8-K: Silence Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update; Cash Runway Extended into 2027

Silence Therapeutics announced its full year 2024 financial results, provided a business update, and extended its cash runway into 2027 by prioritizing key programs and seeking a partner for zerlasiran Phase 3 development.

Summary

• Silence Therapeutics reported its financial results for the full year ended December 31, 2024.
• The company's cash guidance is now extended into 2027 due to a decision to only initiate the zerlasiran Phase 3 cardiovascular outcomes study once a partner is secured.
• Silence ended the year with over $147 million in cash, cash equivalents, and short-term investments.
• Collaboration revenue was $43.1 million for the year ended December 31, 2024, compared to $30.9 million for the year ended December 31, 2023.
• Research and development (R&D) expenses were $67.9 million for the year ended December 31, 2024, compared to $56.9 million for the year ended December 31, 2023.
• General and administrative (G&A) expenses were $26.9 million for the year ended December 31, 2024, compared to $26.2 million for the year ended December 31, 2023.
• Net loss was $45.3 million, or $0.33 basic and diluted net loss per share for the year ended December 31, 2024, compared to a net loss of $54.2 million, or $0.49 basic and diluted net loss per share for the year ended December 31, 2023.
• The company anticipates full enrollment in the SANRECO Phase 2 study of divesiran in PV by year-end 2025.
• A Phase 1 study of SLN548, Silences wholly owned siRNA product candidate for complement-mediated diseases, is planned for the second half of 2025.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the extended cash runway, increased collaboration revenue, and reduced net loss. However, the delay in initiating the zerlasiran Phase 3 trial and the termination of the Hansoh Pharma collaboration temper the overall outlook.

Positives

• The company's cash runway is extended into 2027.
• Collaboration revenue increased by $12.2 million year-over-year.
• Net loss decreased from $54.2 million in 2023 to $45.3 million in 2024.
• Positive regulatory feedback received from the FDA, EMA, and PMDA on the Phase 3 cardiovascular outcomes study design for zerlasiran.
• Divesiran has FDA Fast Track and Orphan Drug Designations in PV.

Negatives

• The company will only initiate the zerlasiran Phase 3 cardiovascular outcomes study once a partner is secured.
• Hansoh Pharma opted not to pursue further development under the collaboration agreement to develop siRNAs for three undisclosed preclinical targets.
• The company experienced a net loss of $45.3 million for the year ended December 31, 2024.
• Research and development expenses increased from $56.9 million in 2023 to $67.9 million in 2024.

Risks

• The company's ability to secure a partner for the zerlasiran Phase 3 study is uncertain.
• Clinical trial delays could impact timelines for divesiran and SLN548.
• Competition in the siRNA therapeutics market could affect the company's prospects.
• Unexpected safety or efficacy data observed during clinical trials could impact the development of product candidates.
• Actions of regulatory agencies may affect the initiation, timing and progress of clinical trials or future regulatory approval.

Future Outlook

Silence Therapeutics is prioritizing the development of divesiran in PV and programs in rare conditions with high unmet needs, and extending its projected cash runway into 2027. The company plans to initiate the zerlasiran Phase 3 CVOT study once a partner is secured.

Management Comments

• Craig Tooman, President and CEO of Silence, stated that 2024 was marked by strong clinical execution and pipeline advancement, highlighting the broad potential of their mRNAi GOLD platform.
• Rhonda Hellums, Chief Financial Officer at Silence, noted that the decision not to initiate the zerlasiran Phase 3 outcomes study without a partner extends their projected cash runway into 2027.

Industry Context

Silence Therapeutics is operating in the competitive field of RNA interference (RNAi) therapeutics. The company's focus on rare diseases and cardiovascular conditions aligns with the growing interest in precision medicine and targeted therapies. The decision to seek a partner for the zerlasiran Phase 3 trial reflects the high costs and risks associated with late-stage clinical development in the pharmaceutical industry.

Comparison to Industry Standards

• Alnylam Pharmaceuticals is a leader in the RNAi therapeutics space, with several approved products targeting rare diseases.
• Ionis Pharmaceuticals focuses on antisense oligonucleotide (ASO) therapies, which are similar to siRNA but have different mechanisms of action.
• Silence Therapeutics' collaboration revenue of $43.1 million is relatively modest compared to the multi-billion dollar partnerships that some larger pharmaceutical companies have established in the RNAi field.
• The company's R&D expenses of $67.9 million reflect its commitment to advancing its pipeline, but are lower than those of larger, more established biotech companies.

Stakeholder Impact

• Shareholders may be positively impacted by the extended cash runway and focus on key programs.
• Patients with PV may benefit from the continued development of divesiran.
• Employees may experience job security due to the company's financial stability.

Next Steps

• The company plans to prioritize development of divesiran in PV and programs in rare conditions with high unmet needs.
• Silence intends to secure a partner to fund further clinical development of zerlasiran.
• The company anticipates full enrollment in the SANRECO Phase 2 study of divesiran in PV by year-end 2025.
• A Phase 1 study of SLN548 for complement-mediated diseases is planned for the second half of 2025.
• Phase 1 data from the SANRECO study is anticipated in 2H 2025.

Key Dates