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Silence Therapeutics Achieves $10 Million Milestone Payment from AstraZeneca Collaboration Following the Initiation of Phase 1 Trial

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Silence Therapeutics (SLN) announces a $10 million milestone payment from AstraZeneca for the initiation of a phase 1 clinical trial under their siRNA collaboration. This marks the first clinical milestone under their partnership and the third program to enter the clinic from their mRNAi GOLD™ platform. The collaboration aims to develop innovative therapies for cardiovascular, renal, metabolic, and respiratory diseases, with potential milestone payments of up to $140 million in development and $250 million in commercialization, along with tiered royalties on net sales.
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The initiation of a phase 1 clinical trial by AstraZeneca for a product candidate from Silence Therapeutics' pipeline is a significant event for stakeholders. The immediate financial implication is the triggering of a $10.0 million milestone payment to Silence, which is a substantial inflow and can be used to further research and development activities. This event is also indicative of the progress within the collaboration, potentially leading to future milestone payments as the candidate advances through the clinical trial phases. The agreement terms, including up to $140 million in development milestones and up to $250 million in commercialization milestones for each target, reflect a substantial future income stream, contingent on clinical success. The tiered royalty structure also suggests a long-term revenue source post-commercialization. Such agreements are vital for biotech companies as they provide financial stability and support through the capital-intensive clinical trial process.

From a medical research perspective, the advancement of Silence's product candidate into phase 1 trials is a testament to the potential of the mRNAi GOLD™ platform and its siRNA therapeutics. Short interfering RNA (siRNA) technology represents a cutting-edge approach in gene silencing, which can be used to selectively turn off genes associated with disease. The progression to clinical trials is a critical step in validating the therapeutic's efficacy and safety in humans. This milestone not only has financial implications but also scientific and medical significance, as it could lead to new treatments for cardiovascular, renal, metabolic and respiratory diseases. The success of this trial may pave the way for further clinical developments and could have a ripple effect on the biotech industry, highlighting the therapeutic potential of gene-silencing technologies.

For the biotechnology sector, collaborative agreements such as the one between Silence Therapeutics and AstraZeneca are instrumental in driving innovation and bringing novel therapies to market. The initiation of the phase 1 clinical trial is a positive signal to the market, potentially increasing investor confidence in Silence's capabilities and the value of its proprietary platform. The focus on a range of diseases, including both rare and common genetic disorders, expands the potential market for these therapies. As such, the successful progression of these trials could position Silence as a key player in the siRNA space, attracting further partnership opportunities and investment. Monitoring the trial's progress and subsequent milestones will be crucial for understanding the long-term market impact and the potential expansion of Silence's therapeutic portfolio.

LONDON--(BUSINESS WIRE)-- Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), an experienced and innovative biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced that the initiation by AstraZeneca of a phase 1 clinical trial of the first product candidate under its siRNA (short interfering RNA) collaboration, has triggered a $10.0 million milestone payment to Silence.

“This represents the first clinical milestone under our collaboration with AstraZeneca and the third program to enter the clinic from our mRNAi GOLD™ platform,” said Craig Tooman, President and CEO of Silence. “This is a very exciting time for Silence as we are beginning to establish ourselves as a platform company progressing multiple clinical programs targeting both rare and common genetic diseases. In addition to this great achievement under our collaboration with AstraZeneca, we are also pleased with the continued advancement of our proprietary pipeline with encouraging clinical data now emerging from our zerlasiran program in high Lp(a) and divesiran program in polycythemia vera.”

“We are pleased to have achieved this important clinical milestone through our collaboration with Silence Therapeutics. Our goal in working together is to advance these novel programs and develop the next wave of innovative therapies that address cardiovascular, renal and metabolic diseases,” said Regina Fritsche Danielson, SVP, Early Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca.

Silence and AstraZeneca initiated a multi-target collaboration in March 2020 focused on using Silence’s proprietary mRNAi GOLD™ platform to develop siRNA therapeutics for cardiovascular, renal, metabolic and respiratory diseases. Under the agreement, AstraZeneca will pay Silence an option fee of $10 million for each selected target at the point of candidate nomination. The deal covers up to ten targets. For each target selected, Silence is eligible for up to $140 million in development milestones and up to $250 million in commercialization milestones as well as tiered royalties on net sales ranging from high single digit to low double digit.

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) (“Lp(a)”) and divesiran designed to address hematological diseases, including polycythemia vera. 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 cash runway and forecast operating cash flow, 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 “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” 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 on March 15, 2023. 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.

Inquiries:

Silence Therapeutics plc

Gem Hopkins, Head of IR and Corporate Communications

ir@silence-therapeutics.com

Tel: +1 (646) 637-3208

Source: Silence Therapeutics plc

FAQ

What milestone payment did Silence Therapeutics (SLN) receive from AstraZeneca?

Silence Therapeutics received a $10 million milestone payment from AstraZeneca for the initiation of a phase 1 clinical trial under their siRNA collaboration.

What is the focus of the collaboration between Silence Therapeutics (SLN) and AstraZeneca?

The collaboration aims to develop siRNA therapeutics for cardiovascular, renal, metabolic, and respiratory diseases using Silence's proprietary mRNAi GOLD™ platform.

What are the potential milestone payments for Silence Therapeutics (SLN) under the agreement with AstraZeneca?

Silence Therapeutics is eligible for up to $140 million in development milestones and up to $250 million in commercialization milestones, along with tiered royalties on net sales ranging from high single digit to low double digit for each selected target.

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About SLN

silence therapeutics develops a new generation of medicines by harnessing the body’s natural mechanism of rna interference, or rnai, within its cells. our proprietary technology can selectively inhibit any gene in the genome, specifically silencing the production of disease-causing proteins. using our enabling delivery systems, we have achieved an additional level of specificity by delivering our 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. for more information, visit us at www.silence-therapeutics.com