sodium nitrite (RESP301) / 30 Technology - LARVOL DELTA

Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis (clinicaltrials.gov) - P2 | N=20 | Terminated | Sponsor: Thirty Respiratory Limited | N=75 ➔ 20 | Trial completion date: Jul 2025 ➔ Mar 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2025 ➔ Jul 2024; Decision was made by the sponsor not to progress to Stage 2

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

PROTECT-Surg: Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 (clinicaltrials.gov) - P3 | N=6400 | Suspended | Sponsor: University of Birmingham | Trial completion date: May 2026 ➔ Mar 2027 | Not yet recruiting ➔ Suspended | Trial primary completion date: May 2022 ➔ Dec 2026

Trial completion date • Trial primary completion date • Trial suspension • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CORVIS: COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2 (clinicaltrials.gov) - P2 | N=88 | Terminated | Sponsor: Thirty Respiratory Limited | N=39 ➔ 88

Enrollment change • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: Thirty Respiratory Limited | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2024 ➔ Apr 2025

Enrollment closed • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

NOMAB: Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus (clinicaltrials.gov) - P2 | N=6 | Terminated | Sponsor: Papworth Hospital NHS Foundation Trust | N=12 ➔ 6 | Trial completion date: Oct 2024 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2024 ➔ Jan 2024; TSC recommended early termination due to lack of futility of the trial.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT) (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Thirty Respiratory Limited | N=600 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: Thirty Respiratory Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: Thirty Respiratory Limited

New P2 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

CORVIS: COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2 (clinicaltrials.gov) - P2 | N=39 | Terminated | Sponsor: Thirty Respiratory Limited | N=150 ➔ 39 | Suspended ➔ Terminated; Study stopping criteria were met. A safety event has occurred which was classified as an SAE and was related to the study intervention.

Enrollment change • Trial termination • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

NOMAB: Phase II Open Label Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Papworth Hospital NHS Foundation Trust | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Oct 2024 | Trial primary completion date: Oct 2022 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

30 Technology’s Clinically Validated Antimicrobial Nitric Oxide Platform Acquired by Convatec Group Plc for Several Applications (GlobeNewswire) - "Strategic divestment of wound care division validates 30 Technology’s world-leading proprietary Nitric Oxide (NO) technology...The sale encompasses all wound care assets, research and development and commercial applications of the technology related to the topical treatment of chronic and acute wounds, burns, and tissue repair. 30 Technology retains the rights to, and will continue to develop products for respiratory medicine, animal health, oral surgery, rare diseases and ophthalmology indications, each of which represent billion-dollar opportunities. Divestment enables 30 Technology to accelerate the development of its innovative and differentiated NO platform, with lead respiratory products already in Phase II trials for cystic fibrosis (CF) and bronchiectasis (NCFB). Initial consideration of £45 million, with further potential payments of up to £131 million upon the achievement of specific regulatory approvals and commercial milestones."

M&A • Cystic Fibrosis • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis

CORVIS: COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2 (clinicaltrials.gov) - P2 | N=150 | Suspended | Sponsor: Thirty Respiratory Limited | Recruiting ➔ Suspended

Trial suspension • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

NOMAB: Phase II Study of a Nebulised Nitric Oxide Generating Solution in Patients With Cystic Fibrosis (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Papworth Hospital NHS Foundation Trust | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: May 2022 ➔ Oct 2022

Enrollment open • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 (clinicaltrials.gov) - P2/3; N=19; Completed; Sponsor: Thirty Respiratory Limited; Recruiting ➔ Completed; N=300 ➔ 19

Clinical • Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • PCR

CORVIS: COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2 (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Thirty Respiratory Limited; Trial completion date: Dec 2022 ➔ Apr 2023; Trial primary completion date: Dec 2022 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

NOMAB: Phase II Study of a Nebulised Nitric Oxide Generating Solution in Patients With Cystic Fibrosis (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Papworth Hospital NHS Foundation Trust

Clinical • New P2 trial • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

CORVIS: COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2 (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Thirty Respiratory Limited; Not yet recruiting ➔ Recruiting; Trial completion date: Jun 2022 ➔ Dec 2022; Trial primary completion date: Jun 2022 ➔ Dec 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Trust launches a new clinical trial for cystic fibrosis patients (National Health Executive) - "Royal Papworth Hospital NHS FT has launched phase II of the clinical trial for patients with cystic fibrosis with serious lung infections, such as Mycobacterium abscessus....The study – known as NOMAB – will treat patients with RESP301 over a 28-day period, aiming to measure the changes in the amount of mycobacteria in the lungs before and after treatment....There will initially be 12 subjects recruited, and if successful, expanded to a larger trial, broadening the scope of RESP301 in cystic fibrosis and other lung conditions....The study will be conducted at the trust, one of the UK’s leading centres for cystic fibrosis."

New P2 trial • Cystic Fibrosis

CORVIS: COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2 (clinicaltrials.gov) - P2; N=150; Not yet recruiting; Sponsor: Thirty Respiratory Limited

Clinical • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

PREvent Viral Exposure aNd Transmission Study: a SARS-CoV-2 PEP Study (PREVENT) (clinicaltrials.gov) - P2/3; N=600; Recruiting; Sponsor: Thirty Respiratory Limited

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COmmunity patients at Risk of Viral Infections including SARS-CoV-2 (CORVIS) (clinicaltrialsregister.eu) - P2; N=150; Ongoing; Sponsor: Thirty Respiratory Limited

Clinical • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 (clinicaltrials.gov) - P2/3; N=300; Recruiting; Sponsor: Thirty Respiratory Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease