Member Info for spinnaker

Thanks for reminding us about that Prion.

Having a quick look for the second time what really hits me is they are forecasting a compound annual growth rate over the next few years of just 3.5% from the 2020 sales. This is despite mentioning Synairgen hospital trial. It would appear therefore that they are not assuming any sales for our drug against Covid. It may be that the company protocol does not allow any assumptions in respect of drugs that are not approved at the time of estimate. The figures given are relating to I/V and I/M treatment for Mutliple Sclerosis.

In any event I don't think the figures give any particular insight regarding the potential sales of an inhaled version of Interferon Beta 1a either as anti Covid treatment or a general respiratory anti-viral.

There are a lot of hoops still left to jump through but I am pleased that the SP has held up pretty well and seems less volatile at present.

Best to all

Spinnaker

Thanks Hank and F&V

Significant discussions or agreements re backing surely should be RNS'd. We have had RNSs stating production agreements are being progressed but that is all. Confidential discussions ongoing shouldn't need RNSing of course.

On pricing , Hank, the example of £50 for a nebuliser may well be £50 at present but if we produce 100,000 treatments and therefore need 100,000 nebulisers every month then I am confident we could either find a way of sterilising the used units or agree a reduced price with the current manufacturer or approach a different manufacturer. It may be that this latter would require some limited further trialing though. Similarly volume and longevity of production will inform costs of the vials.

The production for Covid-19, its variants and future respiratory viruses is potentially a market that would be orders of magnitude larger than the original asthma and COPD exacerbation target intentions. We can't expect the first years worth of purchases by customers to pay for all the 15 years research costs assuming we have a product which was originally developed for for a rather more niche although still important purpose.

Indeed the outcome of the 'At home' arm of the UK trial together with the US Activ-2 may well determine the overall market size for the future. It could be huge but if it is then downward pricing pressures could increase fairly quickly particularly since Interferons cannot be protected by IP. Recent and current panic spending will not last; see NCYT as an example.

If we get the positive results from all the trials that we expect I concur with F&V and Hank that there will be a few suitors and it will most probably then be in everyone's interest for J/V or J/Vs or takeover. The only worry is that a takeover is not a swift option and may delay optimum roll-out. The involvement of a large Pharma or Pharmas will reduce costs of production and enable faster production no doubt which would potentially increase the market size.

Spinnaker

My long post continued.

A lower price could be negotiated with the government for a long term contract and of course production could be ramped up to and above RM suggestion of I think 100,000 plus per month. I expect us to be able to sell multi-nationally quite readily once authorisation is approved.

Sorry for my ramblings but I am interested in what everybody else thinks on this topic. If we can bring down the price to a few hundred pounds then there is scope for tens of thousands of sales to the general public. Me for one.

Good luck all

Spinnaker

Scinv

I know you have suffered a lot of adverse comment on this board because people think, wrongly in my view that you are de-ramping. However you have gone to the trouble of crunching some numbers and answering questions so thank you.

I am interested in pricing potential and accept that there is the opportunity of differential pricing across different markets. As you imply, the cheaper we can produce, the more competitive we can be in the market. However as in most industries the price of raw materials is only a small fraction of the cost of finished goods and for instance the production of the vials with such a small amount of interferon is going to be a much larger proportion of the cost than for I/V treatments . It is now clear that there are a number of drugs that will be competing. Ours may be the best in its niche but that doesn't mean that we should seek to maximise sale price over the short term. Maximising sale price is not the same as maximising profits of course. Cost efficient production and future proofing will be key.

I consider it likely that one of the reasons SNG001 is not on the Recovery trial is that Horby or whoever was responsible on the UK gov. side thought that the expected treatment price would not be attractive. The posts have shifted since then particularly in America where as we know the US gov. have contracted to buy several expensive mAb treatments at between $1,000 (AZN) and $2000 (Regeneron) a pop.

I have been thinking about this pricing today mostly because of the fall-out that has occurred between Novacyte and the DHSC notified on Friday last week. It appears it is to do with pricing although I may be wrong. The GP shown by NCYT in their latest accounts was something like 85% and I think this was for product supply, machines and tests. Now I am not certain what the proportion of the total cost of a PCR test is the kit since the lab cost will be significant. Also, using GP as an indicator is not very reliable since the recoup of R&D and trial costs need to amortised through the production numbers and lifetime of the product sales . In any event, the relationship between NCYT and government has soured. The media picked up on possibly Matt Han****'s comments and the main take was that certain private companies are seeking to make excessive profits out of government contracts. This is obviously not a good look resulting in a one day 40% SP hit for NCYT..

I suggested back in early March that perhaps we could produce treatments including vials etc for £10 per dose or £140 plus say £10 for the nebuliser. Is this feasible based on say 50,000 per month? If head office and research costs were say £50 per treatment then costs would be £20m per month. If this was the case then we could sell at say £400 per treatment and still make a reasonable profit of £20m per month. This would be a GP of 62.5%.

Thanks chaps for your responses to my post.

Doc, I am sorry but I missed the post about the email from the company confirming they had seen the initial results. Nevertheless I believe the protocol allows for a few people close to the trial within the company to see these early but still mainting the blinding as far as patients and doctors are concerned. Therefore it is quite possible that Ghia is correct and it is thought that an RNS release prior to the the last 90 day follow up could allow bias. Therefore it is still feasible that the early data may be released by RNS after that 90 day period has elapsed.

Meelie, I am sure you are correct that the BoD are not interested in the view of short term investors or traders and have consistently shown to date that they are only prepared to do things in a proper and considered manner with regard to the long term benefit of the company.

I also take on board the point that RNS's such as the one we are expecting are important and do take time to prepare. I recall there was a second RNS rushed out directly after the 20 July one for clarification. Therefore although it is possible that we will get 2 RNSs with the 60/90 day results separate and subsequent it is also possible that all will be rolled into one. In the latter case I think I am still sticking by my earlier view that we may not hear anything until 2 weeks either side of 24 May.
I think I missed my chance this morning to top up in my new ISA but see my limit trade at 145p was actioned this morning and already in profit.

A nice little move up at the moment. Strong RSI. What's happened?

Best Spinnaker

Well done Mike.

How long did that answer take to get? It must be at least 6 weeks. At least it was very positive and specific re SNG001. Possibly the first time I have seen anything official emanating from the government mentioning the company name. Are you able to post the link please.

However, in comparison to vaccines where orders were placed before authorisation and well before conclusion of trials, it is clear that there are no plans to contract orders before authorisation for use be that emergency use or not.

I am just considering whether to add to my holding at current SP but my confidence in AIM companies and government shenanigans has taken a knock since the unbelievable NCYT news.

I still am unsure why Synairgen appear not to be releasing the initial results for the home trial which they could have had by now. Is it the case that once the 90 day review had been incorporated into the trial they would not un-blind any of the results until all the information was collected due to possibility of bias? My slight concern is that they have already analysed the initial findings up to 28 or 30 days but have decided not to to release these if inconclusive or non-significant in the hope that the longer term analysis would strengthen the case. If the former scenario is correct and they have not yet un-blinded any results then I would feel a bit happier.

Overall I am still confident with the company and product but agree with most posters that the UK home trial results will probably not be sufficient in themselves to gain authorisation in the UK. I would love to be proved wrong.

Good luck all.

Spinnaker

I have just listened to the recording and agree with the thrust of most of the comments, particularly I agree with you Matterhorn about the guy from Relief Therapeutics and him spending 3 minutes telling us not only the three names of his drug but all the stockmarkets the company was listed on, all the tickers and surprised we didn't get the current share price. Not really what the panel was set up for and he hogged a chunk of the time.

RM was confident and clear in his analysis but never pushed forward. I too picked up on the need for 'a fire to put out' definitely implying the HT results may not be mind blowing. The small numbers involved may mean that only 5 or 10 from the placebo group worsened enough to go to hospital and not being a statistician I am concerned that this arm on its own may not be able to show statistical significance of any substantial improvement for the patients.

I assume the RNS, when it comes will give HT results only but also amalgamate them with the hospital patients results to give overall figures for the whole P2. Of course this will serve to show not only a larger number of patients in all in the trial but also may give statistical significance on the amalgamated figures.

What do others think? I remember the Ox/AZ fiasco withe amalgamation of data sets and averaging which did not go down too well at all.

Spinnaker

Whoops, my apologies to everyone, particularly Bryosa.

I have just realised that I was using 28 Jan as last patient recruited . It should have been 20 January. Therefore all my suggested dates are one week out and my favoured date for RNS is 24 May with a likely window of 2 weeks each side.

Stupid error. Sorry.

Spinnaker

Thin Shins
Home trial was started 26 May 2020 see 26 May RNS. A long time ago, as you say.

Bryosa

I do tend to agree that we may now have to wait until full 90 day results are available before we get the RNS we are waiting for.

I had, until recently, favoured 10 May as well. I am now thinking that we could be waiting slightly longer before I will start to fret.

Hospital trial last patient recruited 28 May 2020. It was 8 weeks less 3 days until top line results released 20 July.

Last patient first dose in home trial was 28 Jan 2021. 90 days later would be 28 April 2021.

There are three changed situations to take account of in the home trial compared to the hospital arm;-
1) Familiarity with analysis
2) Rather than a limited number of hospitals transmitting data to the number crunchers, in this latter case (home trial) the nurses/researchers need to contact each of the 120 patients by phone and ask a list of questions. Most of the patients will now be long past their 90 day period and therefore most of this work will have been done by now. The last few patients are what the statisticians will be waiting on. This may take a week or more, particularly if some are away visiting family.
3) As others have previously stated the initial analysis including first follow up which I think from memory was 28 days should have been completed by now, i.e. before the 90 day follow up is undertaken. Therefore rather than 8 weeks being required to completed the final analysis I would hope that 4 weeks would be adequate plus the week to obtain the data from the final few patients after their 90 days are completed.

Five weeks from 28 April would be Wednesday 2 June so I think the window for the RNS we are waiting for will be 10 May to 14 June and most likely between 17 May and 7 June.

All these dates are well within the Q2 time window given by RM.

I would be interested in any comments on my suggestions.

Best wishes to all.

Spinnaker

Hi Axe

Thanks for that. Could you please post the link to FDA and point me to where the note is hidden. Thanks.

I assume the March date refers to 2020 hospital P2 trial and well before the MAP was authorised?

Thanks

Spin

Hi 1509
I would like to have a go please for April with
NCYT
AVCT
SNG

Many thanks for organising this bit of fun.

Spinnaker

Axe - You missed me off the list! I would love to meet everyone in due course.

Thanks
Spinnaker

I agree that Synairgen's successes to date have been generally underplayed by the government and the media. Also, although there may be nefarious agendas at play this is not necessarily the main reason.

The end game vision in conjunction with vaccines has always been for a pill or tablet to use as a broad anti-viral and this is the medium term goal similar to penicillin for bacterial infections. SNG-001 is likely to be vastly expensive and a lot more hassle to use in treatment in comparison. Therefore I don't disagree with the government's actions in searching for the Holy Grail. However this does not mean that near term effective treatments such as Synairgen will be of no use in the meantime (and it could be a long time). Basically multi-strand research and trialling and roll-out of effective treatments need to be supported by the government in parallel with each other. The reporting mentioned is a positive in that it shows the government's gaze is moving to treatment from vaccination and PPE

The results of each of the SNG001 trials now ongoing will continue to strengthen the case for our product until the weight of evidence reaches a tipping point and the scales will fall from the decision makers eyes.

In the meantime we need to prepare for a potentially very high level of demand worldwide. One of the requirements for getting on Activ-2 was the drug availability levels. Synairgen just scraped in IMO, reference the reduced number of trial sites in the US. I very much hope that there are now legal agreements and physical, technical and operational facilities in place to supply large quantities at short notice this summer.

These are my hopes and expectations.

Best to all.

Spinnaker

Thanks for all the responses and I'm sorry that I ****ed up the link. Thanks especially gkb for rectifying this.

Thanks are also due to Aston who first posted the link and who doesn't normally have a good press on this board but does come up with some sensible posts when not being baited.

Tatty, re SP, I am in a similar place to you and even bought at 220. Also I got my brother in law in at about 223 I think, so I do realise others will have been caught out. I have been very attached to this company since I first bought in at 73p about a year ago and have continued to top up but just not at the most auspicious times. It has been a very bumpy journey and I have been tearing my hair out at times wondering why the MAP availability doesn't seem to have been taken up, why SNG didn't contact every respiratory medic and GP to try and get the Home Trial filled in less than the eight months or so that it took, just two examples of my frustration.

We have missed being able to help out this winter but I am confident the science seems really good and has been seconded by multiple research groups in several countries. SNG must be made available by the end of the summer.

My doctor friend I mentioned previously is convinced that SNG001 will become standard treatment for all respiratory viral infections in the future irrespective of Covid. Covid is not going to disappear though and our product on approval will be very well placed to be included in the government's arsenal of treatments that will be needed to be stockpiled in case a new vaccine resistant strain occurs and to prepare for further waves and other pandemics that may occur in the future.

Politically and practically the government's proactive attitude and high stakes bet on vaccines has been proven a winner, especially in comparison with all the mess ups on pretty much everything else and they won't forget that for at least two or three years! Therefore I think they will be easily persuaded that investing in efficacious treatments with broad application (virus agnostic), will be a brilliant investment. Even better if it is a British company.

UK may be playing second fiddle to the US if positive UK P2 home trial results are not jumped on quickly and stakes placed. I am pretty sure there is now enough knowledge of Synairgen within government circles to make this a real possibility and MHRA may even surprise us with an EUA. Not holding my breath though.

Conclusion --I am holding tight and expecting some great news by the end of April or possibly up to mid May.

Best wishes for Easter to all and finally some family interaction at long last.

Spinnaker

Thank you TLW

That is a fairly comprehensive NHS overview and paints a situation quite a lot worse than I realised. Hopefully the vaccines prove as effective as indicated at preventing most severe disease and therefore most 'long Covid'. SNG001 should soon be able to help with the exceptions and those at most risk.

Hopefully full approvals will be in place in time for next Autumn by which time we will quite probably have new variants of the virus. If so, the one most successful at by-passing the vaccine induced antibodies will tend to become most prevalent.

Best to all and good wishes for Easter.

Spinnaker

Hear Hear Prion.

Spin

I have started a new thread because Aston's link below was lost in a long petty squabble thread. I am hopeful the name calling will stop as requested by many and that this board again becomes helpful and worth reading.

This pre-print published 1 April (hopefully after midday!) has names of quite a few scientists from Porton Down and UCL which I think is of potentially huge import. I don't know what the links are between the UK gov., MHRA and Porton Down but they must surely be close.

https://www.medrxiv.org/content/10.1101/2021.03.30.21254540v2Aston01
“ Our data support a protective role for rapid induction of type 1 IFN and CD8 T cell responses to SARS-CoV-2”

I found this short paper interesting because it states that very early, including pre-symptomatic, expression of type 1 Interferons was found in patients that recovered promptly or were asymptomatic with Covid-19. This is what I am sure we all expected and one of the main reasons SNG001 works on people who have inhibited or low level interferon production usually due to age, existing treatments or chromosome abnormality. These people are precisely the ones that will become most ill with the disease.

Despite vaccines, so long as the disease is present some people will become ill, some will die and some will survive and possibly suffer 'long Covid' including becoming permanently impaired. Our company's product can mitigate this suffering and, in due course, become standard care for any respiratory virus affecting 'at risk' patients.

I am proud to have contributed in the share offer and to remain an investor. The short term movement in SP is not particularly relevant except to traders as value will out in due course.

Best Easter wishes to all.

Spinnaker

Just a thought, slightly tongue in cheek.

The first graph shows a positive correlation between low level of INFB1 and length of time in ICU. It doesn't state how many patients died in either group so it could mean that all those with high levels of INFB1a survived even if some were in ICU for 70 days whilst all those with low INFB1 died within 35 days. This a variation of the Gee Whizz graph derided by my Zoology master at school.

Best wishes

Spinnaker

Thanks SDG for re-posting this thread. I was looking through the postings from Saturday and couldn't find it because the thread was on today's posting list of course.

I finally found and realised I had been reinventing the wheel since Peelweight got there first on Saturday..

I think I understand what Richlist and Prion are saying. However I agree that the whole extract of the paper is confusing and potentially misleading and I await peer review comments. If it takes as long as SNG did that will not be until May or June though. The graphs are not understandable to me either.

I think I will put it to the back of my memory shelf now.

Best

Spinnaker

Right Oak. Thanks. I'll trawl through Sat posts and see if I can get anywhere, that is if Faye can't come up with the mathematical proof if she ever gets hold of H.

Spin