Member Info for ciaskin

Our lead GlyMab® candidate, SC134, has generated strong in vivo data and commercial interest. Positive scientific advice has been received from the FDA and MHRA to support initiation of a Phase 1/2 clinical trial. Scancell also has two active revenue-generating collaborations with Genmab A/S for other candidates under which it expects to receive further milestone payments.

Well done Team Scancell!! Achieving IND approval after only 30 days or so indicates a very smooth passage through FDA, based no doubt on a thoroughly well-prepared and comprehensive submission. No mean feat!

https://www.thefdagroup.com/blog/investigational-new-drug

Well they haven't got long left to submit the IND so it must be imminent for Phil to be so sure. Would the actual submission normally warrant an RNS?

IND submission before year end - BIG tick. Modi data now Q1 - a shame, but delayed for good reasons. Overall, possibly the best investor presentation I've seen from SCLP (in over 12 years!) and both Phil and Nermeen were very impressive.

Dr Heather Shaw, lead for the Medical Oncology Skin Cancer Service at University College London Hospital, London and principal investigator of the SCOPE trial at Mount Vernon Cancer Centre, said: "The prolonged progression free survival demonstrates iSCIB1+ in combination with checkpoint inhibitors has potential to redefine standard of care. This therapy combination increases the number of advanced melanoma patients who would benefit and improves the duration of their clinical response versus equivalent timepoints with checkpoint inhibition alone, thus representing an important step forward for patient outcomes."

Also great to see it's Heather Shaw from UCLH presenting the late beaking abstract at ESMO on Thursday. With all due espect to Nermeen and other staffers within SCLP, it's always stronger to have an independent opinion leader presenting the news - especially one of Heather's calibre.

With an investor presentation on Thursday, I wouldn't rule out another RNS on financing in the next 48 hours ...

Fantastic to see PFS so strong at 74% compared with SOC at 50%. That means 3 out of 4 patients are surviving with the addition of iSCIB1+ compared to 'only' 1 in 2 without. In other words, it's half as many again (48% to be precise). Great work, Team Scancell!!

Professor Caroline Dive, a long term KOL and advocate for Parsortix, is heading up a 3 part Channel 4 documentary. She will be talking about CTCs. A very welcome spotlight, methinks...

https://www.channel4.com/press/news/new-landmark-channel-4-documentary-series-cancer-detectives-finding-cures-will-explore

and:

https://www.proactiveinvestors.com/companies/news/33114/angle-signs-parsortix-research-agreement-with-the-paterson-institute-39438.html

And all over the BBC:

BBC News - Prostate cancer screening urgently needed, says Rishi Sunak

https://www.bbc.com/news/articles/cwykxqerk12o

On Radio 4 Today programme this morning...

Total revenues in H1 2025 increased by 44% to £73.2 million (£73.4 million constant currency) (H1 2024:

£50.8 million), demonstrating continued momentum

• £149 million contracted value of client orders1 signed during H1 2025 (+166% y-o-y, H1 2024: £56 million) reflecting the strong demand for CDMO services and improving long-term revenue visibility

• Significant improvement in profitability, with Operating EBITDA loss of £(8.3) million (£(3.9) million constant currency) (H1 2024: £(20.3) million loss)

• Full year 2025 guidance confirmed: £160-170 million in revenues and low single digit £ million operating EBITDA profitability on a constant currency basis

• Post-period end, re-entered FTSE 250 index in September 2025

Well done Frank and the team!

Now THAT'S a vote of confidence...!

On September 16, 2025, Renalytix PLC announced that UBS Group AG, through UBS AG, crossed a threshold on September 12, 2025, regarding major holdings. UBS AG now holds a total of 16,713,424 voting rights attached to shares, representing 5.046232% of the total voting rights in the issuer. This notification indicates an acquisition of voting rights, as the previous notification showed 0.000000%. The full chain of controlled undertakings shows UBS AG holding 5.046232% of the voting rights.

Don't forget that Phil was Head of Business Development at MSD (aka Merck in US) for 4 years (2017 -2021) so he and Michel will know each other well. Good that Michel approves though and does so publicly. I suspect Phil will be all over MSD/Merck like a rash at the moment ...

Nice mention at end of article

Finally, one that has flown under the radar. Scancell’s prelims brought into focus the significant clinical progress made in the last 12 months, as well as spelling out what investors should expect next.

Its preparations follow encouraging results from its melanoma vaccine trial in July, and Panmure Liberum, its house broker, reckons the next 18 months will be busy.

The house keeps a 'buy' rating and a 32p target, compared with Thursday's 8.45p share price. It argues that the shares already discount much of the risk.

Data from SCOPE and Modi-1, regulatory feedback, a potential partner for iSCIB1+ and progress with GlyMab are all in the diary.

The risk is still high. A randomised trial is expensive and demanding, and further funding will be needed.

But after years of work, Scancell has produced evidence that has convinced its broker to call it a step towards registrational development. The next question is whether it can persuade regulators and partners, too.

https://www.thisismoney.co.uk/money/markets/article-15092075/SMALL-CAP-MOVERS-Lupus-drug-patent-lights-market.html

ANGLE plc announced that Chief Executive Andrew Newland and Finance Director Ian Griffiths have agreed to step down from their positions on the Board following discussions with a significant shareholder. Both Newland and Griffiths intend to support the company with an orderly handover. The Board now consists of Dr. Jan Groen, Non-executive Chairman, and Dr. Joseph Eid, Non-executive Director, with plans to expand the Board in due course.

RNS out...

Earlier still this year, Burble - September 11th.

Genentech now getting cold feet about personalised vaccines? If only there were something more akin to a universal cancer vaccine...

https://www.fiercebiotech.com/biotech/genentechs-summer-struggle-continues-scrapped-2b-cell-therapy-deal