Eiger BioPharmaceuticals, Inc.

Good day, ladies and gentlemen, and welcome to the Iger Biopharmaceutical Second Quarter 2021 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require operator assistance, please press star then zero on your telephone. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference, Mr. Sri Rayali, Chief Financial Officer of Iger. You may begin.

Good afternoon, and thank you for joining us today. Welcome to our quarterly financial results and business update call. We issued a press release earlier this afternoon with our Q2 financial results, which is available on our website at IgerBio.com. For today's call, we will have prepared remarks from the management team, followed by Q&A. We will be using slides for the webcast, and we'll have a replay available on the investor section of our website. Joining me on the call are David Corey, our president and CEO, Eldon Mayer, our chief commercial officer, and Dr. Ingrid Chung, senior vice president of clinical development. Dr. Colin Hislop, senior vice president of clinical and development operations, will be available for the Q&A portion of the call. I would like to remind investors that this call will include forward-looking statements within the meeting of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to the types of statements identified as forward-looking in our 2020 Annual Report on Form 10-K, our quarterly reports on Form 10-Q, and our subsequent periodic reports filed with the SEC, which will all be available on our website in the Investors section. For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, please see our periodic reports filed with the SEC. These forward-looking statements represent our views only as of the date of this call and involve substantial risks and uncertainties, including many that are beyond our control and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. I'll now turn the call over to David.

Thanks, Sri. Good afternoon, everyone, and thank you for joining us today. We are making great progress across our pipeline, which includes multiple late-stage therapies for rare diseases. We are very proud at Iger that every one of our rare disease programs now has FDA breakthrough therapy designation. And these include lonafarnib and PEG interferon lambda for hepatitis delta virus infection, Avexatide for post-bariatric hypoglycemia and now congenital hyperinsulinism, and Zokinvi for progeria, which is now commercially approved. Iger is well positioned to advance several catalysts for value creation in 2021 and beyond. We look forward to updating you today on our progress and future plans. Our lead clinical development programs are focused on hepatitis delta virus, the most severe form of human viral hepatitis. Hepatitis delta virus is always a co-infection with HBV and is found in approximately 6% of HBV-infected patients. However, hepatitis delta virus causes a much more rapid progression of liver disease than HBV alone. Sadly, 60% of HDV patients die within 10 years after diagnosis. This is a large orphan disease in the US and Europe with an urgent unmet medical need. There is no FDA approved therapy for hepatitis delta virus. Iger is pioneering the development of treatments in this space. We are often asked, what would a win look like for HDV patients? HDV is a devastating, rapidly progressive disease. The first goal of therapy is reduction in HDV viral load and reduction in liver inflammation to slow progression of disease, which has been shown to lead to improved outcomes. Importantly, this is consistent with FDA guidance for development of HDV therapies. Additionally, HDV therapies will require chronic dosing. Convenient administration for long-term treatment could improve compliance and outcomes, which are critical to both patients and physicians. We believe that lonafarnib, a daily oral medication, and PEG interferon lambda, a weekly subcutaneous injection, offer the most convenient dosing compared to other late-stage HDV programs in development. At Iger, we are advancing an HDV platform strategy that provides multiple paths to win for patients. We have two well-characterized, promising late-stage product candidates in lonafarnib and PEG interferon lambda. Both have different mechanisms of action, are conveniently administered, and should benefit HDV patients alone and in combinations. Lonifarnib, the only oral treatment in development for HDV, is currently dosing in the Phase III DELIVER study. DELIVER is the largest global Phase III study to be conducted in HDV, with over 100 sites across 20 countries. The DELIVER study design opens the door to deliver a win for HDV patients with the all-oral lonifarnib-based regimen and in combination with PEG interferon-alpha, we are pleased to see continued momentum in DELIVER, which is now over 90% enrolled. This includes patients randomized to date and patients in screening that are expected to be randomized. We are on track to complete enrollment before end of 2021, setting up for pivotal top-line data release in late 2022. Our second therapy in development for HDV is PEG interferon-Lambda, a well-tolerated interferon, which is beginning phase 3. We have concurrence with FDA and EMA for a single pivotal study called Limit 2, and we expect to enroll our first patient in this study before the end of the year. Limit 2 represents an efficient pathway for PEG interferon lambda approval in HDV, and we are excited to begin this study. For over a decade, Iger has been engaged in the clinical development of therapies for viral hepatitis. we have gained a deep understanding of the needs of HDV patients and of physicians who care for them. We believe that lonafarnib and PEG interferon lambda will become foundational therapies to be used alone and in combination for the treatment of HDV. Iger is well positioned to be a leader in HDV, a billion dollar plus commercial market opportunity. Beyond HDV, we continue to advance the rest of our rare disease pipeline. Avexetide is a novel first-in-class targeted therapy for two very different orphan metabolic disorders, post-bariatric hypoglycemia, which has been granted FDA breakthrough therapy designation, and congenital hyperinsulinism, which has been granted FDA breakthrough therapy designation and rare pediatric disease designation. We plan to complete manufacturing and device development as well as regulatory activities this year to support registration enabling clinical trials as early as 2022 for both indications. Avexatide represents a significant commercial opportunity and we will provide guidance in the future on how we plan to advance this program. While we remain focused on our mission to develop and commercialize targeted therapies for serious rare and ultra rare diseases, we have opportunistically and in a capital efficient manner explored the potential of PEG interferon lambda as a convenient outpatient treatment for COVID-19. The placebo controlled phase three together study is enrolling and dosing patients across multiple clinical sites in Brazil. Positive results from this study could support a submission for emergency use authorization. We look forward to reporting interim futility data analysis potentially by year end. Turning to our first approved product, we were pleased that Zoe Kinvey was the recipient of the 2021 National Organization of Rare Disorders Industry Innovation Award and is now a nominee for the 2021 PreGallion USA Best Pharmaceutical Agent Award. The U.S. launch of Zokinvi continues to progress very well, and we expect EMA approval later this year. Zokinvi has demonstrated our ability to go from IND to NDA to approval and launch, and to successfully navigate complex global regulatory landscapes. Importantly, we have established infrastructure along with commercial and medical affairs functions that can scale and grow for additional commercial launches across larger orphan disease indications in the future. Before turning the call over to Ingrid to discuss our clinical development programs in more detail, I'd like to note that we ended the quarter with approximately $140 million in cash and investments, enough to fund our planned Phase III HDV studies and sufficient runway to fund planned operations into Q4 2023. Ingrid?

Thanks, David. We're making great progress across our clinical development programs. We have deliberately designed and are executing an HDV platform strategy with potential to generate approvals for multiple HDV treatment regimens. Taking a moment to dive deeper into our HDV strategy, As David mentioned, we believe a win for HDV patients are approved therapies that suppress HDV virus, which has been shown to lead to improved hepatic function, improved liver histology, and improved survival. We also believe that for chronic HDV therapies, convenient administration as well as antiviral activity are important considerations for patients and their physicians. Lonifarnib and Peganifran Lambda potentially offer both. In Phase II, the all-oral regimen of lonofarnib 50 mg BID with ritonavir achieved a composite endpoint of a two-log decline in HDV RNA and normalization of liver enzyme, or ALT, in 29% of patients at Week 24 of treatment. When lonofarnib was combined with PEG-interferon-alpha, the response rate more than doubled to 63%. Importantly, the combination of lonafarnib and peganifron-alpha was synergistic on the composite endpoint, improving both reduction in HDV viral load as well as ALT normalization. These data were the basis for our Phase III DELIVER study design. DELIVER is a foundational global Phase III trial that we believe positions Iger to be a leader in HDV. The DELIVER primary endpoint is a composite of a two-log decline in HDV RNA plus ALT normalization, as was demonstrated in Phase II. The DELIVER study design creates two opportunities for regulatory approval of Lodafarna-based regimens, an all-oral and a combination with PEG interferon-alpha. In addition, DELIVER is the only HDV study requiring baseline and end-of-treatment biopsies, which will support key secondary endpoints examining histologic improvement. Biopsies have been shown to be significantly more reliable than fibro scans in assessing liver inflammation. As David mentioned, the Phase III DELIVER study is now over 90% enrolled. This puts us on track to report top-line data in late 2022. When complete, DELIVER will provide the largest global safety database from a single HDV study and a wealth of data to inform and drive Iger's HDV platform strategy. We are equally excited to advance our second therapy in development for HDV. PEG interferon lambda is a first-in-class, type 3, well-tolerated interferon, now in phase 3 and limit 2 study. In phase 2, PEG interferon lambda was dosed once weekly in HDV-infected patients for 48 weeks with 24-week follow-up. 36% of patients who received PEG interferon lambda achieved a durable virologic response, or DVR, which is HDV RNA below limit of quantitation or undetectable at 24 weeks post-treatment. This post-treatment DVR endpoint is most meaningful for both regulatory agencies and physicians, as it demonstrates durability of response to treatment for HDV patients. Limit two is a randomized two-arm study. Arm one is 48 weeks of Pegner-Fraun-Lambda once-weekly treatment followed by 24 weeks off treatment. Arm two is 12 weeks of no treatment. The primary endpoint is the proportion of patients with a durable virologic response at 24 weeks post-treatment in arm one compared to 12 weeks of no treatment in arm two. This is a very straightforward study of 150 patients that we anticipate will enroll across 40 to 50 global sites. Limit two sites will be primarily selected from the best performing sites in the DELIVER study, which should allow us to enroll quickly and efficiently. We have agreement with EMA and FDA on Limit 2 as a single pivotal study of PEG interferon lambda for HDV and are on track to enroll our first patient by end of year. We believe Limit 2 is the most expeditious pathway for PEG interferon lambda approval in HDV. A successful outcome in Limit 2 could lead to approval of PEG interferon lambda as a monotherapy for HDV and open the door for it to become the interferon of choice in combination therapies for the treatment of HDV. We believe that PEG interferon lambda's tolerability profile will be preferred by physicians and patients, leading to better compliance and improved outcomes. Lonefarnib and PEG interferon lambda have distinct and complementary mechanisms that can be used alone, in combination with each other, and in combination with other HDV regimens to suppress virus, reduce liver inflammation, and improve outcomes. Ultimately, our goal will be complete suppression of HDV virus and HDV cure, To that end, the combination of peganefrion lambda and lonafarnib with ritonavir achieved the most robust antiviral effect, further demonstrating the opportunity for this combination in the future. I'll now turn the call over to Elden for a commercial update.

Thanks, Ingrid. I'm pleased to provide an update on our commercial progress and the Zakinvi launch. Our initial efforts have been focused on the approximately 20 identified patients in the U.S. where we launched in January. In anticipation of EMA approval later this year, we're actively preparing for launch in Europe, where there are also approximately 20 identified patients. As David noted, the U.S. Zikinvi launch continues to progress very well. We reported 2.1 million in Zikinvi net sales in Q2, bringing our year-to-date net sales to 5.7 million. Importantly, we've converted the vast majority of the 20 identified U.S. patients to commercial supply. The patient support center we established, known as Iger OneCare, has facilitated an efficient U.S. launch. The primary goal of Iger OneCare is unencumbered patient access to Zikinvi, and this program has delivered continuous access with zero out-of-pocket costs for all patients. At Iger, our commitment is to provide Zikinvi access for every child and young adult with progeria and processing-deficient progeric laminopathies. Ultimately, the Our goal is to deliver global commercial launches across our late-stage rare disease programs. Our execution of this Akinbi launch has enabled us to serve the Pretoria community while establishing a commercial distribution network, patient support services, and payer engagement that will be scalable for future HCV and other larger orphan indications. And with that, I'll hand the call over to Sri for a financial update.

Thanks, Elton. The press release we issued this afternoon included a financial update, and I'll call out a few of the highlights. As Elton noted, Q2 Zokinvi net sales were $2.1 million. This compares to $3.6 million reported in the first quarter, which included initial channel inventory at our specialty pharmacy after we commercially launched in the U.S. in January of this year. The contribution from Zokinvi will help offset expenses as we advance the rest of our pipeline. Turning to our GAAP operating expenses, cost of goods sold was approximately $0.3 million in the quarter. For second quarter, R&D expenses were $14.3 million and SG&A expenses totaled $5.9 million. We did report a net loss of $19.2 million, or $0.57 on a per share basis. Finally, we continue to operate with a strong cash position and ended the quarter with $139.8 million in cash, cash equivalents, and investments. This provides us with runway into Q4 2023, fully funds our ongoing phase three HDB studies, as well as the activities required to enable phase three of exotide studies as early as 2022. I'll now have to call back to David for closing comments.

Thank you, Sri. As you've heard in our prepared remarks today, Iger continues to successfully execute on our strategy and deliver on our pipeline commitments across the board. Our HDV platform is advancing with multiple opportunities to win for patients chronically infected with hepatitis delta virus infection. The phase three deliver study is over 90% enrolled. Full enrollment is expected before the end of 2021 and release of top line data is expected in late 2022. The phase three limit two study is on track for first patient enrolled by year end. We are planning for Avexatide to be phase three ready for post bariatric hypoglycemia and congenital hyperinsulinism as early as 2022. We expect EMA approval of Zokindi before the end of the year, building on a successful U.S. commercial launch. Importantly, we have the cash necessary to support the execution and achievement of these milestones. With our pipeline of multiple breakthrough therapy designated programs rapidly advancing, we look forward to several investor updates this year, including participation in six upcoming banking and investor conferences, attendance at AASLD in November, including a planned Iger-sponsored HDV-focused KOL investor event, future earnings calls, and continuous communication efforts on our progress. At this point, I'd like to acknowledge the Iger team for their relentless efforts across our programs and thank all of you for joining us on our Q2 financial results and business update call. Operator, at this time, please provide instructions for the Q&A portion of the call.

Thank you. Ladies and gentlemen, if you have a question at this time, please press the star then the one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We ask that you please limit yourself to one question and one follow-up. One moment for our questions. Our first question comes from the line of Murray Raycroft of Jefferies. Your line is now open. You may ask your question. Again, this is Raycroft.

Hi. This is Kenny Chanon for Murray Raycroft. So I have one question regarding the HDV program. What are your thoughts on Gilead's Boveritide 301 data from ESO, and how does it compare to lona monotherapy in terms of HDV and the composite HDV plus ALT normalization endpoints? And are there any implications for Boveritide combo therapy? Thanks.

Sure. Thanks very much for your question. I'll ask Ingrid Chung to address those.

Thanks, Kenny. Yes, our Phase II lonofarnabratonavir all-oral achieved a 30% composite endpoint after 24 weeks of therapy. At 24 weeks, bilvirotide monotherapy, which is a daily subcutaneous injection, achieved a 30% composite endpoint as well. When lonofarnabratonavir was combined with peganifran alpha, 60% of patients achieved the composite endpoint after 24 weeks of therapy. Bilvirotide combined with peganifran alpha showed a composite response rate of 30%. So we believe that our phase two data suggests that lonafarnib with ritonavir in combination with PEG-interferon-alpha has a synergistic impact on the FDA-guided composite endpoint of the reduction in both viral load and liver inflammation. And we look forward to deliver top-line 48-week data in late 2022.

I'll just add to answer the second part of your question. Given the fact that lonafarnib and pellated interferon lambda work by different mechanisms to fight HDV viral infection, we believe that there is an opportunity for combination therapies in the future, as Ingrid outlined in her prepared remarks. To answer your question with regard to potential combinations with other agents with different mechanisms, Investigators and key opinion leaders are already talking about cocktail options for the future to drive toward a cure, and we look forward to providing more updates as those studies actually are initiated and data read out. Thanks.

Thank you. We have the next question comes from the line of from Citigroup. Your line is now open. You may ask a question.

Hi, team. This is Ashik Mubarak on for you all, and thanks for taking my question. I guess the first one will be on the deliver readout next year. Can you talk a little bit about how or to what extent you will release the data? I just want to confirm there isn't going to be an interim look ahead of the sort of end 48-week data point, and maybe at one point after the deliver study is over, will you start engaging with the FDA about a potential filing?

Sure, I'll turn that one over to Ingrid as well. Ingrid?

Sure. So as we said in our prepared remarks, the timing of the delivery readout is at 48 weeks after the last patient has received last dose. So this is planned for the end of 2022. We are not planning for any interim readouts. So the top line data will be at the end of next year. And with that, once we've cleaned and locked the data reported out the data, we will discuss next steps as to when we would go to FDA.

Okay, got it. And maybe a quick one on Avexatide. Sounds like you've been engaging with the FDA on both post-periatric hypoglycemia and congenital hyperinsulism. I guess, when can we expect some details on what those studies might look like and maybe how long they'll take to run, etc.? ?

Sure. So, I'll provide thoughts, and then if Sri would like to add any additional thoughts, I'll turn it over to him. We believe that the post-bariatric hypoglycemia indication, as well as congenital hyperinsulinism, are both significant unmet medical needs. And more and more we view Avexatide as a significant commercial opportunity at Iger for both of these indications. We were obviously very pleased to announce that congenital hyperinsulinism as an indication for Avexatide has been granted breakthrough therapy designation. and that pairs with the Avexatide post-bariatric hypoglycemia indication already having obtained breakthrough therapy designation. This year, we are focused on completing manufacturing, doing all device modification, and Per the BTD or breakthrough announcement today, we are in active discussions with regulators about next steps for Phase III study design for both PBH and congenital hyperinsulinism, and we'll definitely provide additional guidance as it becomes available. Okay. Thank you very much.

Next question we have from the line of Brian Skorny of Bayer. Your line is now open. You may ask a question.

Hi, thank you. This is Jack Allen, dolling in for Brian. Congrats on all the progress this quarter, and thank you for taking our questions. Our question is mainly focused on avexetide as well, being it is so timely with the breakthrough therapy designation being granted this morning. We were hoping that you provide a little bit more context around the congenital hyperinsulism disorder and the current treatment landscape in this space, and then I know you just touched on this, but any other additional color you could provide with respect to the timing of development here would be greatly appreciated. Thank you.

Sure. Ingrid, would you like to comment?

Yes, so congenital hyperinsulinism is an ultra-rare disease, one in 5,000 patients, and it's a disorder that, if left untreated, results in brain damage in 50% of patients. And so what Avexetide offers is a targeted therapy to block GLP-1 as a GLP-1 antagonist to alleviate these hyperinsulinemic episodes.

Yeah, and I would just add to that that, as you're probably aware, the congenital hyperinsulinism space in terms of therapeutics targeting this indication has grown in the last 12 to 24 months, heightening not only our awareness of this disorder and the unmet medical need, but I think of the medical community at large, which makes us even more excited today to announce breakthrough therapy designation having been granted from FDA. And as you probably know, again, there are now multiple therapeutics available in clinical phases of development, importantly, but none of them have the targeted mechanism of blocking GLP-1, which we believe is a necessary approach and mechanism towards treating this very, very difficult disorder. And so we'll provide updates as we move forward, obviously, with regulatory announcements in terms of opportunities moving forward.

Awesome. Thank you so much for the call.

Thank you. Next question comes from the line of Michael Higgins of Ladin Bridge Tallman. Your line is now open. You may ask your question.

Thanks, Operator, and congrats, guys, on the continued development successes, including the breakthrough of Krug, DESE, and the Vexatide. A couple questions, if I could start off here with HTV, your primary programs. If you can confirm for us any material changes in the design and or execution of those sites globally, including any differences in the pretreatment or prior treatment differences across the globe. And then as you're getting ready to get through the start of limit two, any potential to be cannibalized and deliver with the enrollments of the two trials. Thanks. Sure.

I'll turn that one over to Ingrid.

Hey, Michael, thanks for your question. For your first question regarding study design for DELIVER, there's been no material changes from what we've discussed in the past. It's been very consistent. And I think the follow-on to your first question was about maybe patient demographics across all sites. And so far, our understanding is that patient demographics is balanced pretty evenly across all sites.

And I'll just add to the third part of your question, Michael, which was are we concerned about limit two patients cannibalizing deliver patients? The reality is we have staged the nature of the deliver study completing enrollment and the ramp up of the limit two study really well, such that we plan to complete enrollment of 400 patients within 2021, literally as targeted sites are ramping up to begin enrolling patients in the Lambda Limit 2 study. And so we do not see cannibalism of patients out of deliver by the Limit 2 study. Quite the opposite. We are opportunistically able to select the best performing deliver sites that will be a part of the Limit 2 study, which we think will allow us to quickly and efficiently enroll 150 patients in the Lambda Limit 2 trial to get that study completed as quickly as possible.

Thanks, David. That's really helpful. Just to follow up to that then, typically there's a hockey stick pattern with trial enrollment. Is there a way for that to bleed over into Limit 2's enrollment such that the sites are up and going, they've identified patients, or were they designed to be different such that it's kind of a restart for Limit 2?

Yeah, that is a great question and I will respond and the group can add color if they like. The good news with hepatitis delta virus infection is that there are multiple treatments now in the clinic and awareness is growing day by day. And with that interest in presenting studies to patients who are diagnosed, is increasing, and that is allowing for increased opportunities to enroll patients in clinical trials, which, as you appreciate, are critical for us to move both Lonefarnib and Lambda towards registration. We're very excited, actually, to report that awareness of hepatitis delta is growing, and this is good for patients because more are being identified and diagnosed that ultimately we believe will get into clinical trials that we can then treat with commercial product in the future.

And I'll just add to that, Michael, that physicians and patients alike are very excited about a well-tolerated interferon for the treatment of HDV, and so there's a lot of excitement and enthusiasm ahead of us starting to enroll the Limit 2 study.

Makes sense. Just one last follow up on that. Are you comfortable with roughly a year and a half to enroll, limit two, considering what you just said about patients coming in and kind of having that base available? Any comments on the timing to enrollment would be super helpful. Thanks.

Hey, Michael, it's Sheree. We haven't provided specific guidance yet on enrollment for limit two. As Ingrid said, it's 150 patients, so less than half the size of deliver, and we'll be selecting the best performing sites to deliver. So we think we've got some good line of sight as to where we're going to get those patients, but we're not providing specific guidance yet in terms of timing of enrollment.

I appreciate all the time and the answers. Thanks, guys, and congrats again. Thank you.

Thank you. Next question comes from the line of Bert Hazlett of VTIG. Your line is now open. You may ask your question.

Thanks. Congratulations on the progress in the breakthrough designation. Just two questions, one with regard to EMA and the approval. Should we be thinking about the same type of label that we got in the U.S., kind of with broader progerioid-like disorders? And then when should we actually be thinking about revenue with regard to that? And then secondly, I have a follow-up on congenital hyperinsulinism.

Sure. I'll turn your question on Zokin, the progress in Europe, to Elden.

Yeah, hi there. So we have not stated anything about the label that we expect at this point. And I think for that question it's really uncertain until we have the final label. So I think we'd like to provide an update when we do get that later this year.

But we are, as mentioned in the prepared comments, we are tracking, we believe, toward approval. Forzo can be in Europe by year end. And so we're obviously anxiously anticipating and looking forward to providing an update as soon as possible.

Okay, terrific. And then with regard to congenital hyperinsulinism, could you just provide a little bit more color as to what really – what types of the data that you accrued in phase two that drove the breakthrough designation. Was it a particular patient group, the neonates or others? Just a little more color on your interaction that really drove the breakthrough designation for that program.

Sure. I'll let Ingrid provide some commentary and then maybe add color after.

Yeah, so for the breakthrough designation, we shared with the agency all available data that had been generated in congenital hyperinsulin with abexetide, and that included three studies, one in neonates, one in children, and one in adolescents for a total of 39 patients dosed with abexetide.

Yeah, I'll just add, Bert, and thank you for your question. The phase two studies, as Ingrid mentioned, provided, we believe, very solid proof of concept. And when I say we, I speak to the investigators at CHOP, or Children's Hospital of Philadelphia, who demonstrated POC across 39 patients. in three different phase two studies. And to further answer your question, those included neonates, children, and adolescents with congenital hyperinsulinism. And that data was the basis for Avexatide being granted breakthrough therapy designation by FDA. We think that this is an unmet medical need that the metabolic group at FDA is very much focused on moving forward with therapeutics to help this patient population, and we're very excited to have such a positive dialogue with the agency and look forward to providing updates as we move forward.

I know this question was asked maybe in slightly different terms earlier, but in terms of the scale of next steps and the interaction with agency given the breakthrough designation. How large do you think a kind of a confirmatory work might need to be for licensure in the U.S.? ?

Yeah, that's a fair question, Bert. And while we're continuing to have active and ongoing discussions with the agency, what we have commented publicly on is that the size for the neonate and child studies in congenital hyperinsulinism for other therapeutics have been in the range of 40 to 50 patients. So a very focused program, especially with an active and effective therapy, we believe may lead in a similar direction, but obviously we'll provide guidance as we have that from FDA.

Okay. Thank you. I'll get it back in the queue. Thanks. Thank you.

Thank you. Again, if you have questions, please press star and then 1P on the touchstone telephone. I'm not showing any further questions. I would now like to turn the call over to Sri Rayali for any further remarks.

Well, thank you, Mel. This concludes our call. If you have any additional questions, please contact us at info at Igerbio.com, or you can reach out to a member of the management team. Thanks, everyone, for joining us today.

Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.