Assembly Bioscie - ASMB STOCK NEWS

Assembly Biosciences (NASDAQ: ASMB) reported positive interim Phase 1a results for ABI-1179, their investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor for recurrent genital herpes. The drug demonstrated a favorable safety profile and approximately four-day half-life, supporting once-weekly oral dosing potential.

Key findings from the Phase 1a trial include:

• Well-tolerated safety profile across all doses (50mg, 100mg, and 300mg)
• Exceeded target plasma concentrations for antiviral activity even at lowest dose
• All treatment-emergent adverse events were mild and deemed unrelated to treatment

The company will advance directly to Phase 1b testing in participants with recurrent genital herpes, running concurrently with their ongoing Phase 1b study of ABI-5366. Interim data for both candidates is expected in fall 2025.

Assembly Biosciences (ASMB) announced interim results from its Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator for chronic hepatitis B virus. The first cohort, receiving 150 mg daily oral dose, showed strong antiviral activity with a mean HBV DNA reduction of 2.9 log IU/mL over 28 days. The drug demonstrated favorable safety profile and half-life supporting once-daily dosing.

Among participants with detectable HBV RNA at baseline, a mean decline of 2.5 log10 U/mL was observed. Enrollment is ongoing for the final 400 mg cohort, with data expected in 1H 2025. Under the collaboration agreement, Gilead has the option to further develop and commercialize ABI-4334 after Phase 1b study completion.

Assembly Biosciences (ASMB) has secured a significant financial boost through a $30.1 million investment from Gilead Sciences, comprising a $20.1 million equity investment and $10 million in accelerated funding. This investment increases Gilead's ownership stake in ASMB to 29.9% and extends ASMB's cash runway to mid-2026.

The funding will support ASMB's clinical pipeline development of antiviral therapeutics targeting herpesviruses, hepatitis D virus (HDV), and hepatitis B virus (HBV). The company has initiated clinical studies for four small molecule antiviral candidates: ABI-5366, ABI-4334, ABI-1179, and ABI-6250. An interim Phase 1b proof-of-concept data readout for ABI-5366 is expected in the first half of 2025.

Assembly Biosciences (ASMB) reported Q3 2024 financial results and updates. The company announced positive Phase 1a interim data for ABI-5366, their genital herpes treatment candidate, supporting once-weekly and monthly oral dosing. Cash position was $95.0 million as of September 30, 2024, with funding projected into Q1 2026. Q3 revenue was $6.8 million from Gilead collaboration. R&D expenses increased to $13.5 million, while G&A expenses remained stable at $4.3 million. Net loss was $9.6 million ($1.51 per share), improved from $14.4 million loss in Q3 2023.

Assembly Biosciences (Nasdaq: ASMB) reported positive interim results from the Phase 1a portion of its ongoing Phase 1a/b study evaluating ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate for recurrent genital herpes. Key findings include:

1. ABI-5366 was well-tolerated with a favorable safety profile up to 70 days of exposure.
2. Single doses surpassed target plasma concentrations for antiviral efficacy.
3. Half-life of approximately 20 days supports once-weekly or once-monthly oral dosing.
4. Both weekly and monthly dosing cohorts will be included in Phase 1b.
5. Screening for Phase 1b in participants with recurrent genital herpes has begun.
6. Interim Phase 1b results expected in the first half of 2025.

Assembly Biosciences (ASMB) reported Q2 2024 financial results and updates. Key highlights include:

- Dosing initiated in Phase 1a/b trial for ABI-5366 (genital herpes treatment) and Phase 1b trial for ABI-4334 (chronic HBV treatment)

- Two additional pipeline candidates expected to enter clinic by year-end

- Q2 revenue: $8.5 million; R&D expenses: $16.3 million; Net loss: $11.2 million ($1.98 per share)

- Cash position: $109.2 million as of June 30, 2024, projected to fund operations into Q1 2026

- Upcoming milestones: ABI-5366 Phase 1a interim data in Q3 2024, ABI-4334 Phase 1b interim data by year-end

Assembly Biosciences (Nasdaq: ASMB) presented new preclinical data on its investigational helicase-primase inhibitors for recurrent genital herpes at the International Herpesvirus Workshop. The company highlighted promising results for two candidates: ABI-5366 and ABI-1179.

Key findings for ABI-5366 include low nanomolar activity against HSV-1 and HSV-2, specificity for HSV, and a favorable safety profile. The Phase 1a/b study for ABI-5366 began in May 2024, with interim Phase 1a data expected in Q3 2024.

ABI-1179, licensed from Gilead Sciences, demonstrated potent activity against HSV strains, including acyclovir-resistant isolates, and showed potential for once-weekly oral dosing. Assembly Bio plans to initiate a Phase 1a/b study for ABI-1179 by the end of 2024.

Assembly Biosciences (Nasdaq: ASMB) has dosed the first participant in its Phase 1b clinical trial for ABI-4334, a next-generation capsid assembly modulator (CAM) targeting chronic hepatitis B virus (HBV) infection. The trial aims to evaluate the safety, pharmacokinetics, and efficacy of ABI-4334 over a 28-day period. Interim data is expected by the end of 2024. ABI-4334 has shown promising preclinical results with strong antiviral activity and is optimized to inhibit HBV DNA replication and prevent cccDNA formation. Chronic HBV is a leading cause of chronic liver disease and liver transplants, making this study important for potential therapeutic advancements.

Assembly Biosciences announced the closure of $12.6 million in equity financings from Armistice Capital and Gilead Sciences. The funds will support Assembly's antiviral portfolio, with clinical data readouts expected for ABI-5366 and ABI-4334 in the coming years.

The equity financings involve the sale of common stock and warrants at $15.46 per share with warrants exercisable at $17.00. These transactions extend Assembly's cash runway into Q1 2026 and maintain Gilead's 19.9 percent ownership, with an option to increase up to 29.9 percent.

Assembly intends to use the proceeds for general corporate purposes and further advance its clinical candidates, with significant near-term milestones anticipated.