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Spero Therapeutics, Inc. (SPRO)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $5.44M and diluted EPS was $(0.13); net loss narrowed to $(7.38)M versus $(17.15)M in Q3 2024, driven by sharply lower R&D and G&A, partially offset by reduced collaboration and grant revenue .
  • Collaboration partner GSK plans to file tebipenem HBr with the FDA in Q4 2025; management anticipates a regulatory decision in 2H 2026, positioning regulatory milestones as the primary near-term stock catalysts .
  • Cash and equivalents were $48.62M at quarter-end; management guides runway into 2028, supported by reduced Phase 3 trial costs and earned milestones .
  • The PIVOT-PO Phase 3 cUTI trial (stopped early for efficacy) met its primary endpoint, with oral tebipenem HBr non-inferior to IV imipenem-cilastatin on overall response at test-of-cure; safety profile remained consistent, with diarrhea and headache most frequent AEs .
  • Wall Street consensus for Q3 2025 EPS was $(0.25)* and for revenue $0.0* (only one estimate); actuals exceeded both, implying a beat on EPS and revenue, though estimates breadth was limited (1 estimate each)* .
    Values marked with an asterisk were retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • “We are working alongside our partner, GSK, to enable them to submit the FDA filing this quarter and we anticipate regulatory decision in 2H 2026” — reinforcing the near‑term filing and visibility on review timeline .
  • Phase 3 PIVOT‑PO non‑inferiority achieved; trial stopped early for efficacy at interim analysis, supporting oral tebipenem HBr’s potential to change cUTI care with comparable outcomes to standard IV carbapenem therapy .
  • Operating discipline: R&D fell to $8.6M (from $26.9M YoY) and G&A to $4.2M (from $5.2M YoY), helping improve net loss and extend cash runway into 2028 .

What Went Wrong

  • Revenue fell to $5.44M from $13.47M in Q3 2024 due to lower collaboration revenue with GSK and grant revenue, highlighting dependence on milestone/collaboration timing .
  • SPR720 program discontinued in Q3 2025 following completion of data review, removing a pipeline option and underscoring portfolio concentration in tebipenem HBr .
  • Q3 earnings call transcript not available in our catalog; limits direct Q&A insight for the quarter. We reviewed prior calls and documents to assess trends .

Financial Results

Income Statement and EPS vs prior periods

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$13.47 $5.87 $14.19 $5.44
Net Loss ($USD Millions)$(17.15) $(13.87) $(1.70) $(7.38)
Diluted EPS ($)$(0.32) $(0.25) $(0.03) $(0.13)
R&D Expense ($USD Millions)$26.86 $13.61 $10.67 $8.60
G&A Expense ($USD Millions)$5.20 $6.82 $5.88 $4.17

Cash and Balance Sheet

MetricQ1 2025Q2 2025Q3 2025
Cash & Cash Equivalents ($USD Millions)$48.89 $31.19 $48.62
Total Assets ($USD Millions)$77.71 $62.12 $54.17
Total Liabilities ($USD Millions)$43.90 $29.29 $27.68
Stockholders’ Equity ($USD Millions)$33.81 $32.83 $26.49

Revenue Breakdown (Q3)

Revenue Line ($USD Millions)Q3 2024Q3 2025
Grant Revenue$5.65 $2.39
Collaboration Revenue – Related Party$7.75 $3.05
Collaboration Revenue (Other)$0.07 $0.00
Total Revenue$13.47 $5.44

Clinical KPIs (PIVOT-PO cUTI)

KPITebipenem HBr (Oral)Imipenem-cilastatin (IV)Notes
Overall Response at TOC (%)58.5% (261/446) 60.2% (291/483) Non-inferiority met (adj. diff −1.3%; 95% CI: −7.5%, 4.8%)
Clinical Response at TOC (%)93.5% (417/446) 95.2% (460/483) Sustained through late follow-up
Microbiological Response at TOC (%)60.3% (269/446) 61.3% (296/483) Similar across drug-resistant phenotypes
Common TEAEsDiarrhea, Headache Diarrhea, Headache Mild/moderate, non-serious

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA Filing (Tebipenem HBr NDA)Timing“Filing in 2H 2025” “Filing in Q4 2025” Clarified (narrowed window)
Regulatory Decision (FDA action)Timing“Likely in 2026” “2H 2026 anticipated” Clarified (more specific)
Cash RunwayDuration“Into 2028” (with earned milestones) “Into 2028” Maintained
SPR720 ProgramStatus“Determining next steps” “Program discontinued in Q3 2025” Lowered/discontinued

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Regulatory Path (Tebipenem HBr)Interim analysis planned Q2; NDA filing 2H 2025; SPA with FDA guiding approvability Filing targeted in Q4 2025; decision anticipated 2H 2026 Progressing; timelines sharpened
R&D ExecutionPIVOT-PO met primary endpoint; stopped early for efficacy Early-stop for efficacy reiterated; detailed NI results disclosed Positive execution; cost containment
Partnership (GSK)GSK to lead filing/commercialization; milestones/royalties outlined Filing this quarter; milestone framework reaffirmed Active coordination; path to monetization
Cash Runway & CostsRunway into 2028 aided by trial stop and milestones Runway into 2028 maintained; cash $48.62M Stable; improved liquidity post Q2
Pipeline Breadth (SPR720)Analysis ongoing; safety signals noted in P2a Program discontinued Portfolio narrowed; focus on tebipenem
Clinical SafetyNo new safety concerns in PIVOT‑PO; common TEAEs mild/moderate Safety consistent; TEAEs diarrhea/headache Consistent profile

Note: A Q3 2025 earnings call transcript was not available in our catalog; we incorporated Q2 call commentary for trend context .

Management Commentary

  • “We are working alongside our partner, GSK, to enable them to submit the FDA filing this quarter and we anticipate regulatory decision in 2H 2026.” — Esther Rajavelu, CEO .
  • “If approved, tebipenem HBr as an oral option could provide an important alternative to IV carbapenem therapies for complicated urinary tract infections, with the potential to shorten hospital stays and improve treatment burden for patients.” — Esther Rajavelu .
  • “We estimate that our existing cash and cash equivalents…will be sufficient to fund the company's current operating and capital expenditures into 2028.” — Esther Rajavelu (Q2 call) .

Q&A Highlights

  • Capital allocation focus: Priority is ensuring tebipenem HBr reaches approval; capital decisions to follow visibility into approval timing — response to Evercore ISI question (Q2) .
  • No Q3 call transcript available; Q2 Q&A indicates disciplined allocation toward regulatory milestones for tebipenem HBr .

Estimates Context

MetricQ3 2025 Consensus# of EstimatesQ3 2025 Actual
Primary EPS Consensus Mean ($)$(0.25)*1*$(0.13)
Revenue Consensus Mean ($USD Millions)$0.00*1*$5.44
  • With only one estimate per metric, headline prints show an EPS beat of ~$0.12* and revenue above a de minimis consensus*, but the limited estimate breadth reduces signal strength. Values marked with an asterisk were retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory milestones are the near-term catalysts: GSK’s planned Q4 2025 NDA filing and anticipated 2H 2026 FDA decision for tebipenem HBr .
  • Clinical de-risking: PIVOT‑PO met NI and was stopped early for efficacy; detailed efficacy and safety readouts support oral tebipenem HBr’s profile versus IV carbapenem standard of care .
  • Financial discipline: Significant YoY reductions in R&D and G&A enabled improved net loss and maintained runway into 2028 despite lower collaboration/grant revenue .
  • Portfolio focus: Discontinuation of SPR720 consolidates resources toward tebipenem HBr and milestone-driven value with GSK .
  • Collaboration economics: Up to $351M in remaining contingent milestones and tiered royalties outline a path to non-dilutive value upon regulatory and commercial execution .
  • Trading setup: Limited consensus coverage and absence of a Q3 call transcript mean news flow is concentrated on regulatory filings; watch for confirmation of NDA submission and any labeling considerations that could affect commercial uptake .
  • Risk checks: Dependence on GSK for filing/commercialization, potential FDA requests for additional data, and timing of milestone recognition remain key variables for the equity story .