Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing transformative, targeted therapeutics to treat
life-threatening cancers, today announced recent corporate updates
and financial results for the third quarter ended September 30,
2021.
“During the third quarter, we expanded our clinical oncology
pipeline with the initiation of a Phase 1b trial of batiraxcept
(AVB-500) for the treatment of pancreatic adenocarcinoma,” said
Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive.
“Aravive is now advancing three clinical trials for life
threatening cancers with unmet medical needs. We look forward to
presenting new preliminary data from our Phase 1b trial of
batiraxcept in clear cell renal cell carcinoma at the upcoming
Society for Immunotherapy of Cancer Annual Meeting in November. We
remain optimistic about the broad potential of batiraxcept to
improve the lives of people living with cancer.”
Recent Corporate Highlights
- Batiraxcept (AVB-500) in Platinum Resistant
Ovarian Cancer (PROC): As a result of the evolving
pandemic and other factors, the pace of enrollment in the
registrational Phase 3 clinical trial of batiraxcept in PROC has
been slower than originally anticipated. Aravive now expects to
conduct the interim analysis in mid-2022. The interim analysis is
being conducted to 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 final analysis of the
primary endpoint preserves the opportunity to evaluate the efficacy
in patients who received bevacizumab prior to study entry, as well
as those patients who never received bevacizumab. This provides an
additional opportunity to be successful in both patient
populations, regardless of the results of the interim analysis. The
global, randomized, double-blind, placebo-controlled adaptive trial
is designed to evaluate efficacy and safety of batiraxcept at a
dose of 15 mg/kg in combination with paclitaxel versus paclitaxel
alone.In October, the European Commission granted orphan drug
designation to batiraxcept for the treatment of PROC. Orphan drug
designation is granted for medicines being developed for the
diagnosis, prevention or treatment of life-threatening or
chronically debilitating conditions that affect fewer than five in
10,000 people in the European Union.
- Batiraxcept in Clear Cell Renal Cell
Carcinoma (ccRCC): Aravive plans to present new
preliminary data from the Phase 1b portion of its Phase 1b/2
clinical trial of batiraxcept in ccRCC at the Society for
Immunotherapy of Cancer Annual Meeting on November 13, 2021. The
Company previously announced positive initial safety,
pharmacokinetic and pharmacodynamic results from three patients
dosed with 15 mg/kg of batiraxcept in combination with cabozantinib
in the Phase 1b portion of the trial. Aravive expects to complete
enrollment in the Phase 1b portion of the trial and initiate the
Phase 2 portion of the trial in the fourth quarter of 2021.
- 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. The Phase 1b portion of the clinical trial will
evaluate safety, tolerability, pharmacokinetics, pharmacodynamics,
and clinical activity of batiraxcept in combination with
gemcitabine and nab-paclitaxel. The Company expects to complete
enrollment in the Phase 1b portion of the trial in the first half
of 2022 and initiate the Phase 2 portion of the trial in the second
half of 2022.
- Achieved Second Development Milestone with 3D
Medicines: In July 2021, Aravive achieved a $3.0
million development milestone based on the Center for Drug
Evaluation of the China National Medical Products Administration
approval of the Investigational New Drug application submitted by
3D Medicines Inc. to participate in Aravive’s registrational Phase
3 clinical trial of batiraxcept in PROC. The Company received the
$3.0 million development milestone payment in the third quarter of
2021. 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.
Third Quarter 2021 Financial ResultsRevenue for
the three and nine months ended September 30, 2021 were $2.4
million and $6.5 million, respectively, compared to $0 for both
periods in 2020. Revenue for the three and nine months ended
September 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 nine months ended
September 30, 2021 were $14.0 million and $33.4 million,
respectively, compared to $10.7 million and $26.7 million for the
same periods in 2020.
Total operating expenses for the three and nine months ended
September 30, 2021 included non-cash stock-based compensation
expense of $0.6 million and $1.7 million, respectively, compared to
$0.4 million and $1.6 million for the same periods in 2020. In
addition, during the nine months ended September 30, 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 nine months ended September 30, 2021, Aravive
reported a net loss of $11.1 million and $26.2 million, or $0.53
per share and $1.33 per share, respectively, compared to a net loss
of $10.7 million and $26.5 million, or $0.66 per share and $1.69
per share, for the same periods in 2020.
Cash PositionAs of September 30, 2021, cash and
cash equivalents were $67.5 million, compared to $60.5 million as
of December 31, 2020. Based upon its current operating plan and
balance sheet as of September 30, 2021, Aravive expects to have
sufficient cash to be able to fund the base operating plan into the
second half of 2022.
About Batiraxcept (Formerly AVB-500)Batiraxcept
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, batiraxcept selectively
inhibits the GAS6-AXL signaling pathway, which is upregulated in
multiple cancer types including ovarian, renal and pancreatic
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. Batiraxcept is currently being evaluated in
multiple clinical trials and has been granted Fast Track
designation by the U.S. Food and Drug Administration and orphan
drug designation by the European Commission in platinum resistant
recurrent ovarian cancer. Analysis of all safety data to date
showed that batiraxcept has been generally well tolerated with no
dose-limiting toxicities or unexpected safety signals.
About AraviveAravive,
Inc. is a clinical-stage oncology company developing
transformative, targeted therapeutics to treat life-threatening
cancers. The Company is currently evaluating its lead therapeutic,
batiraxcept (formerly AVB-500), in a registrational Phase 3 trial
in platinum resistant ovarian cancer, a Phase 1b/2 trial in second
line plus, clear cell renal cell carcinoma, and a Phase 1b/2 trial
in first-line treatment of pancreatic adenocarcinoma. 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 the broad potential
of batiraxcept to improve the lives of people living with cancer,
conducting an interim analysis of the Phase 3 clinical trial of
batiraxcept in PROC in mid-2022, completion of enrollment in the
Phase 1b portion of the Phase1b/2 clinical trial in clear cell
renal cell carcinoma and initiation of the Phase 2 portion of the
trial in the fourth quarter of 2021, plans to present new
preliminary data from the Phase 1b portion of its Phase 1b/2
clinical trial of batiraxcept in ccRCC at the Society for
Immunotherapy of Cancer Annual Meeting in November, completion of
enrollment in the Phase 1b portion of the 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 in the first half of 2022 and initiation
of the Phase 2 portion of the trial in the second half of 2022,
cash and cash equivalents being sufficient to fund operations into
the second half of 2022 and the potential of batiraxcept 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
conduct an interim analysis of its Phase 3 clinical trial of
batiraxcept in PROC in mid-2022, complete enrollment in the Phase
1b portion of the Phase1b/2 clinical trial in clear cell renal cell
carcinoma and initiate the Phase 2 portion of the trial in the
fourth quarter of 2021, the ability to complete enrollment of the
Phase 1b portion of the Phase 1b/2 pancreatic adenocarcinoma trial
in the first half of 2022 and initiation of the Phase 2 portion of
the trial in the second half of 2022, the ability to enroll the
expected number of patients, the ability to combine batiraxcept
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 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 especially in light of the
COVID-19 pandemic; 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
its cash and cash equivalents being sufficient to fund its planned
operations and its 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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
2,412 |
|
|
$ |
— |
|
|
$ |
6,457 |
|
|
$ |
— |
|
Total revenue |
|
|
2,412 |
|
|
|
— |
|
|
|
6,457 |
|
|
|
— |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
11,343 |
|
|
|
5,070 |
|
|
|
25,347 |
|
|
|
11,085 |
|
General and
administrative |
|
|
2,643 |
|
|
|
2,715 |
|
|
|
8,102 |
|
|
|
9,866 |
|
Loss on impairment of
long-lived assets |
|
|
— |
|
|
|
2,914 |
|
|
|
— |
|
|
|
5,784 |
|
Total operating expenses |
|
|
13,986 |
|
|
|
10,699 |
|
|
|
33,449 |
|
|
|
26,735 |
|
Loss from operations |
|
|
(11,574 |
) |
|
|
(10,699 |
) |
|
|
(26,992 |
) |
|
|
(26,735 |
) |
Interest income |
|
|
9 |
|
|
|
8 |
|
|
|
29 |
|
|
|
251 |
|
Other income (expense),
net |
|
|
479 |
|
|
|
31 |
|
|
|
768 |
|
|
|
(13 |
) |
Net loss |
|
$ |
(11,086 |
) |
|
$ |
(10,660 |
) |
|
$ |
(26,195 |
) |
|
$ |
(26,497 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.53 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.33 |
) |
|
$ |
(1.69 |
) |
Weighted-average common shares
used to compute basic and diluted net loss per share |
|
|
20,763 |
|
|
|
16,055 |
|
|
|
19,758 |
|
|
|
15,658 |
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in thousands)
|
|
September 30, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
(unaudited) |
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
67,511 |
|
|
$ |
60,541 |
Restricted cash |
|
|
2,430 |
|
|
|
2,430 |
Other assets |
|
|
4,458 |
|
|
|
1,781 |
Operating lease right-of-use
assets |
|
|
2,394 |
|
|
|
2,958 |
Total
assets |
|
$ |
76,793 |
|
|
$ |
67,710 |
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
Accounts payable and accrued
liabilities |
|
$ |
6,574 |
|
|
$ |
4,823 |
Deferred revenue |
|
|
8,913 |
|
|
|
6,315 |
Operating lease
obligation |
|
|
6,970 |
|
|
|
8,517 |
Total liabilities |
|
|
22,457 |
|
|
|
19,655 |
Total stockholders'
equity |
|
|
54,336 |
|
|
|
48,055 |
Total liabilities and
stockholders’ equity |
|
$ |
76,793 |
|
|
$ |
67,710 |
Contacts:Investors: Luke Heagle, Real
Chemistrylheagle@realchemistry.com (910) 619-5764
Media: Aulani Capuchin, Real
Chemistryacapuchin@realchemistry.com(559) 355-2673
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