Aravive Reports First Quarter 2020 Financial Results and Provides Recent Corporate Updates
May 06 2020 - 4:05PM
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical
company developing treatments designed to halt the progression of
life-threatening diseases, including cancer and fibrosis, announced
recent corporate updates and financial results for the first
quarter ended March 31, 2020.
“The first quarter of 2020 marked an important period for
Aravive, as demonstrated by the accomplishment of several key
events, including the publication of encouraging preclinical
findings supporting the advancement of our lead product candidate,
AVB-500 in abstracts for the Society for Gynecologic Oncology 2020
Annual Meeting,” said Gail McIntyre, Ph.D., chief executive officer
of Aravive. “Patient safety and trial integrity remain our top
priorities as we continue to closely monitor the potential impact
of COVID-19 to our ongoing programs and we are on schedule to have
safety, pharmacokinetic and preliminary efficacy data from our
Phase 1b platinum-resistant ovarian cancer study mid-2020. Looking
ahead, the remainder of 2020 will be an important time for Aravive
as we responsibly navigate the current global environment, enroll
more patients into clinical trials and make progress towards
changing the treatment paradigm for patients with cancer.”
Recent Corporate Updates
- Formed Strategic Collaboration with WuXi Biologics to
Develop Novel High-Affinity Bispecific Antibodies Targeting Cancer
and Fibrosis: In April 2020, Aravive and WuXi Biologics
announced that they are collaborating to develop novel
high-affinity bispecific antibodies against CCN2, also known as
connective tissue growth factor (CTGF), implicated in cancer and
fibrosis and identified from a similar target discovery screen that
identified the significance of the AXL/GAS6 pathway in
cancer.
- Announced Board Composition and Executive Management
Transitions: In April 2020, Aravive announced the
promotion of Gail McIntyre, Ph.D., from chief scientific officer to
chief executive officer and her appointment to the board of
directors. In addition, Aravive announced changes to its board of
directors with the appointment of healthcare entrepreneur, Dr. Fred
Eshelman, Pharm.D. as chairman and the resignations of Jay
Shepard, Srinivas Akkaraju, M.D., Ph.D., Robert Hoffman and
Rekha Hemrajani.
- Unveiled Multiple Abstracts Demonstrating the Potential
of AVB-500 in multiple gynecologic cancers: In March 2020,
multiple abstracts with results from preclinical studies were
published on the website for the Society for Gynecologic Oncology
(SGO) 2020 Annual Meeting. These studies demonstrate that AVB-500
improves anti-tumor effects when combined with the anti-angiogenic
bevacizumab or the PARP inhibitor olaparib in pre-clinical uterine
cancer models and AVB-500 induces ‘BRCA-ness’ through inhibition of
GAS6/AXL signaling, increasing response to platinum and PARPi in a
preclinical ovarian cancer model. The posters and a webcast
of the intended SGO oral presentation are available on Aravive’s
website at https://aravive.com/our-approach/.
Financial Results
Revenue for the three months ended March 31, 2020 was $0,
compared to $1.7 million for the same period in 2019. Revenue for
2019 was derived solely from the Cancer Prevention Research
Institute of Texas (CPRIT) grant.
Total operating expenses for the three months ended March 31,
2020 was $10.3 million, compared to $7.4 million for the same
period in 2019.
Total operating expenses for the three months ended March 31,
2020 includes non-cash stock-based compensation expense of $0.7
million, compared to $1.0 million for the same period in 2019. In
addition, for the three months ended March 31, 2020, there was a
one-time non-cash charge for impairment of our right-of-use asset
and leasehold improvements of $2.9 million.
Net loss for the three months ended March 31, 2020 was $10.8
million, or $0.72 per share, which included a one-time non-cash
charge for impairment, compared to a net loss of $4.7 million, or
$0.42 per share for the same period in 2019.
Cash Position
As of March 31, 2020, cash and cash equivalents was $60.7
million.
About Aravive
Aravive, Inc. (Nasdaq: ARAV) is a clinical-stage
biopharmaceutical company developing treatments designed to halt
the progression of life-threatening diseases, including cancer and
fibrosis. Aravive’s lead product candidate, AVB-500, is an
ultra-high affinity decoy protein that targets the GAS6-AXL
signaling pathway. By capturing serum GAS6, AVB-500 starves the AXL
pathway of its signal, potentially halting the biological
programming that promotes disease progression. AXL receptor
signaling plays an important role in multiple types of malignancies
by promoting metastasis, cancer cell survival, resistance to
treatments, and immune suppression. The GAS6-AXL signaling pathway
also plays a significant role in fibrogenesis. Aravive is
actively evaluating AVB-500 in platinum-resistant ovarian cancer
and clear cell renal cell carcinoma and intends to expand
development into additional oncology and fibrotic
indications. Aravive 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 Statements
This 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 as the potential for topline data in mid-2020 from
the AVB-500 Phase 1b dose escalation ongoing at 20 mg/kg dose in
platinum resistant ovarian cancer, the potential of AVB-500 in
multiple gynecologic cancers and the expansion of the development
of AVB-500 into additional oncology and fibrotic indications.
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 provide topline data as planned especially in light of
COVID-19, the ability to properly fund the Company, the ability of
the new directors and management team to deliver on the Company’s
strategic vision and execute on its business plan, the impact of
COVID-19 on the Company’s clinical strategy and fundraising, the
Company’s ability to expand development into additional oncology
and fibrotic indications, the Company’s dependence upon AVB-500,
AVB-500’s ability to have favorable results in clinical trials, the
clinical trials of AVB-500 having results that are as favorable as
those of preclinical and clinical studies, 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 outbreak; 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, 2019, 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.
Contacts for Aravive:
Investors: Julie Seidel Stern Investor
Relations, Inc. julie.seidel@sternir.com212-362-1200
Media: Heidi Chokeir, Ph.D. Canale
Communications heidi@canalecomm.com 619-203-5391
Aravive, Inc.Condensed
Consolidated Statements of Operations(in
thousands, except per share amounts)
|
|
|
|
Three Months
Ended |
|
|
March 31, |
|
|
2020 |
|
2019 |
|
|
|
|
|
(unaudited) |
|
Revenue |
|
|
|
|
|
|
Grant revenue |
$ |
— |
|
$ |
1,699 |
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
3,491 |
|
|
2,848 |
|
General and administrative |
|
3,951 |
|
|
4,590 |
|
Loss on impairment of long-lived assets |
|
2,870 |
|
|
— |
|
Total
operating expenses |
|
10,312 |
|
|
7,438 |
|
Loss from
operations |
|
(10,312 |
) |
|
(5,739 |
) |
Interest
income |
|
217 |
|
|
346 |
|
Other
(expense) income, net |
|
(701 |
) |
|
689 |
|
Net
loss |
$ |
(10,796 |
) |
$ |
(4,704 |
) |
Net loss per
share- basic and diluted |
$ |
(0.72 |
) |
$ |
(0.42 |
) |
Weighted-average common shares used to compute basic and diluted
net loss per share |
|
15,013 |
|
|
11,273 |
|
|
|
|
|
|
|
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in
thousands)
|
March 31, |
|
December 31, |
|
2020 |
|
2019 |
|
(unaudited) |
|
|
|
Assets: |
|
|
|
|
|
Cash and
cash equivalents |
$ |
60,700 |
|
$ |
65,134 |
Restricted
cash |
|
2,428 |
|
|
2,423 |
Other
assets |
|
2,673 |
|
|
5,867 |
Operating
lease right-of-use assets |
|
5,741 |
|
|
8,697 |
Total assets |
$ |
71,542 |
|
$ |
82,121 |
Liabilities
and stockholders' equity: |
|
|
|
|
|
Accounts
payable and accrued liabilities |
$ |
2,635 |
|
$ |
2,575 |
Operating
lease obligation |
|
9,609 |
|
|
10,233 |
Contingent
payable |
|
295 |
|
|
264 |
Total
liabilities |
|
12,539 |
|
|
13,072 |
Total
stockholders' equity |
|
59,003 |
|
|
69,049 |
Total liabilities and
stockholders’
equity |
$ |
71,542 |
|
$ |
82,121 |
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