– Successful closing of exclusive worldwide
licensing agreement with Sanofi for three potential best-in-class
clinical-stage dual-masked T-cell engagers with initial clinical
data anticipated in Q1 2025 –
– Key Phase 2 SOLSTICE data in chronic
hepatitis delta to be presented at AASLD 2024 –
– The Company will host a Hepatitis Investor
Event following AASLD on November 19, 2024 –
– Jason O’Byrne appointed as Chief Financial
Officer –
– Conference call scheduled for October 31,
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 third quarter ended
September 30, 2024.
“This quarter was transformational for Vir. We have bolstered
our clinical pipeline with three potential best-in-class
dual-masked T-cell engagers in oncology, and have sharpened our
focus within infectious diseases to the areas where we believe we
can make the most significant impact for patients. We are also
thrilled to welcome Jason O’Byrne as our new CFO. Jason brings a
wealth of financial leadership experience, further strengthening
our ability to bring these potentially transformative therapies to
patients as quickly as possible,” said Marianne De Backer, M.Sc.,
Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “Looking
ahead, this is an exciting time for the Company. We eagerly
anticipate critical data in our hepatitis programs in the fourth
quarter and look forward to sharing initial clinical data from our
dual-masked T-cell engagers in the first quarter of 2025.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
- Preliminary data from the Phase 2 chronic hepatitis delta
SOLSTICE study was presented at the European Study of the Liver
(EASL) Meeting in June 2024. This data demonstrated the potential
for transformative treatment for people living with chronic
hepatitis delta, with both tobevibart as a monotherapy, and in
combination with elebsiran, achieving high rates of virologic
response and ALT normalization after 12 and 24 weeks of treatment.
No treatment-related serious adverse events were observed.
- The combination of tobevibart and elebsiran has been granted
Fast Track Designation by the U.S. FDA. Given the robust rates of
virologic suppression observed with the combination, the Company is
diligently working to advance this regimen into a pivotal
development program as quickly as possible to address the urgent
needs of these patients.
- At the upcoming American Association for the Study of Liver
Diseases (AASLD) “The Liver Meeting” in November 2024, the Company
will present additional data from the Phase 2 chronic hepatitis
delta SOLSTICE trial, including: 24-week clinical data for both
study cohorts in approximately 60 patients and further data for
those patients who were on study beyond 24 weeks at the time of
data cut-off.
- One cohort assesses the combination of tobevibart and elebsiran
administered every four weeks, while a second cohort evaluates
tobevibart monotherapy administered every two weeks.
- The SOLSTICE trial is evaluating the safety, tolerability and
efficacy of tobevibart and elebsiran for the treatment of chronic
hepatitis delta.
Chronic Hepatitis B (CHB)
- The Company plans to share end-of-treatment data from the Phase
2 MARCH Part B trial as a Late Breaking presentation at the AASLD
meeting in November 2024.
- The MARCH-B trial is evaluating the safety, tolerability and
antiviral activity of the triplet combination of tobevibart and
elebsiran plus peginterferon alfa-2a in approximately 30
participants, and approximately 50 participants treated with the
doublet combination of tobevibart and elebsiran.
- The Company plans to share further data assessing a potential
functional cure in the second quarter of 2025.
Solid Tumors
- VIR-5818 is a dual-masked HER2-targeted T-cell engager in
clinical development designed to minimize off-tumor toxicity,
potentially allowing for higher doses and increased efficacy to
address the significant unmet needs of patients with HER2
expressing cancers.
- A Phase 1 basket study of VIR-5818 as a monotherapy, and in
combination with pembrolizumab, is on-going in multiple tumor
types, including metastatic breast cancer and metastatic colorectal
cancer.
- The Company plans to share initial clinical data for VIR-5818
in the first quarter of 2025.
- VIR-5500 is a dual-masked PSMA directed T-cell engager in
clinical development designed to minimize off-tumor toxicity and
potentially improve efficacy relative to the existing approved
PSMA-targeted therapies.
- A Phase 1 dose escalation study of VIR-5500 is ongoing to
assess its safety profile and optimal dose levels for future
development in metastatic-castration resistant prostate
cancer.
- The Company plans to share initial clinical data for VIR-5500
in the first quarter of 2025.
- VIR-5525 is a dual-masked EGFR targeted T-cell engager with a
cleared Investigational New Drug Application (IND) from the U.S.
FDA.
- The Company plans to initiate a Phase 1 basket study of
VIR-5525 in the first quarter of 2025 in patients across a number
of solid tumor indications of high unmet need, which may include
metastatic head and neck squamous cell carcinoma, metastatic
adenocarcinoma, squamous non-small cell lung cancer, and metastatic
colorectal cancer.
Preclinical Pipeline Candidates
- The Company continues to advance pre-clinical assets in
respiratory syncytial virus in partnership with GSK and pursue HIV
cure in collaboration with the Bill & Melinda Gates
Foundation.
Corporate Update
- On August 1, 2024 the Company announced an exclusive worldwide
license to three clinical-stage masked T-cell engagers (TCEs) with
potential applications in a range of cancers, as well as the
exclusive use of the proprietary PRO-XTEN™ masking platform for
oncology and infectious disease. The Company announced closing of
the agreement with Sanofi on September 9, 2024.
- Key employees from Sanofi, possessing extensive scientific and
development expertise in TCEs, and in-depth experience with the
PRO-XTEN™ platform, joined the Company following the closing of the
agreement.
- On August 1, 2024 the Company announced the phase-out of
clinical programs in influenza, COVID-19, and its T-cell based
viral vector platform. The Company is seeking partners to advance
these clinical programs through further development. Additionally,
the Company announced a workforce reduction of approximately 25%,
or approximately 140 employees, and expects to end 2024 with
approximately 435 employees – a decrease of approximately 200 from
its peak headcount in the second quarter of 2023.
- On September 10, 2024, the Company announced the appointment of
Jason O’Byrne as Executive Vice President and Chief Financial
Officer, effective October 2, 2024. Mr. O’Byrne is an accomplished
executive with more than 20 years of finance and operations
experience, and brings leadership in capital allocation and
formation, corporate strategy and operational excellence.
- The Company will host two virtual investor events instead of
the previously scheduled R&D Day in the fourth quarter of 2024.
The first event, focusing on our hepatitis programs, will be held
in November 2024, following the AASLD conference, and will provide
detailed updates on our hepatitis delta and hepatitis B programs.
In the first quarter of 2025, the Company will share initial
clinical data for our masked T-cell engager programs during a
second dedicated investor event.
Third Quarter 2024 Financial
Results
Cash, Cash Equivalents and Investments: As of September
30, 2024, the Company had approximately $1.19 billion in cash, cash
equivalents and investments, representing a decrease of
approximately $245.1 million during the third quarter of 2024. The
decrease includes a $103.7 million upfront payment made to Sanofi
upon the closing of the agreement and a $75.0 million escrowed
milestone payment reclassified to restricted cash. The escrowed
milestone is subject to VIR-5525 achieving "first in human dosing"
by 2026. Excluding the impact of the Sanofi agreement, the decrease
in cash, cash equivalents and investments in the third quarter was
approximately $66.4 million.
Revenues: Total revenues for the quarter ended September
30, 2024, were $2.4 million compared to $2.6 million for the same
period in 2023.
Cost of Revenue: Cost of revenue was nominal for the
third quarter of 2024 and 2023.
Research and Development Expenses (R&D): R&D
expenses for the third quarter of 2024 were $195.2 million, which
included $8.9 million of non-cash stock-based compensation expense,
compared to $145.0 million for the same period in 2023, which
included $15.8 million of non-cash stock-based compensation
expense. The increase was primarily driven by $102.8 million of the
Sanofi upfront payment being recognized as in-process research and
development expense, partially offset by lower clinical development
costs and manufacturing costs associated with the discontinued flu
asset, VIR-2482.
Selling, General and Administrative Expenses (SG&A):
SG&A expenses for the third quarter of 2024 were $25.7 million,
which included $7.8 million of non-cash stock-based compensation
expense, compared to $40.9 million for the same period in 2023,
which included $11.1 million of non-cash stock-based compensation
expense. The decrease was largely related to cost savings
initiatives implemented during the second half of 2023.
Restructuring, long-lived assets impairment and related
charges: Restructuring, long-lived assets impairment and
related charges for the third quarter of 2024 were $12.7 million
compared to $3.4 million for the same period in 2023. The increase
was primarily driven by severance charges incurred related to our
strategic restructuring announcement in August 2024 and to a lesser
extent right-of-use asset impairment charges related to the closing
of our Portland, Oregon facility, which was previously announced on
December 13, 2023.
Other Income: Other income for the third quarter of 2024
was $17.8 million compared to $20.1 million for the same period in
2023. The decrease was primarily due to lower interest income.
(Provision for) Benefit from Income Taxes: Provision for
income taxes for the third quarter of 2024 was $0.2 million
compared to a benefit from income taxes of $3.2 million for the
same period in 2023.
Net Loss: Net loss attributable to Vir for the third
quarter of 2024 was $(213.7) million, or $(1.56) per share, basic
and diluted, compared to a net loss of $(163.4) million, or $(1.22)
per share, basic and diluted for the same period in 2023.
2024
Financial Guidance
The Company has updated its operating expense guidance for the
full-year 2024, which includes the upfront in-process research and
development expense associated with the clinical-stage T-cell
engagers licensed through its agreement with Sanofi:
(in $ millions)
GAAP operating expense range:
$
660
to
$
680
The following expenses are included in the
GAAP operating expense range:
Upfront payment to Sanofi recognized as
R&D expense in the third quarter of 2024
$103
Stock-based compensation expense
$
90
to
$
80
Restructuring charges*
$
40
to
$
30
* Restructuring charges include employee
severance cash payouts, as well as non-cash expense related to the
closing of two R&D sites previously announced on December 13,
2023.
The GAAP operating 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 third 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 (VIR-3434)
Tobevibart is an investigational broadly neutralizing monoclonal
antibody targeting the hepatitis B surface antigen. 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, which incorporates
Xencor’s Xtend™ and other Fc technologies, has been engineered to
have an extended half-life and was identified using Vir’s
proprietary monoclonal antibody discovery platform. Tobevibart is
administered subcutaneously, and it is currently in clinical
development for treatment of patients with chronic hepatitis B and
patients with chronic hepatitis delta.
About Elebsiran (VIR-2218)
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
treatment of patients with chronic hepatitis B and patients with
chronic hepatitis delta. It is the first asset in Vir’s
collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical
studies.
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 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 also helps drug
candidates stay in the bloodstream longer in their inactive form,
allowing them to better reach the site of action and potentially
allowing more convenient dosing regimens for patients and
clinicians.
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. Vir’s clinical-stage portfolio includes
infectious disease programs for chronic hepatitis delta and chronic
hepatitis B infections, in addition to programs across several
clinically validated targets in solid tumor indications. Vir also
has a preclinical portfolio of programs across a range of other
infectious diseases and oncologic malignancies. 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 “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. 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 cash balance; Vir’s future
financial and operating results and its expectations related
thereto including Vir’s financial guidance; Vir’s ability to
realize the anticipated benefits from the exclusive worldwide
license agreement with Sanofi; potential of, and expectations for,
Vir’s pipeline; Vir’s clinical and preclinical development
programs; clinical studies, including the enrollment of clinical
studies, and the expected timing of data readouts and
presentations; the potential benefits, safety, and efficacy of
Vir’s investigational therapies; Vir’s strategy and plans; and
risks and uncertainties associated with drug development and
commercialization. Many factors may cause differences between
current expectations and actual results, including whether or when
anticipated cost reductions will be achieved; unexpected safety or
efficacy data or results observed during clinical studies or in
data readouts; the occurrence of adverse safety events; risks of
unexpected costs, delays or other unexpected hurdles; difficulties
in collaborating with other companies; 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 studies due to
geopolitical changes or other external factors; failure to achieve
any necessary regulatory approvals; the timing and amount of actual
expenses, including, without limitation, Vir’s anticipated combined
GAAP R&D and SG&A expenses; 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 studies may not be indicative of
full results or results from later stage or larger scale clinical
studies 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.
PRO-XTEN™ is a trademark of Amunix Pharmaceuticals, Inc., a
Sanofi company.
VIR BIOTECHNOLOGY,
INC.
Condensed Consolidated Balance
Sheets
(in thousands, except share
and per share data)
(unaudited)
September 30,
2024
December 31,
2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
168,350
$
241,576
Short-term investments
740,607
1,270,980
Restricted cash and cash equivalents,
current
89,598
13,268
Equity investments
5,517
9,853
Prepaid expenses and other current
assets
43,085
52,549
Total current assets
1,047,157
1,588,226
Intangible assets, net
19,258
22,565
Goodwill
16,938
16,937
Property and equipment, net
64,791
96,018
Operating lease right-of-use assets
60,779
71,182
Restricted cash and cash equivalents,
noncurrent
6,382
6,448
Long-term investments
271,495
105,275
Other assets
11,556
12,409
TOTAL ASSETS
$
1,498,356
$
1,919,060
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES:
Accounts payable
$
7,305
$
6,334
Accrued and other liabilities
94,658
104,220
Deferred revenue, current
15,198
64,853
Total current liabilities
117,161
175,407
Operating lease liabilities,
noncurrent
93,405
111,673
Contingent consideration, noncurrent
33,170
25,960
Other long-term liabilities
13,893
15,784
TOTAL LIABILITIES
257,629
328,824
Commitments and contingencies (Note 8)
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.0001 par value;
10,000,000 shares authorized as of September 30, 2024 and December
31, 2023; no shares issued and outstanding as of September 30, 2024
and December 31, 2023
—
—
Common stock, $0.0001 par value;
300,000,000 shares authorized as of September 30, 2024 and December
31, 2023; 136,706,350 and 134,781,286 shares issued and outstanding
as of September 30, 2024 and December 31, 2023, respectively
14
13
Additional paid-in capital
1,894,781
1,828,862
Accumulated other comprehensive gain
(loss)
1,127
(815
)
Accumulated deficit
(655,195
)
(237,824
)
TOTAL STOCKHOLDERS’ EQUITY
1,240,727
1,590,236
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
1,498,356
$
1,919,060
VIR BIOTECHNOLOGY,
INC.
Condensed Consolidated
Statements of Operations
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
September 30,
2024
2023
Revenues:
Collaboration revenue
$
(1,102
)
$
(4,387
)
Contract revenue
1,391
289
Grant revenue
2,091
6,737
Total revenues
2,380
2,639
Operating expenses:
Cost of revenue
50
38
Research and development
195,178
145,028
Selling, general and administrative
25,744
40,933
Restructuring, long-lived assets
impairment and related charges
12,712
3,372
Total operating expenses
233,684
189,371
Loss from operations
(231,304
)
(186,732
)
Other income:
Change in fair value of equity
investments
1,130
(2,707
)
Interest income
17,527
21,931
Other (expense) income, net
(893
)
882
Total other income
17,764
20,106
Loss before (provision for) benefit from
income taxes
(213,540
)
(166,626
)
(Provision for) benefit from income
taxes
(177
)
3,213
Net loss
(213,717
)
(163,413
)
Net loss attributable to noncontrolling
interest
—
—
Net loss attributable to Vir
$
(213,717
)
$
(163,413
)
Net loss per share attributable to Vir,
basic and diluted
$
(1.56
)
$
(1.22
)
Weighted-average shares outstanding, basic
and diluted
136,653,753
134,289,620
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241031806056/en/
Media Arran Attridge Senior Vice President, Corporate
Communications aattridge@vir.bio
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio
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