PhaseBio Pharmaceuticals Inc (PHASQ)·Q2 2022 Earnings Summary

Executive Summary

• Q2 2022 was operationally focused on regulatory preparation for bentracimab, but financials reflected minimal revenue with a sharply lower yoy compare: revenue was $0.208M versus $10.338M in Q2 2021; net loss improved to $16.7M, or $0.34 per share, from $28.7M, or $0.60 per share, yoy .
• Management reaffirmed plans to submit the bentracimab BLA in Q4 2022 following a successful pre-BLA meeting with the FDA; uncontrolled bleeding cohort enrollment continued, with FDA open to separating indications for potential accelerated approval if warranted .
• PB6440 IND timing was pushed out to 1H 2023, with manufacturing process optimization completed and first-in-human trials targeted for mid-2023, a timeline shift versus prior “2H 2022” plans from earlier quarters .
• Liquidity is tight: cash and equivalents fell to $7.8M at quarter-end, with $21.0M of additional SFJ reimbursement expected for bentracimab development costs (a decrease from $25.4M expected as of Q1) — raising near-term financing/watch-list risk as the BLA approaches .

What Went Well and What Went Wrong

• What Went Well

  • Regulatory progress: “Following a successful meeting with the U.S. Food and Drug Administration (FDA) during our pre-BLA meeting earlier this year… we have been focused on… a planned BLA submission for… bentracimab in the fourth quarter of this year,” said CEO Jonathan Mow .
  • Clinical/commercial readiness: Bentracimab Phase 1/2 data consistently showed immediate and sustained reversal with no drug-related SAEs; PPQ manufacturing campaign completed earlier supports commercial-scale supply at launch (if approved) .
  • Cost moderation: R&D expense decreased yoy to $20.9M from $27.4M, driven by lower drug manufacturing activity and winding down pemziviptadil, partially offset by PB6440 development and personnel costs .

• What Went Wrong

  • Revenue compare: Total revenue fell to $0.208M versus $10.338M in Q2 2021, reflecting lapping of prior-year sublicense revenue recognition and underscoring the pre-commercial profile; G&A rose to $4.6M from $4.0M yoy .
  • Liquidity: Cash decreased to $7.8M from $18.7M in Q1 and $41.8M at year-end 2021, highlighting cash burn ahead of the planned BLA filing .
  • PB6440 timeline slippage: IND moved to 1H 2023 from prior 2H 2022 plans, extending the path to first-in-human studies to mid-2023 .

Financial Results

Income statement summary (USD, in thousands; oldest → newest):

Balance sheet and liquidity (USD, in thousands; oldest → newest):

Year-over-year Q2 comparison (USD, in thousands):

Estimates vs actuals (Q2 2022):

• S&P Global consensus revenue and EPS for PHASQ were unavailable in S&P Global for this ticker mapping at the time of this analysis; therefore, beat/miss versus Street cannot be assessed.

Guidance Changes

Note: No revenue, margin, tax rate, or OpEx numeric guidance was provided in these materials; guidance was focused on regulatory timelines and development funding .

Earnings Call Themes & Trends

No Q2 2022 earnings call transcript was available in our document catalog; themes are drawn from the Q2 press release and corporate presentation.

Management Commentary

• “The second quarter of 2022 marked a period of continued progress for PhaseBio… we have been focused on clinical development and regulatory efforts to support a planned BLA submission for our lead program, bentracimab, in the fourth quarter of this year.” — Jonathan Mow, CEO .
• “We expect to file our IND for PB6440 in the first half of 2023 and to initiate first-in-human trials in mid-2023.” — Jonathan Mow, CEO .
• “The [pre-BLA] FDA agreed that the plan appeared reasonable… [and] would consider separating the indications for possible Accelerated Approval of either uncontrolled bleeding or surgery.” — Pre-BLA meeting summary .
• “The PPQ campaign… positions PhaseBio to be ready to supply global demand for bentracimab at launch, once approved.” — Manufacturing readiness .

Q&A Highlights

No Q2 2022 earnings call transcript was available to extract Q&A; therefore, no Q&A themes or guidance clarifications can be provided from a call transcript for this period.

Estimates Context

• Wall Street consensus (S&P Global) for PHASQ Q2 2022 revenue and EPS was unavailable due to missing CIQ mapping for this ticker in S&P Global at the time of retrieval; consequently, beat/miss versus Street cannot be assessed from S&P Global for PHASQ.

Key Takeaways for Investors

• The central catalyst remains bentracimab’s Q4 2022 BLA submission; FDA feedback post pre-BLA meeting supports a potential accelerated pathway, with surgical and uncontrolled bleeding indications considered based on submitted data .
• The PB6440 program is advancing but timelines slipped to 1H 2023 for IND and mid-2023 for first-in-human, moderating near-term multi-asset optionality .
• Liquidity has tightened materially (cash $7.8M), with remaining SFJ reimbursement of ~$21.0M expected; investors should anticipate financing decisions or partnership activity as the company approaches BLA filing and potential launch preparation .
• Q2 revenue was de minimis ($0.208M) versus a large prior-year sublicense recognition, spotlighting pre-commercial reliance on external funding and licensing rather than product revenue until bentracimab approval .
• Operating discipline showed yoy R&D reduction due to program reprioritization (pemziviptadil wind-down), but G&A rose with scaling commercial/regulatory capabilities — consistent with pre-launch posture .
• With no Street estimates available for PHASQ, the narrative is driven by regulatory execution and liquidity rather than “beat/miss” dynamics; traders should watch for BLA submission, any FDA filing acceptance milestones, and updates on financing runway .