Iterum Therapeutics plc

Hello, and welcome to the Iterum Therapeutic Q3 Financial Results Conference Call. My name is Alex, and I will be your operator for today. If you would like to ask a question at the end of the presentation, you can press star 1 on your telephone keypad. If you wish to withdraw your question, you can press star 2. I'll now hand it over to your host, Louise Barrett, Senior Vice President of Legal Affairs. Louise, over to you.

Thank you, Alex. Good morning and welcome to Utterham Therapeutics third quarter 2021 financial results and business update conference call. Press releases our third quarter results as issued earlier this morning 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 some details on our financial results and then we will open the lines for Q&A. Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning our plans, strategies and prospects for our business, including with respect to planned interactions and communications with the FDA and our ability to reach agreement with the FDA on the design of any potential future clinical trials. Our expectations with regard to our ability to resolve the matters set forth in the complete response letter received in July 2021 and obtain approval for oral sulipenem, the conduct of potential future clinical and non-clinical development of Sulipenem, and the sufficiency of our cash resources to execute on our strategy. Actual results may differ maturely from those indicated by these forward-looking statements as a result of various important factors, including uncertainties inherent in the initiation and conduct of clinical and non-clinical development, availability and timing of data from such clinical trials and non-clinical development, The timing or likelihood of registry filings and approvals, including the potential resubmission of our NDA for oral sulipenem. Changes in public policy or legislation. The actions of third-party clinical research organisations, suppliers and manufacturers. The accuracy of our expectations regarding how far into the future the company's cash and hand will fund our ongoing operations, including completing potential additional clinical and non-clinical development of oral sulipenem. the impact of COVID-19 and related response measures thereto, our ability to maintain our listing on the NASDAQ capital market, and other risk factors set out in our filings with the SEC, including our most recently filed quarterly report on Form 10Q. 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 obligations 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 the repressed release issued this morning. With that said, I'll turn it over to you, Corey, for your opening remarks.

Thanks, Louise. Welcome, and thank you for joining us today. I'll be providing a brief update this morning. As we previously mentioned, we had requested a Type A meeting with the FDA to discuss our complete response letter that we received in late July. We recently had that meeting, and the FDA informed us that, in their opinion, the totality of our NDA package was not sufficient to warrant approval for oral sulopenem at that time, even though they acknowledged that sulopenem showed statistical significance and the overall response rate by treatment arm against ciprofloxacin in the ciprofloxacin-resistant population in the treatment of uncomplicated urinary tract infections. We then discussed what additional clinical work would be required in order to have a package that they deemed potentially adequate for approval, assuming the trial results were successful. The FDA feedback received was that one additional Phase III clinical trial should be sufficient, subject of course to reaching agreement with the FDA on the design of that trial. We have since requested a Type B meeting with the FDA to discuss the details of that additional trial, including the protocol, endpoints, and other relevant factors. Our hope is that after this meeting, which we expect to occur around year-end, we will have clarity on all major aspects of the additional trial required to support potential resubmission of our NDA and be able to work expeditiously to get that study enrolling patients in the first half of 2022. It's important to note that given the urgent unmet medical need for new oral treatments for uncomplicated urinary tract infections, we remain confident in the value of oral sulopenem to treat multidrug-resistant infections and strongly believe sulopenem could be an important and valuable product for physicians and patients. Lastly, I'll spend just a moment on our cash position and outlook. We ended Q3 with a strong cash balance of approximately $86 million on the balance sheet. Based on our latest forecasts, we anticipate this cash balance will fund the company into 2024 and allow us to complete the proposed additional clinical development of Sulopenem to support If successful, the resubmission of our NDA to the FDA for the treatment of uncomplicated urinary tract infections. Now I'll turn the call over to Judy for details on our financial results.