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CLAIM #27318 · GILD (GILD) · 2025Q3 earnings call · Oct 30, 2025 · due Dec 31, 2025

we continue to expect an update from our Phase III ARTISTRY studies later this year.

Dietmar Berger · Chief Medical Officer

PENDING
graded after results covering Dec 31, 2025 are reported

In context

our Yeztugo launch, we continue to lead HIV innovation with 10 clinical programs across treatment and prevention. Lenacapavir and its prodrugs are foundational in our treatment and prevention programs. And in July, we initiated the registrational Phase III PURPOSE-365 trial evaluating lenacapavir as HIV prevention with once yearly injections. This is a single-arm PK and safety study, which, along with the unprecedented efficacy seen in the Phase III PURPOSE 1 and 2 studies is expected to support a regulatory filing with potential for approval in 2028. Moving to treatment. We have seven ongoing clinical programs evaluating daily, weekly, monthly, quarterly and twice yearly regimens based on lenacapavir or one of its prodrugs. Beginning with our next-generation daily oral regimen, BIC/LEN, we continue to expect an update from our Phase III ARTISTRY studies later this year. ARTISTRY-1 and ARTISTRY-2 are evaluating the potential of Gilead's investigational complete regimen that combines bictegravir, the key integrated inhibitor in Biktarvy and lenacapavir, our breakthrough capsid inhibitor. The regimen is a potential option for virologically suppressed people with HIV, including many people currently on complex regimens. Further, we have a suite of long-acting oral and injectable agents in development for a range of dosing frequencies from once weekly oral to twice yearly injectables. Our strategy has been to set up our pipeline for multiple shots on goal and then choose the best option for each dosing frequency. Notably, for our development of a twice yearly treatment regimen combining a novel integrase inhibitor with lenacapavir, we took two INSTI agents to

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SEC filings for GILD · Claim quote is verbatim from the 2025Q3 earnings call.