Current Report Filing (8-k)
July 31 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 31, 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 31, 2019, Aravive, Inc. (the Company) issued a press release announcing that the preliminary efficacy data from their ongoing clinical
trial with
AVB-500
showed compelling anti-tumor activity in the 12 patients treated from the first cohort of the ongoing Phase 1b portion of the Phase 1b/2 trial of
AVB-500
in patients with platinum-resistant recurrent ovarian cancer where response to standard of care chemotherapy alone in patients is typically
10-15 percent.
The open-label, Phase 1b safety
lead-in
portion of the efficacy and safety study of
AVB-500
in patients with platinum-resistant recurrent ovarian cancer enrolled patients into two cohorts, one investigating a combination of
AVB-500
with pegylated liposomal
doxorubicin (PLD) and the other, a combination of
AVB-500
with paclitaxel (PAC). The overall best response rate (ORR) in the
AVB-500
combination cohorts to date by
investigator determined RECIST v1.1 criteria was greater than response rates observed historically with standard of care chemotherapy alone in this clinical setting. The Company therefore has decided to expand enrollment in the Phase 1b portion of
the study, to validate the unanticipated early positive efficacy signal.
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 31, 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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