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Assembly Biosciences Shares 40% Development Costs with Gilead

Assembly Biosciences (ASMB) announced it has exercised its option to share 40% of the development costs and profits in the United States for its herpes simplex virus helicase-primase inhibitor program for recurrent genital herpes under its collaboration agreement with Gilead Sciences (GILD). This decision follows Assembly Bio's receipt and review of Gilead's complete development plan and budget for the program. Pursuant to the terms of the collaboration agreement, Gilead retains sole right and responsibility for further clinical development and commercialization of the HSV HPI program, which includes both GS-1179 and GS-5366. Assembly Bio is eligible to receive up to $280M in regulatory and commercial milestones and tiered royalties on net sales outside the U.S. ranging from the high single-digits to low teens. Assembly Bio's participation in the U.S. profit share is subject to certain opt-out and conversion rights of either party, which may result in a transition to up to $330M in regulatory and commercial milestones and tiered royalties on net sales ranging from the high single-digits to low teens.

Assembly Bio Reports Q2 Revenue of $13.37M, Exceeds Expectations

Reports Q2 revenue $13.37M, consensus $6.45M. "During the second quarter, we advanced several important strategic priorities, including expanding ABI-6250 into cholestatic liver diseases and strengthening our balance sheet through a successful financing to support the continued advancement of our pipeline," said Jason Okazaki, chief executive officer and president of Assembly Bio. "We were also pleased to receive Gilead's clinical development plan for the HSV helicase primase inhibitor program, which includes plans for GS-1179 to advance into a Phase 2 clinical trial by the end of 2026. The plan also contemplates evaluation of GS-1179 across broader prevention settings, including in connection with HIV PrEP, further reinforcing the potential opportunity for this program. We expect to make our determination on whether to opt-in to the U.S. cost and profit share soon after we receive the commercial cost estimates from Gilead, which will complete the opt-in package."

Assembly Biosciences Expands ABI-6250 Clinical Development

Assembly Biosciences announced plans to expand the clinical development of ABI-6250, its oral entry inhibitor candidate for chronic hepatitis delta virus infection, into primary biliary cholangitis and primary sclerosing cholangitis, broadening the program into cholestatic liver diseases. "We are excited to expand the ABI-6250 program into PBC and PSC, where there remains significant unmet medical need despite existing PBC therapies, and in the case of PSC, no approved treatments," said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. "The NTCP receptor plays an integral role in both HDV entry and bile acid transport into liver cells, making it a compelling target across multiple liver diseases. We believe ABI-6250 has the potential to address key drivers of disease pathology in these conditions and look forward to advancing clinical evaluation in these populations."