Belite Bio (BLTE) Q3 Earnings call transcript Nov 12, 2024

Belite Bio, a pioneering company in the field of retinal diseases, recently held its Q3 2024 earnings call, showcasing a robust pipeline and a strong commitment to advancing Tinlarebant, its novel oral therapy for Stargardt disease and geographic atrophy. The call was marked by a positive tone, highlighting the potential of Tinlarebant to address significant unmet needs in these indications, which currently lack approved treatments.

New Leadership and Clinical Progress

The call began with the introduction of Dr. Hendrik Scholl, the new Chief Medical Officer, who brings extensive expertise in Stargardt disease and age-related macular degeneration. His appointment underscores Belite Bio's dedication to advancing its clinical programs and driving transformative therapies for patients. The company also reported rapid progress in its clinical trials, with the first patient dosed in the Phase II/III portion of the Phase II/III DRAGON 2 study and the Phase III PHOENIX study for geographic atrophy showing promising enrollment rates.

Clinical Efficacy and Safety

Dr. Scholl provided insight into the Phase II trial data, emphasizing the potential for Tinlarebant to slow lesion growth and stabilize visual acuity loss in patients with Stargardt disease. The safety profile of Tinlarebant was also discussed, with mild and transient adverse events reported, including delayed dark adaptation and xanthopsia, which are anticipated given the mechanism of action.

Financial and Strategic Outlook

Hao-Yuan Chuang, Chief Financial Officer, reported a strong balance sheet, with a $109 million cash reserve, ensuring a 4-year runway to execute key milestones. The company's strategic focus on both Stargardt disease and geographic atrophy, as well as its global Phase III trials, position it well in the competitive landscape.

Investor Questions and Future Outlook

The call concluded with a Q&A session, addressing investor concerns on the potential impact of ocular adverse events on patient uptake, the progress of the Phase III PHOENIX study, and the comparison with other therapeutic approaches. Belite Bio's executives provided reassuring responses, highlighting the convenience of an oral treatment and the potential for better efficacy through the reduction of retinoids across the visual cycle.

Conclusion

Belite Bio's Q3 2024 earnings call presented a compelling case for Tinlarebant, underscoring its potential to address significant unmet needs in Stargardt disease and geographic atrophy. With a robust clinical pipeline, strong leadership, and a clear focus on patient needs, Belite Bio is well-positioned to make significant strides in the treatment of retinal diseases. The company's commitment to advancing its clinical programs and working closely with regulatory authorities bodes well for the future, highlighting a promising outlook for Tinlarebant and Belite Bio as a whole.