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 31, 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 to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule13e-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 31, 2019, Aravive, Inc. (the “Company”) issued a press release announcing that the preliminary efficacy data from their ongoing clinical trial withAVB-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 ofAVB-500 in patients with platinum-resistant recurrent ovarian cancer where response to standard of care chemotherapy alone in patients is typically10-15 percent.
The open-label, Phase 1b safetylead-in portion of the efficacy and safety study ofAVB-500 in patients with platinum-resistant recurrent ovarian cancer enrolled patients into two cohorts, one investigating a combination ofAVB-500 with pegylated liposomal doxorubicin (PLD) and the other, a combination ofAVB-500 with paclitaxel (PAC). The overall best response rate (ORR) in theAVB-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 onForm 8-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 onForm 8-K:
Exhibit | Description | |
99.1 | Press Release issued by Aravive, Inc. on July 31, 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 31, 2019 | ARAVIVE, INC. (Registrant) | |||||
By: | /s/ Jay P. Shepard | |||||
Name: | Jay P. Shepard | |||||
Title: | Chief Executive Officer |