Current Report Filing (8-k)
July 08 2019 - 7:16AM
Edgar (US Regulatory)
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): July 8, 2019
Aravive, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-36361
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26-4106690
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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LyondellBasell Tower
1221 McKinney Street, Suite 3200
Houston, Texas 77010
(Address of principal executive offices, including zip code)
(936)
355-1910
(Registrants telephone number, including area code)
Check the appropriate box below if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (
see
General Instruction A.2. below):
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17
CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to
Rule 14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to
Rule 13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Common stock, par value $0.0001 per share
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ARAV
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Nasdaq Global Select Market
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of
1933 (17 CFR §230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934 (17 CFR
§240.12b-2
of this chapter).
Emerging growth company ☒
If an
emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☒
On July 8, 2019, Aravive, Inc. (the Company) issued a press release announcing that the independent Data Monitoring Committee
(DMC) has reviewed the open-label data following the first
28-day
treatment cycle for the first six patients in each of the two cohorts of the Phase 1b portion of the Phase 1b/Phase 2 trial of
AVB-500
in patients with platinum-resistant recurrent ovarian cancer. The DMC did not identify safety concerns with
AVB-500
(previously called
AVB-S6-500).
Importantly, data demonstrated suppression of serum GAS6 levels, a biomarker associated with efficacy in preclinical tumor models, with the current dose.
The dosing regimen was predicted by the Phase 1 healthy volunteer study. The DMC unanimously recommended the study continue as planned and enroll additional patients into each cohort to collect additional preliminary efficacy, safety, biomarker and
PK/PD data at the current dose. The Company remains on track to report interim safety, pharmacodynamic, and pharmacokinetic data for the phase 1b portion in the third quarter of 2019.
The press release is attached as Exhibit 99.1 to this Current Report on Form
8-K
and is incorporated herein by
reference.
Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits.
The following exhibit is filed with this Current
Report on Form
8-K:
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.
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Dated: July 8, 2019
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ARAVIVE, INC.
(Registrant)
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By:
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/s/ Jay P. Shepard
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Name:
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Jay P. Shepard
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Title:
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Chief Executive Officer
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