Top wikifolio Moonshot Biotechs GilbertGerber -55,0 % seit Beginn -9,2 % 1 Jahr TOP WIKIFOLIO TRADE Verkauf 16.05.2023 um 17:21 ABIVAX SA EO -,01 FR0012333284 Kurs (EUR) 18,080 11,5 % Letzte Aktivität Moonshot Biotechs Hansa Biopharma is a wonderful wonderful story, a story I have been following for 9 years. It is indeed the only commercial company in my selection and as such it could appear to be in breach of my own selection criteria. And it is, but still, we are only talking about conditional approval in one indication in Europe. Many other indications are to follow and the big prize, the US is still a couple of years away. I like it way too much to let it go now. So why did I cut my holding by 50% today ? Nothing sinister there, the price action has just been a bit over the top, with no hard data to justify it. What are we looking at ? European sales gaining traction and a sizable non-dilutive financing. Most investors are very sensitive to these developments, I am more laid back. Maybe just a remark on the side, Nordic equity markets, the Swedish one in particular, are world leading in terms of dilution maximization, so I understand the relief rally. But let's leave the nitty gritty of investment here and allow me a few words about the real story: Idefirix aka imlifidase aka IdeS aka immunoglobulin degrading enzyme of Streptococcus Pyogenes. S. pyogenes is a common bacteria, mostly causing pharyngitis and produces IdeS to defend itself against phagocytizing human antibodies. A bacteria's self defence trick, this is what it is. And how does it work ? What Idefirix does is to cut antibodies, specifically IgGs into their two components, Fab and Fc. And it does so exquisitely, wiping out your entire repertoire within 6 hours with a single injection and a lasting effect of approximately one week. What can it be used for ? Many, many indications in transplantation primarily, but aslo autoimmune diseases, conditioning for gene therapy and even in oncology, mainly indications with potentially curative bone marrow transplant. The lowest hanging fruit is so called "highly sensitized" kidney transplantation, that's potentially 10-15% of the total 22 000 annual interventions realised in Europe. That's the indication that has been conditionally approved in Europe. The challenge now is only operational, getting the procedure recognised by national health authorities and of course, getting reimbursement ! The elephant in the room is the FDA. Whereas EMA has been quick to acknowledge the extraordinary innovation Idefirix offers, the FDA has been, let's say stubbornly sticking to the rule book. Take a look at the price chart in 2018 (above 300 SEK), that's investors anticipating the FDA aligning with EMA. It's been a very long struggle since. Anyway, the US phase 3 trial is under way now and there is no doubt in my mind that it will be positive. Having said that, imposing eGFR at 12 months as the primary endpoint in a RCT trial is, how should I say, soviet-like ? I hope I managed to share a little bit of my enthusiasm for this unique, although niche story. Take a look at the company homepage and explore further. Hans Biopharma is not a platform company, it is a much rarer animal, it has a pipeline in a drug !
Moonshot Biotechs Hansa Biopharma is a wonderful wonderful story, a story I have been following for 9 years. It is indeed the only commercial company in my selection and as such it could appear to be in breach of my own selection criteria. And it is, but still, we are only talking about conditional approval in one indication in Europe. Many other indications are to follow and the big prize, the US is still a couple of years away. I like it way too much to let it go now. So why did I cut my holding by 50% today ? Nothing sinister there, the price action has just been a bit over the top, with no hard data to justify it. What are we looking at ? European sales gaining traction and a sizable non-dilutive financing. Most investors are very sensitive to these developments, I am more laid back. Maybe just a remark on the side, Nordic equity markets, the Swedish one in particular, are world leading in terms of dilution maximization, so I understand the relief rally. But let's leave the nitty gritty of investment here and allow me a few words about the real story: Idefirix aka imlifidase aka IdeS aka immunoglobulin degrading enzyme of Streptococcus Pyogenes. S. pyogenes is a common bacteria, mostly causing pharyngitis and produces IdeS to defend itself against phagocytizing human antibodies. A bacteria's self defence trick, this is what it is. And how does it work ? What Idefirix does is to cut antibodies, specifically IgGs into their two components, Fab and Fc. And it does so exquisitely, wiping out your entire repertoire within 6 hours with a single injection and a lasting effect of approximately one week. What can it be used for ? Many, many indications in transplantation primarily, but aslo autoimmune diseases, conditioning for gene therapy and even in oncology, mainly indications with potentially curative bone marrow transplant. The lowest hanging fruit is so called "highly sensitized" kidney transplantation, that's potentially 10-15% of the total 22 000 annual interventions realised in Europe. That's the indication that has been conditionally approved in Europe. The challenge now is only operational, getting the procedure recognised by national health authorities and of course, getting reimbursement ! The elephant in the room is the FDA. Whereas EMA has been quick to acknowledge the extraordinary innovation Idefirix offers, the FDA has been, let's say stubbornly sticking to the rule book. Take a look at the price chart in 2018 (above 300 SEK), that's investors anticipating the FDA aligning with EMA. It's been a very long struggle since. Anyway, the US phase 3 trial is under way now and there is no doubt in my mind that it will be positive. Having said that, imposing eGFR at 12 months as the primary endpoint in a RCT trial is, how should I say, soviet-like ? I hope I managed to share a little bit of my enthusiasm for this unique, although niche story. Take a look at the company homepage and explore further. Hans Biopharma is not a platform company, it is a much rarer animal, it has a pipeline in a drug !