Silence Therapeutics Announces First Quarter 2022 Results

LONDON–(BUSINESS WIRE)–Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutic agents for the treatment of diseases with significant unmet medical need, today announced 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 outstanding SLN360 data that was presented as a late break at ACC and concurrently published in JAMA, the world’s most widely circulated medical journal,” said Craig Tooman, President and CEO. at Silence. “We have also completed enrollment in the SLN124 thalassemia study and are advancing our partnership pipeline. We remain focused on strong execution and look forward to demonstrating our progress with several upcoming milestones planned for this year. »

First Quarter 2022 Highlights

Proprietary mRNAi GOLD™ program updates

SLN360 (cardiovascular disease)

  • Reported positive data from the Phase 1 APOLLO single-escalating-dose study in 32 healthy individuals with elevated lipoprotein(a) (Lp(a)), a key genetic risk factor for heart disease affecting up to 20% of the world’s population.

  • Initiation of dosing in the multiple-escalation portion of the Phase 1 APOLLO study in patients with elevated Lp(a) who have a history of stable atherosclerotic cardiovascular disease (ASCVD).

SLN124 (blood diseases)

  • Completion of enrollment in the phase 1b GEMINI II single-escalation study in patients with thalassemia.

  • Received orphan drug designation from the FDA for SLN124 in polycythemia vera (PV).

mRNAi GOLD™ Partner Program Updates

  • Achieved $3.0 million milestone payment following submission of clinical trial application for SLN501, our companion program in partnership with Mallinckrodt.

Highlights after period

  • Detailed results of the SLN360 APOLLO study were presented in a late-breaking paper at the American College of Cardiology (ACC) Annual Scientific Session and Exposition and simultaneously published in the Journal of the American Medical Association (JAMA). Key results included:

    • Participants receiving SLN360 300 mg and 600 mg experienced a median reduction of up to 96% and 98% in Lp(a) levels, respectively, and median reductions of up to 71% and 81% from baseline persisted through 150 days with no reported serious security issues.

    • Extended follow-up to 365 days is in progress (300 mg and 600 mg cohorts) to better assess the duration of action.

  • Achieved $2.0 million research milestone in our collaboration with Hansoh Pharma.

Planned milestones

  • Durability data in the single ascending dose study SLN360 (300 mg and 600 mg cohorts) expected in Q3 2022.

  • Key data from the phase 1b single ascending dose study SLN124 in thalassemia patients expected in Q3 2022.

  • The SLN360 phase 2 study in ASCVD patients with elevated Lp(a) is expected to start in the second half of 2022.

  • The SLN124 Phase 1b study in PV patients is expected to start in the second half of 2022.

“We continued execution of our wholly-owned and partnered programs in the first quarter of 2022, demonstrating the potential of our proprietary GOLD™ mRNA platform to treat a broad spectrum of genetic diseases,” said Rhonda Hellums, Chief Financial Officer of Silence. “We believe we are well positioned with our growing clinical pipeline and will continue to prioritize non-dilutive funding options to support future development.”

First quarter 2022 financial results

For the three-month period ending March 31, 2022, net loss after tax was £7.7m, representing a weighted average loss per share of 8.6p, compared to £8.4m. sterling, representing a weighted average loss per share of 9.7 pence, for the same period in 2021. The decrease in net loss was primarily related to increased revenue from our collaboration agreements as we achieved a milestone additional and continue to move the programs forward.

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 recognizes revenue from collaborations based on the contract completion percentage and the increase is mainly the result of the achievement of an additional milestone of £2.2 million ($3 million) as well as an increase in the proportion of completion of services. As these current collaborative programs progress and additional programs are launched, revenue is also expected to increase over time.

Cost of sales

Cost of sales increased for the three months ending March 31, 2022 to £2.3 million from £1.5 million for the period ending March 31, 2021. Cost of sales includes expenses for research and development that is directly related to work performed on revenue-generating products. contracts. The increase is largely due to the advancement and launch of new collaborative programs.

Research and development

During the period, research and development expenditure was £7.6 million, compared to £7.5 million for the same three-month period ending March 31, 2021. The minimal increase was primarily the result of additional personnel costs to expand in-house capabilities and expertise to advance the Company’s siRNA platform, offset by lower contractual development costs due to the 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 mainly related to increased costs to meet utility requirements. corporate compliance and R&D portfolio, including personnel.

Cash, cash and cash equivalents

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

About Silence Therapeutics

Silence Therapeutics is developing a new generation of drugs by harnessing the body’s natural RNA interference, or RNAi, mechanism to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with a high unmet need. Silence’s proprietary GOLD™ mRNA platform can be used to create siRNAs (short interfering RNAs) that precisely target and silence disease-associated genes in the liver, representing a substantial opportunity. Product candidates 100% owned by Silence include SLN360 designed to address the widespread and high unmet medical need for cardiovascular risk reduction in people born with elevated lipoprotein(a) levels and SLN124 designed to treat rare hematological diseases. Silence also has 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 United States Private Securities Litigation Reform Act of 1995 and other securities laws, including with respect to the Company’s clinical and business prospects, regulatory approvals of the Company’s product candidates, potential partnerships or collaborations or payments in connection with new and existing collaborations, the initiation or completion of the Company’s clinical trials and the timing or anticipated results of trial data reports Company clinics. These forward-looking statements are not historical facts but rather are based on the Company’s current assumptions, beliefs, expectations, estimates and projections regarding 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 differ materially from those expressed or anticipated. in forward-looking statements, including the risks identified in the Company’s most recent admission document and its annual report on Form 20-F filed with the United States Securities and Exchange Commission (the “SEC”) on March 17 2022. The Company cautions securityholders and potential securityholders not to place undue reliance on these forward-looking statements, which reflect the Company’s views only as of the date of this announcement. Forward-looking statements made in this announcement relate only to events as of the date the statements are made. The Company undertakes no obligation to publicly release revisions or updates to these forward-looking statements to reflect unforeseen events, circumstances or developments occurring after the date of this announcement, except as required by law or any applicable regulatory authority. ‘required.

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