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FDA NDAs are risky period! I wouldn't say that Amryt is a more risky hold now than prior to this extension. If FDA were not supportive of the NDA, they would have simply issued a complete response letter (CRL) which would have been a disaster. Instead, they have asked Amryt for more data. I read that as broadly positive - especially if you look at similar PDUFA extension outcomes.

So now yesterday's announcement makes sense!

This is disappointing but at least it's not a complete response letter (CRL). I guess the FDA had a look at the data and decided they wanted further analysis - extending the PDUFA date is not that unusual. Ironically, the delay will benefit Amryt because they will potentially pay out less to CVR holders. I am more hopeful that the EMA will approve given that they have already approved for partial-thickness wounds.

Very good spot!

Obviously, randomised trials would be required to expand the label but given the difficulty in treating eating disorders, it's possible that an off-label approach from specialist doctors/centers might emerge as these treatment experiences are socialized.

Hopefully we'll get an RNS on Monday morning :-)

If you want to know when they are likely to raise additional cash you should look at previous financing. Cash, cash equivalents and bank deposits at 30 September 2020 were £9.8 million according to the placing notification. According to the latest annual report, they had £22m in April and made a loss of £11M last year. Given that they have hired new people and are still undertaking clinical development, I would guess at a similar loss (stopping CTX is very old news). I think that you can figure out from this that they will be at similar cash levels to the last raise sometime in Q2 2022.

I doubt a licensor will sign up without 12month data from the Ph2a extension. Certainly, jCytes license deal was based on a proper randomised trial using 12 month data.

Olav alluded to the fact that Rene were having problem with the drug payload quantities carried by their exosomes. This is not an insignificant challenge and it's possible that they may not solve the issue at all.

For all of the above reason, I think another fundraiser is innevitable. Reneuron have been in business since 1997 and will still need cah for the forseeable future IMHO.

It takes time to initiate a trial but I'd expect them to start in Q4. The secondary outcomes of progression-free survival and overall survival are timed at 6 months. Given the aggressive nature of these cancers and the lack of treatment options, I would hope that recruitment into the trial would not be an issue. Perhaps we will see early data within 12-18 months. It's an open label trial so interim efficacy data can be released.

Yep - normally the status changes to active not recruiting once dosing has been completed.

Amazing that they have already treated 30 participants in their trial given that they only started at the beginning of this year. I don't know whether that signifies that their procedure is more straightforward than sub-retinal surgery or that they just that they have better organisation. Probably a bit of both..

"Chiasma's existing royalty interest financing agreement expected to be fully repaid on closing". I guess they have to write the cheque - and swallow the hefty repayment premium! From memory, Chiasma had a fair amount of cash when the merger was announced. Hopefully, they will add some color on the Amryt conf call.

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..