UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM8-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)
Delaware | 001-36361 | 26-4106690 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
LyondellBasell Tower
1221 McKinney Street, Suite 3200
Houston, Texas 77010
(Address of principal executive offices, including zip code)
(936)355-1910
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form8-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):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR240.14a-12) |
☐ | Pre-commencement communications pursuant toRule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
☐ | Pre-commencement communications pursuant toRule 13e-4(c) under the Exchange Act (17 CFR240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common stock, par value $0.0001 per share | ARAV | Nasdaq Global Select Market |
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 Rule12b-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. ☒
Item 8.01. | Other Events. |
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 first28-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 ofAVB-500 in patients with platinum-resistant recurrent ovarian cancer. The DMC did not identify safety concerns withAVB-500 (previously calledAVB-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 Form8-K and is incorporated herein by reference.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibit is filed with this Current Report on Form8-K:
Exhibit | Description | |
99.1 | Press Release issued by Aravive, Inc. on July 8, 2019 |
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.
Dated: July 8, 2019 | ARAVIVE, INC. (Registrant) | |||||
By: | /s/ Jay P. Shepard | |||||
Name: | Jay P. Shepard | |||||
Title: | Chief Executive Officer |