REGENXBIO to Acquire Dimension Therapeutics

REGENXBIO Inc. and Dimension Therapeutics, Inc. recently announced they have entered into a definitive agreement under which REGENXBIO will acquire Dimension in an all-stock transaction for an implied value of approximately $3.41 per share. The boards of directors of both companies have unanimously approved the transaction.

Upon completion of the acquisition, REGENXBIO will add two lead product candidates to its pipeline:

-DTX301 for the treatment of ornithine transcarbamylase (OTC) deficiency, which is designed to use the NAV AAV8 vector to deliver a copy of the OTC gene to liver cells. DTX301 is being evaluated under an active investigational new drug (IND) application for a Phase I/II clinical trial; and

-DTX401 for the treatment of glycogen storage disease type Ia (GSDIa), which is designed to use the NAV AAV8 vector to deliver a copy of the glucose-6-phosphatase (G6Pase) gene to liver cells. An IND application is anticipated to be filed for DTX401 in early 2018.

Both DTX301 and DTX401 have been granted Orphan Drug Designation in the United States and Europe.

In addition, REGENXBIO will acquire DTX201 for the treatment of hemophilia A. DTX201 is designed to use REGENXBIO’s NAV Technology to deliver a copy of the Factor VIII gene to liver cells, and is partnered through a global development and commercialization collaboration with Bayer. An IND application is anticipated to be filed for DTX201 in early 2018.

“This acquisition confirms REGENXBIO’s leadership in the field of AAV gene therapy and expands our pipeline in metabolic diseases using NAV Technology with a clinical asset and several preclinical assets. REGENXBIO has the resources and expertise to be successful in advancing a portfolio of gene therapies for inherited metabolic diseases targeting the liver,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We believe that DTX301 and DTX401 are product candidates that address diseases with high unmet need and will become an important part of a strong internal pipeline at REGENXBIO that has the potential to achieve multiple milestones through the end of 2018, starting with our interim updates anticipated for the end of this year on RGX-314 for wet AMD and RGX-501 for HoFH. The acquisition of Dimension is another meaningful step in building a robust clinical pipeline of gene therapy product candidates with the goal of improving treatment options for patients and families in many diseases.”

“I am proud of the accomplishments of the Dimension team and of our partners in the research and clinical communities, who together have made significant contributions to the progress of AAV technologies and the advancement of new therapeutic candidates for devastating rare and metabolic diseases associated with the liver,” said Annalisa Jenkins, MBBS, FRCP, Chief Executive Officer of Dimension. “REGENXBIO has strong leadership, understanding of technology, capabilities, and financial resources that provide significant synergies with Dimension’s R&D portfolio. We are pleased that this transaction provides an opportunity for Dimension shareholders to participate in the future success of what we believe will be an industry-leading gene therapy pipeline.”

Through the transaction, REGENXBIO will also acquire preclinical product candidates for phenylketonuria (PKU), Wilson disease and citrullinemia type I, manufacturing technology and other intellectual property developed by Dimension. All Dimension candidates – including DTX301 and DTX401 – utilize REGENXBIO’s NAV Technology and have been developed under exclusive licenses previously granted by REGENXBIO to Dimension.

Under the terms of the definitive agreement, Dimension will, following consummation of the acquisition, become a wholly owned subsidiary of REGENXBIO. In addition, Dimension shareholders will receive 0.1573 shares of REGENXBIO in exchange for each of their shares in Dimension and are expected to own approximately 10.9% percent of the combined entity. It is anticipated that the transaction will close by year-end 2017, subject to approval by Dimension shareholders, receipt of any required customary regulatory approvals and the satisfaction of other customary closing conditions.
Morgan Stanley is serving as financial advisor and Covington & Burling LLP is serving as legal counsel to REGENXBIO. MTS Health Partners, L.P. is serving as financial advisor and Goodwin Procter LLP is serving as legal counsel to Dimension.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology licensees are applying the NAV Technology Platform in the development of a broad pipeline of product candidates in multiple therapeutic areas.

Dimension is a leader in discovering and developing new therapeutic products for people living with devastating rare and metabolic diseases associated with the liver, based on the most advanced mammalian adeno-associated virus (AAV) gene delivery technology. Dimension is actively progressing its broad pipeline, which features programs addressing unmet needs for patients suffering from inherited metabolic diseases, including OTC deficiency and GSDIa, and a collaboration with Bayer in hemophilia A. Dimension has initiated a phase I/II clinical trial with DTX301 for the treatment of OTC deficiency. The company targets diseases with readily identifiable patient populations, highly predictive preclinical models, and well-described, and often clinically validated, biomarkers. Founded in 2013, Dimension maintains headquarters in Cambridge, Massachusetts.