BX-U001 / Baylx - LARVOL DELTA

Safety and Efficacy Study of Human Umbilical Cord-Derived Mesenchymal Stem Cells(BC-U001) for Rheumatoid Arthritis (clinicaltrials.gov) - P1/2 | N=9 | Active, not recruiting | Sponsor: Beijing Baylx Biotech Co., Ltd. | Trial completion date: May 2025 ➔ Nov 2025

Trial completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Baylx Inc. | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (clinicaltrials.gov) - P1/2 | N=39 | Not yet recruiting | Sponsor: Baylx Inc. | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Safety and Efficacy Study of Human Umbilical Cord-Derived Mesenchymal Stem Cells(BC-U001) for Rheumatoid Arthritis (clinicaltrials.gov) - P1/2 | N=9 | Active, not recruiting | Sponsor: Beijing Baylx Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2023 ➔ May 2025

Enrollment closed • Trial completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (clinicaltrials.gov) - P1/2 | N=39 | Not yet recruiting | Sponsor: Baylx Inc. | Trial completion date: May 2024 ➔ Feb 2026 | Trial primary completion date: Mar 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Baylx Inc. | Trial completion date: Dec 2024 ➔ Feb 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Baylx Inc. | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Nov 2022 ➔ Dec 2024

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (clinicaltrials.gov) - P1/2 | N=39 | Not yet recruiting | Sponsor: Baylx Inc. | Trial completion date: Mar 2022 ➔ May 2024 | Trial primary completion date: Mar 2022 ➔ Mar 2024

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Safety and Efficacy Study of Human Umbilical Cord-Derived Mesenchymal Stem Cells(BC-U001) for Rheumatoid Arthritis (clinicaltrials.gov) - P1/2 | N=9 | Recruiting | Sponsor: Beijing Baylx Biotech Co., Ltd. | Trial primary completion date: Apr 2022 ➔ Dec 2022

Trial primary completion date • Immune Modulation • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL6

Safety and Efficacy Study of Human Umbilical Cord-Derived Mesenchymal Stem Cells(BC-U001) for Rheumatoid Arthritis (clinicaltrials.gov) - P1/2; N=9; Recruiting; Sponsor: Beijing Baylx Biotech Co., Ltd.

Clinical • New P1/2 trial • Immune Modulation • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL6 • TNFA

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (clinicaltrials.gov) - P1/2; N=39; Not yet recruiting; Sponsor: Baylx Inc.; Trial completion date: Dec 2021 ➔ Mar 2022; Initiation date: Mar 2021 ➔ Jul 2021; Trial primary completion date: Dec 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (clinicaltrials.gov) - P1/2; N=39; Not yet recruiting; Sponsor: Baylx Inc.; Phase classification: P1 ➔ P1/2; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Apr 2021 ➔ Nov 2021

Clinical • Phase classification • Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Preclinical Evaluation of a Single Intravenous Infusion of hUC-MSC (BX-U001) in Rheumatoid Arthritis. (PubMed, Cell Transplant) - "The concentration of (interleukin) IL-6 in TA group was significantly reduced by 80.0% (P < 0.0001) 2 days after treatment and by 93.4% at the experimental endpoint compared with levels prior to hUC-MSC injection. A single intravenous infusion of hUC-MSC (2 × 10 cells/mouse), to CIA-induced DBA/1 J mice, resulted in significant alleviation of RA symptoms and may provide significant therapeutic benefits in humans."

Journal • Preclinical • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology • IL6

BAYLX, INC. Receives US FDA Clearance of COVID-19 IND Application For Umbilical Cord Tissue Mesenchymal Stem Cells Product (Odessa American) - "Baylx, Inc. (Baylx)...announced that the U.S. Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with COVID-19....This Phase 1/2a clinical trial of Baylx will recruit approximately 30 COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS), an acute hypoxemic respiratory failure with high mortality rate."

Cytokine storm • IND • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (clinicaltrials.gov) - P1; N=9; Not yet recruiting; Sponsor: Baylx Inc.; Trial completion date: Dec 2021 ➔ Jun 2021; Initiation date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Dec 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Baylx Inc.; Trial completion date: Sep 2022 ➔ Dec 2022

Clinical • Trial completion date • Immunology • Rheumatoid Arthritis • Rheumatology • CRP

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (clinicaltrials.gov) - P1; N=9; Not yet recruiting; Sponsor: Baylx Inc.

Clinical • New P1 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Baylx Inc.; Trial completion date: Sep 2021 ➔ Sep 2022; Initiation date: Oct 2019 ➔ Oct 2020; Trial primary completion date: Sep 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date