Breath Therapeutics

Breath Therapeutics was a clinical-stage biopharmaceutical company focused on developing inhalation therapies for severe, underserved respiratory diseases. The company was founded in 2016 as a spin-out from PARI Pharma GmbH, a specialist in nebulizer equipment. The founding team included Dr. Jens Stegemann (CEO), Dr. Oliver Denk (COO), Dr. Gerhard Boerner (CSO), and Anne Burger (CFO). Dr. Stegemann brought over two decades of management experience in the pharmaceutical and med-tech industries, with a background that also includes being a former Olympic canoeist. Dr. Gerhard Scheuch, a seed investor and founding shareholder, is a physicist and renowned expert in aerosol medicine and pulmonary drug delivery.

The company's primary business was the development of drug-device combination products. Its lead asset, L-CsA-i, is a proprietary liposomal formulation of Cyclosporine A designed for inhalation. This therapy was specifically aimed at treating Bronchiolitis Obliterans Syndrome (BOS), a rare and fatal lung disease that often affects patients following lung or stem cell transplants and has no approved treatment. The L-CsA-i formulation is administered via a customized, high-performance eFlow® nebulizer technology licensed from PARI Pharma, designed to deliver the drug directly to the site of the disease in the lungs while minimizing systemic side effects. The business model was centered on advancing this lead candidate through clinical trials to gain regulatory approval and eventual commercialization, targeting a global patient population estimated to be over 30,000.

A significant milestone was achieved in March 2017 when Breath Therapeutics secured €43.5 million in a Series A financing round co-led by Sofinnova Partners and Gimv, with participation from Gilde Healthcare. This funding enabled the company to advance L-CsA-i into global Phase III clinical trials (BOSTON-1 and BOSTON-2) across Europe and the US, and to establish commercial-scale production for both the drug and the device. The therapy received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency, highlighting the significant unmet medical need. In July 2019, the Italian multinational pharmaceutical company Zambon acquired Breath Therapeutics for an upfront payment of €140 million, with the potential for the deal to reach up to €500 million based on regulatory and sales milestones. This acquisition integrated Breath Therapeutics' specialized pipeline and team into Zambon's larger infrastructure, aiming to accelerate the final development and market launch of L-CsA-i.

Keywords: Breath Therapeutics, Zambon, L-CsA-i, Bronchiolitis Obliterans Syndrome, BOS, inhaled therapy, respiratory disease, orphan drug, PARI Pharma, eFlow nebulizer, liposomal Cyclosporine A, lung transplant, clinical trials, Jens Stegemann, Sofinnova Partners, Gilde Healthcare, Gimv, biopharmaceutical, drug-device combination