Gilead Sciences (NASDAQ:GILD) Chief Medical Officer Dietmar Berger outlined the company’s priorities across HIV, oncology and inflammation at the Wells Fargo conference, describing a portfolio that has expanded through internal development and acquisitions and is now entering a period of prioritization and execution.
Berger said Gilead’s management team began pursuing diversification seven years ago while maintaining its virology franchise. The company is seeking to advance treatment and prevention options for HIV while building broader oncology and inflammatory disease businesses.
HIV Portfolio Emphasizes Patient Choice
“It is really about optionality,” Berger said, noting that some patients prefer long-acting injections while others do not want injections at all.
He said more than 500,000 people are currently using PrEP, compared with a Centers for Disease Control and Prevention estimate of more than 2.2 million people who could qualify for the preventive treatment.
Gilead expects a decision on weekly oral lenacapavir during the first quarter of next year, according to Berger. The submission is based on model-informed drug development, pharmacokinetic data and Gilead’s experience with an oral bridging therapy used when patients miss a Yeztugo injection. Berger said the company has held extensive discussions with the FDA and does not view the filing as riskier than other submissions.
For HIV treatment, Gilead is developing a combination of lenacapavir and its long-acting integrase inhibitor, GS-3242, with a goal of delivering treatment every six months. Berger said the company knows GS-3242 can provide coverage for four months and is studying higher doses to support a longer interval. Gilead expects to know more by the end of the year and plans to advance the combination into Phase II studies.
Oncology Additions Include Anito-cel and Tubulis Platform
Berger highlighted the addition of anito-cel through Gilead’s acquisition of Arcellx. The company is seeking approval for anito-cel in fourth-line-plus multiple myeloma toward the end of the year and is studying the CAR-T therapy in second- through fourth-line treatment settings, with earlier-line studies being prepared.
He said the therapy’s potential differentiation is its safety profile. Gilead has not observed delayed neurotoxicity, Parkinsonism, Guillain-Barré syndrome or enterocolitis in more than 400 treated patients, Berger said. He noted that some competing products have reported such effects within 100 days of treatment, while certain anito-cel patients have been followed for as long as 38 months.
“We see a clear differentiation and a clear opportunity,” Berger said, adding that Gilead is also encouraged by anito-cel’s response-rate, progression-free survival and minimal residual disease data.
The company also acquired Tubulis, adding antibody-drug conjugate candidate TUB-040 and its linker and payload technology platform. Berger said TUB-040 produced a 60% objective response rate in an unselected platinum-resistant ovarian cancer population in data presented at ASCO. Gilead plans to further explore the candidate and move rapidly toward Phase III studies in ovarian cancer.
Berger said Tubulis’ technology is designed to create a stable linkage between antibody and payload, potentially reducing circulating toxin exposure and supporting improved tolerability. The platform could also enable different payload approaches beyond topoisomerase inhibitors, he said. TUB-040 targets NaPi2b, which Berger said is highly expressed in 85% of ovarian cancer tumors. A second Tubulis candidate, TUB-030, targets 5T4 and is already in clinical development.
Inflammation Pipeline Readouts Expected
Gilead expects “quite meaningful news flow” for its inflammation and immunology portfolio in the second half of the year, Berger said. Planned presentations include Phase II data for oral alpha-4 beta-7 candidate emvistegrast and data for IRAK4 inhibitor edecesertib in cutaneous lupus.
The company has completed its Phase II analysis for emvistegrast, an oral candidate directed at a target Berger described as validated by ENTYVIO’s role in inflammatory bowel disease. If efficacy is maintained, he said the drug could be considered as a monotherapy backbone and potentially in combination regimens.
Gilead has already said it will advance edecesertib into a Phase IIb study following the COSMIC Phase IIa study in cutaneous lupus. Berger also pointed to an early-stage IRAK4 degrader and a STAT6 degradation program.
Additionally, the acquisition of Ouro brought BCMA T-cell engager gamgertamig, now designated GS-O336, into the portfolio. Berger said Gilead has reported favorable efficacy and durability data in immune thrombocytopenia and plans to begin Phase III studies in 2027 in immune thrombocytopenia and autoimmune hemolytic anemia.
Execution and Prioritization Ahead
Berger said Gilead now has enough opportunities across virology, oncology and inflammation that it must prioritize programs with the strongest probability of success and potential patient and revenue impact. The company will continue to seek additional earlier-stage opportunities while advancing internally discovered assets, he said.
Looking ahead, Berger said a successful year would include execution on recent and anticipated launches, including Bixlenvo, weekly lenacapavir prevention, the islatravir-lenacapavir program, TRODELVY in first-line settings and a potential anito-cel launch.
About Gilead Sciences (NASDAQ:GILD)
Gilead Sciences, Inc is a biopharmaceutical company that discovers, develops and commercializes medicines for serious and life-threatening diseases. The company’s research focuses primarily on virology, oncology, inflammation and related areas, with products serving patients in the United States and international markets.
Gilead is best known for its HIV treatments, including Biktarvy, Genvoya, Descovy and other antiretroviral therapies. Its portfolio also includes medicines for viral hepatitis, such as Epclusa and Vemlidy, and Veklury (remdesivir), an antiviral treatment for COVID-19.
