Vir Biotechnology (NASDAQ:VIR) expects to report the first phase 3 results for its experimental hepatitis delta treatment in the fourth quarter of 2026, with data from two additional studies due in the first quarter of 2027, executives said on the company’s third-quarter earnings call.
The company is also preparing for potential late-stage studies of its prostate cancer treatment VIR-5500 with partner Astellas, while a new research collaboration with Gilead has added funding for its oncology work.
Vir ended the third quarter with $901 million in cash, cash equivalents and investments. Chief Financial Officer Aziz Sawaf said the balance did not include $90 million received in October under the Gilead agreement. Based on its current operating plan, the company expects its cash to fund operations into the second half of 2028.
Hepatitis delta data expected over coming quarters
Vir’s phase 3 hepatitis delta program is evaluating a combination of elebsiran and tobevibart. President and Chief Executive Officer Marianne De Backer said the ECLIPSE 1 study, which enrolled about 120 treatment-naïve patients, will be the first of the three trials to report top-line data.
ECLIPSE 1 compares monthly injections of the combination with deferred treatment. Its primary endpoint measures the proportion of patients who have both undetectable hepatitis delta virus RNA and normalized ALT, a liver enzyme, after 48 weeks. De Backer said the top-line disclosure will also include information on secondary endpoints, patients with cirrhosis, and safety and tolerability.
Results from ECLIPSE 2 and ECLIPSE 3 are expected in the first quarter of 2027. ECLIPSE 2 enrolled approximately 150 patients who had an inadequate response to bulevirtide and examines whether switching to Vir’s combination can produce undetectable viral RNA at 24 weeks. ECLIPSE 3 enrolled approximately 100 treatment-naïve patients and compares the combination directly with bulevirtide at 48 weeks.
De Backer cited earlier phase 2 SOLSTICE results showing undetectable viral RNA in approximately 66% of patients after 48 weeks. She said Vir would present expanded 96-week SOLSTICE results at the American Association for the Study of Liver Diseases meeting. The company also is exploring finite treatment in ECLIPSE 2 and ECLIPSE 3, though she did not provide details of that analysis.
Asked about commercial preparations, De Backer said Vir has conducted research with healthcare professionals and payers and examined diagnosis and distribution options, including home administration. She said hepatitis delta RNA testing had increased following the launch of Gilead’s Hepcludex earlier in 2026.
Prostate cancer program moves toward pivotal trials
Vir and Astellas have concluded that VIR-5500, an experimental T-cell engager targeting PSMA, has achieved proof of concept, De Backer said. The Food and Drug Administration also granted the treatment fast-track designation for late-line metastatic castration-resistant prostate cancer.
The proof-of-concept assessment considered clinical efficacy, safety, pharmacology and biomarker data, De Backer said, but she declined to disclose the specific criteria or provide updated response-duration results. Vir and Astellas aim to start multiple phase 3 studies in early- and late-line settings in 2027 and plan to share more about trial designs next year.
VIR-5500 is being studied in a phase 1 trial as a standalone treatment and in combination across six dose-expansion cohorts. The companies are also working on manufacturing readiness.
Vir has refined its phase 1 study of VIR-5818, a HER2-targeted T-cell engager, after FDA feedback on its monotherapy arm. The company plans to add backfill cohorts with a more homogeneous patient population to help determine the optimal dose and schedule. Vir had previously expected to provide a data update in 2026 but now anticipates presenting an update at a future scientific conference.
A third oncology candidate, the EGFR-targeted VIR-5525, remains in dose escalation as both a monotherapy and in combination with pembrolizumab, De Backer said. Vir plans to discuss its broader immuno-oncology strategy at a virtual investor event in the first quarter of 2027.
Gilead deal and quarterly spending
Under the preclinical collaboration with Gilead, Vir is responsible for discovering, designing and optimizing three masked T-cell engager candidates for solid tumors. Gilead has the exclusive right to advance candidates from the collaboration and will be responsible for subsequent development, manufacturing and commercialization.
Sawaf said the $90 million received consisted of a $65 million upfront payment and a $25 million equity investment at a 30% premium. Vir is eligible for up to $45 million in near-term preclinical milestones and up to $1.74 billion in additional development, regulatory and commercial milestones, plus tiered royalties ranging from high single digits to low double digits. He said a 20% pass-through arrangement with Sanofi had expired before the agreement, so none of the collaboration’s milestone payments will be shared with Sanofi.
Third-quarter research and development expense fell to $80 million from $151 million a year earlier, primarily because the prior-year period included a one-time $75 million milestone payment related to VIR-5525. Selling, general and administrative expense rose to $24 million from $22 million, primarily because of higher advisory and legal fees.
About Vir Biotechnology (NASDAQ:VIR)
Vir Biotechnology, Inc is a clinical-stage immunology company focused on developing medicines to prevent and treat serious infectious diseases and other immune-related conditions. The company uses antibody engineering, immunologic approaches and other technologies to identify and advance therapies designed to harness or modify the immune system.
Vir’s research and development programs have included treatments and vaccines for hepatitis B, human immunodeficiency virus (HIV), influenza and other infectious diseases.
