AB-1002 / Bayer - LARVOL DELTA

GenePHIT: Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Asklepios Biopharmaceutical, Inc. | Trial primary completion date: Dec 2030 ➔ Oct 2026

Gene therapy • Trial primary completion date • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

GenePHIT: Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Asklepios Biopharmaceutical, Inc. | Trial completion date: Dec 2029 ➔ Dec 2030 | Trial primary completion date: Dec 2029 ➔ Dec 2030

Gene therapy • Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

NAN-CS101: NAN-101 in Patients With Class III Heart Failure (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Asklepios Biopharmaceutical, Inc. | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

GenePHIT: Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Asklepios Biopharmaceutical, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

Genephit, A Phase 2 Trial Of Ab-1002 (formerly Nan-101), A Novel Gene Therapy For Congestive Heart Failure (HFSA 2023) - P1 | "Key secondary efficacy endpoints include hospitalizations, ECG assessments, NT-proBNP levels, and safety. Participants will be monitored for an additional 4 years following the 52-week observation period."

Gene therapy • P2 data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure • TNS1

GenePHIT: Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Asklepios Biopharmaceutical, Inc. | Not yet recruiting ➔ Active, not recruiting | Initiation date: Apr 2023 ➔ Sep 2023

Enrollment closed • Gene therapy • Trial initiation date • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

GenePHIT: Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Asklepios Biopharmaceutical, Inc. | Initiation date: Dec 2022 ➔ Apr 2023

Gene therapy • Trial initiation date • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

NAN-CS101: NAN-101 in Patients With Class III Heart Failure (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Asklepios Biopharmaceutical, Inc. | Trial primary completion date: Dec 2021 ➔ Dec 2023

Trial primary completion date • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

GenePHIT: A Phase 2, Adaptive, Double-blinded, Placebo Controlled, Randomized, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Intracoronary Infusion of NAN-101 in Adult Subjects With New York Heart Association (NYHA) Class III Heart Failure and Non-ischemic Cardiomyopathy (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Asklepios Biopharmaceutical, Inc.

New P2 trial • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

GenePHIT, A Phase 2 Trial Of Nan-101, A Novel Gene Therapy For Congestive Heart Failure (HFSA 2022) - "GenePHITwill continue for 52 weeks, at which point outcomes will be assessed. The primary efficacy endpoint will use a modified win ratio defined by a hierarchical evaluation of the following assessments as shown in this order:cardiovascular-related death; functional class; LVEF change from baseline; peak exercise VO2 change from baseline; and 6MWT change from baseline.Secondary efficacy endpoints, including functional status, hospitalizations, echocardiographic assessments, NT-proBNP levels, and quality of life measures will be assessed, as well as safety endpoints."

P2 data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure

A PHASE 2, ADAPTIVE, DOUBLE-BLINDED, PLACEBO CONTROLLED, RANDOMIZED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF INTRACORONARY INFUSION OF NAN-101 IN SUBJECTS WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS III NON-ISCHEMIC HEART FAILURE (HFSA 2021) - "These endpoints include: Primary Efficacy Endpoint • Win Ratio at 52-weeks as defined by hierarchical evaluation of the following assessments in the given order: o 52-week NYHA Classification (Ordinal) o 52-week LVEF change from baseline (Binary, =5% increase) o 52-week Peak VO2 change from baseline (Binary, =5% increase) o Peak VO2 change from baseline (Binary, < 1.5 mL/kg/min increase or <= 1.5 mL/kg/min increase) o Observed and changes from baseline in Peak VO2 assessed by cardiopulmonary exercise testing o Observed and changes from baseline in 6MWT • Physiologic Assessments at baseline, Weeks 4, 12, 24, 36 and 52 o Observed and changes from baseline in Echocardiographic assessments of: a. LVEF − Left ventricular diastolic volume (LVEVD) & left ventricular end diastolic index (LVEDVI); b. Left ventricular end systolic volume (LVESV), & left ventricular end systolic volume index (LVESVI); c. Sphericity index (SpI); d. Global longitudinal strain (GLS) and..."

Clinical • P2 data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Transplantation • TNS1

NAN-CS101: NAN-101 in Patients With Class III Heart Failure (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Asklepios Biopharmaceutical, Inc.; Trial completion date: Jul 2021 ➔ Dec 2024; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure