Versartis Presents Confirmatory 18-Month Data From Ongoing Somavaratan Extension Study at Late-Breaker Session at ESPE Annual Meeting

Versartis, Inc.

, 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 released confirmatory data from its ongoing Extension Study of somavaratan in pre-pubertal GHD children at the 54th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) in Barcelona, Spain. These data were previously disclosed in the poster abstract (see press release), and today is the first time the results are being shared as a poster presentation. George Bright, MD, Versartis Vice President of Clinical Development, will discuss the results at the Growth Hormone and IGF Treatment poster session (poster LBP-1267) from 1:30-2:30 PM Barcelona Time (CEST) on Saturday, October 3. Jay Shepard, Chief Executive Officer, commented, "Data presented at the ESPE conference provide further validation of the 3.5 mg/kg dose of somavaratan that we are currently using in our VELOCITY Phase 3 trial for pediatric growth hormone deficient patients. As we have demonstrated in previous trials and continue to show with these recent data, somavaratan is a long-acting treatment for GHD that may provide a safe and effective alternative to the daily injections that are the current standard of care. We continue to collect data from our ongoing global studies to support filing for approval in targeted markets and potential commercialization of somavaratan worldwide." Highlights from Poster Presentation Increasing the twice-monthly dose of somavaratan from 2.5 mg/kg to 3.5 mg/kg increased mean peak IGF-I SDS from −0.30 ± 1.2 to 0.32 ± 1.6. Mean height velocity (HV) was 7.9 ± 2.1 and 8.5 ± 2.1 cm/year for 5.0 mg/kg monthly and 2.5 mg/kg twice-monthly dosing after 12 months, respectively. Upon switching to the 3.5 mg/kg twice-monthly dose the mean (annualized) 12-18 month HV was 8.1 ± 2.4 and 8.3 ± 1.8 cm/year for each dose group respectively. The Extension Study continued to show that somavaratan is well tolerated and that the safety profile at the 3.5 mg/kg Phase 3 dose is comparable to daily growth hormone therapy. More specifically, the number of adverse events declined over the 12 to 18-month period of therapy and there were no unexpected or serious adverse events. The few events noted were mild and transient. As part of its ongoing pediatric Extension Study, the Company evaluated whether an increase in twice-monthly dosing of somavaratan from 2.5 mg/kg to 3.5 mg/kg would offset the decrease in height velocity in patients during the second year of rhGH treatment, which is commonly seen with daily rhGH therapy. The analysis consisted of 56 subjects who completed 18 months of treatment in the Extension Study. Results from the analysis showed that an increase in the twice-monthly dose from 2.5 mg/kg to 3.5 mg/kg increased mean peak IGF-I SDS from −0.30 ± 1.2 to 0.32 ± 1.6 (paired t-test, P=0.007). The number of peak IGF-I SDS results greater than 2.0 for all subjects receiving the 3.5 mg/kg twice-monthly dosing regimen was limited to three individual values. The increased dose demonstrated a stabilized height velocity consistent with the initial 12 months of treatment. The mean height velocity was 7.9 ± 2.1 and 8.5 ± 2.1 cm/year for 5.0 mg/kg monthly and 2.5 mg/kg twice-monthly dosing, respectively, compared with 8.1 ± 2.4 and 8.3 ± 1.8 cm/year (annualized), respectively, after 18 months (3.5 mg/kg twice-monthly). In addition, adverse events (AE) continued to be mild and transient in nature at the 3.5 mg/kg dose. There were no new or unexpected AE occurrences and injection site discomfort decreased with time on treatment, with only four subjects reporting discomfort after 18 months. Poster and Program Details: Title: "Safety and Efficacy of Long-Acting Growth Hormone Somavaratan (VRS-317) in Children with GHD: Effects of Dose Change in the Second Treatment Year" Session: GH & IGF Treatment Poster: LBP-1267 Location: Fira Barcelona Gran Via venue, Hall 8 Dates: Poster available for viewing Thursday, Oct. 1 Poster Presentation: Oct. 3, 1:30-2:30PM Barcelona Time (CEST) The poster can be viewed by CLICKING HERE and the abstract can be viewed by CLICKING HERE. Both the poster and abstract are also available online within the "EVENTS AND PRESENTATIONS" section of the Company's investor relations website at www.versartis.com.