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PRECISION BIOSCIENCES INC (DTIL)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 GAAP revenue was $0.018M and GAAP EPS was $(2.13), materially below Wall Street consensus of $6.27M revenue* and $(1.57) EPS*; year-over-year compares are distorted by Q2 2024’s $49.9M non-cash deferred revenue recognition from the Prevail agreement, which ended in April 2024 .
  • Management extended the cash runway to the second half of 2027 and initiated an operating efficiency program targeting ~$25M annual cash OpEx reductions in 2026 and 2027 versus 2025, supporting planned PBGENE-HBV Phase 2 initiation and a potential pivotal trial for PBGENE-DMD .
  • Clinical execution advanced: ELIMINATE-B Cohort 1 showed substantial HBsAg reductions (47–69%), with one patient maintaining ~50% reduction at seven months; Cohort 2 initial safety was favorable and Cohort 3 enrollment was endorsed by the DMC, with a data update expected later in 2025 .
  • Near-term stock catalysts include additional ELIMINATE-B dose-escalation updates later in 2025, PBGENE-DMD regulatory progress (Rare Pediatric Disease and Orphan Drug designations), and potential monetization of non-core assets/royalties to further extend runway .

What Went Well and What Went Wrong

What Went Well

  • Early clinical proof-of-activity in HBV: Cohort 1 delivered substantial HBsAg reductions in all three patients (best responses 56%, 69%, 47%) with one durable ~50% reduction at seven months, reinforcing the mechanism to eliminate cccDNA and inactivate integrated HBV DNA .
  • Safety profile enabled acceleration: No ≥Grade 3 treatment-related AEs, SAEs, or DLTs in Cohorts 1–2; DMC endorsed enrolling Cohort 3 at a higher dose and potentially shortening dosing intervals to deepen responses .
  • Strategic focus and designations: PBGENE-DMD received FDA Rare Pediatric Disease and Orphan Drug Designations, positioning for IND/CTA by year-end 2025 and clinical data in 2026 .

Management quote:

  • “Our data shows that we have a novel, safe and active drug in all patients treated with a durable effect in one third of patients… reinforcing the mechanism of PBGENE-HBV to eliminate cccDNA.” — CEO Michael Amoroso .

What Went Wrong

  • Revenue/EPS miss vs consensus: GAAP revenue of $0.018M vs $6.27M* consensus and GAAP EPS of $(2.13) vs $(1.57)*; lack of collaboration revenue and lapping prior-period non-cash Prevail deferred revenue recognition drove the shortfall .
  • Operating leverage remains negative: Despite total OpEx declining YoY ($21.9M vs $25.8M), limited top-line contribution left operating loss at $(21.9)M and net loss at $(23.5)M .
  • Program reprioritization signals constrained resources: PBGENE-3243 paused to prioritize HBV and DMD; while prudent, it reduces near-term pipeline breadth .

Financial Results

P&L and Operating Metrics

MetricQ4 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.638 $0.029 $0.018
Research & Development ($USD Millions)$15.907 $13.588 $12.768
General & Administrative ($USD Millions)$9.577 $8.553 $9.127
Total Operating Expenses ($USD Millions)$25.484 $22.141 $21.895
Operating Income (Loss) ($USD Millions)$(24.846) $(22.112) $(21.877)
Net Income (Loss) ($USD Millions)$(17.745) $(20.565) $(23.520)
GAAP Diluted EPS ($USD)$(2.22) $(2.21) $(2.13)

Notes:

  • Q2 2024 reference for YoY: Revenue $49.898M; EPS $4.67–$4.70 basic/diluted, driven by $48.2M non-cash deferred revenue recognition at the conclusion of the Prevail agreement in April 2024 .

Balance Sheet and KPIs

MetricQ4 2024Q1 2025Q2 2025
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$108.468 $99.789 $84.806
Working Capital ($USD Millions)$80.009 $69.710 $56.691
Total Assets ($USD Millions)$136.388 $124.411 $108.928
Total Liabilities ($USD Millions)$79.995 $75.074 $74.874
Total Stockholders’ Equity ($USD Millions)$56.393 $49.337 $34.054
Common Shares Outstanding (Units)8,202,715 10,548,852 11,636,981

Estimates vs Actuals (S&P Global)

MetricQ4 2024 Estimate*Q4 2024 Actual*Q1 2025 Estimate*Q1 2025 Actual*Q2 2025 Estimate*Q2 2025 Actual*
Revenue ($USD Millions)$4.28*$0.638*$5.00*$0.029*$6.27*$0.018*
EPS ($USD)$(1.96)*$(2.136)*$(1.72)*$(2.21)*$(1.57)*$(2.13)*
# of Revenue Estimates4*—3*—3*—
# of EPS Estimates3*—3*—3*—

Values retrieved from S&P Global.*

Key takeaway: Q2 2025 was a significant miss vs consensus on both revenue and EPS; the revenue miss reflects minimal collaboration/license revenue and lapping of prior-year non-cash recognition .

  • Revenue surprise: $0.018M vs $6.27M* — bold miss.
  • EPS surprise: $(2.13) vs $(1.57)* — bold miss.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto 2H 2026 (Q1 2025) Into 2H 2027 (Q2 2025) Raised runway by ~1 year
Annual Cash OpEx vs 2025FY 2026, FY 2027Not previously quantifiedReduce by ~$25M per year (2026 & 2027) New cost-reduction target
PBGENE-HBV2025 updatesCohort updates planned (Q1) Cohort 3 initiation; data update later 2025 Maintained timeline, escalated dose
PBGENE-HBV Phase 2Next stageNot previously datedEnable commencement of Phase 2 (runway supports) New operational objective
PBGENE-DMDRegulatoryTarget IND/CTA in 2025; clinical data in 2026 (Q1) Accelerated; Rare Pediatric & Orphan designations Strengthened path/designations

Earnings Call Themes & Trends

No Q2 2025 earnings call transcript was available in the document catalog; analysis relies on the 8-K and press releases [List: 0 documents found for earnings-call-transcript for Q2 2025].

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
HBV clinical executionIND/CTA clearances; Cohort 1 initial safety and early HBsAg reduction; plan for repeat dosing and dose escalation Cohort 1: 47–69% HBsAg reductions; one durable ~50% at 7 months; favorable Cohort 2 safety; Cohort 3 endorsed; data update later 2025 Positive momentum; dose escalation underway
DMD programPreclinical efficacy across cardiac/skeletal muscles; IND/CTA targeted 2025; clinical data 2026 Rare Pediatric Disease and Orphan Drug Designations; continued preclinical data; IND/CTA targeted by year-end 2025 Accelerating; stronger regulatory positioning
Capital & runwayCash ~$108.5M; runway into 2H 2026 Runway extended to 2H 2027; ~$25M OpEx cuts in 2026/2027 Improved liquidity outlook
Partnered programs (iECURE OTC)First patient complete clinical response; enrollment to complete in 2025 Ongoing across multiple geographies; complete data anticipated 1H 2026 On track
Non-core programsPBGENE-3243 advancing; later staged PBGENE-3243 paused to prioritize HBV/DMD Deprioritized
CAR-T monetizationTG Therapeutics equity and milestone roadmap Ongoing exploration of monetizing non-core royalties/milestones Potential cash sources maintained

Management Commentary

  • “We are very pleased with the safety profile demonstrated in Cohorts 1 and 2 which has enabled the Data Monitoring Committee to endorse enrolling Cohort 3 this month to test the next higher dose.” — CEO Michael Amoroso .
  • “These actions are expected to enable commencement of a Phase 2 study for PBGENE-HBV and a potential pivotal trial for PBGENE-DMD… with a longer cash runway, we believe we are now even better positioned.” — CEO Michael Amoroso .
  • “We have also extended our expected cash runway to the second half of 2027… aimed at reducing our annual cash operating expenses in each of 2026 and 2027 by approximately $25 million compared to the 2025 annual cash expense level.” — CFO Alex Kelly .
  • “The ELIMINATE-B trial was designed with two levers to optimize efficacy; the first is dose escalation… The second lever is to shorten the dosing interval.” — CSO Cassie Gorsuch, PhD .

Q&A Highlights

  • No published Q2 2025 earnings call transcript was found; therefore, Q&A themes and any guidance clarifications are unavailable in the source set [List: 0 documents found for earnings-call-transcript for Q2 2025].

Estimates Context

  • Q2 2025 results missed consensus materially: Revenue $0.018M vs $6.27M*; EPS $(2.13) vs $(1.57)* — both significant misses. The miss is explained by de minimis collaboration/license revenues and lapping prior-year non-cash deferred revenue recognition (Prevail), plus continued investment in HBV/DMD development .
  • Prior quarters also trended below consensus, underscoring the need for external funding sources and/or collaboration revenue to bridge to later-stage clinical value inflections.*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Near-term clinical catalysts are central: watch ELIMINATE-B Cohort 3 dosing and the planned data update later in 2025; durable HBsAg reductions and liver biopsy molecular data could be stock-moving .
  • Liquidity improved: runway extended into 2H 2027 with planned ~$25M annual OpEx cuts; monitor execution on additional non-dilutive cash via collaborations and royalty/milestone monetization .
  • DMD program is strategically elevated: Rare Pediatric Disease and Orphan Drug designations enhance the regulatory path and potential value; IND/CTA targeted by end-2025 .
  • Financials will remain noisy and low-revenue until collaborations scale; consensus misses are likely when external/licensing revenue is limited — set expectations accordingly .
  • Trading: In the short term, stock may react to additional safety/efficacy markers (HBsAg trajectories, biopsy data) and regulatory updates; medium term, Phase 2 HBV commencement and DMD IND acceptance are key milestones .
  • Risk management: Program pauses (PBGENE-3243) concentrate execution risk in HBV/DMD; maintain awareness of trial enrollment, dose-escalation safety, and LNP/AAV manufacturing scalability .
  • Strategic lens: A positive HBV efficacy signal at higher doses or shortened intervals, plus DMD IND clearance, could re-rate the story toward later-stage assets with clearer paths to pivotal trials .