Versartis to Hold Conference Call to Discuss VRS-317 Clinical Update From Ongoing Extension Study

Versartis, Inc.

, an endocrine-focused biopharmaceutical company developing a novel, long-acting form of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD), today announced it will hold a conference call and webcast on Monday, January 5, 2015 at 8:30 a.m. ET (5:30 a.m. PT). During the call, Versartis management will provide a safety and efficacy update on pediatric GHD patients currently enrolled in its ongoing long-term Extension Study with VRS-317. Pediatric patients completing the Phase 2a VERTICAL trial were offered the opportunity to continue therapy in the Extension Study and approximately 95% of the Phase 2a patients elected to participate. The Extension Study clinical update will also be announced in a press release prior to the call. Conference Call and Webcast Versartis will hold a conference call on Monday, January 5, 2015 at 8:30 a.m. ET (5:30 a.m. PT). The dial-in numbers are (877) 407-0789 for domestic callers and (201) 689-8562 for international callers. A live webcast of the conference call will be available online from the investor relations page of the Company's corporate website at www.versartis.com. After the live webcast, a replay will remain available on the Versartis website, www.versartis.com, for 90 days. In addition, a telephonic replay of the call will be available until January 19, 2015. The replay dial-in numbers are (877) 870-5176 for domestic callers and (858) 384-5517 for international callers. Please use the replay conference ID number 13598346. The VRS-317 VERTICAL Study The Versartis Trial In Children to Assess Long-Acting Growth Hormone (VERTICAL) study was conducted in approximately 25 US pediatric endocrinology centers and enrolled 64 treatment-naive, pre-pubertal children with GHD documented by auxologic criteria and two growth hormone (GH) stimulation tests. The VERTICAL trial consisted of two stages: a single ascending dose stage (Phase 1b) to determine the safety, PK and PD of VRS-317 doses and to enable selection of dose regimens, which were then used in the repeat-dose second stage (Phase 2a). The primary endpoint of the Phase 2a study was mean 6-month height velocity. Based on observed PK/PD results, 64 subjects were enrolled in the Phase 2a stage and randomized into three cohorts to evaluate three different dosing regimens of VRS-317: 5.0 mg/kg monthly, 2.5 mg/kg semi-monthly or 1.15 mg/kg weekly. At the start of repeat dosing, the subjects (37M/27F) had a mean (SD) age of 7.8 (2.4) years, HT-SDS of -2.5 (0.5) and IGF-I SDS of -1.7 (0.8). Results from the completed Phase 2a stage of the VERTICAL study were first reported on June 23, 2014 at the 16th International Congress of Endocrinology and The Endocrine Society's 96th Annual Meeting and Expo (ICE/ENDO) in Chicago, IL and announced in the following press release: http://ir.versartis.com/releasedetail.cfm?ReleaseID=856043 As disclosed on its third quarter 2014 financial results conference call, Versartis expects to begin enrollment of its Phase 3 VELOCITY Study of VRS-317 in early 2015. The VRS-317 Phase 3 VELOCITY Study The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY Study) is a randomized, open-label, Phase 3 registration study in the United States, Western Europe and Canada. This study will enroll up to 136 treatment-naïve, pre-pubertal children with GHD and will include a 3:1 randomization of 3.5 mg/kg VRS-317 semi-monthly to daily rhGH at the highest labeled dose of Genotropin® (somatropin [rDNA origin] for injection) and Norditropin® (somatropin [rDNA origin] for injection) 34 µg/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12 month height velocity. GHD patients enrolling in this study will also be offered the opportunity to enroll in the ongoing Extension Study.