Core Insights - Assembly Biosciences, Inc. is advancing its antiviral pipeline with four development candidates in clinical studies, with data expected in 2025 [1][2] - The company reported a significant increase in collaborative research revenues and a reduction in net loss compared to the previous year [11][15] Clinical Development - ABI-5366 and ABI-1179 are long-acting helicase-primase inhibitors for recurrent genital herpes, with interim Phase 1b proof-of-concept data expected in fall 2025 [1][4] - ABI-1179 has shown positive Phase 1a interim data, indicating it is well-tolerated and supports potential once-weekly oral dosing [7] - ABI-6250, an oral small molecule entry inhibitor for chronic hepatitis delta virus (HDV), has initiated dosing in Phase 1a studies [7] - ABI-4334, a capsid assembly modulator for chronic hepatitis B virus (HBV), demonstrated a mean decline in HBV DNA of 2.9 log10 IU/mL in a Phase 1b study [7] Financial Performance - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $112.1 million, an increase from $95.0 million as of September 30, 2024 [11] - Revenues from collaborative research rose to $28.5 million in 2024, compared to $7.2 million in 2023, primarily due to a full year of revenue recognition from the collaboration with Gilead [11] - Research and development expenses increased to $55.9 million in 2024 from $48.9 million in 2023, reflecting more candidates in development [11] - The net loss attributable to common stockholders decreased to $40.2 million, or $6.69 per share, from $61.2 million, or $13.38 per share, in 2023 [11][15] Partnerships and Funding - The collaboration with Gilead Sciences resulted in approximately $20.1 million in equity investment and $10 million in accelerated funding to support clinical development programs [7] - The company plans to run concurrent studies for ABI-5366 and ABI-1179, evaluating weekly and monthly oral dosing for recurrent genital herpes [7] Future Milestones - Key upcoming milestones include interim efficacy, safety, and pharmacokinetic data for ABI-5366 and ABI-1179 in fall 2025, and data from ABI-6250 in Q3 2025 [7] - Efficacy, safety, and pharmacokinetic data from the remaining cohort of ABI-4334 is expected in the first half of 2025 [7]

Core Insights - Assembly Biosciences has initiated a Phase 1a clinical trial for ABI-6250, an oral small molecule candidate targeting hepatitis delta virus (HDV) [1][2] - The trial aims to evaluate the safety, tolerability, and pharmacokinetics of ABI-6250 in healthy participants, with data expected in Q3 2025 [1][2] - ABI-6250 has the potential to be the first oral therapy for chronic HDV, a severe form of viral hepatitis with limited treatment options [4] Company Overview - Assembly Biosciences is focused on developing innovative therapeutics for serious viral diseases, including herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV) [8] - The company is led by a team experienced in virologic drug development and aims to improve patient outcomes [8] Clinical Trial Details - The Phase 1a study will assess single and multiple ascending doses of ABI-6250, including safety, tolerability, pharmacokinetics, and serum bile acids as a biomarker for target engagement [2][6][7] - The trial will involve healthy participants randomized between ABI-6250 and placebo across multiple cohorts [6][7] - Results from this trial will inform dose selection for future clinical studies [7] Current Treatment Landscape - Currently, there is one approved therapy for chronic HDV infection in the European Union, which requires daily injections [3] - There are no approved therapies for chronic HDV infection in the United States, highlighting a significant unmet medical need [3]

Core Insights - Assembly Biosciences, Inc. announced positive interim Phase 1a results for ABI-1179, a long-acting helicase-primase inhibitor targeting recurrent genital herpes [1][4] - The drug demonstrated a mean half-life of approximately four days, supporting a once-weekly oral dosing regimen, and was well-tolerated with a favorable safety profile [2][7][9] - The company plans to advance ABI-1179 into Phase 1b studies concurrently with ABI-5366, another investigational candidate, with interim data expected in fall 2025 [3][10] Study Overview - The Phase 1a study (ABI-1179-101) is a randomized, blinded, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of ABI-1179 in healthy participants [5] - Dosing has been completed for three cohorts (50 mg, 100 mg, and 300 mg), with a randomized allocation of 6:2 between ABI-1179 and placebo [5] Safety and Efficacy - ABI-1179 was well-tolerated across all evaluated doses, with mild treatment-emergent adverse events and no serious adverse events reported [9] - A self-limited grade 2 alanine transaminase elevation was noted in the highest dose cohort, but no significant ECG abnormalities or severe laboratory issues were observed [9] Future Plans - The Phase 1b study will evaluate multiple ascending doses of ABI-1179 in participants with recurrent genital herpes, focusing on safety, tolerability, pharmacokinetics, and antiviral activity [10][11] - The study will assess changes in viral parameters and clinical outcomes, including lesion recurrence rates [11] Industry Context - Recurrent genital herpes affects millions, with current treatments being only partially effective; no new drugs have been approved for over 25 years [13] - The helicase-primase inhibition mechanism has shown potential for superior efficacy compared to existing nucleoside analogs [14]

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]

Financial Performance - The net loss for the three months ended September 30, 2024, was $9,613,000, compared to a net loss of $14,420,000 for the same period in 2023, reflecting a reduction in losses of about 33.5%[7]. - The net loss for the nine months ended September 30, 2024, was $29,842,000, compared to a net loss of $50,266,000 for the same period in 2023, indicating a reduction in losses[11]. - The company reported a net loss of $9.6 million for the three months ended September 30, 2024, compared to a net loss of $14.4 million for the same period in 2023, representing a 33.5% improvement[25]. - Basic net loss per share for the nine months ended September 30, 2024, was $(5.12), an improvement from $(11.61) in the same period of 2023[25]. - Comprehensive loss for the three months ended September 30, 2024, was $9,476,000, compared to $14,370,000 for the same period in 2023, showing a 33.5% improvement[7]. Revenue and Collaboration - Collaboration revenue from a related party for the three months ended September 30, 2024, was $6,845,000, compared to $0 for the same period in 2023[7]. - The company recognized $6.8 million in collaboration revenue from the Gilead Collaboration Agreement during the three months ended September 30, 2024[27]. - Collaboration revenue recognized from the Gilead Collaboration Agreement was $6.8 million for the three months ended September 30, 2024, and $21.2 million for the nine months ended September 30, 2024[52]. - The total transaction price for the Gilead Collaboration Agreement was determined to be $90.7 million as of September 30, 2024[50]. - The Company entered into a collaboration agreement with Gilead in October 2023, receiving total proceeds of $100.0 million[46]. Assets and Liabilities - As of September 30, 2024, total assets decreased to $100,262,000 from $136,823,000 as of December 31, 2023, representing a decline of approximately 26.5%[6]. - Total liabilities decreased to $74,259,000 as of September 30, 2024, from $95,726,000 as of December 31, 2023, a decrease of approximately 22.4%[6]. - The accumulated deficit increased to $815,590,000 as of September 30, 2024, from $785,748,000 as of December 31, 2023[6]. - Total stockholders' equity decreased from $41,714,000 as of September 30, 2023, to $26,003,000 as of September 30, 2024, indicating a significant decline[10]. - Total current liabilities rose to $41.635 million from $39.225 million, an increase of about 6.1%[6]. Cash Flow and Expenses - Cash and cash equivalents increased to $28,452,000 from $19,841,000, marking a growth of about 43.3%[6]. - The company reported net cash used in operating activities of $50,710,000 for the nine months ended September 30, 2024, slightly lower than $50,904,000 for the same period in 2023[11]. - The company reported total operating expenses of $17,801,000 for the three months ended September 30, 2024, compared to $15,048,000 for the same period in 2023, an increase of approximately 18.4%[7]. - Research and development expenses rose to $13,515,000 for the three months ended September 30, 2024, up from $10,824,000 in the same period of 2023, an increase of approximately 24.9%[7]. - The company incurred $0.3 million in reimbursable expenses due to Gilead during the nine months ended September 30, 2024[52]. Stock and Equity - The weighted average common shares outstanding for the three months ended September 30, 2024, was 6,351,431, compared to 4,380,444 for the same period in 2023[7]. - The company completed a reverse stock split at a ratio of 1-for-12, reducing the number of shares outstanding from 65.8 million to 5.5 million[22]. - The exercise price of warrants sold was set at $17.00 per share, with an expiration date of June 18, 2029[41]. - The company has $2.9 million of total unrecognized stock-based compensation related to outstanding equity awards as of September 30, 2024[44]. - The weighted average number of common shares outstanding increased to 6,351,431 for the three months ended September 30, 2024, up from 4,380,444 in the same period of 2023[25]. Future Outlook - The company has not generated any revenue from product sales to date and continues to incur substantial losses as it develops its product pipeline[13]. - The company expects to continue incurring substantial losses for the next several years as it advances its product development efforts[13]. - The company has sufficient funds to meet its operating requirements for at least the next twelve months, but may need to secure additional funding through various means[13]. - The company intends to secure additional funding through strategic relationships, public or private equity or debt financings, and grants[13]. - Gilead will support the collaboration with extension fees of $75.0 million in each of the third, fifth, and seventh years of the collaboration[48].

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 ...