Member Info for Bermudashorts

Mayo/TF

Absolutely wasn't intended to be heavy handed on the response and if that's how it came across then many apologies but the implications of what was being suggested in terms of the integrity of the Board was pretty strong too I think.

Mayo,

That's a pretty serious suggestion. IMO the facts around the delays to the publication of the annual report are exactly as stated. For your suggestion to have any truth you would have to believe that Lindy Durrant would lie to shareholders and that BDO would sit back and allow their reputation to be tarnished by those lies. In reality , at the very least BDO would demand that Scancell immediately retract their comments and set the record straight. They also would probably not be prepared to continue to act as Scancell's auditors.

Burble - thanks! Think marcus came up with the same answer on advfn.

TF - just to clarify that Texas Biomedical aren't a biotech, they're a not for profit research institute funded by government grants and public donations (hence the PR). So they're not a commercial organisation.

Violindog,

Yes, it seems to me that the strategy is to complete the current study and quickly follow on with a randomised phase IIb for iSCIB1+. This is the 100 patient trial mentioned by Lindy. Based on the results of that trial I think the intention would be to cut a deal rather than continue to phase III. So I don't think Scancell intend to complete registration studies themselves, nor file for marketing approval. Pure speculation of course, but if Moderna and BioNTech's vaccines continue to do well then the timing would be perfect in terms of optimising the valuation. Much better to license a phase III ready product to a market that has been created for you by your competitors, than a phase IIa that has not been through a randomised study to an emerging but still unproven market. Just as importantly though, the timing fits in nicely with the redemption date of Redmile's CLNs and perhaps this is their planned exit.

I realise that the above won't be popular with some here but it's just my opinion and I may well be wrong. They could decide to try and license at the end of the current study. Time will tell, but it's good to be talking about the possibility of licensing SCIB1.

All of the above with the obvious caveat that we need to see the rest of the current study continue to produce fantastic results.

Have now had a chance to listen to the recording and FWIW these are the points that stood out for me:-

1) Genmab have advised that they intend to take SC129 into clinical trials. It's just over a year since they licensed the mAb and this decision means that it must have performed well in preclinical development. It will be interesting to find out what product they have created and the setting for future trials. It's likely that clearance of an IND (clinical trial approval in the US) and/or first patient dosed will trigger milestone payments. As Lindy has confirmed, it's not going to be enormous, I'd have thought probably similar to the upfront payment, but Genmab's decision to continue development is much more important than just the cash. Plenty of licensing deals fall down at this first hurdle and it was by no means a given that they would go ahead. It's an important endorsement of the platform and the path to future deals with other biopharma companies will be that much easier.

2) Genmab are interested in another mAb

3) The Modi-1 neoadjuvant study was cleared to open for recruitment at the end of July and first patient will be dosed tomorrow. An example of just how long things can take in biotech..

4) When talking about the Modi-1 combination trial, Lindy explained why they can't run an ovarian cohort and that they need to demonstrate synergy in other cancer types. She said they're recruiting for head and neck cancer and then went on to say that they're considering opening a new cohort but I couldn't hear the cancer type - it was ............carcinoma. Did anyone else catch what she said?

5) Good to hear from the new CFO, Sath Nirmalananthan who I thought spoke very well, as did the new Chairman and his comments regarding the future of vaccines was particularly encouraging.

Ciaskin - posts crossed

miavoce - thanks to you too for cleaning up the audio and for the link

WTP - the KOLs are part of Scancell's Clinical Advisory Board. As the name suggests, a CAB is a panel of experts who advise on strategy, design and exectution of clinical trials. Scancell established their CAB back in 2019 - see link below for the members. They've obviously have recently had a meeting to discuss the SCOPE trial.

https://www.lse.co.uk/rns/SCLP/clinical-advisory-board-and-update-on-modi-1-hsxy84fbmswobie.html

Botski,

Haven't had the time to listen yet, but just wanted to say thanks for taking the trouble to record and for generously sharing it..........am sure it's much appreciated by all here.

There was a discussion here way back in May which outlined the history here and the connection with Texas Biomedical. Hopefully this summary will help to clarify matters regarding publication of this research:-

1) June 2021 original Covidity preclinical research published online ahead of peer review as a preprint on bioRxiv.org https://www.biorxiv.org/content/10.1101/2021.06.18.448932v1?versioned=true

2) January 2023 - version 2 of above paper published again as a preprint. This was an updated version to reflect additional data on dosing regimes, immune response analysis AND live virus challenge experiments on animal models carried out by the Texas Biomedical Institute. https://www.biorxiv.org/content/10.1101/2021.06.18.448932v2

3) June 2023 - following peer review the paper was published in Fortune https://www.fortunejournals.com/articles/sarscov2-spike-rbd-and-nucleocapsid-encoding-dna-vaccine-elicits-t-cell-and-neutralising-antibody-responses-that-cross-react-with-.html

All the same research which has evolved as additional analysis and testing has been carried out by Scancell or by Texas Biomedical at the request of Scancell.

Nice find Konar.

Scancell used the Texas Biomedical Research Institute to carry out viral challenge animal experiments for Covidity. During the pandemic Texas Biomed became world leaders in animal testing with live SARS-COV-2 virus. As they had the facilities, animal models and expertise to carry out this work, it makes sense for Scancell to have collaborated with them and use their services for this aspect of the Covidity preclinial testing. The news report in the video was originally screened back in Jan 2022, although it looks like it's only recently been uploaded to youtube.

Ray - completely agree.

Moving on, the link below is to an excellent new report from Stifel 'Why Invest in Biotech?'.

Well worth a read to understand the current landscape, especially the section on valuations but also to appreciate the potential of the sector and the interdependent relationship between pharma and biotechnology companies.

https://www.stifel.com/newsletters/investmentbanking/bal/marketing/healthcare/biopharma_timopler/StifelWhyInvestInBiotech_11.22.2023.pdf

The article doesn't say that this patient is taking part in a clinical trial. It simply seems to be highlighting the efficacy of routine standard of care immunotherapy as well as Clatterbridge's expertise in managing toxicity. In view of the fact that he's receiving treatment after surgery, the dosing regime is 4 weekly and toxicity is an issue, it's possibly the PD-1 checkpoint inhibitor Nivolumab (Opdivo) which is approved in the UK for use in the adjuvant and advanced setting. Whatever it may be, it's wonderful that it's working so well for this patient.

Please ignore post below - it's nonsense (well half nonsense). Just noticed that the SMR abstract was also a LBA. Can only assume that they submitted with an earlier set of data which then allowed the latest data to be presented at SITC (must contain previously unpublished data)

Burble/Johnny,

The abstract sumbission deadline for this presentation was the end of June whereas the SITC poster was a late breaking abstract with a submission deadline of September 6th. If you look at the SITC poster, several patients had only just reached the first imaging point (13 weeks) so would not have been evaluated back in June.

Johnny,

I'm confused - shouldn't those options have expired in July? I know Lindy Durrant's 4.5p options were extended (again) back in July, but there was no mention of Richard's also being extended. So unless I'm missing something, either the dates on the SH01 are incorrect or Richard's were also extended .

BOJO

https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ang-010-inform-study/

Burble - did you used the contact us link on Scancell's website? If so, a while ago it wasn't working so you may need to email someone directly.

Ciaskin - poor show from Consilium

2023 revenue guidance

Merck 2023 $60 billion

BioNTech $4 billion

Moderna $6 billion

Attempting to compare share price of Scancell based on one or two early stage drugs is absolutely meaningless.

We have discussed valuations here many times but never seem to look beyond Scancell in those discussions. Even if you're just invested in the one bio, valuations need to be looked at in the context of the wider market.

We are hopefully getting to the end of one of the deepest and longest biotech downturns. It's not just Scancell and it's not just AIM - take a look at the NASDAQ biotech index which is facing its 3rd straight year of falling returns. Dozens of bios are trading below cash, IPOs are down by over 90% compared to 2021, funding is much harder to come by as generalist funds steer clear and about 30% of bios have less than one years cash. The whole sector has had a torrid time and the companies most affected are those with a market cap below $200m. Instead of covid vaccine trackers we now have biotech layoff trackers. This all against a backdrop of high inflation, high interest rates and economies on the brink of recession.

Unsurprisingly this has a knock-on effect on valuations and Scancell are not alone or immune. This doesn't mean that anyone should dismiss investing in the sector, the slump has forced companies to become more streamlined and commercially focused and to concentrate on the science with the very best chance of success. Companies with genuinely innovative science, creating and developing their own IP may come out of this leaner and more efficient but the lifestyle companies (we all know who they are) may well struggle.

Scancell have all the ingredients, novel products, ongoing trials with the promise of frequent (in bio terms) and positive newsflow and crucially are backed by specialist life science funds who have a deep understanding of the industry.

Don't forget Scancell simply licensed the mAb, Genmab have to carry out all the development work and preclinical testing to create and define a product. Assuming it's successful, they then have to evaluate where it sits in their overall pipeline and strategy and get the budget and approval from heads of R&D to proceed. Then they'll have to go through the usual applications to the regulators for CTA. etc. etc. There's a huge amount of work involved and a year really isn't a long time when it comes to drug discovery and development.