Vir Biotechnology Provides Corporate Update and Reports Second Quarter 2026 Financial Results

• Phase 2 SOLSTICE data presented at the EASL Congress showed that elebsiran and tobevibart achieved undetectable HDV RNA in 88% of participants with chronic hepatitis delta (CHD) at Week 96 of treatment

- Topline data from Phase 3 ECLIPSE 1 trial expected in the fourth quarter of 2026

- Closed global strategic collaboration with Astellas and initiated additional VIR-5500 Phase 1 monotherapy and combination therapy dose-expansion cohorts in patients with metastatic prostate cancer

- Ended quarter with over $1.0 billion in cash, cash equivalents and investments

- Conference call scheduled for August 5, 2026, at 4:30 p.m. ET / 1:30 p.m. PT

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR), today provided a corporate update and reported financial results for the second quarter ended June 30, 2026.

“This is a pivotal time for the CHD community, when availability of new therapies could improve awareness, testing and access to care. At EASL, experts emphasized that achieving durable suppression of hepatitis delta virus to undetectable levels is a key predictor of improved clinical outcomes for people with CHD. Our Week 96 SOLSTICE results demonstrate the potential of our dual-acting elebsiran and tobevibart combination regimen to rapidly achieve undetectable virus in most patients and raise the bar for treatment of this devastating condition,” said Marianne De Backer, Chief Executive Officer of Vir Biotechnology. "Beyond CHD, we remain focused on rapid execution of our joint clinical program with Astellas in prostate cancer and have initiated monotherapy and combination therapy dose-expansion cohorts in our VIR-5500 Phase 1 study that will help inform pivotal trial design."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

• The Company completed enrollment in the Phase 3 ECLIPSE 2 trial, and the entire ECLIPSE registrational program is now fully enrolled. ECLIPSE 2 evaluates the efficacy and safety of switching from bulevirtide to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy and is intended support medication transitions as appropriate. These data, along with data from ECLIPSE 1 and 3, will be part of a comprehensive global filing package. Topline data from the Phase 3 ECLIPSE 1 trial are expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.
• The Company presented complete Week 96 Phase 2 SOLSTICE data at the European Association for the Study of the Liver (EASL) Congress in May 2026. In the intent-to-treat (ITT) analysis, the data showed 88% (28/32) of participants treated with the combination of elebsiran and tobevibart achieved undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) compared to 53% (17/32) of participants on antibody monotherapy. In the last observation carried forward analysis, the data showed the combination regimen achieved HDV RNA TND in 97% (31/32) of participants. The combination regimen continues to be generally well tolerated. Treatment-emergent adverse events were generally mild to moderate and transient, and there were no treatment-related serious adverse events or discontinuations.

Solid Tumors

VIR-5500

• The Company closed its global strategic collaboration with Astellas to advance PSMA-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) VIR-5500 for the treatment of prostate cancer. The companies have built a strong operational infrastructure for collaboration and rapidly worked together on Phase 1 trial design to advance the dose-expansion cohorts.
• The Company initiated additional Phase 1 dose-expansion cohorts evaluating VIR-5500 at Q3W 800/2000/3500 µg/kg step-up dosing. The first patients were dosed in three monotherapy cohorts evaluating VIR-5500 in taxane naïve metastatic castration-resistant prostate cancer (mCRPC), radioligand therapy naïve mCRPC and radioligand therapy exposed mCRPC, and one combination cohort evaluating VIR-5500 in combination with enzalutamide in early-line mCRPC.
• The Company anticipates initiating two additional Phase 1 dose-expansion cohorts, including VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone-sensitive prostate cancer.
• The Company anticipates initiating pivotal Phase 3 trials in 2027.

VIR-5818

• The Company expects to report updated dose-escalation data from its Phase 1 trial evaluating VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, as a monotherapy and in combination with pembrolizumab, in the second half of 2026. The dose-escalation parts of the Phase 1 trial have a basket design, enrolling across multiple tumor types.

VIR-5525

• The Phase 1 trial of VIR-5525, an EGFR-targeted PRO-XTEN® dual-masked TCE, as a monotherapy and in combination with pembrolizumab continues enrollment as expected.

Preclinical Pipeline Candidates

• The Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors.

Corporate Update

• The Company appointed Timothy Coughlin, CPA to its Board of Directors and as Chair of the Audit Committee.

Second Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2026, the Company had approximately $1.01 billion in cash, cash equivalents and investments, representing an increase of approximately $198.5 million during the second quarter of 2026. During the second quarter of 2026, the Company received a $240.0 million upfront payment and a $75 million equity investment payment from Astellas and made a $48.0 million pass-through payment to Sanofi.

Revenues: Total revenues for the second quarter of 2026 were $238.9 million, primarily reflecting license and collaboration revenue recognized in connection with the $240.0 million upfront payment received from Astellas in the quarter.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $135.3 million, which included $5.5 million of non-cash stock-based compensation expense, compared to $97.5 million for the same period in 2025, which included $6.9 million of non-cash stock-based compensation expense. The increase was primarily driven by a $48.0 million milestone payment to Sanofi triggered by the closing of our agreement with Astellas, as well as higher CHD contract manufacturing costs associated with process performance qualification batches in preparation for commercialization.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2026 were $30.2 million, which included $6.9 million of non-cash stock-based compensation expense, compared to $22.3 million for the same period in 2025, which included $5.5 million of non-cash stock-based compensation expense. The increase was primarily due to one-time advisory and legal fees in connection with the closing of our Astellas agreement.

Net Income (Loss): Net income for the second quarter of 2026 was $80.1 million, or $0.48 per share, basic and $0.47 per share, diluted, compared to a net loss of $111.0 million, or $0.80 per share, basic and diluted for the same period in 2025. The change from net loss to net income was primarily driven by $238.9 million in license and collaboration revenue recognized this quarter from the $240.0 million Astellas upfront payment.

2026 Financial Guidance

Based on our current operating plans, including the net effects of the Astellas global collaboration, the Company expects its cash, cash equivalents and investments to fund operations into the second half of 2028.

Conference Call

Vir Biotechnology will host its second quarter 2026 financial results conference call at 4:30 p.m. ET / 1:30 p.m. PT today. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days.

About the ECLIPSE Registrational Program

ECLIPSE is a registrational program to evaluate the safety and efficacy of elebsiran in combination with tobevibart in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of elebsiran in combination with tobevibart compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination elebsiran and tobevibart compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets.

About Elebsiran and Tobevibart

Elebsiran and tobevibart are investigational agents being evaluated as a novel combination regimen administered monthly as two separate sequential subcutaneous injections for the treatment of chronic hepatitis delta (CHD). The combination is designed to disrupt the hepatitis delta virus (HDV) life cycle at multiple points by addressing both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg.

Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting 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 mAb 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.

About Chronic Hepatitis Delta (CHD)

CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 Because ongoing hepatitis delta virus (HDV) replication drives disease progression, achieving undetectable virus, as defined by HDV RNA TND (target not detected), is considered an important virologic marker associated with improved clinical outcomes in CHD.4 Individuals with CHD who have detectable HDV RNA are at a higher risk of experiencing any liver-related event, including developing compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and mortality, compared to patients with undetectable HDV RNA.4 There are currently limited approved treatments in the U.S. and globally.

About VIR-5500, VIR-5818 and VIR-5525

VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN® masking technology and target PSMA, HER2 and EGFR, respectively.

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal 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 T-cells. By confining the activity 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 Advanced Prostate Cancer

Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.5 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).6 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).7 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.8 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.

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 programs for chronic hepatitis delta and multiple PRO-XTEN® 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.

References:

1 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov). 2 Karagas, Margaret R et al., “Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus” The Lancet Oncology, vol. 26, no. 8 (2025): 994 – 995. doi: 10.1016/S1470-2045(25)00403-6. 3 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC. 4 Gish R. (2024). Association of hepatitis delta virus with liver morbidity and mortality: A systematic literature review and meta-analysis. Hepatology. 79:1129-1140. 5 Kratzer TB, et. al. “Prostate cancer statistics, 2025.” CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028. 6 Bernard-Terrier A & Beltran H. “Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine.” J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920. 7 Leith A, et. al. “Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan.” Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w. 8 Huo, X et al. “Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram.” Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070.

VIR BIOTECHNOLOGY, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (unaudited)

June 30, 2026

December 31, 2025

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$

278,729

$

232,185

Short-term investments

249,864

228,753

Restricted cash and cash equivalents, current

1,929

1,922

Equity investments

4,133

6,077

Prepaid expenses and other current assets

39,084

45,143

Total current assets

573,739

514,080

Intangible assets, net

7,702

7,850

Goodwill

16,937

16,937

Property and equipment, net

50,430

55,620

Operating right-of-use assets

59,391

62,099

Restricted cash and cash equivalents, noncurrent

6,944

6,963

Long-term investments

475,016

314,575

Other assets

24,647

24,699

TOTAL ASSETS

$

1,214,806

$

1,002,823

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES:

Accounts payable

$

17,754

$

9,803

Accrued and other liabilities

77,207

83,012

Total current liabilities

94,961

92,815

Operating lease liabilities, noncurrent

84,137

89,054

Contingent consideration obligation, noncurrent

34,340

34,100

Other long-term liabilities

18,875

21,578

TOTAL LIABILITIES

232,313

237,547

Commitments and contingencies (Note 7)

STOCKHOLDERS’ EQUITY:

Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2026 and December 31, 2025; no shares issued and outstanding as of June 30, 2026 and December 31, 2025

—

—

Common stock, $0.0001 par value; 300,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 169,185,671 and 139,474,954 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

17

14

Additional paid-in capital

2,230,464

1,965,090

Accumulated other comprehensive loss

(4,602

)

(2,057

)

Accumulated deficit

(1,243,386

)

(1,197,771

)

TOTAL STOCKHOLDERS’ EQUITY

982,493

765,276

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

1,214,806

$

1,002,823

VIR BIOTECHNOLOGY, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited)

Three Months Ended June 30,

2026

2025

Revenues:

License and collaboration revenue

$

238,935

$

(495

)

Grant revenue

11

183

Other revenue

—

1,526

Total revenues

238,946

1,214

Operating expenses:

Cost of revenue

—

11

Research and development

135,283

97,509

Selling, general and administrative

30,196

22,283

Restructuring, long-lived assets impairment and related charges, net

—

(172

)

Total operating expenses

165,479

119,631

Income (loss) from operations

73,467

(118,417

)

Other income:

Change in fair value of equity investments

(1,723

)

(3,382

)

Interest income

8,966

10,785

Other (expense) income, net

(451

)

226

Total other income

6,792

7,629

Income (loss) before provision for income taxes

80,259

(110,788

)

Provision for income taxes

(179

)

(170

)

Net income (loss)

$

80,080

$

(110,958

)

Net income (loss) per share, basic

$

0.48

$

(0.80

)

Net income (loss) per share, diluted

$

0.47

$

(0.80

)

Weighted-average shares outstanding, basic

167,719,015

138,447,469

Weighted-average shares outstanding, diluted

168,879,127

138,447,469

Contacts

Media Contact

Caren Scannell Director, Communications [email protected]

Investor Contact

Kiki Patel, PharmD Head of Investor Relations [email protected]

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