Member Info for Burble

An interesting read exploring the current M&A landscape

https://bradfordstanleycfa.substack.com/p/biotech-m-and-a-radar

Just playing catch-up, interesting slip of the tongue by Sath when talking about the Genmab milestone payments. He said something along the lines of 'in the next few.....this year'.

I’m annoyed, I’m stuck in a reorganisation call. Looking forward to watching this on catchup

This to me is one of the standouts, the fact that possibly some people are showing an interest in the immunobody platform is interesting. Why partner with iSCIB1+ and your competitors then start licensing/buying the immunobody platform (or flavours there of), when you could just buy the whole lot....hopefully for a decent figure.

Yes! Hopefully soon. Then we have modi results on top

Interesting read - Moderna won’t run Ph3 trials in the US due to increasing vaccine scepticism

https://www.biospace.com/business/moderna-wont-run-phase-iii-vaccine-trials-as-skepticism-grows-in-us-bloomberg

Make it 5830% and you get to the magical £8!

Yes for sure! In a way that does provide us with some insulation.

Interesting write-up about this in the FT. 'EQT’s latest approach follows several deals by global buyout firms to take European public companies private as the industry seeks to profit from the continent’s relatively cheap stocks.' I guess this is a risk that we face on the daily with the current share price.

I popped a few more into my SIPP earlier today - shall be interesting to see how the rest of the week and the coming months play out.

Perfect!

Surely the only appropriate thing to post is a load of rocket emojis?

Phil said they were aiming to submit in December. We are now a week into January without any news.

Do people think we will get an RNS when the FDA submission has occurred? Or only when it’s approved a month later.

Https://carnewschina.com/2025/12/27/china-mandates-no-fire-no-explosion-ev-battery-rule-as-294-national-standards-finalized/

This good news for our Goliath (and Stereax) batteries

Happy Christmas to you all, I wish you the very best for the festive period and for 2026 being the year that we finally get our time in the limelight.

MBUski, if you listen to the most recent investor call, Phil spoke to the delay in Modi results. He said that whilst they had planned on releasing them in Q4, their focus currently is on the SCOPE trial IND and all efforts are going into getting that over the line in December.

He also said that (paraphrasing here), 'there is no point drip feeding results to pharma, because if initial results are not incredibly strong, it doesn't matter if the data then matures over time and gets better with each reported patient, you've already lost their ear'. So he has said that it will come in 2026 when there is a sufficient data package to get pharma interested, rather than releasing an interim update and losing any appetite for it.

An interesting report came out last week from ABPI regarding clinical trials in the UK. I would love to see what the split will be for patient recruitment for the Phase 3 across the US, UK and EU. Whether the focus will be more focussed on the US and Europe. I would assume cost for the US would be higher, though there may be some incentives running trials in the US.

https://www.abpi.org.uk/publications/uk-industry-clinical-trials-translating-actions-into-impact/

Was not expecting that! Seems like they're going for scale.

Oh and also trial design

Phase 3 double blinded, randomised adaptive registration trial.

233 patients per arm, 466 patients total

1:1 randomisation between invesigational arm (iSCIB1+/Ipi/Nivo) and control arm (placebo/Ipi/Nivo)

Stratification factors:

BRAF status: WT/Mutant

Previous adjuvant therapy: Yes or No

No of metastatic lesions: 3

Baseline LDH: 1.5 ULN

Selected product is iSCIB1+

Target polulation is stage 3 and 4 unresectable melanoma

HLA Haplotypes: A2, A3, A31, B35, B44, Bw4

Excludes acral melanoma and active metastasis

Control arm is standard of care ipilimumab and nivolumab

Treatment arm is SoC + iSCIB1+

An interesting investor call. Some snippets - will update when back home later.

- Modi-1 moved back to 2026Q1 - logical reasons behind this. Team focussing on IND filing for iSCIB1+ registration trial and also dont want to drip feed data to pharma. Want to wait till this is mature enough to get interest.

- Good discussions with FDA - IND to be filed before end of year.

- PFS will be the primary end point at the primary analysis point (registration analysis point).

- EMA has agreed to look at FDA minutes

- CMC process has support from FDA but have requested some additional information about the comparability of batches (though they have that infomration so just need to pull that together with no additional work needed)

- FDA happy with 8mg dose (no need to do dose escalation studies as would be required by project optimus)

- No DART study needed (Developmental and Reproductive Toxicology studies)

- Some product has been made which can kick off the study. Early 2026 further manufacturing to be done to enable full clinical trial.

- Off to JPMorgan in san Francisco 2026 for partnering discussions

- Engaging with Large Pharma and also mid-caps for partnering

- Positive with overall data set

- Cohort 4 - primarily stopped to conserved resource. This has saved 6-12 months worth of time to progress. Recruited 31 patients to date. Data still in early stage, have some T-cell data. Reluctant to share data from Cohort 4 - Phil says this could distract from discussions. But may publish in due course once registration trial is going on.

- Data from this has allowed SCLP to decide that the accelerated immunisation protocol will be taken forward.

- Hoping that partnering or going along won't impact timelines. Regulatory filings will help with both partnering and raising finance to go alone.

- 'We are leaning heavily towards partnering the programme working with a partner for the next stage of development and we have had a very broad outreach to the large pharma and mid caps that are working in oncology and melanoma'