Member Info for Doc.Daneeka

Comedy special with Tommyd "Dupixent (Sanofi) is an Il-33 inhibitor and has shown great promise in COPD "

Dupixent - Approved in the EU last month - expecting approval in the US next month "30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint." (in Boarea and Notus trials respectively )

Already approved for

Atopic Dermatitis - for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

Asthma - as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.

Chronic Rhinosinusitis with Nasal Polyposis - as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

Eosinophilic Esophagitis - for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).

Prurigo Nodularis - for the treatment of adult patients with prurigo nodularis (PN).

Sales ? Expected global net sales $14b in 2024 without COPD

Yeah - showing promise

" where there's money, there is many, as they say...." you're getting funnier by the minute Fruits. There was money - £80m or so in cash and £220m in sp value. Now there's barely enough to pay the salaries and nothing to conduct a tiny trial.

And given this title - I do wonder if TommyD has ever been invested. Never seen until Sprinter crashed and since then he's never been away. More posts than anyone, day after day, week after week. Always pushing the company narrative, always finding something positive as the walls crashed down around us. All his reassurances coming to nought one by one as deadlines come and go and the end approaches and still singing the company song.

The lights are about to go on. The dj has packed up his decks but Tommyd and Fruits are still there - dancing together in the empty hall. ( pmjh is at his laptop in the corner sipping his perrier and wondering what happened to the wifi )

How is AZ, a bit part player, reporting on UNIVERSAL at ERS before the trial has completed and before Southampton or Janssen post anything ?

It's irrelevant to Synairgen in any case - as is the possible Sanofi link - but I'd be interested to know.

"I think they've done something few here have done - they've listened to the BOD and read what they've put out. " Another Fruits classic. As if WE haven't listened to and read every single meagre syllable the BOD has deigned to release in the last 4 years. Analysed to death every tiny cough and splutter and allowed them grace when they kept missing deadlines and failing to even tell us why.

Instead of communicating properly they waited until the last moment and dropped an A bomb in the full year results RNS. Told us it was all but over - the big clever multi-viral project we'd all hoped and believed in. Finito. But would someone please step forward to help them with cash for an absolute punt in mechanically ventilated patients.

Fruits still belives. Fervently. Tommy and PMJH are still onboard - but the rest of us saw that for the surrender that it was.

Here's the only question that matters. Would you invest in this company now ? If you were a big pharma or the major investor and thought the drug still had some potential ? Would you really give these clowns millions more to play around with ?

" And yet, they remain in situ. " It's true Fruits, and it's also the reason an EGM wouldn't work. No matter the sp or missed deadlines and calamitous RNS, TFG remain silent, steadfast, and inscrutable as the Sphinx. I guess they believed the science and explanations after Sprinter the way we all did. The good numbers in the deep dive and apparently supportive research along with Synairgen's assurance that they understand what had gone wrong and that 2 good trials would begin in H1 2024.

Are they still supportive now I wonder, In the wake of that dismal statement in the FY RNS or just silent ? They seem to be keeping their hands in their pockets anyway, as the company looks for new funds.

You're doing this deliberately Fruits - but goodness knows why. If they don't have the cash - and they've said they don't - they have to find the cash. That's what they're still trying to do. That's why the AGM is delayed because they know they will be shredded if they invite shareholders in with nothing to show for the last 2 years of bluster. They're not waiting for a grant or an invite onto a platform trial or any of the other nonsense you continue to postulate. They're scratching around for £5m or £10m to get the MV underway and keep the lights on until it delivers. However they do this will inevitably result in a huge loss of current equity or the same dilution through a huge percentage of future sales.

If they hold an AGM without a positive RNS announcing the trial is about to start there will be motions to cut staff and salaries and for the CEO to be removed. You might still have faith in good old Dicky but nobody else does. The founders must be looking at him slant-eyed as he wanders the silent corridors , wondering how he managed to fu.ck it all up so badly.

Nice post Size.

"I don’t remember reading the company saying “They cannot afford a small trial” " And yet they are looking for funds.... Raising funds for a small trial that have the money to run themselves ? That makes sense.

and " pivoted " is not what they're doing. The MV trial was always part of last years's proposal, the minor part - but a part nonetheless. They have now concluded after 2 and a half years that the science does not support their long term goal of a multi virus trial in hospitalised patients. And so they're taking a swing at MV - without any specific data to back up the hypothesis. The fact that they don't already have funding in place suggests to me that they were surprised at how far short they fell in chasing the main objective, that it happened relatively recently, and are now scrambling to go for the secondary target. Maybe Janssen was standing by and has now withdrawn. Conjecture of course but the delays make it at least possible that they're struggling to convince anyone of the economic risk/reward of supporting even a small MV trial.

TP - surely both of your examples are dilutory ?

" The use of convertible debt, which allows investors to convert their investment into equity at a later date.

Another method is to use revenue-based financing, which allows companies to sell a portion of their future revenues in exchange for capital. "

2 months ago you said they could do both trials without dilution Fruits. The cash runway to 2026 is to pay salaries. Nothing else.

Sanofi with UNIVERSAL might be something I suppose - but you know, the odds are that it isn't. It already has the biggest new respiratory therapeutic in the world and will keep adding new approvals to the growing list. But having Dupixent doesn't mean they don't want more, you cry and that's true, but Synairgen said partners wanted to see more evidence, and they haven't produced anything since sprinter.

I agree with TP though that the downside from here is negligible and there are still ways the current sp can be left far behind. But I don't believe in fairies and do believe what the company told us, which is that they're trying to find a sponsor for a small MV trial.

FYI Fruits I think you've accidentally cut and pasted and hit send on a post you must have written 3 months ago.

Of course nothing in your best case scenario is now possible. Most of it would have been comical even before they confirmed they'd hit the buffers in the results RNS but today it's priceless.

" it makes sense for Synairgen to instead seek out a mutually beneficial innovative funding solution "

"Imo it would be better for the company to maintain some form of control in any financing deal until approval is granted. "

What you meant to say is " Let's face it - we'll take anything to get the P2 done - and of course it'll burn through what's left of the equity, with probably a 20% chance of success. "

You got the joke then Fruits

Sanofi already has a hugely successful drug in COPD and a wide range of other respiratory diseases. Dupixent - the monoclonal developed with Regeneron was EUAd last month in the EU and expected to be approved next month in the States and worth $4b a year. Doesn't mean they wouldn't look at SNG but its trial data is not in the same league.

Maybe Sanofi has added something else to UNIVERSAL or maybe it's just an interesting red herring.

If you missed all of my posts on the COPD sphere google COPD paradigm shift. And if you're in any doubt about the current ambitions of Synairgen, you might re-read the RNS.

This is not negative - there's plenty of money to be made if they find funding and prove the drug works with MV patients

Fair enough SD.

" the company has hired a new Senior Analytical Scientist "

Not clarified Pmjh - an incorrect post corrected.

RNS incoming I hope. Still don't have an answer to the Sanofi link. UNIVERSAL well underway for 2 years - heading towards the finish. What can they possibly offer to it ? Do they have analytics maybe to help grind the data. ?

Or are they to be the P2 sponsors ?

Useful contribution Fruits. Thanks ever so.

It's a complicated link PMJH as the trial is listed as both ACTIVE and NOT ACTIVE. Doesn't matter anyway, they had 100s of patients to study and it didn't lead to a multi viral P2. I'm not expecting the full readout to change anything ( I would also be very surprised if they have completed so soon, when the last update showed how slow recruitment had been.)

Could you - or someone else - also explain what role Sanofi has in this ? First time I've seen their name. We previously knew the trial was funded by Janssen and supported by Synairgen ( with extra funding from AZ )

Have I missed something ( very likely ) or is this a new involvement, or even a typo.

" I would love to have been a fly on the wall when RM told

them they did not have funds for even one small P2!!!! "

Yes that would have been interesting Mani - but TFG have known for as long as we have, longer probably, that the finances were getting to the point of no return and would have expected a dilution of some kind to begin the trials.

What they would not have been expecting was the news that the main focus and thrust for the last 2 years, almost the entirety of the company's raison d'etre as a multi-viral, variant agnostic candidate was in the bin. Not on hold, or delayed, or subject to further investigation - but in the bin and over.

Happy to see the ' many good science papers ' that support the case for SNG in MV Fruits. Post a couple directly relevant. Anyone who wants to can remind themselves of the rational that I've given that it MIGHT work. You've never posted anything useful on the topic - but then you've been serially wrong on the drug and company for so long that it's hardly surprising and probably a good thing. Whole you're scratching around for something that amounts to a smoking gun, ill remind you that Aabs for Ifns are present in up to 18% of very ill ICU patients. That might be the start point for some of the trialists - but Synairgen will need a fast test to find these patients and it's entirely possible, given the lack of anything substantive in the results RNS, that they don't have it

I'll await the links ........