Q1 2024 Iterum Therapeutics plc Earnings Call

Operator: Hello and welcome to the Iterum Therapeutics 4th Quarter 2024 Financial Results and Business Update. My name is Karla, and I will be hosting the call today. During the presentation, you can register to ask questions by pressing a star followed by one on your telephone keypad. If you change your mind, please press a star followed by two. I will now hand over to your host, Louise Barrett, Senior Vice President of Legal Affairs, to be your guest. Louise, please go ahead.

Hello, and welcome to D. At your own Therapeutics first quarter 'twenty 'twenty four financial results.

And the business update.

Carla: My name is Carla and I will be operating the call today. During the presentation. You can register 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 Luis marriage.

Luis: Your vice President of legal affairs to begin Louie.

Luis: Please go ahead.

Louise Barrett: Thank you, Carla. Good morning, and welcome to Iterum 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 are joined this morning by our Chief Executive Officer, Corey Fishman, and our Chief Financial Officer, Judith Matthews.

Luis: Thank you Karen.

Luis: 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 are joined this morning by our Chief Executive Officer, Corey Fishman, and our Chief Financial Officer, Julie Mathews.

Louise Barrett: Corey will provide some opening remarks, Judy will provide detailed 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 sulopenum, 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.

Judith M. Matthews: Cory will provide some opening remarks, Judy will provide details on our.

Judith M. Matthews: Actual results and then we'll open the lines for Q&A.

Louise Barrett: The sufficiency of Iterum's cash resources to fund its operating expenses into 2025, and our strategic process to sell, license or otherwise dispose of our rights to Zulipan and 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 developments, 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 oil seal abandonment is approved, the accuracy of our expectations and to 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.

Judith M. Matthews: 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 of therapeutic and market potential of the whole suite of Pan am our ability to address the deficiencies in the complete response letter received from the FDA in July 2021.

Judith M. Matthews: The expected timing I'll review of the resubmitted NDA by the FDA.

Judith M. Matthews: This action by the FDA with respect to the resubmitted NDA the sufficiency of interim cash resources to fund its operating fast into 'twenty 'twenty five.

Judith M. Matthews: And our strategic process to sell license or otherwise dispose of our rights to do the patent to maximize shareholder value.

Judith M. Matthews: 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 conduct of clinical and non clinical development changes in regulatory requirements or decision to brand tree authority, the timing or likelihood of regulatory filings and approval.

Judith M. Matthews: And public policy or legislation commercialization plans and time lines of oilfield Panama's improved the accuracy of our expectations as to how far into the future. Our cash on hand will fund our ongoing operations our ability to maintain our listing on the NASDAQ capital market.

Louise Barrett: 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 included under the captioned risk factors in the quarterly report and Form 10K 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.

Judith M. Matthews: Risks and uncertainties concerning the icon 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 compete when it all and then other factors issued under the caption risk factors and the quarterly report on Form 10-K filed with the SEC.

Judith M. Matthews: This morning.

Judith M. Matthews: 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.

Judith M. Matthews: We will also be referencing non-GAAP financial measures during the call. We have provided reconciliations of GAAP reported non-GAAP adjusted information in the press release issued this morning.

Louise Barrett: 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.

Judith M. Matthews: With that said I'll turn it over to unite Cory for your opening remarks.

Corey N. Fishman: 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 top-line results from our REASSURE 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 pseudopenem for the treatment of adult women with uncomplicated urinary tract, The potential approval of sulopenem, which could occur early in the fourth quarter of 2024, would mark the first oral penem approved in the U.S. and the second new oral treatment for uncomplicated urinary tract infections in over 25 years.

Cory: Thanks Louise welcome.

Cory: Welcome and thanks for joining us today.

Cory: You May know, we have recently, we submitted our new drug application to the FDA.

Cory: We are very pleased to have accomplished this resubmission within just three months of announcing our positive topline results from our reassure.

Cory: Charles.

Cory: 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 sema.

Cory: The treatment of adult women with uncomplicated urinary.

Primary tract infections with.

Cory: The potential approval of <unk>, which could occur early in the fourth quarter of 2024 would mark the first oral Panama approved in the U S and the second new oral treatment for uncomplicated urinary tract infections and over 25 years.

Corey N. Fishman: We believe that the pseudopenem data we have generated shows that pseudopenem would be a safe and effective treatment. 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, "The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective." End quote.

Cory: We believe that superb superb data we have generated shows that <unk> would be a safe and effective treatment.

Cory: We are encouraged by recent comments from the director of the division of anti Infectives.

Cory: <unk> Center for drug evaluation and research who stated.

Cory: <unk>.

Cory: <unk> is committed to fostering new antibiotic availability when they proved to be safe and effective.

Cory: And we.

Corey N. Fishman: We look forward to working closely with the FDA during our review. Lastly, as we look at our cash as of March 31st, we have $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.

Cory: We look forward to working closely with the FDA during our review period.

Cory: Lastly, as we look at our cash as of March 31.

Cory: $18 2 million in cash and cash equivalents.

Cory: And our current operating plan.

Cory: Ill provide a cash runway into 2025, including through the expected producer date in early Q4.

Judith M. Matthews: 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.

Cory: I'll now turn it over to Judy for information on our financial results.

Judith M. Matthews: 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. This is due primarily to an increase in legal fees and an increase in consultants used to support pre-commercialization activity.

Judy: Thanks, Corey total operating expenses were six $2 million in the first quarter 2024, compared to eight 5 million in the first quarter 2023.

Judy: 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.

Judy: 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.

Judy: G&A costs were $2 2 million for the first quarter of 2024, which is $100000 higher than G&A cost of $2 1 million in the first quarter of 2023, due primarily to an increase in legal fees and an increase in consultant.

Judy: To support pre commercialization activities.

Judith M. Matthews: Our net loss on a U.S. gap 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, which excludes certain non-cash adjustments, our net loss of 5.8 million dollars 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 3 trial was completed in October 2023.

Judy: Our net loss on a U S. GAAP basis was $7 $1 million for the first quarter of 2024 compared to $9 9 million for the same period in 2023.

Judy: On a non-GAAP basis, which excludes certain noncash adjustment.

Judy: Our net loss of $5 8 million in the first quarter of 2024.

Judy: Her to our non-GAAP net loss of $7 4 million in the first quarter of 2023.

Judy: The one $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 2222 patients in this phase III trial was completed in October 2023.

Judith M. Matthews: 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 of 2024, we resubmitted to the FDA the NDA for oral sulopenem for the treatment of UUTI, and we expect the FDA to assign a PDUFA date early in the fourth quarter of 2024.

Judy: At the end of March we had cash cash equivalents and short term investments of $18 $2 million, which based on our current operating plan. We will provide a cash runway into 2025 include a potential FDA approval expected early in the fourth quarter of 2024.

Judy: April 2024, we resubmitted to the FDA. The NDA for also opined that the treatment of UTI and expect the FDA to assign a paducah date early in the fourth quarter of 2024.

Judith M. Matthews: As of April 30, 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 a 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.

As of April 32020, part, 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 one.

Judy: One 2 million shares.

Judy: If the notes are not exchanged we will be obligated to pay the note holders $11 1 million plus accrued interest in January 2025.

Judy: Now I will turn it back over to Corey for some closing comments.

Corey N. Fishman: Thanks, Judy. We'll go ahead and open up the line for questions.

Corey N. Fishman: Thanks, Judy we'll go ahead and open up the line for questions now.

Operator: 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 make sure your device is unmuted locally. Our first question comes from Jason McCarty from Maxine Group. Your line is now open.

Thank you if you'd like to ask a question. Please press star followed by one on your telephone keypad.

Corey N. Fishman: If you change your mind, Please press star followed by two.

Speaker Change: When preparing to ask a question. Please make sure your devices on mute it locally.

Jason Wesly McCarthy: Our first question comes from Jason Mccarthy from Maxim Group.

Your line is now open.

Jason Wesly McCarthy: Yes.

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

Jason Wesly McCarthy: Hey, guys. Thanks for taking the question. This is Michael on the line for Jason.

Jason Wesly McCarthy: Yes.

Michael: I guess to start off just with the BLA Resubmission could you remind us.

Speaker Change: What the original deficiencies noted in the prior TRL.

Michael: And then why you're confident that the new NDA package addresses those.

Corey N. Fishman: Yeah, we, this is a Corey. Thanks for the question, Michael. The original CRL was pretty straightforward and just said, we didn't, 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 2,200 patients.

Speaker Change: Yeah. This.

This is corey thanks for the question Michael the original zero was pretty straightforward and just say we.

Speaker Change: We didn't we.

Corey N. Fishman: <unk> didn't think that you had provided enough data.

Corey N. Fishman: To approve the drug and what they said was they would request or at least one more phase III study and so we had.

Corey N. Fishman: Extensive conversations with the agency about that other phase III study and eventually put in place a special protocol assessment agreement or Spa agreement with them to address that.

Corey N. Fishman: <unk> deficiency of them feeling like there wasn't sufficient amount of data.

Corey N. Fishman: And put together a pretty substantial study as you saw over 'twenty 200 patients.

Corey N. Fishman: We feel very confident that this addresses their underlying question of, you know, was there enough data here? And, 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, but we also showed statistical superiority to augmentin in that augmentin susceptible population, we feel very confident that we have provided sufficient data for them to approve the drug.

Corey N. Fishman: We feel very confident that addresses their.

Corey N. Fishman: There are underlying the question though.

Corey N. Fishman: Was there enough David here I mean, 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. I mentioned you also showed statistical superiority to augment and that augmented susceptible population.

Corey N. Fishman: We're very confident that we have provided sufficient data for them to two approved drugs.

Corey N. Fishman: And then I'd like to see if you can provide just a bit more color on the strategic review process, when 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?

Thank you for that.

And then.

Corey N. Fishman: Let's see if you could provide just a bit more color on the <unk>.

Corey N. Fishman: Strategic review process when.

Corey N. Fishman: And when you think of sale or license agreement could be finalized just thinking in broad stroke, because it's something that would make most sense post an approval decision.

Corey N. Fishman: Or is that something that could be finalized leading into that.

Corey N. Fishman: 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, disclosable, we obviously will go ahead and disclose it. But, you know, I think, I think that's probably sufficient on that topic.

Speaker Change: Yeah, as we've said publicly we arent going to comment on the process in terms of anything that's that's ongoing.

Speaker Change: What I would tell you is the process is ongoing we continue to have discussions and as soon as there is something that is <unk>.

Speaker Change: <unk>, obviously, we'll go ahead and disclose it but you know I think.

Speaker Change: I think that's probably sufficient on that topic.

Michael Okunowicz: All right, thank you. And then there's one last one. It's more of a modeling question.

Speaker Change: Alright. 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.

Michael Okunowicz: 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?

Judith M. Matthews: This is Judy Matthews. Yeah, it should come down some more there. We are done with the current cost for that trial.

Speaker Change: Let's say about JD market, yeah. It shouldnt come down some more there and we are done at the current cost for that trial.

Michael Okunowicz: All right, thank you very much, and congratulations on all the progress.

Speaker Change: Alright, Thank you very much and congratulations on all the progress.

Speaker Change: Thanks, Michael.

Operator: Our next question comes from Ed Arce from HS Wainwright. Your line is now open.

Speaker Change: Our next question comes from Ed Arce from H C. Wainwright. Your line is now open.

Thomas: 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 PIDIA for uncomplicated UTI last month, how do you envision psilopendium progressing in the market? And also, can you discuss any points of differentiation between the two trials, assuming psilopendium received the approval later this year?

Alright, good morning, everyone has established.

Antonio Eduardo Arce: A couple of questions for Eric. Thank you so much for taking my questions.

Antonio Eduardo Arce: So first question given the FDA approval.

Antonio Eduardo Arce: PPO or complicated UTI last month.

Antonio Eduardo Arce: How do you envision sort of patterns, especially in the <unk>.

Antonio Eduardo Arce: Market and also can you discuss any poised so congratulation between between the two charts assuming to repair them.

Antonio Eduardo Arce: Received approval later this year.

Corey N. Fishman: Yeah, so PIVIA, yes, PIVIA got approved by the FDA at 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 talked about that as yet.

Speaker Change: Yeah. So could you just could you got approved by the FDA in.

Speaker Change: The end of April we arent quite sure based on public disclosures, what the timing of the launches.

Corey N. Fishman: And what we've always said, Thomas, is 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 entrants. And again, there could only be potentially two over the next few years, that would be PIVIA.

Speaker Change: And I don't think they have talked about that as a view and what we've always said Thomas as well.

Speaker Change: 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.

Speaker Change: Issue to work through irrespective of any new entrants and again, there could only be potentially too over the next few years that would be trivia and also GSK has said that they would potentially file their new drug in.

Corey N. Fishman: 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 pennant antibiotic, we have a very solid reputation in terms of the class of drug.

Speaker Change: 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 are addressable market with elevated risk patients is about two thirds of that.

So a very large market.

Speaker Change: Given that we're a pennon 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 pseudo panel.

Corey N. Fishman: And we believe that there will be a very strong response by physicians wanting to use something like Sulopenib 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 if they both make it to market and launch, we feel that we've got a very good commercial position.

Speaker Change: For those high risk patients. So we feel very good that we've got a very solid position I don't believe that we're <unk> or <unk> product will be playing primarily and therefore I feel very comfortable in a scenario where both if they both make it to market and launch.

Speaker Change: We feel like we've got a very good commercial positioning for that.

Corey N. Fishman: 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, but would independently bring games to the market. Would that be an option on the table?

Speaker Change: Understood.

Speaker Change: Thank you so much.

Speaker Change: Perhaps one follow up.

Speaker Change: I know you mentioned earlier that piece.

Speaker Change: Appreciate it.

Akshay portion is still ongoing.

Speaker Change: Independently, bringing silicon into the market would that create an option on the table.

Corey N. Fishman: Yeah, as we've said, our priority is a strategic transaction. And you know, 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 think today, but it certainly is an option down the road.

Speaker Change: Yeah, as we've said our priority is a strategic transaction.

Speaker Change: We will prepare to the best of our ability to bring it to market independently over time.

Speaker Change: The strategic process doesn't result in something that the board feels maximizes value for the shareholders. So again it is not our priority with regard to how we're thinking today.

Speaker Change: <unk> is a potential down the road.

Speaker Change: Understood. Thank you would therefore take other questions.

Speaker Change: We look forward to a particular date later this year.

Thomas: Understandable. Thank you again for taking our questions, and we look forward to a particular day later this year.

Corey N. Fishman: Thanks, Thomas, for your questions.

Speaker Change: Thanks, Thomas for your questions.

Operator: We currently have no further questions. I will hand the microphone back over to Corey Fishman for any final remarks.

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

Corey N. Fishman: Thanks Carl.

Corey N. Fishman: 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 sulopetum, 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.

Corey N. Fishman: We appreciate you joining us today.

Corey N. Fishman: 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 suitable for them 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.

Operator: And that concludes our conference call. Thank you for joining us. You may now disconnect your line.

And that concludes our.

Speaker Change: Conference call. Thank you for joining you may now disconnect your lines.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Yes.