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
second quarter ended June 30, 2022 and provided corporate updates.
“We continued to achieve great progress for Aravive in the
second quarter of 2022. All of our batiraxcept clinical trials for
the treatment of ovarian, kidney and pancreatic cancers continued
to advance at a strong pace,” said Gail McIntyre, Ph.D., DABT,
Chief Executive Officer of Aravive. “We remain on track with our
lead Phase 3 registrational study in ovarian cancer to complete
enrollment around year-end 2022, which would enable us to read out
topline data mid-2023 and potentially file a BLA with the FDA by
year-end 2023.”
“We continue to successfully enroll patients in our Phase 2
trial of batiraxcept in clear cell renal cancer and will have
updates throughout the remainder of this year. Our Phase 1b
trial in pancreatic cancer has completed enrollment and updated
results are anticipated later this year. We remain confident in the
execution of our clinical trials and encouraged by the continued
signals of the potential therapeutic success of batiraxcept.”
“Finally, we hired two industry seasoned veterans to round out
our senior management team. Rudy Howard and Dr. Robert Geller will
not only add tremendous support as we continue our trials, but also
as we potentially move towards and beyond regulatory approval
of a commercially viable portfolio.”
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 around year-end 2022. The Company
expects to report topline data from the trial by mid-2023. CMC
work remains on track with the goal of filing a BLA by
year-end 2023. 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 patients with platinum resistant,
high-grade serous ovarian cancer who have received 1-4 prior lines
of therapy.
- Batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC)
and Serum-Based Biomarker: As of April 30, 2022 and
as presented during the KOL symposium, 26 previously treated (2L+)
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. There were no dose limiting
toxicities observed at either dose and 14 of the 26 patients
remained 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). One of the
objectives of the ongoing Phase 1b/2 ccRCC trial is to evaluate the
correlation of baseline serum soluble AXL (sAXL)/GAS6 (biomarker)
with radiographic response in patients with ccRCC treated with
batiraxcept plus cabozantinib. 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
has discussed a registrational path with the US FDA that includes
use of the sAXL/Gas6 ratio as a basis for an accelerated
approval. The Company is on track to report updated results
from the Phase 1b and Phase 2 portions of the trial in the second
half of 2022.
- Batiraxcept in Pancreatic
Adenocarcinoma: As of May 3, 2022 and as discussed at
the KOL symposium, 21 patients with advanced or metastatic
pancreatic adenocarcinoma 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 (biomarker) to clinical activity was noted in this
trial and the best ORR in the biomarker high population was 40%.
Five patients experienced resolution of one or more target lesions;
however, two 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 half of 2022.
Second Quarter 2022 Financial ResultsRevenues
for the three months ended June 30, 2022 were $1.6 million,
compared to $1.1 million for the three months ended March 31, 2022.
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 1) a portion of initial signing
and milestone payments received from 3D Medicines that is
recognized at the time of the receipt and 2) a portion of the
payments that is deferred and recognized over the PROC trial
period. The increase in revenues is attributable to increased
expenditures related to the PROC trial which drives the recognition
of deferred payments over the PROC trial period.
Total operating expenses for the three months ended June 30,
2022 were $21.0 million, compared to $16.1 million for the
three months ended March 31, 2022. Research and development expense
for the three months ended June 30, 2022 was $17.3 million,
compared to $13.0 million for the three months ended March 31,
2022. The increase in research and development expense is
attributable to the continued progression of the Company’s PROC and
ccRCC clinical trials, as well as increases in related CMC
costs. General and administrative expense for the three
months ended June 30, 2022 was $3.7 million, compared to $3.1
million for the three months ended March 31, 2022. The increase in
general and administrative expense is attributable to increased
stock-based compensation, increased consulting fees, and severance
expense.
Aravive reported a net loss of $18.5 million, or $0.61 per
share, for the three months ended June 30, 2022, compared to a net
loss of $13.1 million, or $0.62 per share, for the three months
ended March 31, 2022.
Cash PositionAs of June 30, 2022, cash and cash
equivalents were $46.8 million, compared to $65.8 million as of
March 31, 2022 and $59.4 million as of December 31, 2021. The
Company anticipates that its current cash and cash equivalents will
fund its operating plans into the first quarter of 2023.
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
registration-directed Phase 3 program of batiraxcept in combination
with paclitaxel in PROC remaining on track to complete
enrollment by year end 2022, topline data from the trial
being available in mid-2023, CMC work remaining on track with
the goal of filing a BLA in late 2023 and the trial enrolling 350
patients with platinum resistant, high-grade serous ovarian cancer
who have received 1-4 prior lines of therapy; the open-label Phase
2 portion of the ccRCC clinical trial enrolling 55 patients across
three parts, Part A enrolling approximately 25 patients and
investigating batiraxcept 15 mg/kg in combination with cabozantinib
in 2L+ ccRCC patients, Part B enrolling approximately 20 patients
and evaluating batiraxcept 15 mg/kg in combination with nivolumab
and cabozantinib as a potential front-line treatment for ccRCC,
Part C evaluating batiraxcept 15 mg/kg monotherapy in approximately
10 patients with ccRCC who are not eligible for curative intent
therapies and being on track to report additional updated results
from the Phase 1b portion of the ccRCC trial in the second
half of 2022; being on track to report additional updated data
from the Phase 1b portion of the pancreatic adenocarcinoma trial in
the second half of 2022 and current cash and cash equivalents
funding operating plans into the first quarter of 2023.
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 |
|
|
|
Three Months Ended |
|
|
|
|
June 30, 2022 |
|
|
|
March 31, 2022 |
|
|
|
(unaudited) |
|
(unaudited) |
Revenue |
|
|
|
|
Collaboration revenue |
|
$ |
1,615 |
|
|
$ |
1,092 |
|
Total revenue |
|
|
1,615 |
|
|
|
1,092 |
|
Operating
expenses |
|
|
|
|
Research and development |
|
|
17,315 |
|
|
|
13,002 |
|
General and
administrative |
|
|
3,727 |
|
|
|
3,088 |
|
Total operating expenses |
|
|
21,042 |
|
|
|
16,090 |
|
Loss from operations |
|
|
(19,427 |
) |
|
|
(14,998 |
) |
Other income, net |
|
|
950 |
|
|
|
1,941 |
|
Net loss |
|
$ |
(18,477 |
) |
|
$ |
(13,057 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.61 |
) |
|
$ |
(0.62 |
) |
Weighted-average common shares
used to compute basic and diluted net loss per share |
|
|
30,505 |
|
|
|
21,130 |
|
Aravive, Inc.Condensed
Consolidated Statements of Operations(in thousands, except
per share amounts)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
1,615 |
|
|
$ |
3,789 |
|
|
$ |
2,707 |
|
|
$ |
4,045 |
|
Total revenue |
|
|
1,615 |
|
|
|
3,789 |
|
|
|
2,707 |
|
|
|
4,045 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
17,315 |
|
|
|
8,120 |
|
|
|
30,317 |
|
|
|
14,004 |
|
General and
administrative |
|
|
3,727 |
|
|
|
3,080 |
|
|
|
6,815 |
|
|
|
5,460 |
|
Total operating expenses |
|
|
21,042 |
|
|
|
11,200 |
|
|
|
37,132 |
|
|
|
19,464 |
|
Loss from operations |
|
|
(19,427 |
) |
|
|
(7,411 |
) |
|
|
(34,425 |
) |
|
|
(15,419 |
) |
Other income, net |
|
|
950 |
|
|
|
306 |
|
|
|
2,891 |
|
|
|
310 |
|
Net loss |
|
$ |
(18,477 |
) |
|
$ |
(7,105 |
) |
|
$ |
(31,534 |
) |
|
$ |
(15,109 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.61 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.22 |
) |
|
$ |
(0.78 |
) |
Weighted-average common shares
used to compute basic and diluted net loss per share |
|
|
30,505 |
|
|
|
20,414 |
|
|
|
25,844 |
|
|
|
19,247 |
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in thousands)
|
|
June 30, |
|
|
|
March 31, |
|
|
|
2022 |
|
|
|
2022 |
|
|
|
(unaudited) |
|
|
|
(unaudited) |
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
46,833 |
|
|
$ |
65,825 |
|
Restricted cash |
|
2,431 |
|
|
|
2,431 |
|
Other assets |
|
4,793 |
|
|
|
3,595 |
|
Operating lease right-of-use
assets |
|
1,834 |
|
|
|
2,020 |
|
Total
assets |
$ |
55,891 |
|
|
$ |
73,871 |
|
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities |
$ |
15,202 |
|
|
$ |
13,086 |
|
Deferred revenue |
|
5,412 |
|
|
|
7,027 |
|
Operating lease
obligation |
|
5,211 |
|
|
|
5,787 |
|
Warrant liability |
|
— |
|
|
|
8,772 |
|
Total liabilities |
|
25,825 |
|
|
|
34,672 |
|
Total stockholders'
equity |
|
30,066 |
|
|
|
39,199 |
|
Total liabilities and
stockholders’ equity |
$ |
55,891 |
|
|
$ |
73,871 |
|
Contact:Luke HeagleReal Chemistry(910)
619-5764lheagle@realchemistry.com
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