Silexion Therapeutics Corp · NASDAQ:SLXN
Silexion Therapeutics — SPAC Merger (July 2024)
24 slides from Silexion Therapeutics's SPAC merger presentation, Jul 25, 2024
Slide 1: Silencing Oncogenes at the Level of Gene Expression
Sile ncing Oncogenes at the Level of Gene Expression Corporate Presentation July 2024 Filed by Moringa Acquisition Corp pursuant to Rule 425 under the Securities Act of 1933 , and deemed filed pursuant to Rule 14 a - 12 under the Securities Exchange Act of 1934 Subject Company: Biomotion Sciences Co
Slide 2: Disclaimer
DISCLAIMER • ABOUT THIS PRESENTATION • This investor presentation (this “Presentation”) is for informational purposes only to assist interested parties in making th eir own evaluation with respect to the proposed business combination (the “Business Combination”) between Moringa Acquisition Cor p (“M
Slide 3: Company Overview
Company Overview Silexion ’s siRNA platform technology is designed to silence oncogenes and prevent the production of the mutated KRAS proteins that drive cancer growth Loder siRNA with an extended - release PLGA delivery system • Completed Phase 2 trial • Results observed a 9.3 - month improvement
Slide 4: Focused Pipeline to Address KRAS-driven Solid Tumor Localized Cancers
Focused Pipeline to Address KRAS - driven Solid Tumor Localized Cancers 4 CTA=clinical trial application; SOC=standard of care. Status/ Anticipated Milestone Phase 3 Phase 2 Phase 1 Preclinical Discovery Setting Indication Program Phase 2 completed: observed 9.3 months improvement with LODER over SO
Slide 5: KRAS Oncogene is a Validated Target for Numerous Cancers
KRAS Oncogene is a Validated Target for Numerous Cancers 5 Prevalence of The Most Common Types of KRAS Mutations Across Cancers CRC=colorectal cancer; LAPC=locally advanced pancreatic cancer; NSCLC=non - small cell lung cancer. Lee, J.K. et al. NPJ Precis Oncol. 2022;6(1):91. PDAC CRC Non - sq NSCLC
Slide 6: Pancreatic Cancer Has One of the Highest Mortality Rates of All Major Cancers
Pancreatic Cancer Has One of the Highest Mortality Rates of All Major Cancers BRPC=borderline resectable pancreatic cancer; LAPC = locally advanced pancreatic cancer. 1. Bray F, et al. CA Cancer J Clin . 2024;74(3):229 - 263. 2. Hirshberg Foundation for Pancreatic Cancer Research. Pancreatic cancer
Slide 7: Treating KRAS the Cancer-Driver at the Source and Site of Action
Treating KRAS the Cancer - Driver at the Source and Site of Action Silexion siRNA technology prevents mutated KRAS from being produced while small molecule inhibitors target the functioning KRAS protein Silencing oncogene at the production stage is potentially more efficient and safe approach to tre
Slide 8: Intratumor siRNA Administration is Advantageous to Systemic Delivery in Solid Tumors
Intratumor siRNA Administration is Advantageous to Systemic Delivery in Solid Tumors Especially Pancreatic x May overcome the limitations of systemic delivery, and allow obtaining higher intratumor concentrations, and better exposure throughout the primary tumor x Can potentially lead to lower syste
Slide 9: KRAS Demographics: KRAS mutations are present in ~92% pancreatic cancer cases
G12D G12V G12C G12A G12R Multiple Other KRAS Demographics KRAS mutations are present in ~92% pancreatic cancer cases 1 LAPC = localized advanced pancreatic cancer; ROW=rest of the world.*Number of KRAS G12D/V mutated LAPC were calculated based on KRAS mutations being present in 92% of pancreatic can
Slide 10: LODER Phase 2 Trial Data
LODER Phase 2 Trial Data
Slide 11: Phase 2 Trial of Loder Completed in 2023 – a Proof-of-Concept
Phase 2 Trial of Loder Completed in 2023 – a Proof - of - Concept Two - part, open label, study of LODER + SoC chemotherapy vs SoC chemotherapy alone across the U.S. and Israel in patients with non - resectable pancreatic cancer SoC=standard of care. Arm 1: LODER + SOC Chemo (n=18) Day 0 Randomizati
Slide 12: Baseline Characteristics and Cohorts Information
Baseline Characteristics and Cohorts Information Due to results of a clinical trial indicating FOLFIRINOX’s advantage over GnP as SoC chemotherapy, cohort 2’s SoC chemotherapy was changed from GnP (used in cohort 1) to FOLFIRINOX. *KRAS mutations were determined in 31 patients in total. In cohort 1
Slide 13: Patients Treated with Loder Bearing KRAS G12D/V Mutation Had 9.3 Months Improvement in Overall Survival
Cohort 1 Patients Treated with Loder Bearing KRAS G12D/V Mutation Had 9.3 Months Improvement in Overall Survival 13 * SoC (Control) OS consistent with recent trials for LAPC ( Gemenetzis G, et al. Ann Surg. 2019;270(2):340 - 347). • A subgroup of subjects with the D or V KRAS mutation, the median OS
Slide 14: Loder Was Overall Well Tolerated
Loder Was Overall Well Tolerated • The Phase 2 PoC c linical trial investigators reported that Loder treatment was well tolerated; Safety events were primarily related to procedure – Intratumor administration of extended - release siRNA via endoscopy (EUS) • N o Treatment Emergent Adverse Events (TE
Slide 15: KRAS G12D/V and KRAS amplification siRNA formulation
SIL - 204 KRAS G12D/V and KRAS amplification siRNA formulation
Slide 16: Leveraging Loder Clinical Data to Further Improve Potential Efficacy and Safety
Leveraging Loder Clinical Data to Further Improve SIL - 204 Potential Efficacy and Safety *EUS endoscopy is a standard procedure used to obtain ultrasound guided biopsies once every 3 months . SIL - 204 LODER ` KRAS G12D/V+ KRAS amplify KRAS G12D/V siRNA target Added hydrophobic lead to increase siR
Slide 17: Inhibited Human Pancreatic Cancer Xenograft Growth in Mice
SIL - 204 Inhibited Human Pancreatic Cancer Xenograft Growth in Mice • p<0.05 • PBS = Control tumors inoculated with PBS buffer; S.C. = sub cutaneous; UT = untreated control. 0.0 50.0 100.0 150.0 200.0 250.0 300.0 350.0 400.0 450.0 500.0 6 7 8 9 10 11 Avg tumor volume (ml) Days Untreated PBS SIL-204
Slide 18: SIL-204 is Stable In Vitro for Over 48 Hours in Human Serum
SIL - 204 is Stable In Vitro for Over 48 Hours in Human Serum siRNA strand placed in human serum and tested for stability Stability of siRNA Strand in Human Serum Potential longer effectiveness of siRNA Greater ability to diffuse throughout the fibrous tumor environment Potential in other indication
Slide 19: SIL-204 is Stable In Vivo in Rats for Five Hours
SIL - 204 is Stable In Vivo in Rats for Five Hours 19 1. Givlaari ( givorisan ). EMA. 2. Alnylam. Givosiran NDA MULTI - DISCIPLINE REVIEW. 3. Lumasiran . Review ( fda.gov ). 4. Lumasiran . Leqvio , INN - inclisiran ( europa.eu ) . 5. Inclisiran . Leqvio , INN - inclisiran ( europa.eu ). 6. Inclisira
Slide 20: Development Strategy in LAPC
SIL - 204 Development Strategy in LAPC 2023 H1 2024 H 1 2025 H 2 2025 H1 2026 Clinical proof of concept for Loder in LAPC in an approvable endpoint for FDA Optimization of siRNA on various fronts; selection of SIL - 204 with new extended - release formulation Received guidance on trial design from t
Slide 21: Phase 2/3 Trial in LAPC: Proposed Study Design
Phase 2 / 3 Trial of SIL - 204 in LAPC: Proposed Study Design Received positive guidance from German regulatory agency on suggested trial design. Arm 1: SIL - 204B + SOC Chemo Arm 2 : SOC Chemo End of Study Day 1 , 2:1 Randomization DSMB ~ 15 subjects for safety following 1 mo. FU If pancreatectomy
Slide 22: World-Renowned Expert Scientific Advisory Board
World - Renowned Expert Scientific Advisory Board Eileen M. O'Reilly, MD Memorial Sloan Kettering, NY, NY Winthrop Rockefeller Endowed Chair of Medical Oncology; Co - Director, Medical Initiatives, David M. Rubenstein Center for Pancreatic Cancer Research; Section Head, Hepatopancreatobi Hana Algul
Slide 23: Highly Experienced Leadership Team
Highly Experienced Leadership Team Ilan Hadar , MBA Chairman and Chief Executive Officer > 25 years of multinational managerial and corporate experience with pharmaceutical and high - tech companies Mitchell Shirvan, PhD, MBA Chief Scientific and Development Officer > 25 years of experience in R&D,
Slide 24: Investment Highlights
Investment Highlights CTA=clinical trial application; IND=investigational new drug. • Clinical - stage company with proprietary oncogene siRNA platform • Intratumor siRNA delivery for pancreatic cancer allow for better drug exposure compared with systemic KRAS inhibitors • Phase 2 clinical trial wit