Silence Therapeutics and Mallinckrodt Announce Submission of Clinical Trial Application for SLN501

Silence to receive $3 million research milestone payment from Mallinckrodt

The phase 1 study is expected to start in the first half of 2022

LONDON & DUBLIN–(BUSINESS WIRE)–Silence Therapeutics plc (Nasdaq: SLN), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapies for the treatment of diseases with significant unmet medical need, and Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced the filing of a clinical trial application (CTA) for SLN501, an siRNA targeting the protein C3 complement, triggering a $3 million milestone payment to Silence.

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Craig Tooman, President and CEO of Silence, said: The CTA submission for SLN501 represents another key milestone in our Mallinckrodt collaboration leveraging our proprietary GOLD™ mRNA platform for complement-mediated diseases. This underscores the importance of partnerships to expand our pipeline opportunities while providing non-dilutive funding to support our development activities.

Mark Trudeau, President and CEO of Mallinckrodt, said: “We remain excited about the potential of Silence’s GOLD™ mRNA platform to address the unmet needs of patients suffering from a range of complement-mediated diseases. We look forward to entering the clinic with our first product candidate, SLN501, in the first half of this year, as well as advancing work on two other complementary targets.

As part of this collaboration, Silence is responsible for executing the SLN501 development program through the completion of Phase I, after which Mallinckrodt will assume responsibility for clinical development and global commercialization. The phase I study is expected to start in the first half of 2022.

In July 2019, Silence and Mallinckrodt launched a collaboration focused on leveraging Silence’s proprietary GOLD™ mRNA platform to develop siRNAs for complement-mediated diseases. Under the agreement, Silence received an upfront payment of $20 million from Mallinckrodt for an exclusive worldwide license to siRNAs developed against a complementary target, C3, and options to license siRNAs against up to two additional complementary targets, each exercised by Mallinckrodt in 2021 at $2 million per target. Silence is responsible for preclinical activities and development execution of each target through Phase 1, after which Mallinckrodt will assume responsibility for clinical development and global commercialization. Silence is also eligible to receive double-digit net sales royalties for each product candidate and up to $2 billion in total milestone payments across all three targets.

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/.

About Mallinckrodt
Mallinckrodt is a global company comprised of several wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The segment’s focus areas to feature the Company’s specialty brands include autoimmune and rare diseases in specialty areas such as neurology, rheumatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory intensive care therapies; painkillers; cultured skin substitutes and gastrointestinal products. Its segment to introduce specialty generics includes generic specialty drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.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 clinical and business prospects and expected timing of reports. clinical trial data. These forward-looking statements are not historical facts, but rather are based on current industry expectations, estimates and projections; beliefs; and assumptions. 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 companies’ control, are difficult to predict and could cause results to differ. actual differ materially from those expressed or expressed. provided in the forward-looking statements, including the risks identified from time to time in the Company’s and/or Mallinckrodt’s filings with the United States Securities and Exchange Commission (“SEC”), including in the Company’s most recent admission and its annual report on Form 20-F filed with the SEC on March 17, 2022 and/or Mallinckrodt’s most recent annual report on Form 10-K and other documents filed with the SEC. Each company cautions securityholders and potential securityholders not to place undue reliance on these forward-looking statements, which reflect each 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 companies will undertake 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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