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Very good quarter - looks mainly due to a LATAM order. Cash has increased to $142m. If they carry on throwing off cash, I will feel happier about the debt.
As expected, Chiasma stockholders approved the merger..
https://ir.chiasma.com/node/9426/html
I agree nothing is certain in medical research but did you bother reading the details around the trial? I like the fact that:
1. In prior FDA approved Phase 1 clinical trials, oral GaM demonstrated low toxicity and was well tolerated. So, this is not a first-in-man trial and safety seems to have been established to some degree.
2. In animal models, treatment with oral GaM caused a dramatic inhibition of tumor growth that was matched by a significant increase in overall survival. It's true that results in animal models are not always reflected in human trials but it seems a reasonable bet given the risk reward.
https://www.imagingbiometrics.com/wpib/wp-content/uploads/2021/04/GaM-Phase-I-IQAI-US-2020-04-20-1.pdf
The clinical trial to evaluate the safety and efficacy of Gallium Maltolate (GaM) in the treatment of Glioblastoma Multiforme (GBM) could really add huge value and seems an extremely shrewd investment. As was stated in the press release, GBM is the most common and aggressive primary brain cancer, with limited treatment options and a dismal prognosis. Normally drug development takes a decade or more. However, in the case of aggressive, fatal disease, the regulator(s) may offer an accelerated pathway based on limited trials and post-approval, confirmatory studies. A trial showing the drug extends or enhances quality of life will IMHO catapult the Mcap into the 100s of millions.
I guess we will have to wait to see what Mr Wiley has to say next Friday. Hopefull he is feeling the heat :-)
It's pretty clear that Amryt will be reducing management headcount once the Chiasma deal closes - the whole rationale for the merger is to make savings in the combined operations. I assume not all the losses will be from the Chiasma team and some Amryt execs will have been lining up other contingency opportunities, I suspect.
Based on the fall in Amryt's SP, US investors were not overly impressed by the terms of the deal. However, there has been a more general decline in pharma of late so It's not entirely down to Amryt's prospects. I would imagine that once the deal closes next week investors will start to look forward. August is generally a bad month for small caps but the pdufa date for Oleogel-S10 will likely cause more interest (and buying) as we go into September..
You should read the section titled "Risks and Uncertainties" in the 2021 annual report to gain an understanding of what you are investing in.
Summer doldrums - this always affects smaller cap stocks over the summer holiday period. The brave will buy. Expect to see them drift back up towards the end of August and into September..
Good question... It didn't actually mention this in the latest RNS which specified dates for CREST and Certified delivery of shares. Somewhat puzzling..
From the 2020 annual report published April this year - "At balance sheet date, the Group had cash balances of £478,910 (2019: £865,875). The financial forecasts indicate that the Group is expected to have sufficient liquid resources to meet its obligations under all reasonably expected circumstances."
Dumb - I like to hear multiple opinions so always pay attention to your comments. When you say Pensana has "no experience in refining REE", aren't you forgetting that they have bought in the expertise - or does Rocky Smith's hiring count for naught?
My reading of the RNS is that they are issuing shares to LSE holders so I'd expect them to be traded on the LSE. The ADR is a depository receipt (for an LSE share) that will be traded on NASDAQ.
This does seem to differ from the last RNS that seemed to suggest they were going to list only on NASDAQ..
www.fiercebiotech.com/biotech/4dmt-will-regain-full-rights-to-blinding-disease-therapy-from-roche-to-initiative-new
"Another reason for Roche's exit may have been Adverum Biotechnologies' recent shaky safety results and a Biogen trial failure earlier this month. Those events have put a damper on the entire gene therapy field in eye diseases. "
Certainly seems like Gene therapy is challenging.
My experience of licensing deals is that, after the technology transfer phase is complete, the licensor may not have that much to do with the licensee's development program. In any case, you are absolutely right, RENE would be unable to disclose anything regarding FOSUN's development without explicit permission - not least because it would be market-sensitive information (for FOSUN).
I agree, neither study really matches. The first trial is using RPE (cells) rather than hRPC. The second is similar to the CTX trial but I would expect it to have explicitly stated if they were CTX cells.
Anyway, how's the food in the camp :-)
Edison research is paid for by the company so Vivien won't ever be asking difficult questions. However, based on PA's comments, seems she is buying a Porsche Taycan so the job pays well! :-)
Very interesting. I had a quick look back through the RNS catalogue and found this extract
JULY 20, 2020
Source: RNS
RNS Number : 4161T
"Clinical trial applications have recently been filed by Fosun Pharma to open clinical sites in the licensed territory to build on the Phase 2b clinical data already generated with the CTX cell therapy candidate for stroke disability...."
Assuming the regulator in China agreed, the CTX trial could have started at the beginning of this year. I'd estimate 3-4 years for headline results for a pivotal phase III. We could see approval in China as early as 2025.
Latest RNS out of hrpc
https://www.londonstockexchange.com/news-article/RENE/update-for-hrpc-therapy-candidate-study/15010809
https://www.bbc.co.uk/news/science-environment-57234610
Food for thought:
- switching to electric vehicles in the UK alone would require an entire year's world production of neodymium (to make electric motor magnets).
- replacing the estimated 1.4 billion internal combustion engine vehicles worldwide would need 40 times this quantity, and that's before the metal and mineral requirements of all the wind turbines and solar farms are considered.
- it takes a decade or more from finding material to actually mining the stuff.
- it isn't just about mines; it's the whole supply chain
Interesting article on RP on the BBC website
https://www.bbc.co.uk/news/health-57226572