Silence Therapeutics Reports First Quarter 2022 Results

Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), 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 reported its financial results for the first quarter ended March 31, 2022 and reviewed recent business highlights.

“The Silence team delivered outstanding results to start 2022, achieving exceptional SLN360 data that were presented as a late breaker at ACC and simultaneously published in JAMA, the most widely circulated medical journal in the world,” said Craig Tooman, President and Chief Executive Officer at Silence. “We also completed enrollment in the SLN124 thalassemia study and advanced our partnered pipeline. We remain focused on strong execution and look forward to demonstrating our progress with several key upcoming milestones anticipated this year.”

First Quarter 2022 Highlights

mRNAi GOLD™ Proprietary Program Updates

SLN360 (cardiovascular disease)

• Reported positive data from the phase 1 APOLLO single-ascending dose study in 32 healthy individuals with high lipoprotein(a) (Lp(a)) a key genetic risk factor for heart disease affecting up to 20% of the world’s population.
• Started dosing in the multiple-ascending dose portion of the phase 1 APOLLO study in patients with high Lp(a) that have a history of stable atherosclerotic cardiovascular disease (ASCVD).

SLN124 (hematological diseases)

• Completed enrollment in the phase 1b GEMINI II single-ascending dose study in thalassemia patients.
• Received FDA orphan drug designation for SLN124 in polycythemia vera (PV).

mRNAi GOLD™ Partnered Program Updates

• Achieved a $3.0 million milestone payment following the submission of the clinical trial application for SLN501, our complement program partnered with Mallinckrodt.

Post Period Highlights

• Detailed results from the SLN360 APOLLO study were presented in a late breaker at the American College of Cardiology (ACC) Annual Scientific Session & Expo and simultaneously published in the Journal of the American Medical Association (JAMA). Key outcomes included:
  • Participants receiving SLN360 300 mg and 600 mg had up to 96% and 98% median reduction in Lp(a) levels, respectively, and median reductions of up to 71% and 81% from baseline persisted at 150 days with no serious safety concerns reported.
  • Extended follow-up to 365 days is ongoing (300 mg and 600 mg cohorts) to further assess the duration of action.
• Achieved a $2.0 million research milestone in our Hansoh Pharma collaboration.

Anticipated Milestones

• Durability data in the SLN360 single-ascending dose study (300 mg and 600 mg cohorts) expected in the third quarter of 2022.
• Topline data in the SLN124 phase 1b single-ascending dose study in thalassemia patients expected in the third quarter of 2022.
• SLN360 phase 2 study in ASCVD patients with high Lp(a) expected to start in the second half of 2022.
• SLN124 phase 1b study in PV patients expected to start in the second half of 2022.

“We continued to execute across our wholly owned and partnered programs in the first quarter of 2022, demonstrating the potential for our proprietary mRNAi GOLD™ platform to address a broad range of genetic diseases,” said Rhonda Hellums, Chief Financial Officer at Silence. “We believe we are well positioned with our advancing clinical pipeline and will continue to prioritize non-dilutive financing options to support further development.”

First Quarter 2022 Financial Results

For the three-month period ending March 31, 2022, the net loss after tax was £7.7 million, or weighted average loss per share of 8.6 pence, compared to £8.4 million, or weighted average loss per share of 9.7 pence, for the same period in 2021. The decrease in net loss was primarily related to increase in revenues from our collaboration agreements as we achieved an additional milestone and continue to further advance the programs.

Revenue

Revenue recognized for the quarter ending March 31, 2022 was £5.7 million, compared to £3.1 million for the quarter ending March 31, 2021. The Company records revenue from collaborations based on percentage of contract completion and the increase was primary a result of the achievement of an additional milestone in the amount of £2.2 million ($3 million) as well as an increase in proportion completion for the services. As these current collaboration programs progress and additional programs are initiated revenues are also expected to increase over time.

Cost of sales

The cost of sales increased for the three months ending March 31, 2022 to £2.3 million from £1.5 million in the period ending March 31, 2021. Cost of sales includes research and development expenditure that is directly related to work carried out on revenue generating contracts. The increase was largely due to the further advancement and initiation of new collaboration programs.

Research and Development

During the period, research and development expenditures were £7.6 million compared to £7.5 million for the same three-month period ending March 31, 2021. The minimal increase was primarily a result of additional personnel costs to expand the internal capabilities and expertise to further advance the Company’s siRNA platform, offset by a decrease in contracted development cost due to completion of studies for SLN360 and SLN124.

General and Administrative

General and administrative expenses increased by £2.0 million to £5.8 million for the three-month period ending March 31, 2022 from £3.7 million for the same corresponding period in 2021. This increase was predominantly related to increase in costs to support requirements for public company compliance and the R&D portfolio, including personnel.

Liquidity, cash and cash equivalents

As of March 31, 2022, the Company had £59.3 million of cash and cash equivalents. The Company also achieved two additional milestones from our existing collaboration agreements totaling $5 million, which are expected to be received during the second quarter of 2022.

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 need. Silence's proprietary mRNAi GOLD™ platform can be used to create siRNAs (short interfering RNAs) that precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. 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 designed to address rare hematological diseases. Silence also maintains ongoing research and development collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals, and Hansoh Pharma, among others. For more information, please visit https://www.silence-therapeutics.com/.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other securities laws, including with respect to the Company’s clinical and commercial prospects, regulatory approvals of the Company’s product candidates, potential partnerships or collaborations or payments under new and existing collaborations, the initiation or completion of the Company’s clinical trials and the anticipated timing or outcomes of data reports from the Company’s clinical trials. These forward-looking statements are not historical facts but rather are based on the Company's current assumptions, beliefs, expectations, estimates and projections about its industry. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including those risks identified in the Company’s most recent Admission Document and its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 17, 2022. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

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