Iterum Therapeutics Extends Cash Runway to 2026 with $13M in Cash and $2.2M in Net Proceeds from ATM Offering.

Iterum Therapeutics has $13.0 million in cash and cash equivalents as of June 30, 2025, which, along with $2.2 million from an at-the-market offering program, is expected to fund its operations into 2026, including the planned commercial launch of ORLYNVAH in August 2025. The company had approximately 44.7 million ordinary shares outstanding as of August 1, 2025.

Iterum Therapeutics plc (Nasdaq: ITRM), a biopharmaceutical company specializing in next-generation oral and IV antibiotics, has reported its financial results for the second quarter ended June 30, 2025. The company announced that it has $13.0 million in cash and cash equivalents, along with an additional $2.2 million from an at-the-market offering program, which is expected to fund its operations into 2026, including the planned commercial launch of ORLYNVAH™ in August 2025.

The company has been actively preparing for the commercial launch of ORLYNVAH™, which is expected to be the first branded antibiotic for uncomplicated urinary tract infections (uUTIs) in over 25 years. The launch is a significant milestone as rising antimicrobial resistance has rendered many commonly used generic treatments ineffective across large parts of the U.S. ORLYNVAH™ is the only FDA-approved oral penem antibiotic in the U.S., offering a much-needed option for patients with limited alternatives due to resistant Gram-negative bacteria, including extended spectrum β-lactamases (ESBL)-producing Enterobacterales.

Iterum has entered into strategic partnerships to support the commercialization of ORLYNVAH™. In June 2025, the company entered into a Product Commercialization Agreement with EVERSANA Life Science Services, LLC, which will provide sales and commercial operations services in the U.S. Additionally, in July 2025, Iterum entered into a Commercial Manufacturing and Supply Agreement with ACS Dobfar S.p.A for the manufacture and supply of ORLYNVAH™ bilayer tablets.

The company has also appointed Christine Coyne as its Chief Commercial Officer to lead all commercial efforts, including the near-term launch of ORLYNVAH™ in the U.S. The appointment of Coyne is part of Iterum's ongoing efforts to strengthen its commercial operations.

Iterum's financial results for the second quarter 2025 showed a net loss of $6.5 million, compared to a net loss of $5.0 million for the same period in 2024. The company's cash runway into 2026 is supported by its current operating plan, which includes the expected commercial launch of ORLYNVAH™ in August 2025.

The company has approximately 44.7 million ordinary shares outstanding as of August 1, 2025. The cost of sales expense for the second quarter 2025 was $0.3 million, representing the amortization related to the finite-lived intangible asset recognized in relation to the regulatory milestone payment payable to Pfizer upon approval of ORLYNVAH™ by the FDA. Research and development expenses for the second quarter 2025 were $1.0 million compared to $2.1 million for the same period in 2024. The decrease in expenses was primarily due to a decrease in clinical trial costs associated with the REASSURE trial.

General and administrative expenses for the second quarter 2025 were $4.2 million compared to $1.9 million for the same period in 2024. The increase in expenses was primarily due to an increase in spend associated with pre-commercialization activities.

Iterum will host a conference call today, Tuesday, August 5, 2025, at 8:30 a.m. Eastern Time to discuss its financial results. The dial-in information for the call is as follows: United States: 1 833 470 1428; International: 1 404 975 4839; Access code: 740801.

References:
[1] https://www.globenewswire.com/news-release/2025/08/05/3127171/0/en/Iterum-Therapeutics-Reports-Second-Quarter-2025-Financial-Results.html