Versartis Reports Third Quarter 2016 Financial Results

MENLO PARK, Calif., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced financial results for the third quarter ended September 30, 2016 and provided an update on its clinical development programs.

"Our achievements this past quarter further validate our robust development program for somavaratan and highlight the global demand for a long-acting treatment for growth hormone deficiency," said Jay Shepard, Versartis' President and Chief Executive Officer. "Our recent strategic alliance with Teijin puts somavaratan in the hands of an experienced endocrine partner for commercialization in Japan and offers us strong economics over the life of the agreement. We also completed enrollment in our Phase 3 VELOCITY trial, with data expected in the third quarter of 2017, and have initiated the Phase 3 portion of our Japanese trial in pediatric GHD patients. These trials, in combination with the initiation of our pediatric "switch" study in 2017, will provide us with an extensive data package to support our efforts to gain approval and commercialize somavaratan globally."

Corporate Highlights & Milestones
  • Entered strategic alliance with Teijin Limited in which Teijin will have exclusive license to commercialize and further develop somavaratan in the Japanese market in exchange for a $40 million upfront payment and up to $125 million in milestone payments to Versartis
  • Presented positive safety, efficacy, and adherence data at the International Congress of Endocrinology (ICE) and the European Society of Paediatric Endocrinology (ESPE) with up to 30 months of somavaratan dosing in the Phase 2a trial and VISTA long-term safety study of children with GHD
  • Initiated the Phase 3 portion of the J14VR5 study in Japan following the review of the study's Phase 2 data by the Steering Committee, the Data Safety Monitoring Board, and the Pharmaceuticals and Medical Devices Agency
  • Based on data from the Phase 2 VITAL trial in adult GHD patients, the Company selected a lower starting dose and a dosing schedule of twice-monthly for its Phase 3 trial
  • Presented details of planned preloaded disposable autoinjector device, intended to provide simplified administration 
  • Raised gross proceeds of $63.4 million through a follow-on offering of 5,176,545 shares at a price of $12.25, which includes shares issued pursuant to the underwriters' partial exercise of their over-allotment option

Anticipated Milestones and Other Key Events
  • Top-line data from the pediatric Phase 3 VELOCITY trial in Q3 2017
  • Initiation of Phase 3 trial in adult GHD patients by the end of 2017

Third Quarter 2016 Financial Results

For the third quarter ended September 30, 2016, Versartis reported a net loss of approximately $27.3 million, or $0.92 per share, basic and diluted, compared to a net loss for the quarter ended September 30, 2015 of $20.4 million, or $0.69 per share, basic and diluted.

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