Spero Therapeutics, Inc. (NASDAQ: SPRO) Q2 2025 Earnings | 08/13/2025

7 days ago

15:29

Inside Ticker

Earnings Calls

AI Summary

Key Highlights:

Positive Phase III Results for Tebipenem HBr (CUTI Treatment):
- The PIVOT-PO trial (evaluating oral tebipenem HBr for complicated urinary tract infections (cUTIs) met its primary endpoint (clinical cure + microbiological eradication) and was stopped early for efficacy.
- Demonstrated non-inferiority to IV imipenem-cilastatin (current standard of care).
- Safety profile consistent with prior carbapenem studies (most common AEs: diarrhea, headache).
- GSK (partner) plans to submit data to the FDA in 2025, with potential approval in H2 2026.
- Spero could receive up to $351M in milestones (including $25M upon FDA submission) + tiered royalties.
Market Opportunity & Unmet Need:
- ~2.9M cUTI cases/year in the U.S., often requiring hospitalization due to IV-only carbapenems.
- Tebipenem HBr could be the first oral carbapenem, reducing healthcare costs (~$6B/year burden) and improving patient access.
SPR-720 (NTM-PD Program) Update:
- Phase IIa trial failed to meet primary endpoint; showed limited efficacy vs. placebo and safety concerns (hepatotoxicity in high-dose group).
- Company evaluating next steps for the program.

Financials & Cash Runway:

Cash & equivalents: $31.2M (as of June 30, 2025).
Additional $23.8M non-contingent milestone payment from GSK expected in August 2025.
Extended cash runway into 2028 due to early trial stoppage (cost savings).
Q2 2025 Financials:
- Revenue: $14.2M (vs. $10.2M in Q2 2024) – driven by GSK collaboration.
- R&D expenses: $10.7M (down from $23.7M YoY due to reduced PIVOT-PO costs).
- Net loss: $1.7M (vs. $17.9M in Q2 2024).

About this video

Spero Therapeutics, Inc. (NASDAQ: SPRO), a clinical-stage biopharmaceutical company focused on rare diseases and multi-drug resistant bacterial infections, reported strong financial and operational results for the second quarter of 2025. Total revenue increased 39.1% year-over-year to $14.2 million, up from $10.2 million in Q2 2024, driven primarily by collaboration revenue from GSK. The company significantly reduced its net loss to $1.7 million for the quarter, a substantial improvement from a net loss of $17.9 million in the same period last year. Diluted net loss per share improved to $0.03 from $0.33. This improvement was supported by a successful cost-saving strategy, including the early termination of the Phase 3 PIVOT-PO trial for tebipenem HBr after meeting its primary endpoint, which reduced clinical expenses. Research and development expenses declined notably to $10.7 million from $23.7 million in Q2 2024, primarily due to lower clinical trial costs. General and administrative expenses were slightly higher at $5.9 million compared to $5.5 million a year earlier, reflecting increased personnel and professional service costs. Strategic highlights include the early stoppage of the Phase 3 trial for tebipenem HBr due to demonstrated efficacy, positioning the drug for a planned FDA regulatory submission in the latter half of 2025 in collaboration with GSK. The company’s financial runway has been extended through 2028, supported by milestone payments from GSK totaling $23.8 million received in August 2025. However, the SPR720 program for NTM-PD was suspended after failing to meet primary endpoints in Phase 2a trials, highlighting continued operational challenges. Management emphasized focus on navigating the regulatory pathway for tebipenem HBr as the primary driver of future value. Risks remain related to regulatory uncertainty, competitive landscape, and ongoing clinical development expenses. About Inside Ticker: Inside Ticker delivers timely, in-depth financial news and earnings analysis to empower investors with actionable insights on global companies across sectors. For comprehensive video analysis and real-time updates, visit https://www.insideticker.com/. Hashtags: #SperoTherapeutics #SPRO #Q22025 #Earnings #FinancialResults #RevenueGrowth #NetLossImprovement #EPS #ClinicalTrials #TebipenemHBr #PIVOTPO #GSKPartnership #Biopharma #DrugDevelopment #RareDiseases #MultiDrugResistance #R&D #CostSavings #FDAApproval #CollaborationRevenue #Pipeline #Phase3Trial #ClinicalSuccess #RegulatoryUpdate #CashRunway #MilestonePayments #PharmaNews #InvestorRelations #StockMarket #BiotechStocks #HealthcareInnovation #Q2Results #EarningsReport #NASDAQ #BiotechInvesting #Pharmaceuticals #DevelopmentMilestones #OperationalUpdate #StrategicFocus

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