Iterum Therapeutics plc

Welcome to Eterin Therapeutic Second Quarter 2024 Financial Results and Business Update. My name is Kiki, and I will be your conference operator today. During the presentation, you will have the opportunity to ask a question 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 you over to your host, Louise Barrett, Senior Vice President legal affairs to begin. Louise, please go ahead.

Thank you, Kiki. Good morning and welcome to Iterum Therapeutics' second quarter 2024 financial results and business update conference call. A press release with our second quarter 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 will open the lines for Q&A. Before I 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. These include statements regarding the topics that will be covered at the upcoming advisory committee meeting in relation to our resubmitted NDA for Oral Sulipenem, the date by which the FDA will take action regarding our NDA, the expected use of proceeds from our recently completed rights offering, the planned extraordinary general meeting of shareholders to consider the disapplication of preemption rights, the sufficiency of ITERM's cash resources to fund its operating expenses into 2025, and our strategic process to sell, license, or otherwise dispose of our rights to Sulipenem to maximize stakeholder value. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of a 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 likelihood of regulatory filings and approvals, changes in public policy or legislation, commercialisation plans and timelines of oral sulipenem as approved, the accuracy of our expectations regarding how far into the future our cash-in-hand will fund our ongoing operations, the sufficiency of our cash resources and our ability to continue as a going concern, our ability to regain compliance and maintain our listing on the NASDAQ capital market, and risks and uncertainties concerning the outcome, impact, effects and results of our pursuit of strategic alternatives. And those other factors discussed under the caption risk factors in our quarterly report on Form 10Q filed 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've provided reconciliation of GAAP reported to non-GAAP adjusted information in the press release issued this morning. With that all said, I'll turn it over to you now, Corey, for your opening remarks.

Thanks, Louise. Welcome, and thanks for joining us today. It continues to be a very busy and productive time for ITERM, and I'm pleased to share the following updates. We were pleased to have recently closed our rights offering, which generated $5.8 million of net proceeds after taking into account fees and expenses. This additional capital will allow us to continue to pursue our business plan and strategy, including funding our ongoing strategic process to maximize the value of sulopenem for our stakeholders. Now, turning to upcoming milestones. On September 9th, ITERM will meet with the FDA's Antimicrobial Drugs Advisory Committee to discuss our resubmitted new drug application for oral sulopenem for the treatment of uncomplicated urinary tract infections in adult women. The general function of the Antimicrobial Drugs Advisory Committee is to provide advice and recommendations to FDA on regulatory issues. We have been working diligently to prepare materials for this upcoming meeting and are looking forward to the discussion. Another important date is October 25th. That is the PDUFA action date assigned by FDA to ITERM's resubmitted new drug application for oral sulopenem. We continue to work with the FDA during their review process. If the FDA completes its review within their general timeframe, on or about this date, we should receive a decision regarding the approvability of oral sulopenem for the treatment of uncomplicated urinary tract infections in adult women. If approved, oral psilopenem would be the first oral penem approved in the United States. We continue to expand our intellectual property estate. Most recently, we announced that two pending U.S. patent applications and one pending Canadian patent application were recently allowed. One allowed U.S. patent application is directed to the method of use of oral psilopenem in treating uncomplicated urinary tract infections, while the other allowed U.S. patent application is directed to the method of use of sulopenem exodroxyl, probenicid, and valproic acid in treating multiple diseases. The allowed Canadian patent application is directed to the bilayered tablet of oral sulopenem and its related preparations and or uses. Once these new patents issue, in addition to in-license patents, we will have owned patents in the U.S., Japan, Australia, Korea, and Canada with patent applications pending in Europe, China, and other key territories. As we look at our cash, as of June 30th, we had $11.7 million in cash and cash equivalents. Based on our current operating plan, we believe that the current cash, cash equivalents and short-term investments, plus the newly raised cash from the rights offering, provides a runway into 2025, including through the expected PDUFA date in late October of this year. Looking to future capital requirements, we are once again seeking approval of our shareholders at an upcoming extraordinary general meeting of shareholders to disapply the statutory preemption rights applicable to the increase in authorized share capital that was approved by our shareholders at our 2023 annual general meeting. This will enable us to quickly take advantage of opportunities to raise capital through share issuances for cash which in turn allow us to fund the continued execution of our business plans and strategies further into 2025, including funding our ongoing strategic process and repayment of $14.7 million of principal and interest due in January 2025 on the outstanding 6.5% exchangeable senior subordinated note. The granting of the preemption opt-out authority eliminates the competitive disadvantage we are placed at compared to non-Irish NASDAQ-listed public companies and the risks associated with seeking transaction-specific shareholder approvals or having to first offer those shares that we propose to issue for cash to all our existing shareholders in a time-consuming and costly manner. As an example, our recently completed rights offering was both time-consuming and costly, taking approximately three and a half months to implement, with total costs in excess of $1.6 million, including dealer manager fees. Our Board of Directors continues to view this proposal as being in the best interest of the company and our shareholders and recommends a vote in favor thereof. Now I'll turn the call over to Judy Matthews for an update on our financial performance.