Q2 2026 Belite Bio Inc Earnings Call

August 13, 2026

Speaker #1: Ladies and gentlemen, thank you for joining us, and welcome to the BELITE BIO second quarter 2026 earnings call. After today's prepared remarks, we will host a question-and-answer session.

Operator: Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio Q2 2026 Earnings Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star 9 to raise your hand and star 6 to unmute. I will now hand the conference over to Julie Fallon. Please go ahead.

Operator: Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio Q2 2026 Earnings Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press *9 to raise your hand and *6 to unmute. I will now hand the conference over to Julie Fallon. Please go ahead.

Speaker #1: If you would like to ask a question, please raise your hand. If you have dialed in to today's call, please press star 9 to raise your hand, and star 6 to unmute.

Speaker #1: I will now hand the conference over ahead.

Speaker #2: Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of BELITE BIO; Dr. Hendrik Scholl, Chief Medical Officer; Dr. Nathan Matta, Chief Scientific Officer; and Hao-Yuan Chuang, Chief Financial Officer.

Julie Fallon: Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of Belite Bio, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Yuan Chuang, Chief Financial Officer. Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today we will be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. Now I will turn the call over to Dr. Lin. Dr. Lin?

Speaker #2: Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially.

Speaker #2: We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today we will be discussing certain non-GAAP financial measures.

Speaker #2: Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. And now I'll turn the call over to Dr. Lin.

Speaker #2: Dr. Lin?

Speaker #3: Thank you, Julie. Good afternoon, everyone. Thank you for joining our second quarter 2026 financial results and corporate update call. The first half of this year has been both exciting and deeply productive for BELITE BIO.

Tom Lin: Thank you, Julie. Good afternoon, everyone. Thank you for joining our Q2 2026 financial results and corporate update call. The first half of this year has been both exciting and deeply productive for Belite Bio as we rapidly approach a potential regulatory approval of Tinlarebant for Stargardt disease in the US. We are very pleased to announce that the FDA has accepted our new drug application for Tinlarebant with priority review and establishing a PDUFA date of 12 February 2027. We believe this reflects the strength, consistency, and depth of clinical data generated across our development program. In parallel with our pre-commercial preparations, we remain highly engaged with the medical and patient communities. The enthusiasm we are seeing underscores the profound need for a new treatment paradigm in Stargardt disease.

Tom Lin: Thank you, Julie. Good afternoon, everyone. Thank you for joining our Q2 2026 Financial Results and Corporate Update Call. The first half of this year has been both exciting and deeply productive for Belite Bio as we rapidly approach a potential regulatory approval of Tinlarebant for Stargardt disease in the US. We are very pleased to announce that the FDA has accepted our new drug application for Tinlarebant with priority review and establishing a PDUFA date of 12 February 2027. We believe this reflects the strength, consistency, and depth of clinical data generated across our development program. In parallel with our pre-commercial preparations, we remain highly engaged with the medical and patient communities. The enthusiasm we are seeing underscores the profound need for a new treatment paradigm in Stargardt disease.

Speaker #3: As we rapidly approach a potential regulatory approval of Tadao Brand for Stargast disease in the U.S., we are very pleased to announce that the FDA has accepted our new drug application for Tadao Brand with priority review.

Speaker #3: And establishing a PDUFA date of February 12, 2027. We believe this reflects the strength, consistency, and depth of clinical data generated across our development program.

Speaker #3: In parallel with our pre-commercial preparations, we remain highly engaged with the medical and patient communities. The enthusiasm we are seeing underscores the profound need for a new treatment paradigm in Stargardt disease.

Speaker #3: This quarter we presented our Phase 3 Dragon study results at 4 medical countries. Including the recent American Society of Retinal Specialists, ASRS, annual meeting.

Tom Lin: This quarter, we presented our phase III DRAGON study results at 4 medical conferences across 4 countries, including the recent American Society of Retina Specialists, ASRS, annual meeting. At ASRS, we presented new secondary endpoint data demonstrating subjects treated with Tinlarebant showed a halt to slight decreased QAF values, decreased by approximately 2% at month 25 compared to baseline. In contrast, subjects in the placebo group exhibited an approximately 20% increase in QAF values over the same period. Quantitative autofluorescence, or QAF, is a marker of toxic bisretinoid accumulation, a key driver of retinal degeneration in Stargardt disease. The prevention or reduction of QAF strongly aligns with Tinlarebant's mechanism of action, reinforcing its potential to halt or slow lesion growth. Looking ahead, we remain confident in our data, our science, and the transformative potential of Tinlarebant for patients living with Stargardt disease.

Speaker #3: At ASRS, we presented new secondary endpoint data demonstrating subjects treated with Tadao Brand showed a healthy to slightly decreased QAF values, decreased by approximately 2% at month 25 compared to baseline.

Speaker #3: In contrast, subjects in the placebo group exhibited an approximately 20% increase in QAF values over the same period. Quantitative autofluorescence, or QAF, is a marker of toxic bisretinoid accumulation.

Speaker #3: A key driver of retinal degeneration in Stargast disease. The prevention or reduction of QAF strongly aligns with Tadao Brand's mechanism of action, reinforcing its potential to health or slow lesion growth.

Speaker #3: Looking ahead, we remain confident in our data. Our science and the transformative potential of Tadao Brand for patients living with Stargast disease. We look forward to providing further updates as they become available.

Tom Lin: We look forward to providing further updates as they become available. I will now turn the presentation over to Hao-Yuan to discuss the financials. Hao?

Speaker #3: I'll now turn the presentation over to Hao-Yuan to discuss the financials. Hao?

Speaker #4: Thank you, Tom. We have had a strong first half of the year and continue to execute well against our plan. Let me recap our financial statements.

Hao-Yuan Chuang: Thank you, Tom. We have had a strong H1 of the year and continue to execute well against our plan. Let me recap our financial statements. For Q2 2026, our R&D expenses were $18.2 million, compared to $11 million for the same period in 2025. The increase was primarily due to a royalty payment for additional milestone achieved under the license agreement. On a non-GAAP basis, excluding share-based compensation expenses, R&D expenses for Q2 were $17.2 million, compared to $8.6 million in Q2 2025. SG&A expenses in Q2 were $16.7 million, compared to $6.5 million for the same period in 2025. The increase was primarily due to increase in professional service fee, wages, and salary resulting from our team extensions. On a non-GAAP basis, SG&A expenses for Q2 were $10.9 million, compared to $1.3 million in 2025 Q2.

Speaker #4: For the second quarter of 2026, our R&D expenses were $18.2 million, compared to $11.0 million for the same period in 2025. The increase was primarily due to a royalty payment for an additional milestone achieved under the license agreement.

Speaker #4: On a non-GAAP basis, excluding share-based compensation expenses, R&D expenses for the second quarter were $17.2 million, compared to $8.6 million in the second quarter of 2025.

Speaker #4: As GNA expenses in Q2 were $16.7 million, compared to $6.5 million for the same period in 2025. The increase was primarily due to increase in professional service fee, wages, and salary, resulting from our team extensions.

Speaker #4: On a non-GAAP basis, SGNA expenses for the second quarter were $10.9 million, compared to $1.3 million in 2025 second quarter. The GAAP net loss in the second quarter was $28.4 million, compared to $16.3 million in the same quarter in 2025.

Hao-Yuan Chuang: The GAAP net loss in Q2 was $28.4 million, compared to $16.3 million in the same quarter in 2025. On a non-GAAP basis, we report a net loss of $21.6 million for Q2, compared to $8.7 million in 2025, same quarter. We ended the quarter with $780 million in cash equivalents, and U.S. Treasury bills. Overall, our balance sheet remained very strong and we are extremely well-funded into the future with a cash runway to commercialize Tinlarebant following a potential regulatory approval and to continue to advance our pipelines. With that, I will now turn the call back to the operator for Q&A. Operator?

Speaker #4: On a non-GAAP basis, we report a net loss of $21.6 million for the second quarter, compared to $8.7 million in the same quarter of 2025. We ended the quarter with $780 million in cash and cash equivalents in the U.S.

Speaker #4: Treasury bills. Overall, our balance sheet remained very strong, and we are extremely well-funded into the future with a cash runway to commercialize Tadao Brand following a potential regulatory approval and to continue to advance our pipelines.

Speaker #4: With that, I'll now turn the call back to the operator for Q&A. Operator?

Speaker #1: We will now begin the question-and-answer session. If you would like to ask a question, please raise your hand now. If you have dialed in to today's call, again, please press star 9 to raise your hand.

Operator: We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. If you have dialed in to today's call, again, please press star 9 to raise your hand, star 6 to unmute. Please stand by as we compile the Q&A roster. First question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead.

Speaker #1: Star 6 to unmute. Please stand by as we compile the Q&A roster. First question comes from a line of Judah Frommer with Morgan Stanley.

Speaker #1: Your line is open. Please go ahead.

Speaker #5: Yeah, hi, guys. Congrats on the progress, and thanks for taking the questions a couple from us. I guess with the NDA accepted now, what are your thoughts on the role that Dragon 2 can play for the U.S.

Judah Frommer: Yeah. Hi, guys. Congrats on the progress and thanks for taking the questions, a couple from us. I guess with the NDA accepted now, what are your thoughts on the role that DRAGON II can play for the U.S. filing and/or regulatory process? Any incremental interaction with FDA that would shed light on what that trial could be potentially utilized for in the U.S.? Then, latest thinking on going lower in age, going into peds, for Tinlarebant. Do you have trial plans to move the label below 12 years old in the near term? Thank you.

Speaker #5: Filing and/or regulatory process? Any incremental interaction with FDA that would shed light on what that trial could be potentially utilized for in the U.S.?

Speaker #5: And then, any latest thinking on going lower in age—going into peds—for Tadao brand? Do you have trial plans to move the label below 12 years old in the near term?

Speaker #5: Thank you.

Speaker #1: Thanks. Good questions. For the Dragon 2, I think at this stage it's still pretty much a Japan study for the PMDA. Right now we don't think we don't believe that the Dragon 2 will contribute to the NDA process.

Tom Lin: Thanks. Good questions. For the DRAGON II, I think at this stage it's still pretty much a Japan study for the PMDA. Right now, we don't believe that the DRAGON II will contribute to the NDA process. As for the pediatric study, we do have plans, and I'll let Hendrik shed more light on the details of that study.

Speaker #1: As for the pediatric study, we do have plans, and I'll let Hendrick shed more light on the details of that study.

Speaker #5: Yeah, happy to. Thank you, Tom. So, Judah, we are initiating a PIP study—a pediatric study—in London, where we will investigate Tadao Brand in patients ages 3 to 11.

Hendrik Scholl: Yeah, happy to. Thank you, Tom. Judah, we are initiating a ped study, a pediatric study, in London, where we will investigate Tinlarebant in patients of the age 3 to 11. This will be the basis to inform regulatory processes for patients that are younger than 12 years old.

Speaker #5: And this will be the basis to inform regulatory processes for patients that are younger than 12 years old. Thanks.

Judah Frommer: Thanks.

Speaker #1: And your next question comes from the line of Mark Goodman with Lyric. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead.

Speaker #5: Yeah, hi. Could you tell us how much the royalty payment was—the one-timer that’s within R&D? Second question, just tell us what you’re thinking with respect to European filing.

Marc Goodman: Yeah. Hi. Could you tell us how much the royalty payment was, the one-timer that is within R&D? Second question, just tell us what you are thinking with respect to European filing. Third, have you done any claims database analysis to figure out exactly the number of patients that are in the United States that have actually under the claims database? Thanks.

Speaker #5: And then third, have you done any claims database analysis to figure out, like, exactly the number of patients that are in the United States that have actually under the claims database?

Speaker #5: Thanks.

Speaker #1: Hao, you want to take this, given that it's the royalty payments?

Tom Lin: Hao, you want to take this given that it is the royalty payments?

Speaker #5: Yes, yes. Well, the first one is related to the completion of the Phase 3 study, and I think I can also take the third question.

Hao-Yuan Chuang: Well, the first one is related to the completion of the phase III study. I can also take the third question. As we said on the press release, we do plan to host a commercial day event. It is going to be virtual in September, and we will disclose about the numbers that we have survey about the question you just asked.

Speaker #5: As we said in the press release, we do plan to host a commercial day event. It's going to be virtual and will take place in September.

Speaker #5: And we will disclose about the numbers that we have surveyed about, about the question you just asked. How much was the royalty payment? No, we cannot disclose that.

Marc Goodman: How much was the royalty payment?

Hao-Yuan Chuang: No, we cannot disclose that. Columbia asked us to keep that as confidential.

Speaker #5: Columbia asked us to keep that confidential. But, yeah, it's related to the Phase 3 completion. Okay. And then, just thoughts on the European filing?

Marc Goodman: Oh.

Hao-Yuan Chuang: But it is related to the phase III completion.

Marc Goodman: Oh, okay. Then just thoughts on European filing.

Speaker #1: Oh, okay. So I can take that. So right now we are focused on the FDA with the PDUFA date on February 12. So that's our top priority.

Tom Lin: Okay. I can take that. Right now we are focused on the FDA with the PDUFA date in 12 February. That is our top priority. We will be highly focused in the next six months on getting the drug approved. The European filing will probably be sometime after the FDA approval. We want to align everything with the FDA, the approval and all that, and there will be a consistent message and communications with the regulatory authorities outside of the US, given what we discuss with the FDA and the approval, and then there will be our strategy for ongoing regulatory filings.

Speaker #1: We'll be highly focused in the next six months on getting the drug approved. So, the European filing will probably be sometime after the FDA approval.

Speaker #1: We want to align everything with the FDA, and the approval, and all that. And that will be the consistent message and communications with the regulatory authorities outside of the U.S.

Speaker #1: Given what we discussed with the FDA and the approval, there will be our strategy for ongoing regulatory filings.

Speaker #5: Thanks.

Marc Goodman: Thanks.

Speaker #1: And your next question comes from Tazeen Ahmad with Bank of America. Your line is open. Please go ahead.

Operator: Your next question comes from Tazeen Ahmad with Bank of America. Your line is open. Please go ahead.

Speaker #3: My questions. In terms of manufacturing, have you stated where your manufacturing site is and whether or not that facility has completed an FDA inspection recently or is that going to be part of the requirement to get approval?

Tazeen Ahmad: My questions. In terms of manufacturing, have you stated where your manufacturing site is and whether or not that facility has completed an FDA inspection recently, or is that going to be part of the requirement to get approval? Secondly, just wanted to get your latest thoughts on the possibility of an Advisory Committee, just given the consolidated time that the FDA would have to review. When do you think is the latest, realistically, that you would be told if the agency decided to hold one? Thanks.

Speaker #3: And then secondly, just wanted to get your latest thoughts on the possibility of an ADCOM, given the condensed timeframe that the FDA would have to review.

Speaker #3: When do you think is the latest, realistically, that you would be told if the agency decided to hold on? Thanks.

Speaker #1: If there's a few questions there. So I'll answer the first one. And then I probably have to get you to repeat the last two, three-oh questions.

Tom Lin: There's a few questions there. I'll answer the first one, and I probably have to get you to repeat the last two, three questions. The first one, we do have a CDMO, in the US. We're not at the privilege to reveal right now the names of the CDMOs, but these are all big names in the field, in the industry. So we have an ex-US and then a US-based CDMO for that. I hope that answers your question. What's the second and third question?

Speaker #1: So the first one, we do have a CDMO in the U.S. These are all the we're not at the privilege to review right now the names of the CDMOs, but these are all big names in the field.

Speaker #1: In the industry. So we have an XUS and then a US-based CDMO for that. So I hope that answers your question. What's the second and third question?

Tazeen Ahmad: It was more about the FDA and, given the consolidated timeline for review, what is your thought about having an Advisory Committee? Has the agency talked about that? Realistically, when is the latest they could tell you if they were going to give you an Advisory Committee?

Speaker #3: It was more about the FDA, and given the consolidated timeline for review, what is your thought about having an AdCom, as the agency talked about that?

Speaker #3: And realistically, when is the latest they could tell you if they were going to give you an ADCOM?

Speaker #1: So right now, we don't believe there is an ADCOM being planned. But that doesn't mean that further down the line, the FDA would want to use an ADCOM.

Tom Lin: Right now, we don't believe there is an Advisory Committee being planned. That doesn't mean that further down the line, the FDA would want to use an Advisory Committee. Nothing on that right now. I would say that once we have more updates further down the line, then we'll probably reveal that at update that at a more appropriate time. At this stage, we just received the acceptance, so we don't have any further details on that.

Speaker #1: So, nothing on that right now. I would say that once we have more updates further down the line, we'll probably reveal that at a more appropriate time.

Speaker #1: But at this stage, we just received the acceptance, so we don't have any further details on that.

Speaker #3: Okay. Thanks.

Tazeen Ahmad: Okay, thanks.

Speaker #1: And your next question comes from the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead.

Speaker #4: Great. Thanks so much. Congrats on the NDA filing acceptance in the U.S. I was hoping you could just confirm or clarify that you expect a priority review voucher if you receive approval.

Steve Seedhouse: Great. Thanks so much. Congrats on the NDA filing acceptance in the US. I was hoping you could just confirm or clarify that you expect a priority review voucher if you receive approval, and if so, if you'd look to auction that, just for the purposes of us modeling cash runway.

Speaker #4: And if so, if you'd look to auction that, just for the purposes of us modeling cash runway.

Speaker #1: Hao, do you want to cover cash runway? Do you want to answer this?

Tom Lin: Hao, you want to cash runway.

Hao-Yuan Chuang: Yep

Tom Lin: You want to answer this?

Speaker #5: Yep. Well, yeah, we do expect that if we receive approval, we should get the priority review voucher just because we do have the rare pediatric disease designation.

Hao-Yuan Chuang: Well, yeah, we do expect that if we receive approval, we should get the priority review voucher, just because we do have the rare pediatric disease designation. We have not decided whether we are going to sell it or we are going to use it. So we will confirm that later, but we continue to monitor the market and our own pipeline, et cetera.

Speaker #5: We have not decided whether we are going to sell it or use it. So we will confirm that later, as we continue to monitor the market and our own pipeline, et cetera.

Speaker #4: Okay. Thanks for that. And then I also was hoping you could just provide an update on the geographic atrophy trial, whether you're still planning an interim readout later this year and what the precise timing of an update from that interim analysis might be.

Steve Seedhouse: Okay, thanks for that. And then I also was hoping you could just provide an update on the Geographic Atrophy trial, whether you are still planning an interim readout later this year, and what the precise timing of an update from that interim analysis might be. Thank you.

Speaker #4: Thank you.

Speaker #1: Sure, I can answer this question. But isn't the question regarding the cash runway?

Tom Lin: Sure. I can answer this question. Isn't that question regarding the cash runway?

Speaker #5: No, I think.

Hao-Yuan Chuang: I think-

Speaker #4: I was just interested in the pediatric.

Steve Seedhouse: I was just interested in the PD-

Tom Lin: Oh, okay.

Speaker #1: Oh, okay.

Speaker #4: Voucher for our own modeling purposes. But how you want to answer it. Thank you.

Steve Seedhouse: voucher as for our own modeling purposes. Hao, you want to answer it? Thank you.

Speaker #1: All right. Thanks. So the GA interim analysis falls during the busiest time with interacting with the FDA. So with the Patufa date, in mid-February, I would expect the busiest time to be in December and January 2027.

Tom Lin: All right. Thanks. The GA interim analysis falls during the busiest time with interacting with the FDA. With the PDUFA date in mid-February, I would expect the busiest time to be in December and January 2027. With that timeline, our top priority is with the FDA approval. I suspect that with the interim analysis for the GA will probably be sometime Q1 next year, probably after February.

Speaker #1: So, with that timeline, our top priority is the FDA approval. I suspect the interim analysis for the GA will probably be sometime in the first quarter next year.

Speaker #1: Probably after February.

Speaker #4: Great. Thank you for clarifying.

Steve Seedhouse: Great. Thank you for clarifying.

Speaker #1: And your next question comes from the line of Greg Savinovich with Zoho. Your line is open. Please go ahead. A reminder that you may need to unmute locally.

Operator: Your next question comes from the line of Greg Scepanovic with Mizuho. Your line is open. Please go ahead. A reminder that you may need to unmute locally. We will move on to the next question for now. Your next question comes from Yi Chen with H.C. Wainwright. Your line is open. Please go ahead.

Speaker #1: And we'll move on to the next question for now. Your next question comes from Yi Chen with HC Wainwright. Your line is open. Please go ahead.

Speaker #6: Thank you for taking my questions. Just to clarify, has the FDA clearly indicated that the label will include patients over the age of 20 years old?

Yi Chen: Thank you for taking my questions. Just to clarify, has the FDA clearly indicated that the label will include patients over the age of 20 years old? Is that correct?

Speaker #6: Is that correct?

Speaker #1: So right now, there's haven't been any discussion on the label yet. I believe that will come sometime later in the process, in the review process.

Tom Lin: Right now, there haven't been any discussion on the label yet. I believe that will come sometime later in the review process. But at this stage, given the data and all that, we expect that we would be able to get the full label or the more broader label. I will ask Hendrik to give more expert advice on this. Hendrik?

Speaker #1: But at this stage, given the data and all that, we expect that we would be able to get the full label, or the broader label.

Speaker #1: I'll ask Hendrick to give more expert advice on this. Hendrick?

Speaker #5: Yeah, I'm happy to. And I think it's important to understand that lesion growth is not dramatically different across different age groups. That was shown in the Proxta study.

Hendrik Scholl: Yeah, I am happy to, and I think it is important to understand that lesion growth is not dramatically different across different age groups. That was shown in the PHOENIX study. We have essentially the same progression rate of patients any age underneath 18 and 18 to 50 and patients 50 plus, show the slightly larger but still similar progression rate when we look at DDAF progression. Given that the underlying cause of the disease, namely ABCA4 dysfunction, is exactly the same, I would see no reason why the label would not include patients older than 20. But I think it is important that we do not really want to comment on potential label by the NDA under review.

Speaker #5: We have essentially the same progression rate of patients any age underneath 18 and 18 to 50, and patients 50 plus. So the slightly larger, but still similar progression rate when we look at DDAF progression.

Speaker #5: Given that the underlying cause of the disease, namely ABCO4 dysfunction, is exactly the same, I see no reason why the label would not include patients older than 20.

Speaker #5: But I think it's important that we do not really want to comment on potential labeling while the NDA is under review.

Speaker #6: Got it. Do you currently have data regarding how many work percentage of patients are compliant with the dosing regimen after 24 months?

Yi Chen: Got it. Do you currently have data regarding how many, or percentage of patients are compliant with the dosing regimen after 24 months?

Speaker #1: Sure. Nathan, do you want to answer this question?

Tom Lin: Sure. Nathan, do you want to answer this question?

Speaker #6: I'm sorry. Could you repeat the question? Sorry. I think my audio. 4 percentage of patients are have been compliant with the dosing regimen after 24 months.

Nathan Mata: I'm sorry. Could you repeat the question? Sorry, I think my audio.

Yi Chen: What percentage of patients have been compliant with the dosing regimen after 24 months?

Nathan Mata: In the GA study?

Speaker #6: In the GA study or in the. No, no. In the Saga.

Yi Chen: No.

Tom Lin: In the DRAGON study.

Nathan Mata: DRAGON study.

Nathan Mata: Yeah.

Speaker #1: Yeah.

Speaker #6: In excess of 90 percent. Okay, got it. And my last question is: what's your estimated timeline for submission in Japan?

Nathan Mata: In excess of 90%.

Yi Chen: Okay. Got it. My last question is, what is your estimate timeline for submission in Japan?

Speaker #1: Japan will concurrently it's happening at the same time. So given the Sakigake designation, it will probably be around three months after FDA approval. They will want to approve the drug in Japan.

Tom Lin: Japan will concurrently happen at the same time.

Tom Lin: Given the Sakigake designation, it will probably be around three months after FDA approval, they will want to approve the drug in Japan. It is happening as we speak, with the FDA submission and the PMDA submission in parallel.

Speaker #1: So it's happening as we speak. With the FDA submission and the PMD submission, it's in parallel.

Speaker #6: Got it. Thank you very much.

Yi Chen: Got it. Thank you very much.

Speaker #5: And just a reminder, if you would like to ask a question, you can use the raise hand function or press star 9 if you dialed in.

Operator: Just a reminder, if you would like to ask a question, you can use the raise hand function or press star nine if you have dialed in. I see no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.