Spero Therapeutics Inc
NASDAQ:SPRO
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Spero Therapeutics Inc
Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on identifying, developing, and commercializing novel treatments for multi-drug resistant, or MDR, bacterial infections. The company is headquartered in Cambridge, Massachusetts and currently employs 146 full-time employees. The company went IPO on 2017-11-02. The firm is focused on identifying, developing and commercializing novel treatments for MDR bacterial infections. Its lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide), is developed as the oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). The company is also developing SPR720 as a novel oral therapy product candidate for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections. The firm also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is being developed to treat MDR Gram-negative infections in the hospital setting.
Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on identifying, developing, and commercializing novel treatments for multi-drug resistant, or MDR, bacterial infections. The company is headquartered in Cambridge, Massachusetts and currently employs 146 full-time employees. The company went IPO on 2017-11-02. The firm is focused on identifying, developing and commercializing novel treatments for MDR bacterial infections. Its lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide), is developed as the oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). The company is also developing SPR720 as a novel oral therapy product candidate for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections. The firm also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is being developed to treat MDR Gram-negative infections in the hospital setting.
Phase III Success: Spero and GSK’s PIVOT-PO Phase III trial for Tebipenem HBr in complicated urinary tract infections met its primary endpoint and was stopped early for efficacy.
FDA Plans: GSK aims to submit the Tebipenem HBr regulatory filing by year-end 2025, with possible FDA action in the second half of 2026.
Financial Position: Spero ended Q2 with $31.2 million in cash and expects its runway, including a recent $23.8 million milestone from GSK, to last into 2028.
Revenue Growth: Q2 revenue rose to $14.2 million, up from $10.2 million a year ago, mainly due to GSK collaboration revenue.
Costs Down: R&D expenses dropped sharply year-over-year, driven by the early PIVOT-PO trial stop.
SPR720 Setback: The Phase IIa study for SPR720 in NTM-PD did not meet its primary endpoint and showed safety concerns.