In a release issued under the same headline on Thursday, November
7th by Aravive, Inc. (Nasdaq: ARAV), please note that in the
last sentence of the second paragraph, the year for the IgA
Nephropathy study should be 2019, not 2020. The corrected release
follows:
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 September 30, 2019.
“We are encouraged by the positive data we reported in our
clinical program for AVB-500, an ultrahigh-affinity decoy protein
that targets the GAS6-AXL signaling pathway, being evaluated in
platinum-resistant recurrent ovarian cancer and we are focused on
advancing further clinical development,” said Jay Shepard,
president and CEO of Aravive. “Additionally, we remain on track to
initiate clinical development in renal cell carcinoma in
4Q2019/1Q2020, and we are making progress toward initiating
additional programs including our IgA Nephropathy study in
2019.”
Recent Corporate Updates
- In October 2019, Aravive reported publication of data from a
non-clinical study where AVB-500 reduced tumor size and blood
vessel density in animal models of clear cell renal cell carcinoma,
highlighting the role of GAS6/AXL signaling in promoting tumor
angiogenesis through control of plasminogen receptor S100A10. This
data was published in the peer-reviewed journal Cancer
Research and supports the Company’s development plans for AVB-500
in this indication.
- In September 2019, the Company reported positive data from the
initial 12 patients of the ongoing Phase 1b portion of the
Company’s Phase 1b/2 study of AVB-500 in ovarian cancer patients
treated with 10mg/kg AVB-500. The study showed AVB-500 treatment
led to early proof of concept with overall best response rate (ORR)
by investigator determined RECIST v1.1 criteria and durable
response in responders. AVB-500 was well tolerated with no dose
limiting toxicities (DLT). These data were presented at the
European Society for Medical Oncology Congress (ESMO).
- In September 2019, the Company also reported data on the
initial 28 evaluable patients treated with the 10mg/kg AVB-500 dose
in the same study in ovarian cancer patients demonstrating that the
patients’ current response rates in the clinical study correlate
with drug exposure. As a result, higher doses of AVB-500 will be
tested in the Phase 1b study to investigate the potential to
increase the proportion of patients who achieve the higher drug
exposures. AVB-500 continues to be well tolerated and the clinical
benefit rate in the initial 28 patients is currently at 61 percent
with 25 percent partial response. Once these data mature and the
best response rates are confirmed for each patient, we may see
different response and clinical benefit rates.
- In August 2019, Aravive announced Jay Shepard intends to
step down as president, chief executive officer (CEO) and member of
the Board of Directors for family medical reasons. The Board of
Directors continues to search for his successor, and Mr. Shepard
plans to serve in his current role until a successor is
appointed.
Financial Results
The condensed consolidated statements of operations for the
three and nine months ended September 30, 2019 include the
operations of Aravive Biologics, Inc., which were not included in
the three and nine months ended September 30, 2018, due to the fact
that the merger with Aravive Biologics, Inc. was consummated in
October 2018.
Revenue for the nine months ended September 30, 2019 was $4.8
million derived solely from the Cancer Prevention Research
Institute of Texas (CPRIT) grant.
Total operating expenses for the three and nine months ended
September 30, 2019 were $7.0 million and $21.4 million,
respectively, compared to $6.2 million and $24.2 million for the
same periods in 2018.
Total operating expenses for the three and nine months ended
September 30, 2019 includes non-cash stock-based compensation
expense of $0.8 million and $2.8 million, respectively, compared to
$1.3 million and $6.3 million for the same periods in 2018.
Net loss for the three and nine months ended September 30, 2019
were $6.1 million and $13.9 million, or $0.54 per share and $1.23
per share, respectively, compared to a net loss of $6.6 million and
$25.4 million, or $1.08 per share and $4.23 per share, for the same
periods in 2018.
Cash Position
At September 30, 2019, cash and cash equivalents was $45.0
million.
About AVB-500
AVB-500 is an ultrahigh-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.
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
ultrahigh-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
evaluating AVB-500 in 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 including an IgA Nephropathy study in 2020,
remaining on track to initiate clinical development in renal cell
carcinoma in 4Q2019/1Q2020, the potential to increase the
proportion of patients who achieve the higher drug exposures 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 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 |
|
|
Nine Months Ended |
|
|
| |
September 30, |
|
|
September 30, |
|
|
| |
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
4,753 |
|
|
$ |
— |
|
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,840 |
|
|
|
1,027 |
|
|
|
10,325 |
|
|
|
8,065 |
|
|
|
General and administrative |
|
3,158 |
|
|
|
5,191 |
|
|
|
11,039 |
|
|
|
16,111 |
|
|
| Total operating expenses |
|
6,998 |
|
|
|
6,218 |
|
|
|
21,364 |
|
|
|
24,176 |
|
|
| Loss from operations |
|
(6,998 |
) |
|
|
(6,218 |
) |
|
|
(16,611 |
) |
|
|
(24,176 |
) |
|
| Interest income |
|
232 |
|
|
|
261 |
|
|
|
811 |
|
|
|
703 |
|
|
| Other income (expense),
net |
|
624 |
|
|
|
(593 |
) |
|
|
1,910 |
|
|
|
(1,906 |
) |
|
| Net loss |
$ |
(6,142 |
) |
|
$ |
(6,550 |
) |
|
$ |
(13,890 |
) |
|
$ |
(25,379 |
) |
|
| Net loss per share- basic and
diluted |
$ |
(0.54 |
) |
|
$ |
(1.08 |
) |
|
$ |
(1.23 |
) |
|
$ |
(4.23 |
) |
|
| Weighted-average common shares
used to compute basic and diluted net loss per share |
|
11,285 |
|
|
|
6,040 |
|
|
|
11,280 |
|
|
|
5,998 |
|
|
Aravive, Inc.Condensed
Consolidated Balance Sheets
(in thousands)
| |
September 30, |
|
|
December 31, |
|
| |
2019 |
|
|
2018 |
|
| |
(unaudited) |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
| Cash and cash equivalents |
$ |
44,975 |
|
|
$ |
56,992 |
|
| Restricted cash |
|
2,418 |
|
|
|
2,396 |
|
| Other assets |
|
6,101 |
|
|
|
1,431 |
|
| Build-to-suit lease asset |
|
— |
|
|
|
8,651 |
|
| Operating lease right-of-use
assets |
|
9,092 |
|
|
|
— |
|
| Total
assets |
$ |
62,586 |
|
|
$ |
69,470 |
|
| Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
| Accounts payable and accrued
liabilities |
$ |
3,921 |
|
|
$ |
1,791 |
|
| Deferred revenue |
|
— |
|
|
|
146 |
|
| Build-to-suit lease
obligation |
|
— |
|
|
|
7,324 |
|
| Operating lease
obligation |
|
10,871 |
|
|
|
— |
|
| Contingent payable |
|
264 |
|
|
|
264 |
|
| Total liabilities |
|
15,056 |
|
|
|
9,525 |
|
| Total stockholders'
equity |
|
47,530 |
|
|
|
59,945 |
|
| Total liabilities and
stockholders’
equity |
$ |
62,586 |
|
|
$ |
69,470 |
|
Contacts for Aravive:
Investors:
Christina Tartaglia
Stern IR, Inc.
christina.tartaglia@sternir.com
212-362-1200
Media:
Heidi Chokeir
Canale Communications
heidi@canalecomm.com
619-203-5391
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