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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 6, 2015
Versartis, Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-36361
26-4106690
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
4200 Bohannon Drive, Suite 250
Menlo Park, California
94025
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: (650) 963-8580
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of
the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01
Regulation FD Disclosure.
Spokespersons of Versartis, Inc. (the “Company”) plan to present the information in the presentation poster attached hereto as Exhibit 99.1 at
The Endocrine Society’s 97th Annual Meeting and Expo (ENDO 2015) in San Diego, CA on March 6, 2015.
The furnishing of the attached presentation is not an admission as to the materiality of any information therein. The information contained in
the poster is summary information that is intended to be considered in the context of more complete information included in the Company’s
filings with the Securities and Exchange Commission (the “SEC”) and other public announcements that the Company has made and may make
from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in
this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the
filing of other reports or documents with the SEC, through press releases or through other public disclosures.
The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes
of Section 18 of the Securities Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or
incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set
forth by specific reference in any such filing.
Item 8.01
Other Events.
On March 6, 2015, the Company announced it was selected to present data from its ongoing Extension Study of pre-pubertal children with
moderate growth hormone deficiency (GHD) in a poster presentation at The Endocrine Society’s 97th Annual Meeting & Expo (ENDO 2015)
in San Diego, CA. A copy of the press release regarding this announcement, titled “Versartis Presents 12-Month Data for VRS-317 at
Late-Breaker Session at Endocrine Society’s Annual Meeting” is attached as Exhibit 99.2 hereto and is incorporated herein by reference.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No.
Description
99.1
Company poster presentation dated March 2015
99.2
Press release dated March 6, 2015, titled “Versartis Presents 12-Month Data for VRS-317 at Late-Breaker Session at Endocrine
Society’s Annual Meeting”
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Versartis, Inc.
Dated: March 6, 2015
By:
/s/ Joshua T. Brumm
Joshua T. Brumm
Chief Financial Officer
INDEX TO EXHIBITS
Exhibit
No.
Description
99.1
Company poster presentation dated March 2015
99.2
Press release dated March 6, 2015, titled “Versartis Presents 12-Month Data for VRS-317 at Late-Breaker Session at Endocrine
Society’s Annual Meeting”
Exhibit 99.1
Dose Response and 12 Month Safety and Efficacy of VRS-317 in Pre-Pubertal Children with Moderate Growth Hormone Deficiency (GHD)
George M Bright, MD, Clinical Development, Versartis, Inc., Menlo Park, CA, Wayne V Moore, MD, PhD, Endocrinology,
Children’s Mercy Hospital and University of Missouri-Kansas City, Kansas City, MO, H. Q. Nguyen, MD, Endocrinology,
Sierra Medical Research, Clovis, CA, Gad B. Kletter, MD, Swedish Medical Center, Seattle, WA, Bradley Miller, MD, PhD, Dept of Pediatric Endocrinology, Univ of Minnesota Amplatz
Childr, Minneapolis, MN, Douglas G. Rogers, MD, Pediatric Endocrinology, A120, Cleveland Clin
Fndn, Cleveland, OH, David Ng, PhD, Biostatistics, Research Point Global, Inc, Austin, TX, Eric Humphriss, MBA,
Clinical Operations, Versartis, Inc, Menlo Park, CA and Jeffrey L Cleland, PhD, Versartis Inc., Menlo Park, CA
Background:
Growth hormone deficient (GHD) children are treated for several years with daily injections of recombinant human growth hormone (rhGH) replacement therapy
Naïve to treatment pre-pubertal GHD children were enrolled in a Phase 1b/2a study (6 months of safety and efficacy) in the United States; Data from this study were reported previously1
Children completing the Phase 1b/2a study were offered enrollment in a long-term extension study; 95% of the children and their parents elected to enroll in the extension study
VRS-317: Long-Acting rhGH
VRS-317 is a novel fusion protein of rhGH with amino acid sequences (XTENs) attached to the N-and C-termini. VRS-317 is an investigational new drug.
VRS-317 exhibits a longer half-life than rhGH in prior studies in animals and GHD patients.
Figure 1. VRS-317 Design
Aims:
To study 12 months of safety and efficacy of VRS-317 in pre-pubertal GHD children and to evaluate the
effect of a dose increase on IGF-I and height velocity within a subset of the GHD children.
Methods:
Subjects in the Phase 1b/2a study on a VRS-317 dose of either 2.5 mg/kg semi-monthly or 5.0 mg/kg monthly were continued on the same dose for an additional 6 months in the extension st
udy. Subjects in the Phase 1b/2a study on a VRS-317 dose of 1.15 mg/kg weekly (5 mg/kg/month) were switched to 3.5 mg/kg semi-monthly (7 mg/kg/month) upon their first visit after the
completion of the Phase 1b/2a study. Subjects enrolled in the extension study as they completed the six months of treatment in the Phase 1b/2a study.
Subject Characteristics:
The degree of GHD was moderate as indicated by the screening characteristics including a mean age of 7.47 years,
mean HT-SDS = -2.60, mean IGF-I SDS = -1.75, and mean stimulated GH = 5.4 ng/mL.
Subject Recruitment and Retention:
Of 60 subjects enrolled in the Extension study, 57 completed 6 months of additional treatment (12 months total treatment).
Safety:
In general, the frequency of related AEs decreased from the first 6 months of treatment in the Phase 1b/2a to the second 6 months in the extension study (Table
1). During the second 6 months, there were less reports of related AEs (54% (34 of 63) to 15% (9 of 60))
and fewer reports of injection site discomfort (48% (31 of 64) to 8.3% (5 of 60)). There were no reports of
injection site discomfort among subjects switched at 6 months from 1.15 mg/kg weekly to 3.5 mg/kg semi-monthly. All related AEs were mild (Grade 1) and transient. There were no
related SAEs, no unexpected AEs, and no lipoatrophy or nodules.
Table 1. Related Adverse Events
ADVERSE EVENT 1
1.15 mg/kg Weekly to 3.5 mg/kg Semi-Monthly (6 Months)
1.15 mg/kg Weekly to 3.5 mg/kg Semi-Monthly (3 Months)
2.5 mg/kg Semi-Monthly
5.0 mg/kg Semi-Monthly
# Patients 5 15 18 22
# Patients with any AE 1 2 2 4
Musculoskeletal Pain 0 0 1 0
Injection Site Discomfort 0 2 1 3
Headache 0 0 1 0
Sinus Congestion 1 0 0 0
1 – Adverse events in the extension study. After the dose increase decision to 3.5 mg/kg semi-monthly dose, 5 subjects were treated for 6 months and 15 subjects were treated for 3 months.
Safety/Tolerability Profile Comparable to Daily rhGH
Pharmacodynamics:
As compared to subjects maintained on a 2.5 mg/kg semi-monthly regimen, subjects increased to 3.5 mg/kg semi-monthly had an increase in IGF-I SDS (Figure 2) without overexposure (no
IGF-I SDS > 3).
Figure 2. IGF-I SDS for subjects receiving VRS-317 doses of 2.5 mg/kg semi-monthly or the 3.5 mg/kg semi-monthly
IGF-I SDS (MEAN SD)
2.5 mg/kg SEMI-MONTHLY (n=19)
3.5 mg/kg SEMI-MONTHLY (n=16)
-2 -1.5 -1 -0.5 0 0.5 1 1.5 2 -0.4 0.5
Dose Response for IGF-I SDS No Overexposure in IGF-I SDS
Efficacy:
The annualized height velocity in successive 6 month intervals increased in subjects who were switched from 1.15 mg/kg weekly to 3.5 mg/kg semi-monthly at 6 months (Figure 3).
Figure 3. Annualized height velocity in the same subjects treated for 6 months at 1.15 mg/kg weekly and then treated for 6 months at 3.5 mg/kg semi-monthly (n= 5)
Annualized Height Velocity (cm / year)
0-6 mo 1.15 mg/kg weekly (5mg/kg/mo)
6-12 mo 3.5 mg/kg Semi-Weekly (7mg/kg/mo)
4
5 6 7 8 9 10 11 12 13 14 7.5 9.3
Dose Increase Resulted in Height Velocity Increase
Based on experience with daily rhGH treatment, a decrease in annualized height velocity was expected in subjects maintained on a constant VRS-317 dose
for a second 6 months (2.5 mg/kg semi-monthly and 5.0 mg/kg monthly). As compared to rhGH, a minimal decrease in annualized height velocity was observed in the constant dose
VRS-317 groups (Figure 4).
Figure 4. Height velocity in subjects treated for 12 months at 2.5 mg/kg semi-monthly or 5.0 mg/kg monthly compared to historical daily rhGH
0 2 4 6 8 10 12 14
4
5 6 7 8 9 10 11 12
8.4 8.5 8.6 8.9 7.9 10.9
Monthly 5mg/kg (n=22)
Semi-Monthly 2.5 mg/kg (n=18)
Daily rhGH,34 g/kg/day (n=211)1
1 - Daily rhGH source data: Summary Basis of Approval NDA 19-721 & NDA 21-426; Moderate GHD patients comparable to VRS-317 study
Summary:
VRS-317 is safe and well tolerated after 12 months of treatment
Lower rate of related adverse events in second 6 months
All regimens provide comparable IGF-I responses with minimal excursions (> IGF-I SDS of 2) comparable to daily rhGH3
Adjusting VRS-317 dose from 2.5 mg/kg semi-monthly to 3.5 mg/kg semi-monthly resulted in:
Expected increase in IGF-I response without overexposure
Increase in height velocity demonstrating dose response
Less waning of the growth response was observed over the first 12 months of VRS-317 treatment than typically observed with daily rhGH therapy
Acknowledgments
The study was sponsored by Versartis, Inc. The Sponsor wishes to thank Research Point Global for managing the clinical trial,
Symphony Clinical Research™ for conducting home visits, the investigators and coordinators for excellent patient care, and the patients and their families for their participation in the study.
1. Bright et al, Endocrine Society Meeting Poster # MON-0147 (June 23, 2014)
2. Cleland et al, J. Pharm Sci. 101(8): 2744-2754 (2012)
3. Cohen et al, Clin Endo 81: 71-76 (2014)
Exhibit 99.2
Versartis Presents 12-Month Data for VRS-317 at Late-Breaker Session at Endocrine Society’s Annual Meeting
Data from Ongoing Pediatric Extension Study of Long-acting rhGH Presented Today at 1:00 p.m. PT Poster Session
Menlo Park, Calif., March 6, 2015 — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing
a novel, long-acting form of recombinant human growth hormone (rhGH), today announced it was selected to present data from its ongoing
Extension Study of pre-pubertal children with moderate growth hormone deficiency (GHD) in a poster presentation at The Endocrine Society’s
97 th Annual Meeting & Expo (ENDO 2015) in San Diego, CA. While previously disclosed ( see press release ), this is the first time the results
are being presented in a scientific meeting. George Bright, MD, Versartis Vice President of Clinical Development, will discuss the results at the
clinical poster session “Late-breaking Pediatric Endocrinology II” from 1:00 – 3:00 p.m. PT today.
“We are excited to have data from our ongoing pediatric Extension Study selected as a late-breaking poster presentation at the ENDO 2015
Annual Meeting. These data demonstrated a dose response in the subset of patients that were switched to a higher dose of VRS-317 on a
semi-monthly basis, while maintaining safety and tolerability in line with results from our Phase 2a study,” said Jeffrey L. Cleland, PhD, Chief
Executive Officer. “Importantly, VRS-317 showed less waning of growth response over the 12 month period when compared to current daily
rhGH therapy. With these results in hand, we have further confidence in the design of our global Phase 3 VELOCITY study, which was
initiated in January 2015.”
Highlights from the Poster Presentation
•
VRS-317 is safe and well tolerated after 12 months of treatment
•
•
All regimens provide similar IGF-I responses comparable to those of daily rhGH and with minimal excursions of IGF-I SDS
exceeding 2
•
•
•
Lower rate of related adverse events in second 6 months
Dose response confirmed by IGF-I SDS moving up nearly 1.0 standard deviation (SD); this was achieved by increasing the
dose from 2.5 to 3.5mg/kg semi-monthly
Adjusting VRS-317 dose from 2.5 mg/kg semi-monthly to 3.5 mg/kg semi-monthly resulted in:
•
Expected increase in IGF-I response (mentioned above) without overexposure
•
Patients who switched from 1.15 mg/kg weekly to 3.5 mg/kg semi-monthly (n=5) experienced a height velocity increase
from 7.5 to 9.3 cm/yr
Less waning of the growth response was observed over the first 12 months of VRS-317 treatment than typically observed with
daily rhGH therapy
The Extension Study’s primary objective is to study the safety and efficacy of long-term treatment with VRS-317 in pre-pubertal GHD children
and to evaluate the effect of a dose
increase on IGF-I and height velocity within a subset of the GHD children. In the ongoing Extension Study, subjects in the Phase 2a study on a
VRS-317 dose of either 2.5 mg/kg semi-monthly or 5.0 mg/kg monthly were continued on the same dose for an additional 6 months. Subjects
in the Phase 2a study on a VRS-317 dose of 1.15 mg/kg weekly (5 mg/kg/month) were switched to 3.5 mg/kg semi-monthly (7 mg/kg/month)
upon their first visit after the completion of the Phase 2a study. Subjects enrolled in the Extension Study as they completed the six months of
treatment in the Phase 2a study.
Poster and Program Details:
Title:
“Dose Response and 12-Month Safety and Efficacy of VRS-317 in Pre-Pubertal Children with Moderate Growth Hormone
Deficiency (GHD)”
Program:
Abstracts – Poster Viewing with Presenters
Session:
LBF 024-030 Late-breaking Pediatric Endocrinology II
Poster:
Poster Board LBF-026
Location:
Hall D-F (San Diego Convention Center)
Date:
Friday, March 6, 2015: 1:00 – 3:00 p.m. PT
The poster can be viewed by CLICKING HERE and is also available online within the “ EVENTS AND PRESENTATIONS ” section of the
Company’s investor relations website at www.versartis.com .
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant
human growth hormone for the treatment of growth hormone deficiency (GHD). VRS-317 is intended to reduce the burden of daily injection
therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company
completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, semi-monthly and monthly dosing regimens of VRS-317 in children
with GHD in June 2014 and began a global Phase 3 registration study, VELOCITY, in GHD children in January 2015. Further information
on Versartis can be found at www.versartis.com .
Cautionary Note on Forward Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as “intended,” “potential,” “will” or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions or current
expectations concerning, among other things, plans and timing of our clinical trials and benefits of VRS-317. These statements are subject to
risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks
and uncertainties related to: our success being heavily dependent on VRS-317; VRS-317 being a new chemical entity; the potential for serious
adverse side effects, if they are associated with VRS-317; VRS-317 may not have favorable results in later clinical trials or receive regulatory
approval; other long-acting
rhGH products and product candidates have failed to generate commercial success or obtain regulatory approval; delays in enrollment of
patients in our clinical trials could increase our costs and cause delay; VRS-317 may cause serious adverse side effects or have properties that
delay or prevent regulatory approval or limit its commercial profile; we may encounter difficulties in manufacturing VRS-317; if approved,
risks associated with market acceptance, including pricing and reimbursement; our ability to enforce our intellectual property rights; the
importance of our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We
discuss many of these risks in greater detail under the heading “Risk Factors” contained in the final prospectus dated January 21, 2015 from our
follow-on public offering, which is on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not
guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in
which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements
that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking
statements whether as a result of new information, future events or otherwise, after the date of this press release.
Contacts:
Corporate & Investors:
Joshua Brumm
Chief Financial Officer
(650) 963-8582
[email protected]
Investors:
Nick Laudico/David Burke
The Ruth Group
(646) 536-7030/7009
[email protected]
[email protected]
Media:
Debra Bannister
Corporate Communications
(530) 676-7373
[email protected]
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