Item 7.01. Regulation FD Disclosure.
On January 4, 2023, Aravive, Inc. (the "Company") issued a press release
attached hereto as Exhibit 99.1 announcing that the Company had achieved full
enrollment in its registrational Phase 3 trial of batiraxcept plus paclitaxel
for platinum-resistant ovarian cancer ("PROC"). The global, randomized,
double-blind, placebo-controlled Phase 3 AXLerate-OC trial is evaluating
efficacy and tolerability of 15 mg/kg batiraxcept in combination with weekly
paclitaxel versus placebo in combination with weekly paclitaxel. The Company
also announced that public reporting of topline Phase 3 PROC data remained on
track for mid-2023 and, if successful, would support a potential biologics
license application (BLA) submission for PROC at the end of 2023.
The information in this Item 7.01 and in the press release furnished as Exhibit
99.1 to this Current Report on Form 8-K shall not be deemed to be "filed" for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2)
of the Securities Act of 1933, as amended, and shall not be incorporated by
reference into any filing with the U.S. Securities and Exchange Commission made
by the Company, whether made before or after the date hereof, regardless of any
general incorporation language in such filing.
The Company's press release furnished as Exhibit 99.1 to this Current Report on
Form 8-K includes "safe harbor" language pursuant to the Private Securities
Litigation Reform Act of 1995, as amended, indicating that certain statements
contained therein are "forward-looking" rather than historical.
Item 8.01. Other Events.
On January 4, 2023, the Company issued a press release announcing that the
Company had achieved full enrollment in its registrational Phase 3 trial of
batiraxcept plus paclitaxel for PROC. The global, randomized, double-blind,
placebo-controlled Phase 3 AXLerate-OC trial is evaluating efficacy and
tolerability of 15 mg/kg batiraxcept in combination with weekly paclitaxel
versus placebo in combination with weekly paclitaxel. The Company also announced
that public reporting of topline Phase 3 PROC data remained on track for
mid-2023 and, if successful, would support a potential biologics license
application (BLA) submission for PROC at the end of 2023.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Press release of Aravive, Inc., dated January 4, 2023
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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