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Down -22.6% in 4 Weeks, Here's Why Assembly Biosciences (ASMB) Looks Ripe for a Turnaround
ZACKS· 2025-04-08 14:35
Core Viewpoint - Assembly Biosciences (ASMB) is experiencing significant selling pressure, with a 22.6% decline over the past four weeks, but is now positioned for a potential trend reversal due to being in oversold territory and positive earnings expectations from Wall Street analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - ASMB's current RSI reading is 20.23, suggesting that heavy selling may be exhausting itself, indicating a potential bounce back towards equilibrium in supply and demand [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that ASMB's earnings estimates for the current year have increased by 11.4% over the last 30 days, which often correlates with near-term price appreciation [7]. - ASMB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the stock's potential for a turnaround [8].
Assembly Biosciences (ASMB) Upgraded to Buy: What Does It Mean for the Stock?
ZACKS· 2025-03-26 17:00
Core Viewpoint - Assembly Biosciences (ASMB) has received a Zacks Rank 2 (Buy) upgrade due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Correlation - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, particularly influenced by institutional investors who adjust their valuations based on these estimates [4][6]. - Rising earnings estimates for Assembly Biosciences indicate an improvement in the company's underlying business, suggesting potential for stock price appreciation [5]. Recent Performance and Projections - Assembly Biosciences is projected to earn -$6.78 per share for the fiscal year ending December 2025, reflecting a year-over-year change of -1.4% [8]. - Over the past three months, the Zacks Consensus Estimate for Assembly Biosciences has increased by 11.4%, indicating positive revisions in earnings estimates [8]. Zacks Rating System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, highlighting superior earnings estimate revisions [9][10]. - The upgrade of Assembly Biosciences to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].
Assembly Biosciences(ASMB) - 2024 Q4 - Annual Report
2025-03-20 20:15
Clinical Development - The biotechnology company is developing multiple clinical-stage investigational therapies targeting serious viral diseases, including two helicase-primase inhibitors (HPIs) for recurrent genital herpes and an orally bioavailable hepatitis delta virus (HDV) entry inhibitor [211]. - The company initiated several Phase 1 studies in 2024, including a Phase 1a/b study of 5366 and 1179, both long-acting HPIs for recurrent genital herpes, and a Phase 1a study of 6250, an orally bioavailable HDV entry inhibitor [212]. - Interim results from the Phase 1a portion of the 5366 study showed a mean half-life of approximately 20 days, supporting once-weekly oral dosing, with no serious adverse events reported [221][222]. - The company expects interim data from the Phase 1b portion of the 5366 study to be available in fall 2025 [223]. - The company nominated 6250, a novel orally bioavailable small molecule targeting NTCP, for HBV and HDV entry inhibition, demonstrating low nanomolar potency and a favorable safety profile in nonclinical studies [237]. - A Phase 1a clinical study of 6250 was initiated in Q4 2024, with interim safety and pharmacokinetic data expected in Q3 2025 [238]. - The company plans to report interim data for both 5366 and 1179 concurrently in fall 2025, as both studies are anticipated to be conducted at the same sites [228]. - The company is advancing 1179, which has shown single-digit nanomolar potency against HSV-1 and HSV-2, supporting its potential as a long-acting treatment [224]. - The Phase 1a study of the next-generation CAM, 4334, demonstrated a mean decline in HBV DNA of 2.9 log10 IU/mL in predominantly HBeAg negative participants [244]. - Interim clinical results from the initial 150 mg cohort of 4334 indicated that clinical exposures were multiple folds above those anticipated for potent viral activity [244]. - The company anticipates releasing data from the 400 mg cohort of 4334 in the first half of 2025, following strong antiviral activity observed in the first cohort [244]. Financial Performance - The company has an accumulated deficit of $825.9 million as of December 31, 2024, and expects to continue generating losses as it develops its product candidates [255]. - Collaboration revenue for the year ended December 31, 2024, was $28.5 million, a 298% increase from $7.2 million in 2023, primarily due to a full year of revenue recognition under the Gilead Collaboration Agreement [268]. - Research and development expenses increased to $55.9 million in 2024 from $48.9 million in 2023, reflecting a $7.0 million rise driven by external program expenses related to pipeline advancements [271]. - General and administrative expenses decreased to $18.0 million in 2024, down 21% from $22.9 million in 2023, mainly due to reduced legal expenses and stock-based compensation [274]. - Interest and other income, net, rose to $5.6 million in 2024, a 61% increase from $3.5 million in 2023, attributed to higher interest income from marketable securities following a $100.0 million receipt from the Gilead Collaboration [275]. - Income tax expense for 2024 was $0.3 million, a significant increase of 900% from $0.033 million in 2023, due to taxable income from upfront payments under the Gilead Collaboration [276]. - Total external program expenses for research and development increased by 40% to $28.4 million in 2024 from $20.3 million in 2023 [270]. - The company expects its existing cash, cash equivalents, and marketable securities will fund operations into mid-2026, based on current assumptions [281]. - Future operating expenses are anticipated to increase substantially as the company advances its candidates into clinical trials [280]. - The company has raised an aggregate of $648.0 million in net proceeds from equity financings and $200.9 million from strategic collaborations since its inception [279]. - Net cash used in operating activities for the year ended December 31, 2024 was $51.1 million, a decrease from net cash provided of $22.7 million in 2023 [285]. - Net cash provided by investing activities for the year ended December 31, 2024 was $40.2 million, compared to net cash used of $69.1 million in 2023 [286]. - Net cash provided by financing activities for the year ended December 31, 2024 was $29.4 million, an increase from $13.8 million in 2023 [287]. - The company experienced a net increase in cash and cash equivalents of $18.5 million in 2024, compared to a decrease of $32.6 million in 2023 [284]. Collaborations and Partnerships - Gilead made an upfront cash payment of $84.8 million as part of the collaboration agreement, with potential opt-in fees ranging from $45 million to $125 million per program [249]. - The collaboration with Gilead may yield up to $330 million in potential regulatory and commercial milestones, in addition to royalties ranging from high single-digits to high teens [250]. - Gilead's equity investment included purchasing 1,089,472 shares at $13.92 per share, with a subsequent purchase at $21.37 per share, representing a 35% premium [252]. Market Need and Impact - The World Health Organization estimates that 254 million people are chronically infected with HBV, with only approximately 33 million aware of their infection, highlighting a significant treatment gap [229]. - The current standard of care for chronic HBV infection has not seen new mechanisms of action approved in over 25 years, indicating a need for innovative therapies [230]. - Approximately 95,000 transplant patients in the U.S. and Europe were impacted by uncontrolled viral infections in 2021, highlighting the need for effective antiviral treatments [245]. - The company is developing a broad-spectrum NNPI for transplant-associated herpesvirus infections, with ongoing CTA-enabling studies for candidate 7423 [246].
Assembly Biosciences(ASMB) - 2024 Q4 - Annual Results
2025-03-20 20:10
Financial Performance - Assembly Biosciences reported cash, cash equivalents, and marketable securities of $112.1 million as of December 31, 2024, compared to $130.2 million as of December 31, 2023[7]. - Revenues from collaborative research increased to $28.5 million for the year ended December 31, 2024, up from $7.2 million in 2023, primarily due to a full year of revenue recognition under the collaboration with Gilead[7]. - Research and development expenses rose to $55.9 million in 2024, compared to $48.9 million in 2023, reflecting an increase in candidates under development[7]. - General and administrative expenses decreased to $18.0 million in 2024 from $22.9 million in 2023, mainly due to reductions in legal and non-cash stock-based compensation expenses[7]. - The net loss attributable to common stockholders was $40.2 million, or $6.69 per share, for the year ended December 31, 2024, compared to a net loss of $61.2 million, or $13.38 per share, in 2023[7]. - Total liabilities decreased to $85.8 million as of December 31, 2024, from $95.7 million in 2023[12]. Clinical Development - Positive Phase 1a interim data for ABI-1179 indicated it was well-tolerated, supporting potential once-weekly oral dosing at a low dose[3]. - ABI-4334 demonstrated a mean decline in HBV DNA of 2.9 log10 IU/mL in the initial 150 mg dose cohort, primarily in HBeAg negative participants[3]. - Assembly Biosciences plans to run concurrent studies for ABI-5366 and ABI-1179, with interim efficacy data expected in fall 2025[7]. - The company received approximately $20.1 million in equity investment and $10 million in accelerated funding from Gilead to advance clinical development programs[3].
Assembly Biosciences Reports Year End 2024 Financial Results and Recent Highlights
Globenewswire· 2025-03-20 20:05
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]
Assembly Biosciences Doses First Participant in Phase 1a Clinical Study of Oral Entry Inhibitor Candidate ABI-6250 for Hepatitis Delta Virus
GlobeNewswire News Room· 2025-02-26 13:00
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]
Assembly Biosciences Reports Positive Interim Phase 1a Results from Clinical Trial Evaluating Long-Acting Helicase-Primase Inhibitor ABI-1179 in Development for Recurrent Genital Herpes
GlobeNewswire News Room· 2025-02-20 13:00
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]
Assembly Biosciences Reports Interim Phase 1b Results from Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 in Chronic Hepatitis B
Newsfilter· 2024-12-26 13:00
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].
Assembly Biosciences Announces $30.1 Million Equity Investment and Accelerated Funding from Gilead to Advance Clinical Development Programs
Globenewswire· 2024-12-19 13:00
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]
Assembly Biosciences(ASMB) - 2024 Q3 - Quarterly Report
2024-11-07 21:24
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 ...