Final Results for the year ended 30 April 2016

Landmark four year survival achieved in resected SCIB1 patients
Emerging pipeline of three products across five cancer indications

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2016.

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  • SCIB1 continues to deliver significant survival data from the Phase 1/2 clinical trial in patients with Stage III/IV melanoma
    • Currently 19 of the 20 patients with resected tumours at study entry remain alive
    • Of the 16 patients who received 2-4mg doses of SCIB1
      • Median observation time since entry is 49 months, a landmark survival milestone
      • Only two new incidences of disease progression have been recorded since December 2013
    • Of the four patients who received 8mg doses of SCIB1
      • Median observation time since entry is 18 months
      • None have progressed and none have died
    • As announced on 17 June 2016, treatment for the eight patients in the long-term continued dosing phase has been suspended due to the clinical trial supplies no longer being within the original specification
    • New SCIB1 material being manufactured to support a new study of SCIB1 in combination with a checkpoint inhibitor will also be made available to these continuation patients (subject to regulatory approval)
    • Plans for the US clinical study of SCIB1 in combination with a checkpoint inhibitor remain on track, enrolment expected to commence in Q3 2017
    • The final Clinical Study Report will be issued later this year and will support our US IND submission
  • Continued progress made in development of lead product, Modi-1, from Moditope® platform
    • Enrolment for first-in-man clinical study in triple negative breast cancer, ovarian cancer and osteosarcoma expected to commence in early 2018
  • Strategic collaboration with Karolinska Institutet to explore the role of citrullination in cancer, a key mechanism underpinning the Moditope® platform
  • £6.2m (£5.8m net) raised through a firm placing and open offer involving both existing and new shareholders
  • John Chiplin appointed Chairman
  • Loss for the year of £2,583,273 (2015: loss £2,414,630)
  • Group cash balance at 30 April 2016 was £6,527,435 (30 April 2015: £3,059,001)

Post Period Highlights

  • Scancell’s executive management team restructured to align expertise with the strategic direction outlined in fundraising
  • Dr Alan Lewis appointed to Board as Non-Executive Director
  • Opening of new offices in San Diego, US and Oxford, UK to support Company’s growth plans

Dr John Chiplin, Executive Chairman of Scancell, said:

“We have continued to make significant progress in the period, both in terms of the maturing clinical data with SCIB1 and further scientific developments on both the ImmunoBody® and Moditope® platforms. We now have a pipeline of three products across five cancer indications and clinical success with any one of these products could transform the value of the business. The Board believes that further clinical studies could add significant value to the Company and is continuing to explore a number of funding options to ensure that the Company has the resources to progress these programmes further.

“Scancell has arrived at an exciting point in its development. We now have the opportunity to transform the business from a small UK-based and largely scientifically-based enterprise into an international force in immuno-oncology. We remain committed to driving this process forward in the US and elsewhere, and to realising the value that has been accumulating over recent years, both for the benefit of our shareholders and cancer patients.”

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO Scancell Holdings Plc +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen(Corporate Banking) Panmure Gordon & Co +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.