SLN.L Regulatory News (SLN)

Silence Therapeutics Announces Business Update

07 January 2020

Technology Evaluation Agreement signed with Takeda to generate siRNA molecules against a specific novel, undisclosed target utilising Silence's proprietary platform technology

First patient dose in SLN124 Phase Ib First-in-Human study expected in Q1 2020 and remains on track to report interim results in H2 2020

Silence to establish a U.S. subsidiary in 2020

Management to host a conference call today at 2pm GMT (details below)

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 provides a business update for the year ended 31 December 2019. Silence will announce audited results for the year ended 31 December 2019 in April 2020.

Partnering and business development

Technology Evaluation Agreement with Takeda

Silence is pleased to announce today that it has entered into a Technology Evaluation Agreement with Takeda to explore the potential of utilising Silence's platform to generate siRNA molecules against a novel, undisclosed target discovered by Takeda. Takeda will provide Silence with single-digit million USD of research funding. Silence and Takeda have further agreed to negotiate the terms of a License Agreement should the initial evaluation study prove successful.

Business Development

RNAi therapeutics are a highly innovative, specific, class of medicines with life-saving potential for patients with serious and rare diseases. The Company is encouraged by the growing prominence of RNAi technology, as evidenced by the approval of Alnylam's Givosiran, and a number of significant partnerships and transactions in the RNAi space, including agreements between Dicerna Pharmaceuticals and Novo Nordisk, the $9.7 billion acquisition of The Medicines Company by Novartis and Silence's own collaboration with Mallinckrodt Pharmaceuticals to develop and commercialise RNAi therapeutics for complement-mediated diseases.

Silence continues to explore multiple opportunities to create shareholder value through significant partnerships with large and established pharmaceutical companies that leverage the Company's proprietary GalNAc-siRNA platform.

Given the increased focus on the U.S., Silence plans to establish a subsidiary in the U.S. during 2020.

Pipeline and clinical development

SLN124

Silence continues to progress SLN124, the Company's wholly-owned lead candidate, towards the clinic. Patients are currently being screened for a Phase Ib First-in-Human study, with six sites already open in the UK, Bulgaria and Turkey. The primary objective of the study is to determine the safety and tolerability of SLN124 for the treatment of non-transfusion dependent β-thalassemia and myelodysplastic syndrome (MDS). Following a recent protocol revision, the first patient is expected to be dosed in Q1 2020, and the Company is on track to report interim results in H2 2020. SLN124 has already been granted Orphan Drug Designation by the European Medicines Agency (EMA), highlighting the potential that this product has to transform the lives of patients.

SLN360

SLN360 is a wholly-owned pre-clinical candidate for the potential treatment of cardiovascular disease. SLN360 silences apolipoprotein (a), a component of lipoprotein(a) ("Lp(a)"), which is a highly validated target based on extensive human genetic data. Elevated Lp(a) levels have been associated with increased risk of cardiovascular disease, independent of additional risk factors. The Company has made significant progress with IND-enabling studies and continues to expect to file an IND/CTA in the second half of 2020. A recent pre-IND meeting was held with the U.S. Food and Drug Administration (FDA) in December 2019. Silence looks forward to progressing this candidate towards the clinic in 2020.

SLN500

SLN500 is being developed in partnership with Mallinckrodt for the treatment of complement-mediated diseases (targeting C3). Silence expects to nominate a lead candidate from the programme in the first half of 2020 and to file an IND/CTA in 2021. The partnership with Mallinckrodt continues to progress according to plan with one milestone payment having already been received and the possibility of further options being exercised in 2020 as part of the License and Collaboration agreement signed in July 2019.

Corporate Developments

People

During 2019 the Company has made several high-profile appointments including Dr. Rob Quinn, Chief Financial Officer, Dr. Giles Campion, Head of Research & Development and Chief Medical Officer, Dr Barbara Ruskin, General Counsel, Dr. John Strafford, Head of Business Development and Jorgen Wittendorff, Head of Manufacturing. Executive Chairman, Iain Ross, is leading the Company on an interim basis following David Horn Solomon's resignation in December as Chief Executive Officer. A search for a new Chief Executive Officer has commenced.

The Company is currently in discussion with several world-leading scientists and clinicians to form a Scientific Advisory Board (SAB). The SAB will be led by Sir Gordon Duff, who has previously served as Chair of the UK's Commission on Human Medicines (CHM), Chair of the Biotechnology and Biological Sciences Research Council (BBSRC) and Chair of the Medicines and Healthcare products Regulatory Agency (MHRA).

Cash

The Company reports an unaudited cash balance at 31 December 2019 of £33.5m. This provides the Company with sufficient cash to fund operations under the current business plan into the second half of 2021.

Iain Ross, Executive Chairman of Silence Therapeutics, said: "The Company has made substantive progress in 2019, cementing its reputation as a leading participant in the burgeoning field of RNAi therapeutics, securing a major deal with Mallinckrodt Pharmaceuticals. We are in our most robust health now, both financially and operationally, and today's agreement with Takeda represents further validation of our technology and capabilities.

In 2020, Silence will look to continue leveraging its expertise to advance its pipeline of new medicines through the clinic to show safety, tolerability and efficacy for patients. In addition, we will continue to explore multiple opportunities to create shareholder value through significant partnerships that leverage the Company's proprietary GalNAc-siRNA platform. With our increased U.S. focus, the Board has taken the decision to establish a U.S. subsidiary in the coming year to improve the Company's visibility and capture value for shareholders by more actively participating in the rapidly expanding field and the world's most significant healthcare market."

J.P. Morgan Healthcare Conference in San Francisco

The Executive Chairman and other members of Silence's senior management team will be in San Francisco between 13-16 January 2020. If you would like to meet a member of the management team, please contact Brandon.weiner@westwicke.com.

Conference call today

Iain Ross, Executive Chairman of Silence Therapeutics, Giles Campion, Head of R&D and Rob Quinn, Chief Financial Officer, will host a conference call for analysts and investors today at 14.00 GMT (09.00 EDT). Dial-in details are: Participant UK dial-in: +44 (0) 8003767922; Participant; US Dial-in: +1 8669661396, Conference ID: 4171977.

For more information, please contact:

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/

The information contained within this announcement is deemed by the Silence Therapeutics plc to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain