Vir Biotechnology (VIR) Q2 FY26 earnings call: guidance and Q&A

What is the plan and timing for long-term extension data after the initial ECLIPPS 1 readout, and will it assess TND durability and potential for treatment discontinuation?

ECLIPPS 2 and 3 trial designs incorporate exploration of finite treatment, but ECLIPPS 1 does not. The overall ECLIPPS program will explore this.

“So we have in our trial design for Eclipse 2 and Eclipse 3 incorporated the exploration of the potential for finite treatment. This is not something that is incorporated in our Eclipse 1 trial design where we're really comparing the treatment with elapsed run. and to bevipart versus the deferred treatment. But it is something in our overall Eclipse program that we will be exploring.”

asked by Paul Choi (Goldman Sachs) · answered by Marianne De Backer

What efficacy and safety thresholds are expected from ECLIPPS 2 (bulevertide switch study), and how will this data inform future physician prescribing?

The primary endpoint for ECLIPPS 2 is target not detected (TND) after 24 weeks. The bar is considered low given VIR's significantly higher TND rates compared to bulevertide. The data will be valuable due to bulevertide's black box warning for switches/discontinuations, and VIR expects to be the only company with such data at launch.

“So we think that the bar is considered to be low because our target not detected rates compared to Belevertide are significantly higher, as you recall. So that's really the outcome that we will be watching. And maybe just to add that given the black box warning that Beléver-Tide has now for switches or discontinuations of Beléver-Tide, we believe that the Eclipse 2 data will be very, very valuable. And as mentioned in the prepared remarks, we believe that we are the only company that will have that data at the time of launch.”

asked by Rowana Ruiz (LeRinc Partners) · answered by Marianne De Backer

How much detail (e.g., patient numbers, insights) will be shared with the VIR5818 data set in H2 2026 to help narrow down tumor types?

The H2 2026 update for VIR5818, a signal-seeking basket trial, will share dose escalation data for both monotherapy and combination cohorts. This will provide insight into the optimal dose for next steps and help identify valuable indications for further exploration.

“So we will be sharing. those escalation data. We see it as a signal-seeking study, again, given the heterogeneity of the data. Rana is really a good insight into the dose for any potential next steps and then also insight into what exploration, what indications might really be valuable for the program.”

asked by Rowana Ruiz (LeRinc Partners) · answered by Marianne De Backer

How confident is management in the current team given recent turnover, and what are the plans for bolstering the C-suite?

Marianne De Backer expressed high confidence in the current team, citing evident progress. The company is actively seeking a new CMO with a strong medical oncology profile, as the pipeline's future is largely in immuno-oncology beyond Hepatitis Delta. Interviews for a new CFO have also begun with strong candidates.

“I'm very confident that we have a very strong team in place, as I think is evident from the progress that we are making quarter to quarter. We are looking to bring in a new CMO. And as mentioned before, we are looking there for a very strong profile in medical oncology because beyond Delta, where we are close to having registrational data coming out this quarter and the fourth quarter and then the first quarter next year, the future of our pipeline will nearly entirely be in immuno-oncology. So we're looking for a very strong leader in that field. And for the CFO, yes, we have actually started started interviews last week. And again, you know, we have a roster of, I think, what are very strong candidates to move forward in the process.”

asked by Corey Kazimov (Evercore) · answered by Marianne De Backer

How has thinking around competitive positioning and pricing for the HDV combo changed after bulevertide's US approval and pricing? How will early VIR5500 data, including the docetaxel combo, feed into Phase 3 design?

Bulevertide's approval increases disease awareness. VIR believes its HDV combo has a best-in-class profile (88% TND at 96 weeks, monthly dosing, strong safety) compared to bulevertide's $283,000 price and daily administration, offering significant differentiation. For VIR5500, the ongoing expansion cohorts, including docetaxel, will provide data to determine the full scope of possibilities and inform the design of pivotal trials.

“As mentioned, what is really helpful now is that, you know, there's an increased awareness around the disease. We also know that the blepharotide price has been set at around $283,000, obviously, with Delta being recognized as a rare disease. We believe that we have a potential best-in-class profile. You have seen the phase two data from Solstice at EASL, where we have 88% target not detected at 96 weeks. So very durable data. And even if you use the last observation carried forward analysis, we can... go up to 97%.”

asked by Alex Strawnahan (Bank of America) · answered by Marianne De Backer

Can you detail the HDV human factor study (dosing in trials vs. commercial, at-home vs. clinic)? What is the bar for moving VIR5818 forward in individual indications?

ECLIPPS trials administer the HDV combo in a hospital setting; the human factor study aims to bridge to at-home administration. It's monthly, subcutaneous, two injections, and co-packaging is being explored for convenience. For VIR5818, the signal bar depends on the indication; for example, in microsatellite stable MCRC, the bar is very low (single-digit ORR).

“So in our ECLIPSE trials the combination of elapseron and tobevibart is being administered in a a hospital setting. And what we are doing with the human factor study is really bridging to human, you know, to in-home administration. We've had, as mentioned, had a type B CMC meeting with the FDA, which has been very, very productive. Basically, what the The dosing is, of course, it's monthly, it's subcutaneous, it's two injections at the same time.”

asked by Philip Nadeau (TD Cowan) · answered by Marianne De Backer

What KOL commentary exists on how quickly new HDV patient ID/diagnosis methods could be adopted? What are the expense trends for R&D and SG&A for the balance of the year?

KOLs note increased awareness post-bulevertide, with some major sites implementing universal reflex testing and re-screening. This suggests a gradual change in diagnosis practices. For expenses, Brent Sabatini stated that the larger drug substance PPQ expenses are mostly behind them, and the company maintains its cash runway projection into H2 2028.

“So what we have seen, especially since, again, the lever tide launching a couple of months ago, is that, first of all, we heard and probably you heard it, too, in other independent investor call that some KOLs were mentioning the fact that, you know, testing for COVID. for reflex testing, incorporating that in the guidelines for the US was something that was really getting very acute.”

asked by Etzer DeRoute (Barclays) · answered by Marianne De Backer

What efforts are being made to expedite the BLA filing once ECLIPPS data is in hand? What is the rationale for starting a darolutamide combo in the hormone-sensitive setting for VIR5500?

The company has mapped out the timeline from last patient visit to database lock and filing, focusing on minimizing downtime to expedite the BLA process. The rationale for combining VIR5500 with darolutamide is its complementary mechanism of action, potential to increase PSMA target density, and the more favorable immune context in metastatic hormone-sensitive prostate cancer for T-cell engagers.

“So we have, you know, of course been very focused on mapping out, you know, the from last patient, last visit to database lock and stop line data to filing what that timing would look like. And we're really looking at that as a matter of hours and days. So we have prepared this quite well. And of course, we are trying to really expedite as much as possible and take out any unnecessary. very downtime in that process.”

asked by Sean McCutcheon (Raymond James) · answered by Marianne De Backer