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 second quarter ended June 30, 2021.
“Aravive continued to make strong progress in advancing the
development of AVB-500 in the second quarter of 2021,” said Gail
McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. “We are
very encouraged by the positive preliminary
pharmacokinetic/pharmacodynamic results from the patients dosed at
15 mg/kg in the first portion of the Phase 1b trial of AVB-500 in
clear cell renal cell carcinoma, and we plan to initiate the Phase
2 trial in the second half of 2021. Additionally, we are on track
to initiate the Phase 1b/2 trial evaluating AVB-500 as a first-line
treatment for pancreatic adenocarcinoma, another area of high,
unmet medical need, in the second half of 2021.”
Recent Corporate Highlights
- AVB-500 in
Platinum Resistant Ovarian Cancer (PROC): In April
2021, Aravive announced that the first patient was dosed in its
registrational Phase 3 trial of AVB-500 in PROC. 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
Company expects to conduct the interim analysis in the first
quarter of 2022.
- AVB-500 in Clear Cell Renal
Cell Carcinoma (ccRCC): In June 2021, Aravive announced
positive initial safety, pharmacokinetic and pharmacodynamic
results from the Phase 1b portion of its Phase 1b/2 trial in
patients dosed with 15 mg/kg of AVB-500 in combination with
cabozantinib who have ccRCC (advanced stage kidney cancer). The
data in three evaluable patients showed that AVB-500 was well
tolerated with no adverse findings. Based on the pharmacokinetics,
pharmacodynamics, and safety data at 15 mg/kg of AVB-500, and
approval by the Data and Safety Monitoring Board (DSMB), the
Company has expanded the dosing of 15 mg/kg of AVB-500 to at least
three additional patients to determine the potential of initiating
the Phase 2 portion with this dose. The Company will also continue
to investigate higher doses of AVB-500 in the Phase 1b trial to
obtain additional safety, pharmacokinetics, and pharmacodynamics
information. Aravive expects to complete enrollment in the Phase 1b
portion of the Phase 1b/2 trial and initiate the Phase 2 trial in
the second half of 2021.
- Achieved One Development
Milestone with 3D Medicines in Q2 and One Milestone in July 2021
Totaling $9 million in Milestone Payments: In July 2021,
Aravive achieved a $3.0 million development milestone based on the
Center for Drug Evaluation (CDE) of the China National Medical
Products Administration (NMPA) approval of the Investigational New
Drug (IND) application submitted by 3D Medicines Inc. to
participate in Aravive’s international AVB-500 Phase 3 PROC
clinical trial. The Company also received a $6.0 million milestone
payment in June 2021 related to the first patient dosed by Aravive
in the AVB-500 Phase 3 registrational clinical trial for PROC in
the United States. Under the terms of the collaboration and license
agreement with 3D Medicines, Aravive is eligible to receive up to
an aggregate of $207 million in development and commercial
milestone payments and royalties, including the $9 million already
achieved.
- Expanded and Strengthened
Board of Directors: Aravive appointed three highly
experienced biopharmaceutical industry executives, John A.
Hohneker, M.D., Sigurd C. Kirk, and Peter T.C. Ho, M.D., Ph.D., to
its Board of Directors. Dr. Hohneker serves on the Compensation
Committee of the Board, and Mr. Kirk serves on the Audit
Committee.
Second Quarter 2021 Financial ResultsRevenue
for the three and six months ended June 30, 2021 were $3.8 million
and $4.0 million, respectively, compared to $0 for both periods in
2020. Revenue for the three and six months ended June 30, 2021 was
derived solely from the Company’s collaboration and license
agreement with 3D Medicines, and represents 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 six months ended June
30, 2021 were $11.2 million and $19.5 million, respectively,
compared to $5.7 million and $16.0 million for the same periods in
2020.
Total operating expenses for the three and six months ended June
30, 2021 included non-cash stock-based compensation expense of $0.5
million and $1.0 million, respectively, compared to $0.5 million
and $1.2 million for the same periods in 2020. In addition, during
the six months ended June 30, 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 and six months ended June 30, 2021, Aravive
reported a net loss of $7.1 million and $15.1 million, or $0.35 per
share and $0.78 per share, respectively, compared to a net loss of
$5.0 million and $15.8 million, or $0.32 per share and $1.02 per
share, for the same periods in 2020.
Cash PositionAs of June 30, 2021, cash and cash
equivalents were $75.4 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
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 AVB-500 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 North America,
Europe, and Asia. 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 AXL/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 choose 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 Gynecological
Oncological Trial (ENGOT) groups in Europe. The Phase 3 trial is
listed on clinicaltrials.gov NCT04729608.
About the AVB-500 Phase 1b/2 ccRCC TrialAravive
initiated its Phase 1b portion of the Phase 1b/2 trial of AVB-500
in ccRCC in March 2021. The Phase 1b portion of the clinical trial,
a dose escalation study, is expected to enroll approximately 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 is expected to enroll approximately 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 trial will enroll patients with
advanced ccRCC who have progressed on front-line treatment. The
Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.
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 second line plus, clear cell renal cell carcinoma. Aravive plans
to initiate a Phase 1b/2 trial evaluating AVB-500 in first-line
treatment of pancreatic adenocarcinoma 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 initiation of a Phase
2 clinical trial in clear cell renal cell carcinoma in the second
half of 2021, initiation of AVB-500 Phase 1b portion of Phase 1b/2
clinical trial in pancreatic adenocarcinoma in second half of 2021,
conducting an interim analysis of its Phase 3 clinical trial of
AVB-500 in PROC in the first quarter of 2022, completion of
enrollment in the Phase 1b portion of the Phase1b/2 clinical trial
in clear cell renal cell carcinoma in the second half of 2021, the
expected enrollment of 300-400 patients with high-grade serous
ovarian cancer who have received one to four prior lines of therapy
at approximately 165 sites in North America, Europe, and Asia, the
expected enrollment of approximately 18 patients in three dosing
arms in the Phase1b portion of the Phase 1b/2 trial of AVB-500 in
ccRCC, the expected enrollment of approximately 45 patients in the
Phase 2 portion of the clinical trial of AVB-500 in ccRCC and the
potential of AVB-500 to be combined with multiple anti-cancer
therapies across several tumor types. 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 initiate a Phase 2 clinical trial in
clear cell renal cell carcinoma in the second half of 2021 and a
Phase 1b/2 trial evaluating AVB-500 in first-line treatment of
pancreatic adenocarcinoma in the second half of 2021, conduct an
interim analysis of its Phase 3 clinical trial of AVB-500 in PROC
in the first quarter of 2022, complete enrollment in the Phase 1b
portion of the Phase1b/2 clinical trial in clear cell renal cell
carcinoma in the second half of 2021, the ability to enroll the
expected number of patients, the ability to combine AVB-500 with
multiple anti-cancer therapies across several tumor types, 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 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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
3,789 |
|
|
$ |
— |
|
|
$ |
4,045 |
|
|
$ |
— |
|
Total revenue |
|
|
3,789 |
|
|
|
— |
|
|
|
4,045 |
|
|
|
— |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,120 |
|
|
|
2,522 |
|
|
|
14,004 |
|
|
|
6,014 |
|
General and
administrative |
|
|
3,080 |
|
|
|
3,201 |
|
|
|
5,460 |
|
|
|
7,151 |
|
Loss on impairment of
long-lived assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,870 |
|
Total operating expenses |
|
|
11,200 |
|
|
|
5,723 |
|
|
|
19,464 |
|
|
|
16,035 |
|
Loss from operations |
|
|
(7,411 |
) |
|
|
(5,723 |
) |
|
|
(15,419 |
) |
|
|
(16,035 |
) |
Interest income |
|
|
11 |
|
|
|
26 |
|
|
|
20 |
|
|
|
243 |
|
Other income (expense),
net |
|
|
295 |
|
|
|
656 |
|
|
|
290 |
|
|
|
(45 |
) |
Net loss |
|
$ |
(7,105 |
) |
|
$ |
(5,041 |
) |
|
$ |
(15,109 |
) |
|
$ |
(15,837 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.35 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.02 |
) |
Weighted-average common shares used to compute basic and diluted
net loss per share |
|
|
20,414 |
|
|
|
15,902 |
|
|
|
19,247 |
|
|
|
15,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in thousands)
|
|
June 30, |
|
December 31, |
|
|
|
2021 |
|
2020 |
|
|
|
(unaudited) |
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
75,437 |
|
$ |
60,541 |
|
Restricted cash |
|
|
2,430 |
|
|
2,430 |
|
Other assets |
|
|
4,781 |
|
|
1,781 |
|
Operating lease right-of-use
assets |
|
|
2,582 |
|
|
2,958 |
|
Total
assets |
|
$ |
85,230 |
|
$ |
67,710 |
|
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities |
|
$ |
5,216 |
|
$ |
4,823 |
|
Deferred revenue |
|
|
8,325 |
|
|
6,315 |
|
Operating lease
obligation |
|
|
7,631 |
|
|
8,517 |
|
Total liabilities |
|
|
21,172 |
|
|
19,655 |
|
Total stockholders'
equity |
|
|
64,058 |
|
|
48,055 |
|
Total liabilities and
stockholders’ equity |
|
$ |
85,230 |
|
$ |
67,710 |
|
Contact:Joseph T. SchepersVP, Investor
Relations, Aravive, Inc.jschepers@aravive.com (770) 558-5517
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