Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage
oncology company developing targeted therapeutics to treat
metastatic disease, today announced fourth quarter and full year
ended December 31, 2021 financial results and provided corporate
updates.
“In 2021, Aravive made significant progress in advancing the
clinical development of batiraxcept for the potential treatment of
ovarian, kidney and pancreatic cancer,” said Gail McIntyre, Ph.D.,
DABT, Chief Executive Officer of Aravive. “We initiated the
registrational Phase 3 trial of batiraxcept in ovarian cancer and
recently reported positive safety and efficacy data from the
ongoing Phase 1b trials of batiraxcept in clear cell renal cell
carcinoma and pancreatic cancer. We are encouraged by batiraxcept's
early profile in patients across each of these life-threatening
cancers with unmet medical needs and are laser-focused on building
value for patients and shareholders.”
Recent Corporate Highlights
- Batiraxcept in Platinum Resistant Ovarian Cancer
(PROC): Aravive dosed the first patient in the
registration directed Phase 3 trial in April 2021 and is on track
to complete enrollment in 2H’22. Topline data from the trial is
anticipated to be available in 2Q’23 and the Company expects to be
ready to potentially file a BLA during 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: Aravive dosed the first patient
in the Phase 1b portion of the Phase 1b/2 trial of batiraxcept in
patients with ccRCC in March 2021 and completed enrollment and
reported positive preliminary data in November 2021. In March 2022,
the Company announced positive updated data and 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 anticipates to continue to provide updated biomarker data
throughout 2022.As of February 4, 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 at a
median follow up of 4.9 months, 92% of patients remained on study.
The best overall response rate (ORR, confirmed + unconfirmed) in
the ITT population was 46% and 56% in patients dosed with 15 mg/kg
(the recommended Phase 2 dose). The best ORR in the biomarker high
population was 63%, and 75% in the biomarker high population dosed
at 15 mg/kg. The 6-month progression-free survival (PFS) rate was
79% in the ITT population, 77% in the biomarker high population,
and 91% in the 15 mg/kg biomarker high group. The company is on
track to report additional updated results from the Phase 1b
portion of the trial in the second quarter of 2022.In January 2022,
Aravive dosed the first patient in the Phase 2 portion of the Phase
1b/2 clinical trial of batiraxcept in combination with cabozantinib
for the treatment of ccRCC. The company is on track to report
preliminary results from the Phase 2 portion of the trial in the
second quarter of 2022. The Phase 2 portion of the Phase 1b/2 trial
of batiraxcept in ccRCC is an open-label study and aims to enroll
55 patients across three parts.
- Batiraxcept in Pancreatic Adenocarcinoma: In
August 2021, Aravive dosed the first patient in 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. Enrollment was completed in January 2022. As of February
4, 2022, 13 patients have been treated with 15 mg/kg batiraxcept in
combination with gemcitabine and nab-paclitaxel as a first-line
treatment. Analysis of all safety data to date demonstrates that
batiraxcept has been generally well-tolerated with no unexpected
safety signals. The best ORR was 31% and all patients have had at
least eight weeks of follow-up (one radiological image). 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.
- Expanded Board of Directors: In May 2021, the
Company appointed John A. Hohneker, M.D., Sigurd C. Kirk, and Peter
T.C. Ho, M.D., Ph.D. to its Board. These independent directors
strengthen oversight and broaden the Company’s technical
capabilities in clinical and business development.
Fourth Quarter and Full Year 2021 Financial
ResultsRevenue for the three and twelve months ended
December 31, 2021 was $1.0 million and $7.4 million, respectively,
compared with $5.7 million for the same periods in 2020. Revenues
for 2021 and 2020 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 and twelve months ended
December 31, 2021 were $14.6 million and $48.1 million,
respectively compared with $9.7 million and $36.5 million,
respectively, for the same periods in 2020. Non-cash stock-based
compensation for the three and twelve months ended December 31,
2021 was $0.6 million and $2.3 million, respectively compared with
$0.4 million and $2.0 million, respectively, for the same periods
in 2020. In addition, during the twelve months ended December 31,
2020, there were non-recurring non-cash charges for impairment of
the Company’s right-of-use asset and leasehold improvements of $5.8
million.
For the three and twelve months ended December 31, 2021, Aravive
reported a net loss of $13.0 million and $39.2 million, or $0.62
per share and $1.95 per share, respectively compared to a net loss
of $4.0 million and $30.5 million, or $0.25 per share and $1.93 per
share, respectively, for the same periods in 2020.
Cash PositionAs of December 31, 2021, cash and
cash equivalents were $59.4 million, compared to $60.5 million as
of December 31, 2020. 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 combined approximately $20 million
in new capital strengthened the Company’s financial position ahead
of multiple anticipated clinical milestones throughout 2022 for
each of the Company’s three ongoing clinical programs. 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). 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 additional biomarker data from Phase 1b ccRCC trial
anticipated in 2Q’22, anticipated cash runway into 1Q’23, reporting
updated data in 1H’22 from the Phase 1b trials of batiraxcept in
clear cell renal cell carcinoma and pancreatic adenocarcinoma,
completing enrollment in the registration directed Phase 3
trial in the second half of 2022, topline data from the trial being
available in the second quarter of 2023 and being ready to
potentially file a BLA during the fourth quarter of 2023;
continuing to provide updated biomarker data throughout 2022, being
on track to report additional updated results from the Phase 1b
portion of the trial for the treatment of ccRCC in the second
quarter of 2022, being on track to report preliminary results from
the Phase 2 portion of the trial for the treatment of ccRCC in the
second quarter of 2022, being on track to report additional updated
data from the Phase 1b portion of the trial of batiraxcept in
combination with gemcitabine and nab-paclitaxel as a first-line
treatment in patients with advanced or metastatic pancreatic
adenocarcinoma in the second quarter of 2022, the anticipated
enrollment of 55 patients across three part in the Phase 2 portion
of the Phase 1b/2 trial of batiraxcept in ccRCC and the capital
infusions funding operations 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.Consolidated Statements of
Operations(in thousands, except per share amounts)
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
985 |
|
|
$ |
5,685 |
|
|
$ |
7,442 |
|
|
$ |
5,685 |
|
Total revenue |
|
|
985 |
|
|
|
5,685 |
|
|
|
7,442 |
|
|
|
5,685 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
12,194 |
|
|
|
6,535 |
|
|
|
37,541 |
|
|
|
17,620 |
|
General and
administrative |
|
|
2,448 |
|
|
|
3,199 |
|
|
|
10,550 |
|
|
|
13,065 |
|
Loss on impairment of
long-lived assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,784 |
|
Total operating expenses |
|
|
14,642 |
|
|
|
9,734 |
|
|
|
48,091 |
|
|
|
36,469 |
|
Loss from operations |
|
|
(13,657 |
) |
|
|
(4,049 |
) |
|
|
(40,649 |
) |
|
|
(30,784 |
) |
Interest income |
|
|
8 |
|
|
|
4 |
|
|
|
37 |
|
|
|
255 |
|
Other income (expense),
net |
|
|
693 |
|
|
|
(1 |
) |
|
|
1,461 |
|
|
|
(14 |
) |
Net loss |
|
$ |
(12,956 |
) |
|
$ |
(4,046 |
) |
|
$ |
(39,151 |
) |
|
$ |
(30,543 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.62 |
) |
|
$ |
(0.25 |
) |
|
$ |
(1.95 |
) |
|
$ |
(1.93 |
) |
Weighted-average common shares
used to compute basic and diluted net loss per share |
|
|
20,998 |
|
|
|
16,183 |
|
|
|
20,070 |
|
|
|
15,790 |
|
Aravive,
Inc.Consolidated Balance Sheets (in
thousands)
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
59,424 |
|
|
$ |
60,541 |
|
Restricted cash |
|
|
2,431 |
|
|
|
2,430 |
|
Other assets |
|
|
3,725 |
|
|
|
1,781 |
|
Operating lease right-of-use
assets |
|
|
2,207 |
|
|
|
2,958 |
|
Total
assets |
|
$ |
67,787 |
|
|
$ |
67,710 |
|
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities |
|
$ |
11,073 |
|
|
$ |
4,823 |
|
Deferred revenue |
|
|
8,119 |
|
|
|
6,315 |
|
Operating lease
obligation |
|
|
6,373 |
|
|
|
8,517 |
|
Total liabilities |
|
|
25,565 |
|
|
|
19,655 |
|
Total stockholders'
equity |
|
|
42,222 |
|
|
|
48,055 |
|
Total liabilities and
stockholders’ equity |
|
$ |
67,787 |
|
|
$ |
67,710 |
|
Contact:Marek Ciszewski,
J.D.Vice President, Investor Relationsmarek@aravive.com (562)
373-5787
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