10-Q quarterly report · filed Aug 8, 2018

Assembly Biosciences Inc (ASMB) Q2 2018 10-Q Quarterly Report

Short answer

Assembly Biosciences Inc (ASMB) filed its Q2 2018 10-Q quarterly report on Aug 8, 2018 for the quarter ended Jun 30, 2018.

Assembly Biosciences Inc Q2 2018 10-Q analysis

AI summary of MD&A and risk factor updates

Management Discussion & Analysis

  • Quarterly collaboration revenue $3.2M, up $0.8M from $2.4M YoY
  • HBV-cure R&D expense $14.2M, up $3.1M YoY, versus Microbiome increase of $0.2M
  • Operating loss continued, net loss $43.1M for six months, versus $27.5M YoY
  • Six-month operating cash flow: $31.5M used versus $22.6M provided YoY
  • July equity offering generated $155.4M net proceeds; cash expected to fund operations at least twelve months

Risk Factors

  • Newly emphasized privacy risk: GDPR effective May 25, 2018, with penalties up to €20 million or 4% of worldwide revenue
  • Most material operational update: microbiome manufacturing transition to a small-scale internal facility for planned studies and early trials
  • Regulatory risk: FDA approval requires extensive NDA or BLA evidence, with possible additional trials, post-marketing studies, or restrictions
  • Near-term clinical risk: Phase 1a/1b adverse events included headaches, rashes, and one Grade 3 rash causing treatment discontinuation
  • Financial risk: accumulated deficit reached approximately $294.1 million at June 30, 2018, with funding expected for at least twelve months

Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K

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