Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing innovative therapeutics to treat life-threatening
diseases, today announced recent corporate updates and financial
results for the first quarter ended March 31, 2021.
“We are rapidly advancing development of AVB-500, while at the
same time, expanding into additional oncology indications. We began
dosing patients in our registrational Phase 3 trial in platinum
resistant ovarian cancer and our Phase 1b/2 trial in clear cell
renal cell carcinoma,” said Gail McIntyre, Ph.D., Chief Executive
Officer of Aravive. “We plan to expand the development of AVB-500
as a first-line treatment of pancreatic cancer, another area of
oncology where there is a high, unmet medical need. We look forward
to initiating the Phase 1b portion of this clinical trial in the
second half of 2021. We are optimistic about the broad potential of
AVB-500 in the treatment of multiple cancers and multiple
indications, as we advance and expand our pipeline.”
Recent Corporate Highlights
- Aravive to Expand Development
of AVB-500 with Plans to Investigate AVB-500 in a Clinical Trial as
a First-Line Treatment for Pancreatic Cancer: Aravive
plans to expand development of AVB-500 in a Phase 1b/2 trial as a
first-line treatment for pancreatic cancer. The expected design of
the trial will evaluate AVB-500 in combination with gemcitabine and
nab-paclitaxel (Abraxane®) in patients with advanced metastatic
pancreatic cancer eligible to receive gemcitabine and
nab-paclitaxel (Abraxane®) combination therapy. The Phase 1b
portion of the clinical trial will assess safety, tolerability, and
clinical activity of AVB-500 in combination with gemcitabine and
nab-paclitaxel (Abraxane®). The randomized, controlled Phase 2
portion of the clinical trial will evaluate AVB-500 in combination
with gemcitabine and nab-paclitaxel (Abraxane®) versus gemcitabine
and nab-paclitaxel (Abraxane®) alone. The Company expects to
initiate the Phase 1b portion of the clinical trial in the second
half of 2021.It is estimated that there will be approximately
60,400 new cases of pancreatic cancer and 48,200 deaths from the
disease in the U.S. in 2021. Pancreatic cancer typically has a poor
prognosis and the five-year survival rate is approximately 11%.
There is a clear, high, unmet medical need to improve patient
survival with new effective treatments that are safe and
well-tolerated. Pancreatic cancer is projected to become the second
leading cause of cancer death in the U.S. by 2030.
- AVB-500 in
Platinum Resistant Ovarian Cancer (PROC): In April
2021, Aravive dosed the first patient in its registrational Phase 3
trial of AVB-500 in PROC and simplified the trial’s statistical
analysis plan. The global, randomized, double-blind,
placebo-controlled adaptive trial is designed to evaluate efficacy
and safety of AVB-500 at a dose of 15 mg/kg in combination with
paclitaxel versus paclitaxel alone. The primary endpoint is
progression-free survival. The trial is expected to enroll
approximately 300-400 patients with high-grade serous ovarian
cancer who have received one to four prior lines of therapy at
approximately 165 sites in the U.S. and Europe. A prospectively
defined interim analysis will determine whether randomization will
continue with all patients, regardless of prior bevacizumab
treatment, or only with patients medically ineligible to receive
bevacizumab or who chose not to receive bevacizumab. The Company is
on track to conduct the interim analysis in the first quarter of
2022.
- AVB-500 in Clear Cell Renal
Cell Carcinoma (ccRCC): In March 2021, Aravive dosed the
first patient in its Phase 1b/2 trial of AVB-500 in ccRCC. The
Phase 1b portion of the clinical 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 clinical
trial will enroll up to 45 patients and investigate the recommended
AVB-500 dose identified during the Phase 1b portion of the clinical
trial in combination with cabozantinib versus cabozantinib alone.
The primary endpoint is progression-free survival. The Company is
on track to report topline data from the Phase 1b portion of the
clinical trial in the second half of 2021.
- Achieved First Clinical
Milestone with 3D Medicines and Expected to Receive $6.0 Million
Development Milestone Payment: In April 2021, Aravive
dosed the first patient in its Phase 3 trial of AVB-500 in platinum
resistant ovarian cancer, and based upon this event, the Company
successfully completed its first clinical milestone with 3D
Medicines Inc. (3D Medicines). Aravive’s collaboration and license
agreement with 3D Medicines is for the development and
commercialization of AVB-500 for oncology indications in Greater
China. Under the terms of the agreement, Aravive is eligible to
receive up to an aggregate of $207 million in development and
commercial milestone payments and royalties.
First Quarter 2021 Financial ResultsRevenue for
the three months ended March 31, 2021 was $0.3 million, compared to
$0 for the same period in 2020. Revenue for the first quarter of
2021 was derived solely from the Company’s collaboration and
license agreement with 3D Medicines.
Total operating expenses for the three months ended March 31,
2021 were $8.3 million, compared to $10.3 million for the same
period in 2020.
Total operating expenses for the three months ended March 31,
2021 included non-cash stock-based compensation expense of $0.5
million, compared to $0.7 million for the same period in 2020. In
addition, during the three months ended March 31, 2020, there were
non-recurring non-cash charges for impairment of the Company’s
right-of-use asset and leasehold improvements of $2.9 million.
For the three months ended March 31, 2021, Aravive reported a
net loss of $8.0 million, or $0.44 per share, compared to a net
loss of $10.8 million, or $0.72 per share, for the same period in
2020.
Cash PositionAs of March 31, 2021, cash and
cash equivalents were $78.7 million, compared to $60.5 million as
of December 31, 2020. 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
Pancreatic Cancer Pancreatic cancer is the seventh leading
cause of cancer death worldwide. There were approximately 495,800
new cases of pancreatic cancer and 466,000 deaths from the disease
worldwide in 2020. It is estimated that there will be approximately
60,400 new cases of pancreatic cancer and 48,200 deaths from the
disease in the U.S. in 2021. Pancreatic cancer typically has a poor
prognosis and the five-year survival rate is approximately 11%.
There is a clear, high, unmet medical need to improve patient
survival with new effective treatments that are safe and
well-tolerated. Pancreatic cancer is projected to become the third
leading cause of cancer death worldwide by 2025 and the second
leading cause of cancer death in the U.S. by 2030.
About AVB-500AVB-500 is a therapeutic
recombinant fusion protein that has been shown to neutralize GAS6
activity by binding to GAS6 with very high affinity in preclinical
models. In doing so, AVB-500 selectively inhibits the GAS6-AXL
signaling pathway, which is upregulated in multiple cancer types
including ovarian cancer. In preclinical studies, GAS6-AXL
inhibition has shown anti-tumor activity in combination with a
variety of anticancer therapies, including radiation therapy,
immuno-oncology agents, and chemotherapeutic drugs that affect DNA
replication and repair. Increased expression of AXL and GAS6 in
tumors has been correlated with poor prognosis and decreased
survival and has been implicated in therapeutic resistance to
conventional chemotherapeutics and targeted therapies. AVB-500 is
currently being evaluated in clinical trials and has been granted
Fast Track Designation by the U.S. Food and Drug Administration in
platinum resistant recurrent ovarian cancer. Analysis of all safety
data to date showed that AVB-500 has been generally well-tolerated
with no dose-limiting toxicities or unexpected safety signals.
About the Phase 3 PROC TrialThe global,
randomized, double-blind, placebo-controlled adaptive trial
(GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety
of AVB-500 at a dose of 15 mg/kg in combination with
paclitaxel. The trial is expected to enroll approximately
300-400 patients with high-grade serous ovarian cancer who have
received one to four prior lines of therapy at approximately 165
sites in the U.S. and Europe. The primary endpoint for the trial is
progression free survival and the secondary endpoint is overall
survival. Exploratory endpoints include objective response rate,
duration of response, quality of life, clinical benefit rate,
pharmacokinetic and pharmacodynamic profile, and sAXL/GAS6 ratio. A
prospectively defined interim analysis will determine whether
randomization will continue with all patients, regardless of prior
bevacizumab treatment, or only with patients medically ineligible
to receive bevacizumab or who chose not to receive bevacizumab.
This trial is being conducted in partnership with The GOG
Foundation, Inc. (GOG-F), through the GOG Partners program in the
USA and in partnership with the European Network for Gynaecological
Oncological Trial (ENGOT) groups in Europe. The Phase 3 trial is
listed on clinicaltrials.gov NCT04729608.
About AraviveAravive, Inc. is a
clinical-stage oncology company developing innovative therapeutics
to treat life-threatening diseases. Aravive’s lead therapeutic,
AVB-500, is a first-in-class ultra-high affinity decoy protein that
targets the GAS6-AXL signaling pathway associated with tumor cell
growth, tumor metastasis, resistance to treatment and decreased
survival. AVB-500 has the potential to be combined with multiple
anti-cancer therapies across several tumor types, due to its novel
mechanism of action and favorable safety profile. AVB-500 has been
granted Fast Track Designation by the U.S. Food and Drug
Administration in platinum resistant recurrent ovarian cancer. The
Company is currently evaluating AVB-500 in a registrational Phase 3
trial in platinum resistant ovarian cancer and a Phase 1b/2 trial
in clear cell renal cell carcinoma. Aravive plans to initiate a
Phase 1b/2 trial evaluating AVB-500 in first-line treatment of
pancreatic cancer in the second half of 2021. The Company is based
in Houston, Texas and received a Product Development Award from the
Cancer Prevention & Research Institute of Texas (CPRIT) in
2016. For more information, please visit www.aravive.com.
Forward-Looking StatementsThis communication
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. 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 includes statements regarding plans to expand
development of AVB-500 in a Phase 1b/2 trial as a first-line
treatment for pancreatic cancer, initiating the Phase 1b portion of
the trial in the second half of 2021, the expected design of the
Phase 1b/2 trial as a first-line treatment for pancreatic cancer
evaluating AVB-500 in combination with gemcitabine and
nab-paclitaxel (Abraxane®) in patients with advanced metastatic
pancreatic cancer eligible to receive gemcitabine and
nab-paclitaxel (Abraxane®) combination therapy, the broad potential
of AVB-500 in the treatment of multiple cancers and multiple
indications, enrolling 300-400 patients with high-grade serous
ovarian cancer who have received one to four prior lines of therapy
at approximately 165 sites in the U.S. and Europe in the PROC Phase
3 trial, being on track to conduct an interim analysis in the PROC
Phase 3 trial in the first quarter of 2022, the enrollment of 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 in
the Phase 1b clear cell renal cell carcinoma clinical trial, being
on track to report topline data from the Phase 1b portion of the
clear cell renal cell carcinoma clinical trial in the second half
of 2021 and receipt of a $6 million development milestone payment
from 3D Medicines. 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 Company’s ability to recruit for and enroll the expected number
of patients into the Phase 3 trial of AVB-500 in PROC, its Phase 1b
clear cell renal cell carcinoma clinical trial and its other trials
as planned and its ability to report data as planned, 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 pancreatic cancer as a first-line treatment and
other additional oncology indications, 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 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, 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)(unaudited)
|
Three Months Ended |
|
|
March 31, |
|
|
2021 |
|
|
2020 |
|
Revenue |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
256 |
|
|
$ |
— |
|
Total revenue |
|
256 |
|
|
|
— |
|
Operating
expenses |
|
|
|
|
|
|
|
Research and development |
|
5,884 |
|
|
|
3,491 |
|
General and
administrative |
|
2,380 |
|
|
|
3,951 |
|
Loss on impairment of
long-lived assets |
|
— |
|
|
|
2,870 |
|
Total operating expenses |
|
8,264 |
|
|
|
10,312 |
|
Loss from operations |
|
(8,008 |
) |
|
|
(10,312 |
) |
Interest income |
|
9 |
|
|
|
217 |
|
Other income (expense),
net |
|
(5 |
) |
|
|
(701 |
) |
Net loss |
$ |
(8,004 |
) |
|
$ |
(10,796 |
) |
Net loss per share- basic and
diluted |
$ |
(0.44 |
) |
|
$ |
(0.72 |
) |
Weighted-average common shares
used to compute basic and diluted net loss per share |
|
18,067 |
|
|
|
15,013 |
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in thousands)
|
March 31, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
(unaudited) |
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
78,682 |
|
|
$ |
60,541 |
|
Restricted cash |
|
2,430 |
|
|
|
2,430 |
|
Other assets |
|
3,385 |
|
|
|
1,781 |
|
Operating lease right-of-use
assets |
|
2,770 |
|
|
|
2,958 |
|
Total
assets |
$ |
87,267 |
|
|
$ |
67,710 |
|
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities |
$ |
4,252 |
|
|
$ |
4,823 |
|
Deferred revenue |
|
6,059 |
|
|
|
6,315 |
|
Operating lease
obligation |
|
8,240 |
|
|
|
8,517 |
|
Total liabilities |
|
18,551 |
|
|
|
19,655 |
|
Total stockholders'
equity |
|
68,716 |
|
|
|
48,055 |
|
Total liabilities and
stockholders’ equity |
$ |
87,267 |
|
|
$ |
67,710 |
|
Contact:Joseph SchepersVP, Investor Relations,
Aravive, Inc.jschepers@aravive.com (770) 558-5517
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