Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing transformative therapeutics, today announced recent
corporate updates and financial results for the second quarter
ended June 30, 2020.
“Aravive has made significant progress in the second quarter of
2020, highlighted by the successful completion of our Phase 1b
trial evaluating AVB-500 in platinum resistant ovarian cancer with
encouraging clinical data setting us up to move into what could be
a pivotal study with our lead program,” said Gail McIntyre, Ph.D.,
chief executive officer of Aravive. “A preliminary discussion with
the FDA suggests an adaptive, randomized, controlled trial with
biomarker-based stratification and an interim analysis to drop the
control arm could potentially be an efficient pathway to approval.
We are very encouraged by the Phase 1b trial results and look
forward to formally discussing the data and our development plans
with the FDA in the coming months. The Aravive team is also looking
forward to advancing both the ovarian cancer and renal cancer
programs over the next few months.”
Second Quarter 2020 Financial ResultsRevenue
for the three and six months ended June 30, 2020 were $0 for both
periods, compared to $3.1 million and $4.8 million for the same
periods in 2019. Revenue for 2019 was derived solely from the
Cancer Prevention Research Institute of Texas (CPRIT) grant.
Total operating expenses for the three and six months ended June
30, 2020 were $5.7 million and $16.0 million, respectively,
compared to $6.9 million and $14.4 million for the same periods in
2019.
Total operating expenses for the three and six months ended June
30, 2020 included non-cash stock-based compensation expense of $0.5
million and $1.2 million, respectively, compared to $0.9 million
and $2.0 million for the same periods in 2019. In addition, as
previously reported, during the three months ended March 31, 2020,
there was a one-time non-cash charge 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, 2020, Aravive
reported a net loss of $5.0 million and $15.8 million, or $0.32 per
share and $1.02 per share, respectively, compared to a net loss of
$3.0 million and $7.7 million, or $0.27 per share and $0.69 per
share, for the same periods in 2019.
Cash PositionAs of June 30, 2020, cash and cash
equivalents was $60.1 million, compared to $65.1 million as of
December 31, 2019. The Company expects that its current cash and
cash equivalents will be sufficient to fund its operating plans
into 2022.
Recent Corporate Highlights
• |
AVB-500 in Platinum Resistant Ovarian
Cancer (PROC): On July 23, 2020, the Company announced the
successful completion of its Phase 1b trial of AVB-500 in PROC and
selection of the recommended Phase 2 dose. |
|
o |
AVB-500 plus paclitaxel showed an overall Investigator-assessed
best response rate (per RECIST V1.1) of 35% (95% CI of 16% to 57%)
across all dosing cohorts with 2 complete responses (CR) and 6
partial responses (PR). These data compare favorably to the average
response rate in platinum-resistant ovarian cancer patients of
10-15%.1 |
|
o |
The Company is encouraged with 60% ORR in the sub population that
has not been previously treated with bevacizumab and 71% among
those with high plasma sAXL/GAS6 ratio, a potential biomarker of
response. |
|
o |
Analysis of all safety data to date showed that AVB-500 has been
well-tolerated with no dose-limiting toxicities or unexpected
safety signals. |
|
o |
While the Phase 1b trial was a safety trial and not powered to
demonstrate efficacy, all 5 patients in the 15 mg/kg cohort
experienced clinical benefit, with 1 CR (patient continues to
maintain CR for 3 months on AVB-500 alone following discontinuation
of paclitaxel), 2 partial responses, and 2 stable disease. |
|
o |
The safety, pharmacokinetic and clinical activity at the 15 mg/kg
dose support advancing 15 mg/kg AVB-500 into the next, potentially
registrational enabling PROC trial. An interim analysis of this
study is expected in 2021. |
• |
AVB-500 in Clear Cell Renal Cell Carcinoma
(ccRCC): Aravive is on-track to initiate a Phase 1b/2
trial of AVB-500 in ccRCC in the second half of 2020. This is an
open-label study which is expected to provide safety,
pharmacokinetic, and preliminary clinical activity during the
upcoming year. This study will also explore the biomarkers that
have been identified during the PROC study. |
• |
Investigator-Sponsored Trials (ISTs): The Company
expects to provide an update on the ongoing ISTs within the next
12 months (assuming COVID-19 and other unforeseen
circumstances do not interfere). |
• |
Strategic Decision to Focus on Oncology Assets and Pipeline
Expansion: The Company announced a new strategic focus for
AVB-500 in oncology. Following the positive results from the
AVB-500 Phase 1 trial in PROC, Aravive plans to focus its resources
on advancing the development of AVB-500 in PROC, ccRCC and
potentially additional oncology indications. |
|
o |
Recent preclinical data with AVB-500 has highlighted its promise to
be combined with various oncology compounds (e.g., PARP inhibitors,
bevacizumab, immunotherapy as well as cytotoxic agents) to support
the Company’s pipeline expansion in oncology indications. |
|
o |
Specifically, in addition to Aravive’s focus on PROC, the Company
is also considering moving AVB-500 into frontline therapy in
Ovarian cancer in combination with PAC/Platinum/Bevacizumab, all of
which have biological rationale and supportive data for potential
synergy/additive anti-tumor effects. Importantly, the safety
profile of AVB-500 suggests there may not be added toxicity to the
first line cocktails used in frontline metastatic ovarian
cancer. |
|
o |
The Company expects to announce expansion plans during 2021. |
“I am delighted at the achievements that Gail and her team have
made with AVB-500 and we strongly support moving the program
forward. With a renewed focus on oncology assets, AVB-500 offers a
first-and potentially best-in-class opportunity in oncology,” said
Fred Eshelman, Pharm.D., chairman of the board of directors. “On
behalf of the Aravive Board, we look forward to continuing to grow
our business, add talent to our management team and Board and
assess business development opportunities around our pipeline and
ex-U.S.”
About AraviveAravive, Inc. (Nasdaq:
ARAV) is a clinical-stage oncology company developing
transformative treatments designed to halt the progression of
life-threatening diseases. Aravive’s lead product candidate,
AVB-500, is an ultra-high affinity decoy protein that targets the
GAS6-AXL signaling pathway. On July 23, 2020, Aravive announced the
successful completion of a Phase 1b trial of AVB-500 in platinum
resistant ovarian cancer and selection of the recommended Phase 2
dose, 15 mg/kg. 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. While the Phase 1b trial
was a safety trial and not powered to demonstrate efficacy, all 5
patients in the 15 mg/kg cohort experienced clinical benefit, with
1 complete response (CR), 2 partial responses, and 2 stable
disease. Across all cohorts, AVB-500 plus paclitaxel data showed an
ORR of 35% (8/23 patients, including 2 CRs) and a 60% ORR in
paclitaxel patients who had not previously been given bevacizumab.
For more information, please visit www.aravive.com.
Forward-Looking StatementsThis 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 advancing
both the ovarian cancer and renal cancer programs over the next few
months, being on-track to discuss the potentially pivotal study
with FDA this year and initiation of Phase 1b/2 trial of AVB-500 in
clear cell renal cell carcinoma in second half of 2020, moving into
what could be a pivotal trial, expanding the pipeline in oncology
and announcement of expansion plans in 2021, an adaptive,
randomized, controlled trial with biomarker-based stratification
and an interim analysis to drop the control arm potentially being
an efficient pathway to approval, an interim analysis of the PROC
trial in 2021, current cash and cash equivalents expected to fund
operations into 2022, ISTs providing information within the next
twelve months, moving AVB-500 into frontline therapy in ovarian
cancer and the suggestion that AVB-500 may not be added toxicity to
the first line cocktails used in frontline metastatic ovarian
cancer and continuing to grow the business, add talent to the
management and Board and assess business development opportunities
around the pipeline and ex-U.S. 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 design and obtain approval for
a randomized, controlled trial with an interim analysis and drop
the control arm that potentially could be a pathway to approval,
the ability to properly fund the Company, the ability to initiate
the open-label ccRCC study and potentially pivotal PROC study, the
ability to provide preliminary safety, pharmacokinetic and tumor
response data from the ccRCC study, interim analysis data on the
potentially pivotal study by the end of 2021 and announcement of
pipeline expansion plans in 2021, providing information from ISTs
within the next twelve months, the ability to move AVB-500 into
frontline therapy, the ability to fund operations into 2022 with
current cash and cash equivalents, 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, clinical trials, supply chain and
fundraising, the Company's ability to expand development into
additional oncology 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,
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: Media:Sheryl Seapy,
W2Osseapy@w2ogroup.com(949) 903-4750
Investors: Luke Heagle, W2O lheagle@w2ogroup.com (910)
726-1372
Aravive, Inc.Condensed
Consolidated Statements of Operations(in thousands, except
per share amounts)(unaudited)
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2020 |
|
|
2019 |
|
2020 |
|
|
2019 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
$ |
— |
|
|
$ |
3,054 |
|
$ |
— |
|
|
$ |
4,753 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
2,522 |
|
|
|
3,637 |
|
|
6,014 |
|
|
|
6,485 |
|
General and administrative |
|
3,201 |
|
|
|
3,291 |
|
|
7,151 |
|
|
|
7,881 |
|
Loss on impairment of long-lived assets |
|
— |
|
|
|
— |
|
|
2,870 |
|
|
|
— |
|
Total operating
expenses |
|
5,723 |
|
|
|
6,928 |
|
|
16,035 |
|
|
|
14,366 |
|
Loss from
operations |
|
(5,723 |
) |
|
|
(3,874 |
) |
|
(16,035 |
) |
|
|
(9,613 |
) |
Interest
income |
|
26 |
|
|
|
233 |
|
|
243 |
|
|
|
579 |
|
Other income
(expense), net |
|
656 |
|
|
|
597 |
|
|
(45 |
) |
|
|
1,286 |
|
Net loss |
$ |
(5,041 |
) |
|
$ |
(3,044 |
) |
$ |
(15,837 |
) |
|
$ |
(7,748 |
) |
Net loss per
share- basic and diluted |
$ |
(0.32 |
) |
|
$ |
(0.27 |
) |
$ |
(1.02 |
) |
|
$ |
(0.69 |
) |
Weighted-average
common shares used to compute basic and diluted net loss per
share |
|
15,902 |
|
|
|
11,280 |
|
|
15,457 |
|
|
|
11,277 |
|
Aravive, Inc.Condensed
Consolidated Balance Sheets (in thousands)
|
June 30, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
(unaudited) |
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
60,062 |
|
|
$ |
65,134 |
|
Restricted
cash |
|
2,429 |
|
|
|
2,423 |
|
Other assets |
|
3,128 |
|
|
|
5,867 |
|
Operating lease
right-of-use assets |
|
5,394 |
|
|
|
8,697 |
|
Total
assets |
$ |
71,013 |
|
|
$ |
82,121 |
|
Liabilities and
stockholders' equity: |
|
|
|
|
|
|
|
Accounts payable
and accrued liabilities |
$ |
2,276 |
|
|
$ |
2,575 |
|
Operating lease
obligation |
|
8,995 |
|
|
|
10,233 |
|
Contingent
payable |
|
295 |
|
|
|
264 |
|
Total
liabilities |
|
11,566 |
|
|
|
13,072 |
|
Total
stockholders' equity |
|
59,447 |
|
|
|
69,049 |
|
Total
liabilities and stockholders’
equity |
$ |
71,013 |
|
|
$ |
82,121 |
|
1 A Davis et al., Gynecologic Oncology 133 (2014)
624–631
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