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NorthSea Therapeutics Announces US $40 Million Series B Financing to Complete Phase IIb ICONA study in NASH and to Advance Two Additional SEFAs into the Clinic

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  • Two new US investors; lead investor, venBio Partners and Sofinnova Investments, join syndicate of existing investors
  • Richard Gaster, M.D., Ph.D., Principal at venBio Partners, and Maha Katabi, Ph.D., CFA, Partner at Sofinnova Investments join the Board
  • Proceeds will be used to progress the SEFA development pipeline:
    - Completion of Phase 2b study of lead programme Icosabutate in non-alcoholic steatohepatitis (NASH)
    - Initiation of clinical development of two new programmes for dyslipidaemia and for parenteral nutrition-associated liver disease (PNALD)

Naarden, The Netherlands, 8 January 2020 – NorthSea Therapeutics B.V., (‘NST’) a Dutch biotech company developing novel and innovative strategies for the treatment of NASH (Non-alcoholic Steatohepatitis) and other metabolic, inflammatory and fibrotic diseases, today announced the closing of a US $40 million (€36 million) Series B financing round.
NST welcomes new US investors venBio Partners, which led the Series B round, and Sofinnova Investments. Existing investors, Forbion, Novo Seeds, New Science Ventures (NSV) and BioGeneration Ventures (BGV) all participated.

Richard Gaster, M.D., Ph.D., Principal at venBio Partners and Maha Katabi, Ph.D., CFA, Partner at Sofinnova Investments, will join NST’s board of directors.
The proceeds of this fundraising will be used by NST to drive the development of its pipeline of SEFA (Structural Engineered Fatty Acids) programs. The Company will develop two additional SEFAs within its clinical pipeline in addition to completing the Phase 2b with its lead candidate Icosabutate.

Icosabutate, NST’s lead product, is a structurally designed fatty acid that regulates pivotal pathways involved in hepatic lipids, inflammation and fibrosis. In September 2019, NST announced that it had dosed the first patient in its Phase 2b dose ranging ICONA study (ICOsabutate in NASH) and that around thirty clinical trial sites have been initiated in the US.

NST’s second SEFA program is SEFA-1024 for dyslipidaemia, a condition where there is an abnormal amount of triglycerides and/or atherogenic cholesterol in the blood. Severe or untreated dyslipidaemia can lead to a variety of serious health conditions includingcoronary artery disease (CAD) and peripheral artery disease (PAD). The Company aims to initiate a Phase 1 study in the second half of 2020.

The third SEFA program is SEFA-6179 for the orphan indication, PNALD (Parenteral Nutrition-Associated Liver Disease). PNALD is a liver disease that affects patients with intestinal failure who are dependent on total parenteral nutrition; this is where nutrition is administered to the patient via alternative routes to the mouth or alimentary canal. The disease represents a high unmet medical need as there are currently no approved treatments available. NST’s aim is to initiate a Phase 1 study in the first half of 2021.

Rob de Ree, NST’s CEO, commented: “We are delighted to start the year with a successful Series B financing, which brings both US investment and expertise to our shareholder syndicate and to our Board. The great support from both new and existing shareholders will enable us to leverage our SEFA technology and to enter the clinic with two new clinical programs within the next 18 months. Both new programs have the potential to have a significant impact on patient care.”

Sander Slootweg, NST’s Chairman of the Board and Managing Partner of Forbion, said: “We are very pleased to have added venBio and Sofinnova to our shareholder’s base. As both parties only selectively invest in Europe, we see this as a true testimony to the excitement of our most advanced drug candidate Icosabutate and our SEFA platform. With the proceeds of this round we expect to show both the breadth and strength of our technology in patients and establish SEFAs as a new and exciting therapeutic modality.”

Richard Gaster, Principal at venBio Partners, added: “NorthSea Therapeutics’ structurally designed fatty acid platform has generated compounds with the potential to address a diverse set of metabolic disorders. The Company will initially focus on NASH, which we believe is an area of large unmet medical need and where we are confident there is room for multiple successful approaches with the right cardiometabolic profile. We are excited about Icosabutate based on its impressive clinical data in patients with dyslipidaemia, and robust pre-clinical data in a number of models of NASH. This financing will enable NST to complete its ongoing Phase 2b trial in NASH before the vast majority of NASH assets currently in clinical development. Given the management team’s stellar track record, we are very optimistic and confident about the future.”