BHT-3021 / Bayhill Therap - LARVOL DELTA

Diabetes AutoimmunitY Withdrawn in Established Patients (DAY) (clinicaltrials.gov) - P2b; N=0; Withdrawn; Sponsor: Tolerion, Inc.; N=216 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN) (clinicaltrials.gov) - P2b; N=0; Withdrawn; Sponsor: Tolerion, Inc.; N=210 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

SUNRISE: Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients (clinicaltrials.gov) - P2; N=78; Active, not recruiting; Sponsor: Tolerion, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

SUNRISE: Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients (clinicaltrials.gov) - P2; N=99; Recruiting; Sponsor: Tolerion, Inc.; Trial primary completion date: Aug 2021 ➔ Mar 2021

Clinical • Trial primary completion date • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Diabetes AutoimmunitY Withdrawn in Established Patients (DAY) (clinicaltrials.gov) - P2b; N=216; Not yet recruiting; Sponsor: Tolerion, Inc.; Trial completion date: May 2023 ➔ Dec 2023; Initiation date: May 2019 ➔ Dec 2019

Trial completion date • Trial initiation date

Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN) (clinicaltrials.gov) - P2b; N=210; Not yet recruiting; Sponsor: Tolerion, Inc.; Trial completion date: May 2023 ➔ Dec 2023; Initiation date: May 2019 ➔ Dec 2019

Trial completion date • Trial initiation date

SUNRISE: Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Tolerion, Inc.; Not yet recruiting ➔ Recruiting; N=51 ➔ 90; Trial completion date: May 2023 ➔ Aug 2023; Trial primary completion date: May 2021 ➔ Aug 2021

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

SUNRISE: Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients (clinicaltrials.gov) - P2; N=51; Not yet recruiting; Sponsor: Tolerion, Inc.

Clinical • New P2 trial

Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN) (clinicaltrials.gov) - P2b; N=210; Not yet recruiting; Sponsor: Tolerion, Inc.; Trial completion date: Jan 2023 ➔ May 2023; Initiation date: Jan 2019 ➔ May 2019; Trial primary completion date: Jan 2021 ➔ May 2021

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

Diabetes AutoimmunitY Withdrawn in Established Patients (DAY) (clinicaltrials.gov) - P2b; N=216; Not yet recruiting; Sponsor: Tolerion, Inc.; Trial completion date: Jan 2023 ➔ May 2023; Initiation date: Jan 2019 ➔ May 2019; Trial primary completion date: Jan 2021 ➔ May 2021

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

Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN) (clinicaltrials.gov) - P2b; N=210; Not yet recruiting; Sponsor: Tolerion, Inc.

Clinical • New P2b trial

Diabetes AutoimmunitY Withdrawn in Established Patients (DAY) (clinicaltrials.gov) - P2b; N=216; Not yet recruiting; Sponsor: Tolerion, Inc.

Clinical • New P2b trial