Iterum Therapeutics Sees Cash Runway Through 2026 with Antimicrobial Susceptibility Test Disc Clearance

Iterum Therapeutics (ITRM) has launched ORLYNVAH into the US community market and has received interest from physicians and non-target physicians. The company has secured 510(k) clearance for its antimicrobial susceptibility test disc and expects its cash and cash equivalents to fund operations into 2026. Iterum has also been granted patents in China and Mexico, covering combinations of beta-lactam compounds and probenecid for treating specified diseases.

Iterum Therapeutics (ITRM) has made significant strides in its latest business update, as the company launched its oral antibiotic ORLYNVAH into the U.S. community market in August 2025. The product, designed to treat urinary tract infections, has garnered interest from physicians and non-target physicians alike, with initial prescriptions beginning to be written. This positive reception comes as sales representatives, contracted through EVERSANA Life Science Services, actively engage with target physicians and gather inbound inquiries from non-target physicians.

The company has also secured 510(k) clearance for its 2 microgram Antimicrobial Susceptibility Test Disc, which will allow the device to be marketed and used in microbiology labs for susceptibility testing by the disc diffusion method. This clearance is a key milestone in the fight against antimicrobial resistance, as it helps guide clinicians to use effective and targeted therapy for individual patients.

In terms of market access, Iterum's National Account Managers are actively engaging with key stakeholders across the U.S. payer landscape. They are presenting ORLYNVAH’s differentiated value proposition and advancing formulary coverage discussions with state, regional, and national health plans, including the three largest pharmacy benefit managers serving the health plans. While formal committee reviews and rebate contracting negotiations are ongoing, Iterum is committed to maintaining momentum to secure expanded access and long-term formulary positioning, aiming to achieve this by the end of 2025 and the first quarter of 2026.

Additionally, Iterum has been granted patents in China and Mexico, covering combinations of beta-lactam compounds and probenecid for treating specified diseases. The Chinese patent, covering a combination of sulopenem etzadroxil, probenecid, and valproic acid, is projected to expire in March 2041, while the Mexican patent, covering a bilayer tablet of sulopenem etzadroxil and probenecid, is projected to expire in December 2039. These patents are part of Iterum's ongoing efforts to optimize its patent strategy and expand its valuable patent portfolio.

Based on its current operating plan, Iterum expects its cash and cash equivalents as of June 30, 2025, together with $2.2M of net proceeds raised under its at-the-market offering program from July 1, 2025 through August 1, 2025, to be sufficient to fund its operations into 2026. The company will continue to explore all available financing opportunities, including non-dilutive funding, to extend its operating runway.

Iterum Therapeutics sees cash runway into 2026^[1] https://finance.yahoo.com/news/iterum-therapeutics-sees-cash-runway-121043485.html
Iterum Therapeutics rises on patent wins, UTI drug launch progress^[2] https://www.tradingview.com/news/reuters.com,2025:newsml_L3N3V60XM:0-iterum-therapeutics-rises-on-patent-wins-uti-drug-launch-progress/