Iterum Therapeutics plc

Hello and welcome to the Ethereum Therapeutics fourth quarter 2024 financial results and business update. My name is Carla and I will be operating the call today. During the presentation, you can register to ask questions by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two. I will now hand over to your host, Louise Barrett, Senior Vice President of Legal Affairs to begin. Louise, please go ahead.

Thank you, Carla. Good morning and welcome to Interim Therapeutics' first quarter 2024 financial results and business update conference call. A press release with our first quarter results was issued earlier this morning and can be found on our website. We're 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 the financial results, and then we'll open the lines 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, 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 review of the resubmitted NDA by the FDA, potential action by the FDA with respect to the resubmitted NDA, the sufficiency of interim cash resources to fund operating expenses into 2025, and our strategic process to sell, license, or otherwise dispose of our rights to sue the panel to maximize stakeholder value. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control, including uncertainties inherent in the design, initiation, and conduct of clinical and non-clinical development, Changes in regulatory requirements or decisions of regulatory authorities. The timing or likelihood of regulatory filings and approvals. Changes in public policy or legislation. Commercialization plans and timelines if all seal of pen was approved. The accuracy of our expectations into how far into the future our cash and hand will fund our 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. And then other factors issued under the caption risk factors in the quarterly report on Form 10-K-5 with the SEC this morning. In addition, any forward-looking statements represent our views only as of 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 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 to you now, Corey, for your opening remarks.

Thanks, Louise. Welcome and thanks for joining us today. As you may know, we have recently resubmitted our new drug application to the FDA. We are very pleased to have accomplished this resubmission within just three months of announcing our positive topline results from our reassured clinical trial. We believe that the strong results from this trial, which was conducted under a special protocol assessment agreement with the FDA, addresses the FDA's recommendations for additional data to support approval of oral sulopenem for the treatment of adult women with uncomplicated urinary tract infections. The potential approval of sulopenem, which could occur early in the fourth quarter of 2024, would mark the first oral penem approved in the US and the second new oral treatment for uncomplicated urinary tract infections in over 25 years. We believe that the pseudopenin data we have generated shows that pseudopenin would be a safe and effective treatment option. We are encouraged by recent comments from the Director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, who stated, quote, the FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, end quote. We look forward to working closely with the FDA during our review period. Lastly, as we look at our cash, as of March 31st, we had $18.2 million in cash and cash equivalents. Based on our current operating plan, this amount provides a cash runway into 2025, including through the expected PDUFA date in early Q4. I'll now turn it over to Judy for information on our financial results.