Iterum Therapeutics sees cash runway into 2026

Iterum Therapeutics (ITRM) provided a general business update. ORLYNVAH Launch Update: In partnership with EVERSANA Life Science Services, ORLYNVAH was launched in August 2025 into the community market in the U.S. in targeted territories across seven states. Sales representatives, contracted by and dedicated to Iterum via EVERSANA, have been actively engaging with target physicians who have shown interest in learning more about ORLYNVAH and recommended patient profiles; these discussions have begun to result in prescriptions being written for ORLYNVAH. Iterum has received inbound inquiries from non-target physicians to learn more about ORLYNVAH and potential to gain access to the product. Market Access: National Account Managers continue to actively engage with key stakeholders across the U.S. payer landscape and have been 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. ORLYNVAH remains broadly accessible via prior authorization and medical exception pathways, consistent with standard “new-to-market” coverage protocols. 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, which Iterum aims to achieve later this year and through the first quarter of 2026. Iterum has received 510(k) clearance by the U.S. Food and Drug Administration of 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. Antimicrobial susceptibility testing helps guide clinicians to use effective and targeted therapy for individual patients and is a key component of antimicrobial stewardship, helping to combat the growing threat of antimicrobial resistance. Based on Iterum’s current operating plan, Iterum expects that 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, will be sufficient to fund its operations into 2026. Iterum will continue to explore all available financing opportunities, including non-dilutive funding, to extend its operating runway. Patent Estate Updates: Iterum has been granted a patent in China as patent number ZL202180020106.6, entitled “Combinations of Beta-Lactam Compounds, Probenecid, and Valproic Acid and Uses Thereof”, that covers a combination of sulopenem etzadroxil, probenecid, and valproic acid for treating specified diseases. This Chinese patent is projected to expire in March 2041, absent any patent term extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent. Iterum has been granted a patent in Mexico as patent number 426995, entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof”, that covers a bilayer tablet comprising sulopenem etzadroxil and probenecid, methods of preparing the bilayer tablet, and the bilayer tablet for use in treating specified diseases. This Mexican patent is projected to expire in December 2039, absent any patent term extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent. Iterum continues to optimize its patent strategy by prioritizing key jurisdictions and ensuring the continued expansion of its valuable patent portfolio.