Vir Biotechnology outlines accelerated hepatitis delta milestones and cash runway into mid-2027 as ECLIPSE 1 completes enrollment early

Earnings Call Insights: Vir Biotechnology, Inc. (VIR) Q3 2025

MANAGEMENT VIEW

* CEO Marianne De Backer highlighted the completion of enrollment in ECLIPSE 1, Vir’s first registrational Phase III study for hepatitis delta, ahead of internal projections. She indicated that "we now expect primary completion in the fourth quarter of 2026, with top line data for all 3 ECLIPSE studies expected by the first quarter of 2027." De Backer noted upcoming data presentations, including a comprehensive update for VIR-5500 in the first quarter of 2026 and the 48-week SOLSTICE data at AASLD. She emphasized, "we ended the third quarter with approximately $810.7 million in cash, cash equivalents and investments. Based on our current operating plan, we continue to project our cash runway extending into mid-2027."
* CFO Jason O’Byrne stated, "R&D expense for the third quarter of 2025 was $151.5 million, which included $5.5 million of noncash stock-based compensation and a $75 million milestone payment triggered by first-in-human dosing of VIR-5525." He reported operating expenses of $173.7 million and a net loss of $163.1 million for the quarter, attributing the year-over-year decrease in expenses to "lower license expense and cost savings from previously announced restructuring initiatives, partially offset by increased clinical development expenses."
* Chief Medical Officer Mark Eisner described the acceleration in ECLIPSE 1 enrollment, achieved "approximately 2 months ahead of our aggressive internal enrollment assumptions," and underscored the robust progress of ECLIPSE 2 and ECLIPSE 3. Eisner detailed advancing dose escalation for T-cell engager programs across multiple tumor types and reinforced the strategic focus on the PRO-XTEN universal masking platform.

OUTLOOK

* De Backer guided that a comprehensive data update for VIR-5500 is planned for the first quarter of 2026. She confirmed that top line data for all three ECLIPSE studies is expected by the first quarter of 2027. ECLIPSE 1 primary completion is expected in the fourth quarter of 2026. Eisner stated, "we expect primary completion by year-end 2026 with top line data expected in the first quarter of 2027" for ECLIPSE 2, and said ECLIPSE 3 is "tracking toward a similar completion time line as ECLIPSE 1 and 2."
* Management reiterated that their cash runway is projected into mid-2027 based on the current operating plan.

FINANCIAL RESULTS

* O’Byrne reported R&D expense of $151.5 million for Q3 2025, including a $75 million milestone payment, and SG&A expense of $22.2 million. Operating expenses totaled $173.7 million, reflecting a $46.2 million decrease from the same period in 2024. Net loss for the quarter was $163.1 million. O’Byrne clarified, "disbursements from restricted cash accounts do not affect our projected cash runway."
* Vir ended the quarter with $810.7 million in cash, cash equivalents, and investments. The net change in cash and investments in the third quarter was $81.4 million.

Q&A

* Kun Wang, Barclays: Asked about differentiation of the PSMA asset and clinical bar for the HDV Phase III readout. De Backer responded that a comprehensive data update for VIR-5500 will be provided in Q1 2026, with Eisner elaborating on the dual-masking approach and expectations for "exceptional efficacy in terms of the virologic outcomes" for HDV.
* Rohit Bhasin, Morgan Stanley: Inquired about timing of the VIR-5500 data and focus areas for the AASLD presentation. Eisner indicated the Q1 update timing is to be determined and highlighted the 48-week SOLSTICE data as a key update.
* Kyuwon Choi, Goldman Sachs: Asked if the Q1 2026 VIR-5500 update would include ARPI combination data and about the impact of Gilead's bulevirtide. De Backer clarified that frontline mCRPC combination data will not be in the Q1 2026 update. Eisner viewed Gilead’s launch as a positive catalyst for awareness and testing.
* Mario Joshua Chazaro Cortes, Evercore ISI: Asked about maximum tolerated dose for VIR-5500 and Grade 3 CRS events. Eisner stated he was "not really prepared to share any further details about dose escalation or results today."
* Ellen Horste, TD Cowen: Inquired about prioritization of TCE programs. De Backer said capital allocation is focused on the hepatitis delta registrational study and accelerating VIR-5500, with other programs "gated based on data."
* Sean McCutcheon, Raymond James: Queried about optimal settings for TCE in prostate cancer. Eisner confirmed dose escalation is ongoing in late-line patients and that future positioning will be data-driven.
* Joseph Stringer, Needham: Asked about the relevance of hep B surface antigen reduction. Eisner said, "we can reduce hepatitis B surface antigen levels by about 3 logs...we do think that is important and differentiating."
* Patrick Trucchio, H.C. Wainwright: Sought clarification on the addressable U.S. HDV patient population. Eisner estimated the potential reach is broad, "approximately 60,000 patients in the U.S. who are viremic with HDV."

SENTIMENT ANALYSIS

* Analysts posed probing and technical questions regarding product differentiation, clinical benchmarks, and competitive positioning, reflecting a neutral to slightly positive tone with focus on future data catalysts and commercial opportunity.
* Management maintained a confident tone in both prepared remarks and Q&A, repeatedly emphasizing acceleration, strong execution, and broad opportunity. De Backer and Eisner consistently referenced operational excellence and strategic positioning, with statements such as "we are enthusiastic about this program" and reinforcement of financial runway.
* Compared to the previous quarter, both analysts and management sustained a tone of cautious optimism, while the current quarter reflected heightened confidence due to concrete enrollment achievements and clarified data timelines.

QUARTER-OVER-QUARTER COMPARISON

* The current quarter marked the completion of ECLIPSE 1 enrollment ahead of schedule, while the prior quarter focused on ongoing recruitment. Time lines for pivotal data were accelerated, with top line data for all ECLIPSE studies now projected by the first quarter of 2027.
* Strategic focus shifted from broad portfolio advancement last quarter to clear prioritization of the hepatitis delta program and VIR-5500 in prostate cancer this quarter. Management confidence increased, as reflected in more definitive guidance on study milestones and cash runway.
* Analysts’ questions in both quarters centered on enrollment, regulatory strategy, and competitive landscape, but this quarter included more queries about product differentiation and near-term data catalysts.

RISKS AND CONCERNS

* Management acknowledged substantial risks and uncertainties related to clinical development timelines and regulatory approvals. Eisner highlighted the need for further data to support differentiation in competitive settings, particularly with the entry of bulevirtide in the U.S. market.
* Analyst concerns focused on clinical benchmarks for efficacy, durability of response, and the ability to achieve market differentiation.

FINAL TAKEAWAY

Vir Biotechnology’s third quarter was defined by operational momentum, as the company completed enrollment in its pivotal hepatitis delta trial ahead of schedule and mapped out key data readouts through early 2027. Management emphasized strategic prioritization of its late-stage hepatitis delta and T-cell engager oncology programs, supported by a substantial cash position projected to last into mid-2027. With robust enrollment, clear clinical milestones, and a focused capital deployment strategy, Vir signals readiness for a pivotal period of value creation and regulatory advancement.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/vir/earnings/transcripts]

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