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I think its time RM gave us a strategy update.

The journalist probably missed a zero Dunk. I've heard the Chinese population are not in good shape to deal with this wave. Little natural immunity having been kept under wraps for three years, ineffective vaccines, an average healthcare service and generally poor health (high rates of diabetes etc.).

When BG posted about the conference a few weeks ago I think i mentioned I did not expect any material news to be announced. No news coming out of San Fran is no big deal.

If a JV is going to happen Synairgen and the potential partner will be negotiating away from prying eyes. Further Synairgen would have put the feelers out months ago and they don't need a conference to connect. Importantly, a covid JV is unlikely to happen IMO while Sprinter can still be salvaged via a PT like STRIVE. The BoD would be doing a disservice to share holders if they forfeited the opportunity to participate on a govt. sponsored trial and instead gave away future profits via a JV (a form of dilution).

The risk with a multi virus trial is its complexity, and as Doc.Daneeka astutely points out we'd be starting at phase II. The Sprinter trial shows how something that was meant to be pretty bullet proof can fail. It's hard work.

We simply can't have another failure - we're practical toast as it is. Just look at the sp and the cash balance. We'll be lucky to get a second chance without dilution. If we do I really hope it's a inpatient trial specifically targeting those really struggling with covid in line with the ATS finding. Synairgen need to make sure their next trial succeeds at any cost otherwise it will be their last. Its called risk management and if we're honest they didn't do a good job at protecting shareholder interests when investing our capital in the Sprinter trial. This simply can't happen again. Running a trial under powered for secondary endpoint success is not good risk management. It was a massive oversight and I hope lessons have been learnt.

My question would be. On a shoe string budget how much would it cost to replicate the ATS results on a big enough scale to get authorisation?
GLA

I dont disagree with any of that Ghia, although with finite resources a PT trial with the right primary end points targeting the right patients (as identified from Sprinter) is probably the best option of getting to market without the impact of dilution. Covid doesn't seem to be going away.

Getting approval as broad-spectrum antiviral opens up a massive market though, but at what cost via JV.

Ghia, in your opinion do you think Synairgen have already been told STRIVE is a no go to evaluate SNG001 further?

I agree WaiteOxford with that assessment, but the quickest route to market will be treating hospitalised covid patients with comorbidities and poor respiratory function (i.e., oxygen saturation =92% and/or
respiratory rate =21 breaths/min while on supplemental oxygen).

As the ERJ write up states the Sprinter trial wasn't "powered to evaluate the three key secondary
endpoints related to disease progression".

If it had been then I suspect we would have recieved an EUA by now.

I find it hard to fathom big pharma or the authoities aren't intetested in this data.

As it stands we need a trial ASAP to prove without doubt the finding presented at the ATS. Everything else should come second IMHO.

The great white hope is STRIVE or we're looking at dilution through a jv or raise.
GLA

Xviolet, things can definitely get creative. Polygon could fund a trial via a pref equity or loan with accrued interest and profit share hurdles, maybe debt to equity swaps if things go south. Not much in the way of collateral - guess ip rights / patents / RMs yacht ;). Probably way too funky for Synairgen's board and share holders though to approve.

Ghia, good point. Flipping it around from a potential JV partner's perspective, as you suggest, it would seem logical they'd want to take advantage of the current northern hemisphere winter covid wave as part of the trial. Balanced against the ability to negotiate a better deal as more time passes given Synairgen's limited cash balance. I don't know what weighting they'd place on each point. Maybe big pharma would play the long game and assume the 2023 /'24 winter will be just as bad. However, in time more alternatives might be authorised so you'd think speed to market would be a key consideration.

In my opinion, if Synairgen have done their job correctly they'd be in a position to sign a jv deal as soon as a key platform trial like STRIVE was ruled out. I just don't think Synairgen's board could commit to a JV if there was a strong possibility of rescuing the Sprinter trial through a PT. I'm not sure Polygon would allow them either.

Taking the Financial implications aside, it will be fascinating to see what happens and try to figure out if the BoD made the right calls. Sadly, it is unlikely we'll ever have all the facts to be able to make a completely fair judgement.
GLA

Well said AJ316.

It would be great if it was announced if we were included on STRIVE while in attendance, but I'd have thought the timings would be purely coincidental.

gggg21, I can't see how a buyout right now would be more than pennies. While most of us on here recognise SNG001 to be a real gem there is a small matter of funding a phase 3 trial. No buyout attempts were made pre sprinter read out. Therefore it is unlikely a buyout will happen before the results of a new trial, however funded, that has yet to be announced.

If the company is sold off sooner it will be a distressed sale IMO. I cant see Polygon letting that happen unless the distressed sale is to them! However, this is not my understanding of what they typically do.

More likely is that the much needed trial comes through one of three options. 1) govt. funding such as STRIVE. 2) a licencing deal with a big pharmaceutical or 3). Via a fund raise. In terms of impact on shareholders via dilution the third would be devastating given where the sp sits. A JV / Licencing deal might not be much better, but would depend on competition. Maybe this is the option Synairgen are trying to achieve on their visit to the JP Morgan healthcare conference. Importantly, while the terms of a licencing deal could range widely it would be poor shareholder interest management if one was announced without firm confirmation that Synairgen had been rejected by the NIH for STRIVE. Maybe that has already happened, but it if hasn't then I doubt anything material will come from the JP Morgan conference. Just my opinion and managing expectations. GLA

Doc.Daneeka, I think sadly you're right about 6 weeks then it's out of Synairgen's control in terms of avoiding dilution or a takeover that screws those who invested in the raise.

Reading the Sprinter review journal article I still find the following astonishing (although its good that its openly admitted):

"The study was not powered to evaluate the three key secondary endpoints related to disease progression" (page 12).

I know it's going over old ground, but what were they thinking. This is an open question, is it common to run a trial where it's not designed / powered to achieve 'key secondary endpoints'? What's the point in even including them? Just seems a real clanger of a mistake, almost negligence when investing shareholders equity.
Like the murphys i'm not bitter......
Any way let's hope we get on a free trial ASAP. GLA & Happy New Year

I'm sorry wpa5 but unsubstantiated claims are going to get called out or at least politely questioned by rational investors. Just because a few posters picked up on the same point doesn't mean a 'pack' mentality exists. Hey, let's hope BG is right, but as I posted below I don't see the logic of why that event would act as a catalyst. GLA

What has JP Morgan's Healthcare Conference to got to do with Synairgen getting on a platform trial?! I don't see a possible connection.

No M&A activity will occur until Polygon can avoid their highest price paid over the ast 12 months, which isn't until mid to late Feb '23. If it was going to happen prior it would have already happened after the release of the Sprinter deep dive at the ATS.

Neither do I get why this conference could act as a catalyst for a JV announcement with big pharma to fund a ph3 trial. Those conversations would already be happening if there is interest behind the scenes and would be announced as soon as the deal was inked.

Don't mean to be a spoil sport but please do enlighten me if I'm missing something obvious.
GLA & Merry Christmas x

Has there been any indication of when the next candidate for STRIVE is likely to be announced?
Many thanks
GLA

Lol Mani, no one wants a raise - it would be the last roll of the dice.

If we go down the JV route let's hope there has been interest from more than one party so any licencing deal is negotiated (or has been negotiated) competitively. It would be gutting to see this get to market for hospitalised covid patients and Synairgen receive average royalties. That said would be better than going bust lol, I just don't want to see SNG001 given away.

On a JV I just don't see how RM could effectively give up so much value through a JV with a platform trial like STRIVE there. Why unnecessary give away such a large chunk of future earning if you can get to the same destination for free. It would be a real strategic mistake to turn down a platform trial like STRIVE vs a JV on business grounds.

Also, if a JV was on the cards wouldnt big pharma just buy Synairgen (??) - would probably be cheaper. Hopefully all will be revealed sooner rather than. What gives me hope is the such strong ATS results - I mean 70% reduction in progression to severe illness or death is pretty darn good.
GLA

Doc.Daneeka, hard to disagree with much of your post. My only comment would be that if RM had been approached about a covid JV with big pharma, post the ATS results, wouldn't he have had to put it on the back-burner with the knowledge PTs like STRIVE were out there for the very reason you mention about JVs giving away too much value?
While timing / control goes out the window with the NIH incharge, no future revenues are given up. Its the only route to truly salvage Sprinter IMO with regards to non dilution of shareholder value.

If for some reason we didn't get selected for STRIVE, then once confirmed behind the scenes, I wouldn't be surprised if a covid JV did emerge. If that doesn't materialise then I would support a fund raise for a covid trial, however, it probably isn't feasible with the sp languishing at this level....
GLA

Agreed Doc83 and better than going bust.

Thanks Doc. Fingers crossed we get an invite as it could really save our bacon and avoid dilution.
GLA

Doc.Daneeka, when you mention we might get a tailored protocol below do you mean they might make sure they might specifically track patients with compromised respiratory function (defined as oxygen saturation of = 92% or respiratory rate = 21 breaths/min) and perhaps also monitor reduction in long covid symptoms?