Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results
Key Terms
t-cell engager medical
monoclonal antibody (mab) medical
small interfering rna (sirna) medical
hdv rna target not detected, tnd medical
metastatic castration-resistant prostate cancer (mcrpc) medical
metastatic hormone-sensitive prostate cancer (mhspc) medical
phase 3 registrational program medical
– Announces 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
– Reports updated VIR-5500 Phase 1 dose-escalation data supporting a favorable safety profile and promising anti-tumor activity
– Strong financial position with
– Conference call scheduled for February 23, 2026, at 5:30 p.m. ET / 2:30 p.m. PT
“This is a seminal moment for Vir Biotechnology, marked by key high-potential partnerships on two of our programs showcasing the strength of our pipeline and technology platforms. Today, we announced a global strategic collaboration with Astellas and compelling new Phase 1 data for VIR-5500, demonstrating the potential for our PRO-XTEN® masked TCEs to play a transformative role in oncology and impact the lives of people living with hard-to-treat cancers,” said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. “Additionally, our licensing agreement with Norgine signed in December 2025, for the combination of tobevibart and elebsiran for the treatment of hepatitis delta, positions us to reach patients worldwide who face hepatitis delta, the most severe form of chronic viral hepatitis. Together, these milestones reflect how we are unlocking meaningful value in our pipeline and expanding the reach of our potential therapies.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
-
To support global commercialization of the combination of tobevibart, an investigational neutralizing monoclonal antibody (mAb), and elebsiran, an investigational small interfering RNA (siRNA), for the treatment of CHD, the Company granted Norgine Pharma
UK Limited (Norgine) an exclusive commercial license inEurope ,Australia and New Zealand . -
Phase 2 SOLSTICE data presented at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference in January 2026 showed the combination of tobevibart and elebsiran is well tolerated and achieved undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) in
88% (21/24) of participants with CHD evaluable at Week 96 of treatment.- Previous positive Phase 2 SOLSTICE data at Week 48 were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 and simultaneously published in the New England Journal of Medicine.1
- Topline data from the 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.
Solid Tumors
VIR-5500
- The Company executed a global strategic collaboration with Astellas2 to advance PSMA-targeted PRO-XTEN® dual-masked TCE VIR-5500, currently in development for metastatic castration-resistant prostate cancer (mCRPC).
- Positive updated Phase 1 data for VIR-5500 monotherapy showed dose-dependent anti-tumor activity and a well-tolerated safety profile to date in patients with mCRPC. The data will be shared during the Company’s fourth quarter and full year conference call today and in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 (Oral Abstract #17). The oral presentation will be delivered by Dr. Johann de Bono, Principal Investigator and Director of the Drug Development Unit and Head of Prostate Cancer Targeted Therapy Group at the Institute of Cancer Research.
- Phase 1 monotherapy dose-escalation of weekly and once every three weeks dosing of VIR-5500 is complete, and the Company has defined a preliminary go-forward dose and regimen recommendation for expansion. In parallel, dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients.
- The Company anticipates initiating monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and metastatic hormone-sensitive prostate cancer (mHSPC) in the second quarter of 2026 followed by pivotal Phase 3 trials in 2027.
VIR-5818
- Phase 1 dose-escalation of VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, in combination with pembrolizumab continues, with response data expected in the second half of 2026.
VIR-5525
- The Phase 1 study of VIR-5525, an EGFR-targeted PRO-XTEN® dual-masked TCE, 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, including lung, colorectal and bladder.
Fourth Quarter and Full Year 2025 Financial Results
Cash, Cash Equivalents and Investments: As of December 31, 2025, the Company had approximately
Revenue: Revenue for the fourth quarter of 2025 was
Cost of Revenue: The change in cost of revenue for the fourth quarter and full year of 2025 compared to the same periods in 2024 was nominal.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were
The full year of 2025 R&D expenses include a
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2025 were
Restructuring, Long-Lived Assets Impairment and Related Charges: The decrease in restructuring, long-lived assets impairment and related charges for the fourth quarter and full year of 2025 was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.
Other Income: The decrease in other income for the fourth quarter and full year of 2025 was primarily driven by lower interest income. Additionally, the decrease in the full year was partially offset by lower unrealized loss from the Company’s equity investment.
Benefit from (Provision for) Income Taxes: The change in benefit from (provision for) income taxes for the fourth quarter and the full year of 2025 was nominal.
Net Loss: Net loss attributable to Vir Biotechnology for the fourth quarter of 2025 was
2026 Financial Guidance
Based on current operating plans, including the expected net effects of the Astellas global collaboration and the Astellas equity investment,2 the Company expects its cash, cash equivalents and investments to fund operations into the second quarter of 2028.
Conference Call
Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 5:30 p.m. ET / 2:30 p.m. PT today, when members of the executive team and Dr. de Bono will share the updated VIR-5500 Phase 1 data that is also being presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26. 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 tobevibart in combination with elebsiran 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 tobevibart in combination with elebsiran compared to deferred treatment in the
About Tobevibart and Elebsiran
Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and 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. Tobevibart is administered subcutaneously and is currently in clinical development for the treatment of patients with chronic hepatitis delta (CHD).
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. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously and is currently in clinical development for the treatment of patients with CHD.
About Chronic Hepatitis Delta (CHD)
CHD is the most severe form of chronic viral hepatitis3 and was recently classified as carcinogenic by the International Agency for Research on Cancer.4 People living with the disease rapidly progress to cirrhosis, liver failure5 and liver-related death.3 There are currently no approved treatments in the
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.
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 most common cancer diagnosis in men and the second leading cause of cancer-related mortality in men behind lung cancer.6 Despite diagnostic and therapeutic advances, patients with prostate cancer continue to face substantial unmet medical need. While androgen directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).7 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. While androgen-directed therapies have improved outcomes in mHSPC settings, the majority of these patients still eventually progress to metastatic castration-resistant prostate cancer (mCRPC).8 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately
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 portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Footnotes and references:
1 Asselah T, Chattergoon MA, Jucov A, et al. “A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D” N Engl J Med. vol. 394, no. 4 (2026), 343-353, doi:10.1056/NEJMoa2508827.
2 Closing of the Astellas global collaboration and Astellas equity investment is contingent on customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Act. Under the terms of Vir Biotechnology's licensing agreement with Sanofi, we will share with Sanofi
3 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov).
4 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.
5 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC.
6 Kratzer TB, et al. “Prostate cancer statistics, 2025.” CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028.
7 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.
8 Leith A, et al. “Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (
9 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.
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 collaboration with Astellas, including potential payments to be made to Vir Biotechnology under such collaboration; Vir Biotechnology’s future financial and operating results and its expectations related thereto, including Vir Biotechnology’s financial guidance; the therapeutic and commercial potential of Vir Biotechnology's chronic hepatitis delta program, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the therapeutic and commercial potential of VIR-5500 and the other assets in Vir Biotechnology's oncology solid tumor portfolio, preclinical pipeline and PRO-XTEN® masking technology, 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 plans and expectations for its clinical development 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; 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
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
VIR BIOTECHNOLOGY, INC. Consolidated Balance Sheets (in thousands, except share and per share data) (unaudited) |
|||||||
|
December 31, |
||||||
|
|
2025 |
|
|
|
2024 |
|
ASSETS |
|
|
|
||||
CURRENT ASSETS: |
|
|
|
||||
Cash and cash equivalents |
$ |
232,185 |
|
|
$ |
222,947 |
|
Short-term investments |
|
228,753 |
|
|
|
678,051 |
|
Restricted cash and cash equivalents, current |
|
1,922 |
|
|
|
89,385 |
|
Equity investments |
|
6,077 |
|
|
|
4,350 |
|
Prepaid expenses and other current assets |
|
45,143 |
|
|
|
47,725 |
|
Total current assets |
|
514,080 |
|
|
|
1,042,458 |
|
Intangible assets, net |
|
7,850 |
|
|
|
8,120 |
|
Goodwill |
|
16,937 |
|
|
|
16,937 |
|
Property and equipment, net |
|
55,620 |
|
|
|
63,183 |
|
Operating right-of-use assets |
|
62,099 |
|
|
|
59,680 |
|
Restricted cash and cash equivalents, noncurrent |
|
6,963 |
|
|
|
6,363 |
|
Long-term investments |
|
314,575 |
|
|
|
190,015 |
|
Other assets |
|
24,699 |
|
|
|
12,057 |
|
TOTAL ASSETS |
$ |
1,002,823 |
|
|
$ |
1,398,813 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||||
CURRENT LIABILITIES: |
|
|
|
||||
Accounts payable |
$ |
9,803 |
|
|
$ |
5,081 |
|
Accrued and other liabilities |
|
83,012 |
|
|
|
98,521 |
|
Contingent consideration obligation, current |
|
— |
|
|
|
16,060 |
|
Total current liabilities |
|
92,815 |
|
|
|
119,662 |
|
Operating lease liabilities, noncurrent |
|
89,054 |
|
|
|
90,139 |
|
Contingent consideration obligation, noncurrent |
|
34,100 |
|
|
|
24,050 |
|
Other long-term liabilities |
|
21,578 |
|
|
|
14,577 |
|
TOTAL LIABILITIES |
|
237,547 |
|
|
|
248,428 |
|
Commitments and contingencies |
|
|
|
||||
STOCKHOLDERS’ EQUITY: |
|
|
|
||||
Preferred stock, |
|
— |
|
|
|
— |
|
Common stock, |
|
14 |
|
|
|
14 |
|
Additional paid-in capital |
|
1,965,090 |
|
|
|
1,911,872 |
|
Accumulated other comprehensive loss |
|
(2,057 |
) |
|
|
(1,717 |
) |
Accumulated deficit |
|
(1,197,771 |
) |
|
|
(759,784 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
765,276 |
|
|
|
1,150,385 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
1,002,823 |
|
|
$ |
1,398,813 |
|
VIR BIOTECHNOLOGY, INC. Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) |
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Three Months Ended December 31, |
|
Year Ended December 31, |
||||||||||||
|
|
2025 |
|
|
|
2024 |
|
|
|
2025 |
|
|
|
2024 |
|
Revenues: |
|
|
|
|
|
|
|
||||||||
License and collaboration revenue |
$ |
63,760 |
|
|
$ |
10,589 |
|
|
$ |
63,130 |
|
|
$ |
61,370 |
|
Grant revenue |
|
310 |
|
|
|
1,096 |
|
|
|
2,036 |
|
|
|
10,493 |
|
Other revenue |
|
— |
|
|
|
689 |
|
|
|
3,390 |
|
|
|
2,342 |
|
Total revenues |
|
64,070 |
|
|
|
12,374 |
|
|
|
68,556 |
|
|
|
74,205 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Cost of revenue |
|
26 |
|
|
|
684 |
|
|
|
26 |
|
|
|
845 |
|
Research and development |
|
88,349 |
|
|
|
106,083 |
|
|
|
455,966 |
|
|
|
506,499 |
|
Selling, general and administrative |
|
23,616 |
|
|
|
26,701 |
|
|
|
92,074 |
|
|
|
119,031 |
|
Restructuring, long-lived assets impairment and related charges, net |
|
— |
|
|
|
(3,944 |
) |
|
|
(182 |
) |
|
|
34,995 |
|
Total operating expenses |
|
111,991 |
|
|
|
129,524 |
|
|
|
547,884 |
|
|
|
661,370 |
|
Loss from operations |
|
(47,921 |
) |
|
|
(117,150 |
) |
|
|
(479,328 |
) |
|
|
(587,165 |
) |
Other income: |
|
|
|
|
|
|
|
||||||||
Change in fair value of equity investments |
|
(2,606 |
) |
|
|
(1,172 |
) |
|
|
1,729 |
|
|
|
(5,528 |
) |
Interest income |
|
7,802 |
|
|
|
14,153 |
|
|
|
40,238 |
|
|
|
71,809 |
|
Other expense, net |
|
(335 |
) |
|
|
(506 |
) |
|
|
(409 |
) |
|
|
(2,221 |
) |
Total other income |
|
4,861 |
|
|
|
12,475 |
|
|
|
41,558 |
|
|
|
64,060 |
|
Loss before benefit from (provision for) income taxes |
|
(43,060 |
) |
|
|
(104,675 |
) |
|
|
(437,770 |
) |
|
|
(523,105 |
) |
Benefit from (Provision for) income taxes |
|
137 |
|
|
|
86 |
|
|
|
(217 |
) |
|
|
1,145 |
|
Net loss |
$ |
(42,923 |
) |
|
$ |
(104,589 |
) |
|
$ |
(437,987 |
) |
|
$ |
(521,960 |
) |
Net loss per share, basic and diluted |
$ |
(0.31 |
) |
|
$ |
(0.76 |
) |
|
$ |
(3.16 |
) |
|
$ |
(3.83 |
) |
Weighted-average shares outstanding, basic and diluted |
|
139,232,143 |
|
|
|
136,808,690 |
|
|
|
138,520,419 |
|
|
|
136,246,865 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20260222469334/en/
Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio
Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
Source: Vir Biotechnology, Inc.