Silexion Therapeutics Initiates GMP Clinical Batch Manufacturing of SIL204
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 13 2026
0mins
Silexion Therapeutics announced the initiation of good manufacturing practice, or GMP, clinical batch manufacturing of SIL204, the company's siRNA therapy targeting mutated KRAS, in support of the planned upcoming Phase 2/3 clinical trial in locally advanced pancreatic cancer. Additionally, the company announced that it has received approval from the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center for the planned Phase 2/3 trial of SIL204 at its site, a leading Israeli oncology center. The clinical batches currently in production will serve as the investigational medicinal product supply used to treat the first patients to be enrolled in the safety run-in segment of the Phase 2/3 trial. The drug substance for SIL204 was successfully manufactured in 2025 by a specialist global oligonucleotide contract development and manufacturing organization. The drug product, the finished clinical formulation administered to patients, is now being manufactured by Catalent at its facility in Limoges, France.
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Analyst Views on SLXN
Wall Street analysts forecast SLXN stock price to rise
2 Analyst Rating
2 Buy
0 Hold
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Moderate Buy
Current: 4.276
Low
6.00
Averages
9.00
High
12.00
Current: 4.276
Low
6.00
Averages
9.00
High
12.00
About SLXN
Silexion Therapeutics Corp is an Israel-based oncology-focused biotechnology company. The Company is engaged in development of treatments for unsatisfactorily treated solid tumor cancers, which have the mutated KRAS oncogene. The KRAS gene is an oncogene that is involved in regulation of cell division as a result of its ability to relay external signals to the cell nucleus. Based on its research of refractory solid tumor cancers, it is developing a platform focused on the silencing of the KRAS oncogene using ribonucleic acid (RNA)-interference therapeutics. Its lead product candidate, SIL-204B, consists of locally administered small interfering RNAs (siRNA), in an extended-release formulation, as a preferred treatment of locally advanced pancreatic cancer patients, in combination with standard-of-care chemotherapy. Its clinical-stage pipeline is focused on treatment for pancreatic cancer (PC) tumors bearing the KRAS G12D or KRAS G12V mutations where metastases have not been detected.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Par Value Adjustment: Following the reverse split, the par value of ordinary shares will increase from $0.0135 to $0.135 per share, reflecting the company's commitment to shareholder value and compliance in the capital markets.
- Stock Price Reaction: Following the announcement of the reverse split, Silexion Therapeutics' stock price fell by 6.14% to $0.47, indicating that market reactions to this decision may impact investor confidence and future fundraising capabilities.
- Funding Strategy: The company also plans to issue new warrants at $0.50 per share to raise $1 million, a move that will provide necessary liquidity to support its research and operational needs.
See More
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- Clinical Trial Preparation: Silexion plans to initiate its Phase 2/3 trial of SIL204 this quarter, and the reverse split will provide a stronger foundation for market performance to attract more investors and support its clinical execution.
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See More
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See More
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See More
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- Reverse Stock Split Announcement: Silexion Therapeutics has announced a 1-for-10 reverse stock split effective at market close on May 28, 2026, aimed at increasing the share price to comply with Nasdaq's minimum bid price requirement, thereby mitigating delisting risks.
- Par Value Adjustment: Following the reverse split, the par value of ordinary shares will increase from $0.0135 to $0.135 per share, reflecting the company's commitment to shareholder value and compliance in the capital markets.
- Stock Price Reaction: Following the announcement of the reverse split, Silexion Therapeutics' stock price fell by 6.14% to $0.47, indicating that market reactions to this decision may impact investor confidence and future fundraising capabilities.
- Funding Strategy: The company also plans to issue new warrants at $0.50 per share to raise $1 million, a move that will provide necessary liquidity to support its research and operational needs.
See More
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- Reverse Split Implementation: Silexion Therapeutics announced a 1-for-10 reverse stock split effective after market close on May 28, 2026, aimed at increasing the per-share trading price to comply with Nasdaq's minimum bid price requirement, thereby enhancing the company's position in the capital markets.
- Shareholder Impact: Following the reverse split, the par value of ordinary shares will rise from $0.0135 to $0.135, with shareholders not needing to take any action as their share counts will be automatically adjusted, ensuring liquidity and market stability.
- Clinical Trial Preparation: Silexion plans to initiate its Phase 2/3 trial of SIL204 this quarter, and the reverse split will provide a stronger foundation for market performance to attract more investors and support its clinical execution.
- Strategic Growth Support: This reverse split is not only to meet Nasdaq compliance but also enhances the company's flexibility for equity financing, aiding Silexion's innovative development in the treatment of KRAS-driven cancers.
See More
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- Silexion Clinical Progress: Silexion Therapeutics Corp. (SLXN) received approval from the Israeli Ministry of Health to initiate its Phase 2/3 trial for SIL204 in locally advanced pancreatic cancer, with shares rising 96.95% to $0.53, reflecting market confidence in its development prospects.
- Immunovant Positive Data: Immunovant Inc. (IMVT) reported encouraging results from its Phase 2b trial of MVT-1402, with 72.7% of patients showing over 20% symptom improvement after 16 weeks, leading to a 35.26% stock increase to $35.56, indicating strong potential in autoimmune disease treatment.
- Modular Medical Commercialization: Modular Medical Inc. (MODD) received FDA clearance for its next-generation tubeless insulin patch pump, with initial shipments expected by the end of Q2 2026, resulting in an 18.62% stock rise to $3.95, marking a significant step towards commercialization.
See More
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- Earnings Surprise: Silexion Therapeutics reported a Q1 GAAP EPS of -$0.85, beating expectations by $0.44, indicating an improvement in financial performance despite still being in the red.
- Cash Flow Status: As of March 31, 2026, the company's cash and cash equivalents stood at $2.4 million, down from $6.0 million as of December 31, 2025, primarily due to ongoing operating expenses supporting clinical trial preparations, reflecting continued investment in R&D.
- Clinical Trial Readiness: The cash decrease is mainly attributed to preparations for the Phase 2/3 clinical trial of SIL204, demonstrating the company's commitment to advancing critical R&D projects despite facing funding pressures.
- Financing Initiative: Silexion Therapeutics has priced new warrants at $0.50 each to raise $1 million, aiming to bolster liquidity to support its clinical trials and operational needs.
See More
Israeli Ministry Approves Silexion's Clinical Trial for SIL204
- Clinical Trial Approval: On March 24, 2026, the Israeli Ministry of Health approved Silexion's Phase 2/3 clinical trial for SIL204, marking a significant regulatory milestone that enhances the company's competitive position in KRAS-driven cancer treatment.
- Application Submitted in Germany: On April 28, 2026, Silexion submitted a Clinical Trial Application to Germany via the EU Clinical Trials Information System, indicating the company's strategic expansion into the European market, which is expected to accelerate the clinical development of SIL204.
- Trial Initiation Planned: The Phase 2/3 clinical trial for SIL204 is expected to commence in the second quarter of 2026, initially enrolling approximately 18 patients, followed by an expansion to 166 patients, aiming to evaluate its efficacy in combination with standard chemotherapy, potentially offering new treatment options for patients.
- Financial Update: As of March 31, 2026, Silexion reported cash and cash equivalents of $2.4 million, a significant decrease from $6 million as of December 31, 2025, reflecting increased operating expenses associated with preparations for the upcoming clinical trial.
See More
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- Financing Agreement Signed: Silexion Therapeutics announced the signing of an agreement for the immediate exercise of approximately 2 million outstanding warrants at a reduced price of $0.50 per share, expected to raise around $1 million in gross proceeds, enhancing liquidity to support operations.
- New Warrants Issued: As part of the deal, the company will issue approximately 2.05 million Series C warrants and 1.95 million Series D warrants, both priced at $0.50 per share, with Series C warrants expiring in 5 years and Series D in 24 months, providing flexible financing options.
- Shareholder Approval Required: The new warrants will require shareholder approval before they can be exercised, which may affect the timeliness of the transaction and the company's future financing strategy, ensuring shareholder interests are safeguarded.
- Clear Use of Funds: The net proceeds from this financing will primarily be used for working capital and other general corporate purposes, reflecting the company's cautious approach to capital management aimed at supporting its long-term growth strategy.
See More
