Silence Therapeutics: Interim results for the six months ended 30 June 2019

Interim results for the six months ended 30 June 2019

12 September 2019

LONDON, Silence Therapeutics, PLC (LON: SLN) (“Silence” or “the Company”), a leader in the discovery, development and delivery of novel RNA therapeutics for the treatment of serious diseases, today announces its unaudited interim results for the half year to 30 June 2019.

Operational Highlights

• SLN124 Clinical Trial Application, for the treatment of β-thalassemia and myelodysplastic syndrome (MDS), filed in Q1 2019 with first patient dosed expected before year end
• SLN124 granted Orphan Drug Designation by the European Medicines Agency for the treatment of β-thalassemia
• SLN360, an Lp(a)-targeting siRNA for the treatment of cardiovascular disease, entered IND-Enabling studies in February 2019 and is on track for an IND and/or CTA in H2 2020
• SLN500 progressed to non-clinical development (see Post Period Events below)
• Management team strengthened with the addition of Dr. Rob Quinn as Chief Financial Officer and Dr. Giles Campion as Head of R&D and Chief Medical Officer
• Board augmented with the appointment of Iain Ross as Chairman and James Ede-Golightly as Non-Executive Director
• Collaboration with Genomics England to identify novel target genes associated with human disease

Financial Highlights

• Loss after tax of £8.2 million (H1 2018: £8.7 million), with operating costs in H1 2019 driven by increasing R&D spend on SLN124 in preparation to enter the clinic
• Cash and cash equivalents and term deposits of £16.5 million (FY 2018 £26.5 million)
• Net cash outflow from operating activities £10.3 million (H1 2018: £8.8 million)

Post Period Events

• In July 2019, announced a collaboration with Mallinckrodt Pharmaceuticals to develop and commercialise RNAi therapeutics for complement-mediated diseases
  • Agreement provides Mallinckrodt with an exclusive worldwide license for one preclinical asset that targets a specific protein in the complement pathway, C3 (SLN500), and an option for up to two additional assets with different complement protein targets
  • Silence has received a $20 million upfront payment, with potential for near- and long-term development and commercial milestones and royalties on net sales
• Mallinckrodt equity investment of $5 million in exchange for 5,062,167 new ordinary shares
• Cash and cash equivalents and term deposit balance of £36.0 million at 31 August 2019
• Dr. Steven Romano appointed to the Board as Non-Executive Director as part of the equity subscription agreement with Mallinckrodt, and Jørgen Wittendorff appointed to the management team as Head of Manufacturing

Dr. David Horn Solomon, Chief Executive Officer of Silence Therapeutics, commented:
“The first half of 2019 has been transformational for Silence with the game-changing RNAi collaboration with Mallinckrodt reached in July, following months of business development work in H1 – a deal which provided us with a significant cash injection through the upfront and equity investment and provides for significant development and commercial milestones. We have made excellent progress in returning to the clinic with SLN124 and expect to dose our first patient in H2 2019 and we are excited about the potential of this asset to treat patients with serious diseases such as β-thalassemia. We are well capitalised to deliver on our strategic objectives as we continue to drive value for shareholders and offer hope to patients with rare and serious conditions.”

Iain Ross, Chairman of Silence Therapeutics, commented: “We have made significant progress in our three key R&D programmes, secured a major validating partnership with Mallinckrodt, and significantly strengthened our Balance Sheet. The senior management team under the dedicated leadership of David Horn Solomon has been strengthened considerably through key hires and the Board has been revitalised with the appointment of three experienced Directors.

As the new Chairman of Silence, I have been impressed by the dedication of the management team and the innovation shown by the Company’s scientists. I would like to thank the entire Silence team for their ongoing hard work and the shareholders for their continued support. I believe we are now well placed for the future and will continue to execute on our strategic goals in order to drive value for all our stakeholders.”

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About Silence Therapeutics plc

Silence Therapeutics is developing a new generation of medicines by harnessing the body’s natural mechanism of RNA interference, or RNAi, within its cells. Its proprietary technology can selectively inhibit any gene in the genome, specifically silencing the production of disease-causing proteins. Using its enabling delivery systems, it has achieved an additional level of specificity by delivering its therapeutic RNA molecules exclusively to target cells. Silence’s proprietary RNA chemistries and delivery systems are designed to improve the stability of our molecules and enhance effective delivery to target cells, providing a powerful modular technology well suited to tackle life-threatening diseases. Silence Therapeutics remains focused and is determined to be responsive to creating shareholder value as well as the appropriate growth and development of its business. Silence Therapeutics continues to assess a number of options in addition to its organic plan which it believes would be additive to the Company’s future growth prospects and shareholder value, which may include equity fundraisings as well as other strategic licensing and collaboration opportunities.

For more information, please visit: https://www.silence-therapeutics.com/