Gilead Sciences has exercised its option to exclusively license Assembly Biosciences’ helicase‑primase inhibitor programs, ABI‑1179 and ABI‑5366, for the treatment of recurrent genital herpes. The deal grants Gilead an exclusive license and the sole responsibility for further clinical development and commercialization of the two candidates.
Assembly receives a $35 million upfront payment, reflecting a $45 million option fee net of a $10 million accelerated‑funding credit granted in a December 2024 amendment. The transaction preserves Assembly’s eligibility for up to $330 million in regulatory and commercial milestones and tiered royalties on net sales, providing a substantial non‑dilutive capital infusion and a clear path to future revenue streams.
Assembly’s financial position has strengthened with the new cash injection. The company reported a net loss of $40.2 million for the year ended December 31, 2024, a 34 % improvement over the $61.2 million loss in 2023, and collaboration revenues rose from $7.2 million to $28.5 million. With $112.1 million in cash on hand, the upfront payment and milestone potential are expected to fund operations through mid‑2026 and support continued clinical development.
For Gilead, the acquisition expands its antiviral pipeline into a market with no new therapies approved in over 25 years. The company’s leadership highlighted the strategic fit, noting that the helicase‑primase inhibitors offer a novel mechanism of action and the potential for once‑weekly oral dosing, which could differentiate Gilead’s portfolio in a crowded therapeutic area.
Interim Phase 1b data for ABI‑1179 and ABI‑5366 showed strong antiviral activity, with ABI‑1179 reducing HSV‑2 shedding by 98 % and virologically confirmed genital lesion rates by 91 % at a 50 mg weekly dose. These results underpin the decision to exercise the option and signal a promising clinical trajectory for the programs.
"Our partnership with Assembly Bio has been highly fruitful," said Jared Baeten, Senior Vice President of Clinical Development at Gilead. "The data demonstrate the potential of these candidates to address an unmet need and reinforce our commitment to expanding our antiviral portfolio." Jason Okazaki, CEO of Assembly Biosciences, added, "Gilead’s decision to take control of ABI‑1179 and ABI‑5366 validates our platform and positions us for significant future milestones."
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