Q4 2023 Belite Bio Inc Earnings Call

[music].

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.

Please note that you can submit questions throughout the call by clicking on the Q&A box at the bottom of your screen.

And we will respond to questions following our prepared remarks.

Now I'll turn the call over to Dr. Lynn.

Thank you.

Thank you everyone for joining reporting for 2023 and four this quarter.

Lynn.

Bio <unk>.

He is our CSO Dr <unk> <unk>.

And our CFO.

I'd like to start off with an overview.

So <unk> is a novel once a day oral tablet designed to bind to several retinal binding protein or RV before as it means to specifically reduce retinal delivery to the eye.

This approach is intended to slow or stop the formation of the toxic retroactive byproduct, which are generated in the visual cycle and are implicated in progression of <unk> disease and geographic atrophy.

Okay.

<unk> believes that early intervention.

Director as emerging retro pathology, which is not media buy information will be the best approach to potentially slow disease progression and startups disease and <unk>.

There is still a significant unmet need for both applications is currently there is no approved treatment for <unk> disease and there are currently no approved oral treatments for Ta.

And we're already in global Phase III trials for both indications.

So far we have been granted fast track designation.

Pediatric disease designation and orphan drug designation in U S EU and Japan.

We have several patient several patent families and with composition of matter patents lasting until 2040, and we're patent term extension and new patents, we filed which will have patent protection way past the 2014.

Okay.

Forestalled syndication the phase III is already fully enrolled with estimated interim readouts by end of 2024 or early 2025.

We will also be presenting further positive findings and treatment results from our end of phase II results, which will be presenting at <unk> in may of this year.

For GE in dry AMD indication, we currently have more than 50 subjects enrolled in our global phase III trial.

With this I would like to pass passes onto our CSO to keep it an update on our clinical trials Nathan Thank you Tom.

So I'll get right into the clinical trial designs when we first started.

I would say in the previous financial updates. We've shown you the overview of our open label phase II as well as the a well controlled phase III study design, which is our pivotal phase III study I want to emphasize that the big differences between these two studies was that in the patients in the open label Phase II. They came in with a very early stage of disease, which is.

Characterized by the presence of auto fluorescence, but not atrophy of retinal lesions, whereas in the phase III all of the subjects have retinal atrophy well it turns out that our phase III study when we looked retrospectively back at those baseline images, we find in fact that a number of these subjects actually do have atrophic lesions. They were just not measurable but Rick.

<unk> imaging algorithm that most clinical researchers use so our imaging center has developed a new algorithm much more sensitive in terms of identifying atrophic retinal lesions. So we do in fact know that in the phase two open label study. Many of these studies did start with very very small atrophic lesions that grew over time.

And of course, we showed you the data about the lesion growth, which I'll jump to right now.

Next slide.

So as I mentioned before these kids came in with early lesion types. Some of them did have atrophy, but we wanted to compare to natural history growth to determine whether or not we're having any real treatment effect and we showed this data previously and a comparison to Prague star a cohort of subjects that have similar baseline characteristics as our phase III subjects.

And as you can see here on the left hand side, we see really dramatic slowing of lesion growth engine layer about treatment group, which is the red lines versus the natural history group and <unk>, which is the blue lines and as I said before we know now that these patients did come in with atrophy. So theres a lot of similarities between the phase II patients in the phase III.

The other new updates that we didn't have last time is the genetic analysis because we didn't note in terms of the lesion growth. There were five of 12 subjects that never converted to atrophy over the two year study. We now know that those five subjects have severe of biodiesel with mutations, which predict retinal pathology. So the absence of the two.

Transitioned from the early lesion type two the atrophic lesion types in these five subjects could not be attributed to benign or or or mild mutations. We in fact had very severe mutations. So all these data really point to a profound treatment effect of our drug.

Excellent.

This is an overview of the phase II trial design in geographic atrophy, and as I mentioned before the trial designs between the startup disease Phase III study and the <unk> Phase III study are very very similar it's the same drug. It's the same dose. It's the same endpoint same randomization same trial duration of two years the only real.

Difference in these two studies as well as to first being the indication <unk> rather than <unk> and of course in the <unk> study, we have more patients to reflect a higher prevalence of the disease in the population so with that now I'll throw it over to <unk>. So we can talk about financial year. Thank you. Thank.

Thank you Nathan.

In 2023, we had R&D expenses of $24 8 million compared to $8 9 million in 2022.

The increase was primarily due to increased expenses related to adapting and dragon and the Phoenix trials.

On G&A expenses.

In 2023, we had G&A expenses, $6 8 million compared to $4 million in 2022.

The increase was primary due to the increase in share based compensation granted in 2023.

And an increase in professional service team.

We had lower professional services in 2022, as we complete the IPO by end of April 2022.

We only had eight months of professional services related to being a public company in 2022.

For the year 2023, we had 12 months of professional service fee.

Our net loss, we had a net loss of $31 6 million in 2023 compared to $12 8 million in 2022.

In terms of cash we had $88 2 million in cash and a 2023 as compared with $42 1 million by end of 2022.

The increase was primary due to a total of $52 million right from the follow on offering and exercise of the warrants issued in the fall on offering an additional $29 million from ATM offering.

We expect cash runway to end of 2026.

Thank you Tom.

Tom.

Thank you how are you.

I would like to conclude with the key milestones to expect for this year.

We are currently making good progress in the phase III study.

As they are now many sites activated and enrolling subjects.

We will be presenting further findings and more positive data from our phase III startups disease at major conferences this year.

We're also expecting the interim data for phase III status disease. Later this year early next year.

We have a short presentation today as most of you would be familiar with the MAA by now. So we are focusing this presentation on the key updates and hopefully have more time for Q&A.

We are pleased with the progress we've made in 2023, and we ended 2012 for energized at ups.