Belite Bio Q1 2024 Financial Results and Corporate Update

Belite Bio, Inc., a biopharmaceutical drug development company, has released its financial results for Q1 2024 and provided a business update. The company is focused on creating therapies for retinal degenerative diseases, particularly Stargardt Disease (STGD1) and Geographic Atrophy (GA).

Tinlarebant, Belite Bio's flagship product, is an oral medication designed to slow disease progression in STGD1 and GA patients. STGD1 is linked to toxic vitamin A byproducts that lead to retinal cell death. Tinlarebant works by reducing these byproducts without affecting vitamin A delivery to other bodily tissues.

The company conducted a 24-month Phase 2 trial involving adolescent STGD1 subjects. Results indicated that Tinlarebant significantly slowed atrophic lesion growth compared to a control group with similar characteristics (p<0.001). In subjects with pathogenic ABCA4 mutations, no new atrophic lesions formed, and no change in existing lesions was observed. A novel quantification method showed that Tinlarebant halted the growth of atrophic lesions within the macula during the trial's second year. Visual acuity remained stable for most subjects, with a mean loss of five letters over 24 months, which is not clinically significant. Additional analyses of visual acuity loss and other data further support Tinlarebant's potential efficacy.

The ongoing DRAGON trial, a Phase 3 study of Tinlarebant in adolescent STGD1 subjects, has completed enrollment with 104 participants across 11 countries. This trial aims to assess the primary endpoint of atrophic lesion growth rate, with interim data expected in the fourth quarter of 2024.

Belite Bio has also initiated the DRAGON II trial, which combines a Phase 1b open-label trial to study Tinlarebant's pharmacokinetics and pharmacodynamics in Japanese adolescent STGD1 subjects, and a Phase 2/3 trial in a similar population. The trial aims to enroll approximately 60 subjects, including around 10 Japanese participants. The data from this trial will help facilitate future New Drug Applications (NDAs) in Japan.

The PHOENIX trial, a global Phase 3 study of Tinlarebant in GA subjects, is also progressing. This trial involves around 430 participants and aims to evaluate the slowing of atrophic lesion growth rate. As of now, 99 subjects have been enrolled, with interim data expected at the trial's midpoint.

Financially, Belite Bio raised $12.5 million in Q1 2024 from the exercise of warrants issued in previous offerings. Additionally, in April 2024, the company announced a $25 million registered direct offering, selling up to 651,380 American Depositary Shares (ADSs) at $38.38 per ADS. These funds will support ongoing clinical trials and other initiatives.

As of March 31, 2024, Belite Bio reported $95.5 million in cash and U.S. treasury bills. Research and development expenses for Q1 2024 were $6.8 million, up from $5.7 million in the same period in 2023. This increase was primarily due to the DRAGON and DRAGON II trials, as well as the expansion of the R&D team. General and administrative expenses also rose to $1.6 million from $1.2 million, mainly due to increased share-based compensation.

Belite Bio reported a net loss of $7.9 million for Q1 2024, compared to $6.9 million in the same period in 2023. Despite the losses, the company remains committed to advancing its clinical programs and exploring the potential of Tinlarebant to treat degenerative retinal diseases.

In summary, Belite Bio is making significant strides in the development of Tinlarebant for STGD1 and GA. With ongoing trials and substantial financial backing, the company is well-positioned to continue its efforts in addressing these unmet medical needs.