Respien Appoints Sage to Lead Global Partnering Process for HI-164, a Phase 3-Ready COPD Therapy

Late-stage oral therapy designed to reduce bacterial exacerbations, hospital admissions and the healthcare burden of COPD

Melbourne, Australia; New York, USA; and London, UK – XX June 2026 – Respien Pty Ltd (“Respien”), an Australian biopharmaceutical company developing novel respiratory therapies, has appointed Sage Healthcare Ltd and The Sage Group Inc. (collectively “Sage”) to lead a global partnering process for HI-164, Respien’s lead Phase 3-ready respiratory asset.

HI-164 is an oral biologic designed to prevent bacterial exacerbations associated with chronic obstructive pulmonary disease (COPD) and related chronic airways diseases, including non-cystic fibrosis bronchiectasis (NCFB). The therapy targets persistent bacterial colonisation, a major driver of COPD exacerbations, hospital admissions, healthcare costs and disease progression.

COPD affects an estimated 390 million people globally, including more than 30 million patients in the United States alone, and remains one of the leading causes of death worldwide. Hospitalisations and recurrent exacerbations represent a significant burden on both patients and healthcare systems.

HI-164 has completed two double-blind, randomised, placebo-controlled Phase 2 clinical studies involving more than 500 patients with COPD and chronic airways disease. In these studies, HI-164 demonstrated clinically meaningful reductions in exacerbations and hospital admissions when added to standard of care, including reported reductions of 50–73% in hospital admissions across studies and patient subgroups. Improvements in patient quality of life were also observed.

Respien believes HI-164 is ready to progress into Phase 3 development and is pursuing a strategy initially focused on patients with moderate-to-severe airways disease and chronic bacterial colonisation. The proposed Phase 3 program is expected to utilise established respiratory endpoints, including moderate and severe exacerbations, hospital admissions, microbiology measures and quality-of-life outcomes.

Respien is seeking global or regional partners outside Australia and New Zealand to support late-stage development and commercialisation. Sage will manage the partnering process and coordinate discussions with selected pharmaceutical and biotechnology companies.

Chris Rossidis, CEO of Respien, said:

“HI-164 is a highly differentiated late-stage respiratory asset targeting one of the major unmet needs in COPD — recurrent bacterial exacerbations that drive hospitalisation, healthcare cost and patient decline. The Phase 2 data provides a strong foundation for Phase 3 development, and we believe HI-164 has the potential to become an important adjunctive therapy for patients at risk of repeated infective exacerbations.”

Dr Bill Mason, Executive Director of Sage Healthcare Ltd, added:

“HI-164 combines compelling late-stage clinical data, a differentiated mechanism and a strong pharmacoeconomic rationale in a very large global market. We look forward to supporting Respien in identifying the right strategic partner to advance the program globally.”

Dr. Bill Mason Sage Healthcare Ltd. The Stockyard, Creake Road Syderstone PE31 8SG United Kingdom Mob: +44 7785 950134 wtm@sagehealthcare.com

Chris Rossidis CEO Respien Pty Ltd Australia Cell: +61 417 112 590

About Respien

Respien Pty Ltd is an Australian biopharmaceutical company focused on developing novel therapies for respiratory disease. Its lead asset, HI-164, is an oral biologic designed to reduce bacterial exacerbations and hospital admissions in COPD and related chronic airways diseases. Respien’s broader pipeline includes additional anti-infective and anti-inflammatory respiratory programs.

About Sage

Sage is an international healthcare and life sciences advisory group specialising in strategic partnering, licensing, M&A and financing transactions across the pharmaceutical, biotechnology, diagnostics and medical device sectors.