PhaseBio Pharmaceuticals Inc (PHASQ)·Q3 2021 Earnings Summary

Executive Summary

• Q3 featured continued clinical momentum but limited P&L: total revenue was $0.34M (sublicense recognition), net loss was $(31.9)M or $(0.66) per share, with R&D of $25.1M largely tied to bentracimab development .
• Clinical catalysts dominated: Phase 2b bentracimab achieved its primary endpoint in older volunteers (safety consistent with prior trials) on Nov 3, and the REVERSE-IT Phase 3 prespecified interim analysis showed immediate reversal and >90% effective hemostasis on Nov 15 (accepted by NEJM Evidence) .
• Guidance cadence: BLA submission for bentracimab reaffirmed for mid-2022; China REVERSE-IT enrollment timing shifted from “later 2021” to “early 2022” .
• Stock reaction catalyst: AHA late-breaking presentation of interim REVERSE-IT results (immediate and sustained reversal; 98.4% adjudicated effective hemostasis in eligible patients; low thrombotic SAE rate, none fatal or drug-related) .

What Went Well and What Went Wrong

• What Went Well

  • Clinical efficacy and safety: REVERSE-IT interim analysis (n=150) hit primary reversal endpoint (135% reduction in inhibition within 5–10 minutes; sustained 24h) and >90% effective hemostasis in eligible patients; thrombotic SAEs 5.3% (none fatal/drug-related) .
  • Phase 2b success: trial met primary endpoint in older volunteers with safety consistent with Phase 1/2a; “critical step along our path towards potential regulatory approval” (CMO) .
  • Strategic positioning and timelines reiterated by management: CEO emphasized mid-2022 BLA target and potential to commercialize the first ticagrelor reversal agent .

• What Went Wrong

  • Financials under pressure: net loss widened to $(31.9)M vs $(25.1)M YoY, reflecting elevated R&D; quarterly revenue fell sharply vs Q2’s one-time sublicense recognition ($0.34M vs $10.34M) .
  • Enrollment mix: predominance of urgent-surgery patients limited bleeding cohort enrollment, a COVID-era constraint also cited earlier; required site expansion efforts .
  • Timing slip in China: first patient timing for China enrollment moved from “later 2021” to “early 2022,” modestly pushing ex-U.S. enrollment plans .

Financial Results

Revenue composition and context:

• Notes: Q2 revenue was driven by recognition of the Alfasigma upfront (non-recurring cadence), while Q3 recognized a small portion of the upfront; R&D growth reflects bentracimab manufacturing/clinical activities .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• CEO (Q3 PR): “We… achieved our interim enrollment milestone for the pivotal REVERSE-IT Phase 3 trial… we remain focused on targeting a Biologics License Application (BLA) submission in mid-2022 and are excited about the future prospects of potentially commercializing the first ticagrelor reversal agent” .
• CMO (Phase 2b topline): “These results are a critical step along our path towards potential regulatory approval, and we are pleased with the observations we have seen to date” .
• Dr. Deepak Bhatt (AHA/REVERSE-IT interim): “The emerging safety and efficacy profile of bentracimab is quite compelling… if approved, bentracimab has the potential to become an important tool in the management of patients who could benefit from ticagrelor therapy” .

Q&A Highlights

• No earnings-call transcript was filed; however, the Nov 15 investor event and AHA presentation addressed: (1) verification of immediate, sustained reversal across assays and subgroups; (2) adjudicated hemostasis >90% in eligible patients; (3) low thrombotic SAE rate without prothrombotic rebound biomarkers; (4) BLA preparation and cohort balance considerations per FDA feedback .
• Clarifications included exclusion of patients with normal pre-treatment PRU from reversal efficacy analysis (resulting n=129 for reversal endpoint) and the emphasis on expanding bleeding cohort enrollment and sites post-surgery-cohort completion .

Estimates Context

• Wall Street consensus from S&P Global for PHASQ was unavailable at the time of this analysis (attempted retrieval failed due to missing mapping), so we cannot quantify beats/misses versus consensus for Q3 2021; this is consistent with limited sell-side coverage of pre-revenue clinical-stage biotech names [GetEstimates attempt; no values returned].

Key Takeaways for Investors

• Bentracimab’s REVERSE-IT interim data de-risk the mechanism and support the accelerated approval thesis (immediate/sustained reversal; >90% adjudicated hemostasis; acceptable thrombotic SAE profile), increasing confidence into the planned mid-2022 BLA .
• Sequential revenue volatility underscores a licensing-driven P&L; fundamental value drivers remain clinical/regulatory milestones rather than near-term revenue, with Q3 revenues reflecting limited additional recognition of the Alfasigma upfront .
• Operationally, the shift to bleeding-patient enrollment and site expansion is the next gating factor for full REVERSE-IT completion; monitoring progress on bleeding cohort accrual is key .
• Ex-U.S. strategy is in place (Alfasigma) and China enrollment is now expected to begin early 2022; slight timing slippage should be weighed against strong interim efficacy/safety data .
• Cash of $56.4M plus remaining SFJ funding of $10.9M at 9/30/21 provides near-term support into regulatory milestones; additional $30M from SFJ remains milestone-based upside .
• Near-term trading catalysts: NEJM Evidence publication and continued communications around full REVERSE-IT enrollment/composition and BLA submission progress in 1H–mid-2022 windows .