REGN7508 / Regeneron - LARVOL DELTA

ROXI-CAT-II: Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers (clinicaltrials.gov) - P3 | N=1600 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Cardiovascular • Hematological Malignancies • Oncology • Venous Thromboembolism

ROXI-CAT-I: REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis (clinicaltrials.gov) - P3 | N=860 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Nov 2029 ➔ May 2030 | Trial primary completion date: Jul 2029 ➔ Jan 2030 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Oncology • Solid Tumor • Thrombosis

ASSESSMENT OF GASTROINTESTINAL (GI) BLEEDING VIA FECAL HEMOGLOBIN ANALYSIS AFTER TREATMENT WITH ANTIBODIES TARGETING FACTOR XI VERSUS RIVAROXABAN ON TOP OF BACKGROUND ASPIRIN: RESULTS FROM A PHASE 1 STUDY (ACC 2026) - P=N/A, P1 | "Background: Available anticoagulants effectively treat venous thromboembolism but carry a high bleeding risk, which further increases when combined with antiplatelet therapies (eg, aspirin [ASA]). Addition of Factor XI inhibitors did not increase subclinical GI bleeding vs ASA alone, whereas rivaroxaban + ASA increased bleeding vs ASA alone."

P1 data • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Venous Thromboembolism

TOLERABILITY AND PHARMACODYNAMIC EFFECT OF REGN7508, A MONOCLONAL ANTIBODY DIRECTED AGAINST THE FACTOR XI CATALYTIC DOMAIN: RESULTS FROM A FIRST-IN-HUMAN STUDY (ACC 2026) - P1 | "REGN7508 inhibits the intrinsic coagulation pathway without measurably affecting extrinsic or common pathway activity. REGN7508 was generally well tolerated and may prevent thrombosis without increasing the risk of bleeding."

First-in-human • P1 data • PK/PD data • Back Pain • Cardiovascular • Cough • Hematological Disorders • Inflammation • Musculoskeletal Pain • Respiratory Diseases

R7508-DVT-24116: REGN7508 versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults. (clinicaltrialsregister.eu) - P2/3 | N=1067 | Recruiting | Sponsor: Regeneron Pharmaceuticals Inc.

New P2/3 trial • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

ROXI-INCLINE: Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (clinicaltrials.gov) - P3 | N=2628 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Atrial Fibrillation • Cardiovascular

ROXI-CAT-I: REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis (clinicaltrials.gov) - P3 | N=860 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Cardiovascular • Oncology • Solid Tumor • Thrombosis

ROXI-CATH: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC) (clinicaltrials.gov) - P2 | N=195 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Thrombosis • Venous Thromboembolism

ROXI-PALISADE: Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease (clinicaltrials.gov) - P3 | N=7050 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

Adverse events • New P3 trial • Cardiovascular • Peripheral Arterial Disease

ROXI-ASPEN: REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants (clinicaltrials.gov) - P3 | N=2000 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

ROXI-ATLAS: Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Atrial Fibrillation • Cardiovascular

ROXI-ASPEN: REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants (clinicaltrials.gov) - P3 | N=2000 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

ROXI-ATLAS: Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation (clinicaltrials.gov) - P2 | N=1200 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Atrial Fibrillation • Cardiovascular

ROXI-APEX: REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults (clinicaltrials.gov) - P3 | N=2000 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Jul 2025 | Trial primary completion date: Aug 2025 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date

ROXI-APEX: REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults (clinicaltrials.gov) - P3 | N=2000 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Cardiovascular • Orthopedics • Pain • Venous Thromboembolism

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jul 2025 ➔ Nov 2025 | Trial primary completion date: Apr 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

Regeneron to Advance Two Factor XI Antibodies into a Broad Phase 3 Program Following Positive Phase 2 Proof-of-concept Results (GlobeNewswire) - P2 | N=373 | ROXI-VTE-I (NCT05618808) | P2 | N=179 | ROXI-VTE II (NCT06454630) | Sponsor: Regeneron Pharmaceuticals | "'We are eager to advance REGN7508 and REGN9933 into a broad Phase 3 program beginning in 2025.'...a pooled analysis across both trials showed REGN7508 was superior to enoxaparin and non-inferior to apixaban, and REGN9933 was non-inferior to enoxaparin. All VTE events were asymptomatic, except for one symptomatic case of pulmonary embolism in the apixaban arm...There was no major bleeding (including surgical site bleeding) or clinically relevant non-major bleeding in any arm; the only treatment-related adverse events (AE) in any arm was one case of minimal bleeding (contusion) reported in the enoxaparin arm of ROXI-VTE-I. There were no treatment-related serious AEs (SAEs) in any arm. There were also no AEs in any arm leading to trial discontinuation or dose interruption/modification, and no AEs of special interest or deaths in these trials."

New P3 trial • P2 data • Venous Thromboembolism

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=179 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=224 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder

ROXI-CATH: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC) (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Thrombosis • Venous Thromboembolism

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion

ROXI-VTE II: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Pain • Thrombosis • Venous Thromboembolism