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 quarter
ended June 30, 2019.
“We continue to advance AVB-500 on multiple fronts
and are very encouraged by the recent safety and topline efficacy
data we reported in our AVB-500 clinical program in
platinum-resistant recurrent ovarian cancer,” said Jay Shepard,
president and CEO of Aravive. “The first half of the year is off to
a strong start and we are making progress toward initiating
additional clinical programs.”
Recent Corporate Updates
AVB-500
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.
Below are some recent highlights from the ovarian cancer
program:
- On July 8, we reported that data from the first six patients
enrolled into two cohorts (n=12) of the Phase 1b portion of the
Phase 1b/2 trial of AVB-500 in patients with platinum-resistant
recurrent ovarian cancer, one investigating a combination of
AVB-500 with pegylated liposomal doxorubicin (PLD), and the other,
a combination of AVB-500 with paclitaxel (PAC) was evaluated by an
independent data monitoring committee (DMC). The data demonstrated
suppression of serum GAS6 levels, a biomarker associated with
efficacy in preclinical tumor models, with the current dose. The
DMC did not identify safety concerns and unanimously recommended
the trial continue as planned.
- On July 31, we announced that the preliminary efficacy data
from our ongoing clinical trial with AVB-500, as described above,
showed compelling anti-tumor activity in the 12 patients treated
where response to standard of care chemotherapy alone in patients
is typically 10-15 percent. The overall best response rate (ORR) in
the AVB-500 combination cohorts to date by investigator determined
RECIST v1.1 criteria was greater than response rates observed
historically with standard of care chemotherapy alone in this
clinical setting. We therefore have decided to expand enrollment in
the Phase 1b portion of the study, to validate the unanticipated
early positive efficacy signal. Detailed safety, pharmacokinetic,
pharmacodynamic and preliminary efficacy results for the above 12
patients are anticipated to be presented at an upcoming scientific
meeting.
Second Quarter 2019 Financial Results
The condensed consolidated statements of operations for the
three and six months ended June 30, 2019 include the operations of
Aravive Biologics, Inc., which were not included in the three and
six months ended June 30, 2018, due to the fact that the merger
with Aravive Biologics, Inc. was consummated in October 2018.
Total revenue for the three and six months ended June 30, 2019
was $3.1 million and $4.8 million, respectively, derived solely
from the Cancer Prevention Research Institute of Texas (CPRIT)
grant.
Total operating expenses for the three and six months
ended June 30, 2019 were $6.9 million and $14.4
million, respectively, compared to $9.4 million and $18.0
million for the same periods in 2018.
Total operating expenses for the three and six months ended June
30, 2019 includes non-cash stock-based compensation expense of $0.9
million and $2.0 million, respectively, compared to $2.1 million
and $5.0 million for the same periods in 2018.
For the three and six months ended June 30,
2019, Aravive reported a net loss of
approximately $3.0 million and $7.7 million,
or $0.27 per share and $0.69 per share, respectively,
compared to a net loss of $9.8 million and $18.8 million,
or $1.64 per share and $3.14 per share, for the same
periods in 2018.
Cash Position
At June 30, 2019, cash and cash equivalents were $48.4
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 has
initiated the phase 1b portion of a phase 1b/2 clinical trial of
AVB-500 combined with standard of care therapies in patients with
platinum-resistant ovarian cancer, 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. Aravive was one of
FierceBiotech's Fierce 15 in 2017. 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, concerning making
progress toward initiating additional clinical programs in renal
cell carcinoma and renal fibrosis, the presentation of detailed
safety, pharmacokinetic, pharmacodynamic and preliminary efficacy
results at an upcoming scientific meeting and the
potential of AVB-500 halting the biological programming that
promotes disease progression. 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 expand development in 2019 into additional
oncology and fibrotic indications, the Company’s dependence upon
AVB-500, AVB-500’s ability to have favorable results in clinical
trials or receive regulatory approval, potential delays in the
Company's clinical trials due to regulatory requirements or
difficulty identifying qualified investigators or enrolling
patients; 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 and Form
10-K/A for the fiscal year ended December 31, 2018, 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
(Unaudited)(in thousands, except
per share amounts)
| |
Three Months Ended |
|
|
Six Months Ended |
|
| |
June 30, |
|
|
June 30, |
|
| |
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
$ |
3,054 |
|
|
$ |
— |
|
|
$ |
4,753 |
|
|
$ |
— |
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,637 |
|
|
|
3,438 |
|
|
$ |
6,485 |
|
|
$ |
7,038 |
|
|
General and administrative |
|
3,291 |
|
|
|
6,003 |
|
|
|
7,881 |
|
|
|
10,920 |
|
| Total operating expenses |
|
6,928 |
|
|
|
9,441 |
|
|
|
14,366 |
|
|
|
17,958 |
|
| Loss from operations |
|
(3,874 |
) |
|
|
(9,441 |
) |
|
|
(9,613 |
) |
|
|
(17,958 |
) |
| Interest income |
|
233 |
|
|
|
249 |
|
|
|
579 |
|
|
|
442 |
|
| Other income (expense),
net |
|
597 |
|
|
|
(656 |
) |
|
|
1,286 |
|
|
|
(1,313 |
) |
| Net loss |
$ |
(3,044 |
) |
|
$ |
(9,848 |
) |
|
$ |
(7,748 |
) |
|
$ |
(18,829 |
) |
| Net loss per share- basic and
diluted |
$ |
(0.27 |
) |
|
$ |
(1.64 |
) |
|
$ |
(0.69 |
) |
|
$ |
(3.14 |
) |
| Weighted-average common shares
used to compute basic and diluted net loss per share |
|
11,280 |
|
|
|
6,023 |
|
|
|
11,277 |
|
|
|
6,002 |
|
Aravive, Inc.Condensed
Consolidated Balance Sheets
(Unaudited)(in thousands)
| |
June 30, |
|
|
December 31, |
|
| |
2019 |
|
|
2018 |
|
|
Assets: |
|
|
|
|
|
|
|
| Cash and cash equivalents |
$ |
48,384 |
|
|
$ |
56,992 |
|
| Restricted cash |
|
2,409 |
|
|
|
2,396 |
|
| Other assets |
|
6,452 |
|
|
|
1,431 |
|
| Build-to-suit lease asset |
|
— |
|
|
|
8,651 |
|
| Operating lease right-of-use
assets |
|
9,501 |
|
|
|
— |
|
| Total
assets |
$ |
66,746 |
|
|
$ |
69,470 |
|
| Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
| Accounts payable and accrued
liabilities |
$ |
2,111 |
|
|
$ |
1,791 |
|
| Deferred revenue |
|
— |
|
|
|
146 |
|
| Build-to-suit lease
obligation |
|
— |
|
|
|
7,324 |
|
| Operating lease
obligation |
|
11,500 |
|
|
|
— |
|
| Contingent payable |
|
264 |
|
|
|
264 |
|
| Total liabilities |
|
13,875 |
|
|
|
9,525 |
|
| Total stockholders'
equity |
|
52,871 |
|
|
|
59,945 |
|
| Total liabilities and
stockholders’
equity |
$ |
66,746 |
|
|
$ |
69,470 |
|
Contacts for Aravive:
Investors:
Vinay Shah
CFO
Aravive, Inc.
Vinay@aravive.com
Media:
Heidi Chokeir
Canale Communications
heidi@canalecomm.com
619-203-5391
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