ASMB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• In the second quarter of 2026, we continued to progress each of our investigational product candidates, 5366, 1179, 6250 and 4334.

• 5366 and 1179 – The transition of the HPI program to Gilead is on-going. Gilead controls the clinical development of 5366 and 1179, and initiation of a Phase 2 study of 1179 is expected by the end of 2026. Gilead does not intend to develop 5366 further at this time.

• We received Gilead’s clinical development plan and budget for the HPI program in June 2026. Gilead is also considering the possible evaluation of 1179 as part of a combination strategy with HIV pre-exposure prophylaxis (PrEP). Our decision regarding the Profit-Share (as defined below) will be made a…

• HDV – Preparation for a Phase 2 study is on-going, with initiation expected in the fourth quarter of 2026.

• CLD – Announced expansion of 6250 into PBC and PSC. Preparation for a Phase 2 study is on-going, with initiation expected in the first quarter of 2027. We conducted a pre-IND meeting with the U.S. Food and Drug Administration (the FDA) to discuss our planned development of 6250 in CLD. The official …

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• 2025 was a pivotal year for us, as we reported data readouts for 5366, 1179, 6250 and 4334. We also nominated 7272 and advanced it into regulatory-enabling studies. In 2026, we continued to progress each of these investigational product candidates.

• 5366 and 1179 – All participants in the Phase 1a/b studies have completed dosing and follow up, reinforcing continued confidence in the safety and efficacy findings previously disclosed for both candidates. The transition of the HPI program to Gilead is on-going.

• 6250 – All participants in the Phase 1a study have completed dosing and follow up. Chronic toxicology studies have been completed, establishing support for anticipated Phase 2 doses. Preparation for Phase 2 clinical studies is on-going, with initiation expected in the fourth quarter of 2026.

• 4334 – Initiated process to identify potential partners was initiated in the first quarter; we do not plan to advance 4334 further without a partner.

• We reported interim data from the Phase 1b portion of the 5366 study in August 2025, focused on two different oral doses of 5366 administered on a once-weekly basis. For the powered antiviral endpoint, HSV-2 shedding rate, highly potent antiviral activity was observed with a 94% reduction compared t…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• We do not have sufficient facilities or resources to conduct all our anticipated nonclinical and clinical studies

• We may publicly disclose top-line, preliminary or interim data based on analysis of then-available efficacy, tolerability, PK and safety data, and the results and related findings and conclusions are subject to change following a more comprehensive data review related to the particular study. We als…

• calculations and conclusions as part of our data analyses, and we may not have received or had the opportunity to fully and carefully evaluate all data prior to release. As a result, the top-line, preliminary or interim results that we report may differ from final results of the same studies or diff…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We do not have sufficient facilities or resources to conduct all our anticipated nonclinical and clinical studies internally. As a result, we contract with CROs to conduct a significant portion of the nonclinical and clinical studies required for regulatory approval for our product candidates. Our r…

• We may publicly disclose top-line, preliminary or interim data based on analysis of then-available efficacy, tolerability, PK and safety data, and the results and related findings and conclusions are subject to change following a more comprehensive data review related to the particular study. We als…

• once additional data have been received and fully evaluated. Top-line, preliminary or interim data also remain subject to audit and verification procedures that may result in the final data differing materially from previously published top-line, preliminary or interim data. As a result, top-line, p…