Forbion Portfolio Company, Enterprise Therapeutics’ First-in-Class TMEM16A Potentiator Program for Treatment of Cystic Fibrosis and Other Respiratory Diseases Acquired by Roche

• Enterprise’s novel TMEM16A potentiator portfolio includes ETD002, a first in class compound which is currently in Phase 1
• TMEM16A potentiation is a novel therapeutic approach applicable to all cystic fibrosis patients, independent of genotype, and may provide benefit in other respiratory diseases
• Enterprise’s shareholders received an upfront payment of £75 million

NAARDEN, The Netherlands & BRIGHTON, England--(BUSINESS WIRE)-- Forbion, a leading European life sciences venture capital firm, today announces that its portfolio company, Enterprise Therapeutics Ltd (Enterprise)’s novel TMEM16A potentiator portfolio has been fully acquired by Roche and will be developed by Genentech, a member of the Roche Group. The portfolio includes ETD002 which recently entered Phase 1 trials.

Enterprise’s shareholders received an upfront payment of £75 million and are eligible to receive additional contingent payments, to be made based on the achievement of certain predetermined milestones.

The TMEM16A portfolio is focused toward treating all people with cystic fibrosis (CF), with potential to benefit people with other severe respiratory diseases characterised by excessive mucus congestion.

Dr John Ford, CEO, Enterprise Therapeutics, said: “Roche and Genentech have a proven track record of bringing new medicines to people with respiratory diseases, and have recognised the opportunity that our TMEM16A potentiator portfolio presents. I am very proud of the team at Enterprise for identifying and developing this innovative approach to treat patients, with ETD002 the first of our compounds to reach clinical stage. TMEM16A potentiation has the potential to significantly increase the quality of life for people living with cystic fibrosis, for many of whom existing therapies are not effective.”

Geert-Jan Mulder, MD, Managing Partner and co-founder at Forbion, commented: “We have been investors in Enterprise Therapeutics since 2018, having recognized the critical importance of the work that John and the team were doing in respiratory diseases. We are delighted that Roche after its acquisition of Forbion’s portfolio company Promedior has decided to acquire Enterprise’s TMEM16A potentiator program, adding yet another exciting program to their respiratory portfolio. We expect to see further good progress of the company’s remaining program, a potential best in class ENaC-blocker that targets to restore mucus hydration making it easier for the lungs to be cleared.”

CF is estimated to affect 75,000 people globally. One of the main causes of difficulty in breathing and increased risk of infection is mucus congestion in the lungs. The ETD002 compound targets the underlying mechanisms of mucus congestion, and is expected to restore lung function, reduce the frequency of lung infections and improve patient quality of life. CF is caused by loss of function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR), an anion channel highly expressed by the airway epithelium. Increasing anion conductance via CFTR modulation is a clinically validated approach for treating CF, however it is not currently available or effective for all people with CF.

In pre-clinical models, Enterprise has demonstrated that ETD002 enhances the activity of TMEM16A, an alternative anion channel present in airway epithelial cells, and by doing so increases anion and fluid flow into the airways, thinning the mucus and increasing its clearance. As TMEM16A potentiation is independent of the mutational status of CFTR, this makes the approach potentially applicable to all people with CF, and perhaps patients with non-CF muco-obstructive lung disease.

Notes to Editors

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion’s investment team has built an impressive performance track record since the late nineties with successful investments in over 66 companies. Forbion manages well over EUR 1.25 billion across ten funds. Forbion is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fondsinvestments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. For more information, please visit: www.forbion.com.

About Enterprise Therapeutics www.enterprisetherapeutics.com

Enterprise Therapeutics is discovering and developing new therapies that target the underlying mechanisms of mucus congestion in the lungs, one of the main causes of difficulty in breathing and increased risk of infection in respiratory diseases such as cystic fibrosis and COPD. Reducing mucus congestion will reduce the frequency of lung infections and improve quality of life.

The Company’s novel muco-regulatory therapies target ion channels TMEM16A and ENaC to increase the hydration and clearance of mucus. Enterprise has also identified novel targets and compounds that reduce mucus production, an approach that complements mucus hydration therapies.

The Enterprise Therapeutics management team has significant expertise in drug discovery, drug development, respiratory biology and ion channel pharmacology. The Company is backed by leading life science investors Epidarex Capital, Forbion, IP Group, Novartis Venture Fund and Versant Ventures. In 2019 the company received funding from the Cystic Fibrosis Foundation to advance TMEM16A through to clinical proof of concept in CF.

About Cystic Fibrosis (CF)

Cystic Fibrosis is the most common lethal genetic disease of Caucasians with more than 75,000 patients worldwide living with the disease. The average life expectancy of a CF patient, although improving, is approximately 40 years.

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