89bio Launches into Liver and Metabolic Disorders with $60 Million Series A Financing

PRESS RELEASEPress Release

- Investment round led by company founders, OrbiMed Israel and OrbiMed US, and Longitude Capital, with participation by RA Capital Management and Pontifax -
- Company acquires NASH assets from TEVA Pharmaceuticals, initiates Phase 1 clinical trial, and appoints Rohan Palekar as CEO -

San Francisco, USA and Herzliya, Israel, October 15, 2018
89bio, a clinical-stage biopharmaceutical company focused on nonalcoholic steatohepatitis (NASH) and other liver and metabolic disorders, today announced it has closed a $60 million Series A financing. The funding will be used to advance the Company’s pipeline of biologic and small molecule drug candidates acquired from Teva Pharmaceuticals, Ltd. The investment round was led by OrbiMed Israel, OrbiMed US and Longitude Capital and joined by RA Capital Management® and Pontifax. 89bio was founded by OrbiMed Israel and Orbimed US.

89bio’s lead candidate is BIO89-001 (formerly TEV-47948) for the treatment of NASH. Currently in Phase 1, BIO89-001 is a novel long-acting glycopegylated fibroblast growth factor 21 (FGF21) analogue that was developed using Teva’s proprietary glycopegylation technology to prolong the half-life and enhance the pharmacodynamics of the native FGF21 molecule. In preclinical studies BIO89-001 demonstrated a long half-life, potentially enabling extended-interval dosing, and significant improvements in biomarkers such as body weight, blood glucose, and lipids. 89bio also has an undisclosed preclinical compound with potential utility in treatment of NASH and other related disorders.

“NASH is a common and complex multifactorial disease linked to obesity and type 2 diabetes for which there are no approved treatments,” said Arun Sanyal, MD, professor of gastroenterology and hepatology, Virginia Commonwealth University. “FGF21 is a clinically validated target for NASH. Given its role in metabolism across multiple organs and the liver, it is a particularly compelling approach with the potential of affecting the disease pathway in both metabolic and fibrosis endpoints.”

The company also announced the appointment of seasoned biopharmaceutical executive Rohan Palekar as chief executive officer (CEO). Mr. Palekar most recently served as president and CEO of Avanir Pharmaceuticals, after holding several key executive leadership roles in which he helped guide the company through rapid growth and acquisition by Otsuka Pharmaceuticals. Previously Mr. Palekar was the chief commercial officer of Medivation. He also held senior commercial and strategic management roles at Johnson & Johnson. Mr. Palekar received an M.B.A. from the Amos Tuck School of Business Administration at Dartmouth College and a B.A./B.S. in law and accounting from the University of Bombay.

Additional executive team appointments include:

Dr. Michal Ayalon joins 89bio as head of research & development (R&D). Most recently, Dr. Ayalon led the FGF21 program at Teva. Previously, Dr. Ayalon was vice president of R&D at Galmed, where she was responsible for the Aramchol program targeting NASH.
Ram Waisbourd joins 89bio as chief operating officer and chief business officer. Mr. Waisbourd previously held operational, strategy and business development positions at Teva. Most recently he was vice president of strategy and transformation and a member of the executive leadership team of Teva Specialty R&D.

“I’m excited to join 89bio. The company has been formed around a promising program in NASH and is anchored by BIO89-001, a novel and precisely engineered FGF21 analogue that was developed using Teva’s proprietary glycopegylation technology,” said Mr. Palekar. “I have tremendous confidence in the ability of our team, together with our top-tier life sciences investors, to achieve the company’s full potential and deliver life changing treatments to patients in need.”