Scancell losses deepen as it presses on with development

(Sharecast News) - Novel immunotherapies developer Scancell Holdings reported a deeper operating loss in its final results on Tuesday, to £6.73m compared to £4.91m in the 2018 financial year.
The AIM-traded firm, which is still pre-revenue, said its development expenses grew to £4.15m from £2.86m in the year ended 30 April, while its administrative expenses were £2.58m, rising from £2.09m.

Its loss before tax totalled £6.71m, widening from the £4.94m it reported in the prior financial year.

On the operational front, Scancell noted that during the year it received regulatory and ethical approval for the UK arm of the 'SCIB1' phase 2 clinical trial.

It also exercised its option to a worldwide commercial licence for the use of Ichor Medical Systems' 'TriGrid 2.0' electroporation delivery system with SCIB1.

Patents were granted in Europe and Japan, providing "broad protection" of ots 'Moditope' technology, with a patent granted in the US that provided protection for 'Modi-1', and a further European patent granted relating to 'FG88' - a monoclonal antibody directed against tumour associated glycans.

The company expanded its strategic research collaboration with the rheumatology unit at the Karolinska Institute, it a bid to explore the potential of Moditope to develop multiple immunotherapeutic agents for a range of different cancers.

Pre-clinical development was underway with Modi-2, the board reported, including progress made in the characterisation of homocitrullinated peptides allowing Modi-2 to potentially address tumours with a particularly immunosuppressive environment.

Dr Samantha Paston had been appointed as head of research, and Dr Adrian Parry was appointed as head of manufacturing.

Additionally, £1.1m was raised in an open offer to shareholders, following a placing of £6.9m at the end of the previous financial year.

Scancell's total loss for the 12-month period was £5.63m, compared to £4.19m a year earlier.

The group had cash balances of £4.56m at year-end, down from £10.30m year-on-year.

Since the period ended, the company had initiated the UK arm of the SCIB1 phase 2 clinical trial in patients with advanced melanoma, also receiving the checkpoint inhibitor pembrolizumab.

Following the withdrawal of the investigational new drug application for the US arm of the study, the firm said it planned to re-submit that to allow for US patient recruitment to proceed in due course.

Gross proceeds of £3.9m were raised by the issue of 77,559,311 new ordinary shares to Vulpes Life Sciences Fund since the year ended as well.

A clinical advisory board had been established, chaired by Professor Robert Coleman, to provide strategic guidance around the Moditope clinical development programme, and Modi-1 manufacturing and toxicity testing was now underway to support the anticipated start of a phase 1 and 2 study in the first half of 2020.

Cancer Research UK was planning a phase 1 and 2 trial to investigate the safety and efficacy of SCIB2 using a new nanoparticle formulation in patients with solid tumours, the board added.

"We have made strong progress this year in advancing our pipeline of novel immunotherapies. Importantly, post period, we were pleased to initiate the UK arm of the SCIB1 Phase 2 trial, whilst disappointed with the need to withdraw our IND application to achieve this," said Scancell chief executive officer Cliff Holloway.

"We intend to resubmit the IND at the earliest opportunity."

Holloway noted the company also expanded its research and development team, and established a clinical advisory board, who would inform the clinical strategy for the planned Modi-1 trial in several solid tumour indications.

"We also welcome Vulpes as a significant shareholder and board member.

"Vulpes' investment into Scancell provides further endorsement of the company's future potential."