– Late-breaker SOLSTICE data abstract accepted
for poster presentation at the European Association for the Study
of the Liver (EASL) Congress 2024 –
– Two additional hepatitis program data
readouts on track for the fourth quarter 2024 –
– $1.51 billion in cash, cash equivalents and
investments as of March 31, 2024 –
– Conference call scheduled for May 2, 2024 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 first quarter ended
March 31, 2024.
“We are excited to share important data from our Phase 2 chronic
hepatitis delta SOLSTICE trial at the upcoming EASL congress. This
milestone brings us closer to addressing the significant unmet
medical need for the millions of people living with hepatitis
delta,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief
Executive Officer. “Our team has worked diligently to streamline
our operations and reduce costs, enabling us to focus our resources
on advancing our promising clinical programs in hepatitis delta and
hepatitis B. Looking ahead, we anticipate additional data readouts
in the fourth quarter that could serve as important catalysts for
the company.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
- On March 5, 2024, Vir announced its Phase 2 chronic hepatitis
delta SOLSTICE trial completed enrollment of its current cohorts
one month ahead of schedule with over 60 participants enrolled in
two additional cohorts.
- The trial is evaluating the safety, tolerability and efficacy
of tobevibart and elebsiran for the treatment of people living with
chronic hepatitis delta.
- One cohort is evaluating the combination of tobevibart and
elebsiran given every 4 weeks with a second cohort evaluating
tobevibart monotherapy given every 2 weeks.
- Approximately 50% of participants have compensated
cirrhosis.
- The Company will report data on a subset of SOLSTICE
participants in a late-breaker poster presentation at the EASL
Congress 2024. This includes additional 12-week treatment data on
approximately 30 participants (~15 per regimen) and 24-week
treatment data on approximately 20 participants (~10 per
regimen).
- Additional follow-up data for the initial six SOLSTICE trial
participants will also be shared at the EASL Congress 2024.
- Complete 24-week treatment data is expected in the fourth
quarter of 2024.
Chronic Hepatitis B (CHB)
- Two abstracts have been accepted for poster presentation at the
EASL Congress 2024.
- The Phase 2 MARCH Part B trial is fully enrolled with 48-week
end of treatment data expected in the fourth quarter of 2024. The
trial is evaluating the safety, tolerability and antiviral activity
of the combination of tobevibart and elebsiran with and without
peginterferon alpha.
- Initial data from the Phase 2 PREVAIL platform trial and its
THRIVE/STRIVE sub-protocols is expected in the first half of 2025.
These trials are evaluating combinations of tobevibart, elebsiran
and/or peginterferon alpha in two patient populations:
immune-active but treatment-naïve and inactive carriers.
Human Immunodeficiency Virus (HIV)
- Part A of the Phase 1 trial of VIR-1388, an investigational
novel T cell vaccine for the prevention of HIV, is fully enrolled
with initial immunogenicity data expected in the second half of
2024.
- 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.
Influenza
- On April 4, 2024, the Company published the full data analysis
from the Phase 2 PENINSULA trial evaluating VIR-2482 on
medRxiv.
Preclinical Pipeline Candidates
- Vir is continuing to advance next-generation antibodies using
its proprietary platform, which leverages dAIsY™ (data
AI structure and antibody), the Company’s
proprietary AI engine, enabling the Company to bring high-quality
drug candidates to the clinic more efficiently.
- The Company expects the filing of multiple investigational new
drug applications within the next 18 months, including:
- VIR-1949, an investigational therapeutic T cell vaccine based
on Vir’s human cytomegalovirus (HCMV) vector platform that is
designed to treat precancerous lesions caused by the human
papillomavirus.
- VIR-7229, a next-generation COVID monoclonal antibody candidate
that has been AI-engineered to have increased potency, breadth and
resistance to viral escape. The development of VIR-7229 has been
supported 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.
- VIR-2981, an investigational neuraminidase-targeting monoclonal
antibody against both influenza A and B viruses.
- VIR-8190 and other investigational monoclonal antibodies
against respiratory syncytial virus and/or metapneumovirus as part
of the collaboration established with GSK in May of 2021.
Corporate Update
- The Company plans to host a virtual R&D day in late
November.
- Effective May 3, 2024, Sung Lee, Executive Vice President and
Chief Financial Officer will be stepping down from his role to
pursue another career opportunity. The Company has initiated a
search for a successor.
First Quarter 2024 Financial
Results
Cash, Cash Equivalents and Investments: As of March 31,
2024, the Company had approximately $1.51 billion in cash, cash
equivalents and investments. Cash, cash equivalents and investments
declined by approximately $118 million during the first quarter of
2024.
Revenues: Total revenues for the quarter ended March 31,
2024, were $56.4 million compared to $63.0 million for the same
period in 2023.
Revenues were comprised of the following components:
Three Months Ended March
31,
2024
2023
% Change
(in millions)
Collaboration revenue
$
(1.0
)
$
46.6
(102.1
)%
Contract revenue
52.2
0.1
>100.0
%
Grant revenue
5.2
16.2
(67.9
)%
Total revenues
$
56.4
$
63.0
(10.5
)%
Note: Numbers may not add due to
rounding.
- Collaboration revenue: The decrease in collaboration
revenue for the first quarter of 2024 compared to the same period
in 2023 was driven by the release of profit-sharing amount
previously constrained during the three months ended March 31, 2023
and to a lesser extent, lower sales of sotrovimab during the three
months ended March 31, 2024, under the Company’s collaboration with
GSK.
- Contract revenue: The increase in contract revenue for
the first quarter of 2024 compared to the same period in 2023 was
primarily driven 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 three months ended March
31, 2024.
- Grant revenue: The decrease in grant revenue was
primarily driven by lower revenue related to the Company's
agreement with BARDA.
Cost of Revenue: Cost of revenue for the first quarter of
2024 was nominal compared to $1.9 million for the same period in
2023. 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 first quarter of 2024 were $100.1 million, which
included $13.6 million of non-cash stock-based compensation
expense, compared to $157.6 million for the same period in 2023,
which included $13.4 million of non-cash stock-based compensation
expense. The decrease was primarily driven by lower clinical
development costs and manufacturing costs associated with
VIR-2482.
Selling, General and Administrative Expenses (SG&A):
SG&A expenses for the first quarter of 2024 were $36.3 million,
which included $10.2 million of non-cash stock-based compensation
expense, compared to $46.8 million for the same period in 2023,
which included $12.1 million of non-cash stock-based compensation
expense. The decrease was primarily driven by cost savings
initiatives implemented during the second half of 2023.
Other Income: Other income for the first quarter of 2024
was $15.1 million compared to $0.2 million for the same period in
2023. The increase was primarily due to the decrease in foreign
exchange loss related to remeasurement of liability reserved for
excess sotrovimab supply and manufacturing capacity and a decrease
in loss recognized on the Company's equity investments.
(Provision for) Benefit from Income Taxes: Provision for
income taxes for the first quarter of 2024 was $0.3 million
compared to benefit from income taxes of $2.2 million for the same
period in 2023.
Net Loss: Net loss attributable to Vir for the first
quarter of 2024 was $(65.3) million, or $(0.48) per share, basic
and diluted, compared to a net loss of $(140.9) million, or $(1.06)
per share, basic and diluted for the same period in 2023.
2024 Financial Guidance
The Company reiterates its full year 2024 guidance below,
originally provided on February 22, 2024 (in millions):
GAAP combined R&D and SG&A expense
range:
$
650
to
$
680
The following expenses are included in the
GAAP combined R&D and SG&A expense range:
Stock-based compensation expense
$
115
to
$
105
Restructuring charges*
$
35
to
$
25
* Restructuring charges are primarily
non-cash expenditures, related to the closing of two R&D sites
previously announced on December 13, 2023.
Approximately three to four percent of the GAAP combined R&D
and SG&A expense will be funded by grants. These grants are
recognized as revenue.
The GAAP combined R&D and SG&A expense guidance does not
include the effect of GAAP adjustments caused by events that may
occur subsequent to the publication of this guidance, including,
but not limited to, business development activities, litigation,
in-process R&D impairments, and changes in the fair value of
contingent considerations.
Conference Call
Vir will host a conference call to discuss the first quarter
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 Tobevibart
Tobevibart 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. Tobevibart, 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. Tobevibart was identified using Vir’s proprietary
monoclonal antibody discovery platform.
About Elebsiran
Elebsiran 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. Elebsiran 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 monoclonal antibody discovery platform.
The PENINSULA trial has been supported 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 monoclonal antibody
discovery platform.
About VIR-1388
VIR-1388 is a preclinical subcutaneously administered HIV T cell
vaccine based the T cell-based viral 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 monoclonal antibody 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 monoclonal
antibody 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 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 an investigational 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 an investigational therapeutic vaccine based the T
cell-based viral vector platform that is 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
powering the immune system to transform lives by treating and
preventing infectious diseases and other serious conditions,
including viral-associated diseases. Vir has assembled two
technology platforms that are designed to modulate the immune
system by exploiting critical observations of natural immune
processes. Its current clinical development pipeline consists of
product candidates targeting hepatitis delta and hepatitis B
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 financial guidance;
Vir’s future financial and operating results and its expectations
related thereto; potential of, and expectations for, Vir’s
pipeline; Vir’s clinical and preclinical 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, Vir’s use of artificial intelligence and machine
learning in its efforts to engineer next-generation proteins and in
other research and development efforts; the timing and amount of
actual expenses, including, without limitation, Vir’s anticipated
combined GAAP R&D and SG&A expenses; 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 U.S. 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)
March 31, 2024
December 31,
2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
160,711
$
241,576
Short-term investments
985,125
1,270,980
Restricted cash and cash equivalents,
current
13,335
13,268
Equity investments
3,927
9,853
Prepaid expenses and other current
assets
49,999
52,549
Total current assets
1,213,097
1,588,226
Intangible assets, net
22,465
22,565
Goodwill
16,937
16,937
Property and equipment, net
92,477
96,018
Operating lease right-of-use assets
70,346
71,182
Restricted cash and cash equivalents,
noncurrent
6,428
6,448
Long-term investments
359,724
105,275
Other assets
12,495
12,409
TOTAL ASSETS
$
1,793,969
$
1,919,060
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES:
Accounts payable
$
7,114
$
6,334
Accrued and other liabilities
72,260
104,220
Deferred revenue, current
14,694
64,853
Total current liabilities
94,068
175,407
Deferred revenue, noncurrent
1,526
1,526
Operating lease liabilities,
noncurrent
109,171
111,673
Contingent consideration, noncurrent
27,610
25,960
Other long-term liabilities
14,238
14,258
TOTAL LIABILITIES
246,613
328,824
Commitments and contingencies (Note 8)
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.0001 par value;
10,000,000 shares authorized as of March 31, 2024 and December 31,
2023; no shares issued and outstanding as of March 31, 2024 and
December 31, 2023
—
—
Common stock, $0.0001 par value;
300,000,000 shares authorized as of March 31, 2024 and December 31,
2023; 135,843,560 and 134,781,286 shares issued and outstanding as
of March 31, 2024 and December 31, 2023, respectively
14
13
Additional paid-in capital
1,852,839
1,828,862
Accumulated other comprehensive loss
(2,397
)
(815
)
Accumulated deficit
(303,100
)
(237,824
)
TOTAL STOCKHOLDERS’ EQUITY
1,547,356
1,590,236
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
1,793,969
$
1,919,060
VIR BIOTECHNOLOGY,
INC.
Condensed Consolidated
Statements of Operations
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
March 31,
2024
2023
Revenues:
Collaboration revenue
$
(987
)
$
46,574
Contract revenue
52,191
138
Grant revenue
5,172
16,245
Total revenues
56,376
62,957
Operating expenses:
Cost of revenue
59
1,907
Research and development
100,125
157,643
Selling, general and administrative
36,273
46,778
Total operating expenses
136,457
206,328
Loss from operations
(80,081
)
(143,371
)
Other income:
Change in fair value of equity
investments
(5,915
)
(13,103
)
Interest income
21,283
21,307
Other expense, net
(287
)
(8,021
)
Total other income
15,081
183
Loss before (provision for) benefit from
income taxes
(65,000
)
(143,188
)
(Provision for) benefit from income
taxes
(276
)
2,232
Net loss
(65,276
)
(140,956
)
Net loss attributable to noncontrolling
interest
—
(56
)
Net loss attributable to Vir
$
(65,276
)
$
(140,900
)
Net loss per share attributable to Vir,
basic and diluted
$
(0.48
)
$
(1.06
)
Weighted-average shares outstanding, basic
and diluted
135,280,648
133,552,839
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240502260564/en/
Media Carly Scaduto Senior Director, External
Communications cscaduto@vir.bio +1 314-368-5189
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio +1 978-973-9986
Vir Biotechnology (NASDAQ:VIR)
Historical Stock Chart
From Apr 2024 to May 2024
Vir Biotechnology (NASDAQ:VIR)
Historical Stock Chart
From May 2023 to May 2024