Item 7.01. Regulation FD Disclosure.
On November 19, 2020, Aravive, Inc. (the "Company") issued a press release
announcing that the Company has received guidance from the U.S. Food and Drug
Administration (FDA) on a Phase 3 trial design for AVB-500 in platinum resistant
ovarian cancer (PROC). The global, randomized, double-blind, placebo-controlled
adaptive trial is designed to evaluate efficacy and tolerability of AVB-500 at a
dose of 15 mg/kg in combination with paclitaxel. A copy of the press release is
furnished as Exhibit 99.1 to this Current Report on Form 8-K.
In addition, the Company will be making several presentations to investors over
the next several weeks. In connection with the presentations, the Company
intends to discuss the investor presentation, which is furnished as Exhibit 99.2
to this Current Report on Form 8-K.
The information in this Item 7.01, in the press release attached as Exhibit 99.1
and in the investor presentation attached as Exhibit 99.2 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. The information contained in this Item 7.01, in the press
release attached as Exhibit 99.1 and in the investor presentation attached as
Exhibit 99.2 to this Current Report on Form 8-K 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 press release attached as Exhibit 99.1 and investor presentation attached as
Exhibit 99.2 to this Current Report on Form 8-K include "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.
The Company undertakes no duty or obligation to update or revise the information
contained in this Current Report on Form 8-K, although it may do so from time to
time if its management believes it is appropriate. Any such updating may be made
through the filing of other reports or documents with the Securities and
Exchange Commission, through press releases or through other public disclosures.
Item 8.01. Other Events.
On November 19, 2020, the Company issued a press release announcing that the
Company has received guidance from the U.S. Food and Drug Administration (FDA)
on a Phase 3 trial design for AVB-500 in platinum resistant ovarian cancer
(PROC). The global, randomized, double-blind, placebo-controlled adaptive trial
is designed to evaluate efficacy and tolerability of AVB-500 at a dose of 15
mg/kg in combination with paclitaxel. The Company noted that there was agreement
from the FDA that the Company's preclinical and clinical pharmacology programs
are now complete, and that this trial, if successful, could support the
submission of a biologics license application to the FDA. The Company plans to
initiate the trial in the first quarter of 2021, with an interim analysis
expected a year later, Q12022.
The pivotal, adaptive Phase 3 trial is expected to enroll approximately 300-400
patients with high-grade serous ovarian cancer who have received one to four
prior lines of therapy. This global trial is expected to be conducted at
approximately 100 sites in the U.S. and Europe. The primary endpoint for the
trial is progression free survival, and secondary endpoints include overall
survival, objective response rate, duration of response, quality of life,
clinical benefit rate, and pharmacokinetic and pharmacodynamic profile.
Prospectively defined interim analyses will investigate treatment differences in
patients who have previously received bevacizumab versus those who have not and
will explore the biomarkers identified in the Phase 1b trial in an effort to
test the hypotheses generated from the Phase 1b data. Based on the interim
analyses, the trial can be adapted to include only those patients who have not
previously been treated with bevacizumab and/or whose baseline serum biomarker
results meet the identified threshold.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished to this Current Report on Form 8-K:
Exhibit
Number Description
99.1 Press Release dated November 19, 2020
99.2 Investor Presentation of Aravive, Inc dated November 2020
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