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Spero Therapeutics (SPRO)

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Earnings summaries and quarterly performance for Spero Therapeutics.

Recent press releases and 8-K filings for SPRO.

Spero Therapeutics' Partner GSK Resubmits NDA for Tebipenem HBr
SPRO
Product Launch
New Projects/Investments
  • Spero Therapeutics' development partner, GSK, has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic for complicated urinary tract infections (cUTI), including pyelonephritis.
  • The NDA resubmission is supported by results from the successful Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025 following a planned interim analysis.
  • This resubmission triggers a $25 million milestone payment to Spero, which is expected to be received in Q1 2026.
Dec 19, 2025, 1:00 PM
Spero Therapeutics Announces Q3 2025 Results and Tebipenem HBr FDA Filing Plans
SPRO
Earnings
Guidance Update
New Projects/Investments
  • Spero Therapeutics reported a net loss of $7.4 million and total revenue of $5.4 million for the third quarter ended September 30, 2025.
  • The company's development partner, GSK, plans to submit data from the Phase 3 PIVOT-PO trial for tebipenem HBr to the US FDA in Q4 2025, with a regulatory decision anticipated in 2H 2026. The trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin for complicated urinary tract infection (cUTI), with an overall success rate of 58.5%.
  • Spero Therapeutics has discontinued the SPR720 program in Q3 2025 following a review of Phase 2a and Phase 1 trial data.
  • As of September 30, 2025, Spero had $48.6 million in cash and cash equivalents, which is expected to fund operations into 2028.
Nov 13, 2025, 10:18 PM
Spyre Therapeutics Announces Closing of Public Offering
SPRO
New Projects/Investments
  • Spyre Therapeutics, Inc. announced the closing of its underwritten public offering, which included the full exercise of the underwriters’ option to purchase additional shares.
  • The offering comprised 17,094,594 shares of common stock at a public offering price of $18.50 per share.
  • The gross proceeds generated from the offering totaled approximately $316.2 million.
Oct 15, 2025, 8:15 PM
Spero Therapeutics Updates on Tebipenem Phase III Progress and GSK Partnership
SPRO
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
  • Spero Therapeutics' lead asset, tebipenem (tebi HBr), a potential first oral carbapenem for complicated urinary tract infections (cUTI), has completed over 60% enrollment in its Phase III trial, with full enrollment anticipated in the second half of 2025.
  • The company's cash runway extends into mid-2026.
  • Spero has received $200 million in funding from GSK for tebi HBr, with potential for up to $400 million in additional regulatory and commercial milestones and tiered royalties.
  • An additional $47.5 million in committed milestones from GSK remains, and a $25 million contingent milestone is expected upon GSK's NDA submission, guided for the end of 2025.
  • The wholly-owned asset SPR-720 for non-refractory NTM-PD showed activity but dose-limiting toxicities in a Phase IIa trial; next steps will be determined later in 2025 after full data analysis.
Mar 4, 2025, 8:10 PM
Spero Therapeutics Updates on Tebi HBr Phase III Progress and Pipeline
SPRO
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
  • Spero Therapeutics' lead asset, Tebi HBr, an oral carbapenem for complicated urinary tract infections (cUTI), is in a Phase III trial with over 60% enrollment completed in 2024, and full enrollment is guided for the second half of this year.
  • The company has a financial runway into mid-2026 and has received $200 million in funding from its partnership with GSK for Tebi HBr, with potential for up to $400 million in additional regulatory and commercial milestones.
  • Spero expects to receive $47.5 million in remaining committed milestones for Tebi HBr's Phase III development, and a $25 million contingent milestone upon GSK's NDA submission, which is guided for the end of this year.
  • The SPR-720 program for NTM-PD patients, a wholly owned asset, has suspended its oral program due to dose-limiting toxicities despite showing activity, and the company is exploring potential inhaled formulations.
Mar 4, 2025, 8:10 PM

Quarterly earnings call transcripts for Spero Therapeutics.