Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company primarily focused on developing a cure
for people with chronic hepatitis B virus (HBV) infection, as well
as therapies to treat coronaviruses (including COVID-19), today
reports its fourth quarter and year-end 2020 financial results and
provides a corporate update.
William Collier, President and Chief Executive
Officer of Arbutus, stated, “Our current data set for AB-729, our
lead compound in development for HBV, has grown substantially over
the past 12 months and increases our confidence that it has the
potential to be a cornerstone drug in future HBV combination
regimens.”
Mr. Collier added, “Looking ahead, 2021 is
expected to provide us with important insights regarding the
potential therapeutic value of several compounds in our proprietary
HBV pipeline including: longer term Phase 1a/1b dosing results for
AB-729; the initiation of a Phase 2 combination clinical trial with
AB-729 and Assembly Biosciences’ lead core inhibitor; initiation of
Phase 2 clinical trials for AB-729 and one or more approved or
investigational agents; and initial Phase 1a/1b data from our
proprietary oral capsid inhibitor, AB-836.”
Dr. Gaston Picchio, Chief Development Officer of
Arbutus, commented, “AB-729 has shown impressive reductions in
HBsAg with an unremarkable longer term safety profile in the
clinical data from our Phase 1a/1b clinical trial. The data that
has emerged from this clinical trial so far is encouraging and it
suggests that AB-729 could potentially be dosed less frequently
than every 4 weeks potentially providing a competitive advantage.
As a matter of fact, we are testing a dosing schedule of every 8
weeks in our Phase 2 clinical trial in collaboration with
Assembly.”
Dr. Picchio added, “We are pleased that we have
initiated screening for our proof-of-concept Phase 2 clinical trial
combining AB-729 with Assembly Biosciences’ lead core inhibitor
candidate, also known as a capsid inhibitor, vebicorvir, and a
nucleos(t)ide reverse transcriptase inhibitor.”
Pipeline Update
AB-729
- Arbutus is currently conducting a
single- and multi-dose Phase 1a/1b clinical trial to determine the
safety, tolerability, pharmacokinetics, and pharmacodynamics of
AB-729 in healthy subjects and in subjects with chronic HBV
infection.
- Results to date demonstrate that
treatment of AB-729 using the 60 mg and 90 mg doses has been well
tolerated after a single dose. Efficacy results to date suggest
that repeat dosing using the 60 mg dose every 4 weeks resulted in a
continuous and robust mean HBsAg decline at week 24 (-1.84 log10
IU/mL, N=7). Repeat dosing using the 60 mg dose every 8 weeks
results in comparable mean HBsAg declines relative to the 60 mg
dose every 4 weeks at week 16 (-1.37 log10 IU/mL vs -1.44 log10
IU/mL, p<0.7). In HBV DNA positive CHB subjects, a single 90 mg
AB-729 dose resulted in robust mean HBsAg (-1.02 log10 IU/mL) and
HBV DNA (-1.53 log10 IU/mL) declines at week 12, as well as
decreases in HBV RNA and core-related antigen. Similar mean HBsAg
reductions were observed in HBV DNA positive and negative CHB
subjects supporting complete target engagement by AB-729.
- Arbutus expects to provide
additional data from ongoing cohorts of the Phase 1a/1b clinical
trial in the first half of 2021, except for initial data from the
90 mg every 12 week cohort which is expected in the second half of
2021. Based on these results, Arbutus intends to advance AB-729
into two Phase 2 combination trials with one or more approved or
investigational agents in the second half of 2021 with dosing of
AB-729 as infrequently as every 8 or 12 weeks.
- Arbutus and Assembly initiated
screening in a Phase 2 proof-of-concept combination clinical trial
to evaluate AB-729 in combination with Assembly Biosciences’ lead
core (capsid) inhibitor candidate vebicorvir and a nucleos(t)ide
reverse transcriptase inhibitor for the treatment of subjects with
chronic HBV infection. The randomized, multi-center, open-label
Phase 2 clinical trial will evaluate the safety, pharmacokinetics,
and antiviral activity of the triple combination of VBR, AB-729 and
an NrtI compared to the double combinations of VBR with an NrtI and
AB-729 with an NrtI. Approximately 60 virologically-suppressed
subjects with HBeAg negative chronic HBV are expected to be
enrolled in the first cohort of the trial. Subjects will be dosed
for 48 weeks with VBR 300 mg orally once daily and AB-729 60 mg
subcutaneously every 8 weeks, with a 48-week follow-up period.
AB-836: Oral Capsid Inhibitor
- In January 2020, Arbutus selected
AB-836 as its next-generation oral capsid inhibitor. AB-836 is from
a novel chemical series differentiated from competitor compounds
with the potential for increased efficacy and an enhanced
resistance profile. Arbutus completed CTA/IND-enabling studies in
the fourth quarter of 2020 and anticipates initiating a Phase 1a/1b
clinical trial for AB-836 in the first half of 2021.
Early R&D Programs
- Arbutus’ drug discovery efforts are
focused on follow-on compounds for its current HBV pipeline and new
small molecule antiviral medicines to treat COVID-19 and future
coronavirus outbreaks. Arbutus expects to continue to advance its
research in its oral PD-L1 inhibitor, RNA-destabilizer and
coronavirus programs.
Genevant Sciences Ltd.
Arbutus owns approximately 16% of the common
equity of Genevant Sciences Ltd. (“Genevant”), a company Arbutus
launched with Roivant Sciences, Ltd. and to which Arbutus licensed
exclusive rights to its lipid nanoparticle ("LNP") and ligand
conjugate delivery technologies for RNA-based applications outside
of HBV. We are entitled to receive tiered low single-digit
royalties on future sales of Genevant products covered by the
licensed patents. If Genevant sub-licenses the intellectual
property licensed by us to Genevant, we are entitled to receive,
upon the commercialization of a product developed by such
sub-licensee, the lesser of (i) twenty percent of the revenue
received by Genevant for such sublicensing and (ii) tiered low
single-digit royalties on product sales by the sublicensee.
Financial Results
Cash, Cash Equivalents and
Investments
Arbutus had cash, cash equivalents and
investments totaling $123.3 million as of December 31, 2020,
as compared to $90.8 million as of December 31, 2019. During
the twelve months ended December 31, 2020, Arbutus used $51.4
million in operating activities and made a $2.5 million equity
investment in Genevant, which was offset by $86.3 million of net
proceeds from the issuance of common shares under Arbutus’ ATM
program. Thus far during the first quarter of 2021, Arbutus has
received an additional $24.3 million of net proceeds from the
issuance of common shares under its ATM program. Arbutus expects a
net cash burn between $70 to $75 million in 2021 and therefore the
Company believes its cash runway extends through the third quarter
of 2022.
Net Loss
Net loss attributable to common shares for the
twelve months ended December 31, 2020 was $75.9 million ($1.00
basic and diluted loss per common share) as compared to $164.9
million ($2.89 basic and diluted loss per common share) for the
twelve months ended December 31, 2019. The decrease in the net
loss was due primarily to: i) non-cash impairment charges in 2019
of $43.8 million for an in-process research and development
("IPR&D") intangible asset and $22.5 million for goodwill to
reduce their carrying values to zero, as well as a corresponding
income tax benefit of $12.7 million related to the decrease in the
deferred tax liability associated with the IPR&D intangible
assets; ii) a $20.0 million decrease in non-cash equity losses
associated with the Company’s investment in Genevant; iii) a $10.1
million decrease in research and development expenses; and iv) a
$6.3 million expense in 2019 related to an arbitration award from
the Company's arbitration with the University of British
Columbia.
Net loss attributable to common shares for the
twelve months ended December 31, 2020 and 2019 also included
non-cash expense for the accrual of coupon on the Company’s
convertible preferred shares of $12.1 million and $11.1 million,
respectively.
Operating Expenses
Research and development expenses were $47.5
million for the twelve months ended December 31, 2020 compared
to $57.6 million in 2019. The decrease in research and development
expenses for the year ended December 31, 2020 versus the same
period in 2019 was due primarily to lower clinical expenses in
2020. General and administrative expenses were $14.7 million for
the twelve months ended December 31, 2020 compared to $17.7
million for the same period in 2019. This decrease was due
primarily to $2.3 million in cash severance and $1.1 million of
non-cash stock-based compensation expense related to our former
President and Chief Executive Officer’s departure from the Company
in June 2019.
Outstanding Shares
The Company had approximately 89.7 million
common shares issued and outstanding as of December 31, 2020.
In addition, the Company had approximately 10.7 million stock
options outstanding and 1.164 million convertible preferred shares
outstanding, which (including the annual 8.75% coupon) will be
mandatorily convertible into approximately 23 million common shares
on October 18, 2021.
COVID-19 Impact
In December 2019 an outbreak of a novel strain
of coronavirus (COVID-19) was identified in Wuhan, China. This
virus continues to spread globally, has been declared a pandemic by
the World Health Organization and has spread to nearly every
country in the world. The impact of this pandemic has been, and
will likely continue to be, extensive in many aspects of society.
The pandemic has resulted in and will likely continue to result in
significant disruptions to businesses. A number of countries and
other jurisdictions around the world have implemented extreme
measures to try and slow the spread of the virus. These measures
include the closing of businesses and requiring people to stay in
their homes, the latter of which raises uncertainty regarding the
ability to travel to hospitals in order to participate in clinical
trials. Additional measures that have had, and will likely continue
to have, a major impact on clinical development, at least in the
near-term, include shortages and delays in the supply chain, and
prohibitions in certain countries on enrolling subjects in new
clinical trials. While we have been able to progress with our
clinical and pre-clinical activities to date, it is not possible to
predict if the COVID-19 pandemic will negatively impact our plans
and timelines in the future.
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF LOSS(in thousands, except share and
per share data)
|
Year ended December 31, |
|
2020 |
|
2019 |
Revenue |
|
|
|
Collaborations and licenses |
$ |
3,519 |
|
|
$ |
4,355 |
|
Non-cash royalty revenue |
3,395 |
|
|
1,656 |
|
Total
revenue |
6,914 |
|
|
6,011 |
|
Operating
expenses |
|
|
|
Research and development |
47,481 |
|
|
57,601 |
|
General and administrative |
14,724 |
|
|
17,727 |
|
Depreciation |
1,978 |
|
|
2,028 |
|
Change in fair value of contingent consideration |
473 |
|
|
(173 |
) |
Site consolidation |
64 |
|
|
156 |
|
Impairment of intangible assets |
— |
|
|
43,836 |
|
Impairment of goodwill |
— |
|
|
22,471 |
|
Arbitration |
— |
|
|
6,266 |
|
Loss from
operations |
(57,806 |
) |
|
(143,901 |
) |
Other income
(loss) |
|
|
|
Interest income |
741 |
|
|
2,111 |
|
Interest expense |
(4,011 |
) |
|
(2,108 |
) |
Equity investment loss |
(2,545 |
) |
|
(22,522 |
) |
Foreign exchange gain (loss) |
(124 |
) |
|
41 |
|
Total other
loss |
(5,939 |
) |
|
(22,478 |
) |
Income tax benefit |
— |
|
|
12,656 |
|
Net loss |
$ |
(63,745 |
) |
|
$ |
(153,723 |
) |
Dividend accretion of convertible preferred shares |
(12,123 |
) |
|
(11,149 |
) |
Net loss attributable
to common shares |
$ |
(75,868 |
) |
|
$ |
(164,872 |
) |
Loss per
share |
|
|
|
Basic and diluted |
$ |
(1.00 |
) |
|
$ |
(2.89 |
) |
Weighted average
number of common shares |
|
|
|
Basic and diluted |
75,835,378 |
|
|
57,093,454 |
|
UNAUDITED CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands)
|
December 31, 2020 |
|
December 31, 2019 |
Cash, cash equivalents and marketable securities, current |
$ |
123,268 |
|
$ |
90,834 |
Accounts receivable and other
current assets |
4,436 |
|
2,994 |
Total current assets |
127,704 |
|
93,828 |
Property and equipment, net of
accumulated depreciation |
6,927 |
|
8,676 |
Right of use asset |
2,405 |
|
2,738 |
Other non-current assets |
|
44 |
|
|
293 |
Total assets |
$ |
137,080 |
|
$ |
105,535 |
Accounts payable and accrued
liabilities |
$ |
8,901 |
|
$ |
7,235 |
Liability-classified
options |
|
250 |
|
|
253 |
Lease liability, current |
390 |
|
340 |
Total current liabilities |
9,541 |
|
7,828 |
Liability related to sale of
future royalties |
19,554 |
|
18,992 |
Contingent consideration |
3,426 |
|
2,953 |
Lease liability,
non-current |
2,593 |
|
3,018 |
Total stockholders'
equity |
101,966 |
|
72,744 |
Total liabilities and stockholders' equity |
$ |
137,080 |
|
$ |
105,535 |
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOW(in thousands)
|
Year ended December 31, |
|
2020 |
|
2019 |
Net loss |
$ |
(63,745 |
) |
|
$ |
(153,723 |
) |
Deferred income tax
benefit |
— |
|
|
(12,661 |
) |
Impairment of intangible
assets and goodwill |
— |
|
|
66,307 |
|
Net equity investment
loss |
2,545 |
|
|
22,522 |
|
Other non-cash items |
9,328 |
|
|
8,774 |
|
Changes in working
capital |
431 |
|
|
(2,225 |
) |
Net cash used in operating
activities |
$ |
(51,441 |
) |
|
$ |
(71,006 |
) |
Net cash provided by (used in)
investing activities |
(14,909 |
) |
|
28,338 |
|
Net cash provided by financing
activities |
86,746 |
|
|
37,457 |
|
Effect of foreign exchange
rate changes on cash and cash equivalents |
56 |
|
|
68 |
|
Increase (decrease) in cash
and cash equivalents |
$ |
20,452 |
|
|
$ |
(5,143 |
) |
Cash and cash equivalents,
beginning of period |
31,799 |
|
|
36,942 |
|
Cash and cash equivalents, end
of period |
$ |
52,251 |
|
|
$ |
31,799 |
|
Investments |
$ |
71,017 |
|
|
$ |
59,035 |
|
Total cash, cash equivalents and investments, end of
period |
$ |
123,268 |
|
|
$ |
90,834 |
|
Conference Call and Webcast Today
Arbutus will hold a conference call and webcast
today, Thursday, March 4, 2021 at 8:45 AM Eastern Time to provide a
corporate update. You can access a live webcast of the call, which
will include presentation slides, through the Investors section of
Arbutus’ website at http://www.arbutusbio.com or directly at Live
Webcast. Alternatively, you can dial (866) 393-1607 or (914)
495-8556 and reference conference ID 4084504.
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 (855) 859-2056 or (404)
537-3406, and reference conference ID 4084504.
About AB-729
AB-729 is an RNA interference (RNAi) therapeutic
targeted to hepatocytes using Arbutus’ novel covalently conjugated
N-acetylgalactosamine (GalNAc) delivery technology that enables
subcutaneous delivery. AB-729 inhibits viral replication and
reduces all HBV antigens, including hepatitis B surface antigen in
preclinical models. Reducing hepatitis B surface antigen is thought
to be a key prerequisite to enable reawakening of a patient’s
immune system to respond to the virus. Based upon clinical data
generated thus far in an ongoing single- and multi-dose Phase 1a/1b
clinical trial, AB-729 has demonstrated positive safety and
tolerability data and meaningful reductions in hepatitis B surface
antigen.
About AB-836
AB-836 is an oral HBV capsid inhibitor. HBV core
protein assembles into a capsid structure, which is required for
viral replication. The current standard-of-care therapy for HBV,
primarily nucleos(t)ide analogues that work by inhibiting the viral
polymerase, significantly reduce virus replication, but not
completely. Capsid inhibitors inhibit replication by preventing the
assembly of functional viral capsids. They also have been shown to
inhibit the uncoating step of the viral life cycle thus reducing
the formation of new covalently closed circular DNA (cccDNA), the
genetic reservoir which the virus uses to replicate itself.
About HBV
Hepatitis B is a potentially life-threatening
liver infection caused by HBV. HBV can cause chronic infection
which leads to a higher risk of death from cirrhosis and liver
cancer. Chronic HBV infection represents a significant unmet
medical need. The World Health Organization estimates that over 250
million people worldwide suffer from chronic HBV infection, while
other estimates indicate that approximately 2 million people in the
United States suffer from chronic HBV infection. Approximately
900,000 people die every year from complications related to chronic
HBV infection despite the availability of effective vaccines and
current treatment options.
About Arbutus
Arbutus Biopharma Corporation is a publicly
traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated
to discovering, developing and commercializing a cure for people
with chronic hepatitis B virus (HBV) infection. The Company is
advancing multiple drug product candidates that may be combined
into a potentially curative regimen for chronic HBV infection.
Arbutus has also initiated a drug discovery and development effort
for treating coronaviruses (including COVID-19). 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 our confidence that AB-729 has the potential to be a
cornerstone drug in future HBV combination regimens; the potential
that AB-729 could potentially be dosed less frequently than every 4
weeks potentially providing a competitive advantage; our
expectation to provide additional data from ongoing cohorts of the
Phase 1a/1b clinical trial of AB-729 in the first half of 2021,
except for initial data from the 90 mg every 12 week cohort which
is expected in the second half of 2021; our intention to advance
AB-729 into two Phase 2 combination trials with one or more
approved or investigational agents in the second half of 2021 with
dosing of AB-729 as infrequently as every 8 to 12 weeks; our plans
with respect to the Phase 2 proof-of-concept combination clinical
trial to evaluate AB-729 in combination with Assembly Biosciences’
lead core/capsid inhibitor candidate vebicorvir and a nucleos(t)ide
reverse transcriptase inhibitor for the treatment of subjects with
chronic HBV infection, including the expected trial design, the
expected number and type of patients to be enrolled in the trial
and the expected dosing schedule; the potential for AB-836 to have
increased efficacy and an enhanced resistance profile; the expected
initiation, in the first half of 2021, of a Phase 1a/1b clinical
trial of AB-836; the expected continued advancement of our research
in the oral PD-LE inhibitor, RNA-destabilizer and coronavirus
programs; our expectation regarding the impact of the COVID-19
pandemic on our business and clinical trials; our expected net cash
burn between $70 to $75 million for 2021; and our expected cash
runway through the third quarter of 2022.
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 studies and clinical trials, and the
usefulness of the data; the timeliness of regulatory approvals; 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, including uncertainties and
contingencies related to the ongoing COVID-19 pandemic.
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 studies 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
product candidate; Arbutus may elect to change its strategy
regarding its product candidates and clinical development
activities; Arbutus may not receive the necessary regulatory
approvals for the clinical development of Arbutus’ products;
economic and market conditions may worsen; market shifts may
require a change in strategic focus; and the ongoing COVID-19
pandemic could significantly disrupt Arbutus’ clinical development
programs.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus’ Annual Report on
Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’
continuous and periodic 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 and Media
William H. CollierPresident and CEOPhone: 267-469-0914Email:
ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone: 267-469-0914Email:
ir@arbutusbio.com
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