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 fourth quarter and twelve months ended December 31,
2019.
With the recent and rapidly evolving impact of COVID-19 on
patient recruitment in clinical trials and considering patient
safety and trial integrity, Aravive has decided to make certain
changes to its clinical plans:
- The company has decided to amend its clear cell renal cell
carcinoma (ccRCC) trial to initiate treatment at 15 mg/kg or 20
mg/kg given the positive safety profile seen with the 15 mg/kg
dosing cohort of the platinum resistant ovarian cancer (PROC) trial
and the recent initiation of the 20 mg/kg dosing cohort in the PROC
population. While this may delay first patient dosing, the
overall timelines for top line data may not be significantly
impacted given the higher starting dose, assuming the COVID-19
situation does not interfere with ongoing clinical studies.
- To reduce the risk of unnecessary exposure of patients to
COVID-19 that may be caused by patients coming to health centers
for their AVB-500 intravenous infusion, the company will pause new
enrollment in its IgA nephropathy (IgAN) trial as this is a
relatively healthy patient population with a chronic disease.
Aravive plans to continue enrollment in its ongoing Ph 1b dose
escalation cohort at the 20 mg/kg dose in patients with PROC with
the goal of targeting up to twelve patients in the trial, subject
to the impact of COVID-19.
Based on updated clinical plans, Aravive anticipates that its
cash and cash equivalents will be sufficient to fund operations
into 2022.
“We are encouraged with the safety and efficacy profile of
AVB-500 seen in the small number of patients in the 15 mg/kg dose
cohort in our ongoing Phase 1b trial in platinum resistant ovarian
cancer that is consistent with the hypothesis generated from the 10
mg/kg dose cohort. The 20 mg/kg dose cohort is ongoing and we
anticipate topline data later this summer, assuming the COVID-19
situation doesn’t interfere with ongoing clinical studies,” said
Rekha Hemrajani, president and chief executive officer of Aravive,
“2019 was a transformative year for Aravive with several clinical
and financial achievements that have set us up well for 2020 and
beyond despite the short-term challenges we may face due to
COVID-19.”
Recent Corporate Updates
- In March 2020, Aravive announced that the first patient has
been dosed in an investigator-sponsored Phase 1/2 clinical trial of
AVB-500 in combination with PD-L1 inhibitor avelumab in patients
with advanced urothelial carcinoma (UC). The trial is being led by
Abhishek Tripathi, M.D., Assistant Professor of Medicine, Section
of hematology/oncology at the University of Oklahoma Stephenson
Cancer Center.
- In February 2020, Aravive announced that the independent Data
Monitoring Committee (DMC) has reviewed the open-label data
following the first 28-day treatment cycle for the three patients
in each of the two 15 mg/kg dosing cohorts of the Phase 1b portion
of the Phase 1b/Phase 2 clinical trial of AVB-500 in patients with
PROC and unanimously recommended the trial continue as planned with
enrollment of patients into the 20mg/kg dose cohorts.
- In January 2020, Aravive announced that the company received
IND Clearance for Phase 1b/Phase 2 clinical trial of AVB-500 in
Patients with ccRCC.
- In January 2020, Aravive announced the appointment of Rekha
Hemrajani as president, chief executive officer and director of the
company and the transition of Jay Shepard’s role from president and
chief executive officer of the company to the chairman of the board
of directors.
- In December 2019, Aravive announced that the company had begun
enrolling patients in the Phase 2a clinical trial of AVB-500 in
patients with kidney fibrosis, specifically IgAN (NCT04042623).
This is an open-label Phase 2a clinical trial designed to evaluate
the safety and efficacy of AVB-500 in patients with biopsy-proven
IgAN and excreting 1-3 grams of protein daily in their urine. The
primary endpoints will be safety as well as measuring the effects
of AVB-500 treatment on protein levels in patient’s urine.
- In December 2019, Aravive raised net proceeds of approximately
$25 million in a public offering. A total of 3,633,334 shares of
its common stock were issued at a price of $7.50 per
share.
- In November 2019, Aravive announced positive data from the
Phase 1b portion of the Phase 1b/2 clinical trial of AVB-500 in
PROC patients. The data from the first 31 patients treated at the
10 mg/kg dose affirmed earlier findings on the relationship between
AVB-500 levels in the blood and clinical benefit. In this data
analysis, high serum drug levels of AVB-500 were strongly
predictive of anti-tumor activity with statistically significant
correlation with progression-free survival.
- In November 2019, Aravive and AstraZeneca announced that an
investigator-sponsored Phase 1/2 clinical trial of AVB-500 in
combination with durvalumab, a PD-L1 inhibitor, in patients with
platinum-resistant, recurrent epithelial ovarian cancer had
initiated and was recruiting patients (NCT04019288).
- In October 2019, Aravive reported publication of data from
a non-clinical trial where AVB-500 reduced tumor size and blood
vessel density in animal models of ccRCC, 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.
Financial ResultsThe consolidated statements of
operations for the three and twelve months ended December 31, 2019
include the operations of Aravive Biologics, Inc. for a full twelve
months, which were not included for the full twelve months in the
consolidated statements of operations for the twelve months ended
December 31, 2018, due to the fact that the merger with Aravive
Biologics, Inc. was consummated in October 2018.
Revenue for the three and twelve months ended December 31, 2019
were $0 and $4.8 million, respectively, compared to $1.4 million
for both periods in 2018. Revenue was derived solely from the
Cancer Prevention Research Institute of Texas (CPRIT) grant.
Total operating expenses for the three and twelve months ended
December 31, 2019 were $5.2 million and $26.5 million,
respectively, compared to $52.6 million and $76.8 million for the
same periods in 2018.
Total operating expenses for the three and twelve months ended
December 31, 2019 include non-cash stock-based compensation expense
of $0.6 million and $3.4 million, respectively, compared to $9.9
million and $16.1 million for the same periods in 2018. In
addition, for the year ended December 31, 2018, there was a
one-time non-cash charge for acquired in process research and
development of $38.3 million incurred in connection with the
completion of the merger in the fourth quarter of 2018.
Net loss for the three and twelve months ended December 31, 2019
was $4.3 million and $18.2 million, or $0.35 per share and $1.57
per share, respectively, compared to a net loss of $51.0 million
and $76.3 million, or $4.82 per share and $10.64 per share,
respectively for the same periods in 2018.
Cash PositionAt December 31, 2019, cash and
cash equivalents were $65.1 million. Based on the updated clinical
plans, Aravive anticipates that its cash and cash equivalents will
be sufficient to fund operations into 2022.
About AVB-500AVB-500 is a therapeutic
recombinant fusion protein that has been shown to neutralize GAS6
activity by binding to GAS6 with very high affinity. In doing so,
AVB-500 selectively inhibits the GAS6-AXL signaling pathway. In
preclinical studies, GAS6-AXL inhibition has shown anti-tumor
activity, both as a single agent and 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 is correlated to poor prognosis and survival, and has been
implicated in therapeutic resistance to conventional
chemotherapeutics and targeted therapies.
Aravive reported positive data from the first 31 patients
enrolled in the Phase 1b portion of a Phase 1b/2 clinical trial of
AVB-500 in platinum-resistant recurrent ovarian cancer. AVB-500
continues to be well tolerated with no dose limiting toxicities. An
investigator-sponsored Phase 1/2 trial of AVB-500, in combination
with durvalumab in patients with platinum-resistant recurrent
epithelial ovarian cancer, is also ongoing. Based on AVB-500’s
safety profile and specifically targeted mechanism of action, this
drug candidate has the potential to be used both in combination
with existing therapies, as well as a maintenance drug. The U.S.
Food and Drug Administration granted Fast Track Designation to
AVB-500 in platinum-resistant recurrent ovarian cancer.
About AraviveAravive, 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 evaluating AVB-500 in platinum-resistant ovarian cancer,
clear cell renal cell carcinoma and kidney fibrosis 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, including the overall
timelines for the ccRCC trial not being significantly impacted by
the amendment given the higher starting dose, assuming the COVID-19
situation does not interfere with ongoing clinical studies, the
planned continued enrollment in the Phase 1b dose escalation cohort
at the 20 mg/kg dose in patients with PROC with the goal of
targeting up to 12 patients in the trial, subject to the impact of
COVID-19, cash and cash equivalents will be sufficient to fund
operations into 2022, early topline data later this summer from the
20mg/kg dosing cohort assuming the COVID-19 situation doesn’t
interfere with ongoing clinical studies, the potential of AVB-500
to be used both in combination with existing therapies, as well as
a maintenance drug, the potential of AVB-500 to halt the biological
programming that promotes disease progression 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 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 and results that are as favorable as those of preclinical
studies and the Phase 1b portion of the Phase 1b/2 trial, the
ability to continue enrollment in the Phase 1b/ 2 trial, especially
in light of COVID-19, 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
corona virus; 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 most recent Annual Report on Form 10-K,
our 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:Christina TartagliaStern Investor
Relationschristina@sternir.com
Media:Heidi Chokeir, Ph.D.Canale
Communicationsheidi@canalecomm.com619-203-5391
Aravive,
Inc.Consolidated Statements of
Operations(in thousands, except per share amounts)
|
|
Three Months Ended |
|
|
Twelve Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
— |
|
|
$ |
1,371 |
|
|
$ |
4,753 |
|
|
$ |
1,371 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,511 |
|
|
|
3,010 |
|
|
|
12,836 |
|
|
|
11,075 |
|
Write-off of acquired in-process research and development |
|
|
— |
|
|
|
38,313 |
|
|
|
— |
|
|
|
38,313 |
|
General and administrative |
|
|
2,652 |
|
|
|
11,284 |
|
|
|
13,691 |
|
|
|
27,395 |
|
Total operating expenses |
|
|
5,163 |
|
|
|
52,607 |
|
|
|
26,527 |
|
|
|
76,783 |
|
Loss from operations |
|
|
(5,163 |
) |
|
|
(51,236 |
) |
|
|
(21,774 |
) |
|
|
(75,412 |
) |
Interest income |
|
|
211 |
|
|
|
286 |
|
|
|
1,022 |
|
|
|
989 |
|
Interest expense |
|
|
— |
|
|
|
(604 |
) |
|
|
— |
|
|
|
(2,429 |
) |
Other income (expense),
net |
|
|
624 |
|
|
|
600 |
|
|
|
2,534 |
|
|
|
519 |
|
Net loss |
|
$ |
(4,328 |
) |
|
$ |
(50,954 |
) |
|
$ |
(18,218 |
) |
|
$ |
(76,333 |
) |
Net loss per share- basic and
diluted |
|
$ |
(0.35 |
) |
|
$ |
(4.82 |
) |
|
$ |
(1.57 |
) |
|
$ |
(10.64 |
) |
Weighted-average common shares
used to compute net loss per share- basic and diluted |
|
|
12,506 |
|
|
|
10,580 |
|
|
|
11,589 |
|
|
|
7,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aravive,
Inc.Consolidated Balance Sheets (in
thousands)
|
December 31, |
|
|
December 31, |
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
65,134 |
|
|
$ |
56,992 |
Restricted cash |
|
2,423 |
|
|
|
2,396 |
Other assets |
|
5,867 |
|
|
|
1,431 |
Operating lease right-of-use
assets |
|
8,697 |
|
|
|
— |
Build-to-suit lease asset |
|
— |
|
|
|
8,651 |
Total
assets |
$ |
82,121 |
|
|
$ |
69,470 |
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
Accounts payable and other
current liabilities |
$ |
2,574 |
|
|
$ |
1,791 |
Deferred revenue |
|
— |
|
|
|
146 |
Build-to-suit lease
obligation |
|
— |
|
|
|
7,324 |
Operating lease
obligation |
|
10,234 |
|
|
|
— |
Contingent liabilities |
|
264 |
|
|
|
264 |
Total liabilities |
|
13,072 |
|
|
|
9,525 |
Total stockholders'
equity |
|
69,049 |
|
|
|
59,945 |
Total liabilities and
stockholders’ equity |
$ |
82,121 |
|
|
$ |
69,470 |
|
|
|
|
|
|
|
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