Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing transformative therapeutics, today announced recent
corporate updates and financial results for the fourth quarter and
full year ended December 31, 2020.
“In the fourth quarter of 2020, we continued to make important
progress on Aravive’s mission to improve the lives of people living
with cancer,” said Gail McIntyre, Ph.D., Chief Executive Officer of
Aravive. “We received guidance from the FDA on a registrational
Phase 3 trial design for AVB-500 in platinum resistant ovarian
cancer and have initiated the trial. We have dosed our first
patient in a Phase 1b/2 trial evaluating AVB-500 in clear cell
renal cell carcinoma and are on track to report topline data from
the Phase 1b portion of the trial in the second half of 2021. On
the corporate front, we established a strategic collaboration with
3D Medicines to develop and commercialize AVB-500 in Greater China
and we recently strengthened our balance sheet with a registered
direct offering with Eshelman Ventures. Our 2021 objectives are
clear, and we are well positioned to achieve our development
milestones for AVB-500 while creating value for patients and
shareholders.”
Recent Corporate Highlights
- AVB-500 in Platinum Resistant Ovarian
Cancer (PROC): Aravive received guidance from the FDA on a
registrational Phase 3 trial design for AVB-500 in PROC and
initiated the trial during the first quarter of 2021. The global,
randomized, double-blind, placebo-controlled adaptive trial will
evaluate the efficacy and tolerability of AVB-500 at a dose of 15
mg/kg in combination with paclitaxel vs paclitaxel monotherapy. The
registrational, adaptive Phase 3 trial is expected to enroll
300-500 patients with high-grade serous ovarian cancer who have
received 1-4 prior lines of therapy across sites in the U.S. and
Europe.
- AVB-500 in Clear Cell Renal Cell Carcinoma
(ccRCC): Aravive dosed its first patient in its Phase 1b/2
trial of AVB-500 in ccRCC during the first quarter of 2021. The
Phase 1b portion of the trial is expected to enroll up to 18
patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to
evaluate tolerability, pharmacokinetics, pharmacodynamics, and
clinical activity of AVB-500 in combination with cabozantinib. The
controlled, randomized, open-label Phase 2 portion of the trial
will enroll up to 45 patients and investigate the recommended
AVB-500 dose identified during the Phase 1b portion of the trial in
combination with cabozantinib versus cabozantinib alone. The
Company expects to report topline data from the Phase 1b portion of
the trial in the second half of 2021.
- Strategic Collaboration with 3D Medicines for AVB-500
in Greater China: Aravive established a collaboration and
exclusive license agreement with 3D Medicines Inc. (3D Medicines)
for the development and commercialization of AVB-500 across all
oncology indications in mainland China, Hong Kong, Macau, and
Taiwan (Greater China). The Company received a signing payment of
$12 million and is eligible to receive up to $207 million in
development and commercial milestone payments and tiered royalties
ranging from the low double digits to mid-teens as a percentage of
annual net sales of AVB-500 in Greater China.
- Strengthened Balance Sheet: In February 2021,
Aravive raised $21.0 million from the sale of 2,875,000 shares of
common stock to Eshelman Ventures, LLC at a price of $7.29 per
share in a registered direct offering. Eshelman Ventures, LLC is an
entity wholly owned by Fred Eshelman, Pharm.D., Chairman of
Aravive’s Board of Directors.
Fourth Quarter and Full Year 2020 Financial
ResultsRevenue for the three and twelve months ended
December 31, 2020 was $5.7 million for both periods, compared to $0
and $4.8 million for the same periods in 2019. Revenue for 2020 was
derived solely from the Company’s collaboration and license
agreement with 3D Medicines. Revenue for 2019 was derived solely
from the Cancer Prevention Research Institute of Texas (CPRIT)
grant.
Total operating expenses for the three and twelve months ended
December 31, 2020 were $9.7 million and $36.5 million,
respectively, compared to $5.2 million and $26.5 million for the
same periods in 2019.
Total operating expenses for the three and twelve months ended
December 31, 2020 included non-cash stock-based compensation
expense of $0.4 million and $2.0 million, respectively, compared to
$0.6 million and $3.4 million for the same periods in 2019. 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, 2020, Aravive
reported a net loss of $4.0 million and $30.5 million, or $0.25 per
share and $1.93 per share, respectively, compared to a net loss of
$4.3 million and $18.2 million, or $0.35 per share and $1.57 per
share, for the same periods in 2019.
Cash PositionAs of December 31, 2020, cash and
cash equivalents was $60.5 million, compared to $65.1 million as of
December 31, 2019. The Company expects that its current cash and
cash equivalents will be sufficient to fund its operating plans
into the second half of 2022.
About AraviveAravive, Inc. is a
clinical-stage oncology company developing transformative
therapeutics designed to halt the progression of life-threatening
diseases. Aravive is based in Houston, Texas and received a Product
Development Award from the Cancer Prevention & Research
Institute of Texas (CPRIT) in 2016. Aravive’s lead product
candidate, AVB-500, is an ultra-high affinity decoy protein that
targets the GAS6-AXL signaling pathway associated with tumor cell
growth. Aravive successfully completed a Phase 1b trial of AVB-500
in platinum resistant ovarian cancer and has initiated a
registrational Phase 3 trial of AVB-500 at a dose of 15 mg/kg.
While the Phase 1b trial of AVB-500 in platinum resistant ovarian
cancer was a safety trial and not powered to demonstrate efficacy,
all 5 patients in the 15 mg/kg cohort experienced clinical benefit,
with 1 complete response, 2 partial responses, and 2 stable
disease. The Company is dosing patients in its Phase 1b/2 trial in
clear cell renal cell carcinoma. For more information, please
visit www.aravive.com.
Forward-Looking StatementsThis communication
contains forward-looking statements (including within the meaning
of Section 21E of the United States Securities Exchange Act of
1934, as amended, and Section 27A of the United States Securities
Act of 1933, as amended), express or implied, such statements
regarding being on track to report topline data from the Phase 1b
portion of the trial in the second half of 2021, the
registrational, adaptive Phase 3 trial enrolling 300-500 patients
with high-grade serous ovarian cancer who have received 1-4 prior
lines of therapy across sites in the U.S. and Europe, the Phase 1b
portion of the trial enrolling up to 18 patients in three dosing
arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to evaluate tolerability,
pharmacokinetics, pharmacodynamics, and clinical activity of
AVB-500 in combination with cabozantinib and current cash being
sufficient to fund its operating plans into the second half of
2022. 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: our ability to
report topline data form our Phase 1b trial when anticipated, our
ability to enroll the number of anticipated patients in each trial,
our ability to show the potential for AVB-500 to treat clear cell
renal cell carcinoma without adding toxicity, our ability to share
updates on our studies as development of AVB-500 across a broad
range of cancers advances, the Company's dependence upon AVB-500,
AVB-500's ability to have favorable results in clinical trials and
ISTs, the clinical trials of AVB-500 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
especially in light of the COVID-19 pandemic, the risk that AVB-500
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
AVB-500, if AVB-500 is approved, risks associated with its market
acceptance, including pricing and reimbursement, potential
difficulties enforcing the Company's intellectual property rights,
the Company's ability to expand development into additional
oncology indications, and the Company's reliance on its licensor of
intellectual property and our cash runaway being sufficient to fund
our operating plans into the second half of 2022 and our 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, 2020, 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 |
|
|
Twelve Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
4,753 |
|
Collaboration revenue |
|
|
5,685 |
|
|
|
— |
|
|
|
5,685 |
|
|
|
— |
|
Total revenue |
|
|
5,685 |
|
|
|
— |
|
|
|
5,685 |
|
|
|
4,753 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
6,535 |
|
|
|
2,511 |
|
|
|
17,620 |
|
|
|
12,836 |
|
General and administrative |
|
|
3,199 |
|
|
|
2,652 |
|
|
|
13,065 |
|
|
|
13,691 |
|
Loss on impairment of long-lived assets |
|
|
— |
|
|
|
— |
|
|
|
5,784 |
|
|
|
— |
|
Total operating expenses |
|
|
9,734 |
|
|
|
5,163 |
|
|
|
36,469 |
|
|
|
26,527 |
|
Loss from operations |
|
|
(4,049 |
) |
|
|
(5,163 |
) |
|
|
(30,784 |
) |
|
|
(21,774 |
) |
Interest income |
|
|
4 |
|
|
|
211 |
|
|
|
255 |
|
|
|
1,022 |
|
Other income (expense),
net |
|
|
(1 |
) |
|
|
624 |
|
|
|
(14 |
) |
|
|
2,534 |
|
Net loss |
|
$ |
(4,046 |
) |
|
$ |
(4,328 |
) |
|
$ |
(30,543 |
) |
|
$ |
(18,218 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.93 |
) |
|
$ |
(1.57 |
) |
Weighted-average common shares
used to compute net loss per share- basic and diluted |
|
|
16,183 |
|
|
|
12,506 |
|
|
|
15,790 |
|
|
|
11,589 |
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in thousands)
|
December 31, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
60,541 |
|
|
$ |
65,134 |
|
Restricted cash |
|
2,430 |
|
|
|
2,423 |
|
Other assets |
|
1,781 |
|
|
|
5,867 |
|
Operating lease right-of-use
assets |
|
2,958 |
|
|
|
8,697 |
|
Total
assets |
$ |
67,710 |
|
|
$ |
82,121 |
|
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
$ |
4,823 |
|
|
$ |
2,575 |
|
Deferred revenue |
|
6,315 |
|
|
|
— |
|
Operating lease
obligation |
|
8,517 |
|
|
|
10,233 |
|
Contingent liabilities |
|
— |
|
|
|
264 |
|
Total liabilities |
|
19,655 |
|
|
|
13,072 |
|
Total stockholders'
equity |
|
48,055 |
|
|
|
69,049 |
|
Total liabilities and
stockholders’ equity |
$ |
67,710 |
|
|
$ |
82,121 |
|
Contacts:Investors:Luke Heagle, W2O
lheagle@w2ogroup.com (910) 726-1372
Media:Sheryl Seapy, W2Osseapy@w2ogroup.com(949) 903-4750
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