Silence Therapeutics Reports Interim Results for the Six Months Ended 30 June 2020

Silence Therapeutics plc, a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, today announces its unaudited interim results for the half year to 30 June 2020.

Business Highlights for H1 2020

• Continued to advance both wholly owned product candidates, SLN360 for the treatment of cardiovascular disease associated with high Lipoprotein(a), or Lp(a), levels and SLN124 for the treatment of beta-thalassaemia and myelodysplastic syndrome (MDS).
  • SLN124 granted rare paediatric disease designation for beta-thalassaemia and orphan drug designation (ODD) for MDS from the FDA.
• Secured significant collaboration with AstraZeneca to discover and develop siRNA therapeutics for up to 10 targets in cardiovascular, renal, metabolic and respiratory diseases.
  • Upfront cash payment of $60 million and an equity investment of $20 million¹
  • Up to $400 million in potential milestones for each target plus tiered royalties
• Commenced a technology evaluation with Takeda to explore the potential of using Silence’s platform to generate siRNA molecules against a novel, undisclosed and proprietary target controlled by Takeda.
• Further strengthened leadership and expertise with the appointments of Dr Giles Campion, as Executive Director, Dr Eric Floyd, Head of Global Regulatory Affairs and Quality Assurance and Dr Barbara Ruskin, General Counsel and Chief Patent Officer.
• Launched a Scientific Advisory Board (SAB) comprising world-leading scientists and clinicians to support the optimisation of Silence’s siRNA platform and guide development strategies for both wholly owned product candidates, SLN360 and SLN124.

Financial Highlights

• Loss after tax of £11.0 million (H1 2019: £8.2 million), with increase in operating costs compared to H1 2019 driven by increasing R&D spend with both SLN360 and SLN124 being prepared for clinical testing.
• Cash and cash equivalents and term deposits of £50.3 million at 30 June 2020 (31 December 2019 £33.5 million), the increase driven by the upfront cash payment under our collaboration with AstraZeneca.
• Net cash inflow from operating activities was £0.8 million (H1 2019: £10.3 million outflow), again driven by the collaboration with AstraZeneca.

Post Period Events

• Announced today the appointment of Mark Rothera as President and Chief Executive Officer and Board member, effective immediately. Iain Ross, who has been Executive Chairman since December 2019, has assumed his previous position of Non-Executive Chairman.
• Completed U.S. listing and trading in the Company’s American Depository Shares began on the Nasdaq Capital Market (Nasdaq) under the symbol “SLN” on 8 September 2020.
• SLN360 received approval of an IND from the FDA in August 2020 to start dose escalation studies in healthy volunteers and secondary prevention patients with elevated Lp(a).
• SLN124 was granted ODD from the FDA for adults with beta-thalassaemia in July 2020. In September 2020, Silence initiated dosing in its Phase 1 trial of SLN124 in up to 24 healthy volunteers. The Company also plans to evaluate SLN124 in a second Phase 1b study in beta-thalassaemia and MDS patients, pending approval of Clinical Trial Applications.
• Expanded the complement RNAi collaboration with Mallinckrodt. Mallinckrodt exercised its option to license two additional complement protein targets from Silence in July 2020. A $2.0 million research milestone payment was triggered following the initiation of work on the second complement target in August 2020. Silence would be entitled to receive an additional $2.0 million research milestone payment if work commences on a third target in the collaboration.

Iain Ross, Chairman of Silence Therapeutics, commented: “The first half of 2020 was an extraordinary period for Silence, highlighted by significant regulatory achievements, advancement of our proprietary pipeline programmes and execution of major collaborations with AstraZeneca and Takeda, despite the challenges posed by the COVID-19 pandemic. Our balance sheet was significantly strengthened through non-dilutive strategic transactions and our team enhanced with key hires throughout the organisation. 

Recently we announced our successful listing on Nasdaq and today we are announcing the appointment of our new President and CEO, Mark Rothera. I am incredibly proud of what we have achieved so far this year and I believe that under Mark’s leadership we are well equipped to drive long-term value. I would like to thank the entire Silence team for their dedication, resilience and personal support during my time as Executive Chairman and our shareholders for their continued support.”

Enquiries:

Silence Therapeutics plc Iain Ross, Chairman Dr Rob Quinn, Chief Financial Officer	Tel:  +44 (0)20 3457 6900
Investec Bank plc (Nominated Adviser and Broker) Daniel Adams/Gary Clarence	Tel:  +44 (0) 20 7597 5970
European IR Consilium Strategic Communications Mary-Jane Elliott/Chris Welsh/Angela Gray silencetherapeutics@consilium-comms.com	Tel: +44 (0) 20 3709 5700
US IR Westwicke Partners Peter Vozzo peter.vozzo@westwicke.com	Tel: +1 (443) 213-0505

About Silence Therapeutics
Silence Therapeutics is developing a new generation of medicines by harnessing the body’s natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet medical need. Silence’s proprietary technology can be used to engineer short interfering ribonucleic acids (siRNAs) that bind specifically to and silence, through the RNAi pathway, almost any gene in the human genome to which siRNA can be delivered. Silence’s wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of Lipoprotein(a) and SLN124 to address beta-thalassaemia and myelodysplastic syndrome. Silence is also developing SLN500 in partnership with Mallinckrodt Pharmaceuticals to reduce the expression of the C3 protein for the treatment of complement pathway-mediated diseases.  Silence maintains ongoing research and collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals and Takeda. For more information, please visit: https://www.silence-therapeutics.com/

Call for analysts and investors

Iain Ross, Executive Chairman, Mark Rothera, Chief Executive Officer, Dr Rob Quinn, Chief Financial Officer and Dr. Giles Campion, Head of R&D and Chief Medical Officer will host a webcast and live conference call for analysts and investors at 13:00 BST | 08:00 ET today.

Details of the webcast and conference call:

Webcast link: https://edge.media-server.com/mmc/p/8yn44oft

Dial-in Details:
United Kingdom               08002796619
United States                    18778709135
Conference ID                   7577462