Silence Therapeutics Plc Q4 FY2020 earnings call

• In 2020, Silence advanced SLN360 and SLN124 into clinical stages, with SLN360 starting patient dosing in the APOLLO Phase 1 study and SLN124 completing enrollment in the GEMINI I Phase 1 study.
• Landmark deal with AstraZeneca in March 2020 for up to 10 targets, receiving an upfront $20 million and due $40 million in H1 2021. Partnerships with Takeda and Mallinckrodt also advanced.
• Strong financial position with pro forma cash of £97.5 million from Nasdaq listing and collaborations, sufficient to fund key clinical data readouts for SLN360 and SLN124.
• Strengthened team with key appointments in clinical, regulatory, IP, and finance, including adding a world-leading lipidology expert to the Board.
• Aim to file 2-3 IND applications per year from 2023, combining wholly-owned and partnership programs.

In 2020, Silence Therapeutics recorded £5.5 million in revenues compared to £0.2 million in 2019, driven by partnership programs. R&D costs rose to £20.2 million in 2020 from £13.3 million in 2019, primarily due to proprietary program costs for SLN360 and SLN124 and headcount increases. General and administrative costs were £14 million in 2020 versus £9.6 million in 2019, mainly due to Nasdaq listing costs. The net loss for 2020 was £32.5 million vs £19.6 million in 2019. Cash, cash equivalents, and deposits were £37.4 million at the end of 2020, but after a £45 million financing and anticipated AstraZeneca proceeds, the pro forma cash position was £97.5 million.

• Anticipated Phase 1 data readouts from SLN360 (H2 2021) and SLN124 (H1 2021).
• Plan to file 2-3 INDs per year from 2023, combining wholly-owned and partnership programs.
• Pro forma cash position of £97.5 million to fund through key clinical data readouts for SLN360 and SLN124 programs.

• Factors affecting business detailed in SEC prospectus, including risks related to clinical development, regulatory approvals, and market acceptance of product candidates.
• Uncertainties in the success of clinical trials and the timing of regulatory approvals.

Q: Tissue distribution is becoming an emerging theme; what gives confidence your sRNA’s can get to where they need to in the context of your LP(a) and hepcidin programs?

A: Giles Campion stated that GalNAc conjugated sRNA targets hepatocytes where LP(a) gene is located, with less than 1% of peak liver levels in other organs, resulting in restricted distribution and reduced off-target effects.

Q: SLN360 target dosing interval and Phase 1 readout expectations?

A: Giles Campion mentioned the Phase 1 study is designed to show dosing intervals, expecting similar or better intervals to Amgen, with Phase 1 data readout in H2 2021.

Q: In the GEMINI Phase 1 study of SLN124 in healthy volunteers, discuss doses and safety/tolerability translation?

A: Giles Campion said dosing is based on modeling from rodent and beta thalassemia models, with safety/tolerability as primary outcomes, and expected proof-of-principle in healthy volunteers to translate to patient studies.

Q: Update on AstraZeneca collaboration and LP(a) vs LDL cholesterol adverse event comparison?

A: Mark Rothera said AstraZeneca collaboration is on track, with 5 targets underway within 3 years; Giles Campion noted it's difficult to directly compare LP(a) and LDL cholesterol adverse events due to differing demographics.