Iterum Therapeutics plc

your call today. After the presentation, there will be the opportunity for you to ask any questions, which you can do so by pressing start, followed by the number one on your telephone keypads. I will now turn the call over to our host, Louise Barrett, Senior Vice President of Legal Affairs. Louise, please go ahead.

Thank you, Emily. Good morning and welcome to Interim Therapeutics' fourth quarter and full year 2023 Financial Results and Business Update conference call. A press release of their fourth quarter of full results was issued earlier this morning and can be found on our website. We are joined this morning by our Chief Executive Officer, Corey Fishman, and our Chief Financial Officer, Judy Matthews. Corey will provide some opening remarks. Judy will provide details on our financial results, and then we'll open the line to Q&A. Before we begin, I'd like to remind you that some of the information presented on this conference call will contain forward-looking statements concerning our plans, strategies, and prospects for our business. including the development of therapeutic and market potential of oral sulipenem, our ability to address the deficiencies set out in the complete response letter received from the FDA in July 2021, the expected timing of resubmission of our NDA, the expected timing of review of the resubmission by the FDA, the sufficiency of our cash resources to fund our operating expenses into 2025, the term and coverage provided by our patent and other intellectual property rights, and the company's strategic process to sell, license, or otherwise dispose of its rights to Zulapenem to maximize shareholder value. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including uncertainties inherent in the design, initiation, and conduct of clinical and non-clinical development, changes on regulatory requirements or decisions of regulatory authorities, The timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for Oral Sulipenem. Changes in public policy or legislation. Commercialisation plans and timelines if Oral Sulipenem is approved. The accuracy of our expectations regarding how far into the future our cash in hand will fund ongoing operations. Our ability to maintain our listing on the NASDAQ capital market. risks and uncertainties concerning the outcome, impact, effects and results of our pursuit of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic process and our ability to complete one at all, whether on attractive terms or at all. And other factors discussed under the caption risk factors in our annual report on Form 10-K filed with the SEC this morning. In addition, any forward-looking statements represent our views only as the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We've provided reconciliations of GAAP reported to non-GAAP adjusted information in their press release issued this morning. With that said, I'll turn it over to you now, Corey, for your opening remarks.

Thanks, Louise. Good morning and thanks for joining us today. I'd like to provide a brief recap of 2023 and outline our key activities and milestones for 2024. Overall, 2023 was a very good year for Iterum as we completed enrollment in our confirmatory phase three clinical trial in adult women with uncomplicated urinary tract infections called the ReAssure clinical trial. As a reminder, This trial was conducted under special protocol assessment agreement with the FDA and compared oral sulopenem to oral Augmentin. As many of you know, we were very pleased to recently announce that the REASSURE trial demonstrated that oral sulopenem was non-inferior to Augmentin with respect to the trial's primary endpoint, which was overall response, which is the combined clinical cure plus microbiologic eradication at the test of cure visit in the microbiological modified intent to treat susceptible population. Additionally, oral sulopenem also demonstrated statistically significant superiority to Augmentin in the same patient population. Oral sulopenem also showed consistent efficacy for all key secondary endpoints. Lastly, Sulopenem demonstrated a very solid safety profile. With regards to the Sulopenem patent estate, in addition to the in-license patents we obtained in our original license agreement with Pfizer, we continue to seek opportunities to enhance the long-term protection of Sulopenem. We now have issued patents directed to the composition of the bilayer tablet of oral Sulopenem granted in the U.S., Japan, Korea, Australia, and these patents will expire no earlier than 2039. We also have an issued patent in the U.S. directed to the method of use of oral sulopenem in treating multiple diseases, including uncomplicated urinary tract infections, which is due to expire no earlier than 2039. In addition to the in-licensed and issued patents, we have a number of pending patent applications in the U.S. and other jurisdictions, including Europe and China. We believe that these patents, plus our potential data exclusivity, would allow oral sulipenem a long runway to capture value. I'll spend just a moment now and talk a bit about the market dynamics into which we see Sulopenem potentially entering. The uncomplicated urinary tract market is quite large with an estimated 40 million prescriptions annually in the U.S. It's estimated that approximately two-thirds of those prescriptions are for elevated risk patients, which are the patients that Sulopenem would target. Elevated risk patients are elderly, patients with diabetes, patients with a history of recurrent infections, or patients that have comorbidities that negatively impact their immune system. There's a significant need for new, efficacious, and safe oral products to treat uncomplicated urinary tract infections as the existing older oral products are experiencing high and increasing resistance rates as well as exhibiting subpar safety profiles. If approved, oral sulopenem would be the first oral penem approved in the United States and one of the first new branded treatments approved in the U.S. for uncomplicated urinary tract infections since the turn of the century. Regarding our upcoming milestones, We plan to resubmit our NDA to the FDA in the first half of the second quarter of this year. Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter we received from the FDA in July 2021, we expect the FDA will complete its review and take action in the first half of the fourth quarter of this year. which would be six months from the date the FDA receives the resubmitted NDA. As we look at our cash position, based on our current operating plan, we have cash on hand to operate the company through the expected PDUFA date early in the fourth quarter of 2024 and into 2025. Lastly, as previously stated, WE HAVE INITIATED A STRATEGIC PROCESS TO SELL, LICENSE, OR OTHERWISE DISPOSE OF OUR RIGHTS TO SULO-PENNUM WITH THE GOAL OF MAXIMIZING VALUE FOR OUR STAKEHOLDERS AND HAVE ENGAGED A FINANCIAL ADVISOR TO ASSIST MANAGEMENT AND THE BOARD IN EVALUATING STRATEGIC ALTERNATIVES. OUR BOARD HAS NOT SET A TIMETABLE FOR COMPLETION OF THIS EVALUATION PROCESS, AND WE DO NOT INTEND TO DISCLOSE FURTHER DEVELOPMENTS UNLESS AND UNTIL it is determined that further disclosure is appropriate or necessary. I'll now turn the call over to Judy for details on our financial results.