Item 7.01. Regulation FD Disclosure.
As previously announced, Aravive, Inc. (the “Company”) will host a Key Opinion
Leader Symposium ( the “Symposium”) on May 11, 2022. At the Symposium, the
Company will present updated information about its clinical trials. A copy of
an updated investor presentation is furnished as Exhibit 99.1 to this Current
Report on Form 8-K. The Company intends to use the investor presentation, in
whole or in part, at the Symposium and in one or more meetings with investors
and analysts.
The information in this Item 7.01 and in the investor presentation 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 investor presentation furnished as Exhibit 99. 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.
Item 8.01. Other Events.
The Company’s updated investor presentation includes the following information.
? New unpublished data from Dr. Katherine Fuh showed that biomarker high naïve
ovarian cancer patients that had been shown to have a 47% response rate in the
Phase 1b platinum-resistant ovarian cancer (PROC) study were poor responders
to initial chemotherapy (i.e., treatment that did not contain batiraxcept).
? Updated data as of April 30, 2022 from the ccRCC Phase 1b trial from 26
patients treated with batiraxcept in the Phase 1b portion of the trial at
doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus cabozantinib 60 mg daily in
previously treated (2L+) patients with ccRCC:
o There were no dose limiting toxicities observed at either dose;
o 14 of the 26 patients remain on study with 9 out of the 12 patients who ended
treatment still in survival follow-up;
o The best overall response rate (ORR, confirmed + unconfirmed) was 46% across
both doses in the ITT population and 50% in patients dosed with 15 mg/kg (the
recommended Phase 2 dose);
o The best ORR 60% across both doses in the biomarker high population and 67% in
the biomarker high population dosed at 15 mg/kg;
o The 7-month progression-free survival (PFS) rate was 71% across both doses in
the ITT population, 83% across both doses in the biomarker high population,
and 91% in the 15 mg/kg biomarker high group; and
o Eight patients (101-004, 101-005, 102-002, 104-003, 105-002, 105-004, 105-006,
and 107-002) experienced resolution of one or more target lesions.
? Updated data as of May 3, 2022 from the 21 patients dosed with 15mg/kg
batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line
treatment in patients with advanced or metastatic pancreatic adenocarcinoma in
the Phase 1b pancreatic adenocarcinoma trial:
o Analysis of all safety data to date demonstrates that batiraxcept has been
generally well-tolerated with no unexpected safety signals;
o The best ORR (confirmed + unconfirmed) was 29%;
o As noted with the other programs, an observable correlation of baseline levels
of serum soluble AXL (sAXL)/GAS6 to clinical activity was noted in this trial
and the best ORR in that biomarker high population was 40%; and
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o Five patients (202-004, 202-005, 206-002, 213-002 and 214-001) experienced
resolution of one or more target lesions with additional information on these
patients:
? 206-002 and 213-002 have since progressed;
? 2 patients (213-002 and 214-001) had CA19-9 level that decreased to within
normal limits during the study; and
? An outline of a registrational ccRCC study recommended by FDA which involves
an integrated P2/P3 study with interim analyses to look at futility in the
biomarker low population and ORR for potential accelerated approval with PFS
endpoint for full approval. This design provides an opportunity for
accelerated approval and full approval in one study. The final PFS analysis
will be conducted in the ITT and the biomarker high populations to increase
the chance for success. The full protocol and statistical plan are in
preparation for submission to FDA.
? Updated milestones to reflect activities in 2H'23: Initiation of P2 PDAC
trial, dependent on results of the P1b PDAC trial.
? Updated milestones to reflect activities in 1H'24: Approval of PROC BLA, if
trial is successful and if the Company successfully submit a BLA in 2H 2023;
Initiate CTGF Clinical Studies, if IND accepted; and Safety and Preliminary
Activity from P2 PDAC Trial, should the Company initiate a P2 PDAC trial.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number Exhibit Description 99.1 Investor Presentation of Aravive, Inc. dated May 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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