Gimv and Sofinnova Partners co-lead €43.5 million Series A round for Breath Therapeutics

Breath Therapeutics Holding BV (Breath Therapeutics), a company developing advanced drug-aerosol therapeutics in pulmonary orphan indications, today announced the closing of a EUR 43.5 million Series A financing. Gimv and Sofinnova Partners co-led the round and were joined by Gilde Healthcare. PARI Pharma supports the program. With the proceeds from the financing, Breath Therapeutics plans to conduct phase 3 trials in Europe and the US, respectively, submit for marketing approval, and prepare for commercialization.

Breath Therapeutics’ lead program develops a first-in-class inhalation therapy for treatment of Bronchiolitis Obliterans Syndrome (BOS). BOS is a lethal orphan respiratory disease, mainly affecting lung transplant patients. It is commonly understood as chronic graft rejection and is the main reason for the poor 5-year survival rates after lung transplantation.

Based on work by PARI Pharma and lung transplantation expert Aldo Iacono, MD, University of Maryland, USA, Breath Therapeutics develops a proprietary drug/device combination. This involves a formulation of liposomal cyclosporine A for inhalation and an optimized high performance eFlow® technology nebulizer enabling remote adherence monitoring. This approach is expected to ensure a safe, well tolerated and targeted delivery of immunosuppressive medication directly into the lungs along with a time saving treatment regime.

Breath Therapeutics is a spin-off of PARI Pharma, Starnberg, Germany. The company’s founding and management team includes highly experienced executives and internationally renowned experts in drug aerosol and immunosuppression therapy: Dr. Jens Stegemann (CEO), Anne Burger (CFO), Dr. Gerhard Boerner (CSO) and Dr. Oliver Denk (COO). Graziano Seghezzi, partner at Sofinnova Partners, Dr. Karl Nägler, partner at Gimv, and Arthur Franken, partner at Gilde Healthcare, will join the board of directors.

Dr. Jens Stegemann, CEO of Breath Therapeutics, said: “BOS is one of the most devastating lung diseases and still today, no effective therapy is available. Our strategy is to deposit high concentrations of an immunosuppressive agent directly into the small airways of the lung. With this top-tier group of investors and the best international lung transplantation centres supporting us, we now are in an excellent position to achieve ground-breaking improvements in the combat of BOS.”

Graziano Seghezzi, partner at Sofinnova Partners, added: “We are thrilled to be involved with Breath Therapeutics. We were really impressed by its highly talented and entrepreneuroriented team, as well as by the potential of its market breaking technology. At Sofinnova Partners we have a strong expertise in turning corporate spin-offs into successful companies, and are happy to share our experience and resources with the team to back Breath Therapeutics’ growth.”

Dr. Karl Nägler, partner at Gimv, commented: “It is a great opportunity to invest in a company focusing on a life-threatening orphan disease with high unmet medical need. We were attracted by the strong expertise of the founding team and by the very promising late-stage 2/3 clinical data. Furthermore, the BOS market will allow for a focused and highly profitable commercialisation strategy.”

Arthur Franken, partner at Gilde Healthcare, said: “This talented team has designed a unique drug/device combination which together with digital adherence monitoring has great potential to improve quality of care for patients suffering from chronic lung graft rejection. Gilde will actively support Breath Therapeutics and its team in its growth strategy of developing and commercializing inhaled drug therapies for severe respiratory disease.”

Dr. Martin Knoch, President of PARI Pharma, said: “The team at Breath Therapeutics has the expertise and focus to bring the first lung-targeted BOS therapy through clinical development and hopefully onto the market. For PARI Pharma it is highly rewarding to see a project that we started advancing into late-stage clinical development and providing BOS patients new hope.”

About Breath Therapeutics

Breath Therapeutics is specializing in advanced and first-in-class inhalation therapies for severe respiratory diseases. For its clinical development, the company is using proprietary drug formulations optimized for inhaled administration with exclusively licenced, high performance nebulizers. Breath Therapeutics is focussing on integrated therapy solutions in the interaction between diagnostic, therapy and eHealth therapy control. The clinical development program is addressing the treatment of Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation. PARI Pharma, a leading nebulizer company, is strategic partner and technology licensee for the BOS development program. Breath Therapeutics is based in Munich and Frankfurt, Germany.

Source: Breath Therapeutics’ press realese

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