Scancell Holdings (SCLP): iSCIB1+ melanoma registration path

This situation live

SCLP Scancell Holdings

£126m · 91.0p · +824% since the first step

7 Nov 2025 · Phase 2 data presented; development accelerated · −2% until the next step Development plans are now accelerated including regulatory and partnering discussions. Randomised studies on the path to registration are anticipated to begin in 2026.

9 Dec 2025 · Regulator feedback aligned; Phase 3 planning, partnering and financing under way · +36% until the next step The feedback received to date supports our plans to move to Phase 3 registrational development with iSCIB1+ with alignment on trial design, dose, manufacturing and progression free survival as the exp

26 Jan 2026 · FDA IND cleared; financing/partnering still open · −3% until the next step Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma

29 Jan 2026 · IND cleared; financing and partnering ongoing · −13% until the next step Subject to financing, we anticipate initiating the global registrational Phase 3 trial later in 2026.

2 Apr 2026 · IND cleared; financing and partnering talks ongoing · +22% until the next step Having David in place enables us to seamlessly advance our constructive financing and partnering discussions on our lead ImmunoBody® iSCIB1+, now with the recently obtained strong regulatory feedback

28 Apr 2026 · IND cleared, Fast Track granted; financing unsecured · +34% until the next step Initiation of the registrational Phase 3 trial with iSCIB1+ in advanced melanoma anticipated in H2 2026

26 Jun 2026 · Financing talks ongoing; still unsecured · −43% until the next step Concurrently, Scancell is in discussions regarding possible equity and debt financing to support a planned global Phase 3 registrational study for its lead asset, iSCIB1+.

23 Jul 2026 · Placing launched; Phase 3 funding still partly unsecured · −10% until the next step The net proceeds of the UK Placing and Retail Offer will enable the Company to continue to prepare for its iSCIB1+ Phase 3 trial, as well as fund the Company's additional pipeline.

23 Jul 2026 · Retail offer launched alongside £9.0m placing · −10% until the next step The result of the Retail Offer is expected to be announced by the Company on or before 7:00 a.m. on 27 July 2026.

23 Jul 2026 · Phase 3 funding path set, conditional · −10% until the next step The equity and debt financing will provide the required capital to conduct the registrational Phase 3 study for iSCIB1+ through key clinical milestones, including the Phase 3 iSCIB1+ primary readout (

23 Jul 2026 · UK Placing upsized to £13.0m; Phase 3 funding conditional · −10% until the next step the Company increased the size of the UK Placing to £13.0 million (approximately $17.4 million), with allocations scaled back due to the level of investor demand.

24 Jul 2026 · Phase 3 funding conditional on US financing · +2% until the next step Private Placement to raise $39.1 million (£29.2 million) through the issue of 324,190,865 new Ordinary Shares (including Ordinary Shares to be represented by ADSs) and Non-Voting Ordinary Shares.

19 Aug 2026 · UK MHRA CTA granted; FDA IND cleared · +900% until the next step Commencement of global registrational Phase 3 trial is expected by the end of 2026 with initial progression-free survival (PFS) data expected in the second half of 2028.

24 Sep 2026 · BlackRock loan signed; EGM approval pending · −3% until the next step Drawdowns under the Loan Facility and the issue of the Warrants are conditional upon shareholder approval at the EGM

9 Oct 2026 · Phase 3 set-up; start later in Q4 2026 · −2% since Scancell expects to initiate its Phase 3 clinical trial later in the fourth quarter of 2026 and to report further PFS data from its Phase 2 SCOPE trial in the first half of 2027.

Project milestones

iSCIB1+ melanoma registration path

Phase 3 set-up; start later in Q4 2026

OCT20 Next: General Meeting to approve BlackRock debt; US$7m drawdown follows

Every step · 15

7 Nov 2025 Phase 2 data presented; development accelerated – Development plans are now accelerated including regulatory and partnering discussions. Randomised studies on the path to registration are anticipated to... ↗
9 Dec 2025 Regulator feedback aligned; Phase 3 planning, partnering and financing under way – The feedback received to date supports our plans to move to Phase 3 registrational development with iSCIB1+ with alignment on trial design, dose,... ↗
26 Jan 2026 FDA IND cleared; financing/partnering still open – Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma ↗
29 Jan 2026 IND cleared; financing and partnering ongoing – Subject to financing, we anticipate initiating the global registrational Phase 3 trial later in 2026. ↗
2 Apr 2026 IND cleared; financing and partnering talks ongoing – Having David in place enables us to seamlessly advance our constructive financing and partnering discussions on our lead ImmunoBody® iSCIB1+, now with the... ↗
28 Apr 2026 IND cleared, Fast Track granted; financing unsecured – Initiation of the registrational Phase 3 trial with iSCIB1+ in advanced melanoma anticipated in H2 2026 ↗
26 Jun 2026 Financing talks ongoing; still unsecured – Concurrently, Scancell is in discussions regarding possible equity and debt financing to support a planned global Phase 3 registrational study for its lead... ↗
23 Jul 2026 Placing launched; Phase 3 funding still partly unsecured – The net proceeds of the UK Placing and Retail Offer will enable the Company to continue to prepare for its iSCIB1+ Phase 3 trial, as well as fund the... ↗
23 Jul 2026 Retail offer launched alongside £9.0m placing – The result of the Retail Offer is expected to be announced by the Company on or before 7:00 a.m. on 27 July 2026. ↗
23 Jul 2026 Phase 3 funding path set, conditional – The equity and debt financing will provide the required capital to conduct the registrational Phase 3 study for iSCIB1+ through key clinical milestones,... ↗
23 Jul 2026 UK Placing upsized to £13.0m; Phase 3 funding conditional – the Company increased the size of the UK Placing to £13.0 million (approximately $17.4 million), with allocations scaled back due to the level of investor demand. ↗
24 Jul 2026 Phase 3 funding conditional on US financing – Private Placement to raise $39.1 million (£29.2 million) through the issue of 324,190,865 new Ordinary Shares (including Ordinary Shares to be represented... ↗
19 Aug 2026 UK MHRA CTA granted; FDA IND cleared – Commencement of global registrational Phase 3 trial is expected by the end of 2026 with initial progression-free survival (PFS) data expected in the second... ↗
24 Sep 2026 BlackRock loan signed; EGM approval pending – Drawdowns under the Loan Facility and the issue of the Warrants are conditional upon shareholder approval at the EGM ↗
9 Oct 2026 Phase 3 set-up; start later in Q4 2026 – Scancell expects to initiate its Phase 3 clinical trial later in the fourth quarter of 2026 and to report further PFS data from its Phase 2 SCOPE trial in... ↗

What is happening

Scancell Holdings: iSCIB1+ melanoma registration path – Phase 3 set-up; start later in Q4 2026. ['Phase 3 set-up; start later in Q4 2026']

In short: Since Nov 2025 Scancell has moved iSCIB1+ towards registration: IND cleared, Fast Track granted, MHRA CTA granted 19 Aug 2026, and BlackRock loan of up to US$25m signed 24 Sep 2026. Results of 9 Oct 2026 confirm CROs engaged and Phase 3 start 'later in Q4 2026'. The loan needs shareholder approval at the 20 Oct GM, with US$7m to be drawn after.
Announced: 7 Nov 2025 · Phase 2 data presented; development accelerated
Latest: 9 Oct 2026 · Phase 3 set-up; start later in Q4 2026
Cost: 10.50% cash interest on term loans; 10.95% capitalised on convertibles; warrants of 4.5% of each drawdown
Repayment: 18-month interest-only, then 24 monthly instalments; repayable in full on change of control
Trial timing: Phase 3 start by end 2026; initial PFS data H2 2028
Next milestone: General Meeting 20 October 2026 to approve the Debt Financing; US$7.0m drawdown follows
Trial start: Phase 3 expected later in Q4 2026; first-site opening awaited for further tranches
Further regulatory: Further regulatory applications expected later in 2026
Data: Further Phase 2 SCOPE PFS data in H1 2027
Debt: Up to US$25m BlackRock loan; US$8m more after Merger, PIPE and first site; 18-month interest-only

What comes next

General Meeting to approve BlackRock debt; US$7m drawdown follows (20 Oct 2026).

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