425: Biomotion Sciences Eyes Nasdaq Listing Through Moringa Acquisition Corp Merger, Advancing KRAS-Targeted Cancer Therapies

Biomotion Sciences is set to go public via a merger with Moringa Acquisition Corp, aiming to advance its siRNA platform technology targeting KRAS-driven cancers, with promising clinical data from its lead candidate, SIL-204.

Summary

• Biomotion Sciences is merging with Moringa Acquisition Corp to become a publicly listed company (PubCo) on Nasdaq under the ticker SLXN.
• The company is focused on developing siRNA-based therapies to silence oncogenes, particularly mutated KRAS, which drives cancer growth.
• Their lead candidate, SIL-204, is an optimized version of their Loder siRNA, designed for intratumoral delivery to treat KRAS G12D/V mutations in locally advanced pancreatic cancer (LAPC).
• A Phase 2 trial of Loder showed a 9.3-month improvement in overall survival when combined with chemotherapy compared to chemotherapy alone in patients with KRAS G12D/V mutations.
• SIL-204 has demonstrated improved stability and extended-release properties compared to Loder, potentially leading to better efficacy and safety.
• The company plans to initiate a Phase 2/3 trial of SIL-204 in LAPC in the EU, with a CTA submission expected in late 2025 and trial initiation in 2026.
• Biomotion Sciences has a strong IP portfolio with exclusivity through December 2043, covering siRNA and microparticle technologies.

Sentiment

Score: 7

Explanation: The document presents a positive outlook with promising clinical data and a clear development plan. However, risks associated with clinical development, regulatory approval, and financing temper the overall sentiment.

Positives

• The merger with Moringa Acquisition Corp provides access to public markets and capital to advance clinical development.
• The siRNA platform offers a targeted approach to silencing oncogenes, potentially overcoming limitations of systemic therapies.
• The 9.3-month overall survival improvement in the Loder Phase 2 trial is a promising clinical signal.
• SIL-204's improved stability and extended-release profile could enhance efficacy and reduce systemic toxicity.
• Positive guidance from the German regulatory agency (BfArM) on the SIL-204 Phase 2/3 trial design.
• The strong IP portfolio provides a competitive advantage and long-term market exclusivity.

Negatives

• Silexion is a development-stage company with no history of revenue from product sales and may never be profitable.
• Pubco will need to raise substantial additional funding, which may not be available on acceptable terms, or at all, and which will cause dilution to Pubcos shareholders.
• The approach Silexion is taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products.
• Silexion does not have experience producing its product candidates at commercial levels, currently has no marketing and sales organization, has an uncertain market receptiveness to its product candidates, and is uncertain as to whether there will be insurance coverage and reimbursement for its potential products.

Risks

• The business combination may not be completed.
• The company may not be able to obtain necessary regulatory approvals.
• Clinical trials may not be successful.
• The company may not be able to raise sufficient capital.
• The company may face competition from other therapies.
• The company's IP may be challenged.

Future Outlook

Biomotion Sciences aims to advance SIL-204 through clinical trials and regulatory approval, targeting KRAS-driven cancers, particularly LAPC. The company plans to initiate a Phase 2/3 trial in the EU and is seeking partnerships for GMP production and commercialization.

Industry Context

The focus on KRAS-targeted therapies aligns with a growing interest in precision oncology and addressing previously 'undruggable' targets. Several companies are developing KRAS inhibitors, but Biomotion's siRNA approach offers a unique mechanism of action by silencing the gene at the production stage.

Comparison to Industry Standards

• KRAS G12C inhibitors like sotorasib (Lumakras) and adagrasib (Krazati) have shown efficacy in NSCLC, but their applicability to pancreatic cancer is limited due to the lower prevalence of the G12C mutation.
• Alnylam Pharmaceuticals has pioneered siRNA therapeutics with drugs like Onpattro and Givlaari, demonstrating the potential of this modality.
• The 9.3-month overall survival improvement observed with Loder compares favorably to historical data for LAPC, but further validation in a larger, randomized trial is needed.

Stakeholder Impact

• Shareholders may benefit from the potential value creation through successful clinical development and commercialization.
• Employees may have opportunities for growth and advancement within the company.
• Patients with KRAS-driven cancers may gain access to new and effective treatment options.
• Suppliers and partners may benefit from increased business opportunities.

Next Steps

• Initiate GMP production of final formulation SIL-204.
• Submit CTA in E.U. for Phase 2/3 trial of SIL-204.
• Initiate Phase 2/3 trial of SIL-204 in patients with locally advanced pancreatic cancer in E.U.
• Continue development of SIL-204.

Key Dates

Keywords

siRNA, KRAS, Pancreatic Cancer, SIL-204, Loder, Moringa Acquisition Corp, Biomotion Sciences, Oncogene, Therapeutics, Clinical Trial