Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Tommy, it would in terms of getting the drug to market, but not from a commercial perspective. A JV with big pharma will be a trade off between funding and loss of future earnings VS a PT which would enable Synairgen to remain fully indipendent and receive all revenues from future sales. The former would dampen valuation.
This is why I believe Synairgen haven't arranged a JV since the ATS. They have to exhaust the PT route for hospitalised covid patients on behalf of shareholder interests.
GLA
I think this excellent news. With all that is going on in US politics right now with the well publicised funding issues it wasn't clear, to me anyway, that STRIVE would actually be initiated.
Fingers crossed we are one of next drugs to be trialed. It would be a real shot in the arm for Synairgen to get on this PT trial in what is shaping up to be a very ugly looking winter on the respiratory virus front.
GLA
Mani, I don't think an EUA is viable unless something dramatic happens with hospitalisations and deaths this winter (i.e. a new more dangerous, vaxine evasive, anti body resistant strain emerges). Any new LC data isn't going to change that.
The ONLY data from Sprinter which really matters is the deepdive analysis showing 70% efficacy in reducing progression to serious illness / death for those most in need (i.e. respiratory issues with oxygen level <92% and breaths per min 21>). This pretty much replicates the benefit shown from phase 2 and on top of a much improved SoC.
While a third of the patients in the Sprinter trial broadly fell into this category, it is an unfortunate fact that the sample size is still considered too small for an EUA. It might be different if Sprinter had been 2,000 to 3,000 patients but it wasn't. That is why RM stated he didn't envisage commercialisation within 12 months.
Confirming this data, presented at the ATS, is the most important / pressing issue for Synairgen as it is pretty obviously the fastest route to market. It might even mean the ifference of the company surviving or not let alone making or being worth alot of money. I find it highly unlikely that this result isn't on the radar of BP, but RM has to exhaust a PT first. Let's hope he has been proactive on this front.
If you really believe the LC data can outweigh what is already know and lead to a EUA then good for you, but I really do think it is a pipe dream if I'm honest.
GLA
Aether, I'd say to the end of the year for a PT for Covid, however, suitable PTs could arise in the future - especially if the northern hemisphere has a terrible twindemic winter of covid and flu to resharpen focus. We also know in the states politics / funding is an issue. IMO until a PT for covid is ruled out I don't think RM will go down the JV route for covid as it unnecessarily gives too much value away to BP. I imagine he is trying to line this up as a fallback position in the background though.
A COPD licencing deal / JV could come at any time I guess. I don't think PT trials have been mentioned for COPD research, but I might be wrong.
GLA
Out of curiosity just checked and the title of the embargoed ID Week presentation this afternoon was:
"LB1533 - Impact of Treatment of Hospitalised COVID-19 Patients With Inhaled Interferon Beta-1a (SNG001) on Long COVID Symptoms: Results From the SPRINTER ".
I would guess the presentation will posted on Synairgen's website next week, although still tome for a pre market opening RNS. I would be surprised if anything ground breaking was revealed though.
However, hopefully any positive LC analysis will help build the case for a confirmatory PH III trial (however funded). GLA
I agree Doc83 it was gun ho! I'd still like to know how the Sprinter futility test was passed!! I don't think I've ever seen a satisfactory explanation and certainly not a formal statement from Synairgen.
Mani, never say never. I don't think we'll go bankrupt either, but it is a risk. It is obviously a risk. Fortunately we have no debt - long may that continue. For what its worth I personally think SNG001 will be commercialised...
Mani, in terms of looking after shareholders certainly a PT is preferable and really has to be exhausted by the management team. However, raising cash to fund a trial and remain independent Versus a JV / Licencing deal with BP depends on the terms of the latter and is a real balancing act (right now a raise isn't viable as the sp is 20 gbx). Making sure we don't give away too much value to BP or dilute shareholders unnecessarily is critical. This is against a backdrop of time being of the essence for trialling purposes and a cash balance which is finite.
A takeover pre commercialisation will leave too much value on the table IMO, but might be welcome by many shareholders who have been badly burnt. IMO a takeover having confirmed the deepdive results is probably where it is at in terms of a clean exit and maximising value for shareholders.
Nevertheless we could still go bankrupt and watch polygon buy the ip rights off an administrator for peanuts.....
GLA
Ghia, I agree with that. I'd back one now for this winter, except with a suppressed sp it isn't feasible without almost an unacceptable level of dilution. If I was RM and was certain a PT wouldn't materialise, I'd cut a COPD with big pharma. Off the back of an elevated sp raise cash to confirm the ATS presented sprinter results.
I agree Doc. Daneeka, I'd be completely and utterly amazed if SNG001 gets trialed specifically for long covid and the LC data with have from Sprinter was from a tiny sample size. Prevention of long covid is added, if not important benefit, but it is pretty clear SNG001's role is in prevention in progression to severe illness and death for those ending up in hospital in trouble with serious respiratory problems. This could possibly be extended to at home patients with serious underlying health conditions, but less likely given trial size required to prove worth.
At the moment, given the current variants circulating and immunity from vaccines / past infections, the pool of patients ending up in hospital versus the number of infections is low. However, with a more lethal strain this ratio could change dramatically. This is why I strongly believe the biggest market for this drug is stockpiling for pandemic preparedness. It could be worth billions. In time it could also be extended to respiratory viruses other than covid. Hence the current JV.
True Joey D, if it all goes wrong and trials doen't materialise.
We have a proven drug that now just needs authorising so we are pretty close - polygon will recognise the commercial viability as much as a layperson. The ATS results on a bigger scale (i.e. 70% efficacy for those with oxygen levels sub 92% etc.) would result in authorisation and serious revenues.
All to play for. However, until we get on the right trial uncertainty remains.... the sp tells the story.
Gla
Well professional anything is possible. We live in a capitalist world afterall, although I find the scenario doubtful.
It assumes Poly would be happy to sell on for a relitively low equity multiple 2 or 3x. Why do that when they could wait another 12 to 18 months to see a phase III trial through to commercialisation and earn as much as 10x EM or more. A legendary return for a fund.
Of the two scenarios you mention I'd prefer dilution, but I don't think 50m would be needed to confirm the ATS results via a phase 3 say run in the US or UK.
It would be interesting to hear views on how much would be needed.
Gla
So I think what you are insinuating is the their break even after they'd made an offer for the remaining 71.85%. Say it was low at 35gbx (still another £50.5 million to invest) their average would be around 50 to 53 gbx. Looks like they've accumulated 28.154% in the range of 90 to 100 gbx (already a £50 million + investment).
If their offer for the remaining c.a. 72% was at current sp their overall breakeven would be around 40 gbx.
They could attempt the above to take the company private to then sell on, but there is a hell of a lot risk involved. For one that is hostile and would be rejected by the BoD and shareholders on a vote. I just don't see that happening.
It would also mean the sp would have to remain suppressed over the winter months.....
Any sort if trial news and the sp should rerate.
GLA