Vir CEO Says Hepatitis Delta Combo Could Be 'Best-In-Class' As Rival's Phase 3 Data Land
The first of three late-stage readouts is due this quarter, and the company says its Phase 2 showed undetectable virus in 66% of patients.
Vir Biotechnology, which develops antibody and other investigational medicines for serious infectious diseases and cancer, defended its hepatitis delta regimen against a rival's Phase 3 results on its third-quarter earnings call Wednesday. CEO Marianne De Backer said the combination has "the potential to be a best-in-class treatment," with the first of three pivotal readouts due this quarter.
66% against 17%
Asked by an analyst whether the competitor's data raises the bar, De Backer pointed to Vir's mid-stage SOLSTICE trial, where 66% of patients had undetectable virus after 48 weeks. She said she believed the competition's figure was 17% at a 24-week endpoint. The analyst had acknowledged that the programs differ in endpoints and in how a responder is defined.
An analyst from Needham asked how much better than bulevirtide the combination must be in the head-to-head ECLIPSE 3 trial. De Backer would not say how much differentiation is needed. She put bulevirtide's reported 48-week undetectable-virus levels at somewhere between 12 and 20 percent, depending on dose.
She also contrasted bulevirtide's daily injection, taken chronically, with Vir's monthly regimen, calling it "fundamentally a very, very different regimen" on convenience.
Three pivotal trials, one this quarter
Topline data from ECLIPSE 1 are due this quarter, and from ECLIPSE 2 and 3 in the first quarter of 2027. Expanded 96-week SOLSTICE results are due in an oral presentation at the AASLD liver meeting this weekend.
De Backer said the FDA agreed that ECLIPSE 3 has a 48-week primary endpoint of undetectable virus alone. ECLIPSE 1, with about 120 participants, will report its primary endpoint of undetectable virus plus normalized liver enzyme (ALT) levels at week 48, along with cirrhosis and safety data.
Cash and the Gilead deal
Chief Financial Officer Aziz Sawaf said Vir ended the quarter with $901 million in cash, equivalents and investments, not counting $90 million received in October from a new Gilead collaboration. He said the cash funds operations into the second half of 2028.
The Gilead package is $65 million upfront plus a $25 million equity investment at a 30% premium, up to $45 million in near-term preclinical milestones, and as much as $1.74 billion in further milestones, plus royalties. Sawaf said none of the milestones will be shared with Sanofi because a 20% pass-through arrangement has expired.
Third-quarter research and development spending was $80 million, against $151 million a year earlier, when it included a one-time $75 million milestone payment.
De Backer is scheduled to give a fireside chat at the Jefferies London Healthcare Conference on November 18.
Sources
- Vir Biotechnology Non-GAAP EPS of -$0.57 beats by $0.18 (VIR:NASDAQ) — seekingalpha.com
- Vir Biotechnology Provides Corporate Update and Reports Third Quarter 2026 Financial Results — businesswire.com
- Vir Biotechnology to Participate in the Jefferies 2026 London Healthcare Conference — businesswire.com
