Iterum Therapeutics Reports Q2 2025 Results, Expects ORLYNVAH Launch

Iterum Therapeutics reported a Q2 2025 non-GAAP loss per share of ($0.13), $0.02 below analyst expectations, and revenue of $0 million, in line with estimates. The company's operating loss increased due to a significant jump in general and administrative costs, but made progress in manufacturing, patent protection, and financial runway extension. Iterum focuses on bringing new solutions to patients with serious infectious diseases and is gearing up for the commercial launch of its oral antibiotic, ORLYNVAH™.

Iterum Therapeutics (Nasdaq: ITRM) reported its Q2 2025 financial results, highlighting the company's progress towards the upcoming launch of ORLYNVAH™, the first branded antibiotic for uncomplicated urinary tract infections (uUTIs) in over 25 years. The company reported a non-GAAP EPS loss of $0.13, missing estimates by $0.02 due to higher pre-commercialization spending. Research and development (R&D) expenses fell by 48.2% year-over-year (YoY), while general and administrative (G&A) costs rose by 121.1% [1].

Key financial highlights include a cash position of $13.0 million as of June 30, 2025, with an additional $2.2 million raised through an at-the-market offering program from July 1, 2025, through August 1, 2025. This cash position is expected to fund operations into 2026, providing a runway through the critical launch period of ORLYNVAH™ in August 2025. The company's net loss for Q2 2025 was $6.5 million, compared to $5.0 million in Q2 2024, primarily driven by a $4.2 million increase in G&A expenses related to pre-commercialization activities [1].

The upcoming launch of ORLYNVAH™ addresses a critical medical need as antimicrobial resistance has rendered many generic treatments ineffective. ORLYNVAH™ is the only FDA-approved oral penem antibiotic in the U.S., targeting resistant Gram-negative bacteria, including ESBL-producing Enterobacterales. The company's near-term cash flow has been significantly improved by deferring the $20 million regulatory milestone payment to Pfizer until 2029 [1].

While the ORLYNVAH™ launch represents a transformative opportunity, the relatively modest cash position will require careful management as Iterum transitions from R&D to commercial operations. The company is expected to host a conference call today at 8:30 AM ET to discuss the financial results and the upcoming launch [1].

References:
[1] https://www.stocktitan.net/news/ITRM/iterum-therapeutics-reports-second-quarter-2025-financial-wevke35bjb7c.html
[2] https://www.marketscreener.com/news/iterum-therapeutics-plc-reports-earnings-results-for-the-second-quarter-and-six-months-ended-june-30-ce7c5ed8dc8ff626
[3] https://www.iterumtx.com/news/press-releases/detail/154/iterum-therapeutics-reports-second-quarter-2025-financial