Member Info for Doc.Daneeka

What exactly do you need proof of Fruits ? Everything I've said is self evidently true. You might quibble over how long they've known the multi-viral trial wasn't a runner - but the financial realities have been staring them in the face since they missed their first 2 deadlines to start trialing.

Show me the money Fruits. They must have known for a long time that the MV trial was the only pathway forward - and even if they didn't, they knew they didn't have the money for even the cheapest of the P2s, let alone both. So where is the money ? And how strong is the case they're presenting to potential investors ? None of the circa 1k SNG patients dosed since trialing began have been ventilated. Zero. The proposal is based almost entirely on viral clearance data and the hope that ventilated patients are not already too sick to benefit from SNG.

The longer the wait goes on the clearer it is that they have struggled to sell the proposition. And are maybe STILL struggling. How much do we think an MV trial for 50 patients might cost ? £5m ? £6m ? Pocket change surely for any big pharma "partner" with the remotest interest in the drug.

The results RNS was a big shock. Until it landed you and others were telling us the money was there for both mini trials - that finances were solid. That we wouldn't even see the value diluted. Then suddenly, in a few short paragraphs the scientific case for the multi viral trail collapsed and they admitted they couldn't run even one trial without a sponsor.

Now we have a delayed AGM - which is symptomatic of the poor management that has brought us to this sorry pass. If they'd communicated with us at all over the last 2 years we might now have some faith that they're not contemplating something dastardly to save themselves and screw us over. When you are silent and then miss deadlines without explanation, and the only news you have is disastrously negative, you can't expect LTHs to keep the faith or remain invested.

There you are Org. Andrewp prophesied your return. Sorry for your loss.

Well done TP. I guess you might get a Ctrl C Ctrl V of the insulting reply Jonnyboy received " Synairgen’s directors note that there is interest in the timing of the AGM "

I think that's a US guide TP. AGMs here must be held within 6 months of the accounting date and not more than 15 months after the previous one. Synairgen's accounting date is 31st December - so the AGM should have been held by the end of June.

With the 21 day notification period this means they are already 6 weeks late

Gampy fyi

Synairgen plc

(‘Synairgen’ or the ‘Company’)

Results for the year ended 31 December 2023

https://www.synairgen.com/media/results-for-the-year-ended-31-december-2023

Gampy. It's safe to say the company does NOT have a financial solution already. That's what they're working on and what we're waiting for.

Enjoyed your post TP - 22 ticks in this flat environment and nobody accusing you off deramping. We're living in the real world at last.

Cheers Jonnyboy at least that reads like it was written by a human. Clear that the delay is financing - as nobody would offer backing without knowing exactly what the trial will look like and seeing solid foundational data that points to a successful outcome. The positive is that they believe those foundations are convincing. Let's hope Janssen or AZ feel the same. Possible other sourcing of funding but unlikely I'd say. I'm certain that Janssen came to UNIVERSAL for SNG and hopefully they still want a piece of it

"The use case for Synairgen strengthens with every bit of (related /IFN) new research data coming out, and it keeps coming."

Did you miss the RNS Fruits ? They've admitted that their own " use case" for SNG in any of the areas they have data for - has not been made. If they still had faith in it at all they'd be raising cash for the main multi-viral p2 they've been working on since Sprinter landed, and not the hopeful little ventilated trial. Supportive IFN research is meaningless when your own data tells you that even targeted use is futile. The Aab-ifn work will give them 15% of patients for the MV trial - if they can produce a test. That's the only relevant bit of recent Ifn research.

If Simon Shaw is to believed they are almost ready with the MV trial - as they've been working on the design for at least the last year in house, we can assume that the hold up is funding. That's what we're waiting for - and crazy as Gampy might find it that one of the interested BP or Govt parties wouldn't just chuck in the £5m it'll take to run this little trial - nevertheless they haven't yet and here we are. Waiting.

As soon as the funding is there they will RNS it and call the AGM. There is nothing beyond this.

Securing FDA approval is one thing - offering the drug at a price that offers value for money is quite another. Ensifentrine is by far the smaller of the 2 new COPD drugs, with projected sales of $1b by 2029, whereas Dupixent is expected to add $3.5b annually if it's approved in the US ( having already been approved in the EU)

“The Institute for Clinical and Economic Review (ICER) has issued an "access and affordability alert" for Verona Pharma’s newly approved Ohtuvayre (ensifentrine), a long-awaited, first-in-class treatment for chronic obstructive pulmonary disease (COPD).... At an annual list price of $35,400, Ohtuvayre costs nearly three times more than the top of ICER’s valuation range for the product. In its final evidence report, ICER calculated a health-benefit price benchmark for Ohtuvayre of $7,500 to $12,700 per year.

"Unfortunately, the manufacturer chose a price for ensifentrine far above the value-based price,” Rind added.

This may lead payers to implement formulary hurdles that could limit provider and patient access to this promising new treatment.”

https://www.fiercepharma.com/pharma/icer-says-veronas-price-copd-treatment-ohtuvayre-will-restrict-access

Dippfs I did say that a platform trial was the only way to avoid dilution. But there aren't any as far as I know for MV patients and the Full year results RNS suggests they are not really expecting to get invited onto one, having not managed to clarify the trial population in hospitals and having made no progress with outpatients since A2 finished.

I agree that squaring the financing for the trial is probably the reason for the delay, although they could also be waiting to complete the trial design, and also that the Porton Down ivs and the deleted tweet remain something of a mystery.

It's still bewildering that they have fallen so far short in the quest to find the correct multi-virus inpatient population - but take that at face value and accept RM's positivity that there is " a substantial unmet medical need with 25% to 45% mortality and few antiviral therapeutic options. "

With other treatments coming on stream for some of the viruses they were hoping to target, and no funds to mko0unt further investigative work, they've sensibly decided that the MV population is the best and only shot. Simon Shaw's "on the verge" means we shouldn't have too long to wait before we discover exactly where the company is. Most of us accept dilution is inevitable, but all that matters from here is that somehow they stay in business and manage to run a successful trial, which will ameliorate the loss of equity. 100% of nothing is still nothing.

Just repeating what the RNS said Elsol - I can repost if you've forgotten so soon. I've never been rude to you despite the utter nonsense you've posted for the last 3 months. Perhaps you should filter me if you can't keep a civil tongue in your head.

And if engagement of this sort doesn't suit you Tommy - push off back to those other fora.

For anyone not familiar with little Tommy. THIS is his usual crap.

"It could mean area beyond VP, like the original multi trials. " They have said really clearly that they are not going beyond the VP trial. This is where they are - what they're left with, unless an invite from a platform trial lands on the mat. Which it almost certainly won't.

Obviously if they're holding their hand out it would make sense to grab as big a handout as possible - and hold the biggest mini trial they can - so the points about bigger trial populations and more sites might be closer to the mark. But it's not research or wizardry to speculate on this.

And Dippfs - there is NO non dilutory road ahead except a platform trial. They are currently looking for finance to do the only trial they are able to attempt. Hopefully a big pharma will chuck them a few quid, but it won't be for nothing.

Positivity and hope is one thing but anyone who read the RNS and still thinks there's a non dilutory route forward from here is delusional.

Mani and Spacman both called the financial reality months ago - and their worst fears have been realized.

Boom !! Fruits would have known that too im sure but he's still observing the election purdah ;)

Prize for the final line reference ( easy if you anything over 50 and like your films)

They've trialled circa 1000 patients but I don't know that they have any data for MV patients. Certainly nobody on a ventilator has ever been given SNG - and though it's possible some of the SG016/SG018 or even the COPD cohort might have ended up on ventilators in the drug or placebo group, I don't think they've ever produced anything related to it.

It was the extra free hit - based on viral clearance data from the COPD trial and the belief that SNG still works when the cytokine storm is raging and even after steroids. The free hit takes on extra significance now only because the main area of investigation has failed so completely and they know that they haven't yet managed to identify the cohort of hospitalised patients who might do well on SNG, and they can't afford the larger trial that is probably needed to get anywhere near the bull.

Anyway all of this is academic as they can't even afford to do the MV trial and until we are informed how the funds will be raised, we're all just picking our feet in Poughkeepsie.

You read a different RNS to the one I read Dippfs. In the one I read they had effectively called time on the pre-trial investigations of the last year and were pinning their slim hopes of resurrection on an almost entirely speculative mini P2 in MV patients.

There's zero chance of funding from the US. Outpatient signal from A2 nowhere near strong enough to merit further investigation, when there are other much more promising candidates. They still want cheap and effective mass market options in the outpatient setting and that's not SNG. And neither - now that they've abandoned the search for an inpatient cohort before the HDU - is the hospital route.

The Synairgen Norwegian blue is nailed to the perch at the moment

Pretty standard keep-calm-and-carry-on Simon Shaw language as far as I can see. His has been the only positive voice in the last 2 years - and he's invariably been spectacularly wrong.

The only positive that might come in the next communication is if they have a funding deal in place for the MV trial. Without this there can be no trial as there will not be NIH or MHRA support, despite Bob's hopes, and there's no money to do it. Unless the RNS is about funding then "on the verge" means parked up in the middle of nowhere, waiting for the AA man to arrive.