Member Info for Burble

Multiple industries - haven’t they always said things like consumer goods? Hoovers etc.

BOB - they're not. They're dropping Cohort 4. 'We have decided not to continue with Cohort 4'. Suggesting either no improvement or strategically it not making sense.

A interesting update after a brief skim through before heading out to work. Still waiting for financing decision but good FDA conversations are shaping up well, but one thing that stood out to me was this ‘ we have decided not to continue with Cohort 4, with iSCIB1+ delivered intradermally.’

All designs for the trial now can be finalised and costed and not have to wait for ID results. My question I guess is will they be silently dropped or will they be published at a later date? (This is more for my curiosity tbh)

I suspect you may be right.

I can buy small amounts in my SIPP instantly. But anything greater than a few thousand pounds in my ISA it’s just sat pending for ages.

Just topped up in both.

‘ With new data incoming, commercial-scale supply ready, and regulators engaged, Scancell is clearly positioning for the next major step’

I wonder if this is all going to be announced in a single RNS. Data on the SCOPE trial and the plan going forward and next steps announced.

You’re possibly right there! Especially with the fact we have platform technologies. If they are using AI to help identify new targets then that data package could be definitely more valuable than we realise. Though this is currently only speculation rather than factually proved. So until the point where that is confirmed, imho its value is basically 0 at this moment in time. Unless I’ve missed something at the AGM/ whilst I’ve been away travelling

I guess like any biotech, it's understanding where you will be able to demonstrate to investors/partners that there is value and potential and not spreading yourself too thinly across multiple indications without the finances to progress these all forward to meaningful inflection points. Focussing on indications where CPIs are already approved is logical because it means if you can demonstrate efficacy then people will take interest. In my opinion, if Modi was then able to make it through and show clinically meaningful impacts on these patients as a combo therapy with checkpoint inhibitors, then there may be an appetite to revisit other indications in the future where traditionally CPIs have failed to have a statistical significance, but the combination therapy could show promise for these patients.

Add to the fact that Toyota have been saying about solid state batteries for years. They have doubled down on hydrogen, on fuel cells. I'll believe it when I see it.

https://optimisticstorm.com/toyotas-failure-with-solid-state-batteries/

Berm - 'the UK seems incapable of supporting home grown innovation to scale up but that's another soapbox for another time' - welcome to my working life. Having to deal with businesses who would love to grow and scale their innovation in the UK, but risk appetites from both government and VC funding seems a fraction of what other counties are prepared to work with. It's so annoying listening to the same government ministers wringing their hands, lamenting the fact that companies start here and then move abroad because investment is easier, cost of raw materials is cheaper and the general environment has far more fertile ground than here.

Going to be abroad without any real access to a phone till early November. So if news drops when I’m away, don’t worry I’ve not sold out! Also will be good to catch up on the AGM if anyone decides to go.

Sadly I won’t be at the AGM this year as I’ll be in India. But hopefully someone can give us the run down of what’s discussed

And the AGM.

Wonder when it will be this year?

EE - This is all linked to the VPAG scheme (which in itself is a follow-on from VPAS). VPAG is a five year scheme which stipulates that the NHS can claw back a percentage of payments for drugs from pharma companies to keep its spending within a set budget. For context, when negotiated this was considered an improvement since VPAG aimed to keep rates lower than the 26.5% rebates reached under VPAS.

However what has happened is this initial rate of 15.1% in 2024 has risen to 22.9% in 2025 due to increased sales from the pharma companies into the NHS. Hence big pharma throwing their toys out the pram and canning investment in the UK. It is believed that this is one of the levers they are trying to use to get the government back around the negotiating table. In late August Wes Streeting walked out of negotiations with the Association of the British Pharmaceutical Industry because both sides failed to reach an agreement as to the details of the VPAG scheme and how these issues could be addressed.

Then add into that the geopolitical shift with Trump in the Whitehouse and his frustrations with the fact medicines outside of the US are cheaper than they are within the US, and it all starts escalating.

Emptyend now you say that, you may be right there re Glymab Therapeutics. Previous we had been told at the last AGM that milestone payments were imminent. So you may be right that something bigger is in the pipeline for the platform

Having said all that.

The results today clearly say 'Modi-1 in combination with doublet checkpoint therapy in renal cell carcinoma continues strong recruitment with further data expected in Q4 2025'. Therefore, given that the previous presentations have all said mid-year or Q3, one could argue that this constitutes a slip into Q4. Whilst it may only be a few weeks when data is announced (I'm postulating here), it is important not to give Phil a free ride and assume he just misspoke. Results categorically said Q4 and previously had said Q3, therefore the answer to the question on the presentation should be 'yes it has slipped into the next quarter'.

Bibio, there was a question posed to Phil

[Mary-Ann] 'A comment on the Modi one renal study there was a, has this study been delayed a quarter and why?'

[Phil] 'No, I don't think it has. It's certainly recruiting well and we're collecting data from patients as we speak for that. I think we've signalled the second-half of the year and now we can be a little bit more precise on the timing of that, but there's been no delay in recruitment or read out a data from that cohort'.

July 2025

(https://scancell.co.uk/wp-content/uploads/2025/07/Scancell-iSCIB1-strongly-improved-outcomes-in-Late-Stage-Melanoma-SCOPE-study-results.pdf)

Modi-1 RCC + CPIs interim data (Q3 2025)

Modi-1 H&N further data (Q4 2025)

July - Clinical and Corporate update

(https://youtu.be/RZ8yA1XJseY?t=1548)

Modi-1 RCC + CPIs interim data (Q3 2025)

Modi-1 H&N further data (later in 2025)

April - Investor update

(https://youtu.be/8ARuWSMNNTM?t=1220)

Modi-1 RCC + CPIs interim data (mid year)

Modi-1 H&N further data (full cohort readout December 2025)

Agreed, both Sath and Phil had an air of confidence in their voices. Especially around the conversation on how the next trial would proceed. The fact they're saying they expect trials to start in 2026 was also good to hear.

Overall thoughts from me. Solid presentation, a few interesting points raised either directly or in passing. I think the rest of the year will be an interesting ride - my hope is upwards to reflect our true value over the coming months. Especially was pleased to here that conversations with potential partners gave the impression that there are multiple interested parties. This should help give SCLP a strong hand to negotiate with.

CLN partial redemption 'Redmile are very supportive investor, they continue to hold their equity stake. The partial redemption relates to some old funds that were requiring a little bit of liquidity and given our runway and our confidence in our runway there was a small partial redemption [of CLNs]'.

Phil also addressed the points raised by people on this board previously regarding removing patients from datasets. He said 'we have now a full set of patient profiles...and what we've seen looking at that data is our patients are very similar to the Checkmate 067 [trial] and so we wouldn't be able to really compare more precisely to 067 when we first put this data out we took out a couple of patients from the target population that had progressed or died before their first scan. We realised that in Checkmate 067 that was not done, so we put these two patients in the target population back into the data so we can strictly compare with Checkmate 067 and we've got 20 patients showing a response out of 31 or 65% response rate. We are still waiting for a furtehr 7 patients to read out. We screened patients as they came onto the study for the target HLA haplotypes but we also took patients that were non-target as it represents the target population which represents 80% of patients. We did have some patients that were non-target an dthat ended up to be 11 patients and what we're seeing here is a response rate of 27%....so I do think that this non-target population could be a representation of what the double checkpoints do without iSCIB1+.....one patient got through screening with active brain mets and are [patients with active brain mets] not included in Checkmate 067.

The fact that Phil has addressed this to me shows a level of professionalism. Acknowledge your mistake, re-evaluate the data, see what it says and explain why you have done that, rather than sweeping it under the carpet.

Sath on Genmab 'next milestones are on IND submission and Ph1 initiation. So taht's on the 1st antibody and the same for the second antibody. We've got a recent update and things looking good, increasing our confidence and I anticipate them within the next 12 months obviously the timing is reliant on Genmab'.

Phil 'during the year we also established Glymab Therapeutics, this was a strategic initiative giving us optionality about how we could develop that portfolio, to me there's a little goldmine there that it was difficult as we were structured to apply significant resource to move that preclinical pipeline forwards'

Interesting choice of words.

Phil also acknowledged in passing the fact there are other SCIB and Modi products which are parked currently, but could be developed once iSCIB1+/Modi-1 are moved forwards and go into commercialisation.

'The monotherapy study that was conducted in the adjuvant setting in melanoma with SCIB1. I raise this because monotherapy activity is an important part of our pharma conversations'

This peaked my interest. We have always said that the early SCIB1 trials were interesting and if potential partners are also looking at this early data that can only be a good sign.

'We do not anticipate any delays [with manufacturing] and we have material ready to start the phase three estudy on the timeline that we've liad out. The investment that we made in the last period to make sure we were ready and could have a seamless transition into a late stage study....so we will be yielding the benefits of that earlier investment because we've got a good process now that should be late stage ready'.

This is good to hear, especially given that getting slots at CDMOs can need to be done months/years in advance. The last thing we would want is for regs approval to come through but material to then be the hold up.

'We have accelerated the regulatory conversations...for us but also perhaps more importantly for the partnering and investor conversations they're asking us the question what does the FDA or MHRA think of this study, so we have accelerated those conversations to coincide with our investor and partnering conversations'.

This sounds like these conversations are advanced and positive and I read that as they have multiple options in front of them for how to proceed with the Ph3 trial - whether pharma or investor led.

When asked about the financing gap Seth said 'we are within our runawy at the guidance I previously guided to, we have all of the regulatory spend planned and a little more on manufacturing to make sure we are ready to initiate the study. We will evaluate our options following the active conversations we're having with partners [plural] right now, so based on those conversations, based on their feedback as well asht econfirmation from the regulators that we've got the right study design we will come back and update you on what the right financing will be. So we're confident we've got the runway to do it'

'Yes absolutely there is a real possibility of breakthrough or accelerated development here. For the FDA we have to go through the conversation with the FDA, submit our IND and then be able to then have a conversation first of all about breakthrough but then accelerated approval. But if you look at the data that I was sharing with you then I think we are a very very good prospect'.

With the CVLP and other means to accelerate recruitment, this could move quickly if accelerated development and approval is granted. However, I would caution that given geopolitical things going on across the pond, it will be interesting to see whether the FDA and their approach to vaccines may shift. Though Phil alluded to the fact that they are in conversations with other regulatory agencies if needs arise to shift trial focus elsewhere.