Scancell Holdings plc (LSE:SCLP) has reported progress across its cancer immunotherapy development programmes and outlined financing arrangements expected to provide approximately $75 million in near-term proceeds, alongside existing cash held by Neuphoria Therapeutics, as it prepares for a proposed Nasdaq listing.
The biotechnology company is advancing its lead cancer vaccine candidate, iSCIB1+, towards a global Phase 3 clinical trial in patients with unresectable Stage IIIB or Stage IV melanoma.
Scancell said iSCIB1+ has received Fast Track designation from the US Food and Drug Administration and regulatory clearance in the UK for the planned Phase 3 study.
The trial is expected to enrol approximately 550 patients across clinical sites in the United States, European Union, United Kingdom, Canada and Australia.
The company is also evaluating a potential randomised Phase 2 study of iSCIB1+ in patients with earlier-stage, resectable melanoma, which would extend its clinical development programme into a different treatment setting.
Alongside its ImmunoBody platform, Scancell continues to develop its Moditope immunotherapy technology through the Modi-1 programme.
Early Phase 2 data from patients with head and neck cancer showed partial responses in three of seven patients evaluated.
The findings represent preliminary clinical observations from a small patient group, with further trial data required to assess the treatment’s efficacy and safety.
Scancell is also investigating Modi-1 in renal cell cancer as part of its broader oncology development activities.
In a separate corporate development, Scancell has agreed an all-share merger with Neuphoria Therapeutics, under which the combined business is expected to pursue a Nasdaq listing under the Scancell name and ticker SCLT.
The proposed transaction forms part of the company’s strategy to expand its presence in the United States and access additional funding for its clinical programmes.
The financing arrangements include a $39.1 million private investment in public equity (PIPE), a £15.7 million UK fundraising and a debt facility of up to $25 million from BlackRock.
Together, the arrangements are expected to provide approximately $75 million in near-term proceeds, in addition to Neuphoria’s existing cash resources.
The company intends to direct the additional funding towards late-stage clinical development, including the planned Phase 3 melanoma study, and the expansion of its US operations.
Scancell also reported an operating loss of £17.4 million for the financial period, representing an increase from the previous reporting period.
The higher operating loss was recorded despite a reduction in research and development expenditure, with administrative expenses increasing partly because of costs associated with the proposed merger.
The company also reported higher finance expenses related to interest and derivative instruments.
Scancell’s near-term development priorities include progressing iSCIB1+ into Phase 3 testing, evaluating additional clinical applications for the treatment and continuing the Modi-1 programme.
The proposed merger, Nasdaq listing and associated financing arrangements are intended to provide additional resources for these activities, subject to completion of the relevant transactions.
About Scancell Holdings
Scancell Holdings plc (LSE:SCLP) is a UK biotechnology company developing active immunotherapies for cancer treatment through its ImmunoBody and Moditope technology platforms.
Its clinical pipeline includes iSCIB1+, a cancer vaccine candidate being developed for advanced melanoma, and Modi-1, which is undergoing clinical evaluation in head and neck cancer and renal cell cancer.
The company is pursuing a proposed merger with Neuphoria Therapeutics and a Nasdaq listing under the ticker SCLT as part of its plans to expand its US presence and fund further clinical development.
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