Member Info for Burble

Some interesting tid-bits dotted through the Q&A part of this presentation.

Scope

‘We have scheduled discussions with US, UK and European regulators, with the intention to initiate a randomised study in 2026… A pre-IND meeting with the US FDA is currently being planned to take place in 2025, alongside regulatory discussions with the UK's MHRA and EMA.’

In parallel to these plans, we are in active discussions with potential partners to find the right development path forward, with timely development and shareholder value in mind.’

This is promising. I’m curious what they mean by partners. Is that Pharma? Or is that manufacturing and clinical trial delivery partners?

‘ Initial clinical data from this cohort is expected towards the end of 2025 and will inform development plans rather than define or delay them.’

Good.

‘ Stability data generated using a GMP batch of SCIB1 demonstrates that the ImmunoBody platform results in a product which remains stable at -20°C for up to seven years.’

Given increasing pressure on Scope 1, 2 and 3 emissions for medicines across the NHS this is really good in comparison to the carbon footprint of mRNA vaccines (especially personalised ones!).

Modi-1.

‘Modi-1 in combination with doublet checkpoint therapy in renal cell carcinoma continues strong recruitment with further data expected in Q4 2025’

Frustrating but I guess Q4 is only a few weeks away.

‘ The Modi-1 formulation has been optimised to support the ongoing clinical trial, streamline future development, and enable scalable production.’

IMHO you wouldn’t be doing that if you didn’t think there was a need. So to me that hints at Modi-1 results looking promising.

GlymAbs

‘ Development of the first Genmab partnered SC129 remains on track with further milestones payments anticipated in the near-term.’

This is good, whilst we know payment isn’t huge or will help increase the cash runway further into 2026 or possibly 2027.

Interesting statement from the Chairman ‘ with the team determined to realise the GlyMab® platform's real value.’ does this hint that more could have been done with the Genmab deals?

Share price

‘As a Board, we recognise the tough macro-environment for biotechnology companies. This has widespread impacts including on our share price.’ Interesting that this is being directly addressed - for me as a shareholder my question is it’s great to acknowledge, but how do we proactively fix that?

‘ Post-period, in September 2025, the Company agreed to the early partial redemption of £1 million of the 3% unsecured CLNs held by funds managed by Redmile Group, LLC (the "Redmile Funds"). The total amount of the CLNs which remains outstanding following the early partial redemption will be £18.2 million.’

Interesting.

Ciaskin, yes you are correct - my apologies. I realise the years are out in my post. It should be 2024-2019 (not the 2025-2020 that I posted). If only this site had an edit button!

Interesting this is earlier still than last year. IMHO results before Modi results later this month (if keeping to deadlines) will give the clinical trial RNS more room to breathe. It’ll be interesting to see how much information on Modi-1 is included in the corporate results.

2025 - 19th September

2024 - 24th September

2023 - 31st October (results debacle that year)

2022 - 28th October

2021 - 29th October

2020 - 16th October

Crusty, I do take your points on board and yes I agree maybe I was too harsh. I would be interested in a parallel universe whether if Phil had been at the helm during the Genmab discussions whether the up front payment would be higher. I guess we will never know - especially given that we would never be privy to what was asked and what data was available. Which is linked into the progress - with progress and data, comes increased value.

I do agree with the lack of product range meaning more eggs in one basket means increased risk. I think where my thought process was going was more around how much time and energy was being spent on SCIB2 and the stuff going on with CRUK, when SCIB1 had basically stalled, Moditope was going on in the background. Then we've had Modi-2 development going on and in-licensing the SNAPVax formulation, whilst Modi-1 progress has been slow. I'm curious how much this was linked to diversifying the product portfolio or how much it was driven by curious minds following new leads.

Then you look at the addition of Glymabs - again, this probably hasn't helped with how the business looks from outsiders. Are they an antibody company (known modality and people understand) or are they a cancer vaccine company (less known modality but getting more traction). Or are they both? I absolutely applaud Phil for splitting off the Glymab side of things. It makes so much sense and should have been done ages ago.

True, hence why I sit tight and hold. I just know I would be out when news lands.

I do wonder whether Phil’s broadcasting (and hopefully sticking to) timelines will help or hinder the share price.

Dracula - I'm happy to give you a few of my thoughts but please do take with a pinch of salt.

1) Right product, wrong time - I think Immunobody was ahead of it's time and the market wasn't really receptive to it.

2) At times a lack of focus - it's great having a diverse portfolio of products, but if none of them are moving towards commercialisation quick enough, you end up constantly needing to dilute to keep the lights on. We see this with many biotech firms, they spend time/money iterating rather than getting a product to market and using the revenue to then start building out further.

3) Additional issues - the Ichor debacle definitely impacted timelines, as did Covid. Whilst we have gleaned some great insight from Covidity which has helped the development of iSCIB1+ and tested new delivery technologies and Avidimab etc I think it may have been a distraction.

4) A lack of business acumen, I definitely think that Phil is demonstrating a step change in the way the organisation is run. He seems more switched on - whether this is because the company is now at a stage when you can be doing interviews etc, or whether it's just his nature. There definitely seems to be a change in the organisation for the better and one I wish had happened years ago.

5) Drug discovery takes time and that takes money. It's a balance of selling out too early and not extracting the value from your assets, vs dragging your heels and somebody else catching Pharma's eye. IMHO I see the perfect storm happening soon - pharma blockbusters coming off patent, cancer vaccines coming into vogue, healthcare costs going up with aging population so looking for cheaper off the shelf medicines, more clinical data etc. It's why I've been invested here for getting on for 15 years or more.

6) AIM unfortunately is renowned for people wanting a quick buck - the ramping and pump and dump crews, we see this with other shares which go through the spikes and crashes. I think a lot of these fundamentally do not care about shares and will bounce between different shares making money (or for some losses) along the way. As such, I think we've always suffered from the fact Biotech is a long term high-risk high reward investment. I know some on here have downsized investments because they've realised there are other gains to make along the way before news lands. So AIM I dont think has done us as much good.

7) UK investment (especially in biotechs) is pretty lousy - I think had we gone through with a NASDAQ listing, I think we would be valued higher or have had less need to continually raise or would have been brought out a while back.

Having said all that, I have enough time to see this through to the end game - whatever and whenever that may be.

Add to this a new network of 18 clinical trial hubs (Commercial Research Delivery Centres) which is being created as part of a £400m investment from Voluntary Branded Medicines Pricing, Access and Growth Scheme. These are to fast-track the development and testing of new medicines within the NHS. So we should see an acceleration of clinical trial activity over the coming years - which would support the next phase of SCOPE, Modi trials and anything else that SCLP would like to do.

What’s Next For The CVLP?

Work is also under way to expand the number of hospitals that are signed up to the CVLP. The aim is to expand the CVLP to include all suitable NHS Trusts, and multiple cancer vaccine and immunotherapy trials covering different tumor groups run by multiple companies.

The CVLP is more suited to Phase II or Phase III trials, as they need more patients, than Phase I trials, which are smaller.

Last month, NHS England announced that BioNTech’s AHEAD-MERIT study of BNT113-01BNT113-01 had become the third cancer vaccine trial to be run through the launch pad – the trial testing BNT122 was the first. Through the initiative, more than 100 patients with advanced head and neck cancer in England are set to be matched to the trials running across 15 NHS hospitals over the next year.

On Aug. 8, the NHS noted that CVLP had already helped refer around 550 patients to trials of vaccines for bowel and skin cancer.

(finished)

Scancell is one of two companies known to be using the NHS launch pad, so far. The other is BioNTech, which is using it to recruit patients into clinical trials for two investigational mRNA cancer vaccines – BNT122 (autogene cevumeran, RO7198457), for colorectal cancer, and BNT113-01, for advanced head and neck cancer.

L’Huillier noted that Scancell was the first British company selected for the CVLP. This “underscores the confidence in our experimental medicines being developed in the SCOPE study, where the data is showing long term immune control of tumors with excellent duration of response and this is translating into superior progression free survival,” he said

The company’s iSCIB1+ is a modified version of SCIB1.

“We recently announced some exciting and positive results showing that by adding SCIB1 or iSCIB1+ to standard of care (checkpoint inhibitors), we enhance efficacy and more importantly durability of responses in patients, and that our therapies are well tolerated,” L’Huillier said. “Initial data for cohort 4, in partnership with CVLP, should be available in Dec 2025.”

The Scancell CEO said that at this stage, “the focus is on late-stage clinical development. We are currently in Phase II with SCIB1 and iSCIB1+ in a number of cohorts (or arms). The objective of the study is translational in nature to identify the key parameters of the Phase II study: which product of the two we should we take forward, which patients should be selected and how do we dose our therapy.”

He believes the CVLP “has the potential to support the clinical development through its broader reach. This also means our therapy, which is demonstrating excellent results in clinical development, would be made available more broadly to NHS patients sooner.”

NHS England is working to ensure there is an integrated infrastructure to support national roll out of new treatments if they prove effective.

(continued)

Scancell has shared positive feedback on its partnership with England’s NHS Cancer Vaccine Launch Pad (CVLP), highlighting how the initiative has successfully accelerated patient recruitment for its advanced melanoma vaccine trial, and signaling that the CVLP is delivering on its promise.

The company has been using the launch pad to recruit patients for SCOPE, a Phase II trial that is testing its second-generation DNA cancer vaccine candidate, iSCIB1+, in patients with advanced unresectable melanoma receiving standard of care immunotherapy treatments.

“For us, the partnership enables faster recruitment because of the greater reach of CVLP to many more hospitals as well as the genomics capacities,” Scancell CEO Phil L’Huillier told the Pink Sheet.

“We hope this will also be the case for larger registrational studies in the future.” Patient recruitment is potentially one of the costliest and least efficient stages of drug development.

The CVLP, launched in May 2024, aims to set the UK at the forefront of cancer research and encourage drug companies to carry out cancer vaccine and other immunotherapy research in the UK with NHS patients.

It is a “match making” service to speed up patient access to clinical trials of cancer vaccines and enable access to patient tissue samples for genetic sequencing. Its scope has been expanded to support other immunotherapy trials as well as cancer vaccines that require molecular or genomic profiling.

L’Huillier said the CVLP was a unique model that had allowed Scancell to “more broadly access hospitals and thereby patients across the UK to participate in the SCOPE study. The patients identified by the CVLP, from up to 50 hospitals, are screened by them and then if suitable they move to one of our 15 clinical centres to be evaluated for the study.”

There are currently 63 NHS hospitals (or 56 NHS Trusts) across England signed up to the CVLP, and drug sponsors that take part in the initiative can expect patients from these hospitals to be signposted to their trials by clinical staff. Through the initiative, people with cancer who are receiving treatment in the NHS in England can be assessed to see if they might be eligible to join a cancer vaccine clinical trial and then referred to a hospital that is running a trial.

(continued)

Jamboian you say a 'lack of activity over the past few months leads me to believe there is nothing on the horizon' - we should have an update on Moditope by the end of the month. If Modi+CPIs look promising, that could be the spark the SP needs. Especially given it would be a first in class and focussing on a common cancer target (meaning plenty of potential revenue streams were it to make it through the various phases of trials and to market).

This is a great example of somebody using AI to generate LinkedIn content and not realising/caring that their AI is hallucinating. If you type in Scancell "blood cancer" into google it gives back an AI summary which is as follows:

Scancell has been working on an innovative immunotherapy for blood cancer, with a milestone reached for the first patient dosed in a Phase 3 trial of their therapy for blood cancers in a development reported in August 2025. While specific details on the type of blood cancer and the drug's mechanism are not provided in the search snippets, the mention of "Scancell's innovative blood cancer therapy" indicates the company is advancing a treatment for this disease.

Key Points

Scancell's Focus:

Scancell is a biotech company focused on immunotherapies, which aim to boost the body's own immune system to fight cancer.

Therapeutic Approach:

The therapy is described as an "innovative blood cancer therapy," and it is expected to be a treatment that works with the immune system.

Clinical Trial Progress:

A significant development was the dosing of the first patient in the Phase 3 trial for this blood cancer therapy in August 2025, indicating progress in clinical development.

If you then look at the reference the google search points to https://patientworthy.com/tag/cancer/#:~:text=ScanCell's%20Skin%20Cancer%20Vaccine%20Shows%20Phase%202%20Promise%2C%20but&text=Milestone%20Reached:%20First%20Patient%20Dosed%20in%20Phase%203%20Trial%20of%20Innovative%20Blood%20Cancer%20Therapy you'll find an article in response to SCLP announcing the Ph2 SCOPE results for melanoma. On the same page, there is another article celebrating the first patient dosed in a phase 3 blood cancer therapy which is in fact itself scraping information from a linked article for Ionis Pharma's Phase 3 trial announcement for the genetic disorder Angelman syndrome which itself is not a blood cancer.

I've not had a chance to look into each point in turn, but T-cypher bio is focussed on solid malignancies and autoimmune and with a quick search I've not been able to identify anywhere on their website where they say they are researching blood cancers.

Safe to say, this person needs to learn how to correctly use AI and not just copy and paste into LinkedIn what has been generated.

The fact markets are closed on Monday, means I don't think it'll be tomorrow. I suspect September is probably more realistic, but yes I agree the new CEO definite seems to understand that markets like clarity and deadlines being hit. So mid- to late-September is also my view.

We find out tomorrow if your prediction is correct Chester! If it is, can I ask you what Friday's lottery numbers will be?

I'm curious whether this is the same person. https://www.thedoctorskitchen.com/podcasts/73-the-cancer-series-3-of-3-my-cancer-journey-with-dr-lauren-macdonald

'...the greatest thing for me was actually finding a girl in Australia who was about six months ahead of me. Our stories are so similar, it's ridiculous. And we still talk now, which is lovely. But she had progressed to stage four about six months or maybe a little bit before me. And then she'd started this amazing new drug, Pembrolizumab, which is an immunotherapy. And she, like me, had been one of the first patients in obviously I was in the UK, she was in Australia, but to get the drug off trial and she'd had a really quick response and she was in remission about four months later. '

'and so I was in this a bit of a sticky position for about three months because the my oncologist at the Royal Marsden just said, look, unfortunately, there is no treatment available at this moment for you. That you are not eligible for any trials and immunotherapy hasn't yet been approved by, well, I think NICE had just approved it, but it hadn't come onto the NHS yet. So he said, hold tight, which are not words you want to hear when you've got stage four cancer. Hold tight, potentially in the new year, the treatment will be available.'

'It really was divine timing that in the January, I was one of the first patients to receive immunotherapy and yeah, I had an amazing response. I think it really helped that I'd had the four months to focus on my gut health prior to starting treatment. And within four or five months, I was no evidence of disease and I just had a scan two weeks ago and that's so I'm now four years NED, which is just amazing.'

If this is the same person, then it suggests she was one of the first patients in the UK to have Pembrolizumab, I would assume around 2016 given this podcast at the link above was from 2020.

;-)

Hey ChickenBee, don't you worry your little head about me. I'm still here, sat in the sidelines with you happily on filter (apart from briefly unfiltering you to see what the drama was about). I've not gone anywhere, I've not sold a single share and don't plan to any time soon. It's obvious that you are craving attention and desperate to have an argument and seem to be getting yourself worked up because you're not getting the drama you so desperately want. But sorry to say it isn't going to be forthcoming from me because you're going back on filter where you will permanently now stay.

Whatever happens, I'm happy to sit back and watch the next few years play out. I'm sorry if it's not what you want, but I have got better things to do than spend my life arguing with people who don't have better things to do with their lives. My suggestion. Go peck some grain or pollinate some flowers or something.

Https://reneweconomy.com.au/fortescue-pulls-plug-on-queensland-green-hydrogen-plant-but-insists-real-zero-target-still-on-track/

Someone needs to point them towards our cracker technology.

Almost 20% more buys than sells today, yet we drop 7.4%