Q3 2025 Belite Bio Inc Earnings Call

A question and answer session.

If you would like to ask a question. Please raise your hand, if you have dialed into todays call. Please press star nine to raise your hand and star sixth on mute.

I will now hand, the call over to Julie Fallon. Please go ahead.

Good afternoon, everyone. Thank you for joining us.

On the call today are Dr Tomlin, Chairman and CEO would be like bio Dr.

Dr Hinrich Shaw Chief Medical Officer.

Dr. Nathan Matto, Chief Scientific officer, and how long Zhang Chief Financial Officer.

Operator: 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 nine to raise your hand and star six to unmute. I will now hand the call over to Julie Fallon. Please go ahead.

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.

Encourage you to consult the risk factors discussed in our SEC filings for additional detail.

And now I'll turn the call over to Dr. Lynn.

Julie Fallon: Good afternoon, everyone. 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 Q4, Q2, 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. Now I'll turn the call over to Dr. Lin. Dr. Lin?

Dr Lynn.

Thank you for joining today's call to discuss our third quarter 2025 financial results.

Now I'd like to stop immediately by highlighting our recent progress.

For Gea.

We completed the enrollment of the phase III Phoenix trial with 530 subjects.

Targets disease.

We have completed the phase III <unk> trial, and we now look forward to reporting the final topline data by end of this month.

The <unk> II trial have enrolled approximately 35 subjects of our targeted enrollment of approximately 60 subjects, including 10 Japanese subjects.

The data from the Japanese subjects is intended to expedite our new drug application in Japan.

Tom Lin: Thank you for joining today's call to discuss our Q4 2025 financial results. I'd like to start immediately by highlighting our recent progress. For GA, we completed the enrollment of the phase 3 Phoenix trial with 530 subjects. For Stargardt disease, we have completed the phase 3 Dragon trial, and we now look forward to reporting the final top-line data by the end of this month. The Dragon 2 trial has enrolled approximately 35 subjects of our targeted enrollment of approximately 60 subjects, including 10 Japanese subjects. The data from the Japanese subjects is intended to expedite a new drug application in Japan. We have been in close communications with Japan's PMDA and Sakigake designated concierge to ensure that our JNDA is submitted as one of the first countries for market authorization. We also recently received positive feedback from regulatory authorities.

We have been in close communications with Japan's <unk> and savvy chocolate designated concierge to ensure that our J NDA be submitted as one of the first countries for marketing authorization.

We also recently received positive feedback from regulatory authorities, specifically China's NPA agreed to accept NDA for priority review based on the interim analysis results from the Phase III Dream trial.

Additionally, the Uk's image I agreed to accept conditional marketing authorization application based on triggers intravenous as results.

The consistent feedback from our major regulatory agencies across the world. We are encouraged that the Dragon trial provides a strong foundation for global submissions and potential approvals lastly, we have completed a $50 million registered direct offering and the upsize of $125 million private placement with <unk>.

Tom Lin: Specifically, China's NMPA agreed to accept NDA for priority review based on the interim analysis results from the Phase 3 Dragon trial. Additionally, the UK's MHRA agreed to accept conditional marketing authorization application, also based on Dragon's interim analysis results. With the consistent feedback from major regulatory agencies across the world, we are encouraged that the Dragon trial provides a strong foundation for global submissions and potential approvals. Lastly, we have completed a $50 million registered direct offering and an upsized $125 million private placement with leading healthcare investors, with the potential for an additional $165 million upon full bond exercise. This investment puts us in a very good position to advance and prepare for the Narbanz commercialization. I'll now turn over the presentation to Hau Yin. Hau Yin?

Business will.

Speaker #1: Ladies and gentlemen, thank you for joining us and welcome to the BELITE BIO third quarter 2025 earnings call. After today's prepared remarks, we will host a question-and-answer session.

The potential for an additional $165 million upon full warrant exercise this investments puts us in a very good position to events and prepare for <unk> commercialization.

Speaker #1: 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'll now turn over the presentation to Hollywood Brian.

Thank you Tom.

For Q3, 2025, we had R&D expenses of $10 3 million compared to $6 8 million for the same period last year the.

Speaker #1: I will now hand the call over to Julie Fallon. Please go ahead.

The increase was mainly due to expenses related to the Dragon trial entertaining trial, partially offsetting by the Australian R&D tax incentive program.

Speaker #2: Good afternoon, everyone. 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.

Due to increasing share based compensation expenses.

Regarding G&A expenses, we have G&A expenses of $12 7 million compared to $2 9 million for the same period last year.

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.

The increase was primarily driven by an increase in share based compensation expenses from the new grant of equity incentive plan. This year, which has become higher as our share price and exercise price increased.

Hao-Yuan Chuang: Thank you, Tom. For Q3 2025, we had R&D expenses of $10.3 million compared to $6.8 million for the same period last year. The increase was mainly due to expenses related to the Dragon trial and the Phoenix trial, partially offset by the Australian R&D tax incentive program. It was also due to an increase in share-based compensation expenses. Regarding G&A expenses, we had G&A expenses of $12.7 million compared to $2.9 million for the same period last year. The increase was primarily driven by an increase in share-based compensation expenses from the new grant of equity incentive plan this year, which has become higher as our share price and exercise price increased. Overall, we had a net loss of $21.7 million compared to a net loss of $8.7 million for the same period last year.

Speaker #2: We encourage you to consult the risk factors discussed in our SEC filings for additional detail. And now I'll turn the call over to Dr. Lin.

Overall, we had a net loss of $21 7 million compared to a net loss of $8 7 million for the same period last year.

Speaker #2: Dr. Lin?

Speaker #3: Thank you for joining today's call to discuss our third quarter 2025 financial results. I'd like to start immediately by highlighting our recent progress. For GA, we completed the enrollment of the phase three Phoenix trial with 530 subjects.

It is important to note as I said the majority of our expense increase came from the share based compensation, which was about $12 9 million and was not cash related.

Our total operating cash outflow for third quarter was approximately $9 3 million similar to $8 6 million in the second quarter.

Speaker #3: For STARGUS disease, we have completed the phase three dragon trial and we now look forward to reporting the final top-line data by the end of this month.

Moving to the balance sheet.

We were pleased to complete a registered direct offering in the second half of the pipe with.

Speaker #3: enrolled approximately 35 subjects, of our targeted enrollment of approximately 60 subjects, including 10 Japanese The dragon two trial has subjects. The data from the Japanese subjects is intended to expedite a new drug application in Japan.

With gross proceeds of total 140 million with.

With potential for up to additional 165, nearly half hour or exercise.

With that at the end of Q3, we had $275 6 million in cash liquidity from time deposits and U S Treasury bills.

Hao-Yuan Chuang: It is important to note that, as I said, the majority of our expenses increase came from the share-based compensation, which was about $12.9 million and was not cash-related. Our total operating cash outflow for the third quarter was approximately $9.3 million, similar to $8.6 million in the second quarter. Moving to the balance sheet, as Tom shared, we were pleased to complete a registered direct offering and a significant PIPE with gross profit of total $140 million, with potential for up to an additional $165 million upon full order exercise. With that, at the end of Q3, we had $275.6 million in cash, liquidity from time deposit, and US Treasury bills. We have made significant progress toward our key milestone year to date. We sincerely appreciate the continued trust and support from our shareholders.

Speaker #3: We have been in close communications with Japan's PMDA and Sakigake designated concierge to ensure that our JNDA is submitted as one of the first countries for market authorization.

We have made significant progress to our key milestones year to date.

We sincerely appreciate the continued trust and support for our shareholders.

Speaker #3: We Additionally, the UK's MHRA agreed to accept conditional marketing authorization application also based on dragon's interim analysis results. With the consistent feedback from major regulatory agencies across the world, we are encouraged that the dragon trial provides a strong foundation for global submissions and potential approvals.

Speaker #3: also recently received positive feedback from regulatory authorities. Specifically, China's NMPA agreed to accept NDA for priority review based on the interim analysis results from the phase three dragon trial.

LNG remained strong and expected to provide sufficient funding to support clinical trials and preparation for commercialization, we are well positioned to achieve our future objectives.

With that I'll turn the call back to the operator for Q&A.

Operator.

We will now begin the question and answer session, if you'd like to ask a question. Please raise your hand now.

We've dialed into todays call. Please press star nine to raise your hand and star sixth on mute. Please.

Please standby, while we compile the Q&A roster.

Speaker #3: Lastly, we have completed a 50 million registered direct offering and an upsized 125 million private placement with leading healthcare investors. With the potential for additional 165 million upon full bond exercise.

Hao-Yuan Chuang: Our balance sheet remains strong and is expected to provide sufficient funding to support our clinical trials and preparation for commercializations. We are well-positioned to achieve our future objectives. With that, I'll turn the call back to the operator for Q&A. Operator?

Your first question comes from the line of E. Chen with H C. Wainwright. Your line is open. Please go ahead.

Okay. Thank you for taking my questions.

Speaker #3: This investment puts us in a very good position to advance and prepare for the narrowband commercialization. I'll now turn over the presentation to Hao-Yuan.

So can you.

Whether you have submitted the application to the regulatory agency in China.

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 into today's call, please press star nine to raise your hand and star six to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Ye Chen with HC Wainwright. Your line is open. Please go ahead.

Speaker #3: Hao-Yuan?

When do you plan to do so.

Speaker #4: Thank you, Tom. For Q3 2025, we had R&D expenses of 10.3 million, compared to 6.8 million for the same period last year. The increase was mainly due to expenses related to the dragon trial and the Phoenix trial.

No we have not we plan to submit our first half.

Next year as you can see there's a couple of regulatory agencies. There has given us the green light to submit whether it be based on interim analysis.

Speaker #4: Partially offsetting by the Australian R&D tax incentive program. It was also due to an increase in shared-based compensation expenses. Regarding Q&A expenses, we had Q&A expenses of 12.7 million, compared to 2.9 million for the same period last year.

We're waiting for their final report.

For the triggered study to come out.

We want to maintain the consistent data package across all regulatory agencies and.

Yi Chen: Hello. Thank you for taking my questions. Can you tell us whether you have submitted the application to the regulatory agency in China and the UK, and if not, when do you plan to do so?

And therefore, the timeline for it will be first half of 'twenty three six.

Speaker #4: The increase was primarily driven by an increase in share-based compensation expenses from the new grant of equity incentive plan this year, which has become higher as our share price and exercise price increased.

And can you also provided us with the current amount of shares outstanding after the most recent.

Tom Lin: Oh, hi. No, we have not. We plan to submit the first half next year. As you can see, there's a couple of regulatory agencies that have given us the green light to submit, whether it be based on internal analysis or waiting for the final report for the Dragon study to come out. We want to maintain the consistent data package across all regulatory agencies. Therefore, the timeline for that will be the first half of 2026.

This is probably a question for you yeah somewhere like that.

The total outstanding shares I think lift on the on the recent necessary I think somewhere like $35 million.

Speaker #4: Overall, we had a net loss of 21.7 million compared to a net loss of 8.7 million for the same period last year. It is important to note that, as I said, the majority of our expenses increase came from the share-based compensation, which was about 12.9 million and was not cash-related.

Okay got it thank you.

Thanks Keith.

Your next question comes from the line of Bruce Jackson with Benchmark. Your line is open. Please go ahead.

Speaker #4: Our total operating cash outflow for the third quarter was approximately $9.3 million, similar to $8.6 million in the second quarter. Moving to the balance sheet, as Tom shared, we were pleased to complete a direct offering and a significant PIPE with gross proceeds of $140 million, with the potential for up to an additional $165 million upon full order exercise.

Good afternoon, and thank you for taking my questions.

Yi Chen: Got it. Got it. Can you also provide us with the current amount of shares outstanding after the most recent?

Following up on the last question about the international submissions. When do you think you might be submitting the application in Japan.

Tom Lin: How? That's probably a question for you.

Hao-Yuan Chuang: Yeah, yeah. I think it's somewhere like the total outstanding shares. I think it's listed on the recent F3. I think it's somewhere like 35 million.

Yeah.

Actually we are still in discussions with Japan on how the.

But basically the different modules that we need to sort of estimate with Japan.

Yi Chen: $35 million. Okay. Got it. Thank you.

Speaker #4: With that, at the end of Q3, we had 275.6 million in cash, liquidity from time deposit and US treasury bills. We have made significant progress through our key milestone year to date.

Tom Lin: Thanks. Thanks to you.

We're still going through this with Japan. So the expected timeline will be first half, but given that we have several countries that we need to prioritize.

Operator: Your next question comes from the line of Bruce Jackson with Benchmark. Your line is open. Please go ahead.

Speaker #4: We sincerely appreciate the continued trust and support from our shareholders. Our balance sheet remains strong and is expected to provide sufficient funding to support our clinical trials and preparation for commercialization.

Bruce Jackson: Hi. Good afternoon, and thank you for taking my questions. Following up on the last question about the international submissions, when do you think you might be submitting the application in Japan?

We still haven't had a.

We still we still need to wait until that date.

Data comes out and then prioritize which countries will be submitted for Sydney, Japan is an update.

Speaker #4: We are well positioned to achieve our future objectives. With that, I'll turn the call back to the operator for Q&A. Operator?

But having three or four countries submitted ones, we definitely wouldn't have the bandwidth to handle all of those submissions, indicating questions with regulatory agencies across several.

Tom Lin: Actually, we are still in discussion with Japan on how basically the different modules that we need to submit with Japan. We're still going through this with Japan. The expected timeline will be the first half. Given that we have several countries that we need to prioritize, we still haven't had a—we still need to wait until the data comes out and then prioritize which countries we'll be submitting first. Certainly, Japan is up there. Having three, four countries submitted at once, we definitely wouldn't have the bandwidth to handle all those submissions and getting questions from regulatory agencies across several regions. We still haven't had the list of where to prioritize first. Certainly, FDA is one of the first authorities that we need to submit first. Yeah.

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 into today's call, please press *9 to raise your hand and *6 to unmute.

Regions. So we still haven't had the list of where to prioritize Suezmax survey FDA is one of the.

The first authorities that we can do submit first.

Speaker #1: Please stand by while we compile the Q&A roster. Your first question comes from the line of Yi Chen with HC Wainwright. Your line is open.

Yeah, So don't have an answer.

This is a question, but at this point, we got several that we had a green light to submit.

Japan, yes, okay.

Then turning over to the Phoenix trial are you going to have a and interim analysis that is structured in a way that was similar to the Dragon trial. So we're gonna be testing for either futility or for adequacy of the sample size.

Speaker #1: Please go ahead.

Speaker #5: Hello. Thank you for taking my questions. So can you tell us whether you have submitted the application to the regulatory agency in China and the UK, and if not, when do you plan to do so?

Yes, we do so at.

At this point, we have an interim.

Speaker #3: Oh, hi. No, we have not. We plan to submit our first half next year. As you can see, there's a couple of regulatory agencies that have given us the green light to submit, whether it be based on interim analysis or waiting for the final report for the dragon study to come out.

This is planned for next year, probably around second half next year.

But regarding the how.

Tom Lin: I don't know if that answers your question, but at this point, we got several that we had a green light to submit, including Japan. Yeah.

How are we going to go above that.

Probably we will refer to Nathan do you have a better idea on.

The structure of the interim analysis.

Bruce Jackson: Okay. Turning over to the Phoenix trial, are you going to have an interim analysis that is structured in a way that was similar to the Dragon trial? We're going to be testing for either futility or for adequacy of the sample size?

Very likely it will be a sample size re estimation as we did for dragon.

Speaker #3: We want to maintain a consistent data package across all regulatory agencies. Therefore, the timeline for that will be the first half of 2026.

I'm sort of scenario, where we set up a conditional window.

Currently referred to as a promising zone to look for efficacy trends within that window to determine whether or not we can supplement the sample size of the additional subjects.

Speaker #5: Got it. Got it. And can you also provide us with the current amount of shares outstanding after the most recent?

Tom Lin: Yes, we do. At this point, we have an interim analysis planned for next year, probably around the second half of next year. Regarding how we're going to go about that, I probably will refer to Nathan. Do you have a better idea on the structure of the interim analysis?

Super.

Then last question for me.

Speaker #3: Uh-huh. There's probably a question for you.

The SG&A levels have been moving around a little bit with all the milestone payments what.

Speaker #4: Yeah, yeah. I think it's somewhere like the total outstanding shares, I think it's listed on the recent S3. I think it's somewhere like 35 million.

Should we be assuming as kind of like the baseline level for SG&A expenses going forward.

Oh, Oh, well that's a that's a good one but those are relatively hard to estimate at this point of time as a as you can see we are start to prepare for commercialization so expanding the team now.

Speaker #5: 35 million. Okay, got it. Thank you.

Speaker #3: Thanks. Thanks, Yi.

Nathan Mata: Well, very likely, it will be a sample size re-estimation as we did for Dragon. Same sort of scenario where we set up a conditional window, simply referred to as a promising zone, to look for efficacy trends within that window to determine whether or not we can supplement the sample size with additional subjects.

Speaker #1: Your next question comes from the line of Bruce Jackson with Benchmark. Your line is open. Please go ahead.

So we don't have a clear and also you know many of that will involve some yourself as well.

Speaker #6: Hi. Good afternoon, and thank you for taking my questions. Following up

<unk> has become a big.

Bruce Jackson: Okay. Super. Last question for me. The SG&A levels have been moving around a little bit with all the milestone payments. What should we be assuming as kind of like the baseline level for SG&A expenses going forward?

Moving faster based on a share price.

Actual expenses being recognized on the income statement. So we have a better understanding about the cash flow.

But for the for the income statement itself. The G&A is that it would be hard to estimate a correct number given you so much.

Tom Lin: Well, Bruce, that's a good one. It's also a little bit hard to estimate at this point in time. As you can see, we are starting to prepare for commercialization. We're expanding the team now. We don't have a clear—and also, many of that will involve some ESOP as well. ESOP has become a big moving factor based on the share price on the actual expenses being recognized on the income statement. We have a better understanding about the cash flow. For the income statement itself, the G&A, it's a little bit hard to estimate a correct number given it was so much related to the valuation of the ESOP. Okay. Got it. Thank you.

Related to the valuation of that you saw.

Okay got it thank you.

Thank you.

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If you have dialed into the call. Please press star nine to raise your hand and star sixth on mute.

Your next question comes from the line of Michael sooner, which with Maxim. Your line is open. Please go ahead.

Hey, guys. Thank you so much for taking my questions today.

Hao-Yuan Chuang: Thank you.

Just wanted to ask a couple of questions on your commercial preparations in particular.

Operator: As a reminder, if you would like to ask a question, please raise your hand. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop, and on the left side of the toolbar on Zoom mobile. If you have dialed into the call, please press star nine to raise your hand and star six to unmute. Your next question comes from the line of Michael Okunowitch with Maxim. Your line is open. Please go ahead.

What steps, you're taking right now to prepare for a potential approval and launch and then how are you prioritizing different reed regions since the Dragon trial should serve for several different geographies.

Sure.

Now you want to give more details on this.

Sure well around the U S is the focus given the potential size, though we are you know are.

Applying for NBA in all the regions.

Michael Okunewitch: Hey, guys. Thank you so much for taking my questions today. I just wanted to ask a couple of questions on your commercial preparations. In particular, what steps are you taking right now to prepare for a potential approval and launch? How are you prioritizing different regions since the Dragon trial should serve for several different geographies?

Probably U S or some smaller single market.

Japan will be relatively easy for us to focus on.

And we remain open to see cooperation and partnership all of the other regions.

Yeah, but for now I think you know.

We're targeting on those market that we think it will be easier to handle by herself.

Tom Lin: Sure. Hao-Yuan, you want to give more details on this?

Hao-Yuan Chuang: Sure. Sure. Well, apparently, US is the focus given the potential size. We are applying for NDA in all the regions. Probably US or some smaller single market such as Japan will be relatively easy for us to focus on. We remain open to seek cooperation and partnership for all the other regions. Yeah. For now, I think we're targeting on those markets that we think will be easier to be handled by ourselves.

Mhm and do you have a sense of how large of a sales force you would need for the U S.

Sure, we probably will start with 20 people and then may be up to 40 people.

And then one last from me and I'll hop back into the queue. Just given that you have raised this additional 125 and you have a pretty strong cash position are you anticipating that your current cash should be sufficient for the commercial preparation of launch of tomorrow ban.

Well that's a good question.

So you know we estimate it could be probably about 200 million commercialized.

Startup in the U S.

Michael Okunewitch: Do you have a sense of how large of a sales force you would need for the US?

That's how we designed the recent transaction with additional cash.

Hao-Yuan Chuang: Sure. We probably will start with 20 people, then maybe up to 40 people.

Cash coming from the Warren so.

So potentially yes, we think we should have enough, but you know of course that is just estimation.

Michael Okunewitch: One last for me, and I'll hop back into the queue. Just given that you have raised this additional $125 million and you have a pretty strong cash position, are you anticipating that your current cash should be sufficient for the commercial preparation and launch of Tinlarebant?

Thank you very much and congratulations on all the progress.

Thanks, Mike.

As a final reminder, if you would like to ask a question. Please raise your hand now if you've dialed into todays call. Please press star net star nine to raise your hand and star sector on mute.

Hao-Yuan Chuang: Well, that's a good question. We estimate it could be probably about $200 million to commercialize startup in the US. That's how we designed the recent type transaction, with additional cash coming from the warrant. Potentially, yeah, we think we should have enough. Of course, that is just estimation.

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

Yeah T O confirmed that the U K.

Basically they ask for the sale. It's forever observation that you said so the U S. FDA that got you the breakthrough destination. It is all of this the same exact escalation of it.

Michael Okunewitch: Thank you very much. Congratulations on all the progress.

Hao-Yuan Chuang: Thank you.

Tom Lin: Thanks, Mike.

And China as well so they get anything different everybody got the same installation.

Operator: As a final reminder, if you would like to ask a question, please raise your hand now. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. Your next question comes from the line of Mark Goodman with Leerink Partners. Your line is open. Please go ahead.

Yes, so everyone will presented the same information.

Hendrik.

So this Christmas since he presented to them.

Yeah. Thank.

Tom Yes, Martha just post the same set of information the type of presentation was different as Wilson with an in person.

Hao-Yuan Chuang: Yeah. Can you all confirm that in the UK, they simply asked for the same interim information that you sent to the US FDA that got you the breakthrough designation? I mean, is all of this the same exact information? China as well, did they get anything different? Everybody got the same information?

Presentation in Beijing to the NPA.

Including a large panel of experts from China.

Volume for the UK as an example, this wasn't online meeting with the agency, but the data sets.

That was the basis for the presentation and the discussion was exactly the same.

Tom Lin: Yes. Everyone will present the same information. I'll let Hendrik answer this question since he presented to them. Hendrik?

There are no further questions at this time. This concludes today's call. Thank you for attending you may now disconnect.

Hendrik Scholl: Yeah. Thank you, Tom. Yes, Mark, this was the same set of information. The type of presentation was different. It was an in-person presentation in Beijing to the NMPA, including a large panel of experts from China. While for the UK, as an example, this was an online meeting with the agency. The dataset that was the basis for the presentation and the discussion was exactly the same.

Uh, cooperation and partnership for all the other regions. Um, yeah. But for now I think um, you know, we're targeting on those uh Market that we think will be easier to to be handled by ourselves.

And do you have a sense of how large of a Salesforce you would need for the U.S.?

Sure you probably will start with uh 20 people. Uh and then maybe up to uh 40 people.

Operator: There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.

Can launch up to maraban.

Well, that that's a good question. Um, so you know, we estimate, it could be probably about 200 million. Uh, commercialized, um, shot up in the US. Uh, that's how we designed the the recent type transaction with additional uh, cash coming from the, from the warrant. Uh, so potentially. Yeah, we think we should have enough. Uh, but you know, of course, that is just estimation

Thank you very much, and congratulations on all the progress.

Thank you. Thanks. Mike.

As a final reminder, if you would like to ask a question, please raise your hand. Now if you have dialed into today's call, please press starritt, star 9, to raise your hand and star 6 to unmute

Your next question comes from the line of Mark Goodman with Lee rink. Your line is open, please go ahead.

Yes. Okay confirm did um the UK uh basically asked for the same interim information that you sent to the US FDA that got you, the Breakthrough destination. I think it was all of this, the same exact information or, or or and China as well. Did they get anything different? Everybody got the same information

Yes. Um so everyone um will present to the saving information. Um, I'll let Hendrick. Um answer his question since he presented to them.

Henrik. Yeah uh thank you Tom. Yes, Mark this, this was the same set of information. The, the type of presentation was different. It was an it was an in-person presentation in Beijing uh, to the nmpa um uh including a large panel of experts from China. Um, while for the UK as an example, this was an online meeting with the agency, but uh, the data set, um, this that was the basis for the presentation. And the discussion was exactly the same.

There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.

Q3 2025 Belite Bio Inc Earnings Call

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Belite Bio

Earnings

Q3 2025 Belite Bio Inc Earnings Call

BLTE

Monday, November 10th, 2025 at 9:30 PM

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