Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the
“Company”), a clinical-stage biopharmaceutical company leveraging
its extensive virology expertise to develop a functional cure for
people with chronic hepatitis B virus (cHBV) infection, today
reports third quarter 2024 financial results and provides a
corporate update.
“We are making significant progress in advancing
the development of imdusiran to bring hope to millions of cHBV
patients globally,” said Michael J. McElhaugh, Interim President
and Chief Executive Officer of Arbutus Biopharma. “In June, we
shared promising data from our IM-PROVE I Phase 2a clinical trial,
showing that some patients treated with imdusiran and interferon
were trending towards a functional cure. We look forward to
presenting follow-up data from this trial, as well as
end-of-treatment data from patients that received nivolumab in
addition to imdusiran and VTP-300 in our IM-PROVE II Phase 2a
trial, at the upcoming AASLD meeting. Assuming continued positive
data, and with a projected cash runway extending into the fourth
quarter of 2026, we are well-positioned to advance imdusiran into a
Phase 2b clinical trial as a cornerstone in a treatment regimen
aimed at functionally curing cHBV.”
Mr. McElhaugh continued, “Our proprietary oral
PD-L1 checkpoint inhibitor, AB-101, is progressing well, as we
continue to see dose-dependent receptor occupancy and have now
advanced into dosing cHBV patients in our Phase 1a/1b clinical
trial. We look forward to providing updates as this trial
progresses.”
Clinical Development Update
Imdusiran (AB-729, RNAi
Therapeutic)
- End-of-treatment
data from the IM-PROVE I Phase 2a clinical trial evaluating the
safety, tolerability and antiviral activity of the combination of
imdusiran (4 or 6 doses over 24 or 48 weeks, respectively),
nucleos(t)ide analogue (NA) therapy and a short course of pegylated
interferon alfa-2a (IFN, 12 or 24 weeks) in patients with cHBV was
presented at the EASL Congress in June. The data showed that 33.3%
(n=4/12) of patients in Cohort A1 receiving 48 weeks (6 doses) of
imdusiran combined with 24 weeks of IFN and NA therapy achieved
HBsAg loss at the end-of-treatment that was maintained in 100% of
these patients 24 weeks after completing imdusiran and IFN
treatment. HBsAg loss was achieved and maintained in 67% of those
patients with HBsAg less than 1000 IU/mL at baseline. A total
of six patients from Cohort A1 (n=4) and Cohort A2 (n=2)
seroconverted with HBsAg loss. At the time the data was reported,
all six of those patients had stopped all therapy, with two of
those patients reaching 12 weeks off all therapy with sustained
HBsAg and HBV DNA loss. The combination of imdusiran and IFN in
this clinical trial was generally safe and well-tolerated. The
Company will present a late-breaker poster with additional
follow-up data at the upcoming AASLD-The Liver Meeting 2024 later
this month.
- End-of treatment
data from the IM-PROVE II Phase 2a clinical trial evaluating the
safety and immunogenicity of imdusiran, NA therapy and Barinthus
Bio’s VTP-300, an HBV antigen-specific immunotherapy was presented
at the EASL Congress in June. The data showed that the
combination of imdusiran and VTP-300 was generally safe and
well-tolerated. At 24-weeks post-end of treatment, statistical
significance (p<0.05) was achieved in HBsAg levels between the
VTP-300 arm (n=5) and placebo (n=6). IM-PROVE II includes an
additional cohort of patients who received 4 doses of imdusiran
plus NA therapy for 24 weeks followed by VTP-300 plus up to two low
doses of nivolumab, an approved anti-PD-1 monoclonal antibody. The
Company will present a late-breaker poster with preliminary
end-of-treatment data from this additional cohort at the upcoming
AASLD - The Liver Meeting 2024 in November.
AB-101 (Oral PD-L1
Inhibitor)
- AB-101-001 is a
Phase 1a/1b double-blind, randomized, placebo-controlled clinical
trial designed to investigate the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of single- and
multiple-ascending oral doses of AB-101 in healthy subjects and
patients with cHBV.
- Part 2 of this
clinical trial has enrolled to date two sequential cohorts of ten
healthy subjects each receiving 10 mg or 25 mg of AB-101 (n=8) or
placebo (n=2) daily for 7 days. AB-101 was generally well-tolerated
with evidence of dose-dependent receptor occupancy. In the 25 mg
cohort, all subjects showed evidence of receptor occupancy, with
seven of the eight subjects demonstrating receptor occupancy
greater than 70% during the 7-day dosing period.
- Arbutus has moved
into Part 3 of this clinical trial which evaluates repeat dosing of
AB-101 for 28 days in patients with cHBV and expects to report
preliminary data in the first half of next year.
LNP Litigation Update
- Expert reports and
expert depositions continue in the Moderna lawsuit. A trial date
has been set for September 24, 2025, and is subject to the Court’s
availability.
- The lawsuit against
Pfizer/BioNTech is ongoing and a date for the claim construction
hearing has been set for December 18, 2024.
Arbutus continues to protect and defend its
intellectual property, which is the subject of the on-going
lawsuits against Moderna and Pfizer/BioNTech. The Company is
seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use
of its patented LNP technology that was developed with great effort
and at a great expense, without which Moderna’s and
Pfizer/BioNTech’s COVID-19 vaccines would not have been
successful.
Financial Results
Cash, Cash Equivalents and
Investments
As of September 30, 2024, the Company had cash,
cash equivalents and investments in marketable securities of $130.8
million compared to $132.3 million as of December 31, 2023.
During the nine months ended September 30, 2024, the Company used
$54.5 million in operating activities, which was partially offset
by $44.1 million of net proceeds from the issuance of common shares
under its “at-the-market” offering program (ATM Program) and $6.1
million of proceeds from the exercise of stock options. The Company
did not issue any common shares under its ATM program in the third
quarter of 2024. The Company expects its 2024 cash burn to range
from $63 million to $67 million. With the organizational
changes in the third quarter, the Company believes its cash, cash
equivalents and investments in marketable securities will be
sufficient to fund its operations into the fourth quarter of
2026.
Revenue
Total revenue was $1.3 million for the three
months ended September 30, 2024 compared to $4.7 million for the
same period in 2023. The decrease of $3.4 million was due primarily
to: i) a decrease in license revenue recognized under the Company’s
licensing agreement with Qilu Pharmaceutical; and ii) a decrease in
license royalty revenue from Alnylam due to lower sales of ONPATTRO
in 2024 compared to 2023.
Operating Expenses
Research and development expenses were $14.3
million for the three months ended September 30, 2024 compared to
$20.2 million for the same period in 2023. The decrease of $5.9
million was due primarily to the discontinuation of the Company’s
coronavirus and AB-161 programs in September 2023, along with
related headcount reductions. General and administrative expenses
were $4.5 million for the three months ended September 30, 2024
compared to $5.8 million for the same period in 2023. The decrease
of $1.3 million was due primarily to decreased employee
compensation and non-cash stock-based compensation expenses due to
headcount reductions. The Company also incurred a $3.6 million
one-time restructuring charge in the third quarter of 2024 related
to its decision to cease all discovery efforts, discontinue its
IM-PROVE III clinical trial, and reduce headcount to streamline the
organization with a focus on advancing the clinical development of
imdusiran and AB-101.
Net Loss
The Company’s net loss was $19.7 million for the
three months ended September 30, 2024 and $20.1 million for the
same period in 2023, with a loss per basic and diluted common share
of $0.10 and $0.12, respectively.
Outstanding Shares
As of September 30, 2024, the Company had
approximately 189.4 million common shares issued and outstanding.
In addition, the Company had approximately 18.7 million stock
options and unvested restricted stock units outstanding as of
September 30, 2024. Roivant Sciences Ltd. owned approximately 21%
of the Company’s outstanding common shares as of September 30,
2024.
|
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF
LOSS |
|
(in thousands, except share and per share
data) |
| |
| |
Three Months EndedSeptember
30, |
|
|
Nine Months EndedSeptember
30, |
| |
2024 |
|
2023 |
|
|
2024 |
|
|
|
2023 |
|
| Revenue |
|
|
|
|
|
|
|
|
|
|
Collaborations and licenses |
$ |
767 |
|
|
|
$ |
3,935 |
|
|
|
$ |
2,861 |
|
|
$ |
13,329 |
|
|
Non-cash royalty revenue |
572 |
|
|
|
723 |
|
|
|
|
1,736 |
|
|
|
2,667 |
|
| Total
revenue |
1,339 |
|
|
|
4,658 |
|
|
|
|
4,597 |
|
|
|
15,996 |
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
Research and development |
14,273 |
|
|
|
20,169 |
|
|
|
|
45,227 |
|
|
|
56,136 |
|
|
General and administrative |
4,537 |
|
|
|
5,842 |
|
|
|
|
17,396 |
|
|
|
17,374 |
|
|
Change in fair value of contingent consideration |
344 |
|
|
|
205 |
|
|
|
|
735 |
|
|
|
(158 |
) |
|
Restructuring |
3,625 |
|
|
|
- |
|
|
|
|
3,625 |
|
|
|
- |
|
| Total operating
expenses |
22,779 |
|
|
|
26,216 |
|
|
|
|
66,983 |
|
|
|
73,352 |
|
| Loss from operations |
(21,440 |
) |
|
|
(21,558 |
) |
|
|
|
(62,386 |
) |
|
|
(57,356 |
) |
| Other income |
|
|
|
|
|
|
|
|
|
|
Interest income |
1,747 |
|
|
|
1,494 |
|
|
|
|
5,121 |
|
|
|
4,223 |
|
|
Interest expense |
(29 |
) |
|
|
(46 |
) |
|
|
|
(107 |
) |
|
|
(415 |
) |
|
Foreign exchange gain / (loss) |
5 |
|
|
|
6 |
|
|
|
|
(16 |
) |
|
|
11 |
|
| Total other income |
1,723 |
|
|
|
1,454 |
|
|
|
|
4,998 |
|
|
|
3,819 |
|
| Net loss |
$ |
(19,717 |
) |
|
|
$ |
(20,104 |
) |
|
|
$ |
(57,388 |
) |
|
$ |
(53,537 |
) |
| Loss per
share |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.10 |
) |
|
|
$ |
(0.12 |
) |
|
|
$ |
(0.31 |
) |
|
$ |
(0.32 |
) |
| Weighted average
number of common shares |
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
188,997,194 |
|
|
|
167,512,708 |
|
|
|
|
184,244,819 |
|
|
|
165,085,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Comprehensive
loss |
|
|
|
|
|
|
|
|
|
|
|
| Unrealized gain on
available-for-sale securities |
218 |
|
|
|
584 |
|
|
|
|
331 |
|
|
|
1,604 |
|
|
Comprehensive loss |
$ |
(19,499 |
) |
|
|
$ |
(19,520 |
) |
|
|
$ |
(57,057 |
) |
|
$ |
(51,933 |
) |
|
UNAUDITED CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(in thousands) |
| |
| |
September 30, 2024 |
|
December 31, 2023 |
|
Cash, cash equivalents and marketable securities, current |
$ |
127,794 |
|
|
$ |
126,003 |
| Accounts receivable and other
current assets |
4,983 |
|
|
6,024 |
|
Total current assets |
132,777 |
|
|
132,027 |
| Property and equipment, net of
accumulated depreciation |
3,556 |
|
|
4,674 |
| Investments in marketable
securities, non-current |
2,964 |
|
|
6,284 |
| Right of use asset |
1,144 |
|
|
1,416 |
|
Total assets |
$ |
140,441 |
|
|
$ |
144,401 |
| Accounts payable and accrued
liabilities |
$ |
7,544 |
|
|
$ |
10,271 |
| Deferred license revenue,
current |
|
10,911 |
|
|
|
11,791 |
| Lease liability, current |
468 |
|
|
425 |
|
Total current liabilities |
18,923 |
|
|
22,487 |
| Liability related to sale of
future royalties |
5,315 |
|
|
6,953 |
| Contingent consideration |
8,335 |
|
|
7,600 |
| Lease liability, non-current |
978 |
|
|
1,343 |
| Total stockholders’ equity |
106,890 |
|
|
106,018 |
|
Total liabilities and stockholders’ equity |
$ |
140,441 |
|
|
$ |
144,401 |
|
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
|
(in thousands) |
| |
| |
Nine Months Ended September 30, |
| |
2024 |
|
2023 |
|
Net loss |
$ |
(57,388 |
) |
|
$ |
(53,537 |
) |
| Non-cash items |
5,453 |
|
|
4,613 |
|
| Change in deferred license
revenue |
(880 |
) |
|
(10,349 |
) |
| Other changes in working
capital |
(1,720 |
) |
|
(9,371 |
) |
| Net cash used in
operating activities |
(54,535 |
) |
|
(68,644 |
) |
| Net cash provided by
investing activities |
9,537 |
|
|
28,548 |
|
|
Issuance of common shares pursuant to the Open Market Sale
Agreement |
44,124 |
|
|
26,000 |
|
|
Cash provided by other financing activities |
6,451 |
|
|
840 |
|
| Net cash provided by
financing activities |
50,575 |
|
|
26,840 |
|
| Effect of foreign exchange rate
changes on cash and cash equivalents |
(16 |
) |
|
11 |
|
|
Increase/(decrease) in cash and cash equivalents |
5,561 |
|
|
(13,245 |
) |
| Cash and cash equivalents,
beginning of period |
26,285 |
|
|
30,776 |
|
|
Cash and cash equivalents, end of period |
31,846 |
|
|
17,531 |
|
| Investments in marketable
securities |
98,912 |
|
|
127,145 |
|
|
Cash, cash equivalents and marketable securities, end of
period |
$ |
130,758 |
|
|
$ |
144,676 |
|
|
|
|
|
|
|
|
|
|
Conference Call and Webcast Today
Arbutus will hold a conference call and webcast
today, Wednesday, November 6, 2024, at 8:45 AM Eastern Time to
provide a corporate update. To dial-in for the conference call by
phone, please register using the following link: Registration Link.
A live webcast of the conference call can be accessed through the
Investors section of Arbutus' website at www.arbutusbio.com.
An archived webcast will be available on the
Arbutus website after the event.
About Imdusiran (AB-729)
Imdusiran is an RNA interference (RNAi)
therapeutic specifically designed to reduce all HBV viral proteins
and antigens including hepatitis B surface antigen, which is
thought to be a key prerequisite to enable reawakening of a
patient’s immune system to respond to the virus. Imdusiran targets
hepatocytes using Arbutus’ novel covalently conjugated
N-Acetylgalactosamine (GalNAc) delivery technology enabling
subcutaneous delivery. Clinical data generated thus far has shown
single and multiple doses of imdusiran to be generally safe and
well-tolerated, while also providing meaningful reductions in
hepatitis B surface antigen and hepatitis B DNA. Imdusiran is
currently in multiple Phase 2a clinical trials.
About AB-101
AB-101 is our oral PD-L1 inhibitor candidate
that we believe will allow for controlled checkpoint blockade while
minimizing the systemic safety issues typically seen with
checkpoint antibody therapies. Immune checkpoints such as
PD-1/PD-L1 play an important role in the induction and maintenance
of immune tolerance and in T-cell activation. Preclinical data
generated thus far indicates that AB-101 mediates re-activation of
exhausted HBV-specific T-cells from cHBV patients. We believe
AB-101, when used in combination with other approved and
investigational agents, could potentially lead to a functional cure
in patients chronically infected with HBV. AB-101 is currently
being evaluated in a Phase 1a/1b clinical trial.
About HBV
Hepatitis B is a potentially life-threatening
liver infection caused by the hepatitis B virus (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 2.4 million people in the United States suffer from
chronic HBV infection. Approximately 820,000 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 (Nasdaq: ABUS) is
a clinical-stage biopharmaceutical company leveraging its extensive
virology expertise to develop novel therapeutics with distinct
mechanisms of action, which can potentially be combined to provide
a functional cure for patients with chronic hepatitis B virus
(cHBV). We believe the key to success in developing a functional
cure involves suppressing HBV DNA, reducing surface antigen, and
boosting HBV-specific immune responses. Our pipeline of internally
developed, proprietary compounds includes an RNAi therapeutic,
imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran
has generated meaningful clinical data demonstrating an impact on
both surface antigen reduction and reawakening of the HBV-specific
immune response. Imdusiran is currently in two Phase 2a combination
clinical trials. AB-101 is currently being evaluated in a Phase
1a/1b clinical trial. 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 future development plans for our product candidates; the
expected cost, timing and results of our clinical development plans
and clinical trials with respect to our product candidates; our
expectations with respect to the release of data from our clinical
trials and the expected timing thereof; our expectations and goals
for our collaborations with third parties and any potential
benefits related thereto; our expectations regarding our
organizational changes; the potential for our product candidates to
achieve success in clinical trials; our expectations regarding our
pending litigation matters; and our expected financial condition,
including our anticipated net cash burn, the anticipated duration
of cash runways and timing regarding needs for additional
capital.
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 patent litigation matters.
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; Arbutus may not realize
the anticipated benefits from the organizational changes; Arbutus
may incur additional unexpected expenses in connection with the
organizational changes; Arbutus may experience additional employee
turnover as a result of the organizational changes; uncertainties
associated with litigation generally and patent litigation
specifically; and Arbutus and its collaborators may never realize
the expected benefits of the collaborations; 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, 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
Lisa M. CaperelliVice President, Investor RelationsPhone:
215-206-1822Email: lcaperelli@arbutusbio.com
Arbutus Biopharma (NASDAQ:ABUS)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Arbutus Biopharma (NASDAQ:ABUS)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024
