Iterum Therapeutics plc

Ladies and gentlemen, hello and welcome to the interim therapeutics third quarter 2022 financial results call. My name is Maxine and I'll be coordinating the call today. If you would like to ask a question during the presentation, you may do so by pressing star followed by one on your telephone keypad. I will now hand you over to Louise Barrett, SVP of Legal Affairs to begin. Louise, please go ahead when you're ready.

Thank you, Maxine. Good morning and welcome to Agile and Therapeutic's third quarter 2020 financial results call. A press release of our third 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, the Echo. Corey will provide some opening remarks, Judy will provide details on her financial results, and then we'll open the floor for Q&A. Before we begin, I would like to remind you that this call will contain four different statements concerning our plans, strategies, and prospects for our business, including the selfless therapies we can mark potential through the pen, the timing, conduct, progress, and results of a reassured clinical trial, our expectations with regard to our ability to resolve the matter set forth in the complete response letter received by us in July 2021, and to obtain approval for all of those plans. the expected timing of resubmission of our NDA, the term and coverage provided by our patent and other intellectual property rights, and the sufficiency of our cash resources. Actual results can be different from those indicated by these forward-looking statements as a result of various important factors, including uncertainties inherent in the design, notation, and conduct of clinical and non-clinical development, including the reassure clinical trials, and non-clinical development being conducted by us in response to the CRL in July 2021. The ability and timing of data for the reassured clinical trial and the ongoing non-clinical development. Changes in regulatory requirements or decisions with registered authorities. The timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA. The public policy or legislation and commercialization of the timeline, if all two of them are approved. the actions of third-party clinical research organizations and private manufacturers, the accuracy of our expectations regarding how fires will future our cash and handle some of our ongoing operations, and other risk factors set in our findings via SEC, including the quarterly report files today. In addition, any forward-looking statements or representative views only as of the date of this call and should not be related We specifically disclaim any obligation to state such data. We will also be referencing non-GAAP financial measures during the call. We've provided reconciliation to non-GAAP information issued earlier this morning. With that said, I'll turn it over now to you, Corey, for your opening remarks.

Great. Thanks, Louise. Welcome and thanks for joining us today. I'd like to share some very exciting company highlights with you this morning. First, we are thrilled to have begun enrollment in our new phase three clinical trial for uncomplicated urinary tract infections. We have named this trial ReAssure. The ReAssure trial is designed as a non-inferiority trial comparing oral sulopenem and oral augmentin in the augmentin-susceptible population. We are conducting this trial to address certain deficiencies the FDA noted in their complete response letter that we received in July of 2021. The trial is expected to enroll approximately 1,966 patients and is being conducted under a special protocol assessment SPA agreement with the FDA. The SPA agreement provides that the design and planned analysis of the trial as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of the company's new drug application for oral sulopenem. In the REASSURE trial, patients will be randomized to receive either oral sulopenem twice daily for five days or oral Augmentin twice daily for five days. The primary endpoint is the overall response, which is the clinical and microbiologic combined response at day 12 of the trial. We expect to complete enrollment in the first half of 2024, and if successful, we'll resubmit our NDA to the FDA in the second half of 2024. If the resubmission addresses all deficiencies in the complete response letter we received in July of 2021 from the FDA, then the FDA action should occur six months from receipt of our resubmission. It's important to note that there are approximately 33 million uncomplicated urinary tract infections in the US annually, and approximately 30% of those infections are caused by a quinolone non-susceptible organism. Additionally, about 1% of all infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. And as a result, the need for new oral antibiotics in this therapy area remains very high. On the intellectual property front, ITERM has been granted a U.S. patent directed to the composition of the bilayer tablet of oral sulopenem, which contains sulopenem atzidroxyl and pervenacid in a single bilayer tablet. This is an incredibly important milestone, as this patent will extend our existing patent protection until at least 2039, which provides a substantial runway to protect the long-term commercial value of oral sulopenem in the U.S. Outside the U.S., we have pending patent applications including Europe, China, Japan, and parts of South America which were submitted following receipt of the written opinion of the International Search Authority indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive. We are beginning to explore potential new areas where there is an unmet medical need and where Sulopenem could be an important potential alternative in treating those patients. We are currently evaluating a number of potential new indications and subject to that review are planning an initial discussion with the FDA in the first half of 2023. We will share further details as and when this plan develops further. On the corporate front, we regained compliance with the NASDAQ bid price rule by affecting a one for 15 reverse share split in August. Lastly, but quite importantly, our cash position remains solid with a balance of $64 million as of September 30th. As we have stated in our press release, we expect this existing cash to fund operations into 2024 including through the top line data readout from the REASSURE trial. In summary, we are excited to have begun enrollment in the REASSURE clinical trial and are looking forward to potentially bringing the first new oral penem to the market in order to help address a serious medical need in the community. We are also looking forward to potentially expanding the utility of sulopenem into other areas that are in need of new treatment alternatives. Now I'll turn the call over to Judy for details on our financial results. Thanks, Corey.