Assembly Biosciences(ASMB)
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Assembly Biosciences(ASMB) - 2019 Q3 - Quarterly Report
2019-11-07 21:43
Financial Performance - Collaboration revenue for Q3 2019 was approximately $4.2 million, consistent with $4.3 million in Q3 2018, due to increased reimbursement activities offset by lower deferred revenue recognition [132]. - Collaboration revenue for the nine months ended September 30, 2019, was approximately $11.2 million, consistent with $11.1 million for the same period in 2018 [138]. - Net cash used in operating activities was approximately $63.5 million for the nine months ended September 30, 2019, compared to $48.2 million for the same period in 2018 [146][147]. - Net cash provided by investing activities for the nine months ended September 30, 2019, was $44.7 million, primarily due to $166.9 million of redemptions of marketable securities [148]. - Net cash provided by financing activities for the nine months ended September 30, 2019, was $2.2 million, compared to approximately $159.2 million in 2018 [150][151]. - The company has raised an aggregate of approximately $412.8 million in net proceeds through equity financing since its incorporation [145]. - The company expects to need substantial additional funding to continue operations and pursue research and development activities [152]. Research and Development - Research and development expenses for Q3 2019 were approximately $19.3 million, an increase of $2.7 million from $16.6 million in Q3 2018, primarily driven by increased expenses in the HBV-cure program [133]. - Research and development expense, excluding stock-based compensation, was approximately $54.8 million for the nine months ended September 30, 2019, an increase of approximately $12.0 million from $42.8 million in 2018 [139]. - ABI-H0731 is currently in a Phase 2a long-term study, with final data from earlier studies expected in Q4 2019 [110]. - In Study 201, 73 patients were randomized to receive either 300 mg of ABI-H0731 or placebo, with the study focusing on safety and HBV DNA levels over 24 weeks [112]. - Initial efficacy data from Studies 201 and 202 suggest significant reductions in HBV DNA and RNA levels, with treatment-naïve patients showing declines as early as Week 2 [115]. - ABI-H2158, a second product candidate, is in a Phase 1a/1b study, with interim data expected in Q4 2019 and a Phase 2a study planned for 2020 [119]. - ABI-H3733, a third product candidate, is undergoing IND enabling studies, with Phase 1a studies expected to start in Q1 2020 [122]. - The Microbiome program includes a Phase 1b study for ABI-M201, initiated in February 2019, targeting ulcerative colitis [124]. General and Administrative Expenses - General and administrative expense, excluding stock-based compensation, was approximately $5.5 million for Q3 2019, an increase of approximately $1.3 million from $4.2 million in Q3 2018 [137]. - General and administrative expense, excluding stock-based compensation, was approximately $16.3 million for the nine months ended September 30, 2019, an increase of approximately $3.3 million from $13.0 million in 2018 [142]. Collaboration Agreements - The company has a collaboration agreement with Allergan, which includes an upfront payment of $50 million and potential milestone payments totaling approximately $2.14 billion [125].
Assembly Biosciences(ASMB) - 2019 Q2 - Quarterly Report
2019-08-05 21:08
Financial Performance - Collaboration revenue for Q2 2019 was approximately $3.1 million, a slight decrease from $3.2 million in Q2 2018 due to lower deferred revenue recognition[116] - Collaboration revenue for the six months ended June 30, 2019, was approximately $7.0 million, up from $6.8 million in the same period in 2018, driven by increased reimbursement activities[122] - Net cash used in operating activities was approximately $44.9 million for the six months ended June 30, 2019, primarily due to a $45.6 million net loss[129] - The company has not been profitable and has generated operating losses since its incorporation in October 2005[128] Research and Development - Research and development expenses for Q2 2019 were approximately $15.6 million, an increase of $1.4 million from $14.2 million in Q2 2018, primarily driven by the Microbiome program[117] - Research and development expense, excluding stock-based compensation, was approximately $35.6 million for the six months ended June 30, 2019, an increase of approximately $9.4 million from $26.2 million in the same period in 2018[123] - ABI-H0731, the lead product candidate, is in an ongoing Phase 2a study, with interim results expected in Q4 2019[99] - In Study 201, 73 patients were randomized to receive either 300 mg of ABI-H0731 or placebo, with the study focusing on safety and declines in HBV S antigen and HBV DNA levels[99] - Initial efficacy data from ABI-H0731 suggests significant declines in HBV DNA levels, with reductions starting as early as Week 2 in treatment-naïve patients[102] - ABI-H2158, a second product candidate, is currently in a Phase 1a/1b study, with data expected by Q1 2020[106] - ABI-H3733, a third product candidate, is undergoing IND enabling studies, with Phase 1a studies expected to start in Q1 2020[107] Expenses - Stock-based compensation expense for Q2 2019 was approximately $3.1 million, down $0.6 million from $3.7 million in Q2 2018[118] - Stock-based compensation expense was approximately $(1.1) million for Q2 2019, a decrease of approximately $8.9 million from $7.9 million in Q2 2018[121] - General and administrative expense, excluding stock-based compensation, was approximately $5.1 million for Q2 2019, an increase of approximately $0.5 million from $4.6 million in Q2 2018[120] Funding and Financial Outlook - The company has raised an aggregate of approximately $412.8 million in net proceeds through equity financing since its incorporation[128] - The company expects to need substantial additional funding to continue operations and pursue research and development activities[133] - The company anticipates that existing cash, cash equivalents, and marketable securities will fund operating expenses for at least the next twelve months[135] - As of June 30, 2019, the company had an accumulated deficit of approximately $387.3 million, with expectations of continued losses as product candidates are developed[112]
Assembly Biosciences(ASMB) - 2019 Q1 - Quarterly Report
2019-05-09 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 ASMB The Nasdaq Global Select Market FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to________ ...
Assembly Biosciences(ASMB) - 2018 Q4 - Annual Report
2019-02-28 22:18
Financial Performance - Collaboration revenue for the latest period was $14.8 million, up from $9.0 million in the previous period [311]. - The company generated approximately $14.8 million in collaboration revenue for the year ended December 31, 2018, contributing to an accumulated deficit of approximately $341.8 million [373]. - Collaboration revenue for 2018 was $14,804,000, an increase of 64% from $9,019,000 in 2017 [448]. - Total operating expenses for 2018 were $107,539,000, up 76% from $61,246,000 in 2017 [448]. - Net loss for 2018 was $90,751,000, compared to a net loss of $42,809,000 in 2017, representing a 112% increase in losses [448]. - The net loss for the year ended December 31, 2018, was $90,751,000, compared to a net loss of $42,809,000 for the year ended December 31, 2017 [453]. - The company has not generated any revenue from product sales to date and has incurred losses since inception, expecting to continue incurring substantial losses for the next several years [458]. Research and Development - Research and development expenses totaled $72.741 million in 2018, up from $44.225 million in 2017, reflecting a 64.5% increase [332]. - The increase in research and development expenses was primarily due to an increase of approximately $18.3 million in research expenses for the HBV-cure program [374]. - The company anticipates significant increases in research and development costs as product candidate development programs progress, with no accurate projections possible at this time [334]. - The HBV-cure program includes multiple drug candidates targeting the HBV lifecycle, with the lead candidate ABI-H0731 showing significant antiviral activity in clinical studies [315][317]. - ABI-H0731 has received Fast Track designation from the FDA for chronic HBV infection treatment, with ongoing Phase 2a studies expected to yield initial data in Q2 2019 [316][319]. - ABI-H2158, a second product candidate in the HBV-cure program, has entered Phase 1a/1b clinical studies, with initial data expected in mid-2019 [324]. - The Microbiome program has initiated a Phase 1b clinical study for ABI-M201 in ulcerative colitis, with additional research planned for other disease indications [326]. - The company is exploring additional product candidates for Crohn's disease, irritable bowel syndrome, and non-alcoholic steatohepatitis (NASH) in collaboration with Allergan Pharmaceuticals [457]. Financial Position - Total assets increased from approximately $71.2 million in 2014 to approximately $268.0 million in 2018, primarily due to capital raises totaling approximately $155.4 million in July 2018 [312]. - Cash and cash equivalents decreased to $41,471,000 in 2018 from $82,033,000 in 2017, a decline of 49% [446]. - Total current assets increased to $222,502,000 in 2018, up 80% from $123,119,000 in 2017 [446]. - Total liabilities rose slightly to $57,392,000 in 2018 from $56,184,000 in 2017 [446]. - Stockholders' equity increased to $210,653,000 in 2018, up 86% from $113,120,000 in 2017 [446]. - The company has contractual obligations totaling approximately $22.4 million as of December 31, 2018, including operating leases and license obligations [372]. Cash Flow - Net cash used in operating activities for the year ended December 31, 2018 was approximately $65.0 million, primarily due to a net loss of approximately $90.8 million [391]. - Net cash used in investing activities for 2018 was approximately $135.4 million, primarily due to the purchase of approximately $183.9 million in marketable securities [394]. - Net cash provided by financing activities for 2018 was approximately $159.8 million, resulting from net proceeds of approximately $155.4 million from a public offering of 4,600,000 shares of common stock [396]. - The company raised an aggregate of approximately $412.8 million in net proceeds from public offerings and private placements from inception to December 31, 2018 [387]. - The company expects to continue to incur additional costs associated with operating as a public company and will need to obtain substantial additional funding for ongoing operations [399]. - The company anticipates that existing cash, cash equivalents, and marketable securities will fund operating expenses for at least the next twelve months [401]. Legal and Compliance - The company has not been involved in any material legal proceedings that could have a material adverse effect on its business [290]. - The company’s disclosure controls and procedures were evaluated as effective for the fiscal year ending December 31, 2018, providing reasonable assurance of timely information communication [411]. - Internal control over financial reporting was also deemed effective as of December 31, 2018, based on a comprehensive evaluation [412]. - Ernst & Young LLP confirmed the effectiveness of the company's internal control over financial reporting as of December 31, 2018 [413]. - The company has adopted a Code of Ethics for its principal executive and financial officers, ensuring compliance and governance standards [416]. - Directors and executive officers complied with all applicable filing requirements under Section 16(a) of the Securities Exchange Act during the fiscal year ended December 31, 2018 [417]. Accounting and Reporting - The company adopted a new accounting standard in 2018, changing its revenue recognition method in accordance with ASU No. 2014-09, which may impact future financial reporting [434]. - The independent auditor expressed an unqualified opinion on the financial statements, confirming they present fairly the financial position of the company as of December 31, 2018, and the results of operations for the three years ended on that date [432]. - The financial statements include consolidated statements of operations and comprehensive loss, changes in stockholders' equity, and cash flows for the specified periods [430]. - The company’s internal control system is designed to provide reasonable assurance regarding the reliability of financial reporting and compliance with accounting principles [444]. - The audit procedures included assessing risks of material misstatement and evaluating the effectiveness of internal controls [436]. - The company’s financial reporting may be subject to inherent limitations, which could affect the detection of misstatements in future periods [445].