Breath Therapeutics Announces Presentations at Upcoming Scientific Conferences

MUNICH and MENLO PARK, Calif., March 20, 2019 /PRNewswire/ -- Breath Therapeutics, a private company developing advanced inhaled therapeutics in severe pulmonary orphan diseases, today announced presentations at three upcoming scientific conferences. Breath Therapeutics will present at the 45^th Annual Meeting of the European Society for Blood and Marrow Transplant (EBMT), the International Society for Heart and Lung Transplantation 2019 Annual Meeting (ISHLT), and the American Thoracic Society International Conference (ATS).

"We are pleased to present data that support our lead candidate, L‑CsA‑i, and BOSTON program at the upcoming Spring medical conferences," said Noreen R. Henig, MD, Chief Medical Officer at Breath Therapeutics. "We remain focused on our mission of developing a safe and effective treatment for the estimated 25,000 people worldwide suffering from bronchiolitis obliterans syndrome."

Details of the presentations are noted below:

Bronchiolitis Obliterans Syndrome (BOS)

Bronchiolitis Obliterans Syndrome (BOS), also known as obliterative bronchiolitis (OB) or chronic lung allograft rejection, is caused by T-cell mediated inflammation that leads to blockage of bronchioles, the small and medium airways in the lungs, resulting in respiratory failure and death. BOS most commonly affects people who have received lung or stem cell transplantation, although it is also associated with autoimmune disease and exposure to environmental contaminants. An estimated 15,000 lung transplantation and 9,500 allogeneic hematopoietic stem cell transplantation recipients worldwide are affected by BOS. To view experts discuss their clinical experience with BOS and the BOSTON-1 and BOSTON-2 studies, please visit here.

Liposomal Cyclosporine A for Inhalation (L-CsA-i)

Breath Therapeutics' lead candidate, L‑CsA‑i, is a novel liposomal formulation of cyclosporine A designed for inhaled delivery to the lungs. Calcineurin inhibitors (CNIs), like cyclosporine A, are highly potent immunosuppressive drugs and a cornerstone of lung transplant medicine. Due to a narrow therapeutic window, mainly caused by nephrotoxicity, the systemic administration of CNIs cannot achieve sufficient drug levels in the bronchiolar tissue needed to treat BOS. L‑CsA‑i is administered via a customized drug-specific investigational eFlow® nebulizer (PARI Pharma GmbH). The drug-device combination is designed to deliver L-CsA-i to the site of disease in the lung while minimizing systemic exposure. L‑CsA‑i is an investigational compound and its safety and efficacy have not been established. It is not approved for use by any regulatory authority.

BOSTON Development Program

L-CsA-i is being developed for the treatment of BOS in patients age six and older. Five clinical trials are currently planned. BOSTON-1 and BOSTON-2 are pivotal Phase 3 studies with BOS following lung transplantation. BOSTON-3 is an open-label extension study for all study participants who complete BOSTON-1 or BOSTON-2. BOSTON-4 is a Phase 2 study and will be the first trial of L‑CsA‑i in adults with BOS following allogeneic hematopoietic stem cell transplant. BOSTON-5 is a Phase 2 study in pediatric patients with BOS.

Breath Therapeutics

Founded in 2016, Breath Therapeutics is a private, venture-backed clinical stage biopharmaceutical company specializing in advanced inhaled therapeutics for severe respiratory diseases with high unmet medical need. The company's proprietary drug formulations have been specifically designed for inhaled administration with exclusively licensed, high performance nebulizer technology. L‑CsA‑i, Breath Therapeutics' lead asset, is advancing as the first therapy for BOS, a rare and devastating lung disease with no currently available treatment. Breath Therapeutics has offices in Munich, Germany and Menlo Park, CA. For more information, please visit www.breath-therapeutics.com.

Forward-looking Statements

This press release may contain forward-looking statements which reflect management's expectations regarding Breaths Therapeutics' objectives, plans, goals, strategies, future growth, financial condition, results of operations, cash flows, performance, business prospects and opportunities. All statements other than statements of historical facts included in this press release, including statements regarding Breath Therapeutics' objectives, plans, goals, strategies, future growth, financial condition, results of operations, cash flows, performance, business prospects and opportunities, may constitute forward-looking information.

By its very nature, forward-looking information requires Breath Therapeutics' to make assumptions and is subject to inherent risks and uncertainties which give rise to the possibility that the predictions, forecasts, expectations or conclusions will not prove to be accurate, that Breath Therapeutics' assumptions may not be correct and that Breath Therapeutics' objectives, strategic goals and priorities will not be achieved. Although Breath Therapeutics believes that the predictions, forecasts, expectations or conclusions reflected in the forward-looking information are reasonable, it can give no assurance that such matters will prove to have been correct. Such forward-looking information is not fact but only reflects management's estimates and expectations. These forward-looking statements are subject to uncertainties and other factors that could cause actual results to differ materially from such statements.

Contacts:

Company Contact

Breath Therapeutics B.V.
Bonnie Ortega, VP, Corporate Communications
Tel. +1 858 245 3983
Email: contact@breath-therapeutics.com

Media (US) Inquiries

Canale Communications, Inc.
Jessica Tieszen, Account Manager
Tel. +1 619 322 5969
Email: jessica@canalecomm.com

Media (Europe) Inquiries

MC Services AG
Kaja Skorka, Consultant / Raimund Gabriel, Managing Partner
Tel. +49 89 210 228–0
Email: breath-therapeutics@mc-services.eu

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SOURCE Breath Therapeutics