8-K: Silexion Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update

Silexion Therapeutics announced its Q3 2024 financial results, highlighting progress in clinical and preclinical programs and the completion of its Nasdaq listing.

Summary

• Silexion Therapeutics reported its financial results for the third quarter ended September 30, 2024, and provided a business update.
• The company completed its merger with Moringa Acquisition Corp on August 15, 2024, and became a publicly traded company on Nasdaq under the ticker SLXN.
• Silexion's first-generation candidate, LODER, showed a 56% objective response rate in a Phase 2 trial for patients with KRAS G12D/V mutations in pancreatic cancer, with tumor resectability improving to 67% for some non-resectable cases.
• The company's next-generation candidate, SIL-204, demonstrated substantial anti-tumor effects and enhanced stability in preclinical studies, with a single administration yielding tumor necrosis in pancreatic cancer models.
• Silexion is preparing SIL-204 for toxicology studies and plans to initiate Phase 2/3 clinical trials by the first half of 2026, targeting locally advanced pancreatic cancer.
• The company also plans to initiate preclinical studies for SIL-204 in colorectal cancer models.
• Cash and cash equivalents were $2.0 million as of September 30, 2024, compared to $4.6 million as of December 31, 2023.
• Total operating expenses for Q3 2024 were $8.0 million, compared to $0.7 million in the same period of 2023, with research and development expenses at $3.2 million and general and administrative expenses at $4.8 million.
• Financial expenses for Q3 2024 were $3.8 million, compared to $0.1 million in Q3 2023, primarily due to a one-time loss of $4.8 million upon entering transactions.
• The net loss for the third quarter was $11.9 million, up from $0.8 million in the same period of 2023.
• Silexion raised approximately $0.6 million in net proceeds through its Equity Line of Credit (ELOC) agreement during Q3, and a total of $2.5 million through the date of the report.

Sentiment

Score: 5

Explanation: The document presents a mixed picture. While there is positive progress in clinical and preclinical programs, the significant increase in operating expenses and net loss, along with a decrease in cash reserves, tempers the overall sentiment. The company is making progress but is also burning through cash quickly.

Positives

• The merger with Moringa Acquisition Corp and Nasdaq listing provides Silexion with greater access to capital.
• LODER's Phase 2 trial results show a promising 56% objective response rate and improved tumor resectability in pancreatic cancer patients.
• Preclinical studies of SIL-204 demonstrate substantial anti-tumor effects and enhanced stability.
• The company is advancing SIL-204 towards clinical trials with a planned Phase 2/3 trial start by the first half of 2026.
• Silexion is expanding the potential applications of SIL-204 by exploring its use in colorectal cancer.

Negatives

• Cash and cash equivalents decreased from $4.6 million at the end of 2023 to $2.0 million as of September 30, 2024.
• Operating expenses significantly increased to $8.0 million in Q3 2024, compared to $0.7 million in Q3 2023.
• The net loss for the third quarter was $11.9 million, a substantial increase from $0.8 million in the same period of 2023.
• Financial expenses increased significantly due to a one-time loss of $4.8 million upon entering transactions.

Risks

• Silexion's ability to realize the anticipated benefits of the business combination with Moringa may be impacted by competition and operational challenges.
• There are risks related to Silexion's ability to advance its lead programs, including LODER and SIL-204, through clinical development successfully and in a timely manner.
• Changes in regulatory requirements or potential regulatory delays could impact the company's progress.
• The company's ability to maintain and expand its intellectual property portfolio is a risk.
• The availability and terms of additional capital needed to fund ongoing research and development activities and operational expenses is a risk.
• The evolving market for RNA interference (RNAi) therapies and the competitive landscape in oncology pose risks.
• Silexion may not achieve anticipated milestones within expected timelines, including the initiation of Phase 2/3 clinical trials for SIL-204.
• There are risks associated with reliance on third-party manufacturers and collaborators for development and commercialization efforts.
• Uncertainties related to Silexion's ability to meet Nasdaq listing standards exist.

Future Outlook

Silexion is focused on expanding its clinical pipeline to deliver groundbreaking treatments for hard-to-treat cancers, with the goal of having a real impact on patient lives, and plans to initiate Phase 2/3 clinical trials for SIL-204 by the first half of 2026.

Management Comments

• Ilan Hadar, Chairman and CEO of Silexion, stated that the last few months and Q3 specifically has been pivotal for Silexion as they achieved notable progress across their clinical and preclinical programs and successfully completed their Nasdaq listing.
• Hadar also noted that LODER's promising data reinforces the pipeline's potential as a transformative solution for patients with challenging pancreatic cancer.
• Hadar further commented that the recently reported pre-clinical findings underscore the potential to address the complexities of KRAS-driven cancers.

Industry Context

This announcement is relevant to the broader biotech industry, particularly companies focused on developing RNAi therapies for cancer. The progress of Silexion's clinical and preclinical programs, especially in targeting KRAS-driven cancers, is of interest to investors and competitors in the oncology space.

Comparison to Industry Standards

• The 56% objective response rate for LODER in pancreatic cancer patients with KRAS G12D/V mutations is a positive result compared to standard chemotherapy treatments, which typically have lower response rates.
• Companies like Alnylam Pharmaceuticals and Arrowhead Pharmaceuticals are also developing RNAi therapies, but Silexion's focus on KRAS-driven cancers and its specific candidates, LODER and SIL-204, differentiate it in the market.
• The planned Phase 2/3 trial for SIL-204 by the first half of 2026 is a significant milestone, and its success will be compared to other companies' timelines for similar clinical trials.
• The increase in operating expenses and net loss is typical for a clinical-stage biotech company, but the magnitude of the increase will be closely watched by investors.

Related Party Transactions

• Research and development expenses included $1.8 million and $1.8 million from related parties for the nine and three months period ended September 30, 2024, respectively.
• General and administrative expenses included $3.0 million and $2.9 million from related parties for the nine and three months period ended September 30, 2024, respectively.
• Financial expenses included $(0.05) million and $(0.18) million from related parties for the nine and three months period ended September 30, 2024, respectively.

Stakeholder Impact

• Shareholders may be concerned about the increased net loss and decreased cash reserves.
• Employees may be impacted by the company's financial situation and future development plans.
• Patients with KRAS-driven cancers may benefit from the potential of LODER and SIL-204.
• Suppliers and creditors may be impacted by the company's financial performance.

Next Steps

• Silexion is preparing SIL-204 for toxicology studies.
• The company plans to initiate Phase 2/3 clinical trials for SIL-204 by the first half of 2026.
• Silexion plans to initiate preclinical studies for SIL-204 in colorectal cancer models.

Key Dates

Keywords

RNAi, KRAS, cancer, oncology, pancreatic cancer, colorectal cancer, clinical trials, LODER, SIL-204, biotech, pharmaceuticals