Major Estimate Revision • May 29
Consensus EPS estimates upgraded to US$1.08 loss The consensus outlook for fiscal year 2026 has been updated. 2026 losses forecast to reduce from -US$1.26 to -US$1.08 per share. Revenue forecast unchanged from US$58.0m at last update. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target of US$48.75 unchanged from last update. Share price fell 2.4% to US$27.66 over the past week. Ankündigung • May 22
Assembly Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $100.000038 million. Assembly Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $100.000038 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,358,602
Price\Range: $26.5
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 415,000
Price\Range: $26.499 New Risk • May 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 21% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 21% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (108% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$44m net loss in 3 years). Major Estimate Revision • May 14
Consensus revenue estimates fall by 25% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$41.8m to US$31.5m. Forecast losses increased from -US$1.46 to -US$2.84 per share. Biotechs industry in the US expected to see average net income decline 9.9% next year. Consensus price target of US$48.75 unchanged from last update. Share price fell 2.0% to US$30.30 over the past week. Ankündigung • May 14
Assembly Biosciences Announces Topline Phase 1A Data on Hepatitis Delta Virus Entry Inhibitor Abi-6250 Assembly Biosciences, Inc. announced topline clinical data on ABI-6250, an investigational oral hepatitis D virus (HDV) entry inhibitor, will be presented in a poster presentation at the European Association for the Study of the Liver (EASL) Congress taking place May 27-30, 2026, in Barcelona, Spain. The presentation will feature results from a randomized, blinded, Phase 1a study evaluating the safety, pharmacokinetics and pharmacodynamic activity of ABI-6250 following single- and multiple-dose administration in healthy participants. Presentation details are as follows: Title: Safety, Pharmacokinetics, and Pharmacodynamic Activity of ABI-6250, a First-in-Class Oral Hepatitis D Virus Entry Inhibitor, in Healthy Subjects: Interim Results From a Randomized, Blinded, Phase 1a Study. Presenter: Edward J. Gane, MD, University of Auckland. Poster Number: WED-579. Session: Viral Hepatitis B and D: New therapies, unapproved therapies or strategies. Date: Wednesday, May 27, 2026. Assembly Bio intends to make the poster available on the “Events & Presentations” page in the “Investors” section and on the “Publications” page in the “Pipeline” section of its website at www.assemblybio.com. ABI-6250 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy has not been established. Breakeven Date Change • May 11
Forecast to breakeven in 2028 The 4 analysts covering Assembly Biosciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$6.90m in 2028. Average annual earnings growth of 14% is required to achieve expected profit on schedule. Ankündigung • Apr 23
Assembly Biosciences, Inc., Annual General Meeting, Jun 04, 2026 Assembly Biosciences, Inc., Annual General Meeting, Jun 04, 2026. Major Estimate Revision • Apr 07
Consensus EPS estimates upgraded to US$1.46 loss The consensus outlook for fiscal year 2026 has been updated. 2026 losses forecast to reduce from -US$1.62 to -US$1.46 per share. Revenue forecast unchanged from US$41.8m at last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target up from US$47.75 to US$48.75. Share price rose 2.8% to US$28.53 over the past week. Major Estimate Revision • Mar 27
Consensus revenue estimates increase by 91% The consensus outlook for revenues in fiscal year 2026 has improved. 2026 revenue forecast increased from US$21.8m to US$41.8m. Forecast losses expected to reduce from -US$3.48 to -US$1.62 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$47.75 unchanged from last update. Share price fell 2.7% to US$27.70 over the past week. New Risk • Mar 26
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 7.9% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 7.9% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (111% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Breakeven Date Change • Mar 22
No longer forecast to breakeven The 4 analysts covering Assembly Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$3.00m in 2027. New consensus forecast suggests the company will make a loss of US$33.3m in 2028. Reported Earnings • Mar 20
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: US$0.55 loss per share (improved from US$6.69 loss in FY 2024). Revenue: US$72.3m (up 154% from FY 2024). Net loss: US$6.12m (loss narrowed 85% from FY 2024). Revenue exceeded analyst estimates by 94%. Earnings per share (EPS) also surpassed analyst estimates by 85%. Revenue is forecast to stay flat during the next 3 years compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 65% per year but the company’s share price has only increased by 32% per year, which means it is significantly lagging earnings growth. Ankündigung • Mar 20
Assembly Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $100 million. Assembly Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Dec 09
Assembly Biosciences Reports Positive Interim Results from Phase 1B Clinical Studies of Long-Acting Helicase-Primase Inhibitor Candidates Abi-1179 and Abi-5366 Showing Reductions in Viral Shedding Rate and Virologically Confirms Genital Herpes Assembly Biosciences, Inc. announced positive interim results from two Phase 1b studies of its investigational long-acting herpes simplex virus (HSV) enzyme-primase inhibitors in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes. These interim results include the first reported Phase 1b data for ABI-1179, evaluating weekly oral dosing. The ABI-5366 monthly oral dosing results are also encouraging and show significant reductions in viral shedding and virologically confirmed genital lesion rate, supporting the continued optimization of exposure to evaluate its potential for monthly oral dosing. In the ABI-1179 study, highly potent antiviral activity was observed with a 98% reduction in HSV-2 shedding rate compared to placebo There have been no serious adverse events reported to date. ABI-1179-101 Study Overview: ABI-1179- 101 is a randomized, blinded, placebo-controlled Phase 1a/b clinical study. Positive interim data have been previously reported for Part A (Phase 1a), evaluating the safety, tolerability and PK of ABI-1179 following single dose administration in healthy participants. Part B also evaluates antiviral activity by measuring changes in viral parameters including shedding rate, quantification of HSV-2 DNA levels obtained from anogenital swab samples, and clinical parameters including genital lesion rate and duration. Due to the observed half-life of ABI-1179, the safety follow-up period for participants extends for 29 days after dosing (Day 57), with safety data available as of the data cutoff date through Day 57 for all participants from these cohorts that completed the evaluation period. The study uses pooled data from placebo recipients across cohorts as a control. As additional placebo recipients are enrolled in later cohorts, the sample size for the pooled placebo will change, which is expected to result in adjustments to both the observed effect sizes compared to placebo and the tests of statistical significance for those observed effects. Additional information about the Phase 1a/b trial is available at clinicaltrials.gov using the identifier NCT06698575. ABI-5366-101 Study Overview: A BI-5366-101 is a randomized, blinded, randomized, placebo-controlled Phase 1 a/b clinical study. Positive Interim data have been previously reported for part A (Phase 1a), evaluate the safety, tolerability andPK of ABI-5366 following single dose administration in healthy Participants. These risks and uncertainties include: Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data may not differentiate Assembly Bio's product candidates;clinical and nonclinical data may not differentiated Assembly Bio's product candidates; regulatory and nonclinical data may not differentiation Assembly Bio's product candidates; Company to hold conference call on December 8, 2025 at 6 p.m. ET. Price Target Changed • Nov 29
Price target increased by 7.3% to US$41.00 Up from US$38.20, the current price target is an average from 4 analysts. New target price is 8.5% above last closing price of US$37.79. Stock is up 122% over the past year. The company is forecast to post a net loss per share of US$3.56 next year compared to a net loss per share of US$6.69 last year. Breakeven Date Change • Nov 14
No longer forecast to breakeven The 5 analysts covering Assembly Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$3.00m in 2027. New consensus forecast suggests the company will make a loss of US$12.8m in 2027. Reported Earnings • Nov 12
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third quarter 2025 results: US$0.72 loss per share (improved from US$1.51 loss in 3Q 2024). Revenue: US$10.8m (up 58% from 3Q 2024). Net loss: US$9.20m (loss narrowed 4.3% from 3Q 2024). Revenue exceeded analyst estimates by 16%. Earnings per share (EPS) also surpassed analyst estimates by 7.1%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 62% per year but the company’s share price has only increased by 31% per year, which means it is significantly lagging earnings growth. Ankündigung • Oct 10
Assembly Biosciences, Inc. Presents Interim Phase 1b Data for HSV Helicase-Primase Inhibitor Candidate ABI-5366 at the 38th Congress of the International Union Against Sexually Transmitted Infections (IUSTI) Europe Assembly Biosciences, Inc. announced that interim Phase 1b clinical data for its long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate ABI-5366 are featured in a late-breaking oral presentation during the 38th Congress of the International Union Against Sexually Transmitted Infections (IUSTI)- Europe, taking place October 9-11, 2025, in Athens, Greece. A monthly oral dosing regimen of ABI-5366 is currently being evaluated in the ongoing Phase 1b study. In addition, a Phase 1b study evaluating weekly dosing of ABI-1179, another long-acting HSV helicase-primase inhibitor candidates, is being conducted concurrently. Assembly Bio anticipates sharing interim data from both studies later this fall and expects to initiate Phase 2 clinical studies of ABI-5366 in mid-2026. Under the collaboration agreement between Assembly Bio and Gilead Sciences, Inc. (Gilead), Gilead has the right to opt in to an exclusive license for further development and commercialization of the helicase-primase inhibitor program after reviewing the option data package to be delivered by Assembly Bio following completion of the Phase 1b studies. These risks and uncertainties include: Assembly Bio's ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data may not differentiate Assembly Bio's product candidates from other companies' candidates; potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. Securities and Exchange Commission (the SEC). New Risk • Sep 24
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$39m Forecast net loss in 3 years: US$15m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (145% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Price Target Changed • Aug 18
Price target increased by 8.2% to US$36.25 Up from US$33.50, the current price target is an average from 4 analysts. New target price is 41% above last closing price of US$25.76. Stock is up 73% over the past year. The company is forecast to post a net loss per share of US$3.76 next year compared to a net loss per share of US$6.69 last year. New Risk • Aug 12
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 145% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Ankündigung • Aug 09
Assembly Biosciences, Inc. has filed a Follow-on Equity Offering. Assembly Biosciences, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,591,840
Price\Range: $19.6
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,040,820
Price\Range: $19.599
Security Name: Class A Warrant
Security Type: Equity Warrant
Securities Offered: 6,632,660
Security Name: Class B Warrant
Security Type: Equity Warrant
Securities Offered: 6,632,660
Transaction Features: Registered Direct Offering Reported Earnings • Aug 08
Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2025 results: US$1.33 loss per share (improved from US$1.98 loss in 2Q 2024). Revenue: US$9.63m (up 13% from 2Q 2024). Net loss: US$10.2m (loss narrowed 8.6% from 2Q 2024). Revenue exceeded analyst estimates by 82%. Earnings per share (EPS) missed analyst estimates by 12%. Revenue is expected to decline by 5.5% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 19%. Over the last 3 years on average, earnings per share has increased by 60% per year but the company’s share price has fallen by 2% per year, which means it is significantly lagging earnings. Ankündigung • Aug 08
Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Study of Long-Acting Helicase-Primase Inhibitor Candidate ABI-5366 Showing Reductions in Viral Shedding Rate and Genital Lesion Rate in Recurrent Genital Herpes Assembly Biosciences, Inc. announced positive interim antiviral activity, clinical outcomes, safety and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-5366, an investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor, in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes. For the powered antiviral endpoint, HSV-2 shedding rate, highly potent antiviral activity was observed with a 94% reduction compared to placebo (p104 copies/mL HSV DNA), a potential surrogate for HSV-2 transmission and a secondary endpoint, was reduced by 98% compared to placebo (pStudy ABI-5366-101 - Interim Phase 1b Results Interim Results. The Phase 1b interim analysis reported here includes data from cohort B1, evaluating a loading dose of 150 mg and weekly doses of 30 mg (the 150/30 mg cohort), and cohort B2, evaluating a loading dose and weekly doses of 350 mg (the 350 mg cohort), through the data cutoff date of July 29, 2025. A total of 50 participants have been enrolled in the 150/30 mg and 350 mg cohorts; 40 assigned to ABI-5366 (20 participants in each cohort) and 10 assigned to placebo (five in each cohort). Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. New Risk • Aug 07
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. Minor Risk Shareholders have been diluted in the past year (21% increase in shares outstanding). Ankündigung • Aug 07
Assembly Biosciences Reports Interim Phase 1a Data from Clinical Study of Oral Entry Inhibitor Candidate ABI-6250 for Hepatitis Delta Virus Assembly Biosciences, Inc. announced interim data from several cohorts from the ongoing Phase 1a clinical trial of ABI-6250, the company's orally bioavailable, small molecule hepatitis delta virus (HDV) entry inhibitor candidate. In the cohorts evaluated to date, a mean half-life of four days was observed for ABI-6250 when dosed orally, supporting the target daily oral dosing profile. Additionally, dose-dependent elevations of total serum bile acids (TBA) were seen over both single- and multiple-dose cohorts. Additional studies are planned to explore potential factors associated with these elevations given the role of ABI-6250's target as a bile acid transport. This assessment is expected to include further pharmacological characterization of ABI-6250 and may incorporate additional cohorts in this Phase 1a study. Assembly Bio expects to conduct these activities in parallel with preparations for Phase 2 clinical studies and the completion of ongoing chronic toxicology studies. ABI-6250 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy have not been established. ABI-6250-101 is an ongoing randomized, blinded and placebo-controlled Phase 1a clinical study evaluating the safety, tolerability and pharmacokinetics (PK) of ABI-6250 following single- and multiple-ascending oral dose administration in healthy participants. Changes in TBAs are also evaluated as a biomarker for NTCP engagement. Dosing is complete in two single-dose cohorts evaluating doses of 5 mg and 25 mg and three multiple-dose cohorts evaluating doses of 0.05 mg, 0.2 mg and 1 mg, each randomized 6:2 between ABI-6250 and placebo. These risks and uncertainties include: Assembly Bio's ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, other business operations and continue as a going concern; Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc. (Gilead), including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data may not differentiate Assembly Bio's product candidates from other companies' candidates; potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. Securities and Exchange Commission (the SEC). Ankündigung • Jul 01
Assembly Biosciences Doses First Participant in Phase 1B Portion of Phase 1A/B Clinical Trial of Investigational Long-Acting Herpes Simplex Virus Helicase-Primase Inhibitor Abi-1179 Assembly Biosciences, Inc. announced that the first participant has been dosed in the Phase 1b portion of the Phase 1a/b study of its long-acting herpes complex virus (HSV) helicase-primase inhibitor candidate ABI-1179. The Phase 1b study will evaluate the safety and antiviral activity of weekly oral doses of ABI-1179 over a 29-day treatment period in participants with recurrent genital herpes. Antiviral activity will be evaluated by assessing changes in viral parameters, including HSV type 2 (HSV-2) shedding rate and levels of HSV-2 DNA. Assembly Bio has advanced both ABI-5366 and ABI-1179 into Phase 1b studies after each long-actinghelicase-primase inhibitor candidate exceeded the company's target PK profiles in Phase 1a evaluation in healthy participants. The Phase 1b studies utilize equivalent eligibility criteria and outcome measures and are being conducted at overlapping sites. To maintain enrollment timelines while running both trials concurrently, Assembly Bio has received clearance for an Investigational New Drug application (IND) for ABI-1179 to support expansion of this Phase 1b study to sites in the United States. The studies for both candidates are on track to report interim data in fall 2025. Under the collaboration agreement between Assembly Bio and Gilead Sciences, Inc. (Gilead), Gilead has the right to opt in to an exclusive license for further development and commercialization of ABI-1179 and ABI-5366 after reviewing the Phase 1b data package to be delivered by Assembly Bio following completion of the studies. ABI-1179-101 is a randomized, blinded, placebo-controlled Phase 1a/b clinical study of ABI-1179. Interim data has been reported for Part A (Phase 1a), evaluating the safety, tolerability and PK of ABI-1179 following single dose administration in healthy participants randomized 6:2 between ABI-1179 and placebo in up to five cohorts at different dose levels. In addition to assessing safety, tolerability and PK, Part B will also evaluate antiviral activity by measuring changes in the viral parameters including viral shedding rate and HSV-2 DNA levels obtained from anogenital swab samples, and clinical parameters including lesion recurrence rate and lesion duration. The trial results will support dose selection for future clinical trials. Additional information about the Phase 1a/b trial is available at clinicaltrials.gov using the identifier NCT06698575. Assembly Bio expects to submit data from the trial for presentation at future scientific meetings. Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data may not differentiate Assembly Bio's product candidates from other companies' candidates; potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio. Ankündigung • Jun 25
Assembly Biosciences Reports Positive Topline Results from Phase 1B Clinical Trial of Next-Generation Investigational Capsid Assembly Modulator ABI-4334 in Chronic Hepatitis B Assembly Biosciences, Inc. announced positive topline efficacy, safety and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-4334, an investigational next-generation capsid assembly modulator (CAM), in participants with chronic hepatitis B virus (HBV) infection. In the cohort evaluating a 400 mg oral daily dose, potent antiviral activity was observed over the 28-day treatment period similar to that previously reported for the 150 mg dose cohort. The relationship between ABI-4334's observed antiviral activity and its exposure profile was consistent with having reached full engagement of the first mechanism of action for CAMs, inhibition of viral replication, at the lower 150 mg dose. Under the collaboration agreement between Assembly Bio and Gilead Sciences, Inc. (Gilead), Gilead has the right to opt in to an exclusive license for further development and commercialization of ABI-4334 after reviewing the Phase 1b option data package to be delivered by Assembly Bio following completion of this study. ABI-4334 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy have not been established. Study Overview: ABI-4334-102 (Study 102) was a randomized, blinded, placebo-controlled, dose-ranging Phase 1b clinical study that evaluated the safety, PK and antiviral activity of ABI-4334. The study was conducted in treatment-naive or off-treatment participants with HBeAg positive or negative chronic HBV infection. Two cohorts of 10 subjects each were randomized 8:2 to receive ABI-4334 at 150 mg (cohort B1), 400 mg (cohort B2) or placebo daily for a 28-day treatment period. Topline Results: In Study 102, ABI-4334 was well-tolerated with a favorable safety profile observed in participants with chronic HBV infection. No pattern of safety signals has been identified and there were no serious adverse events or adverse events that led to study drug discontinuation. Two grade three treatment-emergent lab abnormalities were observed, one alanine aminotransferase (ALT) elevation in a participant receiving 150 mg ABI-4334, and one total bilirubin elevation in a placebo recipient. These risks and uncertainties include: Assembly Bio's ability to maintain financial resources necessary to continue its research activities, clinical studies and other business operations; Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data may not differentiate Assembly Bio's product candidates from other companies' candidates; potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. Securities and Exchange Commission (the SEC). Breakeven Date Change • May 21
Forecast to breakeven in 2027 The 2 analysts covering Assembly Biosciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$34.8m in 2027. Average annual earnings growth of 3.4% is required to achieve expected profit on schedule. Major Estimate Revision • May 15
Consensus revenue estimates increase by 33% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$31.0m to US$41.2m. EPS estimate unchanged from -US$3.55 at last update. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target of US$33.50 unchanged from last update. Share price fell 2.4% to US$12.11 over the past week. Reported Earnings • May 10
First quarter 2025 earnings: EPS and revenues exceed analyst expectations First quarter 2025 results: US$1.18 loss per share (improved from US$1.66 loss in 1Q 2024). Revenue: US$9.42m (up 63% from 1Q 2024). Net loss: US$8.82m (loss narrowed 2.9% from 1Q 2024). Revenue exceeded analyst estimates by 9.6%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 8.3% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings. Ankündigung • May 07
Assembly Biosciences, Inc. Announces New Preclinical and in Vitro Data Assembly Biosciences, Inc. announced new preclinical and in vitro data for two therapeutic candidates featured in poster presentations, including one late-breaker, at the European Association for the Study of the Liver (EASL) Congress, taking place May 7-10, 2025, in Amsterdam, the Netherlands. ABI-6250: An oral viral entry inhibitor candidate for hepatitis D virus (HDV) infection. The late-breaker poster presentation titled "Preclinical profiling of ABI-6250, a first-in-class oral therapeutic candidate for chronic HDV infection, a severe form of viral hepatitis with limited treatment options available. Additionally, in vitro data presented for ABI-4334 provide further insights into the potential for next-generation capsid assembly modulators to impact markers of chronic HBV infection. The late-breaker Poster presentation titled "Preclinical profiling the ABI-6250, ABI-6250, an first-in-class oral therapy candidate for chronic HDV infection. Results demonstrate that in cell culture, ABI-6250 specifically inhibits both HDV and hepatitis B virus (HBV) at low nanomolar levels and shows selectivity versus a panel of other viruses. ABI-6250 showed minimal effects on cell viability in vitro across multiple cell types, and also selectively inhibited the sodium taurocholate chotransporting polypeptide (NTCP) bile acid transporter compared to a broad range of other transporters in vitro. In vivo, treatment with ABI-6250 elevated total bile acids at doses that did not increase biomarkers for inhibition of other transporters, indicating selective NTCP target engagement. These results support ABI-6250 as an inhibitor of NTCP and describe total bile acids as a biomarker for target engagement that Assembly Bio plans to evaluate in the ongoing Phase 1a study. Price Target Changed • Apr 24
Price target decreased by 14% to US$31.00 Down from US$36.00, the current price target is provided by 1 analyst. New target price is 194% above last closing price of US$10.53. Stock is down 21% over the past year. The company is forecast to post a net loss per share of US$5.68 next year compared to a net loss per share of US$6.69 last year. Ankündigung • Apr 24
Assembly Biosciences, Inc., Annual General Meeting, Jun 05, 2025 Assembly Biosciences, Inc., Annual General Meeting, Jun 05, 2025. Ankündigung • Apr 09
Assembly Biosciences, Inc. Presents New Data Highlighting Long-Acting Herpes Simplex Virus Candidate Abi-5366 and Genital Herpes Prevalence and Treatment Patterns At the 2025 Escmid Congress Assembly Biosciences, Inc. announced data from its herpes simplex virus program featured in three poster presentations at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases taking place in Vienna, Austria, on April 11-15, 2025. ABI-5366: a Long-Acting Helicase-Primase Inhibitor candidate for Recurrent Genital Herpes. The ePoster entitled "The safety and pharmacokinetics of ABI-5366, a novel, oral, long-acting HSVhelicase-primase inhibitor: Interim results from a Phase 1a/1b study in healthy participants" showcases clinical data from a single-dose Phase 1a evaluation of safety and pharmacokinetics of ABI-5366 in healthy participants. Results demonstrate that ABI-5366 was well tolerated when administered orally up to 350 mg with no Grade 3 or 4 treatment-related laboratory abnormalities or serious adverse events reported. Further, an observed half-life of approximately 20 days across all dosing cohorts supports the potential for once-weekly or once-monthly oral administration. Preclinical data also reinforce a PK profile supportive of the potential for once-weekly and once-monthly oral dosing and demonstrate distribution of ABI-5366 to tissues relevant to HSV infection. ABI-5366 is being evaluated in the Phase 1b portion of an ongoing Phase 1a/b study in participants with recurrent genital herpes. Assembly Bio expects to report interim Phase 1b data for both ABI-5366 and ABI-1179, a second long-acting helicase-primase inhibitor candidate, in fall 2025. Genital Herpes Prevalence and Treatment patterns: The poster entitled "Estimating Genital Herpes Prevalences and Treatment patterns Among U.S. Healthcare-Engaged Individuals: Insights from Claims Data" features results from a retrospective analysis of data from Forian's hybrid claims ecosystem and electronic health record database, CHRONOS, of more than 40 million individuals to estimate genital herpes prevalence and treatment patterns. Major Estimate Revision • Mar 27
Consensus EPS estimates upgraded to US$5.68 loss, revenue downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$33.2m to US$31.0m. 2025 losses expected to reduce from -US$7.65 to -US$5.68 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target of US$34.00 unchanged from last update. Share price was steady at US$10.90 over the past week. New Risk • Mar 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 37% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$51m free cash flow). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (37% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$97m net loss in 3 years). Market cap is less than US$100m (US$82.6m market cap). New Risk • Mar 21
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$51m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$51m free cash flow). Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$101m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (US$67.9m market cap). Ankündigung • Feb 26
Assembly Biosciences Doses First Participant in Phase 1A Clinical Study of Oral Entry Inhibitor Candidate Abi-6250 for Hepatitis Delta Virus Assembly Biosciences, Inc. announced that the first participant has been dosed in the Phase 1a trial of ABI-6250, the company's orally bioavailable, small molecule hepatitis delta virus (HDV) entry inhibitor candidate. This Phase 1a study will evaluate the safety, tolerability and pharmacokinetics (PK) of ABI-6250 across single and multiple ascending dose cohorts in healthy participants. In addition, the study will look at serum bile acids as a biomarker of ABI-6250's engagement of its target, the transporter used by HDV to infect hepatocytes (sodium taurocholate cotran sporting polypeptide or NTCP). Assembly Bio expects to share data from the Phase 1a study in third quarter 2025. In preclinical studies, ABI-6250 has demonstrated low nanomolar potency across multiple HDV genotypes in vitro, selectivity for NTCP versus other bile acid transporters and a PK profile supportive of once-daily oral dosing. ABI-6250 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy have not been established. ABI-6250-101 is a randomized, blinded and placebo-controlled Phase 1a clinical study evaluating the safety, tolerability and PK of ABI-6250 following single and multiple ascending dose administration. Healthy participants will be randomized between ABI-6250 and placebo in up to five single-dose and five multiple-dose cohorts at different doses. Multiple-dose cohorts will evaluate repeat dosing over 10 days. In addition to assessing safety, tolerability and PK, this Phase 1a study will also measure changes in serum bile acid levels, a biomarker of NTCP engagement. The trial results will support dose selection for future clinical studies. Additional information about the Phase 1a trial is available at clinicaltrials.gov using the identifier NCT06740474. Ankündigung • Feb 20
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 Assembly Biosciences, Inc. announced positive interim Phase 1a results in healthy participants from its ongoing Phase 1a/b study of ABI-1179, an investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate for recurrent genital herpes. A half-life of approximately four days and high exposure across the dose range evaluated exceeded Assembly Bio's targets for a once-weekly oral dosing profile. ABI-1179 was well-tolerated with a favorable safety profile observed. At all doses evaluated, including the lowest dose of 50 mg, ABI-1179 exceeded Assembly Bio's target plasma concentrations for antiviral activity, a target established from pharmacokinetic (PK) modelling and projected to achieve increased efficacy compared to approved therapies. This Phase 1b study will be conducted concurrently with the ongoing Phase 1b evaluation of ABI-5366, Assembly Bio's other long-acting helicase-primase inhibitor candidates that began dosing in Phase 1b in the fourth quarter of 2024. The studies are anticipated to be conducted at the same sites using equivalent eligibility criteria and outcome measures for both candidates. Assembly Bio plans to report interim data for both candidates together in fall 2025 given adjustments to enrollment timelines that will enable the studies to run concurrently. ABI-1179 were contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead. ABI-1179 and ABI-5366 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established. ABI-1179-101 is a randomized, blinded and placebo-controlled Phase 1a/b clinical study of ABI- 1179. Part A (Phase 1a) is ongoing, evaluating the safety, tolerability and PK of ABI-1179 following single ascending dose administration in healthy participants. Dosing is complete for three cohorts in Part A, evaluating doses of 50 mg, 100 mg and 300 mg, with each cohort randomized 6:2 between ABI-1179 and placebo. The study protocol includes a food effect cohort, which has not yet been conducted. These risks and uncertainties include: Assembly Bio's ability to maintain financial resources necessary to continue its research activities, clinical studies and other business operations; Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio's product candidates from other companies' candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. Securities and Exchange Commission (the SEC). Ankündigung • Dec 26
Assembly Biosciences Reports Interim Phase 1b Results from Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 in Chronic Hepatitis B Assembly Biosciences, Inc. announced encouraging interim safety, pharmacokinetic (PK) and efficacy results from participants with chronic hepatitis Birus (HBV) infection in its ongoing Phase 1b study evaluating ABI-4334, an investigational next-generation viral assembly modulator (CAM). Improvements in trial-defined measures of antiviral activity were observed in the first Phase 1b cohort that received an oral, once-daily dose of 150 mg of ABI-4334 over a 28-day treatment period. A mean decline in HBV DNA of 2.9 log10 IU/mL was observed in a population of predominately hepatitis B virus (HBeAg) negative participants. Safety data for study participants in both cohorts to date demonstrated that ABI-4334 was well-tolerated with a favorable safety profile observed. Enrollment is ongoing for the second cohort, evaluating an oral once-daily dose of ABI-4334 of 400 mg. Based on antiviral activity observed in the first cohort, Assembly Bio expects that the 400 mg cohort will be the final cohort for this Phase 1b study and anticipates releasing data from this cohort in the first half of 2025. Under the collaboration agreement between Assembly Bio and Gilead Sciences, Inc. (Gilead), Gilead has the right toopt in to further development and commercialization for ABI-4334 after Assembly Bio's delivery of a data package following completion of this Phase 1b study. ABI-4334 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy have not been established. Study Overview ABI-4334-102 is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b clinical study evaluating the safety, PK and antiviral activity of ABI-4334. The study is being conducted in treatment-naive or off-treatment participants with HBeAg positive or negative chronic HBV infection. The study is anticipated to enroll two potential cohorts of 10 subjects each, randomized 8:2 to receive ABI-4334 or placebo daily for a 28-day treatment period; Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio's product candidates from other companies' candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. U.S. and U.S.S.S. and the U.S.S. is currently in the U.S. and the U.,S.S.S.C. (Gilead), the U.S.S., the U.S. and its U.S.S. and U.C. and the U.S., the company will continue to evaluate the safety and safety profile for ABI-4334 in the U.S.C. New Risk • Dec 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 24% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$97m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (US$85.9m market cap). New Risk • Nov 20
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$97.5m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 24% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$97m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (US$97.5m market cap). Major Estimate Revision • Nov 14
Consensus revenue estimates decrease by 11%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$31.7m to US$28.2m. EPS estimate increased from -US$7.82 to -US$6.87 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$35.50 unchanged from last update. Share price was steady at US$16.70 over the past week. Ankündigung • Nov 08
Assembly Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $75 million. Assembly Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $75 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Sep 25
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$98m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (45% increase in shares outstanding). Market cap is less than US$100m (US$96.1m market cap). Ankündigung • Jul 15
Assembly Biosciences Presents New Preclinical Data Highlighting Investigational Helicase-Primase Inhibitors At International Herpesvirus Workshop Assembly Biosciences, Inc. announced new preclinical data from its investigational herpes simplex virus (HSV) portfolio featured in three presentations at the International Herpesvirus Workshop (IHW), taking place July 13-17, 2024, in Portland, Ore. Approximately 50% of individuals with initial symptomatic genital herpes infection have three or more recurrences per year, including over four million people in the United States and France, Germany, Italy and Spain (collectively, the EU4), and the United Kingdom. While genital herpes can be caused by either HSV type 1 (HSV-1) or HSV type 2 (HSV-2), recurrences are more likely to be experienced by individuals infected by HSV-2. The current standard of care for recurrent genital herpes are nucleoside analogs; however, these are only partially effective in preventing recurrences. Assembly Bio’s HSV antiviral candidates target the HSV helicase-primase complex, an essential HSV enzyme complex with no host equivalent, and are designed for long-acting administration. A poster entitled “The Helicase-Primase Inhibitor ABI-5366 Is a Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent Genital Herpes” highlights preclinical data that supported ABI-5366’s entry into Phase 1 clinical evaluation. Results demonstrated that ABI-5366 showed low nanomolar activity against both HSV-1 and HSV-2, including broad activity against HSV clinical isolates, and specificity for HSV. ABI-5366 was shown to be generally non-toxic across a variety of cell types with no off-target effects observed in vitro or in vivo, including no activity against carbonic anhydrase esterases. Further, a favorable in vivo safety profile of ABI-5366 was observed in 28-day oral toxicity studies in two species, and pharmacokinetic (PK) studies evaluating ABI-5366 when administered orally or intramuscularly demonstrated long-acting potential for this compound. The Phase 1a/b study for ABI-5366 was initiated in May 2024 and is currently enrolling; interim Phase 1a data are expected in Third Quarter 2024 and interim Phase 1b data are expected in the first half of 2025. Additionally, an oral and poster presentation entitled “Preclinical Characterization of ABI-1179, a Potent Helicase Primase Inhibitor for the Treatment of Recurrent Genital Herpes” features preclinical data from ABI-1179, a structurally distinct, long-acting helicase-primase inhibitor candidate, licensed from Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead. ABI-1179 has demonstrated low nanomolar activity across HSV-1 and HSV-2 lab strains and clinical isolates, including acyclovir-resistant isolates. In resistance selection studies, ABI-1179 displayed a higher barrier to resistance development than acyclovir. Furthermore, ABI-1179 demonstrated antiviral activity against some HSV-2 strains harboring mutations known to confer resistance to other helicase-primase inhibitors. In a preclinical study, ABI-1179 demonstrated a favorable PK profile that supports the evaluation of once-weekly oral dosing. Further, in a preclinical model of recurrent HSV infection, ABI-1179 significantly reduced the development of recurrent lesions. Assembly Bio expects to initiate a Phase 1a/b first-in-human study of ABI-1179 by the end of 2024. Ankündigung • Jun 18
Assembly Biosciences, Inc. Doses First Participant in Phase 1B Clinical Trial Evaluating Next-Generation Capsid Assembly Biosciences, Inc. announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV) infection. Chronic HBV (cHBV) infection is a leading cause of chronic liver disease and liver transplants globally, with the World Health Organization estimating that over one million people died in 2022 from HBV-related causes. Current treatments are lifelong and reduce, but do not eliminate, the virus with very low cure rates. CAMs are direct-acting antivirals with two distinct mechanisms of action, inhibition of HBV DNA replication and prevention of the formation of new cccDNA, the viral reservoir. ABI-4334 is a highly potent next-generation CAM with a potential best-in-class profile and has been specifically optimized to target both mechanisms. In a Phase 1a study, once-daily oral dosing with ABI-4334 demonstrated a favorable safety and pharmacokinetic (PK) profile in healthy participants, with ABI-4334 exposure levels projected to achieve strong antiviral activity and double-digit multiples over protein adjusted EC50 for both HBV DNA replication and cccDNA formation. In vitro, ABI-4334 has shown single-digit nanomolar potency against both mechanisms of action and the ability to impact HBV DNA integration. The Phase 1b study that is currently enrolling will evaluate safety, PK and antiviral activity in individuals with cHBV infection over a 28-day treatment period. Ankündigung • Jun 06
Assembly Biosciences Presents New Data Highlighting Hepatitis D Virus Entry Inhibitor Abi-6250 At the Easl Congress 2024 Assembly Biosciences, Inc. announced new data for ABI-6250, the company’s orally bioavailable, small molecule hepatitis D virus (HDV) entry inhibitor candidate, featured in a poster presentation at the European Association for the Study of the Liver (EASL) Congress™, taking place June 5-8, 2024, in Milan, Italy. The poster presentation “Preclinical profiling of ABI-6250, a novel orally bioavailable small-molecule therapeutic candidate for the treatment of chronic hepatitis D” will highlight preclinical data that support the advancement of ABI-6250 into Phase 1 clinical studies. Chronic HDV infection is considered the most serious form of viral hepatitis, and can result in liver cirrhosis, liver cancer, decompensated liver disease or death. ABI-6250 acts to prevent the entry of HDV into cells by blocking access to the sodium taurocholate cotransporting polypeptide (NTCP) bile acid transporter, which is a clinically validated target for HDV infection. Results from preclinical evaluation included in this presentation demonstrate that ABI-6250 can effectively inhibit, at low nanomolar levels, HDV infection of the most prevalent genotypes (HDV-1,-2 and-3) in HepG2-NTCP cells. ABI-6250 also effectively inhibited NTCP-mediated bile acid uptake and demonstrated selectivity for the NTCP bile transporter versus other transporters in vitro. In vivo, ABI-6250 elevated total bile acids, indicating NTCP target engagement without increasing biomarkers for inhibition of other transporters, supporting the selectivity seen in vitro and providing a biomarker for target engagement in Phase 1a studies. The presentation also describes the preclinical pharmacokinetic (PK) profile of ABI-6250, which supports low, once-daily oral dosing in individuals with chronic HDV. Ankündigung • Apr 19
Assembly Biosciences, Inc., Annual General Meeting, May 29, 2024 Assembly Biosciences, Inc., Annual General Meeting, May 29, 2024, at 08:00 Pacific Standard Time. Agenda: To elect the ten nominees to Board of Directors (the Board); to consider the executive officers's compensation; to consider the frequency of future advisory votes to approve named executive officers's compensation; to ratify the selection of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; to approve the Assembly Biosciences, Inc. Amended and Restated 2018 Stock Incentive Plan to increase the number of shares reserved for issuance thereunder by 220,000 shares; tp approve the Assembly Biosciences, Inc. Second Amended and Restated 2018 Employee Stock Purchase Plan to increase the number of shares reserved for issuance thereunder to 164,500 shares and remove the maximum number of shares purchasable under the plan per offering period; and to transact such other matters that may properly come before the meeting and any adjournment or postponement thereof. Ankündigung • Dec 08
Assembly Biosciences, Inc. Appoints Tomas Cihlar to Serve on the Board On December 7, 2023, the Board of Directors (the "Board") of Assembly Biosciences, Inc. (the "Company") appointed Tomas Cihlar, Ph.D., a designee of Gilead Sciences, Inc. ("Gilead"), to serve on the Board. Dr. Cihlar is Gilead's Senior Vice President, Virology and has been designated for appointment to the Board pursuant to the previously announced Investor Rights Agreement entered into between the Company and Gilead on October 15, 2023. Dr. Cihlar will not receive any compensation for his service as a member of the Company's Board. New Risk • Nov 10
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings are forecast to decline by an average of 8.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$93m net loss in 3 years). Shareholders have been diluted in the past year (7.9% increase in shares outstanding). Market cap is less than US$100m (US$44.8m market cap). Ankündigung • Nov 09
Assembly Biosciences, Inc. Appoints Anuj Gaggar as Chief Medical Officer Assembly Biosciences, Inc. announced that Anuj Gaggar, MD, PhD, has joined the company as chief medical officer. Dr. Gaggar is an infectious disease specialist and seasoned executive whose experience has focused on the development of new therapies in viral diseases including chronic hepatitis B virus (HBV), hepatitis C virus (HCV) and hepatitis D virus (HDV) infections. Dr. Gaggar joins from Arrive Bio, a private early-stage biotechnology company that he co-founded and served as chief executive officer. Prior to Arrive Bio, Dr. Gaggar served for almost 10 years as a senior member of the Gilead Sciences clinical research team where he was responsible for scientific clinical development strategy and execution. As vice president, clinical research, he led the HBV cure development program, including the design and execution of global clinical trials and was the project lead for early development programs and HBV translational studies. Dr. Gaggar also contributed to the registrational studies for Vemlidy® (tenofovir alafenamide), Sovaldi® (sofosbuvir) and Veklury® (remdesivir) and served as project team lead for a portfolio of approved HCV therapeutics. He is widely published in basic and clinical virology with more than 95 publications. Dr. Gaggar was a clinical fellow in infectious diseases at the University of California, San Francisco, where he also served as chief resident. He received his MD and PhD from the University of Washington and his BS in chemistry from Stanford University. New Risk • Oct 18
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 21% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$76m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$59m net loss in 3 years). Shareholders have been diluted in the past year (8.7% increase in shares outstanding). Market cap is less than US$100m (US$65.8m market cap). Ankündigung • Oct 01
Assembly Biosciences Receives Non-Compliance Notice from Nasdaq On September 27, 2023, Assembly Biosciences, Inc. (the "Company") received a letter from the Listing Qualifications Department of the Nasdaq Stock Market ("Nasdaq") notifying the Company that, as the bid price for the Company's common stock, par value $0.001 per share (the "Common Stock"), had closed below $1.00 per share for the last 30 consecutive business days, the Company was not in compliance with Nasdaq Listing Rule 5450(a)(1), which is the minimum bid price requirement for continued listing on the Nasdaq Global Select Market. Nasdaq's notice has no immediate effect on the listing of the Common Stock, and the Common Stock will continue to trade on the Nasdaq Global Select Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a 180-calendar day period, or until March 25, 2024, to regain compliance with the minimum bid price requirement. The continued listing standard will be met if the closing bid price of the Common Stock is at least $1.00 per share for a minimum of ten consecutive business days during the 180-calendar day period. If the Company is not in compliance by March 25, 2024, the Company may be eligible for a second 180-calendar day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards of the Nasdaq Capital Market, with the exception of the bid price requirement, and provides Nasdaq with written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary. The Company intends to monitor the closing bid price of the Common Stock and is currently evaluating its options for regaining compliance. Ankündigung • Sep 20
Assembly Biosciences, Inc. to Present Pipeline Progress in HBV and HDV at the 2023 International HBV Meeting Assembly Biosciences, Inc. announced that the company will present new preclinical data from multiple hepatitis B virus (HBV) and hepatitis D virus (HDV) pipeline programs at the 2023 International HBV Meeting taking place in Kobe, Japan, September 19-23, 2023. At the meeting, one oral presentation will highlight progress in the company’s HBV/HDV oral entry inhibitor program including activity, selectivity and pharmacokinetic (PK) data that support advancement towards development candidate nomination. A second oral presentation reports new data for ABI-4334 (4334), Assembly Bio’s most potent capsid assembly modulator (CAM) with a potential best-in-class profile, describing the prevention of HBV DNA integration in vitro. The poster presentation, from the company’s interferon-a receptor (IFNAR) agonist program, characterizes small molecule IFNAR agonists that closely mimic interferon-a’s signaling. HBV/HDV Entry Inhibitor Program: HDV is a satellite virus only found in the presence of HBV infection and is considered the most severe form of viral hepatitis. In an oral presentation entitled “Pre-clinical profiling of a novel class of orally bioavailable small molecules potently inhibiting hepatitis B and D virus entry,” the company will present data on a novel class of highly potent, orally bioavailable HBV/HDV entry small molecule inhibitors with favorable drug-like properties. One compound selected for further characterization exhibited potent activity against multiple HBV and HDV genotypes and selective inhibition of sodium taurocholate co-transporting polypeptide (NTCP) compared to other bile acid transporters. This compound further exhibited a favorable PK/pharmacodynamic preclinical profile supporting the potential for once daily dosing. Assembly Bio anticipates nominating a clinical development candidate from the HBV/HDV entry inhibitor program in 2023. Next-Generation HBV CAM Candidate ABI-4334: 4334, which has completed Phase 1a evaluation, is a novel, orally bioavailable investigational next-generation CAM that exhibits nanomolar (nM) potency against pgRNA encapsidation and covalently closed circular (ccc)DNA formation in vitro. In patients with chronic HBV infection, HBV DNA integration has been linked to the development of liver cancer. In the oral presentation entitled “ABI-4334, a novel inhibitor of hepatitis B virus core protein, disrupts DL-DNA containing capsids and prevents HBV DNA integration,” data show that in vitro 4334 disrupts RC (relaxed circular)- and DL (duplex linear)-DNA capsid formation at nM levels and inhibits HBV DNA integration in a dose-proportional manner as shown by inverse PCR and next-generation sequencing analyses?. Based on the Phase 1a PK data, the target plasma levels of 4334 required for inhibition of HBV DNA integration in these models are achievable. Assembly Bio’s IFNAR agonist program seeks to engage IFNa signaling using an orally bioavailable liver-focused small molecule approach to improve tolerability. The poster entitled “Pre-clinical characterization of novel liver-focused small molecules efficiently inhibiting hepatitis B virus by activating type I interferon signaling,” features preclinical data on a novel class of IFNAR agonists that inhibit HBV infection and replication. In vivo analysis of a compound from the series demonstrates that it closely mimics IFNa activity as measured by activating IFN-stimulated response element signaling and inducing the JAK-STAT pathway in the liver and PBMCs. PK data from the same compound exhibit desirable liver exposure and favorable oral bioavailability. Lead optimization of multiple IFNAR agonists is ongoing. New Risk • Aug 18
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.05% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$76m free cash flow). Earnings are forecast to decline by an average of 0.05% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$67m net loss in 3 years). Shareholders have been diluted in the past year (8.6% increase in shares outstanding). Significant insider selling over the past 3 months (US$69k sold). Market cap is less than US$100m (US$48.5m market cap). New Risk • Aug 07
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$69k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$80m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$63m net loss in 3 years). Shareholders have been diluted in the past year (8.1% increase in shares outstanding). Significant insider selling over the past 3 months (US$69k sold). Market cap is less than US$100m (US$57.3m market cap). Ankündigung • Feb 16
Assembly Biosciences, Inc. Nominates First Herpesvirus Development Candidate ABI-5366, a Long Acting HSV-2 Helicase Inhibitor Targeting High-Recurrence Genital Herpes Assembly Biosciences, Inc. announced the selection of development candidate ABI-5366 (5366) to progress to IND-enabling studies for its long-acting herpes simplex virus type 2 (HSV-2) helicase inhibitor program. 5366 is the first development candidate from Assembly Bio’s discovery pipeline nominated for advancement to clinical development since the company announced its expanded research focus outside of hepatitis B last year. Assembly Bio’s HSV-2 program targets the viral helicase-primase, an essential viral enzyme complex and a clinically validated target. Helicase inhibition has demonstrated greater reductions in HSV-2 shedding, lesions and pain compared to approved suppressive nucleoside analog regimens in previous clinical studies. 5366, a small molecule helicase inhibitor with nanomolar potency in vitro, is designed for long-acting administration and has shown favorable pharmacokinetics (PK) for a long-acting therapeutic, including the key property of exceptionally low clearance, in preclinical studies. 5366’s preclinical profile shows the potential for at least monthly dosing, and Assembly Bio will continue to evaluate longer dosing intervals as development and formulation progress. High-recurrence genital herpes associated with HSV-2 infection is characterized by frequent recurrences of lesions (six or more per year) and is estimated to affect up to 40% of HSV-2 genital herpes patients following their first outbreak. Approved suppressive therapy regimens consist of oral daily dosing of nucleoside analogs, a class first approved for genital herpes almost three decades ago, with no new drug approvals in the last 20 years. These suppressive regimens have been shown to reduce the recurrence of genital herpes among patients with high HSV-2 recurrence, but eliminate recurrences for only a minority of these patients. Board Change • Nov 16
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Gina Consylman was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Oct 21
Price target decreased to US$7.38 Down from US$9.10, the current price target is an average from 4 analysts. New target price is 376% above last closing price of US$1.55. Stock is down 52% over the past year. The company is forecast to post a net loss per share of US$2.07 next year compared to a net loss per share of US$3.00 last year. Board Change • Oct 21
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Gina Consylman was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Apr 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Gina Consylman was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Mar 12
Full year 2021 earnings: EPS and revenues exceed analyst expectations Full year 2021 results: US$3.00 loss per share (down from US$1.75 loss in FY 2020). Net loss: US$129.9m (loss widened 109% from FY 2020). Revenue exceeded analyst estimates by 1.5%. Earnings per share (EPS) also surpassed analyst estimates by 43%. Over the next year, revenue is expected to shrink by 100% compared to a 60% growth forecast for the pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 58% per year, which means it is significantly lagging earnings. Major Estimate Revision • Dec 02
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$4.48m to US$6.18m. EPS estimate unchanged from -US$2.11 at last update. Biotechs industry in the US expected to see average net income decline 10.0% next year. Consensus price target of US$9.58 unchanged from last update. Share price fell 3.4% to US$2.24 over the past week. Price Target Changed • Nov 19
Price target increased to US$10.90 Up from US$9.71, the current price target is an average from 7 analysts. New target price is 358% above last closing price of US$2.38. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$2.10 next year compared to a net loss per share of US$1.75 last year. Reported Earnings • Nov 06
Third quarter 2021 earnings released: US$0.41 loss per share (vs US$0.094 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$18.8m (loss widened 462% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 49% per year, which means it is significantly lagging earnings. Price Target Changed • Sep 14
Price target decreased to US$9.71 Down from US$10.75, the current price target is an average from 6 analysts. New target price is 198% above last closing price of US$3.26. Stock is down 82% over the past year. Executive Departure • Jun 05
CFO & Principal Accounting Officer Thomas Russo has left the company On the 4th of June, Thomas Russo's tenure as CFO & Principal Accounting Officer ended after 1.7 years in the role. As of March 2021, Thomas still personally held only 10.85k shares (US$50k worth at the time). A total of 5 executives have left over the last 12 months. The current median tenure of the management team is 2.13 years. Major Estimate Revision • Mar 24
Consensus revenue estimates fall to US$6.63m The consensus outlook for revenues in 2021 has deteriorated. 2021 revenue forecast decreased from US$8.03m to US$6.63m. Forecast losses increased from -US$3.16 to -US$3.21 per share. Biotechs industry in the US expected to see average net income growth of 4.2% next year. Consensus price target broadly unchanged at US$11.60. Share price fell 11% to US$4.45 over the past week. Major Estimate Revision • Mar 04
Analysts update estimates The 2021 consensus revenue estimate was lowered from US$14.0m to US$4.72m. Earnings per share (EPS) saw an improvement, with analysts raising their estimates from -US$3.51 to -US$3.25 for the same period. The Biotechs industry in the US is expected to see an average net income growth of 3.5% next year. The consensus price target was lowered from US$18.60 to US$11.60. Share price is down by 13% to US$4.88 over the past week. Price Target Changed • Mar 03
Price target lowered to US$11.60 Down from US$18.60, the current price target is an average from 5 analysts. The new target price is 132% above the current share price of US$4.99. As of last close, the stock is down 72% over the past year.