Iterum Therapeutics plc

Hello, and welcome to the Iterum Therapeutic Q3 Financial Results Conference Call. My name is Alex, and I will be your operator for today. If you would like to ask a question at the end of the presentation, you can press star 1 on your telephone keypad. If you wish to withdraw your question, you can press star 2. I'll now hand it over to your host, Louise Barrett, Senior Vice President of Legal Affairs. Louise, over to you.

Thank you, Alex. Good morning and welcome to Utterham Therapeutics third quarter 2021 financial results and business update conference call. Press releases our third quarter results as issued earlier this morning can be found on our website. We are joined this morning by Corey Fishman, CEO and Judy Matthews, CFO. Corey will provide some opening remarks. Judy will provide some 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 this call will contain forward-looking statements concerning our plans, strategies and prospects for our business, including with respect to planned interactions and communications with the FDA and our ability to reach agreement with the FDA on the design of any potential future clinical trials. Our expectations with regard to our ability to resolve the matters set forth in the complete response letter received in July 2021 and obtain approval for oral sulipenem, the conduct of potential future clinical and non-clinical development of Sulipenem, and the sufficiency of our cash resources to execute on our strategy. Actual results may differ maturely from those indicated by these forward-looking statements as a result of various important factors, including uncertainties inherent in the initiation and conduct of clinical and non-clinical development, availability and timing of data from such clinical trials and non-clinical development, The timing or likelihood of registry filings and approvals, including the potential resubmission of our NDA for oral sulipenem. Changes in public policy or legislation. The actions of third-party clinical research organisations, suppliers and manufacturers. The accuracy of our expectations regarding how far into the future the company's cash and hand will fund our ongoing operations, including completing potential additional clinical and non-clinical development of oral sulipenem. the impact of COVID-19 and related response measures thereto, our ability to maintain our listing on the NASDAQ capital market, and other risk factors set out in our filings with the SEC, including our most recently filed quarterly report on Form 10Q. 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 obligations to update such statements. 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 the repressed release issued this morning. With that said, I'll turn it over to you, Corey, for your opening remarks.

Thanks, Louise. Welcome, and thank you for joining us today. I'll be providing a brief update this morning. As we previously mentioned, we had requested a Type A meeting with the FDA to discuss our complete response letter that we received in late July. We recently had that meeting, and the FDA informed us that, in their opinion, the totality of our NDA package was not sufficient to warrant approval for oral sulopenem at that time, even though they acknowledged that sulopenem showed statistical significance and the overall response rate by treatment arm against ciprofloxacin in the ciprofloxacin-resistant population in the treatment of uncomplicated urinary tract infections. We then discussed what additional clinical work would be required in order to have a package that they deemed potentially adequate for approval, assuming the trial results were successful. The FDA feedback received was that one additional Phase III clinical trial should be sufficient, subject of course to reaching agreement with the FDA on the design of that trial. We have since requested a Type B meeting with the FDA to discuss the details of that additional trial, including the protocol, endpoints, and other relevant factors. Our hope is that after this meeting, which we expect to occur around year-end, we will have clarity on all major aspects of the additional trial required to support potential resubmission of our NDA and be able to work expeditiously to get that study enrolling patients in the first half of 2022. It's important to note that given the urgent unmet medical need for new oral treatments for uncomplicated urinary tract infections, we remain confident in the value of oral sulopenem to treat multidrug-resistant infections and strongly believe sulopenem could be an important and valuable product for physicians and patients. Lastly, I'll spend just a moment on our cash position and outlook. We ended Q3 with a strong cash balance of approximately $86 million on the balance sheet. Based on our latest forecasts, we anticipate this cash balance will fund the company into 2024 and allow us to complete the proposed additional clinical development of Sulopenem to support If successful, the resubmission of our NDA to the FDA for the treatment of uncomplicated urinary tract infections. Now I'll turn the call over to Judy for details on our financial results.

Thanks, Corey. Total operating expenses were $4.9 million in the third quarter of 2021 compared to $6.3 million in the third quarter of 2020. Operating expenses include research and development expenses and general and administrative expenses. R&D costs were $1.8 million for the third quarter of 2021 compared to $3.9 million for the same period in 2020. The R&D category includes expenses for our clinical and development programs, our CMC costs, and our regulatory expenses. The primary driver of the $2.1 million decrease in R&D costs was the completion of our Phase III program in 2020. G&A costs were $3 million for the third quarter of 2021, which is $600,000 higher than G&A costs of $2.4 million in the third quarter of 2020 due primarily to higher share-based compensation for employees and directors. Moving on to non-operating items, Interest expense was $800,000 for the third quarter of 2021 compared to $4.2 million in the third quarter of 2020. The primary reason for the $3.4 million decrease in interest expense was non-cash interest expense associated with a lower exchangeable notes balance of $12.6 million as of September 30, 2021 versus $51.8 million as of September 30, 2020. On a strictly cash basis, we paid interest related to our term loan with SBB of approximately $90,000 in the third quarter of 2021 versus approximately $220,000 in the third quarter of 2020. The reduction in cash interest is largely due to a lower principal balance on our term loan as monthly amortization began in the fourth quarter of 2019 and will continue until our final payment in March 2022. As of September 30, 2021, there was a remaining balance of $3.2 million on our term loan with FCB. Our net income on a U.S. GAAP basis of $3.7 million was driven by a $9.8 million non-cash adjustment to record a decrease in the value of the derivative components associated with our exchangeable notes as a result of a decrease in the price of our ordinary shares in market capitalization during the period. There was no impact of this adjustment on cash or cash runway, which I will turn to in a moment. On a non-GAAP basis, which excludes certain non-cash adjustments, including adjustments to record derivatives at their fair value, our net loss of $5.2 million in the third quarter of 2021 was $1.8 million less than our non-GAAP net loss of $7 million in the third quarter of 2020 as a result of the lower operating expenses previously discussed. At the end of September, we had cash and short-term investments of $85.7 million. Based on our current operating plan and subject to final determination of the design and planning conduct of potential additional clinical and non-clinical development for sulopenem, we have cash into 2024. As such, we anticipate that our existing cash will be sufficient to allow us to complete the proposed additional development of oral sulopenem to support, if successful, a resubmission of the NDA to the FDA for the treatment of UUTI. As of September 30, 2021, we had approximately 183 million ordinary shares outstanding. Also, as of the end of September, we have 7.2 million warrants outstanding at an average price of $1.61 per share and $12.6 million of exchangeable notes, which can be exchanged for approximately 18 million shares, which includes accrued interest at the option of the note holder. Now I will turn it back over to Corey for some closing comments.

Thanks, Judy. We'd like to take a moment and just open the lines up for questions now.

Thank you. We will now proceed with the Q&A. If you'd like to ask a question, you can press star 1 on your telephone keypad. Please ensure you're unmuted locally when asking a question. Our first question for today comes from Gregory Renzer from RBC Capital Markets. Gregory, your line is now open.

Good morning, Corey. Thanks for taking my question. I look forward to all the upcoming progress. Corey, as you head into the Type B meeting, I'm just wondering if you could provide us with perhaps what your base case is on a trial design or any additional color at this point that you could touch on to just help us understand, and maybe even baselining it to perhaps SURE-1, how you're thinking about that in size and scope. And then just a second question is just around certainly a great deal of data you've generated already. I'm just curious if you have plans or how are you thinking about kind of reengaging the clinical and medical community and maybe sharing that data in parallel as you initiate a second pivotal trial. Thank you very much.

Sure. Well, thanks, Greg, for the questions. Appreciate it. With regard to the first question, we really don't have a lot of details that are in a state that we're able to share yet regarding the study design, simply because we have not yet solidified with the agency what that study design will be. And, you know, I'd rather not share sort of our thinking now and then have to come back to you all and say, well, you know, FDA said this and they said that, and we have to change it. Suffice to say that, you know, we will be doing a study per the guidance that FDA has issued a couple of years back for those trials in uncomplicated urinary tract infections, and our goal of the Type B meeting is to work with them on the specifics of that. We also aren't just sitting on our hands, as you'd imagine. We have begun conversations with a number of external vendors, including CROs, to talk about the generalities, talk about the sites, talk about, you know, we don't have specifics yet to be able to say here's exactly what we want to do, but we've begun all those conversations and our CMC team has been working very hard on, you know, making sure we have plenty of clinical supply, which we do, and figuring out the timelines for all of that to be able to get us to start this study in the first half of next year. I think that's probably as much as I can tell you that is valid and important for now. With regard to your second question, which was regarding the data, I agree with you, and we do actually have a plan to reengage in the medical community, talking about the data that we've generated, because as you know, it is very strong. and we have a great deal of data in uncomplicated UTI. And we also have data in complicated UTI as well that I think is interesting and important and certainly was supportive And we want to make sure we get that out to the physicians, to the KOLs. And so we'll be working on presentations for upcoming meetings and conferences, as well as manuscripts to try to at least help people understand the data that was generated, why we feel so good about the fact that we believe very strongly that this drug works well, and just figuring out how to get that into the hands of the physicians and treating patients. treating physicians and KOLs at the appropriate time is certainly on our radar for what we will be doing here over the next six to 12 months.

That's really helpful, Corey. I appreciate all the color.

Thanks, Greg. Thank you, Gregory. Our final question for today comes from Ed Ask from HC Wainwright. Ed, your line is now open.

Thomas Yip Hi, good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. Happy to see that SILPANM is back on track. Perhaps first, we would like to narrow down the technical meeting timeline. Can you tell us when was the request formally accepted and when do you expect the meeting to take place?

Yeah, we put the request in Oh, I want to say probably one to two weeks ago, and we're expecting, given that timeline, that the meeting should be granted around the end of the year. We'll provide more data as we get a solid date on that and have that conversation, but it should be in that year-end timeframe, and that should allow us, Thomas, to be able to continue our planning as we've started to get this study up and running again. And, you know, importantly, as we've talked about, I think, you know, having the capital to do that is incredibly, incredibly important for the company. So we are in a position that's, you know, pretty favorable from that standpoint.

Yes, understood. And as you alluded to earlier, details for the new Phase 3, you prefer not to discuss while you have a Type B meeting. Okay. Have you given any thoughts on a specific geographical location that you would like to focus on to open sites and considering the ongoing impact of COVID-19?

Yeah, it's a really good question, and it's actually one of the things that our clinical folks as well as the rest of our team have been talking to the CROs. As I mentioned, we've started the conversation to better understand what's happening in various geographies. And that is, you know, from our perspective, that's not only in the U.S. geographies but also in other countries. Historically, what we had done was predominantly in the U.S. for the uncomplicated UTI study. And we will continue to look at that as an option, but we will also look at other countries where there is an opportunity to get the highest quality work done. in the most efficient time manner, which is, of course, what everybody does when they're looking at a study. But as you said, in the COVID world, that can be a little bit different. And so we're going to be sure that we are working with the CROs to understand what the flexibility is in various geographies here, as well as other countries, to be sure that we've got the best sites from a quality standpoint, but also from a timeline standpoint. So it is an important consideration that we are taking into account as we look at who we choose in terms of a CRO and also the timelines for that study.

Okay, that makes sense. Perhaps one last question. This one's for Judy. We noticed that the cash runway estimate, it was previously into second half of 2023 and now it's into 2024. Can you outline some main factors that led to this adjustment?

Yeah, you know, we have a little more specificity internally about, you know, the type of trial that we might run and the cost. So we were able to build that in a little more specifically. And as you know, there has been no financing since the last quarter. But we just have some more specific SMS that we've begun working with the CROs and have been doing some planning during the last quarter.

Got it. And I guess just to confirm that you did say that your current casualty is sufficient to see this entire Phase 3 trial through?

Right, through the Phase 3 that we plan as well as a resubmission to the FDA.

Okay, got it. Thank you, Judy and Corey, for taking our questions. We look forward to your final details of this new phase three study.

Thanks, Thomas. Thanks, Thomas.

Thank you. That concludes the Q&A session. I will now hand back over to Corey Fishman for any closing remarks. Corey, over to you. Thank you very much.

So I just want to take one more moment to say thank you again to all the folks on the call for joining us today. We appreciate the continued support. As stated earlier, we remain very confident in the value of oral sulopenem to treat multidrug-resistant infections. we will continue to work collaboratively with the FDA to provide the additional clinical data requested in the complete response letter that we received in July to support the approval of oral sulopenem as an important treatment option for physicians and patients. And perhaps most importantly, we expect our existing cash will allow us to complete the additional development of sulopenem to support, if successful, the resubmission of the NDA to the agency. So we are in a very good position from a cash perspective to get that work done without the need for additional financing. So thanks again to everyone, and have a great day. Thank you for joining today's call. You may now disconnect.