- Phase 3 ECLIPSE registrational clinical program in chronic
hepatitis delta on track to begin in the first half of 2025
- Tobevibart and elebsiran in chronic hepatitis delta received
U.S. FDA Breakthrough and Fast Track designations and EMA PRIME and
Orphan Drug designations
- Compelling early clinical response signals and promising
safety profiles for dual-masked T-cell engagers VIR-5818 and
VIR-5500 in heavily pretreated patients with solid tumors, with
potential for expanded therapeutic index
- Company plans to initiate a Phase 1 study of VIR-5525, its
dual-masked EGFR-targeting T-cell engager, in the first half of
2025
- Focused prioritization and disciplined capital deployment of
$1.10 billion in cash, cash equivalents and investments enable cash
runway into mid-2027
- Conference call scheduled for February 26, 2025 at 1:30 p.m.
PT / 4:30 p.m. ET
Vir Biotechnology, Inc. (Nasdaq: VIR), today provided a
corporate update and reported financial results for the fourth
quarter and full year ended December 31, 2024.
“2024 was a year of transformation for Vir Biotechnology as we
successfully defined and executed on our renewed strategic
direction, focusing our resources on our most promising programs in
infectious diseases and oncology,” said Marianne De Backer, M.Sc.,
Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “As we
enter 2025, we are poised for significant advancement with the
initiation of our Phase 3 registrational program in chronic
hepatitis delta and further clinical progression of our dual-masked
T-cell engagers in solid tumors. Our disciplined capital deployment
and strategic approach to partnerships enable us to maximize value
creation from our pipeline and deliver transformative therapies to
patients.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
- ECLIPSE Phase 3 registrational clinical program in chronic
hepatitis delta is advancing with the first patient in (FPI)
expected during the first half of 2025.
- Positive data from the SOLSTICE Phase 2 clinical trial were
presented at the American Association for the Study of Liver
Diseases (AASLD) The Liver Meeting® in November 2024. This data
demonstrated the potential of the first-of-its-kind investigational
combination to address a critical unmet need in CHD, showing rapid
and sustained virologic suppression, using the most stringent
measure of zero detectable hepatitis delta RNA in the blood or
target not detected, (TND defined as HDV RNA < 0 IU/mL), and no
treatment-related serious adverse events (SAEs).
- Tobevibart and elebsiran combination therapy has received
multiple regulatory designations potentially supporting an
expedited development and review process and recognizing the
significant unmet need in CHD: U.S. FDA Breakthrough Therapy
designation, U.S. FDA Fast Track designation, European Priority
Medicines (PRIME) designation and European Orphan Drug
designation.
Solid Tumors
- In January 2025, the Company presented encouraging preliminary
safety and efficacy data in ongoing Phase 1 dose escalation trials
for its dual-masked T-cell engager (TCE) programs.
- VIR-5818, the only dual-masked HER2-targeting TCE in clinical
trials, showed tumor shrinkage across various tumor types in 50%
(10/20) of participants receiving doses ≥400 µg/kg, with confirmed
partial responses in 33% (2/6) of participants with HER2-positive
colorectal cancer (CRC).
- VIR-5500, the only dual-masked PSMA-targeting TCE in clinical
trials, showed PSA reductions in 100% (12/12) of metastatic
castration resistant prostate cancer (mCRPC) patients after an
initial dose ≥120 µg/kg. PSA50 response was confirmed in 58% (7/12)
of participants.
- Both clinical candidates have shown promising safety profiles,
with maximum tolerated dose (MTD) not yet reached, no dose-limiting
cytokine release syndrome (CRS) observed and no CRS greater than
grade 2.
- Initial clinical data demonstrate the PRO-XTEN™ masking
technology’s potential to minimize systemic toxicity while enabling
selective killing of cancer cells in the tumor microenvironment,
minimizing CRS and expanding the therapeutic index compared to
traditional therapeutic approaches.
- The Company is advancing VIR-5818 and VIR-5500 through ongoing
Phase 1 dose escalation studies, aiming to further optimize dosing
and efficacy. Additionally, the Company plans to initiate a Phase 1
study of VIR-5525, its dual-masked EGFR-targeting TCE, in the first
half of 2025, evaluating its potential across a number of solid
tumor indications.
Chronic Hepatitis B (CHB)
- The Company anticipates functional cure data from the 24-week
follow-up of the MARCH Part B Phase 2 trial in the second quarter
of 2025.
- Positive end-of-treatment results of the MARCH Part B Phase 2
trial evaluating tobevibart and elebsiran in combination with
PEG-IFNα or tobevibart and elebsiran alone were presented at AASLD
The Liver Meeting® in November 2024. The data demonstrated
compelling hepatitis B surface antigen (HBsAg) loss and
anti–hepatitis B surface antibody (anti-HBs) development at the end
of treatment.
- Future advancement in CHB by the Company will be contingent on
securing a worldwide development and commercialization partner
outside of China Territory (People’s Republic of China, Hong Kong,
Taiwan and Macau) to best enable further development in this area
of high unmet need.
Preclinical Pipeline Candidates
- The Company is advancing multiple undisclosed dual-masked TCEs
against clinically validated targets with potential applications
across a variety of solid tumors. These preclinical candidates
leverage the PRO-XTEN™ masking technology with novel TCEs
discovered and engineered using Vir Biotechnology’s antibody
discovery platform and the Company’s proprietary dAIsY™
(data AI structure and antibody) AI
engine.
- The Company continues to advance its HIV broadly neutralizing
antibody program for HIV cure in collaboration with the Gates
Foundation.
Corporate Update
- In November 2024, the Company hosted an investor event
highlighting positive data from its SOLSTICE Phase 2 trial in
hepatitis delta and its MARCH Part B Phase 2 trial in hepatitis B
presented at AASLD.
- In January 2025, the Company announced positive initial Phase 1
dose escalation data for two of its PRO-XTEN™ masked TCEs through
an investor event.
- The Company announced Maninder Hora, Ph.D. will assume the role
of Executive Vice President, Chief Technical Operations Officer in
February 2025, following the departure of the current Chief
Technology Officer, Aine Hanley, Ph.D.
Fourth Quarter and Full Year 2024
Financial Results
“Our focus on operational efficiency and program prioritization
achieved a 28% year-over-year reduction in operating expense,
excluding the upfront expense related to the Sanofi licensing
agreement," said Jason O'Byrne, MBA, Executive Vice President and
Chief Financial Officer, Vir Biotechnology. "We enter 2025 with a
robust financial position to support our key strategic priorities,
including $1.10 billion in cash, cash equivalents and investments
and a cash runway into mid-2027."
Cash, Cash Equivalents and Investments: As of December
31, 2024, the Company had approximately $1.10 billion in cash, cash
equivalents and investments, representing a decline of
approximately $90.6 million during the fourth quarter of 2024. For
the full year of 2024, cash, cash equivalents and investments
declined approximately $532.3 million. The 2024 full year decrease
includes a $103.7 million upfront payment made to Sanofi upon the
closing of the Sanofi license agreement and $75.0 million that was
reclassified to restricted cash in the third quarter of 2024 and
subject to VIR-5525 achieving “first in human dosing” by 2026.
Revenue: Revenue for the quarter ended December 31, 2024
was $12.4 million compared to $16.8 million for the same period in
2023. Revenue for the full year of 2024 was $74.2 million compared
to $86.2 million in 2023. The decreases in the fourth quarter and
full year were primarily driven by grant revenue, where lower
revenue was recognized in accordance with our agreement with BARDA
and the Gates Foundation. In addition, the decrease in the full
year 2024 was attributable to lower revenues from the release of
profit-sharing amount previously constrained under the 2020 GSK
Agreement, partially offset by the recognition of deferred revenue
related to the expiry of GSK’s rights to select up to two
additional non-influenza target pathogens during the first quarter
of 2024.
Cost of Revenue: Cost of revenue for the fourth quarter
of 2024 was $0.7 million compared to $0.8 million for the same
period in 2023. Cost of revenue for the full year of 2024 was $0.8
million compared to $2.8 million in 2023. The decreases were due to
lower third-party royalties owed based on the lower collaboration
revenue under the 2020 GSK Agreement.
Research and Development Expenses (R&D): R&D
expenses for the fourth quarter of 2024 were $106.1 million, which
included $8.3 million of non-cash stock-based compensation expense,
compared to $109.1 million for the same period in 2023, which
included $16.5 million of non-cash stock-based compensation
expense. R&D expenses for the full year of 2024 were $506.5
million, which included $43.9 million of non-cash stock-based
compensation expense, compared to $579.7 million in 2023, which
included $62.7 million of non-cash stock-based compensation
expense. The decrease of the fourth quarter R&D expense was
primarily due to lower expenses for personnel and de-prioritized
programs, partially offset by non-cash in-process R&D assets
impairment charges and contingent consideration liability
revaluation. The decrease of the full year R&D expense was
primarily due to lower clinical costs and contract manufacturing
costs associated with the Company’s discontinued flu asset,
VIR-2482, lower contract manufacturing costs associated with
elebsiran used in the Company’s CHD and CHB clinical trials and
lower personnel costs, partially offset by the $102.8 million of
the Sanofi upfront payment being recognized as in-process R&D
expense.
Selling, General and Administrative Expenses (SG&A):
SG&A expenses for the fourth quarter of 2024 were $26.7
million, which included $7.5 million of non-cash stock-based
compensation expense, compared to $41.2 million for the same period
in 2023, which included $11.8 million of non-cash stock-based
compensation expense. SG&A expenses for the full year of 2024
were $119.0 million, which included $34.5 million of non-cash
stock-based compensation expense, compared to $174.4 million in
2023, which included $48.6 million of non-cash stock-based
compensation expense. The decrease in both the fourth quarter and
the full year was primarily related to lower personnel and other
expenses associated with previously announced cost-saving
initiatives.
Restructuring, Long-Lived Assets Impairment and Related
Charges: Restructuring, long-lived assets impairment and
related charges for the fourth quarter of 2024 were $(3.9) million
compared to $4.7 million for the same period in 2023. The $(3.9)
million in the fourth quarter of 2024 was primarily related to a
gain from terminating our lease in St. Louis, Missouri. The $4.7
million in the fourth quarter of 2023 was primarily related to the
severance expenses.
Other Income: Other income for the fourth quarter of 2024
was $12.5 million compared to $18.3 million for the same period in
2023. The decrease was primarily due to lower interest income.
Other income for the full year of 2024 was $64.1 million compared
to $56.1 million in 2023. The increase was primarily due to lower
unrealized loss from the Company's equity investment and lower
foreign exchange loss, partially offset by lower interest
income.
Benefit from Income Taxes: Benefit from income taxes for
the fourth quarter and the full year of 2024 was nominal. Benefit
from income taxes for the fourth quarter and the full year of 2023
was $4.8 million and $13.1 million, respectively, primarily due to
a pre-tax loss and the Company’s ability to carry back the research
and development credit to 2022.
Net Loss: Net loss attributable to Vir Biotechnology for
the fourth quarter of 2024 was $(104.6) million, or $(0.76) per
share, basic and diluted, compared to a net loss of $(116.0)
million, or $(0.86) per share, basic and diluted, for the same
period in 2023. Net loss attributable to Vir Biotechnology for the
year of 2024 was $(522.0) million, or $(3.83) per share, basic and
diluted, compared to a net loss of $(615.1) million, or $(4.59) per
share, basic and diluted, in 2023.
2025 Financial Guidance
Based on current operating plans, the Company expects its cash,
cash equivalents and investments to fund its operations into
mid-2027.
Conference Call
Vir Biotechnology will host a conference call to discuss the
fourth quarter and full year 2024 results at 1:30 p.m. PT / 4:30
p.m. ET today. A live webcast will be available on
https://investors.vir.bio and will be archived for 30 days.
About VIR-5818, VIR-5500, VIR-5525
VIR-5818, VIR-5500, VIR-5525 are investigational, clinical
candidates currently being evaluated for the treatment of solid
tumors. These assets leverage the PRO-XTEN™ masking technology with
three different T-cell engagers (TCEs) targeting HER2, PSMA, and
EGFR, respectively.
TCEs are powerful anti-tumor agents that can direct the immune
system, specifically T-cells, to destroy cancer cells. The
PRO-XTEN™ masking technology is designed to keep the TCEs inactive
(or masked) until they reach the tumor microenvironment, where
tumor-specific proteases cleave off the mask and activate the TCEs,
leading to killing of cancer cells. By driving the activity
exclusively to the tumor microenvironment, we aim to circumvent the
traditionally high toxicity associated with TCEs and increase their
efficacy and tolerability. Additionally, the mask is designed to
help drug candidates stay in the bloodstream longer in their
inactive form, allowing them to better reach the site of action and
potentially allowing less frequent dosing regimens for patients and
clinicians.
About Tobevibart and Elebsiran
Tobevibart is an investigational broadly neutralizing monoclonal
antibody targeting the hepatitis B surface antigen (HBsAg). It is
designed to inhibit the entry of hepatitis B and hepatitis delta
viruses into hepatocytes and to reduce the level of circulating
viral and subviral particles in the blood. Tobevibart was
identified using Vir Biotechnology’s proprietary monoclonal
antibody discovery platform. The Fc domain has been engineered to
increase immune engagement and clearance of HBsAg immune complexes
and incorporates Xencor’s Xtend™ technology to extend half-life.
Tobevibart is administered subcutaneously, and it is currently in
clinical development for the treatment of patients with chronic
hepatitis delta and patients with chronic hepatitis B.
Elebsiran is an investigational hepatitis B virus-targeting
small interfering ribonucleic acid (siRNA) designed to degrade
hepatitis B virus RNA transcripts and limit the production of
hepatitis B surface antigen. Current data indicates that it has the
potential to have direct antiviral activity against hepatitis B
virus and hepatitis delta virus. Elebsiran is administered
subcutaneously, and it is currently in clinical development for the
treatment of patients with chronic hepatitis delta and patients
with chronic hepatitis B.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical
company focused on powering the immune system to transform lives by
discovering and developing medicines for serious infectious
diseases and cancer. Its clinical-stage portfolio includes
infectious disease programs for chronic hepatitis delta and chronic
hepatitis B infections and multiple dual-masked T-cell engagers
across validated targets in solid tumor indications. Vir
Biotechnology also has a preclinical portfolio of programs across a
range of infectious diseases and oncologic malignancies. Vir
Biotechnology routinely posts information that may be important to
investors on its website.
Vir Biotechnology has exclusive rights to the PRO-XTEN™ masking
platform for oncology and infectious disease. PRO-XTEN™ is a
trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “should,” “could,” “may,” “might,” “will,”
“plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. Forward-looking
statements contained in this press release include, but are not
limited to, statements regarding: Vir Biotechnology’s cash balance
and anticipated runway; Vir Biotechnology’s future financial and
operating results and its expectations related thereto, including
Vir Biotechnology’s financial guidance; the therapeutic potential
of Vir Biotechnology's CHD and CHB programs, as well as Vir
Biotechnology's strategy, plans and expectations related thereto;
the therapeutic potential of Vir Biotechnology's oncology solid
tumor portfolio, preclinical pipeline and PRO-XTEN™ masked TCE
platform, as well as Vir Biotechnology's strategy, plans and
expectations related thereto; the potential of and Vir
Biotechnology’s expectations for its other pipeline programs; Vir
Biotechnology’s clinical development plans and expectations for its
oncology and hepatitis programs, including protocols for and
enrollment into ongoing and planned clinical studies, potential
partnering opportunities, and data readouts and presentations, as
well as anticipated timelines; the potential benefits, safety and
efficacy of Vir Biotechnology’s investigational therapies; Vir
Biotechnology’s strategy and plans; and any assumptions underlying
any of the foregoing. Many factors may cause differences between
current expectations and actual results, including, without
limitation: unexpected safety or efficacy data or results observed
during clinical studies or in data readouts, including the
occurrence of adverse safety events; risks of unexpected costs,
delays or other unexpected hurdles; the timing and amount of Vir
Biotechnology’s actual operating expenses, as determined in
accordance with U.S. Generally Accepted Accounting Principles;
difficulties in collaborating with other companies, some of whom
may be competitors of Vir Biotechnology or otherwise have divergent
interests, and uncertainty as to whether the benefits of Vir
Biotechnology’s various collaborations can ultimately be achieved;
challenges in accessing manufacturing capacity; clinical site
activation rates or clinical enrollment rates that are lower than
expected; the timing and outcome of Vir Biotechnology’s planned
interactions with regulatory authorities, as well as general
difficulties in obtaining any necessary regulatory approvals;
successful development and/or commercialization of alternative
product candidates by Vir Biotechnology’s competitors, as well as
changes in expected or existing competition; Vir Biotechnology’s
use of artificial intelligence and machine learning in its efforts
to engineer next-generation proteins and in other research and
development efforts; geopolitical changes or other external
factors; and unexpected litigation or other disputes. In light of
these risks and uncertainties, the events or circumstances referred
to in the forward-looking statements may not occur. Drug
development and commercialization involve a high degree of risk,
and only a small number of research and development programs result
in commercialization of a product. Results in early-stage clinical
studies may not be indicative of full results or results from later
stage or larger scale clinical studies and do not ensure regulatory
approval. The actual results may vary from the anticipated results,
and the variations may be material. You are cautioned not to place
undue reliance on any scientific data presented or these
forward-looking statements, which are based on Vir Biotechnology’s
available information, expectations and assumptions as of the date
of this press release. Other factors that may cause Vir
Biotechnology’s actual results to differ from those expressed or
implied in the forward-looking statements in this press release are
discussed in Vir Biotechnology’s filings with the U.S. Securities
and Exchange Commission, including the section titled “Risk
Factors” contained therein. Except as required by law, Vir
Biotechnology assumes no obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
VIR BIOTECHNOLOGY,
INC.
Consolidated Balance
Sheets
(in thousands, except share
and per share data)
(unaudited)
December 31,
2024
2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
222,947
$
241,576
Short-term investments
678,051
1,270,980
Restricted cash and cash equivalents,
current
89,385
13,268
Equity investments
4,350
9,853
Prepaid expenses and other current
assets
47,725
52,549
Total current assets
1,042,458
1,588,226
Intangible assets, net
8,120
22,565
Goodwill
16,937
16,937
Property and equipment, net
63,183
96,018
Operating right-of-use assets
59,680
71,182
Restricted cash and cash equivalents,
noncurrent
6,363
6,448
Long-term investments
190,015
105,275
Other assets
12,057
12,409
TOTAL ASSETS
$
1,398,813
$
1,919,060
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES:
Accounts payable
$
5,081
$
6,334
Accrued and other liabilities
85,873
104,220
Deferred revenue, current
12,648
64,853
Contingent consideration obligation,
current
16,060
—
Total current liabilities
119,662
175,407
Operating lease liabilities,
noncurrent
90,139
111,673
Contingent consideration obligation,
noncurrent
24,050
25,960
Other long-term liabilities
14,577
15,784
TOTAL LIABILITIES
248,428
328,824
Commitments and contingencies
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.0001 par value;
10,000,000 shares authorized as of December 31, 2024 and 2023,
respectively; no shares issued and outstanding as of December 31,
2024 and 2023
—
—
Common stock, $0.0001 par value;
300,000,000 shares authorized as of December 31, 2024 and 2023,
respectively; 136,959,446 and 134,781,286 shares issued and
outstanding as of December 31, 2024 and 2023, respectively
14
13
Additional paid-in capital
1,911,872
1,828,862
Accumulated other comprehensive loss
(1,717
)
(815
)
Accumulated deficit
(759,784
)
(237,824
)
TOTAL STOCKHOLDERS’ EQUITY
1,150,385
1,590,236
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
1,398,813
$
1,919,060
VIR BIOTECHNOLOGY,
INC.
Consolidated Statements of
Operations
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
December 31,
Year Ended December
31,
2024
2023
2024
2023
Revenues:
Collaboration revenue
$
10,413
$
8,858
$
8,379
$
37,266
Contract revenue
865
744
55,333
2,228
Grant revenue
1,096
7,185
10,493
46,686
Total revenues
12,374
16,787
74,205
86,180
Operating expenses:
Cost of revenue
684
798
845
2,765
Research and development
106,083
109,089
506,499
579,720
Selling, general and administrative
26,701
41,217
119,031
174,441
Restructuring, long-lived assets
impairment and related charges
(3,944
)
4,699
34,995
13,559
Total operating expenses
129,524
155,803
661,370
770,485
Loss from operations
(117,150
)
(139,016
)
(587,165
)
(684,305
)
Other income:
Change in fair value of equity
investments
(1,172
)
(992
)
(5,528
)
(21,888
)
Interest income
14,153
20,736
71,809
86,990
Other expense, net
(506
)
(1,485
)
(2,221
)
(8,991
)
Total other income
12,475
18,259
64,060
56,111
Loss before benefit from income taxes
(104,675
)
(120,757
)
(523,105
)
(628,194
)
Benefit from income taxes
86
4,784
1,145
13,077
Net loss
$
(104,589
)
$
(115,973
)
$
(521,960
)
$
(615,117
)
Net loss attributable to noncontrolling
interest
$
—
$
—
$
—
$
(56
)
Net loss attributable to VirBio
$
(104,589
)
$
(115,973
)
$
(521,960
)
$
(615,061
)
Net loss per share attributable to VirBio,
basic
$
(0.76
)
$
(0.86
)
$
(3.83
)
$
(4.59
)
Net loss per share attributable to VirBio,
diluted
$
(0.76
)
$
(0.86
)
$
(3.83
)
$
(4.59
)
Weighted-average shares outstanding,
basic
136,808,690
134,608,811
136,246,865
134,130,924
Weighted-average shares outstanding,
diluted
136,808,690
134,608,811
136,246,865
134,130,924
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250226992564/en/
Media Arran Attridge Senior Vice President, Corporate
Communications aattridge@vir.bio
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio
Vir Biotechnology (NASDAQ:VIR)
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