDA approval.
The reasons for these failures appear to be unchanged: 75 to 80% are due to problems with efficacy and/or safety. And that, to me, is the second most important figure in the pharmaceutical industry, showing just how much we don't know about what we're doing.
Safety and efficacy. Two parameters that MannKind excels in. Technosphere is an inert particle carrier with extensive preclinical, clinical, and post marketing safety data (Afrezza and Tyvaso DPI). MannKind's Afrezza has proven to be the world's safest insulin, and marches physiological insulin with remarkable results. Tyvaso DPI has proven to be not only very safe, but an enormous medical advancement for PAH.
As we can see, little Ole MannKind has been slowly paving the way for an incredible legacy of safe, effective and revolutionary treatments. If Nintedanib DPI gains FDA approval that will be an unheard of success story for a novel, one of a kind treatment platform.
The Rise of Technosphere has begun!
www.ncbi.nlm.nih.gov/pmc/articles/PMC9060042/
www.science.org/content/blog-post/latest-drug-failure-and-approval-rates
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Post by centralcoastinvestor on May 1, 2024 13:17:09 GMT -5
I completely agree with your summary. The question is when will Wall Street recognize the value of Technosphere.
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Post by alethea on May 1, 2024 13:28:36 GMT -5
I completely agree with your summary. The question is when will Wall Street recognize the value of Technosphere. Worst case scenario, soon after the expiration of the strangling convertible debt situation. But maybe, just maybe, well before that.  |
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Post by mango on May 1, 2024 13:57:30 GMT -5
I completely agree with your summary. The question is when will Wall Street recognize the value of Technosphere. It’s a puzzle really. I believe The Street forgot about MannKind and chalked it up to being a company in perpetual struggles. That’s all changed, yet The Street hasn’t woken up to it yet. We have a robust, serious pipeline now that’s making real progress. Clofazimine has the potential to be an enormous revenue generator, which will surely garner the attention of The Street, but the real value of the platform won’t be recognized until MannKind launches a new product using the platform themselves, IMO, like Nintedanib DPI. And just think, by the time it is on the desk at FDA for approval, Dornase Alpha Technosphere for Cystic Fibrosis will be well underway in clinical trials as well. Possibly even the Thirona Bio collaboration in Phase 1. The real world utility of Technosphere and MannKind’s inhalers will be understood sooner rather than later, IMO. I still believe the Golden Years of MannKin will be 2025-2030. |
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Post by BD on May 1, 2024 14:56:56 GMT -5
So, at this point I think people understand what a neural net is? It's a system that learns. We all have a natural one, the brain, and now there are unnatural ones, so to speak. Anyway, the one in my skull has learned through some serious pain and self-flagellation (mostly mental) that putting anything more than play money into MNKD at this point is like you-know-whating it into the wind. I left a token amount in so I'd be a shareholder, and now that position has actually risen to the role of a legitimate "stinker" ... I love that term, it was taught me by a member of one of the previous boards I admin-ed, and nothing fits the moniker as well (or probably ever will) as MNKD does.
And I continue to enjoy the fact I in no way rely on my MNKD position ever again having any salient effect on my net worth.
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Post by bones1026 on May 1, 2024 22:25:47 GMT -5
So, at this point I think people understand what a neural net is? It's a system that learns. We all have a natural one, the brain, and now there are unnatural ones, so to speak. Anyway, the one in my skull has learned through some serious pain and self-flagellation (mostly mental) that putting anything more than play money into MNKD at this point is like you-know-whating it into the wind. I left a token amount in so I'd be a shareholder, and now that position has actually risen to the role of a legitimate "stinker" ... I love that term, it was taught me by a member of one of the previous boards I admin-ed, and nothing fits the moniker as well (or probably ever will) as MNKD does. And I continue to enjoy the fact I in no way rely on my MNKD position ever again having any salient effect on my net worth. m 🫡 |
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Post by mytakeonit on May 2, 2024 2:42:48 GMT -5
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Post by prcgorman2 on May 2, 2024 6:31:36 GMT -5
So, at this point I think people understand what a neural net is? It's a system that learns. We all have a natural one, the brain, and now there are unnatural ones, so to speak. Anyway, the one in my skull has learned through some serious pain and self-flagellation (mostly mental) that putting anything more than play money into MNKD at this point is like you-know-whating it into the wind. I left a token amount in so I'd be a shareholder, and now that position has actually risen to the role of a legitimate "stinker" ... I love that term, it was taught me by a member of one of the previous boards I admin-ed, and nothing fits the moniker as well (or probably ever will) as MNKD does. And I continue to enjoy the fact I in no way rely on my MNKD position ever again having any salient effect on my net worth. Interesting view. I wonder if Blackrock and Vanguard agree. My memory is during the depths of depression (MannKind’s, not yours), the stock was mostly held by retail investors and that as prospects improved, that changed to MNKD being mostly held by institutional investors. If MannKind is able to successfully bring nintedanib to market, it should be shortly (a year or so) after bringing clofazimine to market. At that point, MannKind will have 4 significant revenue streams instead of 2. In that same space of time, the Pediatric trial will have completed and presumably the label changed to permit prescription of Afrezza to children on-label. And Cipla will be selling Afrezza too. Finally, the $230M in convertible bond debt should be retired too, potentially with no dilution whatsoever. That improving outlook should help improve your outlook. I hope it does. |
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Post by mango on May 2, 2024 7:04:00 GMT -5
So, at this point I think people understand what a neural net is? It's a system that learns. We all have a natural one, the brain, and now there are unnatural ones, so to speak. Anyway, the one in my skull has learned through some serious pain and self-flagellation (mostly mental) that putting anything more than play money into MNKD at this point is like you-know-whating it into the wind. I left a token amount in so I'd be a shareholder, and now that position has actually risen to the role of a legitimate "stinker" ... I love that term, it was taught me by a member of one of the previous boards I admin-ed, and nothing fits the moniker as well (or probably ever will) as MNKD does. And I continue to enjoy the fact I in no way rely on my MNKD position ever again having any salient effect on my net worth. Interesting view. I wonder if Blackrock and Vanguard agree. My memory is during the depths of depression (MannKind’s, not yours), the stock was mostly held by retail investors and that as prospects improved, that changed to MNKD being mostly held by institutional investors. If MannKind is able to successfully bring nintedanib to market, it should be shortly (a year or so) after bringing clofazimine to market. At that point, MannKind will have 4 significant revenue streams instead of 2. In that same space of time, the Pediatric trial will have completed and presumably the label changed to permit prescription of Afrezza to children on-label. And Cipla will be selling Afrezza too. Finally, the $230M in convertible bond debt should be retired too, potentially with no dilution whatsoever. That improving outlook should help improve your outlook. I hope it does. Everything is aligning quite nicely, isn’t it? It’s a shame some folks have given up when things are about to get really good! |
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Post by sportsrancho on May 2, 2024 9:24:14 GMT -5
We need to get to a 52 week high and then they’ll be more eyes on it.
Need to get over $5 and stay there.
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Post by BD on May 2, 2024 9:43:08 GMT -5
And it's going to be hard for it to stay there because everyone and their mother is probably used to just swing trading this thing now.
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Post by prcgorman2 on May 2, 2024 11:32:55 GMT -5
I think more institutions will have to add long positions and I assume that requires positive analyst coverage. That exists of course, but there needs to be more, and the way that gets done, is mostly based on fundamentals. Nothing succeeds like success. A friend of mine started a company and couldn't get venture capital to save their life. Five years later venture capitalists came to my friend. It seems money comes most easily available when you least need it.
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Post by uvula on May 2, 2024 12:04:42 GMT -5
When Lumber Liquidators got caught selling wood soaked in formaldehyde
and everyone thought the company was doomed, they changed their name to LL and everyone forgot about their screwup.
Not the same thing, but maybe Mannkind can change their name to Technosphere and start over.
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Post by radgray68 on May 2, 2024 12:44:54 GMT -5
Mannkind United Health
after the merger.
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Post by prcgorman2 on May 2, 2024 13:36:10 GMT -5
When Lumber Liquidators got caught selling wood soaked in formaldehyde and everyone thought the company was doomed, they changed their name to LL and everyone forgot about their screwup. Not the same thing, but maybe Mannkind can change their name to Technosphere and start over. I worked at a company that changed their name. It was an astoundingly expensive process. It is surprising how many places a corporate name appears and how much it costs to completely redo all of the legal and marketing materials, signage (on stadiums, retail outlets, trucks, etc.), badges, HR materials, packaging, on and on, that use an old name.
The name MannKind is not holding back Afrezza, and neither is the name "Afrezza". It's what agedhippie and sayhey24 have said. Lack of recent, compelling, full-scale multi-arm quality clinical data (to get prescribed in the first place) and then high cost (relative to humalog, etc.) which compounds the difficulty of getting insurance coverage.
I'm glad Al Mann chose to commit $1B+ of his own money to develop Afrezza so that this "life-changing" product is available for persons with diabetes, but in terms of a business decision, insulin should maybe not have been the flagship choice for TechnoSphere. What's done is done. TechnoSphere is used in 2 FDA-approved products and on it's way for a 3rd. Fingers crossed, "third times the charm".
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