Iterum Therapeutics plc

Hello everyone and thank you for holding and welcome to the interim therapeutics reports third quarter 2024 financial results. My name is Ezra and I will be your coordinator today. If you would like to ask a question, please press star followed by one on your telephone keypad now. 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. Louise, please go ahead.

Thank you, Edra. Good morning and welcome to Edram Therapeutics third quarter 2024 financial results and business update conference call. A press release with our third 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 we begin, I'd like to remind you that some of the information presented on this conference call today will contain forward-looking statements concerning our plans, strategies, and prospects for our business, including the therapeutic and market potential of our LINVAD, the sufficiency of our cash resources to fund our operating expenses into 2025, including through the repayment date of the exchangeable notes, the listing of patents for our LINVAD in the FDA's Orange Book, the protection provided by our patents for our LINVAD, and our strategic process to sell, license, or otherwise dispose of our rights to our LINVA. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including but not limited to risks and uncertainties concerning the outcome, impact, effects, and results of our evaluation of strategic alternatives, including the terms, timing, structure, value benefits, and cost of any strategic transaction, Our ability to complete a strategic transaction. Our ability to successfully prepare and implement commercialization plans for our LINVA with a commercial partner or directly if we are unsuccessful at entering into or completing a strategic transaction. The market opportunity for and the potential market acceptance of our LINVA. The accuracy of expectations regarding how far into the future our cash and hand will fund our ongoing operations. Our ability to maintain our listing on the NASDAQ capital market. and other factors discussed under the caption risk factors in our quarterly report on Form 10Q5 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 provide reconciliation of gap-reported to non-gap-adjusted information in the press release issued this morning. With that all said, now I'll turn you over to Corey for your opening remarks.

Thank you, Louise. Good morning, and thanks for joining us today. As we previously announced, we are very excited to have received FDA approval for our LINVA, our oral sulopenem product, last month for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms E. coli, Klebsiella pneumonia, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Our approval marks the first U.S. approval of an oral product in the penum class of drugs, which is a very potent and safe class of drugs currently only delivered as intravenous therapy. Having an approved oral penum enables treatment for appropriate patients in the community where new effective agents are desperately needed. As a potential treatment for patients with uncomplicated urinary tract infections that have limited or no other oral treatment options, Orlinva has the potential to not only effectively treat these patients, but also has the opportunity to help combat the growing health crisis of rising antimicrobial resistance by offering a new treatment alternative. We have received formal communication from the FDA of five additional years of exclusivity under the GAIN Act, meaning that Orlynda has marked its exclusivity for 10 years from the date of approval or until October 25, 2034. Additionally, our U.S. patent portfolio provides protection for oral sulopenem into 2039 with issued U.S. patents covering both method of use and composition of matter. We have also submitted patent information for four U.S. patents for Orlinva that will be listed in FDA's Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations. Overall, we are very pleased with the amount of protection that Orlinva should have in the U.S. market to capture value without competition from a potential generic product. Now I'll provide a few comments on why we are so excited about the potential for Orlinva. The uncomplicated urinary tract infection market in the U.S. has not had a new oral treatment launched in about 25 years. The leading product in the uncomplicated urinary tract infection market, nitrofurantoin, was approved in 1953, and the majority of the other oral products in the market were approved in the 1970s and 1980s. The use of these products over time has led to rising resistance rates, resulting in the most widely used products having resistance rates approaching 20% and those rates can run as high as 30% or more. As most prescribing for uncomplicated urinary tract infections occurs empirically, this very high and oftentimes increasing resistance rate creates a challenge for practicing physicians since the efficacy of these products are continuing to be eroded over time. Almost all of the widely used oral products in this therapy area have some safety concerns that, again, create challenges for treating physicians as to their choice of agent to use. Unfortunately, with almost no innovation in decades, physicians have been forced to use agents that may not work as well as they would like for their patients. With the Oralinva approval, there now could be an alternative treatment option for those patients who have limited or no other oral treatment options available. We believe that there are many patients that fall into this category, specifically at-risk patients. We define at-risk patients as women that fall into any of the following categories. Women who are 65 years or older, women who have diabetes, women with a history of recurrent or drug-resistant infections, or women that have other comorbidities that negatively impact their immune system. This group of patients are most at risk given their profiles, and many physicians are challenged to treat these patients with existing oral options that have substantial resistance as well as safety hurdles. Another key group of patients that are in significant need of a new efficacious and safe oral treatment alternative are the patients that have pathogens resistant to all commonly used oral antibiotics. In our Reassure uncomplicated urinary tract infection clinical trial, completed earlier this year and conducted exclusively in the U.S., over almost 1,000 patients, we found that approximately 1% of these patients had an isolate that was resistant to all available oral antibiotics. Or LINVA could play an important role in treating these patients as well. We firmly believe that our LINVA has a very important place in the uncomplicated urinary tract infection market for appropriate patients. As we look at our operating plan and go-forward cash runway, we expect to be able to fund our operations into 2025 including through the repayment date of our exchangeable notes due January 31st, 2025. And now I'll turn the call over to Judy Matthews for an update on our financial performance.