Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF), the developer of novel immunotherapies for the treatment of cancer and infectious disease, has reported its financial results for the year ended 30 April 2022 and issued a business update on progress achieved post-period.
In the statement, professor Lindy Durrant, chief executive officer of Scancell, commented: "It has been a year of strong operational and clinical progress for Scancell with three vaccine candidates now in the clinic and the antibody platforms gathering momentum with expanded internal research and external validation.
"We recently initiated Cohort 2 of the Modi-1 clinical trial, the first candidate from our Moditope platform, and anticipate reporting early safety and efficacy data from the ModiFY study in the next 12 months. In addition, we continue to progress SCOPE for SCIB1 and have completed recruitment in our COVIDITY Phase 1 trial in South Africa.
She added: "It has also been a transformational period for our antibody technology, culminating in post-period signing a licensing agreement with Genmab which provides strong commercial validation of the company's scientific approach. Scancell is one of only a few companies globally which has the capability to produce high affinity, humanised anti-glycan antibodies and the board remains excited for what the future holds for this platform.
"We would like to thank shareholders for their continued support in the company and look forward to reporting further progress on the development of our products as we reach several key clinical milestones over the next financial year."
Highlights (including post-period):
Vaccines:
- Approval by the UK's MHRA of the clinical trial application (CTA) for multicentre Modi-1 clinical trial (ModiFY); dosing in Cohort 1 of the study shown to be safe and three patients recruited to Cohort 2
- Expansion of SCIB1 Phase 2 combination trial (SCOPE) to include SCIB1 in combination with checkpoint doublet therapy
- Continued development of iSCIB1+ with additional epitopes and AvidiMab modification to improve potency, utility and patent life of SCIB1; plan to transition the SCOPE trial to this clinical candidate during 2023
- Recruitment completed in COVIDITY Phase 1 clinical trial in South Africa, with safety and immunogenicity data expected in Q1 2023, providing read across to our second-generation ImmunoBody platform
Antibodies:
- All GlyMab anti-glycan monoclonal antibodies (mAbs) successfully humanised and ready for development
- Post-period, signed licensing agreement with Genmab to develop and commercialise an anti-glycan mAb, with the company being eligible to receive milestone payments of up to $208mln for each product developed and commercialised, up to a maximum of $624mln if Genmab develops and commercialises products across all defined modalities. Scancell will also receive low single-digit royalties from Genmab on net sales of all commercialised products.
- AvidiMab technology has been applied to the company's internal programmes to engineer and enhance potency of its anti-glycan antibodies, ImmunoBody cancer products and COVID-19 vaccine candidates. As well as these internal programmes which will validate the technology we are also evaluating how Avidimab can be used to enhance the efficacy of external antibodies.
On the financial front, Scancell's operating loss for the 12-month period to 30 April 2022 was £13.3mln (2021 operating loss: £8.8mln) reflecting the expenditure associated with the company's three ongoing clinical trials.
The group's cash balance as of 30 April 2022 was £28.7mln (30 April 2021: £41.1mln).
In a separate statement, Scancell also announced that it's Annual General Meeting will take place on Monday 21 November 2022 at 2.00pm GMT and will be held at The Caledonian Club, 9 Halkin Street, London, SW1X 7DR.
-- Adds AGM announcement details --