budesonide inhalation solution (AQ001S) / Aquilon - LARVOL DELTA

Late Breaking Abstract - An innovative inhaled solution of budesonide-cyclodextrin complex is safe and prevents the methacholine-induced hyperreactivity in asthmatics better than a commercial budesonide suspension: a breezy story (BOREAS). (ERS 2023) - P1/2 | "Budesonide solution (AQ1001S) is more effective at reducing airway responsiveness than budesonide suspension in patients with mild asthma."

Late-breaking abstract • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2 | N=23 | Completed | Sponsor: Aquilon Pharmaceuticals S.A. | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

SIROCCO-1: Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms (clinicaltrials.gov) - P2 | N=21 | Terminated | Sponsor: Aquilon Pharmaceuticals S.A. | N=99 ➔ 21 | Recruiting ➔ Terminated; Lack of patient to recruit

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease

SIROCCO-1: Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Aquilon Pharmaceuticals S.A. | Trial completion date: May 2022 ➔ Dec 2022 | Trial primary completion date: May 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Aquilon Pharmaceuticals S.A. | Trial completion date: May 2022 ➔ Jan 2023 | Trial primary completion date: May 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

SIROCCO-1: Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Aquilon Pharmaceuticals S.A. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2021 ➔ May 2022 | Trial primary completion date: Dec 2021 ➔ May 2022

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

BORA: Single-dose AQ001S PK Study in Healthy Volunteers (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Aquilon Pharmaceuticals S.A. | Recruiting ➔ Completed | N=20 ➔ 29

Enrollment change • Trial completion

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Aquilon Pharmaceuticals S.A. | Trial completion date: Nov 2021 ➔ May 2022 | Trial primary completion date: Nov 2021 ➔ May 2022

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

BORA: Single-dose AQ001S PK Study in Healthy Volunteers (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Aquilon Pharmaceuticals S.A.

Clinical • New P1 trial

SIROCCO-1: Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms (clinicaltrials.gov) - P2; N=99; Not yet recruiting; Sponsor: Aquilon Pharmaceuticals S.A.; Initiation date: Aug 2021 ➔ Nov 2021

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease • PCR

SIROCCO-1: Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms (clinicaltrials.gov) - P2; N=99; Not yet recruiting; Sponsor: Aquilon Pharmaceuticals S.A.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • PCR

BOREAS: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (clinicaltrials.gov) - P1/2; N=24; Recruiting; Sponsor: Aquilon Pharmaceuticals S.A.; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases