Iterum Therapeutics plc

Hello and welcome to Iterum Therapeutics Q2 Financial Results Conference call. Please note that all lines are currently on listener-only mode. If you would like to ask a question during the Q&A portion of today's call, you may do so by pressing Start followed by 1 on your telephone keypad. I now have the pleasure of handing over to Louise Barrett, Senior Vice President of Legal Affairs.

Thank you, Hannah. Good morning and welcome to interim therapeutic second quarter 2021 financial results and business update conference call. A press release with the company's second quarter results was issued earlier this morning and 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 details on our financial results and then we'll open the floor 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 following receipt of the complete response letter in July 2021, our expectations with regard to our ability to resolve the matter set forth in the complete response letter and obtain approval for sulipenem, the conduct of potential future clinical and non-clinical development of sulipenem, the potential timing for resuming pre-commercialization activities, and the sufficiency of our cash resources. 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 and non-clinical development, availability and timing of data from clinical trials and non-clinical development, the timing or likelihood of registry filings and approvals, including the potential resubmission of our NDA for Orosula Penham, 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-in-hand will fund our ongoing operations, the impact of COVID-19 and related response measures thereto, and other risk factors set out on our filings at the SEC, including the most recently filed quarterly report on TownQ. 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. With that, I'll turn the call over to Corey for his opening remarks.

Thanks, Louise. Welcome and thanks for joining us today. I want to begin by discussing the complete response letter we received from FDA in late July in response to our new drug application of Sulopenem for the treatment of uncomplicated urinary tract infections for patients with a known or suspected quinolone non-susceptible organism. As we noted in our press release, we are disappointed in this outcome and believe our data package was adequate for approval of Sulopenem. In the complete response letter, The FDA acknowledged that the statistical significance was demonstrated for the difference in overall response rate by treatment arm in the ciprofloxacin-resistant population. In other words, demonstrated statistical significance in difference of overall response rates compared to ciprofloxacin in the quinolone-resistant population. However, the FDA determined that additional data are necessary to support approval and recommended that ITERM conduct at least one additional adequate and well-controlled clinical trial, potentially with a different comparator drug. They also recommended further non-clinical investigation to determine the optimal dosing regimen, although the FDA stated that this recommendation does not raise an approvability issue. There were no CMC issues identified in the complete response letter, nor were there any safety issues identified in the over 1,800 patients treated with Sulopenem across the company's clinical development program. Along with our outside advisors, we have been reviewing the complete response letter, as well as putting together a meeting request for a Type A meeting with the FDA and accompanying briefing book, and will submit this document shortly. Assuming your meeting request is granted and the timeline set out in FDA guidelines for such meeting requests are followed, we'd expect the meeting to be held by the end of the third quarter. Our hope and expectation is that we leave that meeting with a go-forward plan that aligns with FDA requirements to address the issues noted in the complete response letter to support a potential resubmission of the NDA and note that the FDA has indicated their willingness to work with us on the design of any additional clinical trial to be conducted. It's important to note that we remain confident in the value of and the unmet medical need for oral sulopenem to treat multi-drug resistant infections. With regard to pre-commercialization activities undertaken with our partner Eversana to date, we have completed a great deal of research and planning that will ultimately be valuable when commercialization activities are to be resumed following resolution of the issues identified in the complete response letter. However, given the complete response letter and the current uncertainty regarding what additional clinical work may need to be done prior to any NDA resubmission, in order to reduce operating expenses and conserve cash resources, we halted any remaining pre-commercial activities and paused negotiations on the definitive agreement for commercialization services. Lastly, I want to reiterate that with over $90 million of cash on our balance sheet at the end of Q2 and based on the current operating plan, subject to final determination of the design and additional clinical and non-clinical development work required to support a potential resubmission. We believe we are well positioned financially to fund our operation into the second half of 2023. Now I'll turn the call over to Judy for details on our financial results.