Member Info for Doc83

Shortshrift - watch Mike Buck’s interview from December, where he is directly asked the question “will there be any cash raises” and he says nope, we’re fully funded for the foreseeable future. 8 weeks later and well, you know the rest. Now, cash raises aren’t dreamt up and something you can do the next day. I suppose in his world 8 weeks could be long term?

If these “formalities” aren’t concluded soon then the SP could well fall back to 2p or less, at which point it’s going to be very difficult for MB to do a raise. He only managed to get the raise away in February because he pumped the price up from 1.7p to 5p+ by saying he was told in October the LP would be 1-3 months (naive) AND there was no need for a raise for the foreseeable future (lie).

Https://www.bbc.co.uk/news/health-66890505

I’m sure it was Chris Brightling who said SNG001 merits further investigation.

Would get worst case scenario not be having less than good sales on all three points you mention, and then additionally, running out of money?

Well another week comes and goes. One left for September, it’s looking like I was a bit too optimistic with my September prediction and am in danger of falling into the “rampers” bucket!

I still think this will come good. But when? Hopefully before we run out of money and get diluted any further.

“I have concluded we are on a winner.”

I’m glad you clarified that. We’d never have guessed you were keen on AGL!!!

I wonder if anyone can attend? Flights to Mongolia only £609 return!

If you think we'll get authorisation to extract oil before another cash raise is needed, then probably.

It's quiet right now... only ~£20k traded.

Aether - it is most definitely the last roll of the dice. Fail these P2 trials and it's all over.

However, they seem to have designed to trials such that it should hopefully be all fine, in which case I'd expect a decent rerate of the SP. But I've told myself this could be a long old hold now!

Well, we’ve a few chances with POW to strike gold (or uranium, nickel etc etc) so I’ve been slowly building up a position here. Still relatively small in my portfolio but definitely becoming more significant and probably about halfway there to what I want eventually.

I do agree with Roger, though. It does seem that only the largest find of uranium EVER will shift the SP!! :D

But, the sky is the limit if we do get a nice find and certainly makes said portfolio more interesting.

If you believe that SNG will a) get these P2 trials done before they run out of cash and b) pass the trials, then there is still money to be made here.

If in your opinion the answer to either of those questions is no, then you should probably sell up and move on.

Deary, they get shorter and shorter!

Where are the questions to RM?!

R&D update Whilst news that the Phase III SRINTER trial failed to meet its primary endpoint may have been initially disappointing for investors, a detailed analysis of the study data revealed that SNG001 displayed encouraging efficacy in more severe disease populations of COVID-19 patients. It was reported that SNG001 was able to reduce the risk of severe disease progression or death by 70% compared with placebo. As such, management is committed to further developing SNG001 and will look to investigate the treatment’s application in severe lung infections, with a particular focus on optimising the patient selection process and trial eligibility criteria for future studies. This is being undertaken by applying existing and new diagnostic technologies, biomarkers and learnings from existing clinical data packages. In our view, this patient stratification process will be critical to be able to placeSNG001 within a setting more tailored to being able to elicit a stronger therapeutic and clinical response. Synairgen has also communicated about expanding into new patient populations that include (i) hospitalised patients bearing high degrees of viral infection and poor clinical prognosis,(ii) mechanically ventilated patients in an intensive care setting (ICU) with confirmed viral pneumonia,and(iii)immunocompromised (poorly functioning immune system) patients who are unable to clear respiratory viruses and become ‘viral shedders’.To further support SNG001’s utility, thecompany intends to design and establish data from an observational study as well as two investigator-led/Synairgen sponsored Phase II clinical trials. The primary objective of observational studies is for investigators to observe patients in normal settings who may or may not be prescribed an intervention (treatment). This differs from controlled clinical trials where participants are assigned to a specific intervention. Observational studies benefit from being able to generate data quickly, which could help further inform the desired study population for follow-on controlled studies, and tend to be significantly less capital intensive than controlled studies. We expect to hear further details around the designs of these planned future studies, as well as potential target indications, prior to their initiation, which management expects in H1 2024. Upcoming news flow In our view, the next major milestones for Synairgen will be the initiation of the investigator-led Phase II clinical trials for SNG001as well as the planned observational study. These are expected to start in H1 2024 and will be important prerequisites before a Phase III study to inform patient selection and generate further data to demonstrate SNG001’s clinical utility.

"Can you paste a copy of the research note you refer to to Doc83? What I'm reading doesn't make any reference to "they'll need to raise cash or JV to fund a P3" so quite confused by that remark."

Fruits - what is confusing? Clearly, we could not fund a P3! So, that leaves either raising the cash ourselves or partnering with someone else. Or, just selling out post (a hopefully very good) P2 set of results and letting a BP run with.

In any case, here is the paragraph from the note:

"We note that whilst observational and investigator sponsored studies may be more cost efficient, in the absence of strategic partners, we anticipate the company will need to raise funds if it were to independently finance and progress SN001 into any randomised and controlled phase III studies. "

For some reason it will not let me paste the link to the whole note.

I'm not sure too much has changed here. It was always going to be H1... it's just not clear if it's the start, middle or end of H1 - RM, clarify please?

This has always hinged on these new trials. Hopefully the results are good and we'll see a re-rate of the SP, although probably no where close to the £2+ highs. Then, as the research note today says, they'll need to raise cash or JV to fund a P3. But I'm guessing a BP or the likes of a Janssen will come in and take the lot for peanuts instead. However, peanuts could still be 50-100p. For those that have averaged down, potentially still a decent, if not life changing, return. For other LTHs, it'll be something and not a complete loss.

All IMO and could be much better or worse.

Avo - I don't think MB can do much more now. He looks as frustrated as everyone else.

Master - the Prime Minister/MG seem to be on our side. It's the locals that are the problem.

Paladin: “My only positive following today's announcement of further trial delay is that TFG Asset Management continue to hold. ”

TFG have no other option but to hold. They wouldn’t be able to sell even a fraction of their holding, even if they wanted to, it’s such a large holding.

Initiation of which would represent tangible progress in executing SNG001’s clinical development strategy.

Synairgen’s H1 2023 results re-established management’s commitment to progressing its lead respiratory anti-viral asset SNG001 through clinical development. The results of the Phase III SPRINTER trial and the US Government’s ACTIV-2 trial produced valuable data suggesting SNG001 has potential to reduce the risk of disease progression, especially in more severely affected and higher risk patient populations. The company is currently undertaking patient identification activities to select patients most likely to benefit from SNG001 and inform future study designs. Synairgen is also looking to expand into other populations of interest such as those ventilated with viral pneumonia and immunocompromised patients who are unable to clear respiratory viruses. H1 2023 net cash stood at £14.6m, which, at the current run rate, provides an operational cash runway into H2 2024. This estimate includes existing committed costs as well as the estimated costs of a planned observational study and two investigator-led/Synairgen-sponsored Phase II studies. We will look to reinstate a target price once we have greater visibility around SNG001’s clinical development strategy and target indications.- Financials. Adjusted operating losses for H1 2023 amounted to £5.1m, significantly lower than the prior period (H1 2022: £13.7m). This was primarily driven by lower R&D expenses (£3.5m vs. £11.1m) due to the conclusion of the Phase III SPRINTER trial in 2022. Net cash outflow from operating activities was £5.3m (H1 2022: £15.8m) with the company reporting an end of period net cash position of £14.6m, which should be sufficient to conduct preparatory Phase III activities for SNG001 and provides a cash runway into H2 2024.

- Don’t count SNG001 out. We remind investors of the body of clinical data to support SNG001’s utility as a broad spectrum anti-viral treatment for severe lung infections. Post-hoc analysis of the SPRINTER study data revealed stronger effects in higher-risk patient subgroups, reducing the risk of severe disease progression or death by 70% compared with placebo. Symptoms of long COVID were also alleviated, with patient treatment responses assessed at days 60 and 90 corresponding to a 35% reduction in the relative risk of fatigue/malaise. Additionally, anti-viral activity has been demonstrated in vitro against respiratory syncytial virus (RSV) and rhinovirus which, in our view, supports SNG001’s potentially extended application across indications.

Upcomingnewsflow.Managementispursuingthebroad-basedanti-viralsettingforSNG001and plans to conduct (i) an observational study, which benefits from being less capital intensive and can generate data to inform future trial designs, and (ii) two investigator-led/Synairgen- sponsored Phase II trials. In our view, the outputs of these should put the company on track towards, potentially registrational, Phase III study in severe anti-viral infections. Management expects these to begin in H1 2024, i

Dippfs - yes, Simon Shaw was quite clear to me that the trails wouldn’t start this year. So reading H1 doesn’t bother me too much because they could just be playing it safe… they’ve been criticised before for giving too narrow a time frame. But it is loose on detail. It really needs an interview and/or clarification.

We also fed back to SS afterwards that comms really is very poor and he said they’d look to improve that. Let’s see if they do or if it was just lip service.

Regardless, all of this is last chance saloon stuff for Synairgen. Money is running dry, they’ll never be able to raise cash at these levels, and there’s needs to be materially good news within the next 6 months I’d say.