somavaratan (VRS-317) / Aravive, Sanofi - LARVOL DELTA

Safety and tolerability of a new long-acting human growth hormone (VRS-317) in adult GH deficiency (AGHD) (ESPE 2012) - Presentation time: Saturday, Sept 22, 2012, 08:45 - 09:45; P1, N=50; Single SC doses of VRS-317 are safe & well tolerated; No study withdrawals due to AE & no serious AEs; VRS-317 stimulates IGF-I at GH equivalent doses below the conventional GH doses used in GH deficient adults; VRS-317 may have increased biopotency on a molar basis vs. rhGH & has potential to provide persistent biological responses for up to one month

P1 data • Growth Hormone

Growth hormone developer Versartis jumps off the IPO bench next week (Biz Journal) - "Proceeds of Versartis' IPO will be used for a Phase III trial of its drug, called VRS-317. The drug is in a Phase IIa trial in children who lack growth hormone. Combined with the Japanese market, the company said in an SEC filing that the market for a daily pediatric recombinant human growth hormone treatment in 2018 could be $2 billion."

Anticipated sales • Growth Hormone

Open-label Extension Study to Evaluate the Safety of Long-term Monthly Administration of Somavaratan in Adults With GHD (clinicaltrials.gov) - P2; N=250; Recruiting; Sponsor: Versartis Inc.

New P2 trial • Biosimilar • Growth Hormone

Versartis reports first quarter 2014 financial results (Versartis Press Release) - "In the second half of 2014, Versartis anticipates it will initiate discussions with the FDA and EMA following completion of the Phase 2a stage of the ongoing Phase 1b/2a VERTICAL clinical trial and in anticipation of the Phase 3 clinical program for VRS-317 in pediatric patients in the US and Europe...the Company expects the Phase 3 clinical trial for pediatric GHD to commence in early 2015...Versartis plans to initiate the development of VRS-317 in pediatric patients with GHD in Japan and resume the development of VRS-317 in adult patients with GHD in 2015."

Anticipated new P3 trial • Anticipated regulatory • Anticipated trial completion date • Growth Hormone

VISTA: Versartis Long-Term Safety Study of Somavaratan (clinicaltrials.gov) - P2/3; N=300; Active, not recruiting; Sponsor: Versartis Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Growth Hormone

Versartis long-term preclinical safety data for VRS-317 presented at ENDO 2011 (Versartis) - P1 trial enrolling 50 patients initatied in Q1 2011 is underway in US and Europe

P1 trial update • None

RELATIVE CHANGES IN BONE AGE AND LINEAR GROWTH IN CHILDREN WITH GROWTH HORMONE DEFICIENCY (GHD) TREATED WITH TWICE-MONTHLY SOMAVARATAN (VRS-317) (ESPE 2017) - P1b/2a,P2/3; "In this GHD population, the pattern of CA > BA > HA persisted from baseline through 2y of somavaratan treatment, with increasing BA/CA and HA/CA ratios suggestive of catch-up growth. Change in HA/CA exceeded change in BA/CA ratios, indicating relatively greater improvement in linear growth than skeletal maturation. Greatest catch-up growth in BA/HA was observed in those with greatest initial deficits."

Biosimilar • Growth Hormone

Versartis closes $20 million series D venture financing (Versartis Press Release) - "Versartis...announced completion of a $20 million Series D financing led by new investor Sofinnova Ventures. The proceeds from this financing will primarily be used to prepare for an international Phase 3 pediatric trial of VRS-317, the company’s proprietary long-acting recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD). This financing round brings the company’s total venture capital raised in 2013 to $45 million. We remain on track to complete the Phase 2a portion of our ongoing pediatric trial of VRS-317 as planned to enable initiation of our Phase 3 trial in 2014."

Anticipated new P3 trial • Anticipated trial completion date • Financing • Growth Hormone