Iterum Therapeutics plc

Hello and welcome to the interim therapeutics fourth quarter and full year 2021 financial results call. My name is Alex Melby coordinating the call today. If you'd like to ask a question at the end of the presentation, you can press star one on your telephone keypad. If you'd like to withdraw your question, you may press star two. I'll now hand over to your host, Louise Barrett, Senior Vice President of Legal Affairs. Over to you, Louise.

Thanks, Alex. Good morning and welcome to Iterum Therapeutics' fourth quarter and full year 2021 financial results and business update conference call. A press release with our fourth quarter and full year results was issued earlier this morning and could be found on our website. We are joined this morning by Corey Fishman, our CEO, and Judy Matthews, our CFO. Corey will provide some opening remarks. Judy will provide details on our financial results, and then we will open the lines for Q&A. Before we begin, I would just 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 the proposed clinical trial, our expectations with regard to our ability to resolve the matter set forth in the complete response letter received in July 2021 and obtain approval for oral sulipenem, the timing and conduct of potential future clinical development of Sulipenem and the sufficiency of our cash resources to execute on our strategy. Actual results may differ materially 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 development, availability and timing of data from such clinical trials, The timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for oral sulipenem. Changes in regulatory requirements, 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 our cash and handle fund our ongoing operations, including carrying out proposed additional clinical development of oral sulipenem. the impact of COVID-19 and related response measures there too, our ability to maintain our listing on the NASDAQ capital market, and other risk factors set out in our filings with the SEC, including the most recently filed annual report on Form 10-K. 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, and we specifically disclaim any obligations to update such statements. We will also be referencing non-GAAP financial measures during the call and have provided reconciliations of GAAP reported through non-GAAP adjusted information in the press release issued this morning. We believe that the presentation of these measures, when viewed with our results under GAAP and the accompanying reconciliation, provides useful supplementary information and facilitates additional analysis by our investors, analysts and our management in assessing our performance and results from period to period. With that said, I'll turn it over to you, Corey, for your opening remarks.

Great. Thanks, Louise. Welcome and thanks for joining us today on our year-end 2021 conference call. I'd like to begin by highlighting that in 2021, we raised a substantial amount of cash and continued to operate our organization in an extremely streamlined fashion. These proactive steps have allowed us to extend our cash runway into 2024 and subject to final determination of design and planned conduct of additional clinical and non-clinical development of oral sulopenem, which I will discuss more detail later in the call, to carry out the proposed additional development to support, if successful, the resubmission of our NDA to the FDA. We ended 2021 with about $81 million of cash on the balance sheet. Since the end of 2021, there are two significant events that I'd like to share. First, we fully repaid our outstanding term loan, the Silicon Valley Bank, and now have no bank debt at all on the balance sheet. Additionally, as it relates to compliance with NASDAQ's minimum bid price requirement, in early March, we received a 180-day extension to regain compliance with this requirement. We now have until September 5th to meet this requirement, including by effecting a reverse share split if necessary. On the FDA front, over the last few months, we have held three substantive meetings and a number of discussions with the agency to talk about the additional clinical work required to support the potential resubmission of our package. Specifically, based on those discussions to date, The FDA has stated they will require an additional phase three clinical study in uncomplicated urinary tract infection, which, if successful, along with our existing data package, should support the resubmission of our NDA. We are working diligently to align with the FDA on the specifics of this additional clinical study and hope to finalize the details of this study in the second quarter. If we are successful in finalizing the details of that study in the second quarter, we would expect to be in a position to begin this additional Phase III study with oral sulopenem in the second half of this year. Once the design and planned conduct has been finalized, we'll provide an outline of the study and its relevant parameters, including a proposed high-level timeline for enrollment and completion of the study, the likely timing for availability of top-line data, and if the study is successful, potential timing for resubmission of our NDA. As we have said before, we believe that oral sulopenem can play a very important role in the treatment of uncomplicated urinary tract infections in the community for elevated risk patients and those patients with resistant infections. Also, we'd like to thank our investors and stakeholders for their patience as we work diligently with the FDA to define our path forward. Now I'll turn the call over to Judy for details on our financial results.