Core Insights - The article discusses the interim results of a Phase 1b clinical study evaluating ABI-4334, an investigational antiviral treatment for chronic hepatitis B virus (HBV) infection, highlighting its antiviral activity and safety profile [4][8][14]. Study Overview - ABI-4334 is being tested in a randomized, blinded, placebo-controlled, dose-ranging Phase 1b clinical study, which includes treatment-naive or off-treatment participants with either HBeAg positive or negative chronic HBV infection [6]. - The study consists of two cohorts, with the first cohort receiving a 150 mg dose and the second cohort currently enrolling participants for a 400 mg dose [19]. Interim Results - In the first cohort, participants receiving 150 mg of ABI-4334 showed a mean decline in HBV DNA of 2.9 log10 IU/mL and a mean decline in HBV RNA of 2.5 log10 U/mL among those with detectable HBV RNA at baseline over a 28-day treatment period [7][14]. - The safety data indicated that ABI-4334 was well-tolerated, with no serious adverse events reported and only two grade three lab abnormalities observed, both of which resolved with continued dosing [3][4]. Pharmacokinetics and Dosing - ABI-4334 demonstrated a half-life supportive of once-daily oral dosing, with clinical exposures significantly above the levels anticipated to be required for potent antiviral activity [14][17]. - The daily minimum plasma trough concentrations at the 150 mg dose achieved double-digit multiples over the protein-adjusted EC50 for both antiviral activity and cccDNA formation [17]. Future Expectations - Enrollment for the second cohort evaluating the 400 mg dose is ongoing, with data anticipated in the first half of 2025 [19]. - The collaboration with Gilead Sciences allows Gilead the option to further develop and commercialize ABI-4334 following the completion of this Phase 1b study [19].

Core Insights - Assembly Biosciences, Inc. announced a $20.1 million equity investment from Gilead Sciences, increasing Gilead's ownership stake to 29.9% [1][5] - The collaboration includes an additional $10 million in accelerated funding to support the development of Assembly Bio's antiviral pipeline, particularly for hepatitis D virus candidate ABI-6250 [1][6] - The funding and investment are expected to extend Assembly Bio's cash runway to mid-2026 [6] Funding and Investment Details - Gilead's equity investment will raise its ownership from approximately 19.9% to 29.9% [5] - The $10 million accelerated funding is part of option-related payments for ABI-6250 and will be credited against future payments under the collaboration agreement [5] - The amendment to the collaboration agreement adjusts the option timepoints and payment structure for ABI-6250 to support accelerated development strategies [3][5] Clinical Pipeline Progress - The funding will support the advancement of Assembly Bio's clinical pipeline for antiviral candidates targeting herpesviruses, hepatitis D virus, and hepatitis B virus [2] - Assembly Bio plans to release data from multiple ongoing clinical studies, including interim Phase 1b data for ABI-5366 expected in the first half of 2025 [2] - Since the collaboration began in October 2023, Assembly Bio has initiated clinical studies for four antiviral candidates [4] Strategic Implications - The additional investment is seen as a strengthening of Assembly Bio's balance sheet, allowing for key clinical data readouts in 2025 [4] - The updated clinical plan for ABI-6250 aims to significantly reduce the development timeline for the compound [4] - The collaboration highlights the collective efforts of both organizations to change the treatment paradigm for serious viral diseases [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to___________. Commission file number: 001-35005 ASSEMBLY BIOSCIENCES, INC. (Exact name of Registrant as specified in its charter) Delaware 20-8729264 (St ...

Financial Performance - Revenue from collaborative research was $6.8 million for Q3 2024, compared to $0 for the same period in 2023, attributed to the collaboration with Gilead[4] - Net loss attributable to common stockholders was $9.6 million, or $1.51 per share, for Q3 2024, compared to a net loss of $14.4 million, or $3.29 per share, for Q3 2023[4] - Total operating expenses for Q3 2024 were $17.8 million, compared to $15.0 million for Q3 2023[4] Research and Development - Positive Phase 1a interim data for ABI-5366 showed a favorable safety profile with a half-life of approximately 20 days and well-tolerated exposures of up to 70 days[1] - ABI-5366 Phase 1b trial initiated for recurrent genital herpes, with interim data expected in the first half of 2025[1] - ABI-4334 Phase 1b trial ongoing for chronic HBV, with interim data expected by the end of 2024[1] - ABI-1179 and ABI-6250 candidates are on track to enter the clinic by the end of 2024[4] Financial Position - Cash, cash equivalents, and marketable securities totaled $95.0 million as of September 30, 2024, down from $109.2 million as of June 30, 2024, projected to fund operations into Q1 2026[4] - Total liabilities as of September 30, 2024, were $74.3 million, down from $95.7 million at the end of 2023[4] Expense Trends - Research and development expenses increased to $13.5 million in Q3 2024, up from $10.8 million in Q3 2023, due to more candidates in development[4]

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Assembly Biosciences (ASMB) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Assembly Biosciences is a member of the Medical sector. This group includes 1019 individual stocks and currently holds a Zacks Sector Rank of #5. The Zac ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 ASMB The Nasdaq Global Select Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to_________ ...

Exhibit 99.1 Assembly Biosciences Reports Second Quarter 2024 Financial Results and Recent Updates • Dosing initiated in healthy participants in Phase 1a/b trial for ABI-5366 targeting recurrent genital herpes, with interim Phase 1a first-in-human data expected in Q3 2024 and interim Phase 1b data in participants with recurrent genital herpes expected in first half of 2025 • Dosing initiated in Phase 1b trial for ABI-4334 in participants with chronic HBV infection, with interim Phase 1b data expected by end ...

– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented – – Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials – – Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 – SOUTH SAN FRANCISCO, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a bi ...

– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented – – Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials – – Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 – SOUTH SAN FRANCISCO, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a bio ...

Core Insights - Assembly Biosciences, Inc. has initiated dosing for the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator aimed at treating chronic hepatitis B virus (HBV) infection [1][4] - Chronic HBV infection is a significant global health issue, leading to over one million deaths in 2022, with current treatments offering low cure rates [2] - ABI-4334 is designed to inhibit HBV DNA replication and prevent the formation of new cccDNA, showing promising preclinical potency [2][3] Company Overview - Assembly Biosciences is focused on developing innovative small molecule therapeutics for serious viral diseases, including HBV and hepatitis delta virus (HDV) [7] - The company is led by a team experienced in virologic drug development, aiming to improve patient outcomes [7] Clinical Trial Details - The Phase 1b study, ABI-4334-102, is a randomized, blinded, placebo-controlled trial enrolling up to 50 subjects to evaluate safety, pharmacokinetics (PK), and antiviral activity over a 28-day treatment period [5] - The trial will assess the impact of escalating doses of ABI-4334 on HBV DNA levels and gather key safety data [4][5] - Interim results from the study are expected to be reported later in the year [4]