Iterum Therapeutics

ITRMPhase 3

Dublin, IrelandFounded 2015iterumtx.com

Iterum Therapeutics is dedicated to addressing the critical public health crisis of antimicrobial resistance by developing next-generation antibiotics. Its primary candidate, sulopenem, is designed to treat resistant urinary tract infections (UTIs) and intra-abdominal infections where current oral options are failing. Despite facing significant setbacks, including a Complete Response Letter from the FDA for its NDA, the company continues to seek pathways to bring sulopenem to patients. Iterum operates as a lean, publicly traded entity (NASDAQ: ITRM) strategically headquartered in Ireland.

Market Cap

$8.6M

Founded

2015

Employees

1-10

Focus

Biotech

ITRM · Stock Price

USD 0.166.56 (-97.60%)

Historical price data

AI Company Overview

Technology Platform

Focused on the development of sulopenem, an orally bioavailable penem antibiotic designed to combat multi-drug resistant Gram-negative and Gram-positive bacterial infections.

Pipeline Snapshot

9 drugs in pipeline, 5 in Phase 3

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

Funding History

Total raised: $185M

IPO$120MUndisclosedJun 28, 2018

Series A$65MUndisclosedJun 15, 2015

Opportunities

The critical unmet need for new oral antibiotics against multi-drug resistant UTIs represents a significant market opportunity.

Successful approval could position sulopenem as a first-line oral option for resistant infections, enabling step-down therapy from IV and reducing hospital costs.

Risk Factors

The company faces extreme regulatory and financial risk following an FDA Complete Response Letter, with limited cash to pursue a resubmission.

The challenging commercial landscape for antibiotics, including pricing pressure and stewardship, threatens long-term viability even if approved.

Competitive Landscape

Competes against generic fluoroquinolones (though resistance is high) and newer IV-only agents. Direct competition comes from other oral antibiotics in development for resistant UTIs, such as tebipenem. Differentiation hinges on sulopenem's oral bioavailability and specific spectrum against quinolone-resistant pathogens.