Iterum Therapeutics (ITRM) — Stock, Pipeline & Market Cap

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ITRM · Stock Price

USD 0.05-0.97 (-95.59%)

Market Cap: $2.4M

Historical price data

Market Cap: $2.4MPipeline: 9 drugs (5 Phase 3)Founded: 2015Employees: 11-50HQ: Dublin, Ireland

Sector Ranking#375 in Small Molecule Drugs

Overview

Iterum Therapeutics is an Irish biopharmaceutical company with a mission to develop differentiated antibiotics against multi-drug resistant pathogens. Its core achievement is the 2024 FDA approval of ORLYNVAH™ (sulopenem), the first oral penem, for uncomplicated urinary tract infections (uUTI) in patients with limited treatment options. The company's strategy leverages the unique oral/IV profile of sulopenem to address serious community and hospital infections, aiming to reduce hospital stays and combat resistance. Following a strategic restructuring after a 2021 regulatory setback, Iterum is now focused on the commercialization and potential label expansion of its approved asset.

Infectious DiseaseAntimicrobial Resistance

Technology Platform

Focused on the development of sulopenem, a novel penem antibiotic with both oral and intravenous formulations designed to combat multi-drug resistant Gram-negative and Gram-positive bacteria.

Pipeline

9

9 drugs in pipeline5 in Phase 3

Drug	Indication	Stage
Ciprofloxacin	UTI - Lower Urinary Tract Infection	Approved
Sulopenem etzadroxil/probenecid + Amoxicillin/clavulanate	Urinary Tract Infections	Phase 3
Sulopenem-Etzadroxil/Probenecid + Ciprofloxacin	Uncomplicated Urinary Tract Infections	Phase 3
Sulopenem + Sulopenem-Etzadroxil/Probenecid + Ertapenem + Ci...	Complicated Urinary Tract Infections	Phase 3
Ertapenem + Sulopenem-Etzadroxil/Probenecid + Ciprofloxacin ...	Intra Abdominal Infections	Phase 3

Funding History

2

Total raised:$185M

IPO$120MUndisclosedJun 28, 2018

Series A$65MUndisclosedJun 15, 2015

Opportunities

The FDA approval of ORLYNVAH™ creates a first-to-market opportunity in the oral penem class, addressing a critical gap for treating uUTI caused by quinolone-resistant pathogens.

Successful commercialization could establish a revenue base and provide a platform for potential label expansion into other resistant infections.

Risk Factors

Extreme financial and liquidity risk as a pre-revenue micro-cap company attempting a costly launch; commercial adoption risk due to antimicrobial stewardship and a narrow initial label; and reliance on near-term capital raises likely under highly dilutive conditions.

Competitive Landscape

ORLYNVAH™ is the first and only oral penem, competing against generic fluoroquinolones, nitrofurantoin, and fosfomycin for resistant uUTI. Its novel mechanism offers differentiation, but it faces the universal commercial challenges of novel antibiotics, including stewardship-driven low usage.