Iterum Therapeutics plc

Hello, everyone, and welcome to the ITARM Therapeutics fourth quarter and full year 2022 financial results and business update. My name is Charlie, and I'll be coordinating the call today. You'll have the opportunity to ask a question at the end of the presentation. If you'd like to register a question, please press star followed by one on your telephone keypads. I'll now hand over to our host, Louise Barrett, SVP Legal Affairs, to begin. Louise, please go ahead.

Thank you, Charlie. Good morning and welcome to interim therapeutics fourth quarter and full year 2022 financial results and business update conference call. A press release with our fourth quarter and full year 2022 results is issued early this morning and can be found on our website. We are joined this morning by Corey Fishman, CEO and Judy Matthews, CFO. Corey will provide some opening remarks, Judy will provide details on our financial results and then we'll open the line to some Q&A. Before I begin, I would like to remind you that this call will contain forward-looking statements concerning our plans, strategies, and prospects for our business, including the development, therapeutic, and market potential of Sulipenem, the timing, conduct, progress, and results of our ongoing Reassure clinical trial, the expected timing of resubmission of our NDA, the term and coverage provided by our patent and other intellectual property rights, and the sufficiency of our cash resources. Actual results may differ materially from those indicated by these forward-listing statements as a result of various important factors, including uncertainties inherent in the design, initiation, and conduct of clinical development, including the reassure clinical trials, the availability and timing of data from the reassure clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory findings and approvals, including the potential resubmission of our NDA for oral sulipanim, Changes in public policy or legislation and commercialization plans and timelines before Sulapenem was approved. The actions of third party clinical research organizations, suppliers and manufacturers. The accuracy of our expectations regarding how Byron's future our cash in hand will fund our ongoing operations and other factors discussed under the caption risk factors in our annual report filed this morning. In addition, any forward-looking statements represent our views only as the date of this call and should not be relied on as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referring to non-GAAP financial measures during the call. We have provided reconciliations of GAAP reported to non-GAAP adjusted information in the press release issued this morning. With that said, I'll turn it over now to Corey for some opening remarks.

Thanks, Louise. Welcome and thanks for joining us today. I want to share some highlights from 2022 and talk about our 2023 activities. We made significant progress in 2022 to move the clinical development of sulopenem forward. We worked with the FDA to align on a design for an additional phase three clinical trial for oral sulopenem to address certain deficiencies the FDA noted in their complete response letter we received in July 2021. We are conducting our new Phase III clinical trial under a special protocol assessment, SPA, agreement with the FDA. The SPA agreement provides that the design and planned analysis of the clinical trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of the company's new drug application for oral psilopentamide. As a brief reminder, our new phase three clinical trial, known as REASSURE, comparing oral sulopenem to oral augmentin for the treatment of uncomplicated urinary tract infections is currently enrolling subjects. The REASSURE study is designed as a non-inferiority trial comparing oral sulopenem and oral augmentin in the augmentin-susceptible population and is expected to enroll approximately 1,966 patients. In the reassured trial, patients will be randomized to receive either oral psilopennine twice daily for five days or oral Augmentin twice daily for five days. The primary endpoint is the overall response, clinical and microbiologic combined response at day 12 of the trial. We expect to complete enrollment in the first half of 2024, and if successful, we'll resubmit our NDA to the FDA in the second half of 2024. If the resubmission addresses all deficiencies in the complete response letter we received in July 2021 from FDA, then the FDA's review and action should occur six months from receipt of our resubmission. It's important to note that the need for new oral treatments in the uncomplicated urinary tract infection therapy area remains high. Although the market is quite large, with approximately 33 million prescriptions in the US annually, almost all currently available oral treatment options face safety and efficacy challenges, including increasing resistance. leaving community physicians seeking new and effective treatment options. We are very pleased to share that Iterum has been granted two U.S. patents, one directed to the composition of the bilayer tablet of oral sulopenin, which contains sulopenin exudroxil and probenicid in a single bilayer tablet, and one patent directed to the method of use of oral sulopenin in treating multiple diseases, including uncomplicated urinary tract infections. Both of these patents will provide protection into 2039, which allows for a substantial runway to protect the value of oral sulopenin in the U.S. Outside the U.S., we have pending patent applications, including in Europe, China, Japan, and parts of South America, which were submitted following receipt of the written opinion of the International Search Authority, indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive. Additionally, we continue to evaluate potential new areas where there is an unmet medical need and where sulopenem could be an important potential alternative in treating those patients. We will share additional details as and when this plan develops further. Our cash position remains solid with a balance of approximately $61 million as of year-end 2022. We expect that our current cash, cash equivalents, and short-term investments will be able to fund our operations into mid-2024. In summary, we are pleased to have aligned with the FDA and begun enrollment in our reassured clinical trial and are looking forward to potentially bringing the first new oral penum to the market in order to help address a serious medical need in the community. Now I'll turn the call over to Judy for additional details on our financial results. Thanks, Corey.