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The call conveyed substantial positive momentum: a large strategic collaboration with Astellas closed with immediate and near-term cash, meaningful capital raises, strong Phase 1 safety/early efficacy for VIR-5500, and highly differentiated Phase 2 HDV data with regulatory support and multiple registrational trials underway. Offsetting these positives are continued quarterly net losses, high R&D spend, the need for multiple pivotal datasets for filing in HDV, underdiagnosis in the target HDV population, and class-level safety/competitive risks for T cell engagers. On balance, the advances in clinical data, strategic partnerships, and strengthened balance sheet materially outweigh the near-term financial and execution risks.
The call provided specific operational and financial guidance and milestone timelines: the Astellas collaboration (up to $1.7B deal value) closed 04/15/2026 with a $75M equity payment received and a $240M upfront due within 30 days (total $315M), Vir is eligible for a $20M manufacturing milestone in 2027 and up to $1.37B more in milestones plus tiered double‑digit ex‑US royalties, and global development costs will be split 40/60 (Vir/Astellas) with U.S. commercial profits split 50/50; Vir ended Q1 with ~$809.3M cash (not including the $315M) and expects runway into 2028 after a $172.5M follow‑on offering closed 02/27/2026. Clinical guidance included plans to initiate registrational Phase 3 for VIR‑5500 in 2027 after Phase 1/expansion (monotherapy expansion dosing steps of 800, 2,000, and 3,500 µg/kg; no DLTs and no Grade 3 CRS at ≥3,000 µg/kg; durability signals to 27 weeks and case follow‑up at 8–12 months), first patient dosed in expansion and combination cohorts with enzalutamide to start dosing in coming months, and continued updates for VIR‑5818 (preliminary monotherapy and pembrolizumab combo data in 2026) and progressing VIR‑5525 enrollment. For hepatitis delta, SOLSTICE Phase 2 showed 41% TND at 24 weeks, ~66% TND at Week 48, and 88% TND at Week 96 with tobevibart+elebsiran (vs 46% or ~50% for antibody alone), no Grade ≥3 treatment‑related AEs or discontinuations, monthly two‑injection dosing, FDA Breakthrough and Fast Track and EMA PRIME/orphan designations, and registrational ECLIPSE studies on track (ECLIPSE 1: ~120 pts randomized 2:1, primary TND+ALT normalization at Week 48, topline 4Q2026; ECLIPSE 2: ~150 pts randomized 2:1, primary TND at Week 24; ECLIPSE 3: ~100 pts randomized 2:1 vs bulevirtide, primary TND at Week 48). Estimates for market sizing and access noted ~61,000 actively viremic U.S. patients (10–15% diagnosed today), ~104,000 in U.S.+Europe and ~180,000 across U.S./UK/EU composites, and pricing anchor points in the $60K–$165K (Europe) to ~$115K (Canada) range with analyst estimates of ~$150K–$250K for a severe orphan therapy.
Entered and closed a global collaboration and licensing agreement with Astellas for VIR-5500 valued up to $1.7 billion; Vir received $75 million equity at closing and will receive a $240 million upfront payment within 30 days (total $315 million in proceeds), is eligible for up to $1.37 billion in additional milestones, and will share U.S. commercial profit 50/50.
Completed a follow-on equity offering that generated approximately $172.5 million gross; ended Q1 2026 with ~$809.3 million in cash, cash equivalents and investments (excluding the $315M Astellas proceeds received after quarter-end); management expects cash runway into 2028.
Phase 1 data for VIR-5500 showed favorable safety with no dose-limiting toxicities and mostly Grade 1 cytokine release syndrome at ≥3,000 µg/kg with no observed Grade 3 CRS at that dose; observed deep PSA and RECIST responses with sustained responses up to 27 weeks and case-level durability of 8–12 months, including a complete response in a patient who relapsed after actinium-based PSMA RLT.
Dosed first patient in the Phase 1 expansion cohorts (monotherapy) and continuing dose escalation in combination with enzalutamide for early-line mCRPC; plan to initiate registrational Phase 3 program in 2027 pending data.
Advancing multiple PROXTEN-masked T cell engagers: VIR-5818 (HER2) is signal-seeking with planned preliminary response data in 2026, VIR-5525 (EGFR) enrollment progressing, plus seven preclinical PROXTEN assets to broaden pipeline optionality.
Tobevibart plus elebsiran combination showed strong viral suppression: 88% of evaluable participants achieved undetectable HDV RNA (TND) at Week 96 versus 46% on tobevibart monotherapy; rapid effect with 41% TND by Week 24 and 66% TND reported at Week 48 in pooled comments; combination was well tolerated with no Grade ≥3 treatment-related AEs and no discontinuations.
Hepatitis delta regimen has FDA Breakthrough Therapy and Fast Track designations and EMA PRIME and orphan drug designation; ECLIPSE 1 enrollment complete (~120 randomized 2:1) with topline expected in Q4 2026, ECLIPSE 2 (~150) and ECLIPSE 3 (~100) on track to generate additional pivotal/registrational data.
Established commercialization partner Norgine with exclusive license across Europe, Australia and New Zealand for HDV; Astellas partnership adds global prostate cancer reach and shared development/commercial capabilities.
Total operating expenses for Q1 2026 were $132.3 million, a decrease of $10.3 million (≈7.2%) versus Q1 2025, driven by lower R&D and slightly lower SG&A.
Hello, and welcome to Vir Biotechnology, Inc. First Quarter 2026 Financial Results and Corporate Update Conference Call. As a reminder, this call is being recorded. After the speakers' presentation, there will be a question and answer session. I will now turn the call over to Kiki Patel, Head of Investor Relations. You may begin, Kiki.
Thank you, operator. Welcome, everyone. Earlier today, we issued a press release reporting our first quarter 2026 financial results and corporate update. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under applicable securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration outcomes, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the potential benefits of our collaboration with Astellas, the therapeutic potential of 5,500 and our PROXTEN platform, our development plans and timelines, financial terms and milestone payments, and our cash runway and capital allocation priorities. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission including Forms 10-K, 10-Q, and 8-K. Joining me on today's call from Vir Biotechnology, Inc.
are Marianne De Backer, our chief executive officer, and Jason O’Byrne, ...