– Company to present new data at AASLD from
Phase 2 chronic hepatitis B and chronic hepatitis delta clinical
trials –
– Company expanding strategic focus to
autoimmune diseases and immuno-oncology –
– Jennifer Towne, Ph.D., appointed as Executive
Vice President and Chief Scientific Officer, effective November 6,
2023 –
– Secured new BARDA funding for the development
of RNA-delivered monoclonal antibodies –
– $1.7 billion in cash, cash equivalents and
investments as of September 30, 2023 –
– Conference call scheduled for 1:30 p.m. PT /
4:30 p.m. ET, November 2, 2023 –
Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate
update and reported financial results for the third quarter ended
September 30, 2023.
“We continue to execute on our multiple clinical stage programs
and look forward to sharing Phase 2 data from our chronic hepatitis
B MARCH Part B and chronic hepatitis delta SOLSTICE trials at
AASLD,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief
Executive Officer. “Initiating a new Phase 1 HIV T cell vaccine
clinical trial and securing non-dilutive funding from the U.S.
government to advance our next generation COVID-19 mAb through
Phase 1 is reflective of our ongoing momentum. We are well-funded
to both execute on our clinical programs and evaluate complementary
external opportunities to strengthen our platforms and
pipeline.”
Pipeline Programs
Chronic Hepatitis B (CHB) & Chronic Hepatitis Delta
(CHD)
- The Company recently announced that eight abstracts
highlighting new data from its CHB and CHD clinical programs have
been accepted for presentation at the American Association for the
Study of Liver Diseases (AASLD) The Liver Meeting®, taking place in
Boston, MA, from November 10-14, 2023. These include seven poster
presentations, one of which is a late-breaking poster, and one
late-breaking oral presentation. The late-breaking presentations
will be shared on November 13, 2023:
- Phase 2 MARCH Part B 24-week End of Treatment data for VIR-3434
and VIR-2218 with and without peginterferon alpha in CHB.
- Initial data from the Phase 2 SOLSTICE trial evaluating
VIR-3434 and VIR-2218 as monotherapy, and in combination, for the
chronic treatment of people living with CHD.
- The Phase 2 PREVAIL platform trial and its THRIVE/STRIVE
sub-protocols are ongoing. The platform is evaluating combinations
of VIR-3434, VIR-2218 and/or peginterferon alpha in two CHB patient
populations with the potential to evaluate other populations in the
future. Initial data from this platform trial are expected in the
first half of 2024.
Human Immunodeficiency Virus (HIV)
- In September, Vir announced the initiation of the Phase 1 trial
of VIR-1388, an investigational novel T cell vaccine for the
prevention of HIV.
- The trial is supported by the National Institute of Allergy and
Infectious Diseases, part of the National Institutes of Health, and
the Bill & Melinda Gates Foundation, and is being conducted by
the HIV Vaccine Trials Network.
- Initial data from the trial is expected in the second half of
2024.
COVID-19
- In October, the Company announced it was awarded approximately
$50 million in new funding from the Biomedical Advanced Research
and Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response within the U.S. Department of
Health and Human Services.
- $40 million of the total funds is part of Project NextGen and
will support the development of VIR-7229 through Phase 1. It also
supports developing alternative mAb delivery technologies,
including RNA-delivered mAbs. The Company expects to initiate a
Phase 1 clinical trial in 2024 and is exploring partner
opportunities for post Phase 1 development. The Phase 1 trial is
expected to be completed in the second half of 2025.
- $10 million of the total funds will support the discovery of
new mAbs against a second pathogen of pandemic potential in the
context of further advancing alternative mAb delivery technologies.
This effort is receiving support from BARDA’s Division of Chemical,
Biological, Radiological and Nuclear Medical Countermeasures.
- On August 30, Nature published in vivo research findings that
showed the role effector function plays in sotrovimab’s ability to
activate the immune system and clear SARS-CoV-2.
- Sotrovimab currently has emergency authorization, temporary
authorization or marketing approval (under the brand name Xevudy®)
for early treatment of COVID-19. It has been supplied to more than
40 countries and remains in use outside of the US.
Influenza
- The full analysis of data from the Phase 2 PENINSULA trial is
expected in Q1 2024. Initial post-hoc analyses have yielded the
following conclusions:
- VIR-2482’s ability to reduce cases of symptomatic flu improves
to 57% for the 1,200 mg dose when the case definition (how
symptomatic is defined) includes fever.
- This relative risk reduction increases further to 65% when
excluding the confirmed flu cases that occurred within a few days
of dosing.
Preclinical Pipeline Candidates
- Vir is continuing to advance next-generation mAbs based on its
proprietary platform and enabled by AI and machine learning to
deliver high-quality drug candidates more efficiently. The Company
expects the filing of multiple new INDs in the next 12-24 months,
including:
- VIR-2981, an investigational neuraminidase-targeting mAb
against both influenza A and B viruses.
- VIR-8190, an investigational mAb against respiratory syncytial
virus (RSV) and human metapneumovirus.
- VIR-1949, an investigational therapeutic T cell vaccine based
on Vir’s HCMV vector platform that is designed to treat
precancerous lesions caused by human papillomavirus.
Corporate Update
- In October, Vir announced the appointment of Jennifer Towne,
Ph.D., as Executive Vice President and Chief Scientific Officer,
effective November 6, 2023. Dr. Towne joins Vir from The Janssen
Pharmaceutical Companies of Johnson & Johnson, where she spent
nine years holding immunology research leadership roles of
increasing responsibility within Research and Development. Prior to
Janssen, Dr. Towne held a variety of scientific roles during her 13
years at Amgen. During the course of her career, Dr. Towne led the
development of 16 drug candidates from preclinical research to IND
and early clinical development.
Third Quarter 2023 Financial
Results
Cash, Cash Equivalents and Investments: As of September
30, 2023, the Company had approximately $1.7 billion in cash, cash
equivalents and investments. In the third quarter of 2023, a
payment of $67.0 million was made to GSK for largely all of the
remaining excess sotrovimab supply and manufacturing capacity that
was reserved in 2022.
Revenues: Total revenues for the quarter ended September
30, 2023, were $2.6 million compared to $374.6 million for the same
period in 2022.
Revenues were comprised of the following components:
Three Months Ended September
30,
2023
2022
% Change
(in millions)
Collaboration revenue
$
(4.4
)
$
309.1
(101.4
)%
Contract revenue
0.3
40.0
(99.3
)%
License revenue from a related party
—
22.3
(100.0
)%
Grant revenue
6.7
3.1
>100.0
%
Total revenues
$
2.6
$
374.6
(99.3
)%
Note: Numbers may not add due to
rounding.
- Collaboration revenue: The decrease in collaboration
revenue for the third quarter of 2023 compared to the same period
in 2022 was driven by profit share from lower sales of sotrovimab
under the Company’s collaboration with GSK.
- Contract revenue: The decrease in contract revenue was
primarily driven by the recognition of deferred revenue related to
GSK’s selection of RSV under the Company’s 2021 agreement with GSK
in the third quarter of 2022.
- License revenue from a related party: The decrease in
license revenue was driven by certain revenues recognized under the
collaboration with Brii Biosciences in the third quarter of
2022.
- Grant revenue: The increase in grant revenue was
primarily driven by the Company’s grant with BARDA supporting the
wind down of the Company’s Phase 2 PENINSULA trial in the third
quarter of 2023.
Cost of Revenue: Cost of revenue for the third quarter of
2023 was nominal compared to $22.3 million for the same period in
2022. The decrease was due to lower third-party royalties owed on
the sales of sotrovimab.
Research and Development Expenses (R&D): R&D
expenses for the third quarter of 2023 were $148.3 million, which
included $15.8 million of non-cash stock-based compensation
expense, compared to $114.2 million for the same period in 2022,
which included $12.6 million of non-cash stock-based compensation
expense. The increase was primarily driven by the $21.9 million
cancellation of Phase 3 manufacturing activities for VIR-2482 and
to a lesser extent, the advancement of our CHB and CHD clinical
programs.
Selling, General and Administrative Expenses (SG&A):
SG&A expenses for the third quarter of 2023 were $41.1 million,
which included $11.1 million of non-cash stock-based compensation
expense, compared to $43.2 million for the same period in 2022,
which included $12.2 million of non-cash stock-based compensation
expense.
Other Income: Other income for the third quarter of 2023
was $20.1 million compared to $22.8 million for the same period in
2022. The decrease was primarily due to a decrease in foreign
exchange gain related to remeasurement of liability reserved for
excess sotrovimab supply and manufacturing capacity, partially
offset by higher interest income due.
Benefit from (Provision for) Income Taxes: Benefit from
income taxes for the third quarter of 2023 was $3.2 million
compared to $(42.4) million provision for income taxes for the same
period in 2022. The benefit from income taxes was primarily due to
a pre-tax loss and our ability to carry-back the R&D credit to
2022.
Net (Loss) Income: Net loss attributable to Vir for the
third quarter of 2023 was $(163.4) million, or $(1.22) per share,
basic and diluted, compared to a net income of $175.3 million, or
$1.32 per share, basic and $1.30 per share, diluted, for the same
period in 2022.
Conference Call
Vir will host a conference call to discuss the Q3 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 on www.vir.bio
for 30 days.
About VIR-3434
VIR-3434 is an investigational subcutaneously administered
antibody designed to block entry of hepatitis B and hepatitis delta
viruses into hepatocytes and to reduce the level of virions and
subviral particles in the blood. VIR-3434, which incorporates
Xencor’s Xtend™ and other Fc technologies, has been engineered to
potentially function as a T cell vaccine against hepatitis B virus
and hepatitis delta virus, as well as to have an extended
half-life. VIR-3434 was identified using Vir’s proprietary mAb
discovery platform.
About VIR-2218
VIR-2218 is an investigational subcutaneously administered
hepatitis B virus-targeting small interfering ribonucleic acid
(siRNA) that Vir believes has the potential to stimulate an
effective immune response and have direct antiviral activity
against hepatitis B virus and hepatitis delta virus. It is the
first siRNA in the clinic to include Enhanced Stabilization
Chemistry Plus (ESC+) technology to enhance stability and minimize
off-target activity, which potentially could result in an increased
therapeutic index. VIR-2218 is the first asset in the Company’s
collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical
trials.
About VIR-2482
VIR-2482 is an investigational hemagglutinin targeting,
intramuscularly administered influenza A-neutralizing monoclonal
antibody. In vitro, it has been shown to cover all major strains of
influenza A that have arisen since the 1918 flu pandemic. VIR-2482
is designed as a prophylactic for influenza A. VIR-2482
incorporates Xencor’s Xtend™ and was identified using Vir’s
proprietary mAb discovery platform.
The PENINSULA trial has been supported in whole or in part with
federal funds from the Department of Health and Human Services
(HHS); Administration for Strategic Preparedness and Response
(ASPR); Biomedical Advanced Research and Development Authority
(BARDA), under Other Transaction Number: 75A50122C00081.
About VIR-2981
VIR-2981 is an investigational neuraminidase-targeting
monoclonal antibody against influenza viruses. It targets a region
of the neuraminidase protein that is highly conserved across
influenza A and B strains and is designed to inhibit the influenza
neuraminidase, a key viral protein that facilitates release of new
viruses in infected individuals. Preclinical data demonstrate the
antibody’s breadth and potency against all major strains of
seasonal and pandemic influenza viruses and support the potential
of this antibody in the prevention of influenza illness. VIR-2981
was identified using Vir’s proprietary mAb discovery platform.
About VIR-1388
VIR-1388 is a preclinical subcutaneously administered HIV T cell
vaccine based on the human cytomegalovirus (HCMV) vector platform
and has been designed to elicit abundant T cells that recognize HIV
epitopes with the goal of creating a safe and effective HIV
vaccine.
About Sotrovimab
Sotrovimab is an investigational SARS-CoV-2 neutralizing
monoclonal antibody that was developed in collaboration with GSK.
The antibody binds to an epitope on SARS-CoV-2 shared with
SARS-CoV-1 (the virus that causes SARS). Sotrovimab, which
incorporates Xencor, Inc.’s Xtend™ technology, has been designed to
achieve high concentration in the lungs to achieve optimal
penetration into airway tissues affected by SARS-CoV-2 and to have
an extended half-life. Sotrovimab was identified using Vir’s
proprietary mAb discovery platform. Sotrovimab is currently not
authorized in the US.
About VIR-7229
VIR-7229 is an investigational next generation COVID-19
monoclonal antibody with a distinct combination of potency, breadth
and viral inescapability. VIR-7229 is designed as a prophylactic
for COVID-19 and was identified using Vir’s proprietary mAb
discovery platform. VIR-7229 incorporates Xencor, Inc.’s Xtend™
technology and is affinity matured using machine learning to
increase its effectiveness in binding to SARS-CoV and SARS-CoV-2
variants.
The development of VIR-7229 has been supported in whole or in
part with federal funds from the Department of Health and Human
Services (HHS); Administration for Strategic Preparedness and
Response (ASPR); Biomedical Advanced Research and Development
Authority (BARDA), under Other Transaction Number:
75A50122C00081.
About VIR-8190
VIR-8190 is a dual specificity monoclonal antibody that has the
ability to potently neutralize both respiratory syncytial virus
(RSV) and human metapneumovirus (hMPV) strains. RSV and HMPV are
recognized as significant causes of lower respiratory tract disease
in high-risk populations, including infants and immunocompromised
individuals. VIR-8190 was identified using Vir’s proprietary mAb
discovery platform.
About VIR-1949
VIR-1949 is a preclinical therapeutic vaccine designed to treat
HPV-related high-grade squamous epithelial pre-cancer lesions
(HSIL) and cancers. This vaccine uses HCMV as the vaccine vector.
Based on preclinical data, HCMV vectors have the potential to
induce high frequencies of antigen-specific, tissue-localizing
effector memory T cells.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is an immunology company focused on
combining cutting-edge technologies to treat and prevent infectious
diseases and other serious conditions. Vir has assembled two
technology platforms that are designed to stimulate and enhance the
immune system by exploiting critical observations of natural immune
processes. Its current clinical development pipeline consists of
product candidates targeting hepatitis B and hepatitis delta
viruses and human immunodeficiency virus. Vir has several
preclinical candidates in its pipeline, including those targeting
influenza A and B, COVID-19, RSV/MPV and HPV. Vir routinely posts
information that may be important to investors on its website.
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 “may,” “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. These forward-looking statements are
based on Vir’s expectations and assumptions as of the date of this
press release. Forward-looking statements contained in this press
release include, but are not limited to, statements regarding Vir’s
strategy and plans; Vir’s cash balance; Vir’s future financial and
operating results and its expectations related thereto; potential
of, and expectations for, Vir’s pipeline; Vir’s clinical
development programs, clinical trials, including the enrollment of
Vir’s clinical trials, and the expected timing of data readouts and
presentations; the potential benefits, safety, and efficacy of
Vir’s investigational therapies; and risks and uncertainties
associated with drug development and commercialization. Many
important factors may cause differences between current
expectations and actual results, including uncertainty as to
whether the anticipated benefits of the BARDA collaboration can be
achieved; unexpected safety or efficacy data or results observed
during clinical trials or in data readouts; the timing and outcome
of Vir’s planned interactions with regulatory authorities;
difficulties in obtaining regulatory approval; uncertainty as to
whether the anticipated benefits of Vir’s collaborations with other
companies can be achieved; difficulties in collaborating with other
companies; challenges in accessing manufacturing capacity; clinical
site activation rates or clinical trial enrollment rates that are
lower than expected; successful development and/or
commercialization of alternative product candidates by Vir’s
competitors; changes in expected or existing competition; delays in
or disruptions to Vir’s business or clinical trials, geopolitical
changes or other external factors; and unexpected litigation or
other disputes. 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 trials may not be indicative of
full results or results from later-stage or larger-scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements or the scientific data
presented. Other factors that may cause actual results to differ
from those expressed or implied in the forward-looking statements
in this press release are discussed in Vir’s filings with the US
Securities and Exchange Commission, including the section titled
“Risk Factors” contained therein. Except as required by law, Vir
assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
VIR BIOTECHNOLOGY,
INC.
Condensed Consolidated Balance
Sheets
(in thousands, except share
and per share data)
(unaudited)
September 30,
2023
December 31,
2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
452,100
$
848,631
Short-term investments
1,233,628
1,521,517
Restricted cash and cash equivalents,
current
13,193
12,681
Equity investments
10,825
31,892
Prepaid expenses and other current
assets
59,430
104,356
Total current assets
1,769,176
2,519,077
Intangible assets, net
25,457
32,755
Goodwill
16,937
16,937
Property and equipment, net
99,309
105,609
Operating lease right-of-use assets
72,622
82,557
Restricted cash and cash equivalents,
noncurrent
7,057
6,656
Long-term investments
39,617
23,927
Other assets
14,720
14,570
TOTAL ASSETS
$
2,044,895
$
2,802,088
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES:
Accounts payable
$
3,627
$
6,422
Accrued and other liabilities
146,111
489,090
Deferred revenue, current
15,312
15,517
Total current liabilities
165,050
511,029
Deferred revenue, noncurrent
53,207
53,207
Operating lease liabilities,
noncurrent
114,119
123,837
Contingent consideration, noncurrent
24,300
24,937
Other long-term liabilities
13,134
11,115
TOTAL LIABILITIES
369,810
724,125
Commitments and contingencies (Note 7)
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.0001 par value;
10,000,000 shares authorized as of September 30, 2023 and December
31, 2022; no shares issued and outstanding as of September 30, 2023
and December 31, 2022
—
—
Common stock, $0.0001 par value;
300,000,000 shares authorized as of September 30, 2023 and December
31, 2022; 134,497,886 and 133,236,687 shares issued and outstanding
as of September 30, 2023 and December 31, 2022, respectively
13
13
Additional paid-in capital
1,798,823
1,709,835
Accumulated other comprehensive loss
(1,900
)
(9,122
)
(Accumulated deficit) retained
earnings
(121,851
)
377,237
TOTAL STOCKHOLDERS’ EQUITY
1,675,085
2,077,963
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
2,044,895
$
2,802,088
VIR BIOTECHNOLOGY,
INC.
Condensed Consolidated
Statements of Operations
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Revenues:
Collaboration revenue
$
(4,387
)
$
309,145
$
28,408
$
1,483,860
Contract revenue
289
39,998
1,484
52,534
License revenue from a related party
—
22,289
—
22,289
Grant revenue
6,737
3,125
39,501
7,704
Total revenues
2,639
374,557
69,393
1,566,387
Operating expenses:
Cost of revenue
38
22,253
1,967
140,323
Research and development
148,253
114,166
477,756
319,475
Selling, general and administrative
41,080
43,174
134,959
123,019
Total operating expenses
189,371
179,593
614,682
582,817
(Loss) income from operations
(186,732
)
194,964
(545,289
)
983,570
Other income (expense):
Change in fair value of equity
investments
(2,707
)
(13,590
)
(20,896
)
(120,019
)
Interest income
21,931
9,332
66,254
11,920
Other income (expense), net
882
27,026
(7,506
)
30,447
Total other income (expense)
20,106
22,768
37,852
(77,652
)
(Loss) income before benefit from
(provision for) income taxes
(166,626
)
217,732
(507,437
)
905,918
Benefit from (provision for) income
taxes
3,213
(42,420
)
8,293
(288,478
)
Net (loss) income
$
(163,413
)
$
175,312
$
(499,144
)
$
617,440
Net loss attributable to noncontrolling
interest
$
—
$
—
$
(56
)
$
—
Net (loss) income attributable to Vir
$
(163,413
)
$
175,312
$
(499,088
)
$
617,440
Net (loss) income per share attributable
to Vir, basic
$
(1.22
)
$
1.32
$
(3.73
)
$
4.66
Net (loss) income per share attributable
to Vir, diluted
$
(1.22
)
$
1.30
$
(3.73
)
$
4.58
Weighted-average shares outstanding,
basic
134,289,620
132,729,530
133,969,878
132,422,028
Weighted-average shares outstanding,
diluted
134,289,620
134,963,317
133,969,878
134,711,777
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231101298972/en/
Media Carly Scaduto Senior Director, Media Relations
cscaduto@vir.bio +1-314-368-5189
Investors Sasha Damouni Ellis Executive Vice President,
Chief Corporate Affairs Officer sdamouni@vir.bio
Vir Biotechnology (NASDAQ:VIR)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Vir Biotechnology (NASDAQ:VIR)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024