Belite Bio, Inc. — FY2023 Form 20-F
Reporting period: Fiscal year ended December 31, 2023; filed March 11, 2024. This is an annual report, not a standalone fourth-quarter report. Financial statements are prepared under U.S. GAAP and reported in U.S. dollars.
Business context
Belite is a clinical-stage biopharmaceutical company with no approved products or product-sales revenue. Its lead candidate, oral once-daily tinlarebant (LBS-008), is in Phase 3 development for adolescent Stargardt disease type 1 (STGD1) and geographic atrophy (GA) associated with dry age-related macular degeneration. LBS-009, a candidate for metabolic diseases including NAFLD/NASH and type 2 diabetes, remains preclinical.
Key financial results and liquidity
| Metric | FY2022 | FY2023 | Change |
|---|---|---|---|
| Revenue | None | None | No product revenue |
| Research and development expense | $8.9 million | $24.8 million | Up 180.1% |
| General and administrative expense | $4.0 million | $6.8 million | Up 72.7% |
| Operating loss | $12.8 million | $31.7 million | Loss increased |
| Net loss | $12.6 million | $31.6 million | Loss increased 150.1% |
| Net cash used in operations | $11.5 million | $29.8 million | Cash use increased |
| Cash at year-end | $42.1 million | $88.2 million | Up $46.1 million |
- FY2023 total comprehensive loss was $31.6 million; accumulated deficit reached $71.5 million. Basic and diluted loss per ordinary share was $1.19, versus $0.63 in FY2022.
- Cash provided by financing activities was $76.0 million in 2023, primarily from the follow-on offering, ATM sales and warrant exercises. The company issued 2.0 million ADSs in the follow-on offering and sold 731,843 ADSs through the ATM during the year.
- At December 31, 2023, total assets were $94.6 million, total liabilities $4.2 million, and shareholders’ equity $90.4 million. Liabilities were principally accrued expenses and operating lease liabilities; the filing reports no debt securities or off-balance-sheet arrangements.
- Current assets were $89.9 million and current liabilities $3.6 million. Cash was primarily held in demand deposits; balances exceeded applicable deposit-insurance limits. The filing notes that $762,000 of ATM proceeds recorded as a receivable at year-end was collected January 2, 2024.
- Management states that year-end cash is sufficient to fund operating activities, capital expenditures and obligations for one year after issuance of the financial statements, while also anticipating substantial additional funding needs as development advances.
Margins are not meaningful because the company had no revenue. FY2023 R&D expense growth chiefly reflected higher CRO and clinical-trial costs as DRAGON enrollment completed and PHOENIX began, alongside increased R&D staffing and share-based compensation. Share-based compensation totaled $3.8 million in 2023, compared with $1.5 million in 2022.
Material changes and development progress
- For STGD1, the global Phase 3 DRAGON trial had completed enrollment of 104 adolescent subjects by the Latest Practicable Date, March 11, 2024. The primary endpoint is change in definitely decreased autofluorescence (DDAF) lesion growth through month 24 versus placebo; a mid-study interim efficacy and safety analysis is planned.
- For GA, Phase 3 PHOENIX began enrolling in July 2023; 56 subjects had been enrolled by March 11, 2024, against a target of approximately 430. The study is planned for two years of treatment, with lesion growth at month 24 as the primary endpoint and a mid-study interim analysis.
- In the open-label Phase 1b/2 STGD1 study, the company reports 24-month data for 12 subjects, including lower DDAF lesion growth versus an external ProgStar cohort (p<0.001) and mean visual-acuity loss of five letters. This was not a randomized, concurrent-controlled comparison and should not be treated as confirmatory Phase 3 evidence.
- Management reports mostly mild, mechanism-consistent adverse events in the small STGD1 study, including delayed dark adaptation and color-vision changes; no deaths or serious or severe adverse events were reported there. Larger, controlled-trial safety and efficacy remain unestablished.
- After year-end, the company reported investing $39.94 million in U.S. Treasury bills with maturities greater than three months and less than one year on January 17, 2024. It also raised approximately $6.0 million net from ATM sales through March 11, 2024.
Outlook, risks and contingencies
- No numerical revenue, earnings or cash-flow guidance is provided. Belite expects expenses and operating losses to rise as it advances Phase 3 trials and may pursue additional indications. It has no committed external financing source and may need further equity, debt, collaboration or licensing funding, with potential dilution or constraints on operations.
- Clinical success and regulatory approval are uncertain; all candidates remain in development. Key risks include trial outcomes, enrollment and retention, safety, regulatory acceptance of multinational data, manufacturing and CRO/CMO performance, competition, and the ability to obtain financing.
- Belite licenses key intellectual property from Columbia University. The agreement includes up to $20 million in development and regulatory milestones, up to $25 million tied to a cumulative-sales milestone, royalties and sublicense-related payments. The company reports compliance with milestones as of March 11, 2024; license termination or loss of exclusivity is a risk if obligations are not met.
- Future clinical-trial contractual costs for STGD1 and GA were estimated at approximately $24.88 million as of the Latest Practicable Date. The company reported no material pending legal proceedings.
- Lin Bioscience International Ltd. beneficially owned approximately 57.46% of shares as of March 11, 2024, giving it substantial influence. Belite also identifies China-related regulatory, data-transfer and geopolitical risks, and foreign-exchange and bank-deposit concentration risks.
- The financial-statement auditor gave an unqualified opinion on the FY2022 and FY2023 statements; the auditor did not attest to internal-control effectiveness because Belite is an emerging growth company. The filing contains inconsistent internal-control disclosures: management says controls were effective and no material weakness was identified, while a risk-factor passage refers to a material weakness involving formal risk-assessment policies and an internal-control framework.
Most important facts for investors to verify
- Current cash, Treasury-bill balances, deposit concentration and actual runway relative to the company’s stated one-year assessment and planned Phase 3 spending.
- DRAGON and PHOENIX enrollment, interim-analysis timing, primary-endpoint results and complete safety data; distinguish uncontrolled Phase 1b/2 comparisons from randomized Phase 3 evidence.
- ATM usage, warrant exercises, outstanding warrants and options, and resulting potential dilution after December 31, 2023.
- The internal-control disclosure inconsistency and any remediation of the stated risk-assessment/control-framework weakness.
- Columbia University license milestones, royalties, contingent payments and any changes to the company’s licensing rights.