Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage
oncology company developing targeted therapeutics to treat
metastatic disease, today reported financial results for the first
quarter ended March 31, 2022 and provided corporate updates.
“During the first quarter we continued to advance the
development of batiraxcept for the potential treatment of ovarian,
kidney and pancreatic cancer, successfully raised additional
capital and strengthened the management team,” said Gail McIntyre,
Ph.D., DABT, Chief Executive Officer of Aravive. “Our
registrational Phase 3 trial of batiraxcept in ovarian cancer
continues on pace to complete enrollment in 2022, with top line
data anticipated in 2Q’23 and a potential BLA filing with the FDA
in 4Q’23. Our ongoing Phase 2 trial of batiraxcept in clear cell
renal cell carcinoma also continues to successfully enroll patients
across three cohorts and the Phase 1b trial of batiraxcept in
pancreatic cancer completed enrollment in 1Q’22. Updated results
are anticipated throughout 2022. We remain encouraged by the
continued signals of best-in-class potential of batiraxcept and
look forward to providing continued clinical updates on each of our
three active programs throughout 2022.”
Recent Corporate Highlights
- Batiraxcept in Platinum Resistant Ovarian Cancer
(PROC): The registration-directed Phase 3 program of
batiraxcept in combination with paclitaxel in PROC remains on track
to complete enrollment in 2H’22. Topline data from the trial is
anticipated to be available in 2Q’23. CMC work related to the PROC
program remains on track with the goal of filing a BLA in 4Q’23.
The global, randomized, double-blind, placebo-controlled Phase 3
trial is evaluating efficacy and tolerability of batiraxcept at a
dose of 15 mg/kg in combination with paclitaxel versus placebo in
combination with paclitaxel. The trial aims to enroll 350 platinum
resistant, high-grade serous ovarian cancer patients who have
received 1-4 prior lines of therapy.
- Batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC)
and Serum-Based Biomarker: The Company dosed first patient
in the Phase 2 study of batiraxcept in combination with
cabozantinib in 2L+ ccRCC trial in January 2022. Enrollment across
the three patient cohorts of the Phase 2 study continues on pace
for planned completion and updated data releases during 2Q’22. The
Company anticipates providing clinical updates on the Phase 2 study
throughout 2022. In March 2022, the Company announced new biomarker
data from the Phase 1b portion of the trial in patients with ccRCC.
Aravive had previously reported an observable correlation of
baseline levels of serum soluble AXL (sAXL)/GAS6 to clinical
activity in its Phase 1b PROC trial. As such, one of the objectives
of the ongoing Phase 1b/2 ccRCC trial is to evaluate the
correlation of baseline sAXL/GAS6 with radiographic response in
patients with ccRCC treated with batiraxcept plus cabozantinib. The
Company continues to engage the US FDA about utilizing the
biomarker as a basis for an accelerated development strategy.
Updated biomarker data is anticipated in 2022.As of April 30, 2022,
26 patients with ccRCC were 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. There were no dose limiting toxicities
observed at either dose and 14 of the 26 patients remain on study.
The best overall response rate (ORR, confirmed + unconfirmed) in
the ITT population was 46% and 50% in patients dosed with 15 mg/kg
(the recommended Phase 2 dose). The best ORR in the biomarker high
population was 60%, and 67% in the biomarker high population dosed
at 15 mg/kg. The 7-month progression-free survival (PFS) rate was
71% in the ITT population, 83% in the biomarker high population,
and 91% in the 15 mg/kg biomarker high group. Eight patients
experienced resolution of one or more target lesions. The company
is on track to report additional updated results from the Phase 1b
portion of the trial in the second quarter of 2022.
- Batiraxcept in Pancreatic Adenocarcinoma: In
January 2022, Aravive completed enrollment of the Phase 1b portion
of its Phase 1b/2 trial of batiraxcept in combination with
gemcitabine and nab-paclitaxel as a first-line treatment in
patients with advanced or metastatic pancreatic adenocarcinoma who
are eligible to receive gemcitabine and nab-paclitaxel combination
therapy. As of May 3, 2022, 21 patients have been treated with 15
mg/kg batiraxcept in combination with gemcitabine and
nab-paclitaxel as a first-line treatment. Batiraxcept has been
generally well-tolerated with no unexpected safety signals. The
best ORR (confirmed + unconfirmed) was 29%. 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 as well and the best ORR in the biomarker high population was
40%. Five patients experienced resolution of one or more target
lesions; however, 2 of these patients have since progressed. The
company is on track to report additional updated data from the
Phase 1b portion of the trial in the second quarter of 2022.
- Strengthened Balance Sheet: In January 2022,
Aravive raised approximately $10.0 million from the sale of a
pre-funded warrant to purchase 4,545,455 shares of the company’s
common stock to Eshelman Ventures, LLC at a price of $2.20 per
share, which was the consolidated closing bid price of the
company’s common stock on The Nasdaq Global Select Market on
December 31, 2021. Additionally, Fred Eshelman, Pharm.D., was
appointed the Executive Chairman of Aravive, having served as the
Non-Executive Chairman of the board since April 2020. In March
2022, the Company raised an additional approximately $10.0 million
from the sale of common stock and a pre-funded warrant for an
aggregate of a combination of 4,850,241 shares of the company’s
common stock and pre-funded warrants to a single healthcare-focused
institutional investor and Eshelman Ventures, LLC and issued
warrants to purchase an additional aggregate of 4,850,241 shares of
common stock in a registered direct offering priced at-the-market
under Nasdaq rules. Combined, the additional capital infusions
strengthen the Company’s financial position and fund operations as
currently planned into 1Q’23.
First Quarter 2022 Financial ResultsRevenue for
the three months ended March 31, 2022 was $1.1 million compared
with $0.3 million for the same period in 2021. Revenues were
derived solely from the Company’s collaboration and license
agreement with 3D Medicines, executed in November 2020 to develop
and commercialize batiraxcept in oncology indications in Greater
China. Revenues represent a portion of initial signing and
milestone payments received from 3D Medicines that is recognized at
the time of the receipt and a portion of the payments that is
deferred and recognized over the PROC trial period.
Total operating expenses for the three months ended March 31,
2022 were $16.1 million compared with $8.3 million for the same
period in 2021. Total operating expenses for the three months ended
March 31, 2022 included non-cash stock-based compensation expense
of $0.6 million, compared to $0.5 million for the same period in
2021.
For the three months ended March 31, 2022, Aravive reported a
net loss of $13.1 million, or $0.62 per share compared to a net
loss of $8.0 million, or $0.44 per share for the same period in
2021.
Cash PositionAs of March 31, 2022, cash and
cash equivalents were $65.8 million, compared to $59.4 million as
of December 31, 2021. In January 2022, Aravive announced an
approximately $10.0 million investment by Eshelman Ventures and in
March 2022, Aravive announced an additional approximately $10
million investment by a healthcare-focused institutional investor
and Eshelman Ventures, LLC. The company anticipates that its
current cash and cash equivalents will fund operating plans into
1Q’23.
About AraviveAravive, Inc. is a
late clinical-stage oncology company developing targeted
therapeutics to treat metastatic disease. Our lead product
candidate, batiraxcept (formerly AVB-500), is an ultra-high
affinity decoy protein that binds to GAS6, the sole ligand that
activates AXL, thereby inhibiting metastasis and tumor growth, and
restoring sensitivity to anti-cancer agents. Batiraxcept has been
granted Fast Track Designation by the U.S. FDA and Orphan Drug
Designation by the European Commission in platinum-resistant
recurrent ovarian cancer. Batiraxcept is in an active
registrational Phase 3 trial in platinum resistant ovarian cancer
(NCT04729608), a Phase 1b/2 trial in clear cell renal cell
carcinoma (NCT04300140), and a Phase 1b/2 trial in pancreatic
adenocarcinoma (NCT04983407). The Company is based in Houston,
Texas and received a Product Development Award from the Cancer
Prevention & Research Institute of Texas (CPRIT) in 2016.
Additional information at www.aravive.com.
Forward Looking StatementsThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 on
our current expectations and projections about future events. In
some cases, forward-looking statements can be identified by
terminology such as “may,” “should,” “potential,” “continue,”
“expects,” “anticipates,” “intends,” “plans,” “believes,”
“estimates,” and similar expressions and include statements
regarding the registrational Phase 3 trial of batiraxcept in
ovarian cancer continuing on pace to complete enrollment in 2022,
with top line data anticipated in 2Q’23 and a potential BLA filing
with the FDA in 4Q’23, the ongoing Phase 2 trial of batiraxcept in
clear cell renal cell carcinoma also continuing to successfully
enroll patients across three cohorts; updated results are
anticipated throughout 2022, providing continued clinical updates
on each of our three active programs throughout 2022, the Phase 3
trial enrolling 350 platinum resistant, high-grade serous ovarian
cancer patients who have received 1-4 prior lines of therapy, the
potential of utilizing the biomarker as a basis for an accelerated
development strategy for clear cell renal cell carcinoma; updated
biomarker data in 2022, being on track to report additional updated
results from the Phase 1b portion of the clear cell renal cell
carcinoma trial in the second quarter of 2022, being on track to
report additional updated data from the Phase 1b portion of the
pancreatic adenocarcinoma trial in the second quarter of 2022 and
current cash and cash equivalents funding operating plans into
1Q’23. Forward-looking statements are based on current beliefs and
assumptions, are not guarantees of future performance and are
subject to risks and uncertainties that could cause actual results
to differ materially from those contained in any forward-looking
statement as a result of various factors, including, but not
limited to, risks and uncertainties related to: the ability to
report data from the current clinical trials in accordance with
current timelines, the data from patients treated in the future
with batiraxcept being consistent with the results reported, the
ability to enroll the expected number of patients, the impact of
COVID-19 on the Company's clinical strategy, clinical trials,
supply chain and fundraising, the Company's ability to expand
development into additional indications, the Company's dependence
upon batiraxcept, batiraxcept’s ability to have favorable results
in clinical trials and ISTs, the clinical trials of batiraxcept
having results that are as favorable as those of preclinical and
clinical trials, the ability to receive regulatory approval,
potential delays in the Company's clinical trials due to regulatory
requirements or difficulty identifying qualified investigators or
enrolling patients; the risk that batiraxcept may cause serious
side effects or have properties that delay or prevent regulatory
approval or limit its commercial potential; the risk that the
Company may encounter difficulties in manufacturing batiraxcept; if
batiraxcept is approved, risks associated with its market
acceptance, including pricing and reimbursement; potential
difficulties enforcing the Company's intellectual property rights;
the Company's reliance on its licensor of intellectual property and
financing needs. The foregoing review of important factors that
could cause actual events to differ from expectations should not be
construed as exhaustive and should be read in conjunction with
statements that are included herein and elsewhere, including the
risk factors included in the Company's Annual Report on Form 10-K
for the fiscal year ended December 31, 2021, recent Current Reports
on Form 8-K and subsequent filings with the SEC. Except as required
by applicable law, the Company undertakes no obligation to revise
or update any forward-looking statement, or to make any other
forward-looking statements, whether as a result of new information,
future events or otherwise.
Aravive, Inc.Condensed
Consolidated Statements of Operations(in thousands, except
per share amounts)
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
Revenue |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
1,092 |
|
|
$ |
256 |
|
Total revenue |
|
|
1,092 |
|
|
|
256 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
Research and development |
|
|
13,002 |
|
|
|
5,884 |
|
General and
administrative |
|
|
3,088 |
|
|
|
2,380 |
|
Total operating expenses |
|
|
16,090 |
|
|
|
8,264 |
|
Loss from operations |
|
|
(14,998 |
) |
|
|
(8,008 |
) |
Other income (expense),
net |
|
|
1,941 |
|
|
|
4 |
|
Net loss |
|
$ |
(13,057 |
) |
|
$ |
(8,004 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.62 |
) |
|
$ |
(0.44 |
) |
Weighted-average common shares
used to compute basic and diluted net loss per share |
|
|
21,130 |
|
|
|
18,067 |
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in thousands)
|
|
March 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
65,825 |
|
|
$ |
59,424 |
|
Restricted cash |
|
|
2,431 |
|
|
|
2,431 |
|
Other assets |
|
|
3,595 |
|
|
|
3,725 |
|
Operating lease right-of-use
assets |
|
|
2,020 |
|
|
|
2,207 |
|
Total
assets |
|
$ |
73,871 |
|
|
$ |
67,787 |
|
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities |
|
$ |
13,086 |
|
|
$ |
11,073 |
|
Deferred revenue |
|
|
7,027 |
|
|
|
8,119 |
|
Operating lease
obligation |
|
|
5,787 |
|
|
|
6,373 |
|
Warrant liability |
|
|
8,772 |
|
|
|
— |
|
Total liabilities |
|
|
34,672 |
|
|
|
25,565 |
|
Total stockholders'
equity |
|
|
39,199 |
|
|
|
42,222 |
|
Total liabilities and
stockholders’ equity |
|
$ |
73,871 |
|
|
$ |
67,787 |
|
Contact:Marek Ciszewski, J.D.Vice President,
Investor RelationsMarek@Aravive.com(562) 373-5787
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