Iterum Aims for Early ORLYNVAH Launch in August 2025, Targets $40M uUTI Market

Iterum Therapeutics plans to launch ORLYNVAH in the US in August 2025, targeting the $40M UTI market. CEO Corey N. Fishman stated that business development transactions remain possible, but the immediate priority is a successful launch to address unmet patient needs. The company aims to expand in the UTI market with ORLYNVAH.

Iterum Therapeutics plc (Nasdaq: ITRM) has reported its financial results for the second quarter ended June 30, 2025, and announced significant developments ahead of the upcoming launch of its oral antibiotic, ORLYNVAH™. The company is poised to introduce the first branded antibiotic for uncomplicated urinary tract infections (uUTIs) in over 25 years, addressing a critical medical need exacerbated by antimicrobial resistance.

Financial Highlights

Iterum reported a net loss of $6.5 million for Q2 2025, an increase from $5.0 million in Q2 2024. The quarterly net loss increased due to a significant rise in general and administrative (G&A) expenses, which more than doubled to $4.2 million. This increase is primarily attributed to pre-commercialization activities in preparation for the ORLYNVAH™ launch. The company's cash position was $13.0 million as of June 30, with an additional $2.2 million raised through an at-the-market (ATM) offering in July/August 2025. These funds are expected to fund operations into 2026, providing a runway through the critical launch period [1].

Commercial and Strategic Developments

The upcoming launch of ORLYNVAH™, scheduled for August 2025, represents a transformative opportunity for Iterum. The drug is the first FDA-approved oral penem antibiotic in the U.S. and targets resistant Gram-negative bacteria, including extended spectrum ß-lactamases (ESBL)-producing Enterobacterales. This launch addresses a critical medical need as antimicrobial resistance has rendered many generic treatments ineffective.

Iterum has established key commercial infrastructure through its partnership with EVERSANA for U.S. commercialization services and secured manufacturing through ACS Dobfar. These partnerships, along with the appointment of Christine Coyne as Chief Commercial Officer, position Iterum for its commercial transition. The company also secured patent protection in Canada for ORLYNVAH™ until 2039 and published its REASSURE Phase 3 trial results in NEJM Evidence, enhancing clinical credibility.

Market Opportunity and Business Strategy

The market for uncomplicated urinary tract infections (uUTIs) in the U.S. is estimated to be around $40 million. CEO Corey N. Fishman stated that business development transactions remain possible but the immediate priority is a successful launch to address unmet patient needs. The company aims to expand in the UTI market with ORLYNVAH™. The upcoming launch of ORLYNVAH™ is expected to address a critical medical need and provide a much-needed option for patients with limited alternatives due to resistant Gram-negative bacteria [1].

References

[1] https://www.stocktitan.net/news/ITRM/iterum-therapeutics-reports-second-quarter-2025-financial-wevke35bjb7c.html