Spero Therapeutics, Inc. (SPRO)·Q2 2025 Earnings Summary

Executive Summary

• PIVOT-PO Phase 3 for tebipenem HBr (oral carbapenem for cUTI) met its primary endpoint and was stopped early for efficacy (1,690 patients); GSK plans to include data in a U.S. FDA filing in 2H 2025; management expects FDA action likely in 2026 .
• Q2 delivered strong operating leverage: revenue rose to $14.189M (+39% YoY) on higher GSK collaboration revenue; net loss narrowed to $(1.7)M with EPS of $(0.03), versus $(0.33) a year ago .
• Cash runway extended materially “into 2028” due to trial cost savings from early stop and milestone receipts from GSK; cash and equivalents were $31.2M at quarter-end, with a final $23.8M earned milestone received in August 2025 .
• Estimates context: EPS beat meaningfully vs S&P Global consensus (Actual $(0.03) vs $(0.38)); revenue had no meaningful consensus coverage (one estimate showing $0); catalysts ahead include full data disclosure, NDA submission in 2H 2025, and 2026 FDA action potential . Values retrieved from S&P Global*.

What Went Well and What Went Wrong

What Went Well

• Early-stop Phase 3 success de-risks the lead asset: “met its primary endpoint… and was stopped early for efficacy,” with no new safety concerns (diarrhea, headache most frequent AEs) .
• Operating leverage and narrowed loss: revenue increased to $14.2M (from $10.2M), while R&D fell to $10.7M (from $23.7M) as PIVOT-PO costs declined; net loss improved to $(1.7)M (from $(17.9)M) .
• Balance sheet visibility: runway extended into 2028; management highlighted cost savings from early stop and non‑contingent GSK milestones supporting the runway .

Management quotes:

• “PIVOT-PO… successfully met its primary endpoint and was stopped early for efficacy… GSK… plan to… include the PIVOT-PO data as part of an FDA filing at year end 2025.”
• “There remains a critical unmet need for an oral carbapenem… If approved, we believe tebipenem HBr could set a new standard of care…” .

What Went Wrong

• Reduced future first-sale commercial milestone potential (contingent) adjusted to up to $101M (from up to $150M) given early stop reduced total enrollment; other milestones unchanged .
• SPR720 uncertainty persists after Phase 2a oral program was suspended due to lack of efficacy separation and dose-limiting hepatotoxicity; next steps under evaluation .
• Limited Street coverage: one-estimate coverage and zero revenue consensus complicates standard “beat/miss” framing for revenue; underscores micro-cap coverage constraints [GetEstimates].

Financial Results

Sequential Trend (oldest → newest)

YoY Comparison (Q2 2025 vs Q2 2024)

Q2 2025 Actual vs S&P Global Consensus

Values retrieved from S&P Global*.

Revenue Components (oldest → newest)

KPIs (oldest → newest)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The PIVOT-PO trial… met its primary endpoint and was stopped early for efficacy… [and] did not identify any new safety concerns…” .
• “GSK… plan to work with the FDA to include the PIVOT-PO data as part of an FDA filing at year end 2025. We currently believe that FDA action is likely in 2026.” .
• “With the trial stopping early for efficacy, we have achieved meaningful cost savings… which we anticipate will extend our cash runway into 2028.” .
• “Total revenue… was $14.2 million… primarily due to collaboration revenue from GSK… R&D… $10.7 million… decrease… due to reduced clinical expenses related to the PIVOT-PO trial.” .

Q&A Highlights

• Capital allocation and BD vs pipeline: Management prioritized ensuring tebipenem HBr reaches regulatory approval as the primary value driver; capital deployment decisions to follow once there is line of sight to approval .

Estimates Context

• Q2 2025 EPS: Actual $(0.03) vs S&P Global consensus $(0.38)* → Beat by $0.35, driven by higher collaboration revenue and lower trial costs as PIVOT-PO stopped early . Values retrieved from S&P Global*.
• Q2 2025 Revenue: Actual $14.189M vs limited consensus coverage (one estimate at $0.0); collaboration revenue from GSK was $11.802M . Values retrieved from S&P Global.
• Coverage depth: one estimate for both revenue and EPS across recent quarters, limiting traditional consensus analytics [GetEstimates].

Key Takeaways for Investors

• Clinical de-risking: Early-stop Phase 3 success meaningfully increases the probability of approval; SPA framework further supports approvability .
• Clear regulatory path: GSK plans an FDA filing in 2H 2025; management expects potential 2026 action—key stock catalysts include full data disclosure and NDA submission .
• Operating leverage evidence: Collaboration revenue strength and reduced R&D drove a large EPS beat vs S&P consensus in Q2 . Values retrieved from S&P Global*.
• Balance sheet extended: Runway into 2028 lowers financing risk through key milestones; supports holding into regulatory events .
• Economics intact despite milestone re-cut: First-sale commercial milestone opportunity reduced to up to $101M (from up to $150M), but total milestone and royalty framework remains compelling, with up to ~$351M potential plus tiered royalties .
• Risk factors: SPR720 path remains uncertain; reliance on partner execution (GSK) and regulatory outcomes persists .
• Trading setup: Near-term data presentation and NDA submission are likely narrative drivers; 2026 FDA decision is the pivotal event.

Notes:

• All financial figures are from company press releases/filings/transcripts as cited.
• Asterisked estimate figures are from S&P Global consensus and may reflect limited coverage; Values retrieved from S&P Global*.