Belite Bio, Inc (BLTE) Earnings

Management highlights

- Regulatory Progress * The FDA has accepted Be Light Bio's New Drug Application (NDA) for Tendaraband for the treatment of Stargardt's disease, granted priority review, and set a PDUFA action date of February 12, 2027. * Regulatory submission to Japan's PMDA is proceeding in parallel with the U.S. NDA review, with an expected approval timeline approximately three months after U.S. FDA approval, leveraging the drug's Sakigake designation. * No label scope discussions with the FDA have occurred yet during the review process. - Clinical Development Updates * Phase III Dragon Study results for Tendaraband were presented at four international medical conferences in Q2 2026, including the American Society of Retinal Specialists (ASRS) annual meeting. * New secondary endpoint data from the Dragon Study showed that Tendaraband-treated patients experienced an approximately 2% decrease in QAF (a marker of toxic retinoid accumulation that drives retinal degeneration) from baseline at month 25, compared to an approximately 20% QAF increase in the placebo group, consistent with Tendaraband's mechanism of action and potential to halt disease progression. * A pediatric investigation plan (PIP) study for Tendaraband in patients aged 3 to 11 has been initiated in London to support regulatory approval for patients younger than 12 years old. * The Dragon 2 trial is currently designated as a Japan-only study for PMDA and will not contribute to the U.S. NDA review process. * An interim analysis for the Tendaraband geographic atrophy (GA) trial is expected to occur in the first quarter of 2027, after the February 2027 PDUFA date, as the company prioritizes FDA interactions for the lead NDA review. * Dosing compliance in the GA trial exceeds 90% after 24 months of treatment. - Financial Position * The company ended Q2 2026 with $780 million in cash, cash equivalents, and U.S. Treasury bills, providing sufficient funding to commercialize Tendaraband after potential approval and advance the company's full pipeline. * The $7.2 million year-over-year increase in GAAP R&D expenses is primarily driven by a milestone-based royalty payment under the company's license agreement tied to completion of the Phase III trial. * The $10.2 million year-over-year increase in GAAP SG&A expenses is primarily driven by higher professional service fees and expanded payroll from team growth to support pre-commercial and late-stage development activities. - Pre-Commercial Preparation * The company is actively engaging with medical and patient communities to prepare for potential commercial launch, with significant stakeholder enthusiasm for a new treatment paradigm for Stargardt's disease. * A virtual commercial day event is scheduled for September 2026, where the company will disclose surveyed patient population data for the U.S.

Guidance

Management did not provide formal revised or updated full-year financial guidance during this call. The company reaffirmed that its current cash balance of $780 million is sufficient to fund operations through Tendaraband commercialization and ongoing pipeline advancement, with no immediate need for additional financing. Key forward-looking timeline guidance provided includes: * PDUFA action date for the U.S. NDA is confirmed as February 12, 2027 * European regulatory filing is expected to occur after U.S. FDA approval, to align regulatory messaging with FDA outcomes * Japanese approval is expected approximately three months after U.S. FDA approval * Interim analysis readout for the geographic atrophy trial is expected in Q1 2027, after the PDUFA date * A virtual commercial day event is scheduled for September 2026 to share patient population and commercial planning details

Segment performance

Be Light Bio is a clinical-stage biopharmaceutical company with one lead product candidate, Tendaraband, in late-stage development. No product segments are currently generating commercial revenue, as the company has not launched any approved products. All operating expenses are categorized into two functional areas: R&D and SG&A. For Q2 2026, GAAP R&D expenses were $18.2 million (100% of operating expense allocation for R&D), compared to $11 million in Q2 2025. Non-GAAP R&D expenses (excluding share-based compensation) were $17.2 million in Q2 2026, compared to $8.6 million in Q2 2025. GAAP SG&A expenses were $16.7 million (100% of operating expense allocation for SG&A), compared to $6.5 million in Q2 2025. Non-GAAP SG&A expenses (excluding share-based compensation) were $10.9 million in Q2 2026, compared to $1.3 million in Q2 2026. GAAP net loss for Q2 2026 was $28.4 million, compared to $16.3 million in Q2 2025; non-GAAP net loss was $21.6 million in Q2 2026, compared to $8.7 million in Q2 2025.

Risks & headwinds

- Forward-looking statements regarding regulatory approval, trial timelines, and commercial launch are subject to inherent uncertainties, and actual outcomes may differ materially from current expectations, as detailed in the company's SEC filings. * There is a risk that the FDA could call for an Advisory Committee (adcom) meeting during the review period, even though the company is not aware of any current plans for an adcom as of the call date. * Final label scope for Tendaraband (including inclusion of patients over 20 years old) has not been confirmed by the FDA, and final labeling may be narrower than the company currently expects. * The milestone royalty payment that increased Q2 2026 R&D expenses is subject to confidentiality terms, so full breakdown of Q2 expenses cannot be publicly disclosed.

Analyst Q&A

• Q: Now that the NDA for Tendaraband is accepted, what role will the Dragon 2 trial play in the U.S. regulatory process, and do you have near-term plans to test Tendaraband in patients younger than 12 years old? /

  A: Management states Dragon 2 is currently a Japan-only trial for the PMDA, and will not contribute to the U.S. NDA review process. For pediatric patients, the company has already initiated a PIP study in London for patients aged 3 to 11, which will generate data to support regulatory approval for patients under 12 years old.

• Q: When will you file for Tendaraband approval in Europe, can you disclose the amount of the one-time royalty milestone payment in Q2 R&D, and will you share U.S. patient population size data from your claims database analysis? /

  A: The royalty payment amount cannot be disclosed due to confidentiality requirements from the licensor. Management prioritizes the U.S. FDA approval process first, so European filing will occur after FDA approval to align regulatory strategy with U.S. outcomes. Patient population size data will be disclosed at the company's virtual commercial day event in September 2026.

• Q: Can you confirm you expect to receive a priority review voucher upon approval, and do you plan to auction the voucher to extend your cash runway? Also, when will the interim readout for the geographic atrophy trial happen? /

  A: The company does expect to qualify for a priority review voucher upon approval due to Tendaraband's rare pediatric disease designation. Management has not yet decided whether to sell or use the voucher internally, and will make a decision after monitoring market conditions and the company's pipeline needs. The GA interim readout is pushed to Q1 2027 after the February 2027 PDUFA date, as the company prioritizes FDA interactions for the lead NDA review.

• Q: Has the FDA confirmed that the approved label will include patients over 20 years old, and when do you plan to submit your application in Japan? /

  A: Label discussions are still pending in the NDA review process, but based on the clinical data showing similar disease progression across all age groups and the same underlying disease cause, management expects a broad label that includes patients over 20. Japanese submission is already occurring in parallel with the U.S. NDA, and approval is expected approximately three months after FDA approval due to the drug's Sakigake designation.