Gilead Sciences (NASDAQ:GILD) executives outlined the company’s approach to next-generation HIV medicines, ongoing commercialization efforts in liver disease, and a broad slate of oncology and inflammation programs during a discussion hosted by Leerink Partners analyst Daina Graybosch.
HIV: Moving from daily pills to longer-acting regimens
Management said Gilead’s HIV treatment strategy, put in place roughly three to four years ago, centers on “new principles” such as capsid inhibitors and integrase inhibitors, alongside a shift from daily oral therapies toward long-acting options. The goal is to provide dosing intervals that can extend from monthly to every six months, including injectables.
The second approach is an injectable regimen combining lenacapavir with a long-acting integrase inhibitor. Management said it had evaluated multiple integrase inhibitor options as partners for lenacapavir and selected GS-3242 based primarily on pharmacokinetic data. The company said it is currently in dose escalation for the GS-3242 plus lenacapavir combination and that pharmacokinetics support dosing every four months today, with the expectation that higher doses could support dosing every six months.
Targeting gaps in care and access in HIV
Executives emphasized that a significant portion of people living with HIV in the U.S. are either undiagnosed or not virologically suppressed. They cited an estimate that about 40% of patients fall into that category, including roughly 13% who are undiagnosed. Management framed long-acting therapies as one potential way to address adherence and stigma-related barriers, particularly for individuals who do not want to carry a daily pill or who have inconsistent access to care.
In response to concerns about whether underserved patients would be able to access and afford long-acting injectable and infusion-based regimens, the company said the challenge is often that patients move “in and out of care.” Management characterized the population as heterogeneous, including people who are unhoused or marginalized, and said that if patients are in the healthcare system, funding and access pathways typically exist.
HIV prevention: A 12-month lenacapavir pathway and timeline
On HIV prevention (PrEP), Gilead discussed development of a 12-month lenacapavir option. Management said the company’s experience with lenacapavir administered every six months has provided a strong understanding of pharmacokinetics and the target drug coverage needed for protection. Using modeling and a new intramuscular formulation at a higher dose, Gilead said it believes it can achieve 12-month coverage, adding that end-of-period coverage is expected to be higher than what has been observed with the six-month dosing approach.
Executives said the FDA has agreed to a model-based study with a pharmacokinetic endpoint, enabling a smaller program rather than large outcomes programs such as PURPOSE 1 and PURPOSE 2. Management described the ongoing study as involving “a couple of hundred patients,” said recruitment is going well, and provided expectations for a 2027 data readout and a potential 2028 timeframe to bring the 12-month option to patients.
Livdelzi: IDEAL phase III and potential to expand PBC population
Management also addressed Livdelzi in primary biliary cholangitis (PBC), saying it has shown strong efficacy in the treated population, including effects on alkaline phosphatase (ALP) and pruritus (itch). The company said its initial development and launch focused on “inadequate responders,” defined in the discussion as patients with ALP above 1.67 times the upper limit of normal.
Gilead is now studying Livdelzi in “incomplete responders,” described as patients with ALP between one and 1.67 times the upper limit of normal. Management said the biology is the same in this group and that the IDEAL phase III trial is ongoing. If successful, executives said IDEAL could roughly double the addressable patient population. They added that moving into this earlier group has not historically been standard, but characterized it as a “natural path” now that Livdelzi is available, and said competitors are pursuing similar strategies.
Oncology and pipeline: Arcellx, in vivo CAR-T, Trodelvy, and earlier-stage inflammation
On business development, executives discussed the company’s acquisition of Arcellx, describing it as financially attractive and emphasizing their view of a larger commercial opportunity for anito-cel than the market currently reflects. They said anito-cel is a BCMA cell therapy being studied in multiple myeloma, with a first potential approval expected in fourth-line-plus later this year, followed by additional studies in earlier lines. Management pointed to what it described as a differentiated safety profile and said the deal was enabled by a “unique window” in Arcellx’s stock price, allowing Gilead to pay a premium while still meeting shareholder return thresholds. Executives also cited FDA file acceptance in fourth-line-plus as a de-risking milestone and highlighted cell therapy manufacturing complexity as a factor that could support long-term franchise durability.
More broadly, management said Gilead expects to continue using both partnership structures (including board participation, investments, and option-like rights) and outright acquisitions, referencing an “all-in partnership” with Assembly in viral hepatitis/virology and the earlier CymaBay acquisition as examples of different deal types suited to different situations.
In cell therapy, executives described in vivo CAR-T as a long-term evolution of the field in which the body becomes the “bioreactor” for generating CAR-T cells. They said recent proof-of-concept data across companies—including Interius, which Gilead acquired—supports the scientific feasibility, while acknowledging that achieving autologous CAR-T-like efficacy and safety will take years of refinement. Management argued in vivo CAR-T could lower cost of goods, improve delivery, and expand access, while also providing an “off-the-shelf” approach that avoids cell harvesting and could reduce the need for immunosuppression compared with allogeneic approaches.
For Trodelvy, management said it is pursuing a broad clinical program across tumor types. Executives referenced recent success in the ASCENT-03 and ASCENT-04 studies in first-line triple-negative breast cancer (TNBC) across PD-L1 high and low populations, and said the company has multiple pivotal readouts coming. Trials highlighted included:
- EVOKE-03 in first-line PD-L1 high non-small cell lung cancer, combining Trodelvy with pembrolizumab
- ASCENT-GYN-01 in second-line endometrial cancer
- EVOKE-04 in small cell lung cancer
- An adjuvant TNBC study expected to read out in a “couple of years”
In earlier-stage inflammation, management said three programs are currently in phase II, with two expected to have data later this year: an oral α4β7 program (with phase II data anticipated later in the year) and an IRAK4 inhibitor, edecesertib, in phase II for cutaneous lupus (also expected later this year). The company also discussed a TPL2 program in inflammatory bowel disease, positioned in a more treatment-experienced population, with phase II data expected the following year. In oncology research, executives highlighted a CCR8 antibody targeting regulatory T cells as an area of scientific interest, while also emphasizing continued focus on antibody-drug conjugates and direct tumor-targeting approaches as part of a more balanced oncology portfolio.
About Gilead Sciences (NASDAQ:GILD)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
