Two New Drug Candidates Nominated for
DevelopmentARB-1740 Development UpdateCompany to Host a Corporate
Update Conference Call Today at 4:30 PM ET
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading
Hepatitis B Virus (HBV) therapeutic solutions company, today
announced its second quarter 2017 unaudited financial results and
provided a corporate update.
“Our clinical development programs are focused
on HBV s-antigen (HBsAg) reduction and suppression of HBV DNA
replication, which are keys to developing a curative treatment
regimen with a finite dosing duration,” said Dr. Mark J Murray,
Arbutus’ President and CEO. “Our preclinical research continues to
add new agents to expand this strategy and generate great value as
evidenced by our recent drug candidate nominations AB-506, a
next-generation capsid inhibitor and AB-452, a novel and unique HBV
RNA destabilizer, both of which target multiple aspects of the HBV
life cycle."
Recent Highlights and
Developments
- Preclinical combination data was presented at the 30th
International Conference on Antiviral Research (ICAR) showing
clinical assets ARB-1740, AB-423 and preclinical assets ARB-880,
ARB-1820 and ARB-168786, when used in combination with entecavir or
pegylated interferon demonstrate additive, and in some cases
synergistic, anti-HBV activity.
- Cohort 4 of ARB-1467 Phase II study is ongoing, with top-line
results from the three-month bi-weekly dosing phase expected to be
announced in September 2017. Patients who meet the predefined
response criteria will be eligible to receive monthly dosing for an
additional nine months (for a total treatment duration of one
year).
- ARB-1467 is advancing into Phase II triple combination,
multi-dose studies with entecavir and pegylated interferon standard
of care therapeutics to further explore the potential of ARB-1467
and evaluate the importance of immune stimulation in patients who
have achieved low HBV DNA and HBsAg levels.
- AB-423 (capsid inhibitor) ongoing Phase I study in healthy
volunteers is expected to progress into a multi-dosing study in HBV
patients by the end of 2017.
- ARB-1740 (RNAi agent) Phase II, Cohorts 1 and 2 showed
activity, but no significant potency advantage over ARB-1467. As a
result, Arbutus is discontinuing development of ARB-1740 and will
continue to advance ARB-1467.
- AB-506, a second-generation capsid inhibitor, was nominated for
IND-enabling studies. Preclinical studies show that AB-506 has the
potential to be a best-in-class capsid inhibitor based on its
improved potency and superior pharmacokinetics relative to our lead
capsid inhibitor AB-423. This molecule has the potential for once
daily oral dosing. AB-506 is expected to be the subject of an IND
(or equivalent) filing in 2018.
- AB-452, an HBV RNA destabilizer (formerly described as a small
molecule s-antigen inhibitor), was nominated for IND-enabling
studies based on its strong potency as well as its novel activity
in destabilizing HBV RNA. This molecule has the potential for once
daily oral dosing. AB-452 is expected to be the subject of an
IND (or equivalent) filing in 2018.
- Alexion concluded its LNP-licensing agreement as a result of
its strategic decision to discontinue development in several
research areas, including mRNA therapeutics. This collaboration
enabled refinement of the LNP formulation process for mRNA-based
therapeutics at larger scale.
ARB-1740 Update
Arbutus conducted a multi-dosing study with
ARB-1740 to enable a clinical potency comparison between ARB-1467
and ARB-1740. Patients were dosed in two dose cohorts but no
significant potency advantage was observed for ARB-1740 over
ARB-1467. ARB-1740 data posed no safety concerns but the lack of a
significant potency advantage led the Company to discontinue
development of ARB-1740 and focus on further investment in Arbutus’
more clinically advanced RNAi agent, ARB-1467.
Upcoming Milestones
- September 2017: Top-line results from initial ARB-1467 Phase II
Cohort 4 clinical study.
- 3Q17: Phase III top-line results expected for Alnylam’s
Patisiran (Arbutus to receive royalties on sales).
- October 2017: Multiple presentations expected at AASLD.
- 4Q17: Top-line results from the AB-423 healthy volunteer
study.
- 4Q17: Initiate AB-423 Phase II multi ascending dose (MAD) study
in HBV patients.
- 4Q17: Initiate study of longer term dosing of ARB-1467 in
combination with tenofovir and a course of pegylated interferon to
maximize reduction of HBsAg.
Financial Results
Cash, Cash Equivalents and
Investments
As at June 30, 2017, Arbutus had cash, cash
equivalents, short-term investments and restricted investments
totaling $115.6 million, as compared to $143.2 million at
December 31, 2016.
Net Loss
For Q2 2017, net loss was $18.3 million ($0.33
basic and diluted loss per common share) as compared to a net loss
of $130.0 million ($2.47 basic and diluted loss per common share)
for Q2 2016. The net loss for the first half of 2017 was $36.9
million ($0.68 basic and diluted loss per common share) as compared
to a net loss of $145.9 million ($2.80 basic and diluted loss per
common share) for the first half of 2016.
Non-GAAP Net Loss
The non-GAAP net loss for Q2 2017 was $15.3
million ($0.28 loss per common share). The non-GAAP net loss for Q2
2017 excludes the aggregate of $3.0 million non-cash compensation
expense in connection with certain share repurchase provisions
arising from the merger with Arbutus Inc. in March 2015.
Revenue
Revenue was $1.0 million in Q2 2017 as compared
to $0.3 million in Q2 2016.
In March 2017, Arbutus signed a License
Agreement with Alexion that granted them exclusive use of the
Company's proprietary lipid nanoparticle (LNP) technology in one of
Alexion's rare disease programs. Licensing fee revenue recognized
in Q2 2017 relates to the earned portion of the non-refundable
upfront payment of $7.5 million for the use of Arbutus' technology,
which is being recognized over the expected period that the Company
is providing services to Alexion. In addition, from March 2017,
Arbutus has been earning revenue for services provided to Alexion
related to technology development, manufacturing and regulatory
support for the advancement of Alexion's mRNA product candidate.
This agreement was terminated by Alexion in July 2017.
Revenue in Q2 2016 related primarily to the
Dicerna license and collaboration that was terminated in November
2016.
In addition, Arbutus has ongoing license
agreements with Alnylam and Spectrum, under which Arbutus is
eligible to receive commercial royalties.
Research, Development, Collaborations
and Contracts Expenses
Research, development, collaborations and
contracts expenses were $15.4 million in Q2 2017 as compared to
$15.2 million in Q2 2016.
R&D expenses increased during Q2 2017 as
compared to Q2 2016 as Arbutus initiated a Phase I clinical trial
for AB-423 in Q1 2017 and continues to incur costs related to the
Company's recent candidate nominations - a second generation capsid
inhibitor and an HBV RNA destabilizer, as well as costs related to
research and preclinical studies for the Company's other HBV
programs.
General and Administrative
General and administrative expenses were $4.6
million in Q2 2017 as compared to $23.8 million Q2 2016.
The decrease in general and administrative
expenses was largely due to a decrease in non-cash compensation
expense recorded for the expiry of repurchase rights due to the
departure of two of the four former Arbutus Inc. shareholders in Q2
2016. This resulted in a quarterly non-cash compensation general
and administrative expense of $1.5 million in Q2 2017 as
compared to $18.5 million in Q2 2016.
Impairment of Intangible
Assets
In Q2 2016, Arbutus recorded an impairment
charge of $156.3 million for the discontinuance of the ARB-1598
program in the Immune Modulator drug class after extensive research
and analysis, as well as a delay for additional exploration of the
biology of the cccDNA Sterilizer drug class.
Outstanding Shares
The Company had 55.0 million common shares issued and
outstanding and 60.6 million shares on a fully diluted basis as at
June 30, 2017.
UNAUDITED CONDENSED CONSOLIDATED BALANCE
SHEETS |
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2017 |
|
2016 |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
24.2 |
|
|
$ |
23.4 |
|
Short-term
investments |
|
78.8 |
|
|
107.1 |
|
Accounts
receivable |
|
1.1 |
|
|
0.3 |
|
Other current
assets |
|
1.9 |
|
|
1.8 |
|
Restricted
investments |
|
12.6 |
|
|
12.6 |
|
Property and equipment,
net |
|
12.7 |
|
|
6.9 |
|
Intangible assets |
|
99.4 |
|
|
99.4 |
|
Goodwill |
|
24.4 |
|
|
24.4 |
|
Total assets |
|
$ |
255.1 |
|
|
$ |
275.9 |
|
Accounts payable and
accrued liabilities |
|
8.3 |
|
|
9.8 |
|
Total deferred
revenue |
|
6.7 |
|
|
0.0 |
|
Warrant liability |
|
— |
|
|
0.1 |
|
Liability-classified
options |
|
1.0 |
|
|
0.6 |
|
Loan payable |
|
12.0 |
|
|
12.0 |
|
Contingent
consideration |
|
10.0 |
|
|
9.1 |
|
Deferred tax
liability |
|
41.3 |
|
|
41.3 |
|
Total
stockholders’ equity |
|
175.8 |
|
|
203.0 |
|
Total liabilities and stockholders’ equity |
|
$ |
255.1 |
|
|
$ |
275.9 |
|
|
|
|
|
|
|
|
|
|
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOW |
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2017 |
2016 |
|
2017 |
2016 |
|
|
|
|
|
|
|
Net loss for the
period |
|
$ |
(18.3 |
) |
$ |
(130.0 |
) |
|
$ |
(36.9 |
) |
$ |
(145.9 |
) |
Net cash
used in operating activities |
|
(5.1 |
) |
(16.8 |
) |
|
(22.6 |
) |
(28.4 |
) |
Net cash
provided by (used in) investing activities |
|
(1.4 |
) |
(85.4 |
) |
|
21.8 |
|
(99.0 |
) |
Net cash
provided by financing activities |
|
0.0 |
|
0.4 |
|
|
0.4 |
|
0.6 |
|
Effect of foreign exchange rate changes on cash & cash
equivalents |
|
0.8 |
|
0.0 |
|
|
1.2 |
|
3.0 |
|
Net increase
(decrease) in cash and cash equivalents |
|
$ |
(5.7 |
) |
$ |
(101.8 |
) |
|
$ |
0.8 |
|
$ |
(123.8 |
) |
Cash and cash
equivalents, beginning of period |
|
29.9 |
|
144.8 |
|
|
23.4 |
|
166.8 |
|
Cash and cash equivalents, end of period |
|
$ |
24.2 |
|
$ |
43.0 |
|
|
$ |
24.2 |
|
$ |
43.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS |
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2017 |
2016 |
|
2017 |
2016 |
|
|
|
|
|
|
|
Total
revenue |
|
$ |
1.0 |
|
$ |
0.3 |
|
|
$ |
1.3 |
|
$ |
0.9 |
|
Operating expenses |
|
|
|
|
|
|
Research,
development, collaborations and contracts |
|
15.4 |
|
15.2 |
|
|
29.3 |
|
28.4 |
|
General
and administrative |
|
4.6 |
|
23.8 |
|
|
8.9 |
|
31.0 |
|
Depreciation of property and equipment |
|
0.5 |
|
0.3 |
|
|
0.9 |
|
0.5 |
|
Impairment of intangible assets |
|
0.0 |
|
156.3 |
|
|
0.0 |
|
156.3 |
|
Loss from operations |
|
(19.5 |
) |
(195.3 |
) |
|
(37.8 |
) |
(215.3 |
) |
Other income
(losses) |
|
1.2 |
|
0.4 |
|
|
0.9 |
|
4.5 |
|
Income
tax benefit |
|
0.0 |
|
64.9 |
|
|
0.0 |
|
64.9 |
|
Net
loss |
|
$ |
(18.3 |
) |
$ |
(130.0 |
) |
|
$ |
(36.9 |
) |
$ |
(145.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UNAUDITED GAAP TO NON-GAAP RECONCILIATION: NET LOSS
AND NET LOSS PER SHARE |
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2017 |
2016 |
|
2017 |
2016 |
|
|
|
|
|
|
|
GAAP net
loss |
|
$ |
(18.3 |
) |
$ |
(130.0 |
) |
|
$ |
(36.9 |
) |
$ |
(145.9 |
) |
Adjustment: |
|
|
|
|
|
|
Compensation expense of expired repurchase provision rights |
|
3.0 |
|
20.0 |
|
|
6.0 |
|
26.0 |
|
Impairment of intangible assets (net of tax benefit) |
|
0.0 |
|
91.4 |
|
|
0.0 |
|
91.4 |
|
Non-GAAP net loss |
|
$ |
(15.3 |
) |
$ |
(18.6 |
) |
|
$ |
(30.9 |
) |
$ |
(28.5 |
) |
|
|
|
|
|
|
|
GAAP net loss
per common share |
|
$ |
(0.33 |
) |
$ |
(2.47 |
) |
|
$ |
(0.68 |
) |
$ |
(2.80 |
) |
Non-GAAP net
loss per common share |
|
$ |
(0.28 |
) |
$ |
(0.35 |
) |
|
$ |
(0.57 |
) |
$ |
(0.55 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Use of Non-GAAP Financial
Measures
The Company’s consolidated financial statements
are prepared in accordance with generally accepted accounting
principles in the United States (U.S. GAAP) on a basis consistent
for all periods presented. In addition to the results reported in
accordance with U.S. GAAP, the Company provides additional measures
that are considered “non-GAAP” financial measures under applicable
SEC rules. These non-GAAP financial measures should not be viewed
in isolation or as a substitute for GAAP net loss and basic and
diluted net loss per common share.
The Company evaluates items on an individual
basis, and considers both the quantitative and qualitative aspects
of the item, including (i) its size and nature, (ii) whether or not
it relates to the Company’s ongoing business operations, and (iii)
whether or not the Company expects it to occur as part of its
normal business on a regular basis. In the three months ended June
30, 2017, the Company’s non-GAAP net loss and non-GAAP net loss per
common share excludes the compensation expense related to the
expiration of repurchase provision rights connected with certain
common shares issued as part of total consideration for the
acquisition of Arbutus Inc. The Company believes that the exclusion
of this item provides management and investors with supplemental
measures of performance that better reflect the underlying
economics of the Company’s business. In addition, the Company
believes the exclusion of this item is important in comparing
current results with prior period results and understanding
projected operating performance.
Conference Call Today
Arbutus will hold a conference call and webcast
today, Thursday, August 3, 2017 at 1:30 PM Pacific Time (4:30
PM Eastern Time) to provide a corporate update. A live webcast of
the call can be accessed through the Investor section of Arbutus'
website at www.arbutusbio.com. Or, alternatively, to access the
conference call, please dial 1-914-495-8556 or 1-866-393-1607.
An archived webcast will be available on the
Arbutus website after the event. Alternatively, you may access a
replay of the conference call by calling 1-404-537-3406 or
1-855-859-2056 and referencing conference ID 63313299.
About Arbutus
Arbutus Biopharma Corporation is a
biopharmaceutical company dedicated to discovering, developing and
commercializing a cure for patients suffering from chronic HBV
infection. Arbutus is headquartered in Vancouver, BC, and has
facilities in Warminster, PA. For more information, visit
www.arbutusbio.com.
Forward-Looking Statements and
Information
This press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”).
Forward-looking statements in this press release include statements
about HBV s-antigen (HBsAg) reduction and suppression of HBV DNA
replication; top-line results from the three-month bi-weekly dosing
phase of the Cohort 4 of ARB-1467 Phase II study being announced in
September 2017; ARB-1467 advancing into Phase II triple
combination, multi-dose studies; AB-423 (capsid inhibitor) ongoing
Phase I study progressing into a multi-dosing study in HBV patients
by the end of 2017; discontinuing development of ARB-1740; AB-506’s
potential to be a best-in-class capsid inhibitor, with an IND (or
equivalent) filing in 2018; AB-452’s potential for once daily
oral dosing, with an IND (or equivalent) filing in 2018; Phase III
top-line results expected for Alnylam’s Patisiran in 3Q17, with
Arbutus to receive royalties on sales; Multiple presentations
expected at AASLD in October 2017; top-line results from the AB-423
healthy volunteer study in 4Q17; initiating AB-423 Phase II multi
ascending dose (MAD) study in HBV patients in 4Q17; initiating
study of longer term dosing of ARB-1467 in combination with
tenofovir and a course of pegylated in 4Q17; and discovering,
developing and commercializing a cure for patients suffering from
chronic HBV infection.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of preclinical and clinical trials, and the usefulness
of the data; the continued demand for Arbutus’ assets; and the
stability of economic and market conditions. While Arbutus
considers these assumptions to be reasonable, these assumptions are
inherently subject to significant business, economic, competitive,
market and social uncertainties and contingencies.
Additionally, there are known and unknown risk
factors which could cause Arbutus' actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: anticipated pre-clinical and clinical trials
may be more costly or take longer to complete than anticipated, and
may never be initiated or completed, or may not generate results
that warrant future development of the tested drug candidate;
Arbutus may not receive the necessary regulatory approvals for the
clinical development of Arbutus' products; economic and market
conditions may worsen; and market shifts may require a change in
strategic focus.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus' Annual Report on
Form 10-K and Arbutus' continuous disclosure filings, which are
available at www.sedar.com and at www.sec.gov. All
forward-looking statements herein are qualified in their entirety
by this cautionary statement, and Arbutus disclaims any obligation
to revise or update any such forward-looking statements or to
publicly announce the result of any revisions to any of the
forward-looking statements contained herein to reflect future
results, events or developments, except as required by law.
Contact Information
Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604-419-3200
Email: acutler@arbutusbio.com
Tiffany Tolmie
Manager, Investor Relations
Phone: 604-419-3200
Email: ttolmie@arbutusbio.com
Media
David Schull
Russo Partners
Phone: 858-717-2310
Email: david.schull@russopartnersllc.com
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