Q4 2023 Iterum Therapeutics PLC Earnings Call

Okay.

Operator: Hello, everyone, and welcome to the Iterum Therapeutics fourth quarter and full year 2023 financial results and business update. My name is Emily, and I'll be coordinating your call today. After the presentation, there will be the opportunity for you to ask any questions, which you can do by pressing start, followed by the number one on your telephone number. I will now turn the call over to our host, Louise Barrett, Senior Vice President of Legal Affairs. Louise, please go ahead.

Emily: Hello, everyone and welcome to the H M Therapeutics fourth quarter and full year 2020, great financial results and business update my name is Emily and I'll be coordinating Yoko today. After the presentation there will be the opportunity for you to ask any questions, which you can do so by pressing star followed by the number one on your telephone keypads.

I'll now turn the call over to our highest released Barrett Senior Vice President of legal Affairs Nobody's. Please go ahead.

Louise Barrett: Thank you, Emily. Good morning, and welcome to Iterum Therapeutics' fourth quarter and full year 2023 financial results and business update conference call. The press release for their fourth quarter and full 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.

Barrett: Thank you Emily.

Barrett: Good morning, and welcome to the interim therapeutics fourth quarter and full year 2023 financial results and business update conference call.

Barrett: A press release with our fourth quarter and full results, which 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 Matisse Corie will provide some opening remarks, Judy will provide details on our financial results and then we'll open the line to Q&A.

Louise Barrett: Corey will provide some opening remarks, Judy will provide details on our financial results and then we'll open the line 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 Orosula Penum, our ability to address the deficiencies set out in the complete response letter received from the FDA in July 2021, the expected timing of resubmission of our NDA, the expected timing of review of the resubmission by the FDA, the sufficiency of our cash resources to fund our operating expenses into 2025, the term and coverage provided by our patent and other intellectual property rights, and the company's strategic process to sell, license or otherwise dispose of its rights to Zulapenum to maximize shareholder value.

Barrett: 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 almost through the Panama or ability to address the deficiencies set out in the complete response letter received from the F. D. A N July 22.

Barrett: One the expected timing of Resubmission of our NDA the expected timing of review by the of the Resubmission by the F. D. A the sufficiency of our cash resources to fund our operating expenses into towards 25, the term and coverage provided by our patents and other intellectual property rights and the company's strategic <unk>.

Barrett: This T cell license or otherwise dispose of its rights to sue the pan am to maximize shareholder value.

Louise Barrett: Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of 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, including the potential resubmission of our NDA for oral zolopinib. However, changes in public policy or legislation, commercialization plans, and timelines have still been approved. The accuracy of our expectations regarding how far into the future our cash in hand will fund 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, whether on attractive terms, or et al., and other factors discussed under the 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.

Actual results may differ materially from those indicated by these forward looking statements as a result of various factors outside of our control, including uncertainties inherent in the design in a C H and the conduct of clinical and non clinical development changes in regulatory requirements or decisions regulatory authorities, the timing or likelihood of regulatory filings and approvals, including the potential.

Barrett: For Resubmission of our NDA for oral seal of Panama.

Barrett: Changes in public policy or legislation commercialization plans and timelines for OPEC still a Panama has approved the accuracy of our expectations regarding how far into the future. Our cash on hand will fund ongoing operations, our ability to maintain our listing on the NASDAQ capital market risks.

Barrett: Risks and uncertainties concerning the impact of FX and results of our pursuit of strategic alternatives alternatives, including the terms timing structure value benefits and costs of any strategic process and our ability to compete when it all whether on attractive terms or at all.

Barrett: And other factors it goes under the caption risk factors in our annual report on Form 10-K filed with the SEC. This morning.

Barrett: In addition, any forward looking statements represent our views only as 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 provided reconciliations of GAAP reported to non-GAAP adjusted infer.

Louise Barrett: We will also be referencing non-GAAP financial measures during the call. We've provided reconciliations of GAAP-reported to non-GAAP-adjusted information in their press release issued this morning. With that said, I'll turn it over to you now, Corey, for your opening remarks. Thanks, Louise.

Barrett: And in their press release issued this morning.

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

Cory: Thanks Louise.

Corey N. Fishman: Good morning, and thanks for joining us today. I'd like to provide a brief recap of 2023 and outline our key activities and milestones for 2024. Overall, 2023 was a very good year for Iterum as we completed enrollment in our confirmatory phase three clinical trial in adult women with uncomplicated urinary tract infections called the REASSURE clinical trial. As a reminder, this trial was conducted under a special protocol assessment agreement with the FDA and compared oral sulopenum to oral augmentum. As many of you know, we were very pleased to recently announce that the REASSURE trial demonstrated that oral sulopenum was non-inferior to augmentin with respect to the trial's primary endpoint, which was overall response, which is the combined clinical cure plus microbiologic eradication at the test of cure visit in the microbiological modified intent to treat susceptible populations. Additionally, oral sulopenum also demonstrated statistically significant superiority Oral sulopenib also showed consistent efficacy for all key secondary endpoints.

Cory: Good morning, and thanks for joining us today.

Cory: To provide a brief recap of 2023.

Cory: One of our key activities and milestones for 2024.

Cory: Overall 2023 was a very good year for <unk> as we completed enrollment in our confirmatory phase III clinical trial in adult women with uncomplicated urinary tract infections.

Cory: The reassure clinical trial.

Cory: As a reminder, this trial was conducted under special Protocol assessment agreement with the FDA.

Cory: And compared to oral sumo, Panama two oral augment.

Cory: As many of you know we were very pleased to recently announce that the reassure trial demonstrated that <unk> was non inferior to augment them with respect to the trial's primary endpoint, which was overall response, which is the combined clinical cure plus microbiome.

Cory: Logic eradication at the test of cure visit.

Cory: Microbiological modified intent to treat susceptible population.

Cory: Additionally, oral single kind of also demonstrated statistically significant superiority to augment them.

Cory: The same patient population.

Cory: <unk> also showed consistent efficacy for all key secondary endpoints.

Corey N. Fishman: Lastly, Sulopenum demonstrated a very solid safety profile with regard to the Pseudopenum patent estate. In addition to the in-license patents we obtained in our original license agreement with Pfizer, we continue to seek opportunities to enhance the long-term protection of pseudopenem. We now have issued patents directed to the composition of the bilayer tablet of oral sulopenum granted in the US, Japan, Korea, and Australia, and these patents will expire no earlier than 2039. We also have an issued patent in the US directed to the method of use of oral sulopenum in treating multiple diseases, including uncomplicated urinary tract infections, which is due to expire no earlier than 2039. In addition to the in-licensed and issued patents, we have a number of pending patent applications in the U.S. and other jurisdictions, including Europe and China.

Cory: Lastly, sumo patent demonstrated a very solid safety profile.

Cory: With regards to the single kind of pet.

Cory: And at this stage.

Cory: In addition to the in license patents, we obtained in our original license agreement with Pfizer, we continue to seek opportunities to enhance the long term protection of similar pattern.

Cory: We now have issued patents directed to the composition of the bilayer tablet of oral Sunil kind of them granted in the U S, Japan Korea, Australia.

Cory: And these patents will expire no earlier than 2039.

Cory: We also have an issued patent in the U S direct it to the method of use of oral sumo pattern in treating multiple diseases, including uncomplicated urinary tract infections, which is due to expire no earlier than 2039.

Cory: In addition to the in license issued patents, we have a number of pending patent applications in the U S and other jurisdictions, including Europe and China.

Cory: We believe that these patents plus our potential data exclusivity would allow oral single kind of a long runway to capture value.

Corey N. Fishman: We believe that these patents, plus our potential data exclusivity, would allow oral sulopenum a long runway to capture value. I'll spend just a moment now and talk a bit about the market dynamics into which we see Sulopenum potentially entering. The uncomplicated urinary tract market is quite large, with an estimated 40 million prescriptions annually in the US. It is estimated that approximately two-thirds of those prescriptions are for patients at elevated risk, which are the patients that sulopenum would target. Elevated risk patients are elderly, patients with diabetes, patients with a history of recurrent infections, or patients that have comorbidities that negatively impact their immune system. There is a significant need for new, efficacious, and safe oral products to treat uncomplicated urinary tract infections, as the existing older oral products are experiencing high and increasing resistance rates, as well as exhibiting subpar safety profiles. If approved, oral sulopenem would be the first oral penem approved in the United States and one of the first new branded treatments approved in the U.S. for uncomplicated urinary tract infections since the turn of the century.

Cory: I'll spend just a moment now and talk a bit about the market dynamics into which we see sue will kind of potentially entry.

Cory: The uncomplicated urinary tract market is quite large with an estimated 40 million prescriptions annually in the U S.

Cory: It's estimated that approximately two thirds of those prescriptions are for elevated risk patients, which are the patients that zulu with target.

Cory: Elevated risk patients are elderly patients with diabetes patients with a history of recurrent infections or patients that have comorbidities that negatively impact their immune system.

Cory: There is a significant need for new efficacious and safe oral products to treat uncomplicated urinary tract infections.

Cory: The existing older oral products are experiencing high and increasing resistance rates.

Cory: As well as exhibiting sub par safety profiles.

Cory: If approved <unk> would be the first oral Panama approved in the United States and one of the first new branded treatments approved in the U S for uncomplicated urinary tract infections since the turn of the century.

Cory: Okay.

Corey N. Fishman: Regarding our upcoming milestones, we plan to resubmit our NDA to the FDA in the first half of the second quarter of this year. Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter we received from the FDA in July 2021, we expect the FDA will complete its review and take action in the first half of the fourth quarter of this year, which would be six months from the date the FDA received the resubmitted NDA. As we look at our cash position, based on our current operating plan, we have cash on hand to operate the company through the expected HDUFA date early in the fourth quarter of 2024 and into 2025. Lastly, as previously stated, we have initiated a strategic process to sell, license, or otherwise dispose of our rights to pseudopenem with the goal of maximizing value for our stakeholders, and we have engaged a financial advisor to assist management and the board in evaluating strategic alternatives.

Cory: Regarding our upcoming milestones, we plan to resubmit, our NDA to the FDA and the <unk>.

First half of the second quarter of this year.

Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter we received from the FDA in July 2021, we expect the FDA will complete its review and take action in the first half of the fourth quarter of this year, which would be six.

Cory: From the date, the FDA received the resubmitted NDA.

Cory: As we look at our cash position based on our current operating plan, we have cash on hand to operate the company through the expected to do for date early in the fourth quarter of 2024 and into 2025.

Cory: Lastly, as previously stated we have initiated a strategic process to sell license or otherwise dispose of our rates to suture pattern with the goal of maximizing value for our stakeholders.

Cory: And have engaged a financial advisor to assist management and the board in evaluating strategic alternatives.

Corey N. Fishman: Our board has not set a timetable for completion of this evaluation process, and we do not intend to disclose further developments unless and until it is determined that further disclosure is appropriate or necessary. I'll now turn the call over to Judy for details on our financial results. Thanks, Corey. Total operating expenses were $11.4 million and $47.5 million in the fourth quarter and full year 2023 compared to $7.9 million and $30.4 million in the fourth quarter and full year 2022. Operating expenses include research and development expenses and general and administrative expenses.

Cory: Our board has not set a timetable for completion of this evaluation process and we do not intend to disclose further developments unless and until it is determined that further disclosure is appropriate or necessary.

Cory: I'll now turn the call over to Judy for details on our financial results.

Thanks Corey.

Judith M. Matthews: Total operating expenses were 11 wait for $47 $5 million in the fourth quarter and full year 2023, compared to $79 million and $34 million in the fourth quarter and full year 2022.

Judith M. Matthews: Operating expenses include research and development expenses and general and administrative expenses.

Judith M. Matthews: R&D costs were $9.7 million for the fourth quarter and $40 million for the full year of 2023, compared to $5.8 million and $17.6 million for the same periods in 2022. The primary driver of the increase in R&D expense for the fourth quarter and full year was the cost to support our REASSURE trial, which began enrollment in October 2022 and completed enrollment in October 2023, enrolling 2,222 patients. G&A costs were $1.7 million in the fourth quarter of 2023, which is $400,000 lower than G&A costs of $2.1 million in the fourth quarter of 2022, due primarily to lower legal fees and insurance costs. For the full year, GNA costs were $7.5 million in 2023, which is $5.3 million lower than GNA costs of $12.8 million in 2022, primarily due to lower share-based compensation expense for employees and directors, lower insurance costs, lower rent expense, and a decrease in legal fees associated with the lawsuit filed in August 2021, which was dismissed with prejudice in January 2023, which means the case cannot be brought back to court.

Judith M. Matthews: R&D costs were $97 million for the fourth quarter and $40 million for the full year 2023 compared to five 8%.

Judith M. Matthews: $17 6 million for the same period in 2022.

Judith M. Matthews: The primary driver of the increase in R&D expense for the fourth quarter and full year with cost to support our restart trial, which began enrollment in October 2022, and completed enrollment in October 2023, enrolling 2222 patients.

Judith M. Matthews: G&A costs were $1 7 million in the fourth quarter of 2023, which is $400000 lower and G&A costs of $2 1 million in the fourth quarter of 2022, due primarily to lower legal fees and insurance costs.

Full year G&A costs were $7 $5 million in 2023, which is $5 $3 million lower than G&A cost of $12 8 million in 2022.

Judith M. Matthews: Primarily due to lower share based compensation expense for our employees and directors lower insurance costs lower rent expense and a decrease in legal fees associated with the lawsuit filed in August 2021, which was dismissed with prejudice in January 2023, which means the.

Judith M. Matthews: <unk> be brought back to court.

Judith M. Matthews: Our net loss on a U.S. gap basis was $12.4 million for the fourth quarter of 2023 and $38.4 million for the full year. Impacting the full year net loss was a non-cash adjustment of $11.1 million included in other income and expense in connection with the fair value assessment of our royalty-linked note. There was no impact of this adjustment on CACHE or CACHE Runway, which I will turn to in a moment.

Judith M. Matthews: Our net loss on a U S. GAAP basis was $12 $4 million for the fourth quarter of 2023, and $38 4 million for the full year impacting the full year net loss was a noncash adjustment of $11 1 million.

Judith M. Matthews: Included in other income and expense and.

Judith M. Matthews: In connection with the fair value assessment of our royalty linked notes.

Judith M. Matthews: There was no impact of this adjustment on cash our cash runway, which I will turn to in a moment.

Judith M. Matthews: On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $10.7 million and $43.8 million for the fourth quarter and full year 2023 compared to our non-GAAP net loss of $6.4 million and $22.9 million in the fourth quarter and full year 2022. The $4.3 million and $20.9 million increase in our non-GAAP net loss for the fourth quarter and full year was primarily a result of higher R&D expenses related to our REASSURE trials, as the bulk of the 2,222 patients were enrolled in 2023. At the end of December, we had cash equivalents and short-term investments of $23.9 million, which, based on our current operating plan and including amounts raised under our ATM agreement through the end of February 2024, will provide a cash runway into 2025, including through the expected PDUFA date in the first half of the fourth quarter of 2024. We expect to resubmit to the FDA the NDA for oral psilocybin for the treatment of UUTI in the first half of the second quarter of 2024 or over the next four to six weeks. As of February 29, 2024, we had approximately 16.4 million ordinary shares outstanding.

Judith M. Matthews: On a non-GAAP basis, which excludes certain noncash adjustment.

Judith M. Matthews: Our net loss of $10 7 million and $43 8 million for the fourth quarter and full year 2023, compared to our non-GAAP net loss of $6 4 million and $22 9 million in the fourth quarter and full year 2022.

Judith M. Matthews: The $4 $3 million and $8 $9 million increase in our non-GAAP net loss for the fourth quarter and full year with primarily a result of higher R&D expenses related to our reassure trial.

Judith M. Matthews: The bulk of the 2000 and 222 patients were enrolled in 2023.

Judith M. Matthews: At the end of December we had cash cash equivalents and short term investments of $23 $9 million, which based on our current operating plan and including amounts raised under our ATM agreement through the end of February 2024 will provide a cash runway into 2000.

Judith M. Matthews: 25, including through the expected produce a day in the first half of the fourth quarter of 2024.

Judith M. Matthews: We expect to resubmit to the FDA the NDA for <unk> for the treatment of UTI in the first half of the second quarter of 2024 over the next four to six weeks.

Judith M. Matthews: As of February 29, 2024, we had approximately $16 4 million ordinary shares outstanding also as of the end of February 2024, we had approximately $11 $1 million of exchangeable notes outstanding which can be exchanged at the op.

Judith M. Matthews: Also, as of the end of February 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 prior to maturity, 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. Thanks, Judy. We'll go ahead and open the line for questions now. Thank you. As a reminder, if you would like to ask a question today, please do so now by pressing start followed by the number one on your telephone keypad. Our first question today comes from Ed Archie on HC Wayne. Please go ahead. Hi, good morning, everyone.

Judith M. Matthews: Shneur the note holder.

Judith M. Matthews: One 2 million shares.

Judith M. Matthews: If the notes are not exchanged prior to maturity, we will be obligated to pay the note holders $11 $1 million plus accrued interest in January 2025.

Judith M. Matthews: Now I will turn it back over to Corey.

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

Corey N. Fishman: Yeah.

Corey N. Fishman: Thank you.

Corey N. Fishman: As a reminder, if you would like to ask a question today. Please do so now by pressing star followed by the number one on your telephone keypad.

Corey N. Fishman: Our first question today comes from Ed Archie with H C Wainwright.

Ed Archie: Please go ahead.

Ed Archie: Hi, good morning, everyone business Thomas.

Corey N. Fishman: This is Thomas Yip asking a couple of questions for Ed. Thank you for picking up the questions. So, first question we have, just wondering, do you have any specific dates or triggering events to decide on your strategic options, considering that PDUFA is expected as you find our early fourth quarter and then cash runway into 2025. Seems like you have some flexibility there.

Ed Archie: A couple of questions for at thank you for taking my questions.

Ed Archie: So first question we have.

Just wondering do you have any specific dates or triggering events to decide on your strategic options are considering.

Ed Archie: The throughput is expected that's you.

Ed Archie: That's my earlier early fourth quarter and that cash runway into 2025 gives us some flexibility there.

Corey N. Fishman: Thanks Thomas, I appreciate the question. We don't have any specific dates or triggering events with regard to the strategic options, primarily because, as most folks know, these processes take whatever time is required on the counterparty side to figure out whether there's something that is of interest to them, and we just don't know how long that process takes. So, as we said in our remarks, you know, we're not going to talk about it on each of our calls because at the appropriate time, if and when there's something to disclose, we will, of course, do that, but until then, we don't have any specific dates or timelines on it. And that's good.

Thanks, Thomas I. Appreciate the question, we don't have any specific dates or triggering events with regard to the strategic options M, primarily because as most folks know.

These processes take.

None: As required on.

None: You know a counterparty side to figure out whether there is something that is of interest to them and we just don't know how long that process takes so as we said in our remarks, we're not going to we're not going to talk about each of our calls because.

None: At the appropriate time, if and when there's something to disclose we will of course do that but until then we don't have any specific dates or timelines on that.

None: Understood.

Corey N. Fishman: Perhaps, you know, while we understand the date, you know, the timing details are still up in the air; will you consider an option, whether it's indication specific, as we understand the end date of submission for uncomplicated UTI, will you consider carving out other indications for pseudopandem and also for geographic areas as well, you know, or should we consider pseudopandem as a single package? Yeah, it's another good question. And we have flexibility on all of those fronts, depending on how those conversations go. You bring up a very good point.

None: Perhaps.

None: While we understand that.

None: The timing.

None: Details are still up in the air.

None: Considering the option.

None: <unk>.

None: Whether it's the indication specific as we understand the NDA resubmission.

None: In complicated UTI.

None: When you consider carbon no other indications for civil panel and also for geographic areas as well.

None: So we consider that still depend on as a single package.

None: Yes, its another good question.

None: We have flexibility on all of those fronts, depending on how those conversations go you bring up a very good point there is potential for.

Corey N. Fishman: There's potential for carving up different areas depending on the transaction. And there's also potential for other indications as well. So we have flexibility on the company side. And again, it's just all a matter of the conversations with other parties as to what they're looking for.

None: Irving up different areas, depending on transaction and there is also.

None: So potential on other indications as well so we have flexibility on the company side and again, it's just all a matter of the conversations with other parties as to what they're what they're looking for but the short answer is yes, we would certainly consider any or all of those options as potential opportunities.

Corey N. Fishman: But the short answer is yes, we'd certainly consider any or all of those options as potential opportunities. Thank you again for taking our questions, and we look forward to the end day with the mission. Thanks, Tom. The next question comes from Jason McCarthy with Maxim Group. Please go ahead, Jason. Hey, Corey, thanks for taking the questions. Is Iterum still actively or planning to engage physicians and practices, I guess, on an educational level to talk about Zulapenem ahead of any type of divestiture or partnering or the focus just getting the NDA done, getting to the finish line, and seeking to divest or settle their lives? Yeah, thanks Jason for the question. The primary focus is going to be on strategic opportunities.

None: Understood. Thank you again for taking my questions and we look forward to the AMD with the mission briefing.

None: Thanks Thomas.

None: The next question comes from Jason Mccarthy with Maxim Group. Please go ahead Jason.

Jason Mccarthy: Hey, Cory thanks for taking the questions. It is interim still actively or planning to engage physicians and practices I guess on an educational level.

To talk about Philip Hana ahead of any type of.

Jason Mccarthy: Divestiture or partnering or is the focus just getting the NDA done.

Jason Mccarthy: Getting to the finish line and seeking.

Jason Mccarthy: To divest or sell or license.

Cory: Yeah. Thanks, Jason for the question. The primary focus is going to be around the strategic opportunities.

Corey N. Fishman: There is a little bit of work ongoing on the commercial side to continue to refine the parameters of a potential commercialization, which could, of course, be used by, you know, a counterparty at the appropriate time. I don't think you'll see us at this point spending an awful lot of time out in the physician world, but we will, of course, continue to do things like present at conferences, put together manuscripts, etc., which also help get that message out.

None: There is a little bit of work ongoing on the commercial side to continue to refine.

None: The parameters of a potential commercialization, which could of course be used by <unk>.

None: You know a counterparty at the appropriate time, I don't think Youll see us at this point spending an awful lot of time out in the physician world, but we will of course continue to do things like presented conferences put together manuscripts et cetera, which also help get that message out there that is still ongoing and will be ongoing as we can.

Corey N. Fishman: That is still ongoing and will be ongoing as we continue down the road with Sulu. Got it, and um... Does SULO qualify, or could it qualify ultimately under the PASTAR Act? Should I get it? Cleared by Congress, obviously, there's always challenges in getting things done in Congress these days, but it is one of the pure bipartisan bills that is out there in the Senate, and I've heard that it's getting closer and closer, and I wonder if Sulu could be in that discussion for a kind of, quote-unquote, critical need antimicrobial drug. Yeah, I believe Sulu would, because of the coverage that it's got on those critical pathogens, much like we have qualified infectious disease product designation from the FDA through the GAIN Act. I believe that Sulu would be applicable to anything that would come through under the Pasteur Act as well.

None: See you down the road with Zillow.

None: Got it.

None: Does sue qualify or couldn't qualify ultimately under the past our act if it should get.

None: Cleared by Congress, obviously, there is always challenges in getting things done in Congress. These days, but it is one of the pure bipartisan bill that is out there in the Senate and I've heard that it's getting closer and closer and I Wonder if sullo.

Could be in that discussion for kind of quote unquote critical need anti microbial drugs.

None: Yes, I believe I believe sooner would because of the coverage that it's got on those critical pathogens are much like we have qualified infectious disease product designation from the FDA through the gain act I believe that sooner would be apple applicable for anything that would come through.

None: The pass through or act as well.

Corey N. Fishman: Got it. Thanks, Corey. Thanks, Justice. We have no further questions, so I'll turn the call back to Corey for closing. Thank you. We appreciate you joining us today. 2023 was a strong year for Iterum, and we're looking forward to 2024, which will include resubmitting our NDA for oral sulopenum, working with the FDA during the review period with an eye toward potentially bringing this important treatment to patients and physicians in the underserved market of uncomplicated urinary tract infections.

None: Got it thanks Corey.

Corey N. Fishman: Thanks, Jason.

None: We have no further questions. So I'll turn the call back to Corey for closing remarks.

Corey N. Fishman: Thank you.

Corey N. Fishman: We appreciate you joining us today 2023 was a strong year for interim and we're looking forward to 2020 for which we will.

Corey N. Fishman: We'll include resubmitting, our NDA for oral <unk>, who are kind of working with the FDA during the review period with an eye toward potentially.

Corey N. Fishman: Bringing this important treatment to patients and physicians in the underserved market of uncomplicated urinary tract infections. Thanks, again and have a good day.

None: Thank you everyone for joining us today. This concludes our call you may now disconnect your lines.

Corey N. Fishman: Thanks again, and have a good day. Thank you everyone for joining us today. This concludes our call. You may now disconnect your line.

None: [music].