Member Info for Ghia

Teamwork - This morning was one of the few times I have ever called the intra day trading bang on. I closed all my leveraged positions before 8.30 but kept my entire ISA holding untouched.

During the course of the day I bought back what I had sold and I will add if it drops further.

As for what the company should have done differently, Nothing IMO.

They delivered the news that they had and there is a clear route forward.

What’s caused the drop is the state of the wider market there are plenty of opportunities to make reasonable returns and people are impatient to wait.

And for the record I hold more shares at close of play than I did on the opening bell, so my confidence is certainly not diminished.

Teamwork - Without the webinar the RNS alone was not detailed enough.

My message this morning prior to the RNS was a warning shot to those gleefully spouting about another success.

The RNS clearly omitted that they failed to meet the primary end points and that there was no benefit of taking SNG001 early in the majority of patients.

They had to distribute this news and they chose to do it via a webinar which I think was the correct move.

I actually felt more enthused after the webinar than from reading the RNS which I could tell was masking the truth.

If they had put all the info in the RNS I would have expected the price to crash worse than it did today.

Many have run for the hills because they sense another 4-6months before the real inflection point. I don't blame them there have been several clear cut 100% gains that I have not maximised because I was waiting on these results.

I sense from what I read a perception that Activ2 is less exciting and the global P3 is the goal.

Whereas the webinar actually highlighted for me that all of the mabs trials have had similarly low hospitalisation rates in the placebo arm the difference being they where powered to prove stat significance using larger sample sizes.

Activ2 is a bigger P2 I see no reason why we won't proceed to the P3 element and that may open doors earlier than the global P3.

The clinical data set is growing, the treatment clearly has a role to play in probably the most useful place the transition between home and hospital.

We are actually building inventory.

A few people might get caught out playing elsewhere assuming nothing will happen for 6months.

Tyla - Stop being deliberately disruptive. We are fully funded for all the ongoing trials and manufacturing operations there will be no need to raise funds.

Many positives to take from the webinar, not surprised at the response I did try and warn people earlier without explicitly giving advice which I try and avoid.

Now HT is out of the way there is some good clarity moving forward.

-They are accumulating drug in shelf as a bi product of refining and validating the manufacturing process.
- There is a distinct patient profile that benefits from the drug that is not defined by a laboratory test or blood sample
- This patient category is the one that is likely to cost the health system the most therefore a large ticket price on the treatment is justified, the sweet spot has been found.
- The trial design for P3 is geared towards success without compromising on recruitment time.
- Activ2 whilst not optimum trial cohort will be larger numbers and lots of information gathered SNG is likely to progress on this trial just like the mabs. SNG is showing better signals than the mabs if I understand the comments in the q&a correctly.

In summary the wait continues but the risk has reduced.

CW25 - Thank you finally someone with the blinkers off.

This post will take a bit of heat but here goes my objective opinion:

Pro’s
-another 60 patients dosed without any safety concerns
- a trend seen again in breathlessness

Con’s
- we failed both primary end points, the trial failed it was underpowered for the target population
- Global P3 has shifted from summer to H2 suggesting it’s a bit behind schedule we sort of knew that
- no manufacturing update hope they touch on this later

I’m still holding but I expect the boards next moves to be better.

MassiveRay - But you can always just filter...

Mike - Patents aside SNG are light years ahead of other nebuliser IFN trials the closest is probably betterlife.

This in itself is an incentive for others not to bother SNG will have dropped nearly 50-70mil this year on clinical data.

I guess the concern with the Argentinians is they get a greasy palm rushed approval in Argentina.

If that happens I doubt many of the serious regulators FDA etc will take it seriously and will want more data.

But it’s still an approved drug and that would be really annoying.

alinz - They may have found patentable findings but we will shortly find out how watertight their patents really are.

The Argentinians have form of ignoring patents likewise the Chinese.

I’m a bit surprised at the French but then it’s still within academia so I wasn’t overly concerned.

It will be interesting to see how SNG play their hand if the Argentinian drug gets a whiff of approval.

Can people either contribute to the debate or pipe down enough of this labelling a poster because they raise a point that goes against your beliefs. Either counter with some facts or shut up and listen.

Scinv - I’ve done a lot of work on patents in an engineering setting, how does the rules of equivalence get ruled upon with drug formulations.

SNG have a patent on a specific formulation of IFNb1a if a company takes their formulation and swaps one of the non natural components out for another component that does the same job but is a different compound I believe SNG are covered by the rule of equivalence?

Did we listen to the same interview? Sounds like the FDA are not yet satisfied and want extra data which will take 6months to gather. Before MS trial can begin.

Time to switch off and come back in Q4

Can I make one final point Scinv has made a constructive contribution to the board this evening and perhaps people should back off a little bit with the insults. If you don't like what you read or find it a too pessimistic for your tastes then filter or ignore.

What has clearly been shown tonight is this board can be a place for sensible discussion and we can all learn and debate in peace.

Scinv - I certainly think the Activ people know what they are doing, having the screening on that trial is reassuring especially since the entry requirements 18+ mean that a lot of people on that trial will naturally fare quite well against the virus.

Our HT was a bit more specific looking at a more at risk subset of the population so perhaps we will fair well despite not screening, certainly it's a missed opportunity unless you can retrospectively look for this? Although I doubt they will have bloods on the patients unless they got them to take a sample by themself (unlikely) CW would know.

Scinv - That is a really informative post thanks.

We may have been unable to supply Activ with the quantities they wanted that is a positive that they wanted to trial us everywhere and unfortunate that we couldn't meet their demand. However at least we where able to respond quickly we where the first drug to go live out of the 4. I assume we gave them enough to fill the 220 quota.

Regarding the commercials whilst what you say may be the optimum route in hindsight, that's quite some pivot for the company. Off the back of a set of hospital data which is still the best set of P2 for any Covid drug, to then decide to run a P3 only in a subset of patients requiring pre-screening and linked to a specific genetic anomaly that is still being understood ref Covid. That would be a hard sell to investors regardless of the scientific justification.

We want to focus on a subset of the population, and will have to pre-screen to find them with testing that may not be available everywhere with overwhelmed health systems and if approved we will be limited to this patient cohort....

I understand what you are saying and it has merit but would it result in a speedier outcome for SNG I doubt it.

Would it increase the likelihood of excellent trial data probably.

What I don't understand is all of this was known before Christmas the trial protocol was available then so why sell now rather than at any point in the meantime when the price was higher.

part 2/2

5. I think RM is in a difficult situation here the sweet spot for SNG would be treatment of hospitalised patients who are likely to require ventilation if left untreated. They could then justify remdesivir level prices and it's a large market. The issue is the drug is likely to work much earlier, you cannot have 2 pricing structures so if you go for the larger market of at home use the pricing has to arrive at an appropriate level. Ultimately the numbers will be crunched and a decision made accordingly.

6. RM is a CEO not a scientist you cannot expect him to get everything pin point accurate if Holgate slipped up on the science call him out but you have to give RM a bit of slack.

7. I guess this point got cut off by character limit, TW is a paid consultant and not part of Synairgen there may well be plans to do trials in ICU patients but is that for the interest of Southampton University or for Synairgen not everything that is posted in the public domain by the scientists is the company line.

Scinv - Firstly thanks for taking the time to lay out your concerns clearly and in a way that is constructive to the conversation. Just challenging a few of the points.

1. I think we could all use a manufacturing update in the next RNS. I don't think it's clear to me if when mentioning 100k treatments /month RM has been suggesting they would be actually committing to stock 100k treatments or just undertaking the pre-requisite activities to ensure we can supply on mass when the time comes. There have been suggestions that slots are booked for glass vials, nebulisers on the shelf etc. They are also doing trial production runs with 2 manufacturers to iron out the process and sort the fill and finish. I have always been working to the understanding that they will have a supply chain of 100k/month ready to go in the summer.

2. I'm not sure what you mean by this the plan for Activ was to use original stock for P2 and phase in Akron supplied drug when available. I've seen nothing that suggests this didn't happen. I suspect the limited availability of trial drugs at different sites is due to having to randomise 4 therapies 4 placebos. Much easier to just reduce the options at each site. Feel free to clarify what you mean I may be missing something.

3. I think you ignore the commercial implications with this point how much extra time, cost, training would be required to execute this pre-screening. Can this pre-screening be done without the need for a clinic consult face to face and can the result be turned around quickly. I very much doubt Holgate and to a lesser extent RM would be not aware of the benefit doing this pre-screening, but you also then lock in the treatment to only be used for this subset of patients. How many patients would have been turned away from the already filled trials if this screening had taken place, would we have ever filled the HT. The correct scientific approach may be what you suggest but sometimes you have to compromise to get things done.

4. I get the sense you take things very literally. Yes RM initially said it was paused because they didn't want to expose their COPD patient pool to C19 unnecessarily. They hoped to fill the trial from the existing patient pool if any caught Covid. They then decided to apply for an interim analysis to support the C19 process, at this point they didn't explicitly say the trial was stopped but it was fairly obvious they would not try and recruit an additional 9 patients in the future. The P2 was enough to warrant a P3 at a later stage but clearly Covid is the priority. They are most likely to get approval for Covid and repurposing an approved drug is far easier.

Part 1/2

Scinv - So you sized your investment on a risk reward basis when entering and you have slowly un-wound the position because you perceived the risk has increased.

What changes have happened since you first invested that have materially increased the risk.

Stepping back and looking at the big picture I see global Covid cases on the rise, increasing evidence that vaccination programs whilst important are not going to subdue the virus as hoped, still no go to drug for effectively treating the virus.

In addition to the above we have multiple trials progressing and are awaiting a readout for the HT which is scheduled for Q2 which we are bang in the middle of.

So I really don't understand how if you appropriately sized your investment on day 1 you would be reducing. Seems like you've held through all the risk and are bailing at the reward.

It's an Activ2 decision to expand international not a SNG decision. I think part of the reasoning could well be linked to looking at efficacy against other variants of concern. As we have seen with the vaccine efficacy can change dramatically with respect to mutations. So it makes sense for the FDA to try and get as much data as possible to aid their decision making process.

If SNG is indeed rolled out on these international trial sites it can only be a good thing at the very least it spreads the name a bit wider.

Lawyer started in Jan 2021

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Interim CFO Feb 2021
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