Iterum Therapeutics plc

Hello and welcome to the Ethereum Therapeutics fourth quarter 2024 financial results and business update. My name is Carla and I will be operating the call today. During the presentation, you can register to ask questions 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 over to your host, Louise Barrett, Senior Vice President of Legal Affairs to begin. Louise, please go ahead.

Thank you, Carla. Good morning and welcome to Interim Therapeutics' first quarter 2024 financial results and business update conference call. A press release with our first quarter results was issued earlier this morning and can be found on our website. We're 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 the financial results, and then we'll open the lines to Q&A. Before we 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, including the development, therapeutic, and market potential of oral sulipenem, our ability to address the deficiencies set out in the complete response letter received from the FDA in July 2021, the expected timing of review of the resubmitted NDA by the FDA, potential action by the FDA with respect to the resubmitted NDA, the sufficiency of interim cash resources to fund operating expenses into 2025, and our strategic process to sell, license, or otherwise dispose of our rights to sue the panel to maximize stakeholder value. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our 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 timing or likelihood of regulatory filings and approvals. Changes in public policy or legislation. Commercialization plans and timelines if all seal of pen was approved. The accuracy of our expectations into 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. Risks and uncertainties concerning the outcome, impact, effects and results of our pursuit of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic process and our ability to complete one at all. And then other factors issued under the caption risk factors in the quarterly report on Form 10-K-5 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 have provided reconciliations of GAAP-reported to non-GAAP-adjusted information in the press release issued this morning. With that said, I'll turn it over to you now, Corey, for your opening remarks.

Thanks, Louise. Welcome and thanks for joining us today. As you may know, we have recently resubmitted our new drug application to the FDA. We are very pleased to have accomplished this resubmission within just three months of announcing our positive topline results from our reassured clinical trial. We believe that the strong results from this trial, which was conducted under a special protocol assessment agreement with the FDA, addresses the FDA's recommendations for additional data to support approval of oral sulopenem for the treatment of adult women with uncomplicated urinary tract infections. The potential approval of sulopenem, which could occur early in the fourth quarter of 2024, would mark the first oral penem approved in the US and the second new oral treatment for uncomplicated urinary tract infections in over 25 years. We believe that the pseudopenin data we have generated shows that pseudopenin would be a safe and effective treatment option. We are encouraged by recent comments from the Director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, who stated, quote, the FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, end quote. We look forward to working closely with the FDA during our review period. Lastly, as we look at our cash, as of March 31st, we had $18.2 million in cash and cash equivalents. Based on our current operating plan, this amount provides a cash runway into 2025, including through the expected PDUFA date in early Q4. I'll now turn it over to Judy for information on our financial results.

Thanks, Corey. Total operating expenses were $6.2 million in the first quarter of 2024 compared to $8.5 million in the first quarter of 2023. Operating expenses include research and development expenses and general and administrative expenses. R&D costs were $4 million for the first quarter of 2024 compared to $6.4 million for the same period in 2023. The primary driver of the $2.4 million decrease in R&D expense for the first quarter was primarily due to higher costs incurred in 2023 to support our reassure trial, which began enrollment in October 2022 and completed enrollment in October 2023. G&A costs were $2.2 million for the first quarter of 2024, which is $100,000 higher than G&A costs of $2.1 million in the first quarter of 2023, due primarily to an increase in legal fees and an increase in consultants used to support pre-commercialization activities. Our net loss on US GAAP basis was $7.1 million for the first quarter of 2024, compared to $9.9 million for the same period in 2023. On a non-GAAP basis, glued certain non-cash adjustments. Our net loss of $5.8 million in the first quarter of 2024 compared to our non-GAAP net loss of $7.4 million in the first quarter of 2023. The $1.6 million decrease in our non-GAAP net loss for the first quarter was primarily a result of lower R&D expenses related to our REASSURE trial as enrollment of the 2,222 patients in this phase three trial was completed in October 2023. At the end of March, we had cash equivalents and short-term investments of $18.2 million, which based on our current operating plan, will provide a cash runway into 2025, including through potential FDA approval expected early in the fourth quarter of 2024. In April 2024, we resubmitted to the FDA the NDA for all sulopenem for the treatment of UUTI and expect the FDA to assign a PDUFA date early in the fourth quarter of 2024. As of April 30th, 2024, we had approximately 16.6 million ordinary shares outstanding. Also, as of the end of April 2024, we had approximately $11.1 million of exchangeable notes outstanding, which can be exchanged at the option of the note holder for approximately 1.2 million shares. If the notes are not exchanged, we will be obligated to pay the note holders $11.1 million plus accrued interest in January 2025. Now, I will turn it back over to Corey for some closing comments.

Thanks, Judy. We'll go ahead and open up the line for questions now. Thank you.

If you'd like to ask a question, please press star followed by one on your telephone keypad. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. Our first question comes from Jason McCarthy from Maxine Group. Your line is now open.

Hey guys, thanks for taking the questions. This is Michael Okunowich on the line for Jason. I guess to start off, just with the BLA resubmitted, could you remind us of what the original deficiencies noted in the prior CRL, and then why you're confident that the new NDA package addresses those?

Yeah, this is Corey. Thanks for the question, Michael. The original CRL was pretty straightforward in just saying we didn't, we, the FDA, didn't think that you had provided enough data to approve the drug. And what they said was they would request at least one more phase three study. And so we had pretty extensive conversations with the agency. about that other phase three study and eventually put in place a special protocol assessment agreement, a SPA agreement with them to address that basic deficiency of them feeling like there wasn't a sufficient amount of data and put together a pretty substantial study. As you saw, you know, over 2200 patients, we feel very confident that addresses their underlying question of, you know, was there enough data here? And we feel, particularly based on the results of that study, which showed not only that we hit our primary endpoint of non-inferiority to our comparator Augmentin, we also showed statistical superiority to Augmentin in that Augmentin-susceptible population, feel very confident that we have provided sufficient data for them to approve the drug.

Thank you for that. I'd like to see if you could provide just a bit more color on the strategic review process, and when you think a sale or a license agreement could be finalized. Just thinking in broad strokes, is this something that would make most sense post an approval decision, or is that something that could be finalized leading into that?

Yeah. As we've said publicly, you know, we are going to comment on the process in terms of, you know, anything that's ongoing. What I would tell you is the process is ongoing. We continue to have discussions. And as soon as there's something that is, you know, disposable, we obviously will go ahead and disclose it. But, you know, I think that's probably sufficient on that topic.

All right. Thank you. And then one last one is more of a modeling question. Are you still incurring final costs from the reassure trial, or should we expect to see the R&D expense line continue to come down in the next quarter or two?

This is Judy Matthews. Yeah, it should come down some more there. We are done incurring costs for that trial.

All right. Thank you very much, and congratulations on all the progress.

Thank you.

Our next question comes from Ed from HHS Wainwright. Your line is now open.

Hi, good morning, everyone. This is Thomas asking a couple of questions for Ed. Thank you so much for taking our questions. So first question, given the FDA approval of PDA for uncomplicated UTI last month, how do you envision psilopatins in the market? And also, can you discuss any points of differentiation between the two trials, assuming the pendant received approval later this year?

Yeah. So, yes, PIVIA got approved by the FDA in the end of April. We aren't quite sure based on public disclosures what the timing of a launch is. And I don't think they have We have talked about that as of yet. And what we've always said, Thomas, is we believe that given the market size and particularly our positioning within the market, and that positioning, as we've said for many, many years now, is for elevated risk patients. We believe we have a very solid position to work from, irrespective of any new entrant. And again, there could only be potentially two over the next few years. That would be PIVIA. And also GSK has said that they would potentially file their new drug in the second half of this year. So we feel really good about our positioning. We estimate the market to be about 40 million prescriptions annually. And of that, we think our addressable market with elevated risk patients is about two-thirds of that. So a very large market. And given that we're a penum antibiotic, we have a very solid reputation in terms of the class of drug. And we believe that there will be a very strong response by physicians to wanting to use something like a Sulopenem for those high risk patients. So we feel very good that we've got a very solid position. I don't believe that's where Pivia or GSK's product will be playing primarily. And therefore, I feel very comfortable in a scenario where both, you know, if they both make it to market and launch, we feel that we've got a very good commercial position for that.

Understood. Thank you so much, Corey.

And then perhaps one follow up. I know you mentioned earlier that the strategic option exploration is still ongoing.

Would independently bringing Subapenem to the market, would that be an option on the table?

Yeah, as we've said, our priority is a strategic transaction. And we will prepare to the best of our ability to bring it to market independently over time if the strategic process doesn't result in something that the board feels maximizes value for the shareholders. So, you know, again, it is not our priority with regard to how we're thinking today, but it certainly is a potential down the road.

Understood. Thank you again for taking our questions, and we look forward to this year. Thanks, Thomas, for your questions.

We currently have no further questions. I'll hand back over to Corey Fishman for any final remarks.

Thanks, Carla. We appreciate you joining us today. We're very excited about working closely with the FDA during the review period of our new drug application resubmission, and we're looking forward to potentially bringing sulopetam, an important treatment option, to physicians and patients in the underserved markets of uncomplicated urinary tract infections. Thanks very much and have a great day.

And that concludes our conference call. Thank you for joining. You may now disconnect.