ASMB — what changed in the latest 10-Q

Text added 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.

• Genital herpes can be caused by either herpes simplex virus type 1 (HSV-1) or herpes simplex virus type 2 (HSV-2). HSV-1 and HSV-2 are acquired by oral or genital contact either during symptomatic or asymptomatic reactivation of the virus. Both viruses replicate in neurons, where they can remain lat…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Since the beginning of 2024, we have initiated: (1) both the Phase 1a and Phase 1b portions of a Phase 1a/b study of ABI-5366 (5366), a long-acting HPI for the treatment of recurrent genital herpes; (2) both the Phase 1a and Phase 1b portions of a Phase 1a/b study of ABI-1179 (1179), also a long-act…

• We announced interim results from the Phase 1a portion of the 5366 study in September 2024 and interim results from the Phase 1b portion of the 5366 study in August 2025, interim results from the Phase 1a portion of the 1179 study in February 2025, interim results from the Phase 1a study of 6250 in …

• In addition, in December 2024, we identified a development candidate, ABI-7423 (7423), in our broad-spectrum NNPI program targeting transplant-associated herpesviruses. 7423 is a prodrug, and in October 2025, we transitioned our discovery and development from 7423 to its parent molecule, ABI-7272 (7…

• Genital herpes can be caused by either HSV type 1 (HSV-1) or HSV type 2 (HSV-2). HSV-1 and HSV-2 are acquired by oral or genital contact either during symptomatic or asymptomatic reactivation of the virus. Both viruses replicate in neurons, where they can remain latent for the rest of the individual…

• HPIs are antiviral agents in development for the treatment of recurrent genital herpes, with a clinically-validated mechanism of action. HPIs inhibit the HSV helicase-primase complex, which is a unique viral enzyme complex without a human homolog, consisting of helicase, primase and cofactor subunit…

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

• There is no assurance that we will be successful in raising any necessary additional capital on terms that are acceptable to us, or at all. If we are unable to develop and commercialize any product candidates and generate sufficient revenue

• or raise capital, we could be forced to reduce staff, delay, scale back or discontinue product development and clinical studies, forego business opportunities, cease operations entirely and sell, or otherwise transfer, all or substantially all of our remaining assets, which would likely have a mater…

• 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…

• studies is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, including, in the case of clinical studies, Good Clinical Practices (GCPs), even if the study is conducted by a CRO. In the event CROs fail to perform their duties in such a f…

• 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…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• There is no assurance that we will be successful in raising any necessary additional capital on terms that are acceptable to us, or at all. If we are unable to develop and commercialize any product candidates and generate sufficient revenue or raise capital, we could be forced to reduce staff, delay…

• of our remaining assets, which would likely have a material adverse impact on our business, results of operations, financial condition and share price.

• 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…

• In addition, these CROs may also have relationships with other entities, some of which may be our competitors. CRO

• The ongoing shutdown of the U.S. government could prevent government agencies, including U.S. Customs and Border Protection (CBP) and FDA from performing normal business functions on which the operation of our business relies, which could negatively impact our business.