Assembly Biosciences Secures $30.1M Investment and Accelerated Funding from Gilead

Assembly Biosciences, Inc., a biotech firm focused on developing antiviral treatments for severe viral infections, recently announced a significant financial boost from Gilead Sciences, Inc. Gilead has invested $20.1 million in equity to acquire additional common stock of Assembly Bio, thereby increasing its ownership stake in the company to 29.9%. Additionally, Gilead has committed $10 million in accelerated funding to further their collaborative efforts in developing innovative antiviral therapies.

This financial injection is poised to advance Assembly Bio's clinical pipeline, which includes therapeutic candidates for viruses such as hepatitis D (HDV), hepatitis B (HBV), and herpesviruses. The company plans to unveil data from several ongoing clinical trials over the next year, including a pivotal interim Phase 1b proof-of-concept study for their HDV candidate ABI-5366, anticipated in the first half of 2025.

A significant aspect of the renewed collaboration with Gilead is the amended strategy for the development of ABI-6250, a potential oral treatment for HDV. The amendment changes the timing and payment structure of options related to ABI-6250, with the aim of accelerating the clinical development plan. This will allow for the $10 million in accelerated payments to be credited towards future obligations.

Jason Okazaki, CEO and President of Assembly Bio, emphasized the importance of Gilead's investment in strengthening the company's financial standing. He noted that the additional funds would facilitate key clinical readouts in 2025 and enable a more rapid development timeline for ABI-6250. Okazaki expressed optimism that the collaboration with Gilead would significantly impact the treatment landscape for patients suffering from severe viral diseases.

Since the partnership with Gilead was initiated in October 2023, Assembly Bio has launched clinical trials for four antiviral candidates. Among these is ABI-5366, a long-acting helicase-primase inhibitor targeting recurrent genital herpes. In addition, ABI-4334, aimed at combating chronic HBV infection, has also entered Phase 1b trials. Recently, in December 2024, Assembly Bio commenced dosing participants in the Phase 1a segment of a clinical trial for ABI-1179, another helicase-primase inhibitor for genital herpes, contributed by Gilead. Regulatory approval has also been granted for a Phase 1a study of ABI-6250.

The terms of the equity investment and collaboration amendment result in a $10 million accelerated funding alongside the $20.1 million equity purchase, extending Assembly Bio's financial resources until mid-2026. The additional equity also signifies Gilead's increased confidence in Assembly Bio's potential, as reflected by the increased ownership stake.

It is important to note that ABI-5366, ABI-1179, ABI-4334, and ABI-6250 are still under investigation and have not received approval worldwide. Their safety and efficacy remain to be established through ongoing clinical trials.

Assembly Biosciences is dedicated to creating small-molecule treatments that can significantly alter the course of severe viral diseases. The company aims to improve patient outcomes globally, particularly for those affected by chronic infections such as HBV, HDV, and herpesvirus. Led by a team of experts in virology and drug development, Assembly Bio continues to pursue innovative solutions to combat these serious health challenges.