8-K: Silexion Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update

Silexion Therapeutics announces its full year 2024 financial results, highlighting preclinical advancements in its SIL204 program and a strengthened financial position following recent funding.

Summary

• Silexion Therapeutics reported its financial results for the fourth quarter and full year ended December 31, 2024.
• The company completed its business combination with Moringa Acquisition Corp in August 2024, becoming a publicly traded company on Nasdaq under the ticker SLXN.
• The Phase 2 trial of LODER showed a 56% objective response rate (ORR) in patients with KRAS G12D/V mutations, with tumor resectability improving to 67% for some non-resectable cases.
• SIL204 exhibited a marked reduction in tumor growth following systemic administration in preclinical pancreatic cancer models.
• In January 2025, data confirmed that a single systemic dose of SIL-204 maintained effective drug levels for over 56 days.
• March 2025 results confirmed that systemically administered SIL-204 significantly reduced both primary tumor burden and metastatic spread to secondary organs.
• Silexion is preparing SIL204 for toxicology studies, with plans to initiate Phase 2/3 clinical trials by the first half of 2026, targeting LAPC.
• The Company plans to initiate preclinical studies for SIL204 in colorectal cancer models.
• Prof. Amnon Peled was appointed to the Board of Directors in December 2024.
• During 2024, the Company utilized its Equity Line of Credit (ELOC), raising approximately $3.1 million in net proceeds.
• Silexion successfully received further funding through a previously announced priced offering, a warrant inducement transaction, and warrant exercises, together totaling approximately $9.1 million in gross proceeds (approximately $7.9 million net of transaction costs).
• Cash and cash equivalents as of December 31, 2024, were $1.2 million, compared to $4.6 million as of December 31, 2023.
• Total operating expenses for 2024 were $12.6 million, compared to $4.7 million in 2023.
• Net loss for 2024 was $16.5 million, compared to $5.1 million in 2023.

Sentiment

Score: 6

Explanation: The document presents a mixed sentiment. While there are positive developments in the clinical and preclinical pipeline, the financial results show a significant increase in net loss and a decrease in cash position. The company's future prospects are promising, but there are also financial challenges to overcome.

Positives

• Silexion became a publicly traded company on Nasdaq, providing greater access to capital.
• LODER showed promising results in a Phase 2 clinical trial for non-resectable pancreatic cancer.
• SIL204 demonstrated significant preclinical advancements, including tumor growth reduction and long-term drug level maintenance.
• The company is advancing SIL204 towards clinical trials, with plans to initiate Phase 2/3 trials by the first half of 2026.
• Recent financings have strengthened the company's financial position, extending its operational runway.
• Prof. Amnon Peled, a renowned expert in cancer therapeutics, was appointed to the Board of Directors.

Negatives

• Cash and cash equivalents decreased from $4.6 million in 2023 to $1.2 million in 2024.
• Total operating expenses increased significantly from $4.7 million in 2023 to $12.6 million in 2024, including one-time expenses related to the business combination.
• Net loss increased from $5.1 million in 2023 to $16.5 million in 2024, driven by higher operating expenses and one-time financial expenses.

Risks

• The company's ability to successfully complete preclinical studies and initiate clinical trials is subject to risks and uncertainties.
• Silexion's future capital requirements and ability to obtain additional capital are uncertain.
• The company's independent accountants expressed substantial doubt regarding its ability to continue as a going concern in their report on Silexion's 2024 financial statements.
• Regulatory environment and compliance complexities could impact the company's operations.
• Expectations regarding future partnerships or other relationships with third parties may not materialize.

Future Outlook

Silexion is focused on advancing SIL204 towards clinical trials and expanding its potential applications to address unmet needs in oncology, with plans to initiate Phase 2/3 clinical trials by the first half of 2026.

Management Comments

• Ilan Hadar, Chairman and CEO of Silexion, commented: '2024 was a transformative year for Silexion, marked by our Nasdaq listing and the advancement of our clinical and preclinical pipeline.'
• Ilan Hadar stated that the results reinforce SIL204's potential as a novel therapeutic for KRAS-driven cancers.
• Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, commented: 'Our transition to a publicly traded company in 2024 provided critical access to capital that has allowed us to advance our clinical pipeline.'
• Mirit Horenshtein Hadar stated that the recent successful financings reinforce the company's ability to support ongoing and upcoming development initiatives.

Industry Context

Silexion's focus on RNAi therapies for KRAS-driven cancers aligns with the growing interest in targeted therapies for solid tumors. The company's advancements in preclinical studies and plans for clinical trials position it to potentially address a significant unmet need in oncology.

Comparison to Industry Standards

• The 56% objective response rate (ORR) observed in the Phase 2 trial of LODER for non-resectable pancreatic cancer is a promising result compared to historical outcomes for this difficult-to-treat disease.
• Companies like Mirati Therapeutics and Amgen are also developing KRAS inhibitors, but Silexion's RNAi approach offers a different mechanism of action that could provide unique benefits.
• The extended drug levels maintained by SIL-204 for over 56 days following a single systemic dose is a notable achievement compared to other RNAi therapeutics that may require more frequent administration.

Management Changes

Stakeholder Impact

• Shareholders: The company's transition to a public entity and advancements in its pipeline could positively impact shareholder value, but financial losses and going concern doubts could negatively impact shareholder value.
• Employees: The company's growth and development of new therapies could create opportunities for employees.
• Patients: Successful development of SIL204 and LODER could provide new treatment options for patients with KRAS-driven cancers.
• Creditors: The company's financial position and ability to raise capital could impact its ability to meet its obligations to creditors.

Next Steps

• Prepare SIL204 for toxicology studies.
• Initiate Phase 2/3 clinical trials for SIL204 by the first half of 2026, targeting LAPC.
• Initiate preclinical studies for SIL204 in colorectal cancer models.

Key Dates